Author: aweinsoff@channelchek.com

Release – Century Lithium Changes Project Name to Angel Island Mine

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Research News and Market Data on CYDVF

July 23, 2024 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z)

Century Lithium (or the Company) announces it has changed the name of its 100%-owned Clayton Valley Lithium Project in Nevada, USA to the Angel Island Mine (the Project). In April 2024, the Company announced a positive Feasibility Study for the Project, making it one of the few advanced lithium projects being developed in the United States. As the Company now continues to work towards permitting the Project, regulators encouraged a name change for clarity in the permitting process. The Angel Island name distinguishes it from other mining and energy projects in the area by using the name of a topographical feature from the Project.

ABOUT ANGEL ISLAND

Angel Island is named for the ridge of older metavolcanic and clastic rocks bordering the west side of Century’s lithium clay deposit. The name itself dates to the 1800’s, one of three landforms in Clayton Valley named for islands in San Francisco Bay (Alcatraz and Goat islands being the other two). Of the three landforms, Angel Island is the largest, rising to a height 400 meters above the valley floor. Its presence on the east side of the valley, separating Century’s lithium clay deposit from the lithium brine operation of Albemarle Corp., is owed to uplift along a major northeast trending normal fault located along the western base of the ridge. Although not directly related to the formation of Century’s deposit, uplift of Angel Island along this fault was responsible for elevating the clay deposits east of the fault and bringing them to the surface where they are now accessible for mining. The harder rocks in the ridge also likely acted as a physical barrier protecting Century’s lithium clay deposit from erosion.

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced stage lithium company, focused on developing its 100%-owned Angel Island Mine in west-central Nevada, USA. Century Lithium recently completed a Feasibility Study on the Project and is currently in the permitting stage, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

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.

Release – Maple Gold Strengthens Board and Management Team with Addition of Seasoned Mining Executives

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Research News and Market Data on MGMLF

Vancouver, British Columbia–(Newsfile Corp. – July 23, 2024) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to announce the appointments of Mr. Darwin Green, P.Geo. to its Board of Directors, effective immediately, and Mr. Ian Cunningham-Dunlop, P.Eng. to the position of Vice President, Technical Services, effective on or before August 1, 2024. Mr. Green is a veteran mining entrepreneur and professional geologist with a passion for discovery and value creation. Mr. Cunningham-Dunlop is a senior mining executive and professional engineer with over 40 years of diversified experience in domestic/international mineral exploration and advanced project development.

“We are thrilled to have attracted executives of Mr. Green’s and Mr. Cunningham-Dunlop’s caliber to help drive the Company’s next phase of growth,” stated Kiran Patankar, President and CEO of Maple Gold. “These key appointments further enhance the technical, capital markets and corporate governance expertise of our senior leadership team as we continue to transform into a premier Canadian gold exploration and development company. Their endorsement of Maple Gold speaks to the resource expansion, discovery and development potential of our district-scale gold projects in Québec.”

Darwin Green, P.Geo. – Director

Darwin Green, P.Geo. has over 30 years of experience in the minerals mining industry and brings significant industry, corporate and technical knowledge to the Company. He currently serves on the boards of NYSE-listed Contango ORE, Inc., TSX Venture Exchange-listed Onyx Gold Corp. and Evergold Corp., and as a Technical Advisor to other junior mining companies. Mr. Green previously served as Founder, Director, President and Chief Executive Officer of HighGold Mining Inc. from August 2019 until its recent acquisition by Contango ORE in July 2024 and has served as Founder and Executive Chairman of Onyx Gold since July 2023. Between November 2008 and December 2019, he served as the Vice President Exploration for Constantine Metal Resources Ltd. and prior to that, Mr. Green oversaw exploration and underground development programs at the Niblack (Cu-Au-Zn-Ag) deposit in Alaska, for which he received the Commissioner’s Award for Project Excellence by the State of Alaska. Mr. Green holds a B.Sc. from the University of British Columbia and an M.Sc. in Economic Geology from Carleton University.

Ian Cunningham Dunlop, P.Eng. – Vice President, Technical Services

Ian Cunningham-Dunlop, P.Eng. has a proven discovery track record and an excellent familiarity with Archean lode gold systems from work throughout Ontario, Québec, and West Africa. He currently serves as Executive Vice President with Onyx Gold and his extensive exploration and project management experience also includes HighGold Mining’s Johnson Tract (Au-Zn-Cu-Ag-Pb) project in Alaska, NewCastle Gold’s Castle Mountain gold project in California, True Gold Mining’s Karma gold mine in Burkina Faso, Fronteer Gold’s Long Canyon gold mine in Nevada and Agi Dagi/Kirazli/Halilaga/TV Tower gold and gold-copper projects in Turkey, and Aurora Energy’s Michelin uranium deposit in Labrador. Mr. Cunningham-Dunlop also led the exploration team at Homestake Mining’s/Barrick Gold’s Eskay Creek (Au-Ag-Cu-Pb-Zn) mine in British Columbia from 1997-2003 where he was awarded the B.C. & Yukon Chamber of Mines E.A. Scholz Award in October 2003 for “Outstanding Contribution to a Mining Development Project in B.C. and the Yukon”. He holds a B.Sc. in Geological Engineering from Queen’s University and is a Qualified Person under NI43-101.

Stock Option Issuance

The Company’s Board of Directors has approved the grant of stock options (“Options”) to purchase an aggregate of 1,075,000 common shares of the Company (each, a “Common Share”), with an exercise price of $0.085 per Common Share to certain employees, officers, directors and consultants. Once vested, each Option is exercisable into one Common Share for a period of five years from the grant date. The Company’s Equity Incentive Plan (the “Plan”) governs these Options, as well as the terms and conditions of their exercise, which is in accordance with policies of the TSX Venture Exchange. Further details regarding the Plan are set out in the Company’s Management Information Circular filed on May 15, 2023, which is available on SEDAR+.

About Maple Gold

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

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

ON BEHALF OF MAPLE GOLD MINES LTD.

“Kiran Patankar”

Kiran Patankar, President & CEO

For Further Information Please Contact:

Mr. Kiran Patankar
President & CEO
Tel: 604.639.2536
Email: kpatankar@maplegoldmines.com

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

Forward Looking Statements and Cautionary Notes:

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

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/217395

Release – MAIA Biotechnology Announces New Updates From Phase 2 Trial Of Novel Cancer Treatment Agent

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Research News and Market Data on MAIA

July 23, 2024 4:11am EDT

  • THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments
  • 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the 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.

The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

  • 6 patients remain on treatment following at least 12 months of therapy.
  • Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
  • Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.

“Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options.”

  1. https://www.sciencedirect.com/science/article/pii/S0169500217304373

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 cemiplimab (Libtayo®) followed by THIO 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.

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

Source: MAIA Biotechnology, Inc.

Released July 23, 2024

Release – Bitcoin Depot Exceeds Goal Deploying of 8,000 Bitcoin ATMs Five Months Ahead of Schedule

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Research News and Market Data on BTM

July 22, 2024 8:00 AM EDT

Pioneering Bitcoin ATM Provider Continues Market Dominance and Accelerated Growth with the Largest Installed Fleet in Its History

ATLANTA, July 22, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today proudly announced that it has achieved and exceeded its ambitious goal of deploying over 8,000 Bitcoin ATMs five months ahead of schedule, with 8,180 kiosks. This milestone reinforces Bitcoin Depot’s abiding market dominance and showcases its rapid growth trajectory. The achievement solidifies the Company’s previously announced achievement of signing 8,000 locations and its year-end objective of having the largest installed fleet of BTMs in the Company’s history.

“Surpassing our deployment goal well ahead of schedule is a testament to the relentless dedication of our team and our strategic initiatives aimed at expanding Bitcoin’s accessibility,” said Bitcoin Depot CEO Brandon Mintz. “Building on the momentum we’ve already cultivated in the first half of 2024; we have no intention of slowing down as we gear up to provide even more customers with seamless access to the digital financial ecosystem. “

Bitcoin Depot’s aggressive expansion strategy has been a key driver of this achievement. In the first half of 2024, the Company not only secured contracts to exceed over 8,000 kiosk locations but also enhanced its operational footprint significantly.

Highlights of the company’s achievements year-to-date include:

  • Expanded into Australia and Puerto Rico, introducing nearly 225 Bitcoin ATMs.
  • Announced retail partnership announcements with leading national and regional convenience store brands, increasing accessibility and brand reach.
  • Expanded its BTM fleet by over 900 kiosks to support 2024 growth initiatives.
  • Advanced its profit-sharing program through kiosks sales and investments from Sopris Capital.
  • Adopted a Bitcoin treasury strategy to further align with its commitment to the digital financial ecosystem. 

Bitcoin Depot’s ATMs offer a straightforward, quick, and convenient method for converting cash into Bitcoin. This empowers users to participate in the digital financial ecosystem, facilitating payments, transfers, remittances, online purchases, and investments.

Since becoming the largest BTM operator in North America in early 2022, Bitcoin Depot has maintained its market-leading position. Despite market volatility, the Company made history in 2023 by becoming the first BTM operator to go public on a major U.S. stock exchange. The Company and its leadership have earned recognition for their exceptional growth, including accolades from Forbes 30 Under 30, Deloitte’s 2023 Technology Fast 500, and the 2023 Inc. 5000.

About Bitcoin Depot 
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 7,400 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com. 

Cautionary Note Regarding Forward-Looking Statements

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

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

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

Contacts: 

Investors  
Cody Slach, Alex Kovtun  
Gateway Group, Inc.  
949-574-3860  
BTM@gateway-grp.com 

Media  
Christina Lockwood, Brenlyn Motlagh, Ryan Deloney  
Gateway Group, Inc. 
949-574-3860  
BTM@gateway-grp.com

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Source: Bitcoin Depot Inc.

Released July 22, 2024

Release – ZyVersa Therapeutics Announces Publication Demonstrating that Inflammasome ASC Inhibitor IC 100 Restored Retinal Structure and Function in a Retinopathy of Prematurity Animal Model

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Research News and Market Data on ZVSA

Jul 18, 2024

PDF Version

  • Publication showed that IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function.
  • Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., July 18, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Angiogenesis. The paper demonstrates the crucial role of inflammasome ASC and ASC specks in the development of oxygen-induced retinopathy and provides data showing that Inflammasome ASC Inhibitor IC 100 attenuates impairment of retinal structure and function.

The paper titled, “IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice,” summarizes research evaluating mouse models representative of ROP. Following is a summary of key findings:

  • ASC specks, which lead to inflammasome activation, were significantly increased in animal model retinas and colocalized with the abnormal vasculature, along with increased microglial activation indicative of retinal inflammation that leads to retinal damage and disease progression.
  • IC 100 decreased expression of inflammasome-related molecules (ASC, gasdermin D), inflammatory cytokines (IL-1β, IL-6, and TNF), and VEGF in animal model retinas.
  • Importantly, IC 100 reduced ASC speck formation and microglial activation, attenuating inflammation, abnormal vascularization, retinal thinning, and retinal dysfunction.
  • The structural and functional improvements demonstrated with IC 100 treatment correlated with corrections of hyperoxia-modulated gene pathways associated with eye development, leukocyte migration, angiogenesis, inflammation, neurogenesis, and VEGF signaling.

“We have demonstrated that IC 100 effectively treated both phases of oxygen-induced retinopathy in a mouse model that resembles ROP in preterm infants, as it decreased retinal vaso-obliteration and intravitreal vascularization,” said Dr. Shu Wu, Professor of Pediatrics at the University of Miami. “Our data suggest that IC 100 may have potential therapeutic use in the treatment of preterm infants with ROP.”

“This research highlighting that Inflammasome ASC Inhibitor IC 100 attenuated retinal inflammation, abnormal retinal vascularization, and retinal thinning leading to restored retinal function in an animal model of ROP supports the broad range of indications that IC 100 has potential to treat. ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The other promising indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – Conduent Transportation Selected to Transform Public Transport Network in Saint-Étienne Métropole, France

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT

    JULY 18, 2024

    TRANSPORTATION

    Three-phased project begins with implementation of contactless open payment system in advance of the 2024 Olympic Summer Games

    GUILHERAND-GRANGES, France & FLORHAM PARK, N.J. — Conduent Transportation, a global provider of smart mobility technology solutions and business unit of Conduent Incorporated (Nasdaq: CNDT), today announced that Saint-Étienne Métropole (SEM), the public transportation authority for the city of Saint-Étienne and its surrounding metropolitan area in east-central France, has selected Conduent for a three-phase transformation of its STAS bus and tram network. SEM serves a population of more than 400,000.

    In phase one, Conduent implemented an open payment system that allows passengers, on all of the network’s lines, to pay using validators installed on buses and trams. Payments can be made with contactless EMV (Europay, Mastercard and Visa) debit and credit cards, and NFC-enabled digital wallets such as Apple Pay, Google Pay and Samsung Pay. More than 300 validators were installed in this first phase, with one on each bus and at least two on each tram, in time for Saint-Étienne to play its role as a host city for the Summer Olympic Games.

    In phase two, during 2025, Conduent will complete the implementation of its ATLAS ® Ops back-office system as well as associated equipment, thus renewing the network’s entire ticketing system. This phase will include the start of interoperability with the contactless cards used for the regional Oùra system. Regional interoperability will then be enhanced in early 2026 during a third phase, which will enable the use of regional 2D barcode tickets via a mobile application.

    “As a host city for the upcoming 2024 Olympic Summer Games in France, we are anticipating a significant increase in the use of our transportation network. SEM is looking ahead at the opportunity and wants to ensure that riders, whether they are residents of Saint-Étienne Métropole or visitors, can easily and quickly utilize our transit network,” said Luc François, Vice President of Transport and Mobility at SEM. “This is just the first phase of a significant upgrade, to be implemented by Conduent, that will modernize our network, as well as make it a more efficient and accessible public transportation system.”

    Upon completion of all three phases, SEM will have the following new equipment across its network:

    • 1,100 validators on board buses and trams
    • 68 ticket vending machines
    • 75 point of sale terminals in retailers
    • 26 point of sale terminals in transport operator ticket offices
    • 55 inspection terminals

    “Conduent is honored that Saint-Étienne Métropole has selected us for this project,” said Jean Charles Zaia, President, Transit Solutions at Conduent. “When complete, the transformation of Saint-Étienne’s bus and tram network will enhance the customer experience and provide a network that is more customer-friendly, easily accessible and modern.”

    Following Rennes, Marseille and Grenoble, Saint-Étienne is the latest French metropolitan area to implement a Conduent contactless open payment system on its public transport network. Conduent’s open payment solutions are also deployed in Pays Basque, France, as well as in Mexico, the United States, Belgium, Australia and Italy.

    About Conduent
    Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

    Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduent, http://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

    Trademarks
    Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

    Media Contacts

    ROBERT CORBISHLEY

    Conduent

    Robert.Corbishley@conduent.com

    +44 (0) 7703 516569

    GILES GOODBURN

    Conduent

    ir@conduent.com

    +1-203-216-3546

    NEIL FRANZ

    Conduent

    neil.franz@conduent.com

    +1-240-687-0127

    Release – Travelzoo Q2 2024 Earnings Conference Call on July 25 at 11:00 AM ET

    Posted on by aweinsoff@channelchek.com

    News Research and Market Data on TZOO

    Jul 18, 2024, 09:03 ET

    NEW YORK, July 18, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

    WHAT:Travelzoo, the club for travel enthusiasts, will host a conference call to discuss the Company’s financial results for the second quarter ended June 30, 2024. Travelzoo will issue a press release reporting its results before the market opens on July 25, 2024.
    WHEN:July 25, 2024 at 11:00 AM ET
    HOW:A live webcast of Travelzoo’s Q2 2024 earnings conference call can be accessed at http://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
    CONTACT:Travelzoo Investor Relations
    ir@travelzoo.com

    About Travelzoo
    We, Travelzoo®, are the club for travel enthusiasts. Our 30 million members receive exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give us access to irresistible deals.

    SOURCE Travelzoo

    Release – Cocrystal Pharma Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on COCP

    JULY 18, 2024

     DOWNLOAD AS PDF

    BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. It is being developed as the first dual, broad-spectrum antiviral for the treatment of norovirus and coronaviruses.

    “Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a strong candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. We are pleased with the encouraging safety and tolerability data from the CDI-988 Phase 1 study SAD cohorts,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are currently manufacturing drug product for the multiple-ascending dose (MAD) cohorts of this study, with subject enrollment planned to begin in the fourth quarter of this year.”

    The single-center, randomized, double-blind Phase 1 study is evaluating the safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo in healthy adults and is being conducted in Australia. Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.

    About Norovirus
    Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The NIH estimates the annual burden of noroviruses to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

    Coronaviruses Including COVID-19 and Variants
    Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.

    About Cocrystal Pharma, Inc.
    Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

    Cautionary Note Regarding Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 against coronaviruses and noroviruses, the results of the CDI-988 Phase 1 trial for the antiviral treatment of coronaviruses and noroviruses, the expected timing of the CDI-988 MAD cohorts of the study, including estimated subject enrollment in the fourth quarter of fiscal year 2024, and the potential market for such product candidate. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers and procuring materials for the MAD cohorts CDI-988 Phase 1 study by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. 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.

    Investor Contact:
    LHA Investor Relations
    Jody Cain
    310-691-7100
    jcain@lhai.com

    Media Contact:
    JQA Partners
    Jules Abraham
    917-885-7378
    Jabraham@jqapartners.com

    # # #

    Primary Logo

    Source: Cocrystal Pharma, Inc.

    Released July 18, 2024

    Release – The United States Eventing Association Names Zomedica’s PulseVet(R) as the Official Shock Wave of the USEA

    Posted on by aweinsoff@channelchek.com

    News Research and Market Data on ZOM

    Zomedica will sponsor a variety of high-profile events within the USEA

    ANN ARBOR, MI / ACCESSWIRE / July 17, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is honored to announce that the United States Eventing Association, Inc. (USEA), a leading equestrian sports organization, has named PulseVet as the “Official Shock Wave of the USEA” for 2024. As part of its partnership with the USEA, PulseVet Shock Wave is also a “Gold Sponsor” of the USEA American Eventing Championships, “Bronze Sponsor” of the USEA Classic Series, and “Contributing Sponsor” of the USEA EA21 Program, the USEA Annual Meeting and Convention, and the USEA Adult Team Championships.

    Zomedica’s PulseVet system is a world leader in veterinary electro-hydraulic shock wave technology for the treatment of a wide variety of conditions in equine, canine, and feline patients. The high-energy sound waves stimulate cells and release healing growth factors in the body that reduce inflammation, increase blood flow, and accelerate bone and soft tissue development. PulseVet’s technology is used in conditions including tendon and ligament healing, bone healing, osteoarthritis, chronic pain, and wound healing.

    Zomedica CEO Larry Heaton commented, “We are excited to engage with USEA as the Official Shock Wave of their organization. Zomedica is committed to helping veterinarians provide the best possible care for horses at every level of training and competition, from rehabilitation to maintaining peak performance.”

    “We are grateful to Zomedica for partnering with U.S. Eventing as its newest sponsor. Keeping our equine partners healthy and happy is a top priority, and we are thankful to have a brand committed to the same goals. Our event horses are a part of the family, and we are glad that the PulseVet shock wave device is focused on keeping them in top shape,” stated USEA CEO Rob Burk.

    “As a long-time member, I am thrilled to partner with the USEA and help educate all those who enjoy the sport of eventing,” Zomedica’s Senior Product Manager of Therapeutics, Courtney Calnan, commented. “Eventing requires our equine teammates to be an ultimate athlete. I’m excited for the members of USEA to learn how the PulseVet system can help their partners feel their best.”

    PulseVet’s electro-hydraulic shock wave technology has been clinically proven to treat tendon, ligament, and muscle injuries; osteoarthritis; degenerative joint disease; navicular syndrome; chronic back and neck pain; fractures; and wounds. Electro-hydraulic shock wave continues to be the most researched type of shock wave in the veterinary industry. The total addressable market for PulseVet devices in the US is estimated at $1 billion, with additional recurring revenue of $150 million annually for related consumables.

    About the United States Eventing Association

    The USEA is a non-profit 501(c)(3) educational organization committed to providing eventing enthusiasts with a competitive level suited to their individual skills. By assisting and educating competitors, event organizers, and officials; maintaining responsible safety standards; and registering qualified competitions and clinics, the USEA offers a strong and continuous training opportunity for an ever-expanding field of world-class competitors. Just as importantly, the USEA provides a means for all riders, regardless of age or ability, to experience the thrill of eventing. To learn more, visit www.useventing.com.

    About Zomedica

    Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $91 million in liquidity as of March 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

    Follow Zomedica

    Cautionary Note Regarding Forward-Looking Statements

    Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

    Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

    Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the expected market and Zomedica’s share of such market, continued growth of sales, the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work including the development of new cartridges; uncertainty as to the timing and results of verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, or other requirements for our products in the Middle East, Africa and India, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, particularly in the Middle East, Africa and India; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

    The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

    Investor Relations Contact:
    Zomedica Investor Relations
    investors@zomedica.com
    1-734-369-2555

    SOURCE: Zomedica Corp.

    Release – Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    July 17, 2024 8:00am EDTDownload as PDF

    CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

    The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA – Tonix’s Tonmya and one from another U.S. company – there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

    Fibromyalgia Landscape

    According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix’s drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.

    Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each. Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

    Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

    Tonix Enters the Ring with Tonmya

    Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.

    Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity – or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.

    In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

    Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.

    As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.

    Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/

    *Tonmya is an investigational new drug and is not approved for any indication

    Investor Contact

    Jessica Morris
    Tonix Pharmaceuticals
    investor.relations@tonixpharma.com
    (862) 904-8182

    Important notice, please read: Certain statements in this document 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 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

    SOURCE: Tonix Pharmaceuticals Holding Corp.

    View the original press release on accesswire.com

    Released July 17, 2024

    Release – Unicycive Therapeutics Granted Patent On UNI-494 To Treat Acute Kidney Injury By The United States Patent And Trademark Office (USPTO)

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on UNCY

    July 17, 2024 7:03am EDT Download as PDF

    ENSURES INTELLECTUAL PROPERTY PROTECTION UNTIL 2040

    LOS ALTOS, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent No. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494.

    The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from acute kidney injury or contrast induced nephropathy by administering the UNI-494 compound. The UNI-494 compound covered in the method of use claims is not limited to a particular salt, dose or type of administration. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease.

    “We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This patent helps protect our approach and expands our portfolio as we look to develop novel treatments for kidney diseases.”

    About UNI-494

    UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in the second half of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

    About Acute Kidney Injury

    Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined on the basis of increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

    About Unicycive Therapeutics

    Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

    Forward-looking statements

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

    Investor Contact:

    ir@unicycive.com
    (650) 543-5470

    SOURCE: Unicycive Therapeutics, Inc.

    Primary Logo

    Source: Unicycive Therapeutics, Inc.

    Released July 17, 2024

    Release – Codere Online to Release Financial Results for the Second Quarter 2024 on July 31

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CDRO

    07/16/2024

    Download(opens in new window)

    Madrid, Spain and Tel Aviv, Israel, July 16, 2024 (GLOBE NEWSWIRE) – Codere Online Luxembourg, S.A. (Nasdaq: CDRO / CDROW) (the “Company” or “Codere Online”) a leading online gaming operator in Spain and Latin America, today announced that it will release its second quarter 2024 results prior to 8:30AM US Eastern Time on July 31, 2024.

    At 8:30AM US Eastern Time on the same day, Codere Online’s management will host a conference call to discuss the results and provide a business update.

    The Company’s earnings press release and related materials will be available on Codere Online’s website at www.codereonline.com. Dial-in details for the conference call as well as the audio webcast registration link are accessible on the Events & Presentations section of the same website. A recording of the webcast will be available following the conference call.

    About Codere Online

    Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

    About Codere Group
    Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

    Contacts:

    Investors and Media
    Guillermo Lancha
    Director, Investor Relations and Communications
    Guillermo.Lancha@codere.com
    (+34)-628-928-152

    Primary Logo

    Source: Codere Online Luxembourg, S.A.

    Release – Bitcoin Depot Announces Sale of 200 Additional Kiosks to Sopris Capital Through Profit-Sharing Program

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on BTM

    July 16, 2024 8:00 AM EDT

    Underscores the Attractiveness of the Company’s Bold North American Expansion Strategy

    ATLANTA, July 16, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced sale of 200 additional BTM kiosks to Sopris Capital (“Sopris”), a 20-year-old multi-strategy investment firm as part of the Company’s profit-sharing program.

    Bitcoin Depot launched the program in 2023 to provide additional deployment opportunities to qualified partners as part of its North American expansion strategy. Today’s news follows the March announcement, where Sopris joined Bitcoin Depot’s profit-sharing program with the purchase of 50 kiosks. This program allows Sopris to leverage Bitcoin Depot`s operating expertise and receive a passive income stream from its Bitcoin ATMs.

    “Our decision to purchase additional kiosks underscores the attractiveness of this investment opportunity, and the confidence we have in Bitcoin Depot’s strategy and growth potential,” said Andrew Paul, Founder and CEO of Sopris Capital. “As an owner of 250 kiosks and one of the Company’s independent shareholders, we believe Bitcoin Depot presents multiple ways to drive high returns on our capital.”

    Bitcoin Depot’s profit-sharing program provides a comprehensive investment package, including kiosk use, operating software, shipping, installation, and ongoing support. It also offers a passive income stream with monthly profit splits, providing a direct financial benefit to the partner. By partnering with Bitcoin Depot, companies can leverage the Company’s expertise in BTM operations and its integration with BitAccess software, the leading software suite for Bitcoin ATM operations.

    “We are thrilled to deepen our partnership with Sopris Capital,” said Bitcoin Depot CEO Brandon Mintz. “We believe their various investments in our platform and common shares over the past four months underscores their confidence in our strategy and growth potential.”

    Bitcoin Depot’s products and services provide an intuitive, quick, and convenient process for converting cash into Bitcoin, giving users the ability to access the broader digital financial system, including using their Bitcoin for purposes of making payments, transfers, remittances, online purchases, and investments. To learn more about Bitcoin Depot’s profit share program, visit: https://bitcoindepot.com/profit-sharing-program/.

    About Bitcoin Depot 
    Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 7,400 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com. 

    Cautionary Note Regarding Forward-Looking Statements

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

    These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
    We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

    Contacts: 

    Investors  
    Cody Slach 
    Gateway Group, Inc.  
    949-574-3860  
    BTM@gateway-grp.com 

    Media  
    Christina Lockwood, Brenlyn Motlagh, Ryan Deloney  
    Gateway Group, Inc. 
    949-574-3860  
    BTM@gateway-grp.com 

    Primary Logo

    Source: Bitcoin Depot Inc.

    Released July 16, 2024