ATLANTA, March 04, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, will hold a conference call and live audio webcast on Tuesday, March 18th at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) to discuss its financial results for the fourth quarter and full year ended December 31, 2024. Bitcoin Depot plans to release results before the market open on the same day.
Call Date: Tuesday, March 18, 2025 Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time)
Phone Instructions U.S. and Canada (toll-free): 888-596-4144 U.S. (toll): 646-968-2525 Conference ID: 8224936
A replay of the call will be available beginning after 2:00 p.m. Eastern time through March 25, 2025.
U.S. & Canada (toll-free) replay number: 800-770-2030 U.S. toll number: 609-800-9909 Conference ID: 8224936
If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.
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 over 8,400 kiosk locations as of February 25, 2025. Learn more at www.bitcoindepot.com.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized Phase 3 studies
FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia
If approved by FDA, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., March 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria. A copy of the Company’s presentation, titled “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.
“Since fibromyalgia is a chronic pain condition, medicines to treat fibromyalgia need to provide durable benefits,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “A randomized controlled study showed that oral, swallowed cyclobenzaprine fails to provide any durable (>1 month) benefit1. In contrast, TNX-102 SL has shown statistically significant, durable activity (3 months) in reducing fibromyalgia pain in two Phase 3 studies. The U.S. Food and Drugs Administration (FDA) has set a PDUFA goal date of August 15, 2025 for a decision on marketing authorization. TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
Dr. Lederman continued, “TNX-102 SL is designed as a bedtime treatment to target non-restorative sleep, which in turn has shown to result in reduced pain. By providing transmucosal delivery of the tertiary amine tricyclic, TNX-102 SL results in reduced formation of the persistent active metabolite, norcyclobenzaprine (norCBP) relative to oral delivery. NorCBP accumulates after oral delivery and its potent inhibition of the norepinephrine transporter may relate to why oral cyclobenzaprine has transient (one month) activity in fibromyalgia, but not durable (three months) activity in reducing fibromyalgia pain1. Fibromyalgia, has historically been overlooked. Patients’ needs have been inadequately addressed by the three approved products, which results in many patients being prescribed chronic opioids, that are believed to be ineffective, and an actually deleterious, treatment strategy.”
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep. TNX-102 SL is designed for rapid, transmucosal absorption and, as demonstrated in pharmacokinetic studies, bypasses first-pass hepatic metabolism resulting in greater bioavailability of cyclobenzaprine that aligns with the sleep cycle to target non-restorative sleep. The sublingual formulation also results in substantially reduced creation of the active metabolite norCyclobenzaprine (norCBP) due to the bypass of first-pass hepatic metabolism. In two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia, TNX-102 SL 5.6 mg met the pre-specified primary endpoints of significantly reducing daily pain compared to placebo after 14 weeks of treatment. In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed.
About Fibromyalgia Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) 2-4. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.
About TNX-102 SL TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
1Carette S, et al. Arthritis Rheum. 1994, 37(1):32-40. doi: 10.1002/art.1780370106 2Fitzcharles MA, et al. Lancet. 2021;397:2098-110 3Clauw DJ. Ann Rheum Dis. Published Online First: 2024 4Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia, now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC). TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today announced that the Company closed and received the proceeds from the $350 million strategic investment on February 28, 2025. The Company originally announced a binding agreement on the transaction with funds managed by Bain Capital, Morgan Stanley Private Credit, and Newlight Partners on February 10th.
The Company used $260 million of proceeds to pay down its outstanding term loan. The Company now has more than $100 million of available liquidity as it continues to focus on its industry-leading insurance distribution businesses and rapidly expanding healthcare services business.
With the completion of this transaction, SelectQuote also appointed Chris Wolfe of Bain Capital Insurance and Srdjan Vukovic of Newlight Partners to the Board of Directors, each bringing over 20 years of investing and healthcare sector experience to the Company.
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
GROSSE POINTE FARMS, Mich., March 03, 2025 (GLOBE NEWSWIRE) — Saga Communications, Inc. (Nasdaq: SGA) announced today that it will release its 4th Quarter and Year End 2024 results at 9:00 a.m. EST on Tuesday, March 11, 2025. The company will be holding a conference call on the same date at 11:00 a.m. EST. The dial-in numbers are as follows:
Domestic and International Dial-in Number: (973) 528-0008 Conference Entry Code: 424193
In addition to the Company releasing its 4th Quarter and Year End earnings the Company will discuss:
The Company’s execution of its ongoing digital strategy.
The Company’s ongoing efforts to evaluate non-core asset sales and the use of such proceeds for buybacks, dividends and other corporate purposes.
The Company’s plans to refresh the board.
The Company’s continuing evaluation of market and corporate level expenses to be in line with the Company’s operating verticals.
The Company requests that all parties that have a question that they would like to submit to the Company to please email the inquiry by 10:00 a.m. EST on March 11, 2025, to SagaIR@sagacom.com. The Company will discuss, during the limited period of the conference call, those inquiries it deems of general relevance and interest. Only inquiries made in compliance with the foregoing will be discussed during the call.
Saga’s earnings release will contain certain non-GAAP financial measures including station operating income, trailing 12-month consolidated EBITDA, and same station financial information. A reconciliation of all non-GAAP financial measures to the most directly comparable GAAP measures will be provided in the earnings release.
Saga is a media company whose business is devoted to acquiring, developing, and operating broadcast properties with a growing focus on opportunities complimentary to our core radio business including digital, e-commerce and non-traditional revenue initiatives. Saga owns or operates broadcast properties in 28 markets, including 82 FM and 31 AM radio stations and 79 metro signals. For additional information, contact us at (313) 886-7070 or visit our website at www.sagacom.com.
Mr. Long’s Proven Track Record in Driving E-Commerce Growth and Innovation Includes Leadership Roles at Walmart, Ashley Furniture, and Amazon
Mr. Long will Collaborate with the Existing E-commerce Management Team and Founders to Expand SKYX ‘s Sales and Market Penetration of Its Disruptive Advance and Smart Home Plug & Play Technologies in the U.S. and Canadian Markets
MIAMI, March 03, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive advanced and smart home platform technology company for homes and buildings, with more than 97 issued and pending patents globally and a portfolio of over 60 lighting and home décor websites, announces today that Huey Long, former Director of Amazon E-Commerce, Senior Vice President of Walmart, and Executive Vice President at Ashley Furniture, has joined SKYX to lead its e-commerce platform.
Mr. Long will work together with the existing e-commerce management team and founders to drive innovation and expand sales and market penetration of SKYX’s advanced and smart home plug & play technologies across the U.S. and Canadian markets.
Long is renowned for his strategic vision and operational excellence across advanced business ecosystems. With over 28 years of experience in e-commerce, omnichannel retail, and global sourcing, he brings a wealth of expertise and leadership to SKYX. His career includes pivotal roles at industry-leading companies, including as Director at Amazon.com, where he spearheaded the development of Amazon Basics, the company’s first private brand initiative. Additionally, he has served as Senior Vice President at Walmart Stores Inc., General Merchandise Manager at Sam’s Club, and Executive Vice President at Ashley Furniture.
Commenting on his appointment, Huey Long said, “I am honored to join SKYX and work with its e-commerce management team and founders at such an exciting time. The company’s commitment to innovation with its game-changing plug & play technologies aligns perfectly with my passion for driving value through innovation, strategic transformation, and operational excellence. I look forward to driving growth and further expanding the market penetration of SKYX’s technologies in the U.S. and Canadian markets. SKYX’s disruptive and smart platform technologies present a unique opportunity for recurring revenues.”
Rani Kohen, Founder/Inventor and Executive Chairman, of SKYX Platforms, said, “Huey’s extensive experience in e-commerce and omnichannel retail makes him uniquely positioned to drive the next phase of growth of our advanced and smart home plug & play platform technologies. We are excited to have Huey on board and look forward to his leadership as we continue to grow our market penetration.”
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
ATLANTA, GA – March 3, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, underscores the strategic importance of its Modified Vaccinia Ankara (MVA) vaccine platform in helping to bolster U.S. biodefense capabilities. Efforts in MVA vaccine design and manufacturing improvements align with key recommendations from the recent “Bolstering U.S. Biodefense: Recommendations For The New Administration” report, published by the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks, a respected think tank specializing in national security and biodefense policy. The report emphasizes the need for robust, diversified medical countermeasures to protect national and global security.
Addressing Biodefense Gaps with MVA-Based Solutions
The “Bolstering U.S. Biodefense” report highlights the urgency of strengthening U.S. preparedness against biological threats, including deliberate attacks, emerging infectious diseases, and supply chain vulnerabilities. GeoVax’s efforts towards the development of MVA-based vaccines, including GEO-MVA for vaccination against Mpox and smallpox, and efforts to transition to a next-generation manufacturing platform utilizing a continuous avian cell line, directly align with these national security objectives:
Vaccine Supply Chain Resilience: Current reliance on a single non-U.S. manufacturer for critical vaccines, such as MVA, poses a national security risk. GeoVax’s efforts to transition to a next generation manufacturing platform should allow for the use of existing domestic manufacturing facilities, leading to a reduced dependence on foreign suppliers and enhancing supply chain security.
Advanced Biomanufacturing for Scalability: The biodefense report calls for investment in next-generation biomanufacturing. GeoVax is developing a continuous cell line-based MVA manufacturing platform that it expects will result in rapid, high-volume vaccine production, which is currently not feasible utilizing existing MVA directed manufacturing platforms
Diverse Medical Countermeasures for Threat Readiness: The Department of Defense’s Biodefense Posture Review and National Biodefense Strategy emphasize the need for multiple vaccine approaches. GeoVax’s MVA platform complements mRNA and protein-based vaccines, ensuring a broader and more resilient national preparedness framework.
Strategic National Stockpile Shortfalls: The 2022 Mpox epidemic revealed significant vaccine shortages in the National Strategic Stockpile, leaving public health officials unable to meet urgent demand. The reliance on a single foreign supplier for any vaccine can further exacerbate these challenges, reinforcing the need for a diversified, U.S.-based vaccine supply.
Relevance to the New HHS Administration
The transition of leadership at the U.S. Department of Health and Human Services (HHS) presents a pivotal moment for vaccine policy and national preparedness. The Administration has emphasized transparency, safety, and domestic vaccine manufacturing, aligning closely with GeoVax’s mission.
Alignment with National Health Security Goals: GeoVax’s focus on U.S.-based vaccine production supports HHS’s priority of reducing dependency on foreign pharmaceutical supply chains, ensuring America’s self-sufficiency in pandemic preparedness.
Advancing a Diversified Vaccine Portfolio: With a growing consensus that a single vaccine platform is unable to address the breadth of infectious disease concerns, there is a clear recognition of the benefits of having multiple alternative vaccine platforms available. GeoVax’s MVA-based approach provides a proven, durable, and safe alternative, reinforcing a well-rounded immunization strategy.
Public Trust and Transparency: Given the call for increased scrutiny of vaccine development, GeoVax is committed to transparency, publishing full clinical trial results and working collaboratively with HHS to foster public confidence.
Policy Action to Strengthen U.S. Biodefense
GeoVax urges policymakers to act swiftly in supporting domestic vaccine production and biodefense innovation. Key recommendations include:
Expanding Federal Investment in MVA-Based Vaccines: Increased funding from BARDA, the Department of Defense, and the NIH to accelerate the development, next-generation manufacturing scale up and deployment of GEO-MVA.
Accelerating Regulatory Approvals: Streamlined pathways for emergency use authorization and priority review of MVA-based vaccines to strengthen national preparedness.
Public-Private Partnerships: Enhanced collaboration between government agencies, biotechnology firms, and global health organizations to integrate MVA-based solutions into pandemic and biodefense planning.
A Call for Action
“The ‘Bolstering U.S. Biodefense’ report clearly articulates the vulnerabilities in our national health security framework. GeoVax is committed to helping address these gaps with our MVA-based vaccines and next-generation manufacturing capabilities,” said David Dodd, Chairman & CEO of GeoVax. “With a new HHS administration, there is a timely opportunity to strengthen domestic vaccine infrastructure and ensure greater national resilience against emerging threats.”
GeoVax remains dedicated to advancing innovative, scalable, and accessible vaccine solutions to safeguard public health and national security.
References: Council on Strategic Risks. (2025). Bolstering U.S. Biodefense: Strengthening the Nation’s Response to Biological Threats. Janne E. Nolan Center on Strategic Weapons. Retrieved from https://www.councilonstrategicrisks.org.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
New partnership reaffirms ODP Business Solutions’ commitment to the hospitality industry and adjacent categories, fostering a refined guest experience
BOCA RATON, Fla.–(BUSINESS WIRE)–Mar. 3, 2025– ODP Business Solutions, a leading supplier of workplace solutions and services and a division of The ODP Corporation (NASDAQ: ODP), announced today a strategic distribution partnership with Hunter Amenities. ODP Business Solutions will distribute Hunter’s wide range of hotel and guest amenities to hospitality partners, including liquid beauty products, soaps, dry goods and more, all uniquely bundled to accommodate the needs of every client and guest.
“Our partnership with Hunter Amenities demonstrates our commitment to continuing to expand our presence and product offerings in the hospitality industry and other adjacent sectors,” said David Centrella, EVP and president of ODP Business Solutions. “Distributing Hunter Amenities’ premium products further positions ODP Business Solutions to serve as a key-supplier for in-room needs.”
Hunter Amenities is an award-winning global manufacturing company that has been a pioneer in the personal care and hospitality industry for more than four decades. Renowned for its world-class manufacturing facilities that combine artisanal traditions with cutting-edge innovation, the company partners with some of the world’s most prestigious hospitality and retail brands. Hunter Amenities now provides its rich portfolio of high-end personal care products through ODP Business Solutions’ vast network of solutions and service, advancing how the hospitality industry can bring a luxurious, elevated experience to their guests.
“Partnering with ODP Business Solutions as a distribution partner is a natural fit for our company. Their best-in-class distribution capabilities and remarkably agile team give us complete confidence, which is why we’ve gone all in—rolling out our full portfolio within their expansive customer network. This collaboration is a true win-win for both organizations and a game-changer for the entire hospitality industry,” said John Hunter, founder of Hunter Amenities.
Hunter’s extensive product portfolio includes curated shampoo, conditioner, body wash, lotion, and hand wash, along with VIP indulgences such as lip balm, hand cream, eye cream, sleep balm, facial mist, and pillow mist—crafted for discerning travelers who expect nothing but the best.
“Introducing Hunter Amenities to our hospitality distribution services will provide our customers the opportunity to enhance each guest’s stay with custom, high-end offerings that pair seamlessly with ODP Business Solutions’ unparalleled service,” said Nisha Brown, vice president of marketing & product management at ODP Business Solutions. “Hunter is a globally recognized luxury brand that aligns perfectly with our commitment to quality and innovation. We look forward to continuing our growth in the hospitality market and beyond, offering tailored solutions that meet the evolving needs of our clients.”
ODP Business Solutions also delivers high-quality solutions in categories that include technology, professional cleaning and furniture, while expanding into new verticals to better serve the needs of its customers. This partnership announcement follows ODP Business Solutions recent milestone contract with a leading hospitality management company.
To learn more about ODP Business Solutions, visit odpbusiness.com.
About ODP Business Solutions:
ODP Business Solutions is a trusted partner with more than 30 years of experience working with businesses to adapt to the ever-changing world of work. From technology transformation, sustainability, innovative workspace design, cleaning and breakroom, and everything in between, ODP Business Solutions has the integrated products and services businesses need. Powered by a collaborative team of experienced business consultants, world-class logistics and trusted brand names, ODP Business Solutions advances how the working world gets work done. For more information on ODP Business Solutions, visit odpbusiness.com.
ODP Business Solutions is a division of The ODP Corporation (NASDAQ: ODP). ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Any other product or company names mentioned herein are the trademarks of their respective owners.
About Hunter Amenities:
Since 1981, Hunter Amenities has become one of the world’s largest manufacturers and leading formulators of superior personal care guest amenities, servicing hospitality customers in over 100 countries. Our products range from a prominent selection of licensed, internationally recognized designer and cosmetic brands to distinctive luxurious spa hotel amenities and retail collections.
The ODP Corporation (NASDAQ:ODP) is a leading provider of products and services through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; and Veyer, LLC, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
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.
MALVERN, Pa., March 03, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. OCU410 is a novel, multifunctional modifier gene therapy candidate being developed for the treatment of patients with vision loss due to geographic atrophy (GA)—an advanced stage of dry age-related macular degeneration (dAMD)—and OCU410ST is being developed for Stargardt disease due to ABCA4-related retinopathies.
GA affects 2-3 million people in the United States (U.S.) and Europe combined. There are two approved therapies in the U.S. that require frequent dosing (every month or every other month), however neither therapy has been approved in Europe. Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there are no approved treatments available globally.
“Receiving ATMP classification for OCU410 and OCU410ST is a critical step to potentially address these severely unmet medical needs in the very near future,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Dosing of Phase 2 in the ongoing OCU410 ArMaDa clinical trial is complete, and we are on track to initiate the Phase 3 clinical trial next year to pursue potential Marketing Authorization Application (MAA) and Biologics License Application (BLA) filings in 2028. Last week, the U.S. Food and Drug Administration (FDA) endorsed Ocugen’s plan to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST, which can be the basis of BLA and potential MAA submissions in 2027.”
ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance.
Preliminary 9-month data of OCU410 in GA patients demonstrated considerably slower lesion growth (44%) from baseline and clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes in the Phase 1 portion of the trial. Furthermore, a single subretinal OCU410 treatment preserves more retinal tissue around GA lesions of treated eyes at 9 months compared to published data on currently available GA therapies.
6-month data from Phase 1 of the OCU410ST GARDian clinical trial demonstrated considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes and clinically meaningful 2-line (10-letter) improvement in visual function (BCVA), which is statistically significant (p=0.02) in treated eyes. The Company plans to initiate the Phase 2/3 pivotal confirmatory clinical trial for OCU410ST by mid-2025.
“The novel modifier gene in OCU410 and OCU410ST targets all four pathways linked with dAMD and Stargardt and is delivered through a single subretinal injection as a one-and-done treatment,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “We are very pleased with the structural and functional outcomes demonstrated by both of these candidates, along with a stellar safety profile.”
OCU410 and OCU410ST utilize an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements
Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “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,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU410 and OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
CALGARY AB, March. 3, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.015 per common share payable on March 31, 2025, to shareholders of record at the close of business on March 14, 2025. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.
About InPlay Oil Corp.
InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634
FORT WORTH, Texas, March 3, 2025 /PRNewswire/ — AZZ Inc. (NYSE: AZZ), the leading independent provider of hot-dip galvanizing and coil coating solutions in North America, today announced the completion of repricing its $400 million Senior Secured Revolving Line of Credit. The repricing decreased the interest rate margin applicable to the Revolving Credit Loans from margins ranging from 275 basis points to 350 basis points (subject to leverage ratio step-downs) to margins ranging from 175 basis points to 275 basis points (subject to leverage ratio step-downs); (b) reduced the Commitment Fee applicable to the Revolving Credit Loans from fees ranging from 25 basis points to 37.5 basis points (subject to leverage ratio step-downs) to fees ranging from 20 basis points to 30 basis points (subject to leverage ratio step-downs); and (c) reduced the Letter of Credit Fees from 425 basis points to fees ranging from 175 basis points to 275 basis points (subject to leverage ratio step-downs).
Jason Crawford, Chief Financial Officer commented, “We are pleased to announce the successful completion of our revolver repricing. The repricing will result in significantly lower interest costs through the maturity of the facility and demonstrates our ongoing commitment to interest expense reduction.”
About AZZ Inc. AZZ Inc. is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end-markets. Collectively, our business segments provide sustainable, unmatched metal coating solutions that enhance the longevity and appearance of buildings, products and infrastructure that are essential to everyday life.
Safe Harbor Statement Certain statements herein about our expectations of future events or results constitute forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by terminology such as “may,” “could,” “should,” “expects,” “plans,” “will,” “might,” “would,” “projects,” “currently,” “intends,” “outlook,” “forecasts,” “targets,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Such forward-looking statements are based on currently available competitive, financial, and economic data and management’s views and assumptions regarding future events. Such forward-looking statements are inherently uncertain, and investors must recognize that actual results may differ from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made and are subject to risks that could cause them to differ materially from actual results. Certain factors could affect the outcome of the matters described herein. This press release may contain forward-looking statements that involve risks and uncertainties including, but not limited to, changes in customer demand for our products and solutions, including demand by the construction markets, the industrial markets, and the metal coatings markets. We could also experience additional increases in labor costs, components and raw materials including zinc and natural gas, which are used in our hot-dip galvanizing process; supply-chain vendor delays; customer requested delays of our products or solutions; delays in additional acquisition opportunities; an increase in our debt leverage and/or interest rates on our debt, of which a significant portion is tied to variable interest rates; availability of experienced management and employees to implement AZZ’s growth strategy; a downturn in market conditions in any industry relating to the products we inventory or sell or the solutions that we provide; economic volatility, including a prolonged economic downturn or macroeconomic conditions such as inflation or changes in the political stability in the United States and other foreign markets in which we operate; acts of war or terrorism inside the United States or abroad; and other changes in economic and financial conditions. AZZ has provided additional information regarding risks associated with the business, including in Part I, Item 1A. Risk Factors, in AZZ’s Annual Report on Form 10-K for the fiscal year ended February 29, 2024, and other filings with the SEC, available for viewing on AZZ’s website at www.azz.com and on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully when evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. These statements are based on information as of the date hereof and AZZ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Relations and Company Contact: David Nark, Senior Vice President of Marketing, Communications, and Investor Relations AZZ Inc. (817) 810-0095 www.azz.com
Investor Contact: Sandy Martin / Phillip Kupper Three Part Advisors (214) 616-2207 www.threepa.com
OKLAHOMA CITY, OKLAHOMA – FEBRUARY 28, 2025 – Comstock Inc. (NYSE: LODE) today announced a new investment and strategic collaboration with Marathon Petroleum Corporation (NYSE: MPC) to advance its lignocellulosic biomass refining solutions to commercial maturity. Comstock Fuels Corporation (“Comstock Fuels”), a subsidiary of Comstock Inc., has entered into a series of definitive agreements with subsidiaries of Marathon Petroleum Corporation (“Marathon”), involving the purchase of $14,000,000 in Comstock Fuels equity (“Investment”).
The Investment includes $1,000,000 in cash and $13,000,000 in payment-in-kind assets (“Payment-In-Kind Assets”) by Marathon, comprised of equipment, related intellectual properties, and other materials located at a Marathon renewable fuel demonstration facility in Madison, Wisconsin (“Madison Facility”). Comstock Fuels will use the Madison Facility to increase Comstock Fuels’ current pilot production capabilities in Wausau, Wisconsin.
Comstock Fuels’ advanced lignocellulosic biomass refining solutions are designed to align with oil producers by converting massive supplies of historically inaccessible biomass feedstock into “drop-in” hydrocarbon fuels for use in existing petroleum-based infrastructure.
Most current forms of renewable fuel draw from the same pool of conventional feedstocks, including corn, soy and various vegetable oils in the U.S., and the entire universe of those feedstocks only represents a tiny fraction of the domestic fuel demand. In contrast, the U.S. Department of Energy has previously estimated that America can produce upwards of one billion tons per year of biomass for conversion into fuel. That’s enough untapped feedstock to produce more than 3 billion barrels of fuel per year with Comstock Fuels’ refining solutions.
“We’re excited to collaborate with Marathon’s team as we work to integrate the Madison Facility and advance our unique renewable fuels technology to commercial maturity,” said Kevin Kreisler, Comstock Fuels’ chief technology officer.
The transaction documents included Comstock Fuels’ board observation rights for Marathon and reiterated the parties’ commitment to finalize an offtake agreement, joint development agreement, and warrant agreement on or before May 31, 2025.
Additional information on the transaction documents is available online in Comstock’s February 28, 2025, Current Report on Form 8-K.
About Comstock Fuels Corporation
Comstock Fuels Corporation (“Comstock Fuels”) delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable Bioleum™ fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 140 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, site conditions, and other process parameters. Comstock Fuels additionally holds the exclusive rights to intellectual properties developed by Hexas Biomass Inc. (“Hexas”) for production of purpose grown energy crops in liquid fuels applications with proven yields exceeding 25 to 30 dry metric tons per acre per year. The combination of Comstock Fuels’ high yield Bioleum refining platform and Hexas’ high yield energy crops allows for the production of enough feedstock to produce upwards of 100 barrels of fuel per acre per year, effectively transforming marginal agricultural lands with regenerative practices into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost regional energy security and rural economies.
Comstock Fuels plans to contribute to domestic energy dominance by directly building, owning, and operating a network of Bioleum Refineries in the U.S. to produce about 200 million barrels of renewable fuel per year by 2035, starting with its planned first 400,000 barrel per year commercial demonstration facility in Oklahoma. Comstock Fuels also licenses its advanced feedstock and refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.
Comstock Social Media Policy
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: RB Milestone Group LLC Tel (203) 487-2759 ir@comstockinc.com
For media inquiries or questions: Colby Korsun Comstock Fuels Corporation fuels@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
New resource provides a structured framework to help organizations assess, prepare, and govern data for high-quality AI inputs
HOUSTON, Feb. 27, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of The Role of Data in AI Quality, a comprehensive guide developed by Direct Digital Holdings’ AI Council to help organizations enhance the quality and integrity of data used in AI systems.
As artificial intelligence drives innovation across industries, organizations face a fundamental challenge: ensuring they have high-quality data to achieve consistently reliable AI outcomes. Businesses risk inaccurate predictions, biased models, and security vulnerabilities without structured, well-defined instructions and high-integrity data. The Role of Data in AI Quality equips business leaders with the insights needed to establish effective data management practices, ensuring AI solutions produce meaningful and trustworthy results. Additionally, it helps organizations make informed decisions about resource allocation, timelines, and investment in data preparation—critical first steps before embarking on any AI initiative.
Setting a Standard for AI Data Readiness
“AI systems are only as good as the data that powers them,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings. “Businesses investing in AI must first prioritize data quality, ensuring that information is accurate, complete, and ethically sourced. Our guide provides a practical approach for organizations looking to refine their data management strategies, identify gaps that can affect AI performance, and set a strong foundation for AI success.”
The “The Role of Data in AI Quality” guide offers key insights into:
Understanding the impact of data quality on AI performance
Best practices for data assessment, preparation, and governance
Managing compliance and privacy risks in AI-driven environments
Strategies for eliminating bias and enhancing data integrity
Leveraging data enrichment techniques to optimize AI outputs
“Many organizations are eager to adopt AI but struggle with the foundational step of data readiness,” added Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings. “This guide goes beyond theory and provides actionable steps to help businesses effectively clean, structure, and manage their data. By following these best practices, companies can ensure their AI systems deliver accurate and meaningful insights.”
By addressing the complete data lifecycle and establishing rigorous controls for accuracy and security, the comprehensive resource enables organizations to build the strong data foundation essential for successful AI implementation.
Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.
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CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.
“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA. “We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.
“Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval,” Dr. Vitoc added.
MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S.
The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
