aweinsoff@channelchek.com, Author at Channelchek

Release – CoreCivic Enters Into New Management Contract With Hinds County

Posted on September 25, 2023September 25, 2023 by aweinsoff@channelchek.com

September 25, 2023

Continues Momentum to Increase Utilization Through Existing and New Contracts

BRENTWOOD, Tenn., Sept. 25, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today it signed a new management contract with Hinds County, Mississippi for up to 250 adult male pre-trial detainees at the Company’s 2,672-bed Tallahatchie County Correctional Facility in Tutwiler, Mississippi. The initial contract term is for two years, which may be extended for an additional year upon mutual agreement.

Damon T. Hininger, President and Chief Executive Officer commented, “We are pleased to enter into a new management contract with Hinds County and are honored to be entrusted with the care of a portion of their detainee population.”

CoreCivic currently cares for residents at the Tallahatchie County Correctional Facility from the United States Marshals Service, Vermont, South Carolina, the U.S. Virgin Islands, and Tallahatchie County.

Hininger continued, “We continue to see increasing demand for our correctional and detention solutions, evidenced by the new contract with Hinds County. The Tallahatchie County Correctional Facility is a flexible facility, which has capacity to accommodate additional government customers. We have been in discussions with additional federal, state, and local government agencies to utilize capacity in numerous of our facilities, including at the Tallahatchie facility. We have recently accepted approximately 160 additional residents from the state of Idaho under an existing contract at our Saguaro Correctional Facility in Arizona to meet their increasing needs. We have also recently signed contract extensions with the state of Vermont at the Tallahatchie facility, which was scheduled to expire September 30, 2023, with U.S. Immigration & Customs Enforcement at our Elizabeth Detention Center in New Jersey, and with the Texas Department of Criminal Justice for five residential reentry centers in Texas, all of which expired August 31, 2023, and with the state of Montana at our Crossroads Correctional Center in Montana, which expired June 30, 2023.”

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Forward-Looking Statements

This press release contains statements as to our beliefs and expectations of the outcome of future events that 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, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with: (i) changes in government policy, legislation and regulations that affect utilization of the private sector for corrections, detention, and residential reentry services, in general, or our business, in particular, including, but not limited to, the continued utilization of our correctional and detention facilities by the federal government, including as a consequence of the United States Department of Justice, or DOJ, not renewing contracts as a result of President Biden’s Executive Order on Reforming Our Incarceration System to Eliminate the Use of Privately Operated Criminal Detention Facilities, impacting utilization primarily by the BOP and the United States Marshals Service, and the impact of any changes to immigration reform and sentencing laws (we do not, under longstanding policy, lobby for or against policies or legislation that would determine the basis for, or duration of, an individual’s incarceration or detention); (ii) our ability to obtain and maintain correctional, detention, and residential reentry facility management contracts because of reasons including, but not limited to, sufficient governmental appropriations, contract compliance, negative publicity and effects of inmate disturbances; (iii) changes in the privatization of the corrections and detention industry, the acceptance of our services, the timing of the opening of new facilities and the commencement of new management contracts (including the extent and pace at which new contracts are utilized), as well as our ability to utilize available beds; (iv) general economic and market conditions, including, but not limited to, the impact governmental budgets can have on our contract renewals and renegotiations, per diem rates, and occupancy; (v) fluctuations in our operating results because of, among other things, changes in occupancy levels; competition; contract renegotiations or terminations; inflation and other increases in costs of operations, including a continuing rise in labor costs; fluctuations in interest rates and risks of operations; (vi) the impact resulting from the termination of Title 42, the federal government’s policy to deny entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of the coronavirus and related variants, or COVID-19; (vii) our ability to successfully identify and consummate future development and acquisition opportunities and realize projected returns resulting therefrom; (viii) our ability to have met and maintained qualification for taxation as a real estate investment trust, or REIT, for the years we elected REIT status; and (ix) the availability of debt and equity financing on terms that are favorable to us, or at all. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.

We take no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

Contact:	Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
	Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204

Release – Bitcoin Depot Announces Share Repurchase Program

Posted on September 22, 2023September 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BTM

September 22, 2023 08:30 ET

ATLANTA, Sept. 22, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced that its Board of Directors has authorized a share repurchase program pursuant to which the Company is authorized to repurchase up to $10 million of outstanding shares of its Class A common stock beginning immediately and continuing through and including June 30, 2024.

Pursuant to the authorization, repurchases may be made from time to time using a variety of methods, including open market purchases, privately negotiated transactions or by other means in accordance with U.S. securities laws and regulations, including pursuant to Rule 10b-18 and under plans intended to qualify under Rule 10b5-1 of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”). The timing and total amount of share repurchases will be determined by the Company at its discretion and will depend upon a variety of factors, including business, economic and market conditions, corporate and regulatory requirements, management’s assessment of the intrinsic value of the Company’s Class A common stock, available liquidity, compliance with the Company’s debt and other agreements and prevailing stock prices. The exact dollar amount or number of shares to be repurchased by the Company is not guaranteed, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund repurchases with cash on hand and cash provided by operations.

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’s kiosks and at thousands of name-brand retail locations in 48 U.S. states through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of June 30, 2023. 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 and our proposed share repurchase program and the projected timing, purchase price and number of shares purchased under such program, if at all. 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
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com

Release – ZyVersa Therapeutics Announces Research Published in The Journal of Clinical Investigation Reinforcing IC 100’s Rationale for Inhibiting ASC Specks to Attenuate Spread of Inflammation into Surrounding Tissues

Posted on September 22, 2023September 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Sep 22, 2023

Patients with chronic kidney disease (“CKD”) exhibit chronic systemic inflammation characterized by increased circulating levels of IL-1β, IL-6, and CRP.
This study demonstrated that CKD-induced IL-1β activates NLRP3 inflammasomes in the heart’s atria to trigger inflammation promoting the onset and progression of atrial fibrillation (“AF”).
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit inflammasomes and their associated extracellular ASC specks to attenuate propagation of IL-1β that triggers damaging inflammation and its spread to surrounding tissues.

WESTON, Fla., Sept. 22, 2023 (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 publication of a paper in the peer-reviewed Journal of Clinical Investigation highlighting how inflammation in the kidneys can trigger inflammation in the heart.

In the paper titled, “Chronic kidney disease promotes atrial fibrillation via inflammasome pathway activation,” the authors conducted a study in mouse models of CKD and in-vitro studies with serum from CKD patients and atrial samples from CKD and other patients undergoing open heart surgery. Data from the research indicate that CKD creates a substrate (IL-1β) that activates NLRP3 inflammasomes in the heart’s atria triggering damaging inflammation associated with adverse atrial remodeling and dysfunction leading to AF.

The authors stated, “Together, these findings support the idea that CKD-induced systemic inflammatory factors activate the atrial NLRP3 inflammasome thereby promoting the onset of AF. This hypothesis is supported by the fact that genetic ablation of NLRP3 protected against abnormal atrial activation, atrial fibrosis and atrial enlargement induced by CKD.” To read the article, Click Here.

ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple inflammasomes, including NLRP3, and their associated ASC specs to attenuate release and perpetuation of circulating IL-1β to control inflammation in various inflammatory diseases.

“The research published in The Journal of Clinical Investigation reinforces the importance of attenuating extracellular propagation of IL-1β to minimize induction and perpetuation of inflammation in surrounding tissues,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade, and to inhibit their associated ASC specks to reduce perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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, 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.

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 renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. 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 and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Direct Digital Holdings Announces Extension of the Expiration of the Previously Commenced Offer to Purchase and Consent Solicitation Relating to its Warrants

Posted on September 22, 2023September 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on DRCT

September 21, 2023 5:00pm EDTDownload as PDF

HOUSTON, Sept. 21, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company has extended the expiration date of its previously commenced offer to purchase (the “Offer”) all of its outstanding publicly traded warrants (the “Warrants”) to purchase shares of its Class A common stock, par value $0.001 per share, at a purchase price of $1.20 in cash, without interest, to one minute after 11:59 p.m., Eastern Time, on September 28, 2023, unless the Company, in its discretion, extends the period of time during which the Offer will remain open.

As of September 21, 2023, approximately 95 Warrants have been validly tendered and not validly withdrawn from the Offer, representing 0.003% of the outstanding Warrants. Warrant holders who have validly tendered and not withdrawn their Warrants do not need to re-tender their Warrants or take any other action in response to the extension of the tender offer.

Direct Digital Holdings is also soliciting consents (the “Consent Solicitation”) to amend the Warrant Agent Agreement, dated as of February 15, 2022 (the “Warrant Agreement”), by and between Direct Digital Holdings and Equiniti Trust Company, LLC (formerly American Stock Transfer & Trust Company, LLC (the “Transfer Agent”), which governs all of the Warrants, to permit Direct Digital Holdings to redeem each outstanding Warrant for $0.35 in cash, without interest, which is approximately 71% less than the price applicable to the Offer (such amendment, the “Warrant Amendment”). Pursuant to the terms of the Warrant Agreement, the adoption of the Warrant Amendment will require the consent of holders of at least 50.1% of the outstanding Warrants. In order to tender the Warrants in the Offer and receive $1.20 in cash for each of their Warrants, holders of the Warrants are required to consent to the Warrant Amendment. Tendered Warrants may be withdrawn by holders at any time prior to the Expiration Date. The Company’s obligation to complete the Offer is conditioned on the tender of at least 50.1% of the outstanding Warrants.

The Offer and Consent Solicitation are being made pursuant to a Second Amended and Restated Offer to Purchase dated September 21, 2023, and Schedule TO, originally filed on August 29, 2023, as amended and supplemented, each of which has been filed with the SEC and more fully set forth the terms and conditions of the Offer and Consent Solicitation.

The Company’s Class A common stock and Warrants are listed on The Nasdaq Stock Market LLC under the symbols “DRCT” and “DRCTW,” respectively. As of August 29. 2023, a total of 3,217,800 Warrants were outstanding.

Stifel, Nicolaus & Company, Incorporated has been appointed as the Dealer Manager for the Offer and Consent Solicitation, D.F. King, Co., Inc. (“D.F. King”) has been appointed as the Information Agent for the Offer and Consent Solicitation, and Equiniti Trust Company, LLC has been appointed as the Depositary for the Offer and Consent Solicitation. All questions concerning tender procedures and requests for additional copies of the offer materials, including the letter of transmittal and consent should be directed to D.F. King.

Important Additional Information Has Been Filed with the SEC

Copies of the Schedule TO and Offer to Purchase will be available free of charge at the website of the SEC at www.sec.gov. Requests for documents may also be directed to D.F. King at (866) 796-1290 (toll-free) or drct@dfking.com.

This announcement is for informational purposes only and shall not constitute an offer to purchase or a solicitation of an offer to sell the Warrants. The Offer and Consent Solicitation are being made only through the Schedule TO and Offer to Purchase, and the complete terms and conditions of the Offer and Consent Solicitation are set forth in the Schedule TO and Offer to Purchase.

Holders of the Warrants are urged to read the Schedule TO and Offer to Purchase carefully before making any decision with respect to the Offer and Consent Solicitation because they contain important information, including the various terms of, and conditions to, the Offer and Consent Solicitation.

None of Direct Digital Holdings, any of its management or its board of directors, or the Dealer Manager or the Information Agent or Depositary or any other person makes any recommendation as to whether or not Warrant holders should tender Warrants for exchange in the Offer or consent to the Warrant Amendment in the Consent Solicitation. Warrant holders must make their own decision as to whether to tender their Warrants and, if so, how many Warrants to tender.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 136,000 clients monthly, generating approximately 250 billion impressions per month across display, CTV, in-app and other media channels.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to the Company. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; the satisfaction of the conditions to the Offer, including the minimum tender condition; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts:

Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com

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SOURCE Direct Digital Holdings

Released September 21, 2023

Release – Snail, Inc. Announces the Launch of the ARKade Ambassador Program

Posted on September 22, 2023September 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SNAL

September 22, 2023 at 7:52 AM EDT

PDF Version

CULVER CITY, Calif., Sept. 22, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, today announced the launch of ARKade Ambassador Program (the “Program”) in collaboration with the Company’s partners, Noiz and Studio Wildcard. This Program, of limited duration, will continue until the year’s end, and pre-registration will commence on September 21st.

Designed in alignment with the upcoming release of ARK: Survival Ascended, the Program is tailored to offer influencers and streamers a unique and engaging streaming experience. Participants will receive an early access code to the game and can undertake specific activities to earn digital tickets (or points), which can then be redeemed for bespoke rewards including, but not limited to, custom ARK merchandise, streaming equipment, and PC components. In addition, each participant will automatically be enrolled in a grand giveaway and raffle. Detailed information about the ARKade Ambassador Program is available on the official ARKade pre-registration website.

Jim Tsai, Chief Executive Officer of Snail, commented: “Reimagining the classic arcade concept as ARKade offers an innovative approach to connecting with the player community. We expect this initiative bolstering the prominence of ARK: Survival Ascended while enabling content creators to produce unique content and enhance player engagements. Our commitment remains steadfast in exploring fresh strategies to elevate player engagement and deliver unparalleled experiences.”

About Snail, Inc.

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:

investors@snail.com

Release – Ocugen, Inc. Announces Connie Collingsworth Joins Business Advisory Board

Posted on September 21, 2023September 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 21, 2023

MALVERN, Pa., Sept. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Connie Collingsworth, former Chief Operating Officer of the Bill and Melinda Gates Foundation, will join the Company’s Business Advisory Board (BAB). The BAB was established in June 2023 to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.

“Connie brings value-added expertise in all aspects of strategic growth and organizational governance—across a variety of industries—that will offer unique insights to the BAB,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “Connie’s deep financial background at a global level will provide meaningful counsel to Ocugen as we pursue new business development opportunities to support and evolve our clinical programs.”

Ms. Collingsworth has been a primary advisor to Bill Gates, Melinda French Gates, and Warren Buffett regarding governance. During her tenure with the Bill and Melinda Gates Foundation, she designed and implemented the core operational infrastructure and created the intellectual property strategy known as “Global Access,” as well as advising on the creation of a $2.5 billion strategic investment fund.

“I am inspired by Ocugen’s commitment to not only developing novel therapies that address unmet medical needs for patients with serious conditions, but their passion to ensure access to all patients around the world,” said Ms. Collingsworth. “I look forward to sharing my diverse experiences as an executive and a board member so that patients can potentially benefit.”

Ms. Collingsworth joins Senator Pat Toomey, Ambassador Joseph W. Westphal, Ph.D., and Dennis Carey, Ph.D. on the BAB. These advisors will work alongside the Executive Leadership Team to offer guidance to enable the Company to fulfill its mission and achieve its short- and long-term strategy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com

Source: Ocugen

Release – Great American Cookies And Marble Slab Creamery Announce March Of Dimes Partnership Spotlighting NICU Awareness Month

Posted on September 21, 2023September 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FA T

09/21/2023

Milestones Matter! Cookie and Ice Cream Franchises Announce Partnership to Support Mom and Baby Nonprofit

LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) — Great American Cookies, the Original Cookie Cake franchise, and Marble Slab Creamery, the imaginative small-batch ice cream brand, proudly announce their partnership with March of Dimes, the leading nonprofit fighting for the health of moms and babies. Tapping into the brands’ synergies of celebrating family milestones, the three organizations will join forces to honor Neonatal Intensive Care Unit (NICU) patients, their families, and the healthcare professionals caring for them.

To celebrate heroic NICU employees on Sept. 28, NICU Staff Appreciation Day, Great American Cookies and Marble Slab Creamery will provide a sweet surprise to select NICU teams around the country by delivering Original Cookie Cakes and Ice Cream Cakes. In honor of NICU Awareness Day on Sept. 30, Great American Cookies and Marble Slab Creamery will donate $1 to March of Dimes for every purchase made in-store or online. Additionally, customers who order Cookie Cakes or Ice Cream Cakes online on Sept. 30 (and pick up no later than Oct. 7) receive $3 off their Cookie Cake or IceCream Cake with code.

Many babies will spend their earliest days in the NICU due to preterm birth, birth defects, surgical or genetic conditions, or other diagnosis. This time can be stressful and overwhelming for families. The funds raised will help further March of Dimes’ critical support for families through programs like the NICU Family Support^® program, which offers family education, staff training on family-centered care and an improved patient experience.

“With 1 in 10 babies born preterm each year, many of whom will spend time in the NICU, we appreciate the remarkable impact NICU staff have on families,” said Jenn Johnston, Chief Marketing Officer at FAT Brands, Inc. “At Marble Slab Creamery and Great American Cookies, we love sharing milestone moments with families, whether it’s a birthday or first steps – every milestone is worth celebrating. We have the perfect Cookie Cakes and Ice Cream Cakes to do just that! We are proud to raise funds to further the March of Dimes mission to improve the health of all moms and babies.”

“For more than 20 years, March of Dimes has been there for families with a baby in the NICU and as they transition home, offering the support and education they need, right when they need it,” said Kelly Ernst, March of Dimes Senior Vice President, Chief Revenue and Impact Officer. “This NICU Awareness Month, we are inspired by Great American Cookies and Marble Slab Creamery’s commitment to celebrate the dedicated staff that work so hard to take care of thousands of families each year with support from our hospital partners across the country as part of their exciting Milestones Matter initiative.”

For nearly 40 years, Marble Slab Creamery has been an innovator in the ice cream space, dreaming up the frozen slab technique and offering homemade, small-batch ice cream with free unlimited mix-ins, shakes in a variety of flavors, and ice cream cakes.

Since 1977, Great American Cookies has baked up a reputation for not only being the creator of the Original Cookie Cake, but also for its famous chocolate chip cookie recipe. Other craveable menu items include brownies and Double Doozies™, made with delectable icing sandwiched between two cookies.

To donate directly to the cause, please visit the brands’ Milestones Matter website. For more information on Great American Cookies, visit www.greatamericancookies.com. For more information on Marble Slab Creamery, visit www.marbleslab.com. The brands are thankful to partners Southern Champion Tray and Specialty Box & PACKING CO. for enabling this partnership and donation.

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 dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, 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 Great American Cookies
Founded on a family chocolate chip cookie recipe in 1977, Great American Cookies believes that pure, simple delight is part of living a full life. Serving the Original Cookie Cake, fresh baked cookies in a variety of flavors, brownies, and Double Doozies^™, we promise to treat you to bites of bliss that prove how sweet life can be. With more than 400 bakeries across the country and internationally in Bahrain, Guam, Saudi Arabia, and treats available to ship right to your door, the sweet spot is always close to home. For more information, visit www.greatamericancookies.com.

About Marble Slab Creamery
Since dreaming up the frozen slab technique and serving fresh homemade, small-batch Ice Cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite Ice Cream possibilities to feed your curiosity and capture cravings. With our always free mix-in philosophy, delicious Ice Cream and Shakes in a variety of flavors, hand-rolled waffle cones, and Ice Cream Cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Canada, Kuwait, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.

About March of Dimes
March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs, and provide education and advocacy so that every family can have the best possible start. Building on a successful 85-year legacy, we support every pregnant person and every family. To learn more about March of Dimes, please visit marchofdimes.org.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Source: FAT Brands Inc.

Release – Tonix Pharmaceuticals Presents New Preclinical Data at Seventh International Cancer Immunotherapy Conference 2023

Posted on September 21, 2023September 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 21, 2023 7:00am EDT

mTNX-1700 (mTFF2-MSA) suppresses tumor growth and increases survival rates in preclinical colorectal cancer models

mTNX-1700 shows single agent activity and additive effects in combination with anti-PD-1

mTNX-1700 targets myeloid-derived suppressor cells (MDSCs) in a novel mechanism to treat cancer

CHATHAM, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation showing research results for mTNX-1700 (murine trefoil factor family member 2- murine serum albumin, or mTFF2-MSA) at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival, being held September 20-23, 2023, in Milan, Italy. The poster is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The poster presentation, titled, “mTFF2-MSA (mTNX-1700) Suppresses Tumor Growth and Increases Survival in Anti-PD-1 Treated CT26.WT Subcutaneous and CT26-Luciferase Orthotopic Syngeneic Colorectal Cancer Models by Targeting MDSCs in BALB/C Mice,” includes data demonstrating that the novel fusion protein, mTNX-1700 has single agent activity and can improve on the therapeutic effects of anti-PD-1 in treating syngeneic mouse models of advanced colorectal cancer. In two models, mTNX-1700 increases survival rates and suppresses tumor growth. Additive tumor growth suppression effects were observed when mTNX-1700 and anti-PD-1 were used in combination.

“mTNX-1700 is a novel fusion protein that has single agent activity and augments PD-1 blockade therapy in combination therapy in advanced and metastatic syngeneic mouse models of colorectal and gastric cancer,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Certain cancers are unresponsive to anti-PD-1 therapy. Despite the significance of PD-1 checkpoint blockade in treating many types of cancer, there’s a need to better understand why some cancers don’t respond and how to make them responsive. We believe these data show the potential of TNX-1700 in treating cancer both as a single agent and in combination with other immuno-oncology drugs, particularly anti-PD-1, and highlight how mTNX-1700 targets MDSCs as a novel mechanism to treat cancer.”

About Trefoil Factor Family Member 2 (TFF2)

Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 (rTFF2-HSA) for the treatment of gastric and colon cancers under a license from Columbia University. The inventor of the core technology at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8⁺ T cells.¹ He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth.² Dr. Wang proposed the concept of employing rTFF2 in combination with other therapies in cancer prevention and early treatment. Dr. Wang presented data at the American Association for Cancer Research (AACR) conference as a collaboration between Tonix and Columbia University in 2020 that includes data from a preclinical study which investigated the role of PD-L1 in colorectal tumorigenesis and evaluated the utility of targeting myeloid-derived suppressor cells (MDSCs) in combination with PD-1 blockade in mouse models of colorectal cancer. The data show that anti-PD-1 monotherapy was unable to evoke anti-tumor immunity in this model of colorectal cancer, but mTFF2-CTP augmented the efficacy of anti-PD-1 therapy. Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice.

¹Dubeykovskaya ZA et al, Nat Commun 2016
²Kim W et al, Gastroenterology 2021

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourthquarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released September 21, 2023

Release – GeoVax Next-Generation COVID-19 Vaccine Data Presented at Keystone Symposia Conference

Posted on September 20, 2023September 20, 2023 by aweinsoff@channelchek.com

Research News ad Market Data on GOVX

Preclinical Data for GEO-CM02 Demonstrates Single-Dose Protection

Against Multiple SARS-CoV-2 Variants

Atlanta, GA, September 20, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen SARS-CoV-2 vaccine. The new unpublished data were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, being held in Atlanta, Georgia on September 17-20, 2023.

Presentation Details & Summary:

Abstract Title: MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models

Abstract Authors: Shannon Stone¹, Amany Elsharkawy¹, Janhavi Natekar¹, Sreenivasa Rao Oruganti², Mary Hauser², Arban Domi², Pratima Kumari², Anchala Guglani¹, Mark Newman², and Mukesh Kumar¹

¹ Georgia State University ² GeoVax Labs, Inc.

Presenting Author: Shannon Stone, Georgia State University

First-generation SARS-CoV-2 vaccines based on the spike (S) protein induce neutralizing antibodies provide significant levels of protection. However, vaccine efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring updating and booster doses. To address this limitation, GeoVax has designed multi-antigen SARS-CoV-2 vaccines based on the S, membrane (M), and envelope (E) proteins, which are designed to engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity. Efficacy of the vaccine, designated GEO-CM02, was tested using the industry standard, lethal hACE2 transgenic mouse model.

The poster presentation (viewed here), highlighted the following data:

The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.

Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant.

Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer, commented, “As noted in this presentation, the first-generation SARS-CoV-2 vaccines were designed based on the S protein of the SARS-CoV-2 virus with the goal of inducing neutralizing antibodies. While this approach was successful, the limitations in the face of continually emerging variants are now well documented. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. The multi-antigen, MVA-vectored vaccine design is currently being evaluated by GeoVax in three Phase 2 clinical trials using a similar vaccine (GEO-CM04S1).”

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^®, presently 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.

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Release – Fazoli’s Opens Second Little Rock Location

Posted on September 20, 2023September 20, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FAT

09/20/2023

Download(opens in new window)

Hot and Fresh Breadsticks Now Cooking on the West Side

LOS ANGELES, Sept. 20, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, has opened its second location in Little Rock. Located at 11410 W. Markham St., the location is now serving up its beloved hot and buttery breadsticks and signature Italian dishes including pasta, subs, salads and pizzas.

“We have loved serving the Little Rock community and look forward to making our fast and fresh Italian offerings more convenient to the west side of town,” said Doug Bostick, President at Fazoli’s. “Our second location in Little Rock is just the beginning of our commitment to growth in Arkansas, so stay tuned for more updates.”

Since 1988, Fazoli’s has been committed to serving quality Italian food, fast, fresh, and friendly. From unlimited signature breadsticks to freshly prepared pasta entrees, the chain prides itself on serving high-quality menu offerings, all at an affordable price.

The Little Rock Fazoli’s is located at 11410 W. Markham St. Little Rock, AR 72212. Drive-thru and dine-in are open 10:30 a.m. to 10 p.m., seven days a week.

For more information, visit Fazolis.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 dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, 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 fatbrands.com.

About Fazoli’s

Fast. Fresh. Italian. Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, sub sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. For more information, visit www.Fazolis.com.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Release – PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

Posted on September 20, 2023September 20, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PDS0202 (Infectimune^® + COBRA influenza antigens) vaccination also prevented illness/weight loss
Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
Data from Cleveland Clinic’s Ted Ross Lab presented at the 9^th ESWI Influenza Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9^th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

“We are encouraged that PDS0202 has demonstrated activity in generating protective hemagglutination inhibition assay (HAI) antibody responses in pre-immune ferret studies, which are the gold standard in influenza vaccine testing. In addition to active neutralization of various influenza strains, the data demonstrated that PDS0202 prevented illness, weight loss and importantly protected the lungs of vaccinated animals from H1N1,” said Dr. Ross. “In humans, we expect PDS0202 to elicit a similar or more broadly reactive antibody profile due to humans having broader exposure to influenza and thus the recall of a more diverse population of memory B cells than the animals evaluated in our preclinical studies.”

H3N2 HAI Response

^{Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.}

H1N1 Infection Results: D3 Nasal Wash Viral Titers

^{PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.}

PDS0202 combines PDS Biotech’s Infectimune^® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens. The COBRA antigens developed in the laboratory of Dr. Ted Ross were designed using an in-silico layered consensus building approach, which utilizes HA sequence data from influenza surveillance databases. PDS0202’s ability to generate broad, robust antibody and T cell responses position the vaccine to potentially provide durable protection against seasonal and pandemic strains of influenza. PDS0202 is administered through intramuscular injection in a single dose.

“We are pleased that the PDS0202 data presented at the ESWI Influenza Conference are consistent with our previously reported preclinical studies in murine models, marking encouraging progress toward a potential universal influenza vaccine,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “We look forward to our continued discussions with the National Institute of Allergy and Infectious Diseases to advance PDS0202 into clinical trials with the goal of creating a universal vaccine that provides broad protection against multiple strains of influenza.”

In previous preclinical studies, PDS0202 demonstrated the ability to promote robust induction of broadly neutralizing influenza-specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T cells, as well as long-lasting memory T cells. This robust immune response to the COBRA antigens suggests strong potential for PDS0202 as a broad and long-term protecting universal influenza vaccine.

About Infectimune^®
Infectimune^® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune^® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune^® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/322b8fdb-bf6b-4c74-96c9-81b581f74513

https://www.globenewswire.com/NewsRoom/AttachmentNg/f7fe4fb9-3936-4f2b-9673-f571604ed43

Release – Ocugen To Participate in Panel At Cantor Fitzgerald Global Healthcare Conference 2023

Posted on September 20, 2023September 20, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 20, 2023

PDF Version

MALVERN, Pa., Sept. 20, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen will participate in a panel at the annual Cantor Fitzgerald Global Healthcare Conference taking place from September 26-28, 2023 in NYC.

On the panel, Dr. Musunuri will join the CEO of Tarsier Pharma to discuss their companies’ respective work toward developing novel therapies for hard-to-treat ocular diseases. In addition, members of Ocugen’s executive team will conduct one-on-one meetings with registered investors, to showcase the Company’s business and clinical development strategy across its unique gene therapy, cell therapy, and vaccine platforms, and highlight recent corporate achievements and anticipated milestones.

Details of the presentation are as follows:

Date: Tuesday, September 26, 2023
Presentation Time: 1 p.m. ET
Location: Track 1, InterContinental Barclay Hotel, New York City

A live video webcast of the fireside chat will be available on the events page of the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com 

Release – ACCO Brands Publishes 2022 Environmental, Social and Governance (ESG) Report

Posted on September 19, 2023September 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ACCO

09/18/2023

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) a leading global consumer, technology, and business branded products company, today published its 2022 Environmental, Social and Governance (ESG) Report.

“At ACCO Brands, we are committed to operating our business with the highest ethical standards. We foster accountability to our stakeholders with strong governance and risk management policies and practices,” noted Tom Tedford, President, and Chief Operating Officer. “Our ESG report highlights our progress in delivering on our commitments to our employees, the environment, and the communities in which we live and work. Our work is organized under the pillars of People, Planet and Products and is guided by our long-standing values: to act with integrity, embrace diversity and act responsibly in our global community,” concluded Mr. Tedford.

To access the Company’s 2022 ESG Report and learn more about the Company’s ESG efforts, read the full report by clicking here.

About ACCO Brands

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

Lori Conley
Corporate Communications
lori.conley@acco.com

Source: ACCO Brands Corporation