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Fed Holds Rates at New 22-Year High, Hints More Hikes Possible

Posted on by slightbourne@noblecapitalmarkets.com

The Federal Reserve announced its widely expected decision on Wednesday to maintain interest rates at a new 22-year high after an aggressive series of hikes intended to cool inflation. The Fed kept its benchmark rate in a range of 5.25-5.50%, indicating it remains committed to tamping down price increases through restrictive monetary policy.

In its statement, the Fed upgraded its assessment of economic activity to “strong” in the third quarter, a notable shift from “solid” in September. The upgrade likely reflects the blockbuster 4.9% annualized GDP growth in Q3, driven by resilient consumer spending.

However, the Fed made clear further rate hikes could still occur if economic conditions warrant. The central bank is treading cautiously given uncertainty around how past tightening will impact growth and jobs.

For consumers, the Fed’s hiking campaign this year has significantly increased the cost of borrowing for homes, cars, and credit cards. Mortgage rates have essentially doubled from a year ago, deterring many would-be home buyers and slowing the housing market. Auto loan rates are up roughly 3 percentage points in 2023, increasing monthly payments. The average credit card interest rate now sits around 19%, the highest since 1996.

Savers are finally benefitting from higher yield on savings accounts, CDs, and Treasury bonds after years of paltry returns. But overall, households are facing greater financial strain from pricier loans that could eventually crimp spending and economic momentum if rates stay elevated.

“The Fed is deliberately slowing demand to get inflation in check, and that painful process is underway,” noted Bankrate chief financial analyst Greg McBride. “For consumers, the impact is being felt most acutely in the higher costs of homes, autos, and credit card debt.”

Investors have also felt the brunt of aggressive Fed tightening through increased market volatility and falling valuations. The S&P 500 has sunk over 20% from January’s record high, meeting the technical definition of a bear market. Rising Treasury yields have put pressure on stocks, especially higher growth technology names.

Still, stocks rebounded in October based on hopes that easing inflation could allow the Fed to slow or pause rate increases soon. Markets are betting rates could start declining in 2024 if inflation continues trending down. But that remains uncertain.

“The Fed is data dependent, so until they see clear evidence that inflation is on a sustainable downward trajectory, they have to keep tightening,” said Chris Taylor, portfolio manager at Morgan Stanley. “Markets are cheering lower inflation readings, but the Fed can’t declare victory yet.”

In his post-meeting press conference, Fed Chair Jerome Powell emphasized that officials have “some ways to go” before stopping rate hikes. Powell indicated the Fed plans to hold rates at a restrictive level for some time to ensure inflation is contained.

With consumer and business spending still relatively healthy, the Fed currently believes the economy can withstand additional tightening for now. But Powell acknowledged a downturn is possible as the delayed impacts of higher rates materialize.

For investors, the path ahead likely entails continued volatility until more predictable Fed policy emerges. But markets appear reassured by the central bank’s data-dependent approach. As inflation slowly declines, hopes are growing that the end of the Fed’s aggressive hiking cycle may come into focus sometime in 2024, potentially setting the stage for an economic and market rebound.

Release – Noble Capital Markets Initiates Equity Research Coverage on Xcel Brands, Inc.

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

November 1, 2023 at 8:30 AM EDT

NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, is pleased to announce that Noble Capital Markets has initiated company-sponsored equity research coverage on the Company. The full report by Noble Capital Markets Senior Research Analyst Michael Kupinski and Research Analyst Patrick McCann, as well as news and advanced market data on Xcel Brands, Inc., is available on Channelchek.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, production, marketing, live streaming, social commerce and direct-to-consumer sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.com

For further information please contact:

Andrew Berger
SM Berger & Company, Inc.
216-464-6400
andrew@smberger.com

Source: Xcel Brands, Inc

Release – ARK: Survival Ascended Races to #1 Selling Game on Steam within First 24-hours of Launch

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SNAL

November 1, 2023 at 7:59 AM EDT

Within five days of launch ARK Survival Ascended is among the top 8 most popular and played games on Steam.

Exhibiting an all-time concurrent player peak at 98K within five days of launch.

CULVER CITY, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment announced today the newly released ARK: Survival Ascended was the #1 top selling game on Steam on launch day, October 25th.

This latest installment of the ARK franchise has completely recreated and redesigned the artwork and worlds of ARK to take advantage of the latest in video game technology, Unreal Engine 5.

What are the players doing outside the world of ARK?

  • It watched over 5.6 million minutes of ARK Survival Ascended on Twitch during launch day – this equates to nearly 3,910 days or 10.7 years.
  • ARK Survival Ascended was ranked #1 top live games on YouTube gaming on launch day.
  • Was among the top 6 games on Twitch generating 129K concurrent viewers on launch day.

“On behalf of Snail and our incredible partners at Studio Wildcard, I want to say thank you to the community, and millions of new and old Survivors from around the world, who are and will be immersing yourselves in this new dinosaur survival experience. ARK Survival Ascended is the result of passionate teams working together to bring Unreal Engine 5 technology to the mythical world of ARK. We are excited for ARK Survival Ascended to be released on consoles and are committed to ensuring ARK Survival Ascended continues to usher in a new era of innovation and creativity especially in the cross-platform modding systems.” Jim Tsai, Chief Executive Officer of Snail, Inc.

About Snail, Inc.

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

Forward-Looking Statements

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

Contacts:

Investors:
investors@snail.com

Press:
media@snail.com

Release – Vera Bradley, Inc. Announces Reporting Date For Fiscal Year 2024 Third Quarter Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on VRA

Nov 1, 2023

FORT WAYNE, Ind., Nov. 01, 2023 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) (the “Company”) today announced that it plans to report results for the third quarter ended October 28, 2023 at 8:00 a.m. Eastern Time on Wednesday, December 6, 2023.

The Company will host a conference call to discuss its financial results at 9:30 a.m. Eastern Time that same day. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website, www.verabradley.com. Alternatively, interested parties may dial into the call at (888) 204-4368, and enter the access code 7089328. A replay will be available shortly after the conclusion of the call and remain available through December 20, 2023. To access the recording, listeners should dial (844) 512-2921, and enter the access code 7089328.

ABOUT VERA BRADLEY, INC.

Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally connected, and multi-generational female customer bases; alignment as causal, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.

Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.

In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a digitally native, highly engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories. The Company acquired the remaining 25% of Pura Vida in January 2023.

CONTACTS:
Investors:
Julia Bentley
jbentley@verabradley.com

Media:
877-708-VERA (8372)
Mediacontact@verabradley.com

Research – ZyVersa Therapeutics Announces Publication in Molecular Neurobiology Reinforcing Data Demonstrating That Inflammasome ASC Inhibitor IC 100 Attenuates the Inflammatory Response Causing Neuronal Damage in Multiple Sclerosis Model, Potentially Providing Neuroprotection

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Nov 1, 2023

PDF Version

  • Molecular Neurobiology publication demonstrated that NLRP3 inflammasomes have an important role in the pathogenesis of multiple sclerosis (“MS”) based on significant decreases in neuronal damage and demyelination resulting from NLRP3 inhibition in a mouse model of MS.
  • MS, which affects around 2.1 million people worldwide, is a chronic, progressive inflammatory disease of the central nervous system characterized by neuron damage in the brain and spinal cord, leading to significant physical and cognitive disability.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.

WESTON, Fla., Nov. 01, 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 a publication in the peer-reviewed journal, Molecular Neurobiology, demonstrating neuroprotective effects of NLRP3 inflammasome inhibition in a mouse model of MS using a research tool molecule, MCC950.

In the paper titled, “Inhibiting the NLRP3 Inflammasome with MCC950 Alleviates Neurological Impairment in the Brain of EAE Mice,” the authors studied a mouse model which mirrors MS-like pathology and is commonly used to research MS disease progression. Key findings showed that NLRP3 inflammasome inhibition:

  • Ameliorated pathological changes in the spinal cord and neuron damage in the brain of MS mice.
  • Reduced microglia activation and prevention of its conversion to the M1 phenotype which induces neuroinflammation and neurotoxicity.
  • Reduced activation of astrocytes, which are involved in development of MS.

The authors concluded, “our work indicates that inhibition of NLRP3 inflammasome has the therapeutic effects of neuroprotection through immunomodulation and is a promising therapeutic strategy for MS.” To read the article, Click Here.

“There is a need for new therapeutic options for MS. Current drug therapies provide symptom control and help to alleviate disability, but they are not neuroprotective,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “It is encouraging that the research published in Molecular Neurobiology substantiates our published MS data with Inflammasome ASC Inhibitor IC 100, providing support for its use as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate perpetuation of damaging inflammation”. To read the paper on IC 100 in an animal model of MS, Click Here.

About Inflammasome ASC Inhibitor IC 100

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

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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

Release – Largo to Release Third Quarter 2023 Financial Results on November 8, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LGO

October 31, 2023

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TORONTO–(BUSINESS WIRE)– Largo Inc. (“Largo” or the “Company”) (TSX: LGO) (NASDAQ: LGO) will release its third quarter 2023 financial results on Wednesday, November 8, 2023 after the close of market trading. Additionally, the Company will host a conference call to discuss its third quarter 2023 results and other updates on Thursday, November 9 at 1:00 p.m. ET.

To join the conference call without operator assistance, you may register and enter your phone number at https://emportal.ink/3RXJdiN to receive an instant automated call back.

You may also dial direct to be entered to the call by an operator using the dial-in details provided below.

Conference Call Details
Date:Thursday, November 9, 2023
Time:1:00 p.m. ET
Dial-in Number:Local: +1 (416) 764-8650
North American Toll Free: +1 (888) 664-6383
Conference ID:19034623
RapidConnect Link:https://emportal.ink/3RXJdiN
Replay Number:Local / International: + 1 (416) 764-8677
North American Toll Free: +1 (888) 390-0541
Replay Passcode: 034623#
Website:To view press releases or any additional financial information, please visit the Investor Resources section of the Company’s website at: https://www.largoinc.com/investors/Overview

About Largo

Largo is a globally recognized vanadium company known for its high-quality VPURETM and VPURE+TM products, sourced from its Maracás Menchen Mine in Brazil. The Company is currently focused on implementing an ilmenite concentrate plant and is undertaking a strategic evaluation of its U.S.-based clean energy business, including its advanced VCHARGE vanadium battery technology to maximize the value of the organization. Largo’s strategic business plan centers on maintaining its position as a leading vanadium supplier with a growth strategy to support a low-carbon future.

Largo’s common shares trade on the Nasdaq Stock Market and on the Toronto Stock Exchange under the symbol “LGO”. For more information on the Company, please visit www.largoinc.com.

For further information, please contact:

Investor Relations
Alex Guthrie
Senior Manager, External Relations
+1.416.861.9778
aguthrie@largoinc.com

Source: Largo Inc.

 

Release – Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 31, 2023 5:00pm EDT

The study did not achieve statistical significance on the primary endpoint

Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study

Tonix expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia

CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept double-blind, randomized, multi-center, placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) in patients with major depressive disorder (MDD). The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.

“Based on these efficacy results, we are discontinuing development of TNX-601 ER. We look forward to topline results from our Phase 2 study of TNX-1900 in chronic migraine in early December and topline results from our Phase 3 potential NDA-enabling study of TNX-102 SL in fibromyalgia in late December,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We would like to thank the patients, their families, and all the investigators and researchers who participated in the Phase 2 UPLIFT study.”

In the Phase 2 UPLIFT study, TNX-601 ER was orally administered as monotherapy once a day to 132 patients who, upon entering the study, met a DSM-5 diagnosis of moderate-to-severe depression with a duration for the current major depressive episode of at least 12 weeks. Efficacy was assessed using the MADRS to measure any potential change in patients’ depression severity from baseline. In the study, TNX-601 ER was generally well-tolerated with a favorable safety profile. There was one serious adverse event (SAE) experienced in the placebo group, and two SAEs in the active treatment group deemed possibly related to study drug, both of which resolved without sequelae.

About the Phase 2 UPLIFT Study

The Phase 2 proof-of-concept UPLIFT study, TNX-TI-M201, is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken orally once-daily for 6 weeks for the treatment of moderate-to-severe MDD. It is a parallel design study with a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 132 participants were randomized in a 1:1 ratio into the two arms across approximately 27 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of MDD and a duration for the current major depressive episode of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the MADRS total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression – Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).

For more information, see ClinicalTrials.gov Identifier: NCT05686408.

About Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode1, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.4

1 Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults 2020. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

2 IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.

3 Kubitz N, et al. PLoS One 2013, 8 (10), e76882.

4 Rush AJ, et al. Am J. Psychiatry 2007, 163 (11), 1905-1917.

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine designed for once-daily daytime dosing in development as a candidate for the treatment of MDD. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine.

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, and topline results were reported in the third quarter of 2023. 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, including TNX-1800, in development as a vaccine to protect against COVID-19 . 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

Release – Great Lakes Dredge & Dock Corporation Schedules Announcement Of 2023 Third Quarter Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GLDD

Oct 31, 2023

HOUSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (NASDAQ: GLDD) today announced that it will release the financial results for its three and nine months ended September 30, 2023 on Tuesday, November 7, 2023 at 7:00 a.m. C.S.T. A conference call with the Company will be held the same day at 9:00 a.m. C.S.T.

Investors and analysts are encouraged to pre-register for the conference call by using the link below. Participants who pre-register will be given a unique PIN to gain immediate access to the call. Pre-registration may be completed at any time up to the call start time.

To pre-register, go to https://register.vevent.com/register/BI92cc852803b34f5b8e1bcd973d6881d1.

The live call and replay can also be heard at https://edge.media-server.com/mmc/p/u2gfidfp or on the Company’s website, www.gldd.com, under Events on the Investor Relations page. A copy of the press release will be available on the Company’s website.

The Company
Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 133-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Comstock Inc. (LODE) – Development Plans Move into Clearer View

Posted on by cpereira@noblefcm.com


Tuesday, October 31, 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.

Comstock Fuels strategy becomes more apparent. During Comstock’s third quarter update, Mr. William McCarthy, COO, discussed Comstock Fuels’ recent achievements and plans to build and own the first Bioleum hub with a goal to develop and license future hubs to third parties. The goal is to ultimately be involved with developing and licensing 99 additional Bioleum hubs to collectively produce 2.5 billion gallons of advanced biofuel with low carbon intensity using 25 million tonnes of biomass.

Comstock Metals photovoltaics recycling facility. Comstock Metals is deploying a demonstration system to commercialize technologies for use in efficiently crushing, conditioning, extracting, and recycling metal concentrates from photovoltaics and other electronic devices. Comstock Metals has submitted all permits for operating its manufacturing facility in Silver Springs, Nevada, and expects the receipt of permits and full deployment of its entire production system by the end of 2023. Operations are anticipated to commence in early 2024. Comstock Metals expects initial supply-revenue agreements in advance of production.


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MustGrow Biologics Corp. (MGROF) – TerraSante Receives USDA Organic Approval

Posted on by cpereira@noblefcm.com


Wednesday, November 01, 2023

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.

Receiving Approval. MustGrow announced yesterday that the Company has been awarded an organic compliance certification from the USDA National Organic Program for its TerraSante crop fertilizer and soil amendment technology. The product is now OMRI Listed in the following Generic Material Listings: NOP: Plant Extracts, Class: Crop Fertilizers and Soil Amendments.

A Potential Boon to US Farmers. The Organic Materials Review Institute’s (OMRI) organic certification can potentially provide an opportunity for farmers to reduce synthetic chemical and fertilizer use while meeting growing market demand for organic biological products. It involves a strict review of product ingredient composition and observance of manufacturing compliance standards required in organic production in which, upon final registration of product approval from U.S. state agencies, TerraSante will be marketed with “OMRI listed for organic use”.


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. 

Cocrystal Pharma (COCP) – Phase 2a Influenza Trial Receives Authorization To Begin

Posted on by cpereira@noblefcm.com


Wednesday, November 01, 2023

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

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Phase 2a Trial Expected To Begin In The UK Before Year-End. Cocrystal announced that it has received authorization from the United Kingdom’s Medicines Health and Regulatory Agency to begin its Phase 2a clinical trial. This Phase 2a trial will be conducted in the UK and test CC42344 in seasonal and pandemic influenza. The trial is expected to begin before the end of 2023 with results expected around mid-2024.

Study Was Designed To Test Hunan Volunteers In A Controlled Setting. The study will be a single-center, placebo-controlled study designed to challenge healthy human volunteers with influenza A. Subjects will receive pharmaceutically-produced influenza A virus on the first day. This will be followed 24 hours later by either CC-42344 or placebo once daily for 5 days. Endpoints in the trial are changes in viral load, symptoms, and biomarkers, as well as safety and tolerability.


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. 

AMD’s Future Hinges on AI Chip Success

Posted on by slightbourne@noblecapitalmarkets.com

Chipmaker Advanced Micro Devices (AMD) offered an optimistic forecast this week for its new data center AI accelerator chip, predicting $2 billion in sales for the product in 2024. This ambitious target represents a crucial test for AMD as it seeks to challenge rival Nvidia’s dominance in the artificial intelligence (AI) chip market.

AMD’s forthcoming MI300X processor combines the functionality of a CPU and GPU onto a single chip optimized for AI workloads. The chipmaker claims the MI300X will deliver leadership performance and energy efficiency. AMD has inked deals with major hyperscale cloud customers to use the new AI chip, including Amazon Web Services, Google Cloud, Microsoft Azure and Oracle Cloud.

The $2 billion revenue projection for 2024 would represent massive growth considering AMD expects a modest $400 million from the MI300X this quarter. However, industry analysts caution that winning significant market share from Nvidia will prove challenging despite AMD’s technological advancements. Nvidia currently controls over 80% of the data center AI accelerator market, fueled by its popular A100 and H100 chips.

“The AI chip market is still in its early phases, but it’s clear Nvidia has built formidable customer loyalty over the past decade,” said Patrick Moorhead, President of Moor Insights & Strategy. “AMD will need to aggressively discount and wow customers with performance to take share.”

AMD’s fortunes sank earlier this year as the PC market slumped and excess inventory weighed on sales. Revenue from the company’s PC chips dropped 42% in the third quarter. However, AMD sees data center and AI products driving its future growth. The company aims to increase data center revenue by over 60% next year, assuming the MI300X gains traction.

But AMD faces headwinds in China due to new U.S. export rules limiting the sale of advanced AI chips there. “AMD’s ambitious sales target could prove difficult to achieve given the geopolitical climate,” said Maribel Lopez, Principal Analyst at Lopez Research. China is investing heavily in AI and domestic chipmakers like Baidu will be courting the same hyperscale customers.

Meanwhile, Intel aims to re-enter the data center GPU market next year with its new Ponte Vecchio chip. Though still behind Nvidia and AMD, Intel boasts financial resources and manufacturing scale that shouldn’t be underestimated. The AI chip market could get very crowded very quickly.

AMD CEO Lisa Su expressed confidence in meeting customer demand and hitting sales goals for the MI300X. She expects AMD’s total data center revenue mix to shift from approximately 20% today to over 40% by 2024. “The AI market presents a tremendous opportunity for AMD to grow and diversify,” commented Su.

With PC sales stabilizing, AMD raising its AI chip forecast provided a sigh of relief for investors. The company’s stock rebounded from earlier losses after management quantified the 2024 sales target. All eyes will now turn to AMD’s execution ramping production and adoption of the MI300X over the coming year. AMD finally has a shot at becoming a major player in the AI chip wars—as long as the MI300X lives up to the hype.

ZyVersa Data Boosts Promise of Inflammasome Inhibitor for MS Treatment

Posted on by slightbourne@noblecapitalmarkets.com

Clinical stage biopharmaceutical company ZyVersa Therapeutics (NASDAQ: ZVSA) announced compelling new research this week supporting the potential of its drug candidate IC 100 to treat multiple sclerosis (MS). Publication of the preclinical data on IC 100’s neuroprotective effects provided an upbeat development for ZyVersa’s stock and boosted confidence in its inflammasome inhibition technology.

ZyVersa is developing first-in-class therapies for inflammatory and kidney diseases. The company’s pipeline is led by IC 100, an antibody designed to inhibit inflammasome overactivation and reduce pathogenic inflammation. The recent research published in Molecular Neurobiology demonstrated that IC 100 reduced neuronal damage, microglial activation, and demyelination in a mouse model of MS.

MS is an inflammatory disease where the immune system attacks the central nervous system, degrading myelin and eventually causing nerve damage and disability. An estimated 2.8 million people globally suffer from MS, representing a major unmet medical need. Current MS drugs only slow progression of the disease.

ZyVersa believes IC 100’s unique mechanism inhibiting the ASC component of multiple inflammasome types can provide neuroprotection and block inflammation underlying development and progression of MS. The new data provides critical validation of this thesis, according to experts in the field.

ZyVersa’s stock jumped 12% on the news, reflecting increased investor enthusiasm for the company’s inflammasome targeting technology. The data comes right before ZyVersa anticipated beginning Phase 2 testing of IC 100 in MS patients during the first half of 2024.

The MS preclinical results support the potential of ZyVersa’s approach and represent an important step forward. However, some industry observers caution it remains to be seen whether the neuroprotective effects fully translate from animals to humans. But these are viewed as very promising early stage findings.

Beyond MS, ZyVersa believes IC 100 may help treat a range of other neuroinflammatory conditions characterized by overactive inflammasomes such as Alzheimer’s and Parkinson’s disease. The new research helps derisk the company’s pipeline and technology platform.

In the wake of the positive data, ZyVersa appears well positioned to ride the wave of growing interest in leveraging inflammation research to develop better therapies for neurological diseases. While still an early stage company, ZyVersa stock offers an intriguing investment opportunity based on the promise of its science and immunotherapy pipeline. Expectations will be high for the biotech to execute on its MS program and fully tap into the potential of its ASC inhibition technology.