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Release – GeoVax Anticipates Significant 2025 Progress with Catalyst-Rich Milestones Across Key Programs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum

Atlanta, GA – February 5, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.

An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine

GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.

GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.

As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.

GEO-MVA: Addressing Biosecurity and Global Health Gaps

GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.

GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.

Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy

GeoVax’s oncology program, centered around Gedeptin®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.

As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.

GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.

Next-Generation Manufacturing: Pioneering Scalable Vaccine Production

To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.

GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.

AI Integration: Optimizing Processes and Driving Innovation

In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:

  • Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
  • Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
  • Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.

Addressing a $55+ Billion Pipeline Market Opportunity

GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program—GEO-CM04S1, GEO-MVA, and Gedeptin—addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.

David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development.  Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”

For further details on GeoVax’s pipeline and strategic initiatives, 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:
info@geovax.com                     austin.murtagh@precisionaq.com sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Release – PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FDA-cleared amended trial design; First site initiation expected Q1 2025

PRINCETON, N.J., Feb. 05, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.

PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

“The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune® HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

“HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com

Release – Lucky Strike Entertainment Reports Second Quarter Results for Fiscal Year 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LUCK

02/05/2025

RICHMOND, Va.–(BUSINESS WIRE)– Lucky Strike Entertainment (NYSE: LUCK), one of the world’s premier operators of location-based entertainment, today provided financial results for the second quarter of the 2025 Fiscal Year, which ended on December 29, 2024.

Quarter Highlights:

  • Revenue decreased 1.8% to $300.1 million from $305.7 million in the previous year
  • Same Store Revenue decreased 6.2% versus the prior year
  • Net income of $28.3 million versus prior year loss of $63.5 million
  • Adjusted EBITDA of $98.8 million versus $103.1 million in the prior year
  • From September 30, 2024 through February 5, 2025, opened four new builds and acquired one bowling location, six family entertainment centers and one water park. Total locations in operation as of February 5, 2025 is 364

“This most recent quarter came with heightened macroeconomic uncertainty. We began the quarter with the corporate events business on hold due to concerns over the election outcome. Compounding this was Thanksgiving falling later in the year, shortening the corporate holiday events window by about a third. And finally, New Year’s Eve fell into our next quarter vs being in the second quarter last year. Our sticky leagues business continued to grow, and retail walk-in customer traffic has been steady despite headlines of the weak consumer,” said Founder, Chairman, and CEO Thomas Shannon. “During this quarter, we opened four new Lucky Strike centers—two in Denver, one in the heart of Beverly Hills, and one in Ladera Ranch, California. Lucky Strike Beverly Hills and Lucky Strike Ladera Ranch each generated over $1 million in revenue within their first 30 days of operation. They represent an evolution of our best-in-class product that underscores our position as leaders in consumer entertainment. We also began the rebranding of centers to Lucky Strike, with four centers converted to date and the rollout ramping up.”

“In the quarter, we acquired Boomer’s which added six family entertainment centers and one stunning water park to our portfolio. Those assets operate at losses during the winter periods and generate significant cash flow during the summer months. We look forward to incremental earnings during our seasonally slow Fourth and First quarters,” said Bobby Lavan, Chief Financial Officer.

Share Repurchase and Capital Return Program Update

From September 30, 2024 through January 31, 2025, the Company repurchased 5.1 million shares of Class A common stock for approximately $56 million. The company has $101 million currently remaining under the share repurchase program.

The Board of Directors declared a quarterly cash dividend of $0.055 per share of common stock for the second quarter of fiscal year 2025. The dividend will be payable on March 7, 2025, to stockholders of record on February 21, 2025.

Fiscal Year 2025 Guidance

The Company reiterated financial guidance for fiscal year 2025. We expect total Revenue to be up mid-single digits to 10%+ year-over-year, which equates to $1.23 billion to $1.28 billion of total Revenue. Adjusted EBITDA margin is expected to be 32% to 34%, which equates to Adjusted EBITDA of $390 million to $430 million.

Investor Webcast Information

Listeners may access an investor webcast hosted by Lucky Strike Entertainment. The webcast and results presentation will be accessible at 10:00 AM ET on February 5, 2025 in the Events & Presentations section of the Lucky Strike Entertainment Investor Relations website at https://ir.luckystrikeent.com/overview/default.aspx.

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.

Forward Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this document. It is not possible to predict or identify all such risks. These risks include, but are not limited to: our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our locations; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health emergencies and pandemics, such as the COVID-19 pandemic, or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 5, 2024, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.

Non-GAAP Financial Measures

To provide investors with information in addition to our results as determined under Generally Accepted Accounting Principles (“GAAP”), we disclose Revenue Excluding Service Fee Revenue, Total Location Revenue, Same Store Revenue and Adjusted EBITDA as “non-GAAP measures”, which management believes provide useful information to investors because each measure assists both investors and management in analyzing and benchmarking the performance and value of our business. Accordingly, management believes that these measurements are useful for comparing general operating performance from period to period, and management relies on these measures for planning and forecasting of future periods. Additionally, these measures allow management to compare our results with those of other companies that have different financing and capital structures. These measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for revenue, net income, or any other operating performance or liquidity measure calculated in accordance with GAAP, and may not be comparable to a similarly titled measure reported by other companies. Our fiscal year 2025 guidance measures (other than revenue) are provided on a non-GAAP basis without a reconciliation to the most directly comparable GAAP measure because the Company is unable to predict with a reasonable degree of certainty certain items contained in the GAAP measures without unreasonable efforts. For the same reasons, the Company is unable to address the probable significance of the unavailable information. Such items include, but are not limited to, acquisition related expenses, share-based compensation and other items not reflective of the company’s ongoing operations.

Revenue Excluding Service Fee Revenue represents total Revenue less Service Fee Revenue. Total Location Revenue represents total Revenue less Non-Location Related Revenue, Revenue from Closed Locations, and Service Fee Revenue, if applicable. Same Store Revenue represents total Revenue less Non-Location Related Revenue, Revenue from Closed Locations, Service Fee Revenue, if applicable, and Acquired Revenue. Adjusted EBITDA represents Net Income (Loss) before Interest Expense, Income Taxes, Depreciation and Amortization, Impairment and Other Charges, Share-based Compensation, EBITDA from Closed Locations, Foreign Currency Exchange Loss (Gain), Asset Disposition Loss (Gain), Transactional and other advisory costs, changes in the value of earnouts, and other.

The Company considers Revenue Excluding Service Fee Revenue as an important financial measure because it provides a financial measure of revenue directly associated with consumer discretionary spending and Total Location Revenue as an important financial measure because it provides a financial measure of revenue directly associated with location operations. The Company also considers Same Store Revenue as an important financial measure because it provides comparable revenue for locations open for the entire duration of both the current and comparable measurement periods.

The Company considers Adjusted EBITDA as an important financial measure because it provides a financial measure of the quality of the Company’s earnings. Other companies may calculate Adjusted EBITDA differently than we do, which might limit its usefulness as a comparative measure. Adjusted EBITDA is used by management in addition to and in conjunction with the results presented in accordance with GAAP. We have presented Adjusted EBITDA solely as a supplemental disclosure because we believe it allows for a more complete analysis of results of operations and assists investors and analysts in comparing our operating performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:

  • do not reflect every expenditure, future requirements for capital expenditures or contractual commitments;
  • do not reflect changes in our working capital needs;
  • do not reflect the interest expense, or the amounts necessary to service interest or principal payments, on our outstanding debt;
  • do not reflect income tax (benefit) expense, and because the payment of taxes is part of our operations, tax expense is a necessary element of our costs and ability to operate;
  • do not reflect non-cash equity compensation, which will remain a key element of our overall equity based compensation package; and
  • do not reflect the impact of earnings or charges resulting from matters we consider not to be indicative of our ongoing operations.


Lucky Strike Entertainment Corporation Investor Relations
IR@LSEnt.com

Source: Lucky Strike Entertainment Corporation

MAIA Biotechnology (MAIA) – THIO-101 Interim Update Shows Increasing Survival

Posted on by cpereira@noblefcm.com


Wednesday, February 05, 2025

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

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

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

MAIA Provides Phase 2 Interim Data Update In NSCLC. The Phase 2 THIO-101 trial is testing the combination of THIO with cemiplimab (Libtayo), a PD-1 checkpoint inhibitor from Regeneron, in patients with advanced non-small lung cancer (NSCLC). Median overall survival was 16.9 months, compared with expected survival of 5.8 months. Importantly, the lower limit of the statistical confidence intervals for the trial shows a 99% chance of surviving 10.8 months, a statistically significant result.

Combination Uses Two Mechanisms Of Action. The THIO-101 trial combines the killing effects from THIO with the PD-1 inhibition from cemiplimab. THIO uses its telomere targeting to damage cancer cell DNA, causing cell death. This also stimulates an immune response in the tumor through the cGAS/STING pathway and T-cell responses. Cemiplimab provides a second mechanism, allowing the immune cells to recognize and kill the cancer cells.


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

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

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

The ODP Corporation (ODP) – Participation in Another New Award

Posted on by cpereira@noblefcm.com


Wednesday, February 05, 2025

Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.

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

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New Award. Another in a string of new business, ODP Corporation announced its Business Solutions segment is participating in a new award for a multi-year furniture contract with Region 4 Education Service Center (ESC) that brings the potential of up to $500 million in total annual revenue. After a challenging 2024 for Business Solutions, the new year has started positively with the recent contract awards that have the potential to drive top line growth for the segment.

Details. The new contract enables the ODP Business Solutions Workspace Interiors team to offer compliant cooperative purchasing solutions through OMNIA Partners, providing furniture, installation, and related services to K-12 schools, higher education institutions, and cities and counties across the U.S. The new contract grants OMNIA Partners members access to a comprehensive range of products.


Get the Full Report

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

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

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

Alliance Resource Partners (ARLP) – Lowering Expectations for 2025; Growth Outlook Remains Favorable

Posted on by cpereira@noblefcm.com


Wednesday, February 05, 2025

ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.

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

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

Full year and fourth quarter 2024 financial results. On a full year basis, Alliance generated 2024 adjusted EBITDA of $714.2 million and earnings per unit (EPU) of $2.77, respectively, compared to $933.1 million and $4.81 in 2023. Fourth quarter adjusted EBITDA was $124.0 million, and EPU amounted to $0.12, respectively, compared to $185.4 million and $0.88 during the prior year period. Fourth quarter and full year results were impacted by lower coal volumes, operational challenges within ARLP’s coal operations in Appalachia, and a $30.1 million non-cash asset impairment charge which had a negative impact of ~$0.24 per unit.

Management guidance for 2025. Coal sales are expected to be in the range of 32.25 million to 34.25 million tons, while the sales price of coal per ton is expected to be in the range of $57.00 to $61.00. Segmented adjusted EBITDA expense per ton sold is expected to be $40.00 to $44.00. The company has committed and priced 26.0 million tons of its 2025 sales volume, including 23.5 million for the domestic market and 2.5 million tons for the export market.


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

Teladoc Health to Acquire Catapult Health, Expanding Preventive and At-Home Care Offerings

Posted on by cpatches
Key Points:
– Teladoc Health is acquiring Catapult Health for $65 million to enhance its preventive care and at-home diagnostic testing capabilities, further strengthening its integrated healthcare solutions.
– Catapult Health’s VirtualCheckup program will enable Teladoc to expand its chronic condition management services and seamlessly connect high-risk patients to virtual care programs.
– This acquisition comes as Teladoc seeks to regain momentum following its 2020 Livongo acquisition, which initially valued the combined company at $37 billion but has since declined to a market cap under $2 billion.

Teladoc Health has announced a definitive agreement to acquire Catapult Health, a move aimed at strengthening its preventive care and chronic condition management capabilities while expanding its at-home diagnostic testing offerings. This acquisition aligns with Teladoc’s strategy to enhance virtual care accessibility and effectiveness for its over 93 million members.

Catapult Health is recognized for its innovative approach to at-home wellness and diagnostic testing, which integrates virtual clinical support and high-touch patient engagement. Teladoc plans to leverage these capabilities to further enrich its industry-leading suite of integrated healthcare solutions.

“This acquisition will help advance our strategy in meaningful ways — from giving more members access to convenient and impactful wellness and preventive care, to unlocking greater value for our customers,” said Chuck Divita, Chief Executive Officer of Teladoc Health. “Catapult Health brings an experienced team and a strong culture of innovation, and we are thrilled to welcome them to Teladoc Health.”

Strategic Objectives and Synergies

Teladoc Health’s integrated care strategy is built on four key pillars:

  • Expanding Membership and Service Utilization – Enhancing the accessibility and engagement of healthcare services for existing and new members.
  • Leveraging Clinical Expertise and Product Breadth – Strengthening healthcare outcomes by integrating a broader range of clinical solutions.
  • Growing International Presence – Extending Teladoc’s reach beyond domestic markets to serve a global population.
  • Advancing Mental Health Solutions – Building upon its existing leadership in virtual mental health services.

Catapult Health’s flagship VirtualCheckup program exemplifies its innovation in preventive care. The at-home wellness exam provides members with a simple diagnostic kit, allowing them to collect blood samples, measure blood pressure, and submit other key health data. Following this, a virtual consultation with a licensed healthcare professional ensures timely assessment and guidance.

For members identified with high-risk factors or chronic conditions, Catapult’s clinicians can seamlessly enroll them into Teladoc’s condition management programs, including diabetes, hypertension, pre-diabetes, and weight management. Additionally, members can be referred to Teladoc’s virtual mental health specialists and primary care providers for continued support.

Transaction Details

The acquisition is structured as an all-cash transaction valued at $65 million, with up to $5 million in contingent earnout consideration. Catapult Health reported $30 million in trailing 12-month revenue as of Q3 2024. Upon closing, Catapult will be integrated into Teladoc’s Integrated Care segment. The deal is expected to close in Q1 2025.

Impact and Market Expansion

Catapult Health currently serves over 3 million people through its partnerships with hundreds of employer clients. The company is recognized for its strong customer satisfaction, clinical outcomes, and cost-saving benefits, including an estimated $1,400 average savings per participant over a three-year period due to early disease detection and health risk identification.

Teladoc’s Market Challenges and Context

This acquisition comes after a tumultuous period for Teladoc. Following its acquisition of Livongo in 2020, the combined companies had an enterprise value of $37 billion. However, Teladoc’s stock has struggled since then, with a current market capitalization just under $2 billion. The acquisition of Catapult Health represents a strategic effort to regain momentum and strengthen its position in the evolving telehealth market.

U.S. Trade Deficit Hits Second-Highest Annual Total in 2024; December Deficit Sets Record

Posted on by cpatches
Key Points:
– The U.S. trade deficit reached $918.4 billion in 2024, marking the second-largest annual total, while December’s deficit set a record at $98.4 billion.
– Strong consumer demand, a robust U.S. dollar, and rising imports—particularly in industrial supplies and consumer goods—outpaced export growth, widening the trade gap.
– Escalating trade tensions, including newly imposed and proposed tariffs on Mexico, Canada, and China, could further disrupt trade flows and market stability in 2025.

The U.S. trade deficit surged to $918.4 billion in 2024, marking the second-highest annual total in history. This 17% increase from 2023 was driven primarily by a sharp rise in imports, which climbed 6.6% to $4.11 trillion, outpacing export growth of 3.9% to $3.19 trillion.

According to the U.S. Census Bureau and the Bureau of Economic Analysis, December’s trade deficit reached a record-high $98.4 billion, up $19.5 billion from November. Monthly exports dropped to $266.5 billion, while imports surged to $364.9 billion.

Key Trends in 2024 Trade Data

  • Record Merchandise Trade: The U.S. set all-time highs for total merchandise trade, imports, and the December monthly trade deficit.
  • Regional Trade Concentration: Nearly 41% of total U.S. trade involved Mexico, Canada, and China.
  • Strong Consumer Demand: Americans continued spending on imported goods such as weight-loss drugs, auto parts, computers, and food, supported by a strong U.S. dollar that made foreign products more affordable.
  • Declining Vehicle Exports: U.S. auto-related exports fell by $10.8 billion, largely due to intensified competition from China’s expanding auto industry.
  • Growth in Services Sector: Foreign spending on U.S. travel, business, and financial services helped boost service sector exports, which reached $1.107 trillion, up $81.2 billion from 2023.

Policy and Market Impact

Trade flows could face further disruption in 2025 as President Trump escalates trade tensions. This week, the administration imposed—then temporarily paused—25% tariffs on imports from Mexico and Canada. Trump has also proposed an additional 10% tariff on all Chinese imports, building on existing 25% duties from his first term. In response, China announced $20 billion in retaliatory tariffs and new export restrictions on critical minerals.

The U.S. posted its largest bilateral trade deficit with China at $295.4 billion, while also running record deficits with Mexico, Vietnam, India, Taiwan, South Korea, and the European Union. Meanwhile, Trump has made reducing the trade deficit “to zero” a primary policy objective and is considering imposing tariffs on the EU and UK.

Economic Context

A strong U.S. economy and a robust dollar fueled demand for imports, even as American exports faced headwinds in global markets. The U.S. trade deficit as a share of GDP rose to 3.1% in 2024, up from 2.8% in 2023. Many essential goods, such as consumer products and apparel, are no longer produced domestically, further reinforcing America’s reliance on imports.

As businesses rushed to import goods ahead of potential tariff hikes, the trade deficit soared in December, setting a record for the highest monthly deficit and contributing to the second-largest annual trade gap in U.S. history. With ongoing trade disputes and policy shifts, global trade flows could remain volatile in the months ahead.

Release – ODP Business Solutions Joins New, Multi-Year, Multi-Award $500M Annual Furniture Partnership with Region 4 Education Service Center

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on ODP

New Contract unlocks potential growth opportunities and provides discounts on quality furniture and furnishing solutions from hundreds of manufacturers through purchasing cooperative

BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 4, 2025– ODP Business Solutions, a leading supplier of workplace solutions and services and a division of The ODP Corporation (NASDAQ: ODP), announced participation in a new award for a multi-year furniture contract with Region 4 Education Service Center (ESC) that brings the potential of up to $500M in total annual revenue. The contract enables the ODP Business Solutions Workspace Interiors team to offer a compliant cooperative purchasing solution through OMNIA Partners, providing furniture, installation, and related services to K-12 schools, higher education institutions, and cities and counties across the United States.

Region 4 ESC, member of and lead agency for OMNIA Partners, serves as a premier purchasing organization for state and local government, K-12 education, colleges and universities. Region 4 ESC assists school districts in improving student performance, provides efficient fiscal management and builds collaborative relationships and partnerships.

“At ODP Business Solutions we understand that the right learning and working environment can boost productivity and inspire students, educators and administrators,” said David Centrella, executive vice president of The ODP Corporation and president of ODP Business Solutions. “Our Workspace Interiors team is dedicated to delivering innovative and flexible solutions that meet the evolving needs of modern spaces. We look forward to providing these cost-effective products and services through our continued partnership with Region 4 ESC.”

The new contract grants OMNIA Partners members access to a comprehensive range of products designed for diverse environments, including breakrooms, classrooms, administrative offices, libraries, cafeterias, lobbies and more. This competitively solicited, publicly awarded Region 4 cooperative contract ensures compliance with procurement standards, allowing public sector agencies to streamline their purchasing process and save money with discounted offerings.

“Part of our mission is to equip school districts with the services and products they need to operate more efficiently and economically,” said Jorgannie Carter, chief of finance and business services at Region 4 Education Service Center. “Our contract with ODP Business Solutions will allow us to optimize our resources and continue providing schools and professionals with high-quality, affordable products.”

Region 4 serves a seven-county area composed of 48 public school districts and 43 public charter schools, representing more than 1.2 million students and more than 111,000 professional educators.

In recent years, ODP Business Solutions has been awarded five contracts, showing the company’s commitment to supporting public sector organizations with innovative, tailored and cost-effective solutions. To learn more about ODP Business Solutions, visit www.odpbusiness.com.

About ODP Business Solutions:

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

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

FORWARD LOOKING STATEMENTS – THE ODP CORPORATION

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements or disclosures may discuss goals, intentions and expectations as to future trends, plans, events, results of operations, cash flow or financial condition, or state other information relating to, among other things, The ODP Corporation (“the Company”), based on current beliefs and assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “expectations”, “outlook,” “intend,” “may,” “possible,” “potential,” “predict,” “project,” “propose” “aim” or other similar words, phrases or expressions, or other variations of such words. These forward-looking statements are subject to various risks and uncertainties, many of which are outside of the Company’s control. There can be no assurances that the Company will realize these expectations or that these beliefs will prove correct, and therefore investors and stakeholders should not place undue reliance on such statements. Investors and shareholders should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to update or revise any forward-looking statements.

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

Source: ODP Business Solutions

Release – LODE: Comstock Fuels Approved for $152 Million Allocation for Oklahoma Qualified Private Activity Bonds

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

OKLAHOMA CITY, OKLAHOMA – FEBRUARY 4, 2025 – Comstock Inc. (NYSE: LODE) today announced that its subsidiary, Comstock Fuels Corporation (“Comstock Fuels”), was approved by the Oklahoma State Treasurer’s Office to issue up to $152 million in qualified private activity bonds.

This allocation of up to $152 million in Qualified Private Activity Bonds that can be issued by Comstock Fuels represents a major achievement in Comstock Fuels’ plans for financing and building its first 400,000 barrel per year commercial demonstration facility in a soon-to-be-selected site in Oklahoma.

This overall approval by the Oklahoma State Treasurer’s Office comes under the Oklahoma Private Activity Bond Allocation Act and would consist of allocations from the Oklahoma Economic Development Pool, the Oklahoma Exempt Facilities Pool, and the Oklahoma Carryforward Pool. The Oklahoma Development Finance Authority (“ODFA”) sponsored this bond allocation to support the State’s essential infrastructure projects with Comstock’s first Oklahoma commercial biorefining facility.

“This allocation is a foundational component of our overall capital and financing plans for Comstock Fuels, including funding each of our planned Bioleum™ Refineries in the U.S. with dedicated project financing,” said Chad Michael Black, Director of Business Development at Comstock Fuels. “Oklahoma has taken a leadership role in accelerating advanced domestic energy solutions and the support from the State Treasurer’s Office and the ODFA underscores our strong alignment with Oklahoma for developing, deploying and operating diverse, scalable and essential energy infrastructure for our communities.”

“We are rapidly achieving the critical prerequisites for securing the project financing needed to build our first commercial demonstration facility, with over $150 million of that objective supported by Oklahoma’s tax-efficient, municipal revenue bond allocation, $3 million in direct Oklahoma-based grants, and a growing group of strategic investors,” stated Corrado De Gasperis, Executive Chairman of Comstock and Comstock Fuels. “We’re also close to selecting an investment banking partner to facilitate the bond placement and underwriting. We’re thrilled to receive such strong support from Oklahoma as we integrate feedstock, site infrastructure, and offtake into a whole new standard for domestic energy production.”

Private activity bonds under the Internal Revenue Code (the “Code”) are described generally as any bond: (1) of which more than 10% of the proceeds is to be used in a trade or business of any person or persons other than a governmental unit or which is to be directly or indirectly repaid, or secured by revenues from a private trade or business; and (2) in which an amount exceeding the lesser of 5% or $5 million of the proceeds is to be used for loans to any person or persons other than a governmental unit.

The Federal Tax Reform Act of 1986 established limits on the volume of private activity bonds that may be issued in a state during any calendar year. To ensure compliance with federal law, the Oklahoma legislature passed the Oklahoma Private Activity Bond Allocation Act.

Most private activity bonds must be sold on a taxable basis. However, the Code grants exceptions when certain bonds can be sold on a tax-exempt basis (“Qualified Private Activity Bonds”). Such bonds, with certain exceptions, are subject to the federal alternative minimum tax. The Code also imposes a limitation on the amount of Qualified Private Activity Bonds which may be issued by a state in any calendar year.

About Comstock Fuels Corporation

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

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

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

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

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

For media inquiries or questions:
Colby Korsun
Comstock Fuels Corporation
fuels@comstockinc.com

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Job Openings Decline Sharply in December, Falling Below Forecast

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Job openings dropped to 7.6 million in December, the lowest level since September and below the estimated 8 million.
– The decline in openings came despite a net gain of 256,000 nonfarm payroll jobs for the month.
– The Federal Reserve monitors job openings as a key indicator of labor market conditions.

The U.S. labor market saw a significant drop in available positions in December, with job openings falling to 7.6 million, according to the Bureau of Labor Statistics’ latest Job Openings and Labor Turnover Survey (JOLTS). This figure came in below the Dow Jones estimate of 8 million and marked the lowest level since September.

The decline in openings signals a potential softening in labor demand, even as the broader economy continues to add jobs. Nonfarm payrolls increased by 256,000 during the month, but the number of available positions fell by 556,000. As a share of the labor force, openings declined to 4.5%, marking a 0.4 percentage point drop from November.

Several industries saw notable declines in job openings, with professional and business services losing 225,000 positions. Private education and health services recorded a drop of 194,000, while the financial activities sector saw a decrease of 166,000. These losses indicate that some industries may be reassessing hiring plans in response to economic conditions and policy uncertainty.

Despite the drop in job openings, other labor market indicators remained stable. Layoffs for December totaled 1.77 million, down slightly by 29,000. Hiring edged up to 5.46 million, and voluntary quits—a measure of worker confidence—saw a small increase to nearly 3.2 million. Total separations, which include layoffs, quits, and other exits, remained largely unchanged at 5.27 million.

Following the report’s release, major stock market indexes posted gains, while Treasury yields saw mixed movement. Investors appeared to view the data as a sign that the labor market remains resilient, even as job openings decline. A more balanced labor market could provide support for Federal Reserve policymakers considering the timing of future interest rate changes.

The JOLTS report arrives just days ahead of the Bureau of Labor Statistics’ nonfarm payrolls report for January, which is expected to show an addition of 169,000 jobs, with the unemployment rate holding at 4.1%. Federal Reserve officials have been closely watching labor market trends as they assess monetary policy.

Last week, the central bank opted to keep its benchmark interest rate steady at 4.25% to 4.50%. While investors have been hoping for rate cuts, Fed officials have signaled caution, noting that they need more evidence of sustained economic conditions before making policy adjustments. Markets currently anticipate the first rate cut no sooner than June.

Overall, the decline in job openings could be an early sign of a cooling labor market, but steady hiring and stable unemployment suggest the economy is still holding up. The coming months will be crucial in determining whether this trend continues and how it may influence the Fed’s next moves on interest

Release – MAIA Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 04, 2025 8:51am EST Download as PDF

  • Median overall survival (OS) from THIO treatment extends to 16.9 months
  • Newest data strengthens regulatory strategy

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population1. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.2

“Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin,” said Vlad Vitoc, M.D., CEO of MAIA. “THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in third-line treatment where the cancer is typically even more resistant to therapy. Our findings suggest great benefits to patients with unmet medical needs who see little hope for the future.

“With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,” Dr. Vitoc concluded.

Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.

About THIO

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

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

 __________________________
1 Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549.

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

Source: MAIA Biotechnology, Inc.

Released February 4, 2025

Release – Century Lithium Provides Update on Angel Island and Lithium Extraction Facility

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

February 4, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to provide an update on its wholly owned Angel Island project near Silver Peak, Nevada, USA and associated Lithium Extraction Facility (“Pilot Plant”) in Amargosa Valley Nevada. The Company has completed the successful implementation of process improvements at its Pilot Plant. These changes were developed in collaboration with Amalgamated Research, LLC (“ARi”) of Twin Falls, Idaho, a research and development company specializing in industrial implementation of process technologies. Century Lithium is now shifting the focus at its Pilot Plant from research and development to demonstration.

“The initial results from ARi are very encouraging, indicating greater efficiency can be achieved that could result in positive reductions in the estimated capital and operating costs at Angel Island,” said Century Lithium President and CEO, Bill Willoughby. “Century Lithium remains committed to delivering value to our shareholders through Angel Island, one of the few advanced lithium projects in the United States. We are optimistic about the long-term fundamentals of the lithium market and the strategic importance of Angel Island to the future mineral supply in the United States.”

Project Update

The processing testing program (“Program”) implemented ARi’s proprietary adsorption-based technology for Direct Lithium Extraction (“DLE”) and was accomplished in conjunction with ARi’s Twin Falls testing facilities and Century Lithium’s Pilot Plant. The results of the Program are positive and further validate the efficiency of Century Lithium’s extraction technology. The Program augmented Century Lithium’s DLE system with the addition of ARi equipment and expertise. Early results indicate Century Lithium can eliminate the recycle loops within its DLE and lithium carbonate areas, while increasing eluate grades. The Company believes this will result in a substantial reduction in estimated capital and operating costs at Angel Island.

The decision to shift the focus at the Pilot Plant to demonstration mode is two-fold; it will allow the Company to focus on providing dedicated testing to prospective strategic partners or potential end-users and reduce the ongoing operating costs of the Pilot Plant. Current Pilot Plant operations will continue to convert a backlog of lithium solutions, which were made prior to the commissioning of the on-site lithium carbonate process at the Pilot Plant, into battery-grade lithium carbonate.

Moving Forward

The Company recently announced a non-binding Memorandum of Understanding (“MOU”) with Orica Specialty Mining Chemicals (see news release). The non-binding MOU outlines the intent of Century Lithium and Orica to formalize a multiyear offtake agreement for Orica to purchase sodium hydroxide from Angel Island. The favorable outlook for the sodium hydroxide by-product contributes significantly to Century Lithium’s low-cost lithium carbonate production model.

Ongoing engineering is focused on mining, and the leaching, filtration, DLE, and lithium carbonate processing areas. The Company continues to compile all data generated at the Pilot Plant. The data will be used in engineering models and to run analytical tests on full-scale construction designs focused on further reducing the estimated capital and operating costs for producing lithium carbonate at Angel Island.

Century Lithium remains focused on seeking strategic partnerships with potential end-users and market participants interested in securing a domestic supply of battery-grade lithium carbonate. The Company continues to move forward with permitting work to ensure that our future operations at Angel Island will align with both regulatory requirements and Century Lithium’s environmental and social stewardship goals.

Qualified Person

Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.

ABOUT Ari

Amalgamated Research LLC (ARi) is a supplier of chromatography, adsorption, and ion exchange technology and equipment specialized in commercializing innovative technology at large industrial scale. ARi has developed a cost-effective and streamlined solution for adsorption-based direct lithium extraction that maximizes plant profitability while minimizing upfront capital cost. ARi’s patented fluid distribution and mixing technology de-risks scale-up allowing separation processes to be reliably scaled from pilot plant data up to industrial vessels exceeding 20-ft in diameter, with no degradation in equipment performance. ARi provides a full spectrum of customer support services, from proof of concept through to industrial-scale installation. Comprehensive analytical services and a wide range of pilot equipment are available on-site to support process development and scale-up. Please visit arifractal.net for more information.

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
scacos@centurylithium.com
centurylithium.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.