Author: aweinsoff@channelchek.com

Release – CoreCivic Announces 2023 Third Quarter Earnings Release and Conference Call Dates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CXW

October 18, 2023

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BRENTWOOD, Tenn., Oct. 18, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2023 third quarter financial results after the market closes on Monday, November 6, 2023. A live broadcast of CoreCivic’s conference call will begin at 11:00 a.m. central time (12:00 p.m. eastern time) on Tuesday, November 7, 2023.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BI3e522c1e25f444ec98977db80437da4f. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.

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 believe we are the largest private owner of real estate used by government agencies 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.

Contact:Investors: David Garfinkle – Chief Financial Officer – (615) 263-3008
 Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – Baudax Bio Announces Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BXRX

October 18, 2023 8:00am EDT

Company Poised to Initiate TI-168 Clinical Development Following Recent Shareholder Approval of Corporate Actions Related to TeraImmune Acquisition

Phase 1/2a Clinical Study of TI-168 In Hemophilia A with FVIII Inhibitors Projected to Begin Q1 2024

MALVERN, Pa., Oct. 18, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that following recent shareholder approval of corporate actions related to its June 29 2023 acquisition of TeraImmune, the Company is now poised to initiate clinical development of TI-168, the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors. The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.

“We are very pleased with the broad support received in last week’s special shareholder meeting, during which shareholders approved all remaining issues related to our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We believe this combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value. With shareholder support now secured, we can finalize our preparations for initiating a Phase 1/2a clinical study of TI-168 in Hemophilia A patients in Q1 of 2024.”

Stewart Mc Callum, MD, Consulting Chief Medical Officer for Baudax, added, “TI-168 is a TCR Treg designed to eliminate autoantibodies to Factor VIII in Hemophilia A patients, which significantly complicates the management of Hemophilia A. This product candidate previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA. Since our trial has an open label design, we anticipate early visibility on tolerability and initial efficacy data.”

“This trial represents the first time that TCR Tregs will be in a human clinical trial, and will seek to establish a dose where TI-168 eliminates T-cell and B cell mediated production of autoantibodies, demonstrating the potential of TI-168 to make Hemophilia A much less complicated for patients with inhibitors to manage. We are very excited for the opportunity to work toward this potential improvement to patient quality of life, and to deliver enhanced value for our shareholders and other stakeholders,” concluded Ms. Henwood.

About Baudax Bio

Baudax Bio is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibitors.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released October 18, 2023

Release – Direct Digital Holdings Appoints Diana Diaz as Chief Financial Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 18, 2023 9:00am EDT

HOUSTON, Oct. 18, 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 appointed Diana Diaz, who had been serving as the Company’s interim Chief Financial Officer, as permanent Chief Financial Officer, effective October 16, 2023.

Ms. Diaz served as interim Chief Financial Officer of Direct Digital Holdings beginning June 5, 2023. As permanent Chief Financial Officer, she will continue to lead the Company’s finance, accounting and treasury organization and report directly to the Company’s Chief Executive Officer.

Mark D. Walker, Chairman and Chief Executive Officer, commented, “We are grateful for the hard work and dedication Diana has provided our team over the past several months and greatly excited to appoint her as our permanent Chief Financial Officer. She has been a trusted partner and an excellent leader of our finance division. With the help of her leadership and financial acumen, we are now more confident than ever in our team’s ability to execute our various strategies for growth in the coming months and years.”

Ms. Diaz joined the Company from Sharps Compliance Corp. (previously Nasdaq listed (SMED)) until its acquisition, a leading national healthcare waste management provider to customers in multiple healthcare-related markets, specializing in regulated waste streams including medical, pharmaceutical and hazardous, where she served for a total of 13 years, including as Vice President and Chief Financial Officer from June 2010 to February 2022. Ms. Diaz’s prior positions include Chief Financial Officer of University General Hospital in Houston, Texas from September 2006 to May 2009, Controller at Memorial Hermann Healthcare System, Texas Medical Center from September 2002 to August 2006 and Controller of the wholesale group at Reliant Energy from July 1998 to May 2002. Ms. Diaz received her BBA in Accounting from The University of Texas at Austin and her MBA from Rice University’s Jesse H. Jones Graduate School of Management.

Ms. Diaz said of her appointment, “This is a very exciting time to have joined Direct Digital Holdings. As Chief Financial Officer, I will continue to work closely with my fellow executive team members to capitalize on the Company’s strategic position and current favorable market dynamics to continue our growth. I am grateful for this appointment and look forward to continuing my work with this incredible team.”

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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; 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.

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.

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

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SOURCE Direct Digital Holdings

Released October 18, 2023

Research – ZyVersa Therapeutics Announces a Publication in the Peer-Reviewed Journal, Aging, Linking Inflammasome NLRP3 Activation with Age-Related Structural Changes in the Kidney and Reduced Kidney Function

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 18, 2023

  • Chronic kidney disease is most common in people 65 years and older.
  • NLRP3 inflammasomes signaling in the kidneys’ filtration system (“glomerular podocytes”) occurs as early as middle age, leading to scarring, podocyte loss, and impaired function, which may be a critical contributor to a lower threshold for developing kidney disease in older people.
  • Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.

WESTON, Fla., Oct. 18, 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 an article in the peer-reviewed journal, Aging, demonstrating that inflammasome NLRP3 activation is associated with an age-related decline in kidney health, which is compounded in the presence of kidney disease resulting in worsening outcomes.

In the paper titled, “Inhibiting NLRP3 signaling in aging podocytes improves their life-and health-span,” the authors conducted studies in various mouse models, human kidney tissues, and human kidney organoids. Data demonstrate a critical role for NLRP3 inflammasomes in age-related kidney deterioration, which is exacerbated in the presence of kidney disease. Following are key findings reported in the paper:

  • Glomerular NLRP3 levels in human kidney tissue were associated with pathological changes in the kidneys’ filtration system: higher levels of glomerular scarring (glomerulosclerosis) and enlargement (hypertrophy), and reduced podocyte density.
  • Glomerular NLRP3 inflammasome levels were higher in aged mice with experimental focal segmental glomerulosclerosis (FSGS) compared to age-matched mice without disease, indicating that FSGS injury augments the age-dependent increase of NLRP3 signaling.
  • NLRP3 inflammasome signaling and its effects on podocytes may be a critical contributor to a lower threshold for developing kidney disease in older people.
  • Reduction in NLRP3 signaling, either pharmacologically or by gene deletion, in human kidney organoids and in middle-aged mice decreased age-associated podocyte injury.

The authors stated, “By showing that in aged mice with experimental FSGS, injury augments the age-dependent increase of NLRP3 signaling, it makes this pathway an intriguing therapeutic target for podocyte (kidney) diseases in the elderly.” To read the article, Click Here.

“The research published in the Journal, Aging, demonstrates that age-related NLRP3 inflammasome signaling in the kidneys’ filtration system leads to scarring and podocyte loss, which are exacerbated when superimposed by kidney disease, leading to poorer outcomes,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “This research provides support for inflammasome inhibition as a promising treatment option for kidney disease, which is most common in the elderly. ZyVersa is developing Inflammasome ASC inhibitor IC 100. Unlike NLRP3 inhibitors, designed to inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, IC 100 was designed to inhibit formation of multiple types of inflammasomes, and to uniquely inhibit their associated ASC specks to block 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

Research – Tonix Pharmaceuticals Announces Publication of Data in the Journal Nature Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) for the Prevention of Rejection in Kidney Xenotransplantation in Animal Models

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 18, 2023 7:00am EDT

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

TNX-1500 is Enrolling in a Phase 1 Clinical Trial

Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication: Multiple Other Indications, including Autoimmune Disorders, are Planned

CHATHAM, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that a study published in the Journal Nature1 by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with biotechnology company, eGenesis, utilized TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal antibody [mAb]) as part of the immune modulating regimen to prevent organ transplant rejection. Tonix’s TNX-1500 is in development for the prevention of human kidney organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154.

TNX-1500 was invented and developed in-house by Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, and colleagues. TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. Preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft and xenograft organ rejection and was well tolerated. The research in the Nature paper was conducted at MGH, led by principal investigator Tatsuo Kawai, M.D., Professor of Surgery, Harvard Medical School and the Center for Transplantation Science. A “News and Views” editorial2 and a News3 story appeared in the same issue of Nature.

The Nature article titled, “Design and testing of a humanized porcine donor for xenotransplantation” includes data that provide additional support for TNX-1500’s activity in preventing pig xenograft organ rejection and for its tolerability in non-human primates. Because anti-CD40L treatment is widely recognized as critical to the success of xeno organ transplant, no animals were transplanted without anti-CD40L treatment. Four of the transplanted animals received prophylactic treatment with TNX-1500. The other animals were treated with a primate-adapted version of mAb 5c8, which is an earlier antibody that was also discovered by Dr. Lederman, when he was an assistant professor at Columbia University.4 The primate-adapted 5c8 anti-CD40L mAb5 has been provided to qualified researchers at a nominal charge for more than 20 years in an National Institute of Health (NIH)-funded program called the “Non-human Primate Reagent Resource Center” (NHPRRC).

“The animal study described in the Nature publication1 supports the growing evidence that the protein engineering behind the invention of TNX-1500 resulted in a dimeric antibody that retains activity to prevent rejection and preserve graft function. These and other data6,7 confirm the rationale for us to pursue development of TNX-1500 to prevent rejection in human transplantation,” said Dr. Lederman. “We are currently enrolling in a Phase 1 trial with TNX-1500 in healthy volunteers to support the development of TNX-1500 for the prevention of allograft rejection. There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection.”

Dr. Lederman added, “Our primary focus of early development will be allotransplantation in which the donor organ comes from a human volunteer or cadaver. However, long term we hope to develop TNX-1500 for xenograft transplantation in which the donor organ comes from genetically engineered pigs. Several lines of research indicate that anti-CD40L is required for long term xenograft acceptance. I believe it is unlikely for human xenotransplantation to proceed without CD40L blockade. In addition, anti-CD40L monoclonal antibodies have demonstrated efficacy in autoimmune diseases like systemic lupus erythematosus and Sjögren’s Syndrome.”

About TNX-1500

TNX-1500 (Fc-modified anti-CD40L mAb) is a humanized dimeric monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases including multiple sclerosis and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is currently enrolling. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. The disulfide-linked dimeric structure is similar to natural antibodies and in the case of anti-CD40L is believed to confer to TNX-1500 a higher avidity for cell-associated CD40L, relative to soluble CD40L. Two articles were recently published in the American Journal of Transplantation that demonstrate TNX-1500 prolongs nonhuman primate renal and heart allograft survival6,7. Other anti-CD40L mAbs are in development for treating systemic lupus erythematosus, Sjögren’s syndrome and multiple sclerosis.8-10 CD40-L is a member of the TNFα super gene family. Other members have been the targets of successful mAb: TNFα and RANKL for autoimmune diseases and osteoporosis, respectively. Other TNFα super gene family members are targeted by mAbs in development including, TNF-like ligand 1A (TL1A) and CD30L for ulcerative colitis.

  1. Anand R.P., et al. Nature. 2023. 622, 393–401.
  2. Mohiuddin M. Nature. News and Views. 2023. “Pig-to-primate organ transplants require genetic modifications of donor.”
  3. Kozlov M. Nature. New, 2023. “Monkey survives two years after gene-edited pig-kidney transplant.”
  4. Lederman S, et al. J Exp Med. 1992. 175(4):1091-101.
  5. NHPRRC anti-CD154 clone 5C8H1D MassBiologics PR-1547
  6. Lassiter G., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
  7. Miura S., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
  8. UCB Pipeline – https://www.ucb.com/our-science/pipeline
  9. BioSpace. September 12, 2022 – https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-sjoegren-s-syndrome-meets-primary-endpoint/
  10. Business Wire. January 18, 2023 – https://www.businesswire.com/news/home/20230118005359/en/Horizon-Therapeutics-plc-Announces-Phase-2-Trial-Evaluating-Dazodalibep-for-the-Treatment-of-Sj%C3%B6gren%E2%80%99s-Syndrome-Meets-Primary-Endpoint-in-the-Second-Study-Population-Only-Phase-2-Trial-to-Meet-Primary-Endpoint-in-Both-Patient-Populations

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 late December 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 in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a 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 mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 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 fourth quarter 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
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released October 18, 2023

Release – The GEO Group Announces Date for Third Quarter 2023 Earnings Release and Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GEO

October 17, 2023

PDF Version

  • Earnings Release Scheduled for Tuesday, November 7, 2023 Before the Market Opens
  • Conference Call Scheduled for Tuesday, November 7, 2023 at 11:00 AM (Eastern Time)

BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 17, 2023– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its third quarter 2023 financial results on Tuesday, November 7, 2023 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Tuesday, November 7, 2023.

Hosting the call for GEO will be George C. Zoley, Executive Chairman of the Board, Jose Gordo, Chief Executive Officer, Brian R. Evans, Senior Vice President and Chief Financial Officer, Wayne Calabrese, Senior Vice 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 November 14, 2023. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 4528594. If you have any questions, please contact GEO at 1-866-301-4436.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231017118836/en/

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

Source: The GEO Group, Inc.

Release – Gray Sets Date for Third Quarter Earnings Release and Earnings Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GTN

Atlanta, Georgia – October 17, 2023 . . . Gray Television, Inc. (NYSE: GTN) today

announced that it will release its earnings results for the quarter ended, September 30, 2023 on

Wednesday, November 8, 2023.

Earnings Conference Call Information

Gray Television, Inc. will host a conference call to discuss its operating results for the

quarter ended September 30, 2023, on Wednesday, November 8, 2023. The call will begin at

11:00 a.m. Eastern Time. The live dial-in number is 1-800-285-6670. The call will be webcast

live and available for replay at www.gray.tv. The taped replay of the conference call will be

available at 1-888-556-3470 Passcode: 898476# until December 8, 2023.

About Gray:

Gray Television, Inc. is a multimedia company headquartered in Atlanta, Georgia. Gray

is the nation’s largest owner of top-rated local television stations and digital assets in the United

States. Its television stations serve 113 television markets that collectively reach approximately

36 percent of US television households. This portfolio includes 80 markets with the top-rated

television station and 102 markets with the first and/or second highest rated television station. It

also owns video program companies Raycom Sports, Tupelo Media Group, and PowerNation

Studios, as well as the studio production facilities Assembly Atlanta and Third Rail Studios.

Gray owns a majority interest in Swirl Films. For more information, please visit www.gray.tv.

Gray Contacts:

Jim Ryan, Executive Vice President, and Chief Financial Officer, 404-504-9828

Kevin P. Latek, Executive Vice President, Chief Legal and Development Officer, 404-266-8333

Release – Defense Metals Ships Mixed Rare Oxide and Carbonate Samples to Interested Parties

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DFMTF

NEWS PROVIDED BY

Defense Metals Corp. 

17 Oct, 2023, 08:00 ET

VANCOUVER, BC, Oct. 17, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that SGS Canada Inc. in Lakefield, Ontario has shipped samples of mixed rare earth oxide and mixed rare earth carbonate to interested parties on behalf of the Company. These samples were generated during 2023 hydrometallurgical piloting test work performed on concentrate produced by earlier flotation pilot plant testing of a 26-tonne bulk sample taken from the Company’s wholly-owned Wicheeda Rare Earth Element (REE) deposit.

The samples are being distributed to certain select major processors, refiners, and metals traders located in Europe, Asia and North America, allowing the recipients to independently verify the high-quality of REE products from the Wicheeda deposit, and establishing Wicheeda as an important, future North American source of the rare earths needed to satisfy the rapidly increasing demand. The sample specifications are varied based on the recipients’ particular requirements, and these parties could represent future offtake or strategic partners for Defense Metals and these shipments are a critical step toward defining such potential opportunities.

Craig Taylor, CEO of Defense Metals, commented, “Given that rare earth magnet production needs to double in the next decade to satisfy the demand created by electric vehicles, a new and significant western supplier, such as Defense Metals, is essential. To put this increased demand into perspective, it is the equivalent of bringing into production one Mountain Pass mine, currently the only North American rare earth producer, every year for the next ten years. With the Wicheeda Project’s superior logistics, together with our confidence in the metallurgical processing characteristics of Wicheeda mineralization, Defense Metals continues to position itself as a significant contributor to the North American green energy solution.” 

Defense Metals to Attend 19th International Rare Earths Conference

Defense Metals also announces that it will be attending in the 19th International Rare Earths Conference in San Antonio, U.S., hosted by Metal Events, from October 18-20, 2023.

For additional information on the conference please visit the following link:

https://metalevents.com/events/19th-international-rare-earths-conference

About the Wicheeda Rare Earth Element Project

Defense Metals’ 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda deposit is readily accessible by all-weather gravel roads and is near infrastructure, including hydropower transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the deep-water port facilities at Prince Rupert, the closest major North American port to Asia.

About Defense Metals Corp.

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda Rare Earth Element project located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB, and in Germany on the Frankfurt Exchange under “35D”.

Defense Metals is a proud member of Discovery Group. For more information please visit:
http://www.discoverygroup.ca/

For further information, please visit www.defensemetals.com or contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca

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.

Cautionary Statement Regarding “Forward-Looking” Information

This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to the shipment of rare earth samples, advancing the Wicheeda REE Project to production, potential contracts and agreement, technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedarplus.ca. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to, the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.

SOURCE Defense Metals Corp.

Release – Aurania Announces Preliminary Election Results And Loan Agreement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on AUIAF

Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) announces that Mr. Daniel Noboa is the elected President of Ecuador following a runoff election held on October 15th.  Mr. Noboa is a graduate of the Harvard Kennedy school and is expected to be sworn in on November 25. He will be in power for approximately 18 months – completing the term of outgoing President, Guillermo Lasso until the next scheduled presidential election in the first half of 2025.  Noboa’s campaign was focused on the economy and creating jobs, attracting foreign investment and safety/security.  It is the Company’s view that this result may restore political stability and the confidence of international investors in the country. Mr. Noboa is also expected to be supportive of responsible exploration and mining.

The Company also announces that its Chairman, President and Chief Executive Officer, Dr. Keith Barron (the “Lender”) has agreed to provide a loan of up to C$1,000,000 to the Company to be advanced from time to time in principal amounts as agreed by the parties (the “Loan”).

The Loan is unsecured, bears interest at 2% per annum and matures upon notice of twelve months and one day from the Lender.  The Loan will help fund the Company’s working capital and general corporate purposes as well as any exploration expenses in Ecuador.  As of the date hereof, C$50,000 has been advanced under the Loan. 

Dr. Keith Barron is a related party of the Company by virtue of the fact that he is the Chairman, the President and Chief Executive Officer, a promoter and a principal shareholder of the Company, and as a result, each advance and repayment under the Loan constitutes a “related party transaction” for the purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying upon an exemption from the formal valuation and minority shareholder approval requirements under MI 61-101 in respect of the Related Party Transactions, in reliance on Sections 5.5(a) and 5.7(1) of MI 61-101, respectively, as the fair market value of the Related Party Transaction, collectively, does not exceed 25% of the Company’s market capitalization, as determined in accordance with MI 61-101. The Company did not file a material change report related to the Loan more than 21 days before the expected closing of the Loan as required by MI 61-101, as the Company wished to organize the Loan on an expedited basis for sound business reasons.

The Loan was approved by the members of the board of directors of the Company who are independent for purposes of the related party transaction, being all directors other than Dr. Barron. No special committee was established in connection with the Loan, and no materially contrary view or abstention was expressed or made by any director of the Company in relation thereto. 

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Release – QuoteMedia Powers Stirlingshire Investments Trading Platform

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QMCI

PHOENIX, Oct. 16, 2023 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, announced an agreement with Stirlingshire Investments.

Stirlingshire is an exciting market disruptor with a groundbreaking Hybrid Broker-Dealer framework that brings together the most advantageous aspects of the Full-Service Broker-Dealer and Discount Broker-Dealer models, while removing their limitations. By utilizing technology, Stirlingshire is able to dramatically reduce overhead and liability, while tying compensation much closer to performance. The result? A revolutionized industry that is Better for Clients, Better for Advisors.

Pursuant to the agreement QuoteMedia will be incorporating Quotestream® Trader, QuoteMedia’s streaming data application complete with trade integration, into Stirlingshire’s innovative trading platform. This allows Stirlingshire’s network of broker representatives and their retail clients to access real time market data, as well as comprehensive news, research, charting and analysis as part of their trading experience.

“Stirlingshire is dedicated to innovation, and QuoteMedia’s leading edge offerings are a perfect fit with our goals,” said Steven Woods, Stirlingshire’s Founder & CEO. “Our clientele quite justifiably expects best-in-class products and services from us, and the platform is receiving rave reviews. QuoteMedia’s applications and delivery technologies provide up-to-the-second market data and research information, and ensure our correspondent brokers and their customers are able to identify and capitalize on great investment opportunities.”

The partnership is a significant opportunity for QuoteMedia as well, according to QuoteMedia, Ltd. CEO Dave Shworan.

“Stirlingshire’s approach is truly innovative, and they are enjoying tremendous early success and growth,” said Shworan. “We are thrilled that they have chosen to incorporate our data and technology solutions, and that we can join them as they revolutionize the brokerage and investment industry. We look forward to a long and exciting partnership.”

About QuoteMedia

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Avantax, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, The Goldman Sachs Group, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Credential Qtrade Securities, CNW Group, iA Private Wealth, Ally Invest, Inc., Suncor, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Equisolve, Stock-Trak, Mergent, Cision and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com .

QuoteMedia Investor Relations

Brendan Hopkins
Email: investors@quotemedia.com
Call: (407) 645-5295

Stirlingshire Media Relations

Nicole Cox
Email: Nicole@stirlingshire.com
Call: 647-500-2763

News Provided by GlobeNewswire via QuoteMedia

Release – RNC to Partner with NBC News, Salem Radio Network, Republican Jewish Coalition, and Rumble for Third Republican Presidential Primary Debate in Miami

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

 Download as PDFOctober 16, 2023 8:15am EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that the Republican National Committee (RNC) has selected NBC News, Salem Radio Network, the Republican Jewish Coalition, and Rumble as partners for the third Republican presidential primary debate, which will take place at the Adrienne Arsht Center for the Performing Arts of Miami-Dade County on November 8, 2023. As with the first and second debates, Rumble will be the exclusive RNC livestream provider and the RNC’s exclusive online home for the third debate.

“I am eager to announce that the RNC has selected NBC News, Salem Radio Network, the Republican Jewish Coalition, and Rumble as our partners for the third Republican primary debate in Miami. The partners for our third debate will offer our candidates an excellent opportunity to meet the moment and contrast their plans and vision with the failures of the Biden White House.” – RNC Chairwoman Ronna McDaniel

“NBC News has a long history of fostering conversations with the leaders that seek to shape domestic politics and foreign policy. For us, there is no higher responsibility. We look forward to continuing our leading reporting on the 2024 presidential race and spotlighting the issues that matter most to voters as they head to the polls.” – Rebecca Blumenstein, President of NBC News Editorial

“Salem Media Group and the Salem Radio Network are honored to be chosen by the Republican National Committee to be a part of this historic Republican presidential primary debate. Salem is an experienced partner of the RNC, having co-moderated four RNC debates in 2015-2016. We look forward to working closely with NBC News and other selected partners to deliver an event that will shine a light on the candidates and educate voters ahead of the primary.”– David Santrella, Salem Media Group CEO

“We are honored to partner with the RNC in the upcoming GOP Presidential debate. As the horrific events of the last week have unfolded in Israel, the issue of American foreign policy has taken on an even greater role. American strength and American resolve – and our candidates’ vision for America’s role in the world – are more important than ever.” – RJC Chairman, Sen. Norm Coleman

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231016018491/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released October 16, 2023

Release – Johnny Rockets Opens First Location in Iraq

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

October 16, 2023

Download(opens in new window)

Classic Burger Concept Celebrates Nine International Openings This Year

LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Johnny Rockets and 17 other restaurant concepts, announces nine openings for Johnny Rockets. The most recent new opening, in Baghdad, marks the first Iraqi location, and is operated by Alanwar Alarabiya.

Since February, Johnny Rockets has also opened international locations in the following cities: Fortaleza, Brazil, Cumbica International Airport in Sao Paulo, Brazil, Santiago, Chile, Lima, Peru, Dubai, United Arab Emirates, Abu Dhabi, United Arab Emirates, Talca, Chile, and one ghost kitchen in the United Arab Emirates. Johnny Rockets around the world serve the classic fare that put the brand on the map over 35 years ago, including juicy, made-to-order burgers and hand-spun shakes.

“Johnny Rockets is a timeless concept that we are proud to see succeed across many borders and formats,” said Jake Berchtold, COO of FAT Brands’ Fast Casual Division. “We look forward to continued growth in Iraq, where we see the opportunity to capitalize on an impressive customer base.”

The first Johnny Rockets restaurant opened June 6, 1986, on Melrose Avenue in Los Angeles. Since that time, the chain’s timeless all-American brand has connected with customers across the U.S. and in more than 25 other countries around the globe. The Johnny Rockets team’s passion for delivering fresh, classic American fare is only equaled by their commitment to providing a superb guest experience.

The new Johnny Rockets in Baghdad is located in the Alyarmouk neighborhood at The Four Streets, Allay 616, Ste. 17 Bldg. 105 Baghdad, Iraq and is open 12 p.m. to 12 a.m. seven days a week. The new location’s menu includes halal-friendly cooked-to-order burgers, indulgent, hand-spun real ice cream shakes, crispy fries, chicken options and more.

For more information on Johnny Rockets, visit www.johnnyrockets.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, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Smokey Bones, 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 Johnny Rockets
Founded in 1986 on Melrose Avenue in Los Angeles, Johnny Rockets is a world-renowned international franchise that offers high-quality, innovative menu items including Certified Angus Beef® cooked-to-order hamburgers, veggie burgers, chicken sandwiches, crispy fries, and rich, delicious hand-spun shakes and malts. With over 325 locations in over 25 countries around the globe, this dynamic lifestyle brand offers friendly service and upbeat music contributing to the chain’s signature atmosphere of relaxed, casual fun.
For more information, visit www.johnnyrockets.com. 

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

Source: FAT Brands Inc.

Release – Harte Hanks Announces CFO Transition Plan

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HHS

Interim appointment of seasoned executive supports the growth-phase strategic plan launched earlier this year

CHELMSFORD, MA / ACCESSWIRE / October 16, 2023 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced the appointment of David Garrison, an experienced finance executive with more than 20 years of public company CFO experience, as Interim Chief Financial Officer, effective October 23, 2023. Lauri Kearnes is stepping down as CFO but will continue to advise the Company as needed through year end to support a smooth transition. Kearnes’ departure is not related to any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

Garrison brings 20 years of public company CFO experience, with particular expertise in cost containment, streamlining operations, and ERP implementations. He joins Harte Hanks from Digital Lumens Incorporated, an IoT lighting fixture and factory automation technology company that was spun out of Osram Sylvania, where he served as CFO for the last two years. As part of this role, he was instrumental in selling a product line to a strategic buyer and selling the remaining operating entity to a foreign company. Previously, he spent three years as Chief Financial Officer for Sensera, Inc., an Australian listed medical and IoT technology company, where he played an important role in turning around operations to facilitate a sale. Previously, he served as Managing Director of IW Ventures LLC, a financial consultant, and TTcogen LLC, a joint venture between Tecogen Inc. and TEDOM a.s. From 2014 to 2017, Garrison served as CFO of Tecogen Inc., a NASDAQ-listed company that designs, manufactures, and sells industrial and commercial cogeneration systems, where he supported growth with cost controls to drive margin expansion and profitability. He has an MBA from Boston University and has led several Greater Boston-based companies through successful growth-driven integrations, transactions, and implementations.

“Lauri has been a valued, long-standing member of our team and we appreciate all of her contributions as Harte Hanks has evolved over the years,” said Kirk Davis, Chief Executive Officer. “She played an instrumental role in providing the company with stability through restructuring and implementing a foundation for profitable growth. David is a proven financial and operational leader who will help advance the next phase of our comprehensive business plan. He brings a deep background in all facets of SEC reporting, compliance, and governance. Importantly, he brings specific and relevant expertise in information technologies and integration, data analytics, customer satisfaction, and expense management.”

Harte Hanks has already initiated a formal search process to select a permanent Chief Financial Officer to advance the company’s current growth plans and new market goals. Garrison’s interim appointment supports the strategic direction and growth-phase plan launched earlier this year after Harte Hanks celebrated its 100-year anniversary. The plan, which kicked off with the appointment of industry-veteran Kirk Davis as new CEO, is strategically designed to help Harte Hanks continue to adapt, change, and modernize, as it has done successfully for a century in business.

The company’s strategic plan includes a collaboration with the Kearney organization, a highly respected global management consulting firm. “I’ve had previous experience working with Kearney and am confident in their ability to help us mitigate inflation, benefit from their excellence in procurement and for our team to gain a deeper understanding of our profit potential,” said Davis. “Our engagement with Kearney is underway and will conclude before year end. The goal is to achieve the flexibility to not only drive profitability, but also make strategic investments that will support growth and further our technical aptitude.”

The company has also hired a new SVP of Sales and Marketing, with a formal announcement on this role to occur later this month.

“Having just completed my first full quarter with Harte Hanks, I am confident these actions will support our ambitions to have a strong 2024,” said Davis. Davis also noted that he remains comfortable with the most recently disclosed revenue baseline for fiscal 2023.

“Harte Hanks has a proud heritage, and the momentum we have right now is a very positive sign for our next 100 years,” continued CEO Kirk Davis. “We have a highly capable team in place, including many key long-term members of our management team and a creative, smart, motivated group of employees across all departments. We are very enthusiastic about the future and see profitable opportunities ahead for Harte Hanks.”

About Harte Hanks:

Harte Hanks (NASDAQ: HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.



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