Author: [email protected]

Release – Hemisphere Energy Announces Normal Course Issuer Bid Renewal

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July 11, 2024 4:39 PM EDT | Source: Hemisphere Energy Corporation

Vancouver, British Columbia–(Newsfile Corp. – July 11, 2024) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) is pleased to announce that the TSX Venture Exchange (the “TSXV”) has accepted the Company’s Notice of Intention to renew of its Normal Course Issuer Bid (the “NCIB”) to purchase for cancellation, from time to time, as Hemisphere considers advisable, up to 8,255,766 common shares (“Common Shares”) of the Company, representing approximately 10% of the current public float of the Common Shares.

Purchases of Common Shares will be made on the open market through the facilities of the TSXV. For any Common Shares purchased, Hemisphere will pay the prevailing market price of the Common Shares. The actual number of Common Shares that may be purchased for cancellation and the timing of any such purchases will be determined by the Company and dependent on market conditions.

The Company is commencing the NCIB because it believes that, from time to time, the market price of its Common Shares may not properly reflect the underlying, intrinsic value of the Company, and that, at such times, the purchase of Common Shares for cancellation will increase the proportionate interest of, and be advantageous to, all remaining shareholders.

The NCIB will commence on July 14, 2024 and will terminate on July 13, 2025 or at such earlier time as the NCIB is completed or terminated at the option of Hemisphere. The Company has retained Canaccord Genuity Corp. as its broker to conduct the NCIB on its behalf.

Under the Company’s previous notice of intention to conduct a normal course issuer bid, the Company sought and received approval of the TSXV to purchase 8,670,636 Common Shares for the period from July 14, 2023 to July 13, 2024. During that period, the Company purchased 4,074,400 Common Shares on the open market at a weighted-average price of $1.425 per Common Share.

About Hemisphere Energy Corporation

Hemisphere is a dividend paying Canadian oil company focused on maximizing value per share growth with the sustainable development of its high netback, low decline conventional heavy oil assets through polymer flood enhanced recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.

For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:

Don Simmons, President & Chief Executive Officer
Telephone: (604) 685-9255
Email: [email protected]

Website: www.hemisphereenergy.ca

Note Regarding Forward-Looking Statements and Other Advisories

This document contains forward-looking information. This information relates to future events and the Company’s future performance. All information and statements contained herein that are not clearly historical in nature constitute forward-looking information, and the words “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “propose”, “predict”, “potential”, “continue”, “aim”, or the negative of these terms or other comparable terminology are generally intended to identify forward-looking information. Such information represents the Company’s internal projections, estimates, expectations, beliefs, plans, objectives, assumptions, intentions or statements about future events or performance. This information involves known or unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. Hemisphere believes that the expectations reflected in this forward-looking information are reasonable; however, undue reliance should not be placed on this forward-looking information, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. This press release contains forward-looking information concerning, among other things, the anticipated advantages of the NCIB to Hemisphere’s shareholders and the Company’s business strategy, the price to be paid by Hemisphere for purchases of Common Shares under the NCIB and Hemisphere’s plans for maximizing value per share growth with the sustainable development of its high netback high netback, low decline conventional heavy oil assets through polymer flood enhanced recovery methods. The reader is cautioned that such information, although considered reasonable by the Company, may prove to be incorrect. A number of risks and other factors could cause actual results to differ materially from those expressed in the forward-looking information contained in this document including, but not limited to, the risk that the anticipated benefits of the NCIB may not be achieved and the risk that the Company may not be able to successfully execute its business strategy or growth plans. Readers are cautioned that the foregoing list of factors is not exhaustive. Although the forward-looking statements contained in this document are based upon assumptions which management of Hemisphere believes to be reasonable, Hemisphere cannot assure investors that actual results will be consistent with these forward-looking statements. With respect to forward-looking statements contained in this document, Hemisphere has made assumptions regarding, among other things, the ability of Hemisphere to fund purchases of Common Shares under the NCIB and its business strategy. These forward-looking statements are made as of the date of this document and Hemisphere disclaims any intent or obligation to update publicly any forward-looking statements, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

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 news release.

info

SOURCE: Hemisphere Energy Corporation

Release – GeoVax to Raise Approximately $3.1 Million of Gross Proceeds in Offering Priced At-the-Market

Posted on by [email protected]

Research News and Market Data on GOVX

Atlanta, GA, July 11, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 1,085,000 shares of the Company’s common stock (or common stock equivalents) at a price of $2.86 per share in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 2,170,000 shares of common stock. The warrants have an exercise price of $2.86 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of stockholder approval.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.1 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 12, 2024, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the Securities and Exchange Commission (the ”SEC”) and declared effective by the SEC on March 13, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, which recently completed enrollment in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact: Investor Relations Contact: Media Contact:
[email protected]                         [email protected]                        [email protected] 
678-384-7220 212-698-8696 202-779-0929

Release – SKYX Announces Production of its New Global Patented Advanced, Smart, Plug & Play Recessed Light

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Research News and Market Data on SKYX

The Global Recessed Light Market is a Multi-Billion Unit Market

As SKYX Continues to Grow its Market Penetration it Expects its Recessed Light to Significantly Contribute to Growth

SKYX’s New Plug & Play Recessed Light Global Patents include the U.S., China, Canada, Hong-Kong and Mexico

MIAMI, July 11, 2024 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive smart platform technology company with over 94 issued and pending patents in the U.S. and globally, and which owns over 60 lighting and home décor websites with a mission to make homes and buildings become smart, safe, and advanced as the new standard announced today that it will start production of its new global patented advanced, smart, plug & play recessed light.

The global recessed light market is a multi-billion-unit market. SKYX’s new Plug & Play recessed light global patents include the U.S., China, Canada, Hong-Kong and Mexico.

As billions of recessed lights are installed globally with hazardous electrical wires, SKYX’s recessed light solution enables an advanced, simple Plug & Play installation that saves time, cost and lives.

SKYX’s Plug & Play recessed lights can be controlled through SKYX’s App, Voice Control and Phone and works with Apple’s Siri, Amazon Alexa, Google Home and Samsung.

SKYX’s Total Addressable Market (TAM) of over $500 billion with its robust versatile U.S. and global patent portfolio creates tremendous company value and brings the company’s patent portfolio to a total of over 94 issued and pending patents, 36 of which are issued patents covering SKYX’s advanced Plug and Play and smart home platform technologies for safety, smart home, AI, electrical, lighting and ceiling fan industries.

Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said, “We are happy to announce that we will start production of our new patented and advanced, smart, plug and play recessed lights. Our global robust intellectual property portfolio in the critical areas of our advanced safe, smart homes and sensor technologies, position SKYX as a leading technology provider of advanced smart home platform solutions for the smart home, AI, electrical, lighting and ceiling fan industries.”

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 94 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:

Jeff Ramson

PCG Advisory

[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/38d19cf4-206c-442a-929e-44b6ac9a340b

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4166d320-d532-4157-8c72-ede4456a00bd

Release – Comtech Completes First Province-wide Migration to NG9-1-1 Infrastructure in Canada

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BY THE COMTECH EDITORIAL TEAM – JUL 11, 2024 | 2 MIN READ

CHANDLER, Ariz. – July 11, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced it recently completed the full migration and deployment of a Next Generation 9-1-1 (“NG9-1-1”) system in Saskatchewan-marking a significant milestone for the Company and Canada’s NG9-1-1 infrastructure.

In October 2023, Comtech helped Strathcona County in Alberta become Canada’s first Public Safety Answering Point (“PSAP”) to transition to NG9-1-1 services. With the Saskatchewan NG9-1-1 deployment, Comtech is now the first company, in partnership with leading Emergency Services IP Network (“ESInet”) provider SaskTel, to deploy a province-wide NG9-1-1 system in Canada.

“We are honored to build on our longstanding partnership with SaskTel to complete this critical NG9-1-1 transition in Saskatchewan,” said Aaron King, General Manager of Comtech’s Solacom Technologies Division. “With a government mandate to transition to NG9-1-1 services by March 2025, Comtech is partnering with Canada’s public safety agencies to lead the way in building one of the first national transitions to a NG9-1-1 infrastructure. This province-wide NG9-1-1 deployment paves the way for other NG9-1-1 migrations across Canada that will empower PSAPs throughout the country with the ability to leverage new technologies that can significantly enhance safety, reliability, and response in a wide range of emergency situations.”

In addition to the Saskatchewan NG9-1-1 deployment, Comtech also recently completed a local NG9-1-1 PSAP migration in Ontario, Canada. With these NG9-1-1 migrations complete, Comtech is the first public safety provider in Canada to partner with all three major ESInet suppliers in the country-SaskTel, Bell, and Telus-to build out the nation’s NG9-1-1 infrastructure.

As one of the most trusted providers of public safety technologies, Comtech is continuing to expand its NG9-1-1 call routing and call handling solutions, including the Company’s Guardian Call Management platform, for governments and emergency response providers across the globe. The Company’s NG9-1-1 offerings are designed to adapt and continuously evolve over time to meet the needs of emerging use cases as well as future applications.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations

Maria Ceriello

631-962-7115

[email protected]

Media Contact

Jamie Clegg

480-532-2523

[email protected]

Release – FAT Brands Inc. Announces Third Quarter Cash Dividend on Class A Common Stock and Class B Common Stock

Posted on by [email protected]

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07/11/2024

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LOS ANGELES, July 11, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Twin Peaks, Fazoli’s, Smokey Bones and 11 other restaurant concepts, announced today that its Board of Directors has declared the Company’s fiscal 2024 third quarter cash dividend of $0.14 per share on each outstanding share of Class A common stock and Class B common stock. The dividend is payable on August 30, 2024 to holders of record of Class A common stock and Class B common stock as of the close of business on August 15, 2024.

The declaration and payment of future dividends, as well as the amounts thereof, are subject to the discretion of the Company’s Board of Directors. The amount and size of any future dividends will depend upon the Company’s future results of operations, financial condition, capital levels, cash requirements and other factors. There can be no assurance that the Company will declare and pay dividends in future periods.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands Inc. (NASDAQ: FAT) (the Company) is a leading global franchising company that strategically acquires, markets and develops quick service, fast casual and casual dining restaurant concepts around the world. The Company currently owns eighteen restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Smokey Bones, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean, Ponderosa and Bonanza Steakhouses and franchises and owns over 2,300 units worldwide. For more information, please visit www.fatbrands.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these risks, uncertainties and contingencies. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

Investor Relations:
ICR
Michelle Michalski
[email protected]
646-277-1224

Media Relations:
FAT Brands Inc.
Erin Mandzik
[email protected]
860-212-6509

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on by [email protected]

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July 10, 2024 4:30pm EDTDownload as PDF

CHATHAM, N.J., July 10, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 3,393,600 shares of its common stock and pre-funded warrants to purchase up to 3,703,140 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
[email protected]
(978) 360-3151

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Source: Tonix Pharmaceuticals Holding Corp.

Released July 10, 2024

Release – Montana Renews Pharmacy Benefit Management Contract with Conduent

Posted on by [email protected]

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JULY 10, 2024

Company builds on 38-year history of providing innovative Medicaid management solutions to Montana Department of Public Health and Human Services

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced a three-year Pharmacy Benefit Management (PBM) contract renewal with the Montana Department of Public Health and Human Services (MDPHHS). The renewal builds on Conduent’s nearly 38-year relationship with the MDPHHS of providing advanced Medicaid management solutions to further the agency’s mission to deliver healthcare services that help improve and protect the health and safety of Montanans.

As part of the Conduent Medicaid Suite (CMdS), the pharmacy module helps MDPHHS reduce costs and streamline operations within its PBM model with advanced applications for point of sale, prior authorization, rebate, data analytics, consumer relationship management and prospective and retrospective drug review functions. Conduent will also continue to provide medical authorization, precertification, payment method development and inpatient call center services.

The company’s comprehensive PBM system was among the first to be certified in the state of Montana and the first instance of an individual Medicaid management module to earn federal certification.

“Our successful, long-term relationship with Montana reflects our commitment to providing effective solutions and on-going innovations that enable the Montana Department of Public Health and Human Services to continue to manage pharmacy benefits with transparency and cost-effectiveness,” said Lydie Quebe, General Manager, Government Healthcare Solutions at Conduent.

In addition to supporting pharmacy benefit management and claims processing, Conduent provides a range of government solutions including Medicaid enrollment and eligibility support, critical payment disbursement solutions, and child support solutions. The company supports approximately 41 million residents across various government health programs. Visit Conduent Government Healthcare Solutions to learn more.

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.

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Trademarks
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Media Contacts

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Release – Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings From Pivotal Clinical Trial Of Oxylanthanum Carbonate (OLC)

Posted on by [email protected]

Research News and Market Data on UNCY

July 10, 2024 7:03am EDT Download as PDF

– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy –

– Median daily pill burden reduced by half after switch to OLC –

LOS ALTOS, Calif., July 10, 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 initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis were reported on June 25, 2024.

The patient reported outcomes are being evaluated from a satisfaction questionnaire that was a pre-specified exploratory objective of the study. The questionnaire surveyed patients in the UNI-OLC-201 trial to assess characteristics of their current phosphate binder as compared to OLC after switching medications. The questions included patient satisfaction, ease of use, and preferred therapy and were taken at the start and conclusion of the study. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC while 18% preferred their prior therapy, 98% of patients said that OLC was easy to take compared to 55% for their prior therapy, 89% of patients said they were satisfied with OLC while 49% were satisfied with their prior therapy.

“We are gratified by the encouraging patient reported findings from our pivotal trial that mirror the better-than-expected topline clinical results that we reported last month,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “In the design of our pivotal clinical trial for OLC, we believed that it was important to consider the patient perspective and the personal challenges that they face in managing their hyperphosphatemia. Importantly, the results showed that patients preferred OLC greater than 4 to 1 over their prior phosphate binder therapy. Our focus is now directed toward filing our New Drug Application and making OLC available to patients who may benefit from its potential best-in-class profile, if approved.”

Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial, commented, “In this clinical study, our patients stated a clear preference for OLC over their prior phosphate lowering therapies. This positive patient reported experience with OLC is encouraging because hyperphosphatemia outcomes are often negatively impacted by non-adherence to phosphate lowering prescriptions due to side effects and high pill burden. At the end of the study, several of my patients asked not to be put back on their prior phosphate binder.”

Background

Patients screened to enter the trial were taking the following phosphate binder therapies (n=128): 52% Renvela® (sevelamer carbonate), 19% PhosLo® (calcium acetate, 15% Auryxia® (ferric citrate), 13% Velphoro® (sucroferric oxyhydroxide, and 1% Other. Once patients were enrolled into the trial, they went through a washout period for two weeks to clear their current phosphate binder from the body.

Key Findings

Preferred Therapy: In response to the question: Based on your experience in this clinical trial, do you prefer your current phosphate binder or OLC, 79% preferred OLC, 18% preferred their prior phosphate binder, and 3% preferred neither.

Ease of Use: In the trial, the median patient pill burden on OLC was reduced by half compared to their prior phosphate binder therapy. The pill burden on prior therapy at screening was a median of 6 (mean 6.5) pills per day. On OLC, the pill burden at the end of the study was a median of 3 (mean 3.9) pills per day.

In response to the question: My current phosphate binding medication is easy to take, 55% of patients agreed, 41% disagreed, and 4% neither agreed nor disagreed. In response to the question: Oxylanthanum carbonate (OLC) is easy to take, 98% of patients agreed, 1% disagreed, and 1% neither agreed nor disagreed.

Patient Satisfaction: At screening, less than half of the patients in the study agreed with the statement, I am satisfied with my current phosphate binder medication. At the end of the study and after switching to OLC, 89% of patients agreed with the statement, I am satisfied with oxylanthanum carbonate. Only 6% expressed dissatisfaction with OLC.

The initial findings from the Oxylanthanum carbonate (OLC) pivotal trial satisfaction questionnaire are preliminary and subject to change based on further detailed analysis. Full survey results are expected to be presented at a future medical conference.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established. A pivotal clinical trial was also conducted in CKD patients on hemodialysis that achieved the study objective and established favorable tolerability of OLC at clinically effective doses.

About Hyperphosphatemia

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

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

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. 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.

Renvela®️ is a registered trademark of Sanofi.
Phoslo®️ and Velphoro®️ are registered trademarks of Vifor Fresenius
Auryxia®️ is a registered trademark of Akebia Therapeutics
Fosrenol®️ is a registered trademark of Takeda Pharmaceutical Company Limited
1Reason Research, LLC 2022 survey. Results here.

Investor Contact:
[email protected]
(650) 543-5470
SOURCE: Unicycive Therapeutics, Inc.

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/9a233ce4-0844-4e63-b22e-650fa9d140b6
https://www.globenewswire.com/NewsRoom/AttachmentNg/39ea3031-e96f-488a-9212-331b53aa376f
https://www.globenewswire.com/NewsRoom/AttachmentNg/1f4d052e-09f9-4043-bc89-b34cdc87ddcc

Source: Unicycive Therapeutics, Inc.

Released July 10, 2024

Release – The GEO Group Announces Date for Second Quarter 2024 Earnings Release and Conference Call

Posted on by [email protected]

July 9, 2024

  • Earnings Release Scheduled for Wednesday, August 7, 2024 Before the Market Opens
  • Conference Call Scheduled for Wednesday, August 7, 2024 at 11:00 AM (Eastern Time)

BOCA RATON, Fla.–(BUSINESS WIRE)–Jul. 9, 2024– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its second quarter 2024 financial results on Wednesday, August 7, 2024 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Wednesday, August 7, 2024.

Hosting the call for GEO will be George C. Zoley, Executive Chairman of the Board, Brian R. Evans, Chief Executive Officer, Mark Suchinski, Chief Financial Officer, Wayne Calabrese, President and Chief Operating Officer, and James Black, President, GEO Secure Services.

To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:

1-877-250-1553 (U.S.)
1-412-542-4145 (International)

In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.

A telephonic replay will also be available through August 14, 2024. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 4116450. If you have any questions, please contact GEO at 1-866-301-4436.

Pablo E. Paez 1-866-301-4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Release – Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public Offering

Posted on by [email protected]

Research News and Market Data on TNXP

July 09, 2024 9:15am EDT

CHATHAM, N.J., July 09, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 7,096,740 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about July 10, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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.

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact
Katie Dodge
LaVoieHealthScience
[email protected]
(978) 360-3151 

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 9, 2024

Release – Fatburger and Round Table Pizza Announce Co-Branded Concept Headed to Utah

Posted on by [email protected]

Research News and Market Data on FAT

07/09/2024

Beloved California-Born Burger and Pizza Brands Set for Beehive State

LOS ANGELES, July 09, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Fatburger, Round Table Pizza, and 16 other restaurant concepts, announces a new development deal set to bring the iconic California-based pizza and burger chains to Utah. In partnership with franchisee Blacksheep Hospitality Group, LLC, the new deal will bring a total of 12 co-branded Fatburger and Round Table Pizza franchised restaurants to the Beehive State over the next six years, with the first unit set to open in 2025.

“Since debuting the Fatburger and Round Table Pizza co-branded pairing last year, we now have over 50 plus units in the development pipeline,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “This momentum can be attributed to the model’s success right out of the gate in Texas. Shelby Jobe and his team opened the first co-branded store in Texas, and we are confident that he will be just as successful in expanding the concept throughout Utah with Blacksheep Hospitality Group, LLC.”

Ever since the first Fatburger opened in Los Angeles over 70 years ago, the chain has been known for its delicious, grilled-to-perfection and cooked-to-order burgers. Founder Lovie Yancey believed that a big burger with everything on it is a meal in itself. At Fatburger, “everything” is not just the usual lettuce, tomato, onion, mayo, mustard, pickles and relish. Burgers can be customized with multiple patties and toppings including bacon and eggs. In addition to its famous burgers, the Fatburger menu also includes Fat and Skinny Fries, Turkeyburgers, hand-breaded Crispy Chicken Sandwiches, and hand-scooped Milkshakes made from 100% real ice cream.

Since its founding in 1959, Round Table Pizza has been recognized as “Pizza Royalty™” for its homemade dough made from scratch and rolled fresh daily as well as for its dedication to using gold-standard ingredients like hand-sliced vegetables, high-quality meats, and the brand’s signature three cheese blend. Each pizza is hand-crafted with legendary toppings layered to the edge of Round Table’s perfectly baked crust.

For more information on Fatburger, visit www.fatburger.com. For more information on Round Table Pizza, visit www.roundtablepizza.com.

###

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Fatburger

An all-American, Hollywood favorite, Fatburger is a fast-casual restaurant serving big, juicy, tasty burgers, crafted specifically to each customer’s liking. With a legacy spanning 70 years, Fatburger’s extraordinary quality and taste inspire fierce loyalty amongst its fan base, which includes a number of A-list celebrities and athletes. Featuring a contemporary design and ambiance, Fatburger offers an unparalleled dining experience, demonstrating the same dedication to serving gourmet, homemade, custom-built burgers as it has since 1952 – The Last Great Hamburger Stand™.

About Round Table Pizza

Inspired by the honor, valor, and revelry of the Knights of the Round Table, Round Table Pizza’s® superior pizza and commitment to quality and authenticity have earned the reputation of “Pizza Royalty™” for over 60 years. With more than 410 restaurants across the United States, Round Table celebrates community, family, and making merry. For more information, visit www.roundtablepizza.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing and performance of new store openings. Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this press release.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
[email protected]
435-760-6168

Primary Logo

Source: FAT Brands Inc.

Release – MustGrow Joins Industry Consortium “Global Alliance Against TR4” to defeat Banana Fungal Disease Fusarium wilt TR4

Posted on by [email protected]

Research News and Market Data on MGROF

Jul 9, 2024 

  • MustGrow joins alliance of international banana leaders, including Bayer, Chiquita, Del Monte, Dole, and Fyffes.
  • MustGrow is collaborating to bring its uniquely effective technologies to help address this global issue.
  • MustGrow’s mustard-derived biofungicide has shown efficacy versus TR4.

SASKATOON, Saskatchewan, Canada, July 9, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to accept membership into the Global Alliance Against TR4 (https://iica.int/en/global-alliance), an international consortium of world-leading banana players committed to defeat Fusarium wilt TR4 (“TR4”), a fungal disease jeopardizing the future of bananas.  MustGrow is collaborating to bring its uniquely effective technologies to help address this global issue, joining international banana leaders, including Bayer, Chiquita, Del Monte, Dole, and Fyffes.

“I celebrate the willingness of MustGrow to join forces in this endeavor to put an end to this hazard, and contribute in this manner to the food security and the economy of several families involved in the banana value chain,” Gabriel Rodríguez Marqués, IICA Representative in Paraguay Executive Secretariat of the Global Alliance Against TR4. “I extend my gratitude and underscore the assurances of my highest consideration.”

The deadly disease pathogen TR4 has been wreaking havoc and ravaging the $25 billion global banana industry – with infected plantations experiencing 100% loss and being quarantined for decades.  A flurry of apocalyptic media accounts are revealing a race to save bananas from extinction after the disease has left a trail of scorched banana plantations in its wake.

MustGrow vs. TR4

Under commercial partnership with Bayer, Bayer has the option to continue to build on MustGrow’s work in treating TR4.  MustGrow’s approach harnesses the natural defense mechanism of the mustard plant to develop organic, safe, and effective biofungicides and biopesticides to treat a variety of pests, fungus, and disease, including TR4.

MustGrow’s previously-disclosed work has demonstrated 100% control of TR4 in a laboratory setting of five different plate samples at five different application rates.  All 25 plates showed 100% disease control utilizing MustGrow’s biofungicide technology after a five-day period. In field trial settings, application of MustGrow’s biofungicide demonstrated positive dose response with reduced incidence and severity of TR4 symptoms in banana plants after 21 days. Importantly, even at higher application rates there was no damage or phytotoxic effects to the banana plants, allowing MustGrow to explore treating the banana plants directly, in addition to soil applications.

Sustainable innovations and green technologies are necessary to ensure agricultural production continues to address food safety and security as well as soil health. MustGrow’s rapidly developing solutions are focused on sustainable, safe, and effective, organic plant-based crop protection solutions that harness the mustard seed’s natural defense mechanism to treat diseases, pests and weeds.  MustGrow’s technology has shown consistent efficacy in multiple global regions, in multiple crops, in multiple applications, over multiple years.  The commercial development collaboration between Bayer and MustGrow demonstrates the importance of innovation in sustainable technologies in agricultural regions around the world.

Additional Sources

Bananas As We Know Them Are Doomed VICE News
Disease Is Ravaging the $25 Billion Banana Industry Bloomberg
Why The World’s Most Popular Banana May Go Extinct  Business Insider
The world’s bananas are in trouble BBC World Service
Why The Banana Business Of Chiquita And Dole Is At Risk CNBC

About Global Alliance Against TR4

At the Global Alliance Against TR4, our purpose is bringing together the world’s efforts to defeat TR4, a fungal disease jeopardizing bananas’ future. We’re a worldwide, multi-stakeholder community, uniting food brands, value chain companies, researchers, trade associations, financial services, the public sector and civil society. We recognize that TR4 is an urgent threat, and that we can fight it more effectively together than we ever could alone. As the Global Alliance, we’re co-ordinating research and training efforts at every stage, from the lab to the plantation. And we’re raising funds and awareness through our business and public engagement campaign, The Banana Action Group.

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation.  Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its Organic Materials Review Institute (OMRI Listed®) and California’s Organic Input Material (OIM) Program registered biofertility product, TerraSanteTM, in key U.S. states including California.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  MustGrow has approximately 51.6 million basic common shares issued and outstanding and 54.1 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
[email protected]

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” 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”, “occur” or “be achieved”.  Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the commencement of its membership into the Global Alliance Against TR4; the outcome or the ability of its technologies to combat TR4;; whether MustGrow’s organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide; the application of MustGrow’s biofungicide, and the efficacy of MustGrow’s technology. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow.  Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2023 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2024 MustGrow Biologics Corp. All rights reserved.

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on by [email protected]

Research News and Market Data on TNXP

July 08, 2024 5:00pm EDT

CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

Investor Contact 
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact 
Katie Dodge
LaVoieHealthScience
[email protected]
(978) 360-3151

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Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024