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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

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  • 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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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).

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.

Release – GeoVax to Report Third Quarter 2023 Financial Results and Provide Corporate Update on November 8, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, October 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report third quarter 2023 financial results on Wednesday, November 8, 2023, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Dial-in numbers:

Domestic:                     800-715-9871

International:                646-307-1963

Conference ID:             7519986

Webcast:

A webcast of the live call may be accessed here and on the Events page of the GeoVax website.

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

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

Company Contact:          Investor Relations Contact:          Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

Release – Smokey Bones Announces Partnership with Celebrity Chef Robert Irvine

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

October 31, 2023

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The acclaimed culinary chef and Masters of Meat join forces to support military, veteran, and first responder personnel.

Plantation, Fla., Oct. 31, 2023 (GLOBE NEWSWIRE) — Smokey Bones today announces that world-class culinary personality and philanthropist, Chef Robert Irvine, will join the Masters of Meat to introduce a limited-time menu, Robert’s Ribfeast, starting on October 31, 2023. Fans are asked to bring their appetites to try this delicious new menu, which will benefit the Robert Irvine Foundation, dedicated to transforming the lives of service members, veterans, first responders and their families. Smokey Bones has committed to donate 10 percent of sales from “Robert’s Ribfeast” promotion, up to $100,000.

As a Smokey Bones fan and loyalist, particularly of its award-winning ribs, Chef Irvine is working with the brand to share good food with guests while supporting and showing appreciation for the country’s military and veterans. Robert’s Ribfeast includes:

  • Robert’s Ribfeast for One ($19.99): A half-rack of Smokey Bones’ signature house-smoked St. Louis ribs, two sides, a piece of garlic bread, and choice of appetizer or dessert.
  • Ribfeast for Two ($29.99): A full rack of St. Louis ribs, four sides, two pieces of garlic bread, and choice of appetizer or dessert.

“We are honored to partner with Chef Irvine, who shares our appreciation for not only our ribs but also for our active-duty military and veterans,” said Cole Robillard, Chief Marketing Officer at Smokey Bones. “Chef Irvine is a frequent guest at Smokey Bones and a natural fit for our brand as he has made a significant impact on both the restaurant industry and military community. We are excited to not only offer guests a terrific deal on his favorite meal, but to bring our communities together to support this important cause.”

Chef Irvine is an acclaimed chef, entrepreneur, and longtime philanthropic supporter of America’s military. He’s also the host of Food Network’s hit show “Restaurant: Impossible,” where he gives struggling restaurateurs a second chance to turn their lives and businesses around.

“We are thankful for the generosity of Smokey Bones in their efforts to support the Robert Irvine Foundation,” said Chef Irvine. “These funds will go towards our Food, Wellness, Community, and Financial-Support programs which impact thousands of service members, veterans and their families. We look forward to kicking off this partnership with the Masters of Meat in supporting America’s heroes.”

Robert’s Ribfeast will be available at all Smokey Bones locations until January 1, 2024, while supplies last.

Smokey Bones is available for dine-in and online orders for pick-up, as well as delivery on SmokeyBones.com. To make a reservation at your nearest location, visit https://reservations.getwisely.com/location-search/reservations?g=smokey-bones.

About FAT (Fresh. Authentic. Tasty.) Brands

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

About Smokey Bones

The ‘Masters of Meat,’ Smokey Bones is a full-service restaurant delivering great barbecue, award-winning ribs, crave-worthy cocktails and memorable moments in 61 locations across 16 states. Smokey Bones serves lunch, dinner, and late night every day. Smokey Bones also has a full bar featuring a variety of bourbons and whiskeys; a selection of domestic, import and local craft beers; and signature, handcrafted cocktails. Smokey Bones offers a 10 percent discount to active duty and veterans with ID. 

About the Robert Irvine Foundation

The Robert Irvine Foundation was established by chef, entrepreneur and TV personality Robert Irvine. The Robert Irvine Foundation supports and strengthens the physical and mental well-being of our service members, veterans, first responders, and their families. They provide these heroes with life-changing opportunities that unlock the potential in their personal and professional lives through food, wellness, community, and financial support. For more information, please visit: www.robertirvinefoundation.org.

###

Media Contact:
Kaitlyn Ianiro
kaitlyn@inklinkmarketing.com
305-631-2283

Source: FAT Brands Inc.

Release – Direct Digital Holdings Announces Completion of Redemption of Outstanding Warrants

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 31, 2023 9:00am EDT

HOUSTON, Oct. 31, 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 it completed the redemption of its outstanding warrants (the “Warrants”) to purchase shares of the Company’s Class A Common Stock, par value $0.0001 per share (the “Common Stock”) that remained outstanding following 5:00 p.m. New York City Time on October 30, 2023 (the “Redemption Date”), for a cash redemption price of $0.35 per Warrant. A notice of redemption was distributed on October 23, 2023 to the registered holders of outstanding Warrants announcing the redemption pursuant to the terms of the Warrant Agency Agreement, dated as of February 15, 2022, by and between the Company and Equiniti Trust Company, LLC (formerly known as American Stock Transfer and Trust Company, LLC), governing the Warrants. The redemption follows the expiration and closing of the Company’s offer to each holder of outstanding Warrants to purchase any and all outstanding Warrants for $1.20 in cash per Warrant, without interest.

The Warrants were listed for trading on the Nasdaq Capital Market (“Nasdaq”) under the symbol “DRCTW.” In connection with the redemption, the Warrants ceased trading on Nasdaq and were delisted, with the trading halt announced after close of market on October 30, 2023. The Common Stock continues to trade on Nasdaq under the symbol “DRCT.”

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 

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-announces-completion-of-redemption-of-outstanding-warrants-301972758.html

SOURCE Direct Digital Holdings

Released October 31, 2023

Release – Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

OCTOBER 31, 2023

BOTHELL, Wash., Oct. 31, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with its broad-spectrum, oral PB2 inhibitor CC-42344 as a potential treatment for pandemic and seasonal influenza A. Cocrystal expects to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.

In late 2022 Cocrystal reported highly favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia. The Phase 2a single-site, double-blind, placebo-controlled human challenge trial will evaluate the safety, viral and clinical measurements of orally administered CC-42344 in subjects infected with influenza A.

“We are pleased to have met the regulatory requirements of the MHRA to begin this Phase 2a human challenge trial in the UK,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Influenza is a major global health threat that may become more challenging to treat due to emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. The need for new therapeutic and prophylactic treatments is clear. Our encouraging Phase 1 data demonstrated that CC-42344 has a favorable safety profile and is well-tolerated. CC-42344 has the potential to be a best-in-class antiviral treatment for pandemic and seasonal influenza infections.”

“We are closely working with a world leading clinical research organization that is experienced in testing infectious and respiratory disease antivirals using human challenge clinical trials,” said James Martin, Cocrystal’s CFO and Co-CEO. “Receiving authorization to move ahead with our Phase 2a trial is a major step in our quest to bring CC-42344 to market and make a meaningful contribution to improving health and reducing the cost of care.”

About Seasonal Influenza
Each year there are approximately one billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About CC-42344
CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology and is a novel approach to treating pandemic and seasonal influenza A. In vitro data show that CC-42344 is highly active against drug-resistant influenza A strains with a high barrier to resistance, while also demonstrating favorable pharmacokinetic and safety profiles.

About Cocrystal Pharma, Inc.
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.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 2a study for CC-42344 and the potential efficacy and clinical benefits of such product candidate and the demand for such a product. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from manufacturing and research delays arising labor shortages and other factors, the ability of our Clinical Research Organization partner to recruit volunteers for, and to proceed with, the Phase 2a clinical study for CC-42344, general risks arising from conducting a clinical trial, receipt of regulatory approvals for future trials, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the governmental authorities, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we may develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

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Source: Cocrystal Pharma, Inc.

Released October 31, 2023