Month: October 2023

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.

Comstock Inc. (LODE) – All Pieces Are In Place To Commercialize Full Fuels Product Suite

Posted on by cpereira@noblefcm.com


Wednesday, October 18, 2023

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Innovative products for producing renewable fuels. Comstock Fuels, a wholly owned subsidiary, converts lignocellulosic biomass into cellulosic ethanol and proprietary Bioleum bio-intermediate blends at yields exceeding 100 gallons per dry tonne of biomass on a gasoline gallon equivalent (GGE) basis with low market-leading carbon intensity scores.

Hydro-deoxygenated Bioleum Oil (HBO). The innovative break throughs are achieved in part by using catalytic esterification and hydro-deoxygenation to process Bioleum into Hydro-deoxygenated Bioleum Oil (HBO). HBO is a proprietary drop-in bio-intermediate that can be sold to advanced biofuel refineries for use in blending with fat-based feedstocks to produce sustainable aviation and renewable diesel fuels.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PCTEL to be Acquired by Amphenol in $139.7 Million All-Cash Deal

Posted on by slightbourne@noblecapitalmarkets.com

PCTEL, a leading global provider of wireless technology solutions, announced last week that it has reached a definitive agreement to be acquired by Amphenol Corporation in an all-cash transaction valued at approximately $139.7 million.

Under the terms of the agreement, Amphenol will acquire all outstanding shares of PCTEL common stock for $7.00 per share. This offer price represents a premium of over 50% compared to PCTEL’s closing share price of $4.62 on October 13, 2023, the last full trading day before the deal was announced.

The acquisition will allow PCTEL to leverage Amphenol’s global presence, dedicated customer base, and scale to accelerate the growth of PCTEL’s business. Amphenol is one of the world’s largest providers of high-technology interconnect, sensor and antenna solutions.

PCTEL is seen as a clear innovation leader in wireless technology solutions, making it an excellent strategic fit within Amphenol’s portfolio. PCTEL’s capabilities in antennas and test and measurement will complement Amphenol’s strengths in interconnect and sensor technologies.

The deal has been approved by PCTEL’s Board of Directors and is expected to close either in Q4 2023 or early 2024, subject to shareholder approval and customary closing conditions. Once the acquisition is completed, PCTEL will no longer be a publicly traded company on the Nasdaq.

PCTEL provides purpose-built Industrial IoT devices, antenna systems, and test and measurement products to customers worldwide. The company has built trusted relationships through nearly 30 years of experience solving complex wireless challenges and helping organizations stay connected, transform and grow.

Take a moment to take a look at Comtech Telecommunications Corp., a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies.

Amphenol has a diversified presence across high-growth segments including automotive, broadband communications, commercial aerospace, industrial, information technology, military, mobile devices and mobile networks. Amphenol’s sustained financial strength and entrepreneurial culture will support taking PCTEL’s business to new heights.

The transaction follows a nearly year-long strategic review process overseen by PCTEL’s Board of Directors. In their announcement, PCTEL highlighted that Amphenol’s culture is well-aligned and will provide a valuable home for PCTEL’s global employees after the acquisition.

For investors, the all-cash deal provides certainty of value at an attractive premium to PCTEL’s recent trading prices. The $7.00 per share price is over 50% higher than the 30-day volume weighted average share price prior to the deal announcement.

PCTEL’s CEO David Neumann noted that the company’s team has done an excellent job growing the business and meeting strong customer demand globally, especially for high reliability applications. This established market position made PCTEL an appealing target for Amphenol.

The deal marks an exciting milestone for PCTEL, allowing the company to join forces with an industry leader in Amphenol. Investors can expect an accelerated growth trajectory as the combined companies leverage their technical strengths and customer relationships.

After 29 years as an independent public company, PCTEL is set to start an exciting new chapter as part of Amphenol. This transaction highlights the ongoing demand for antennas, sensors and other wireless connectivity technology solutions.

Investors Await Powell’s Speech for Cues on Future Rate Hikes

Posted on by slightbourne@noblecapitalmarkets.com

Federal Reserve Chair Jerome Powell is set to deliver a closely watched speech on Thursday before the Economic Club of New York that could offer critical guidance on the future path of monetary policy.

Markets are looking for clarity from Powell on how the Fed plans to balance improving inflation data against surging Treasury yields and risks of recession. His remarks come at a precarious time – inflation shows early signs of easing but remains well above the Fed’s 2% target, while rapidly rising interest rates threaten to slow economic growth.

Powell faces the tricky task of conveying that the Fed remains vigilant in combating inflation while avoiding cementing expectations for further aggressive rate hikes that could hammer markets.

“Powell has to present himself to investors as the dispassionate neutral leader and allow others to be more aggressive,” said Jeffrey Roach, chief economist at LPL Financial. “They’re not going to declare victory, and that is one reason why Powell is going to continue to talk somewhat hawkish.”

Cues from within the Fed have been mixed recently. Several officials, including Philadelphia Fed President Patrick Harker, have advocated holding fire on rate hikes temporarily to evaluate incoming data. This “wait and see” approach comes after a torrent of large rate increases this year, with the Fed Funds rate now sitting at a 15-year high of 3.75%-4%.

But hawkish voices like New York Fed President John Williams insist the Fed must keep policy restrictive for some time to combat inflation. Markets hope Powell will provide definitive guidance on the prevailing consensus within the central bank.

Policymakers are navigating a complex environment. Inflation data has been gradually improving from 40-year highs earlier this year. But inflation expectations remain uncomfortably high, pointing to the need for further tightening.

“Powell has to present the recent inflation data as welcome news, but not evidence that the job is done,” said Ryan Sweet, chief U.S. economist at Oxford Economics. “The Fed still has more work to do.”

At the same time, the rapid rise in Treasury yields in recent weeks has already tightened financial conditions substantially. Another massive rate hike could be unnecessary overkill.

According to Krishna Guha of Evercore ISI, Powell will likely underscore “that the data has been coming in stronger than expected, but there has also been a big move in yields, which has tightened financial conditions, so no urgency for a policy response in November.”

Markets are currently pricing in a 65% chance that rates remain on hold at next month’s policy meeting. But there is still roughly a one-in-three chance of another 0.75 percentage point hike.

All eyes will be parsing Powell’s speech for any clues or direct guidance on the Fed’s next steps. While he is expected to avoid concrete commitments, his language choices will be dissected for shifts in tone or any hints at changes in thinking around the policy trajectory.

Powell’s remarks will also be scrutinized for takeaways on how long the Fed may need to keep rates elevated before ultimately cutting. Luke Tilley of Wilmington Trust expects Powell “to keep talking about staying vigilant” and the need for rates to remain higher for longer to ensure inflation comes down sustainably.

With growing recession fears on Main Street and Wall Street, Powell faces a defining moment to communicate a clear roadmap of where monetary policy is headed, while retaining flexibility. Walking this tightrope will be critical to shoring up the Fed’s credibility and avoiding unnecessary market turmoil.

All eyes are on the Fed chair tomorrow as investors and economists eagerly await guidance from the man himself holding the levers over the world’s most influential interest rate.

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.

Nvidia and Chip Stocks Tumble Amid Escalating China-U.S. AI Chip Export Tensions

Posted on by slightbourne@noblecapitalmarkets.com

Shares of Nvidia and other semiconductor firms tumbled Tuesday morning after the U.S. announced stringent new curbs on exports of artificial intelligence chips to China. The restrictions spooked investors already on edge about the economic fallout from deteriorating U.S.-China relations.

Advanced AI chips like Nvidia’s flagship A100 and H100 models are now barred from shipment to China, even in downgraded versions permitted under prior rules. Nvidia stock plunged nearly 7% on the news, while chip stocks like Marvell, AMD and Intel sank 3-4%. The Philadelphia Semiconductor Index lost over 5%.

The export crackdown aims to hamper China’s progress in developing cutting-edge AI, which relies on massive computing power from state-of-the-art chips. U.S. officials warned China could use next-generation AI to threaten national security.

“We have specific concern with respect to how China could use semiconductor technologies to further its military modernization efforts,” said Alan Estevez, an under secretary at the Commerce Department.

But hampering China’s AI industry could substantially dent revenues for Nvidia, the dominant player in advanced AI chips. China is estimated to account for billions in annual sales.

While Nvidia said the financial impact is not immediate, it warned of reduced revenues over the long-term from tighter China controls. Investors are concerned these export curbs could be just the beginning if tensions continue to escalate between the global superpowers.

The escalating trade barriers also threaten to disrupt global semiconductor supply chains. Many chips contain components sourced from the U.S., Japan, Taiwan and other countries before final manufacturing and assembly occurs in China. The complex web of cross-border production could quickly seize up if trade restrictions proliferate.

Nvidia and its peers sank Tuesday amid fears of being caught in the crossfire of a technology cold war between the U.S. and China. Investors dumped chip stocks on worries that shrinking access to the massive Chinese market will severely depress earnings.

AI chips are essential to powering everything from data centers, autonomous vehicles, and smart devices to facial recognition, language processing, and machine learning. As AI spreads across the economy, demand for specialized semiconductors is surging.

But rivalries between the U.S. and China now threaten to put a ceiling on that growth. Both nations are aggressively competing to dominate AI research and set the global standards for integrating these transformative technologies. Access to the most powerful AI chips is crucial to these efforts.

By curbing China’s chip supply, the U.S. administration aims to safeguard America’s edge in AI development. But tech companies may pay the price through lost revenues if China restricts access to its own market in retaliation.

For the broader stock market already on edge about resurgent inflation, wars in Ukraine and the Middle East, and rising interest rates, the intensifying technology cold war represents yet another worrying threat to global economic growth. While a severe downturn may ultimately be avoided, the rising risk level underscores why investors are growing more anxious.

E.W. Scripps (SSP) – Heading Into A Favorable Cycle

Posted on by cpereira@noblefcm.com


Tuesday, October 17, 2023

The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Highlights from a recent NDR. On October 12th, Adam Symson, CEO; Jason Combs, CFO; and Carolyn Micheli hosted investor meetings in New York. Management highlighted positive developments in retransmission revenue and Scripps Sports. Notably, Scripps Sports employs a unique model that offers sports teams wider viewership than the traditional RSN model that is now failing.

Renegotiates 75% of its subscribers.  The company recently announced that it has completed retransmission negotiations with 75% of its current subscribers. As a result, the company reaffirmed its guidance that retransmission revenue will increase a strong 15% in 2024 to roughly $750 million.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Comtech Telecommunications (CMTL) – A Transformational Year

Posted on by cpereira@noblefcm.com


Tuesday, October 17, 2023

Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q23 Results. Revenue of $148.8 million was up 9.2% sequentially, well above the management’s 1%-4% projected sequential growth. Y-o-Y revenue was up 17.2%. We were at $140 million. Adjusted EBITDA totaled $18.9 million, versus $12.7 million in 4Q22. We were at $13.4 million. Comtech reported a net loss of $5.3 million, or a loss of $0.19 per share, compared to a net loss of $6.9 million, or $0.26 per share last year. Adjusted EPS was $0.29 versus $0.24. We had forecast a net loss of $8.2 million, or a loss of $0.29 per share, and adjusted EPS of $0.21.

Transformational Year. We believe FY23 was a transformational year for Comtech. The business structure has been simplified, synergies are becoming apparent, cost savings can be seen in the operating results, and major new contract awards provide a solid foundation for future growth.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.