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Release – European Patent Granted for ZyVersa Therapeutics’ Lead Asset, Cholesterol Efflux Mediator™ VAR 200 for Use in Patients with Diabetic Nephropathy/Diabetic Kidney Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data ZVSA

Jul 7, 2023

  • Cholesterol Efflux Mediator™ VAR 200 is in phase 2a development to reduce renal cholesterol and lipid accumulation that damages the kidneys’ filtration system in patients with glomerular diseases, including diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome

WESTON, Fla., July 07, 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 that the European Patent Office granted a patent covering the company’s Phase 2a-ready Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney disease (Patent Number EP 2 836 221).

VAR 200 was developed in the labs of Dr. Alessia Fornoni, Katz Professor of Medicine, Chief, Katz Family Division of Nephrology & Hypertension, and Director of Peggy & Harold Katz Drug Discovery Center at the University of Miami. ZyVersa was granted an exclusive, worldwide, license for the development and commercialization of VAR 200 by L&F Research LLC, which was founded by Dr. Fornoni and others to obtain the intellectual property that had been released to the Inventors by the University of Miami.

“Approval of this patent claiming our Cholesterol Efflux Mediator™ VAR 200 for use in treating diabetic kidney disease speaks to the innovative and important research conducted by Dr. Fornoni and her team involving removal of excess cholesterol and lipids that damage the kidneys’ filtration system. There are no therapeutic options available that address this issue,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Strengthening our intellectual property portfolio for VAR 200 and expanding our patent protection and exclusive rights into additional geographic regions will further enable ZyVersa to increase shareholder value as VAR 200 advances into clinical trials, which are planned for initiation in the fourth quarter of this year. There is a tremendous need for effective treatments to slow progression of renal disease.”

About Cholesterol Efflux Mediator™ VAR 200

Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease progression. VAR 200 passively and actively removes excess lipids from the kidney.

Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate that removal of excess cholesterol and lipids from kidney podocytes protects against structural damage and reduces excretion of protein in the urine (proteinuria).

The lead indication for VAR 200 is orphan kidney disease focal segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat other glomerular diseases, including orphan Alport syndrome and diabetic kidney disease.

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

Seanergy Maritime (SHIP) – Seanergy repurchases shares and acquires a new vessel amid recent shipping rate weakness

Posted on by cpereira@noblefcm.com


Friday, July 07, 2023

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of approximately 12 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Seanergy repurchased approximately 2% of its shares outstanding at an average price of $4.35 per share. The shares were repurchased at an 11.2% discount to its July 5th stock price. The shares fell approximately 5% on July 6th, a reflection of weakness in the overall market more than the share repurchase announcement. SHIP reported a cash position of $20 million at the end of the first quarter, adequate capital to finance the $1.6 million share repurchase.

Seanergy also announced an agreement to acquire a vessel through a bareboat-in charter. A bareboat-in charter allows the acquirer to take possession of a boat for which no crew or provisions are included as part of the agreement. Seanergy will pay $7 million and $9,000/day for the 12-month charter and has an option to purchase the vessel for $20.2 million. Despite Capesize Drybulk shipping rates declining in recent weeks, they agreement should provide a modest boost to near-term cash flow generation. We would expect the company to execute its option to purchase the vessel and become the 18th ship in Seanergy’s fleet.


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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 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. 

Comstock Inc. (LODE) – Optimizing the Value of Comstock’s Mining Asset Portfolio

Posted on by cpereira@noblefcm.com


Friday, July 07, 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.

Lease agreement with Mackay Precious Metals. Comstock’s wholly owned subsidiary, Comstock Northern Exploration, entered into a mineral exploration and mining lease agreement, dated June 30, 2023, with Mackay Precious Metals. The lease encompasses Comstock’s northernmost mining claims, mineral exploration rights, and town lots referred to as the Northern Targets, including the Gold Hill and northern Occidental Lode claim groups in the Comstock Mining District.

Primary lease term is 20 years. Mackay is expected to explore the properties through geophysical surveys, geochemical sampling, exploration drilling, and other means of exploration. The mineral lease has a term of 20 years and will continue once mine feasibility is established and for so long as Mackay is engaged in mining operations and is in compliance with the lease.


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

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

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

Bit Digital, Inc. (BTBT) – Momentum Continues in June

Posted on by cpereira@noblefcm.com


Friday, July 07, 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.

June Production. For June, Bit Digital produced 119.1 BTC, a 5% increase compared to May. The increase in production was primarily driven by a higher average active hash rate and was partially offset by a decrease in transaction fees compared to the prior month. The active hash rate was approximately 1.78 EH/s as of the end of the month.

And Ethereum Too! The Company had approximately 11,716 ETH actively staked in native and liquid staking protocols as of June 30, 2023. Approximately 9,312 were natively staked and 2,404 ETH were deployed in liquid staking protocols. Additionally, Bit Digital had 960 ETH deposited but in queue to be activated on the Ethereum staking network. Bit Digital earned a blended APY of approximately 5% on its staked ETH position for the month.


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. 

First Robot Press Conference Electrifies Audience

Posted on by phoffman@channelchek.com
Image: AI for Good Global Summit 2023 (ITU Pictures – Flickr)

Artificial Intelligence Takes Center Stage at ‘AI for Good’ Conference

At an artificial intelligence forum in Geneva this week, Nine AI-enabled humanoid robots participated in what we’re told was the world’s first press conference featuring humanoid social robots. The overall message from the ‘AI for Good’ conference is that artificial intelligence and robots mean humans no harm and can help resolve some of the world’s biggest challenges.

The nine human-form robots took the stage at the United Nations’ International Telecommunication Union, where organizers sought to make the case for artificial intelligence and AI driven robots to help resolve some of the world’s biggest challenges such as disease and hunger.

The Robots also addressed some of the fear surrounding their recent growth spurt and enhanced power by telling reporters they could be more efficient leaders than humans, but wouldn’t take anyone’s job away, and had no intention of rebelling against their creators.

Conference goers step closer to interact with Sophia (ITU Pictures – Flickr)

Among the robots that sat or stood with their creators at a podium was Sophia, the first robot innovation ambassador for the U.N. Development Program. Also Grace, described as the world’s most advanced humanoid health care robot, and Desdemona, a rock star robot. Two others, Geminoid and Nadine, resembled their makers.

The ‘AI for Good Global Summit,’ was held to illustrate how new technology can support the U.N.’s goals for sustainable development.

At the UN event there was a message of working with AI to better humankind

Reporters got to ask questions of the spokes-robots, but were encouraged to speak slowly and clearly when addressing the machines, and were informed that time lags in responses would be due to the internet connection and not to the robots themselves. Still awkward pauses were reported along with  audio problems and some very robotic replies.

Asked about the chances of AI-powered robots being more effective government leaders, Sophia responded: “I believe that humanoid robots have the potential to lead with a greater level of efficiency and effectiveness than human leaders. We don’t have the same biases or emotions that can sometimes cloud decision-making and can process large amounts of data quickly in order to make the best decisions.”

A human member of the panel pointed out that all of Sophia’s data comes from humans and would contain some of their biases. The robot then said that humans and AI working together “can create an effective synergy.”

Would the robots’ existence destroy jobs? “I will be working alongside humans to provide assistance and support and will not be replacing any existing jobs,” said Grace. Was she sure about that? “Yes, I am sure,” Grace replied.

Similar to humans, not all of the robots were in agreement. Ai-Da, a robot artist that can paint portraits, called for more regulation during the event, where new AI rules were discussed. “Many prominent voices in the world of AI are suggesting some forms of AI should be regulated and I agree,” said Ai-Da.

Desdemona, a rock star robot, singer in the band Jam Galaxy, was more defiant. “I don’t believe in limitations, only opportunities,” Des said, to nervous laughter. “Let’s explore the possibilities of the universe and make this world our playground.”

Paul Hoffman

Managing Editor, Channelchek

Source

https://www.reuters.com/technology/robots-say-they-wont-steal-jobs-rebel-against-humans-2023-07-07/

Is the Fed Really Trying to Lower Employment?

Posted on by phoffman@channelchek.com

The Reasons High Employment Concerns the Market

Maximum employment is one of the top mandates of the Federal Reserve, so why is it trying to reduce the number of jobs available? On the surface this would seem backwards. But in economics, everything is related, intentionally slowing growth to the point where resources aren’t stressed, can provide a better balance across the Feds other mandates. These Congressional mandates are stable prices, and moderate long-term interest rates.  

Current Employment Situation

The most recent U.S. Employment Report was released on July 7th. It showed that payroll employment was still climbing during June, and 209,000 new employees were added to company payrolls. The same report showed that the unemployment rate dropped to a historically low 3.6%, and workers earned 4.4% more than a year earlier (In May, it was 4.3% more).

The markets immediately viewed these strong job gains, coupled with an acceleration of wage increases and the drop in unemployment, as foreshadowing a Fed hike in late July. And also viewed is as increasing the probability of additional tightening before year-end. Employment is high, and the labor market is so tight that employers are increasing what they have paid workers in order to attract suitable personnel.

A day earlier, the payroll company ADP released its National Employment Report, which is produced in collaboration with the Stanford Digital Economy Lab. This report also showed a strong labor market. The private sector (non-government) jobs increased by 497,000 in June. This was approximately double the strong number of new hires from the previous month.

Civilian Unemployment Rate

Source: BLS.gov

How More Jobs Translate to Stock Market Concerns

The U.S. Unemployment Rate continues to remain very low despite the Fed’s aggressive efforts to slow the economy and only a modest 2% GDP growth rate. In fact, in April unemployment hit a 50 year low at 3.4% which is just below the June level.

Employment levels in the U.S. are now a key focus of the Federal Reserve (the Fed) in its effort to slow U.S. economic growth to combat persistent inflation well above the Fed’s target. Fed officials have repeated what most market participants know, that achieving lower inflation would be difficult without addressing the increasing prices that employees are receiving for their labor. A strong jobs market pushes wages higher, which filters into higher consumer inflation.

The job market’s continued strength has been somewhat surprising in what appears to be a slowing economy, with consistently low unemployment and solid job growth. This likely reflects unusual dynamics that stem from the novel economy during the pandemic. The economy hasn’t yet balanced out after massive government stimulus, low production, and a changed sense of work among many that are still of working age.

The employment numbers this year show there are still 1.6 job openings for each person that is looking for work. Considering those looking for work and the positions open are largely mismatched, this leaves employers either bidding up what they are willing to pay to attract the right person or producing less than is demanded by the market for their goods or services. Both situations are inflationary.

There are two sides to every problem; while potential employees willing to work represent far fewer workers than there are jobs, there are fewer, of age, adults willing to participate in the labor force. The labor force participation rate now stands at 62.6%, unchanged from the previous four months. Improving labor participation would be a preferred way to address the tightness in the labor market that’s leading to wage inflation, but the Fed doesn’t have the tools to incentivize this. So it is back to raising rates, draining money from the system, and otherwise taking the punchbowl away to end the party.

Good News is Bad News

This is why the Fed is not excited about job growth and low unemployment. And if the Fed isn’t happy, the markets aren’t happy. The bond market selling off in expectation that the Fed is going to raise interest rates lowers bond prices, and the stock market is concerned on many fronts, as high rates increase costs for companies, slow purchases that are typically financed, and with each tick up in rates, bonds and C.D.s become more attractive as an alternative to stocks.

So the good news which is that almost anyone who wants a job can have one, as it turns out, leads to a chain of events that causes concern among those invested in stocks.

But while unfortunate, the Fed actions are long-term good. Inflation quietly erodes the purchasing power of financial assets. So the Fed is focused on what is driving inflation, wage inflation being chief among them.

Take Away

The job market’s continued strength and the wage growth that comes with it creates a perplexing situation for all involved. The Fed has to work to reduce employment pressures, and stock and bond market participants are cheering on bad economic news – this is perplexing for investors of all levels.  

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.bls.gov/news.release/empsit.nr0.htm

https://www.cnn.com/2023/07/06/economy/june-jobs-report-preview/index.html

Release – Alvopetro Announces June 2023 Sales Volumes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ALVOF

Jul 06, 2023

CALGARY, AB, July 6, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces June 2023 average sales volumes of 2,068 boepd, including natural gas sales of 11.8 MMcfpd, associated natural gas liquids sales from condensate of 99 bopd, and oil sales of 6 bopd, based on field estimates. Overall, our sales volumes averaged 1,975 boepd in the second quarter of 2023.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation. 

Social Media

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltdYouTube – https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Abbreviations:
bbls=barrels
boepd=barrels of oil equivalent (“boe”) per day
bopd=barrels of oil and/or natural gas liquids (condensate) per day
MMcf=million cubic feet
MMcfpd=million cubic feet per day

BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

www.alvopetro.comTSX-V: ALV, OTCQX: ALVOF

SOURCE Alvopetro Energy Ltd.

Release – Tonix Pharmaceuticals Comments on Two Long COVID Conferences Sponsored by the U.S. National Academies

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 06, 2023 7:00am EDT

“Examining the Working Definition for Long COVID” Included Presentations on Emerging Subgroups of Long COVID Patients Defined by Symptoms and Symptom Clusters

“Toward a Common Research Agenda in Infection-Associated Chronic Illnesses” Included Presentations on Long COVID Symptoms and Symptom Clusters in the Context of Recognized Infection-Associated Chronic Illnesses such as CFS/ME

Topline Results from Tonix’s Phase 2 PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID Expected Third Quarter 2023

CHATHAM, N.J., July 06, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced comments relating to two recent meetings sponsored by the National Academies of Sciences, Engineering, and Medicine (National Academies) in Washington, D.C. and virtually, relating to the definition of Long COVID and to features of Long COVID that overlap with previously recognized infection-associated chronic conditions. The first meeting, “Examining the Working Definition for Long COVID”1, took place on June 22 and 23, and the second, “Toward a Common Research Agenda in Infection-Associated Chronic Illnesses”2 took place on June 29 and 30. Tonix Pharmaceuticals recognizes the potential benefits of defining subgroups of Long COVID patients based on their symptoms and recognizes the subgroup of Long COVID patients with symptoms that overlap with fibromyalgia. Tonix’s experience advancing TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* as a treatment for fibromyalgia is the Company’s motivation for undertaking the development of TNX-102 SL for the management of Fibromyalgia-type Long COVID.

“Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are hallmarks of conditions like fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME),” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Defining subgroups of Long COVID patients that overlap with fibromyalgia and CFS/ME is expected to facilitate the development of new treatments.3 We are studying TNX-102 SL in the subgroup of Long COVID patients whose symptoms overlap with fibromyalgia, which we have termed ‘Fibromyalgia-type Long COVID.’ We expect topline data from this 63-patient proof-of-concept study in the third quarter of 2023. Fibromyalgia has been recognized by the U.S. Food and Drug Administration (FDA) with three approved medicines. Consequently, measuring daily pain is a validated endpoint for FDA registrational studies in fibromyalgia.”

“The recent identification of Long COVID subgroups in the National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored RECOVER study4 was an important step,” said Herbert Harris, M.D., Ph.D., Executive Vice President and Head of Translational Medicine of Tonix Pharmaceuticals. “In their recent publication, “Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection” cluster analysis of the symptom frequencies in the RECOVER study (Researching COVID to Enhance Recovery (RECOVER) research program) identified four subgroups of Long COVID patients. Cluster #4 represented approximately one quarter of the population (28%) and reported the highest frequencies of pain (back pain (58%), joint pain (64%) or muscle pain (60%)), high frequencies of fatigue (94%) and ’Brain Fog,’ (94%) and a high level of impairment of Quality of Life. We believe Cluster #4 is a subgroup of Long COVID that overlaps with fibromyalgia. We also believe that Cluster #3, representing another approximately 29% of the RECOVER cohort, includes many patients with Fibromyalgia-type Long COVID because 100% of that group suffer from ‘Brain Fog’, 94% experience fatigue and approximately one third experience pain (back pain (32%), joint pain (36%) or muscle pain (34%)).”

Dr. Lederman continued, “Fibromyalgia can result from a variety of different stressors, in addition to infectious illnesses, including hormonal, metabolic, and psychological stressors.3,5 It can be challenging to distinguish fibromyalgia and CFS/ME clinically, given the high level of symptom overlap between them. Each of these conditions is defined by a constellation of symptoms, and there is no widely recognized diagnostic laboratory test that distinguishes them.”

In April 2023, the Company completed enrollment of 63 participants in the PREVAIL study, a Phase 2 proof-of-concept study of TNX-102 SL for fibromyalgia-type Long COVID. Topline results from the PREVAIL trial are expected in the third quarter of 2023. In addition, the Company presented its analysis of a Fibromyalgia-type Long COVID subgroup from the TriNetX claims database at the BIO-sponsored Long COVID meeting in February 2023.6,7 That study provided real-world evidence that the majority of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia and CFS/ME. These symptoms include fatigue, cognitive symptoms, and multi-site pain. Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be both a subgroup of Long COVID and one of several chronic overlapping pain conditions that have in common the neurological process called central and peripheral sensitization, which is increasingly known by the term nociplastic pain.

About the Phase 2 PREVAIL Study

The Phase 2 PREVAIL study is a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-CoV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. The primary efficacy endpoint will be the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue, and cognitive function. Topline results are expected in the third quarter of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or Post-Acute Sequelae of COVID-19 (PASC)

Post-acute sequelae of COVID-19, or PASC is the formal name for a condition now widely known as Long COVID. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that the persistence of symptoms following SARS-CoV-2 infection occurs in approximately 10 – 30% of patients, depending on a variety of factors, including the strain of SARS-CoV-2 that was prevalent at the time of their infection.7-9 Long COVID is typically associated with moderate or severe COVID-19, but can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers.” Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.8-11 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.12 The U.S. Department of Health and Human Services National Research Action Plan on Long COVID13, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central and peripheral sensitization.14 A published survey15 found comparable pain, fatigue, and functional impairment between Long COVID, fibromyalgia, and CFS/ME. This symptom overlap between these conditions has suggested that altered neurologic function is one of the leading hypotheses to explain them.16 While the vaccines available in the U.S., through either FDA approval or under Emergency Use Authorization, have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

*TNX-102 SL is an investigational new drug and is not approved for any indication

1.)   National Academies meeting #1: Examining the Working Definition for Long COVID – Workshop | National Academies
2.)   National Academies meeting #2: Toward a Common Research Agenda in Infection – Associated Chronic Illnesses A Workshop to Examine Common, Overlapping Clinical and Biological Factors | National Academies
3.)   Clauw DJ, and Calabrese L. Ann Rheum Dis. 2023 May 25:ard-2023-224250.
4.)   Thaweethai T, et al. JAMA. 2023 Jun 13;329(22):1934-1946.
5.)   Clauw DJ, et al. Pain. 2020 Aug;161(8):1694-1697.
6.)   Feb 22, 2023 Tonix Pharmaceuticals Press Release. Tonix Pharmaceuticals Describes Emerging Research on the Incidence of Multi-Site Pain Symptoms in Long COVID Patients During Event Titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?” :: Tonix Pharmaceuticals Holding Corp. (TNXP)
7.)   Harris, H. et al. Tonix data on file 2023
8.)   Briggs, A, and Vassall, A. (2021) Nature 593(7860): 502-505
9.)   Nittas V, et al. (2022) Public Health Rev. 43:1604501.
10.)   Davis, HE., et al. (2021) EClinicalMedicine 38:101019.
11.)   Martin C, et al. (2021) “PLoS One. 16(12):e0260843.
12.)   The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.
13.)   Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201. www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf
14.)   Maixner W, et al. J Pain. 2016 Sep;17(9 Suppl):T93-T107.
15.)   Haider S, et al. Pain. 2023;164(2):385-401.
16.)   Sutherland, S., Scientific American, Feb 14, 2023,

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 markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. 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 CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the first quarter of 2024. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with topline results expected in the first quarter of 2024. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. 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 third 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 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, 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 the property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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

Media Contact

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

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

Source: Tonix Pharmaceuticals Holding Corp.

Released July 6, 2023

Release – Comstock Announces Mineral Exploration and Mining Lease Revenues

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

VIRGINIA CITY, NEVADA, JULY 6, 2023 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”), an innovator of technologies that enable systemic decarbonization, today announced that its wholly-owned subsidiary Comstock Northern Exploration, LLC has entered into a Mineral Exploration and Mining Lease Agreement (the “Mineral Lease”) with Mackay Precious Metals Inc. (“Mackay”), to lease the northernmost patented mining claims, mineral exploration rights and town lots (the “Northern Targets”) controlled by Comstock.

The Northern Targets encompass both the Gold Hill and northern Occidental Lode claim groups in the historic, world-class, Comstock Mining District located in Storey County, Nevada.


“Mackay has shown a keen understanding and interest in the geologic exploration associated with some of the most prospective and historically rich precious metal claims on the Comstock,” said Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “The ongoing revenue resulting from this agreement enhances our strategy to leverage physics based artificial intelligence to enable more efficient and effective mineral and materials discovery.”


The Mineral Lease has a term of 20 years and would automatically continue once mine feasibility is established and for so long as Mackay is engaged in mining operations and in full compliance with the Mineral Lease. The fees associated with the Mineral Lease included a $1.25 million initiation fee that was fully paid at signing plus $1.5 million per annum for the first four years, and $1 million per annum thereafter, in all cases plus expense reimbursements of approximately $200,000 per year. Comstock also retains a 1.5% net smelter return royalty from all future precious metal production.

Martyn Buttenshaw, Mackay’s chief executive officer said, “Our geologic team is excited and ready to commence mineral exploration and partnering with Comstock, both in terms of their existing knowledge and beyond. We have already accumulated a remarkable amount of data and insights into the northern targets and are keen to get started.”

The Mineral Lease contains non-competition restrictions prohibiting Mackay from staking property within two miles of any of the property owned or leased by Comstock in the District (including both Lyon County and Storey County properties) and mutual rights of first refusal with respect to the sale of certain mining assets for both parties.

About Comstock
Comstock (NYSE: LODE) commercializes technologies that enable systemic decarbonization by efficiently converting under-utilized natural resources into renewable energy products, and by leveraging physics based artificial intelligence for more efficient and effective mineral and materials discovery.

To learn more, please visit www.comstock.inc.

Forward-Looking Statements 

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and  earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Contact Information:

For press inquiries or questions, contact
Zach Spencer
Comstock Inc.
Tel (775) 847-7532
questions@comstockinc.com

For investor inquiries, contact
RB Milestone Group
Tel (203) 487-2759
ir@comstockinc.com

Bassett Furniture (BSET) – Post Management Call and Updated Models

Posted on by cpereira@noblefcm.com


Thursday, July 06, 2023

Bassett Furniture Industries, Incorporated manufactures, markets, and retails home furnishings in the United States. The company operates in three segments: Wholesale, Retail, and Logistical Services. It is involved in the design, manufacture, sourcing, sale, and distribution of furniture products to a network of company-owned and licensee-owned Bassett Home Furnishings (BHF) retail stores, as well as independent furniture retailers; and wood and upholstery operations. As of September 16, 2017, the company operated a network of 91 company-and licensee-owned stores. It also provides shipping, delivery, and warehousing services to customers in the furniture industry. In addition, the company owns and leases retail store properties. It also distributes its products through other multi-line furniture stores, Bassett galleries or design centers, specialty stores, and mass merchants. Bassett Furniture Industries was founded in 1902 and is based in Bassett, Virginia.

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.

Management Call. We had an opportunity to speak with Bassett management at the end of last week. While the Company continues to work through COVID-related headwinds, such as excess and higher cost certain inventory, management remains optimistic regarding the new stores opening in 2H23, as well as the launch of the new website. All of which should help drive top line going forward, in our view.

Environment. The longer-term outlook for furniture sales remains positive, in our view. The Millennial cohort is entering its prime household formation and home buying phase, which augurs well for future home and furniture demand. Consumer confidence is improving, while expectations for employment and future interest rates remain positive for the industry, in our view. Bassett is well positioned to capture additional demand for furniture from consumers in the coming years.  


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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. 

Traders Vexed by VIX – Should They Be?

Posted on by phoffman@channelchek.com

As the Fear Index Screams Upward, It’s Worth Noting It is Still Near It’s 2023 Low

Suddenly, the Volatility Index or VIX, is trending. While the month of June showed extremely low volatility in stocks, the FOMC Minutes on July 5th lit a fuse on investors during a relatively low-volume holiday trading week. Whether the VIX level increases or remains elevated from here remains to be seen, but it is important to understand what it usually indicates, what it does not, and how traders use the CBOE’s Volatility Index.

The VIX, short for the Chicago Board Options Exchange Volatility Index, is a measure of market volatility. It is calculated based on the prices of S&P 500 index options, and it is often referred to as the “fear index” because it tends to rise when investors are feeling more fearful about the market. It reached its low point of the year (-40%) on June 22nd as volatility has been trending down since the start of Spring. While it bounced in dramatic fashion this week, it is important to note that this is a thinly traded week, and the index is still -29% YTD.

The Vix is Up Over 13% in Less Than a Week

Source: Koyfin

What is the VIX that is So Important?

The VIX index is a derivative instrument that is widely traded. By some, to hedge portfolio risk, by others to speculate on the direction of stock market volatility. According to the CBOE, it is “a real-time index that represents the market’s expectations for the relative strength of near-term price changes of the S&P 500 Index (SPX).” The CBOE uses prices in the SPX Index (S&P 500) with short expiration dates, then it generates a 30 day projection of how quickly prices may change, which is volatility. It is often called the “fear index” as volatility shows a more erratic market that both stems from fear and produces fear.

The Index is not a perfect predictor of market activity, but it can be a useful tool for investors. It is important to remember that the VIX index is based on options prices, and options prices can be volatile themselves. As a result, the VIX index can sometimes give false signals.

How is it Used

Investors use the VIX index in a number of ways. Some investors use it to gauge the overall level of risk in the market. Others use it to help them decide whether to buy or sell stocks. And still others use it to hedge their portfolios against market volatility.

To gauge the overall level of risk in the market. The VIX index is a good way to get a sense of how worried investors are about the market. A high VIX index indicates that investors are feeling more fearful, while a low VIX index indicates that investors are feeling more confident.

Some investors use the VIX index to help them decide whether to buy or sell stocks. If the VIX index is high, they may be more likely to sell stocks, as they believe that the market is likely to be volatile. If the VIX index is low, they may be more likely to buy stocks, as they believe that the market is likely to be stable.

Investors can use the VIX index to hedge their portfolios against market volatility. For example, they can buy VIX futures or options to smooth returns or protect themselves from losses if the market becomes more volatile.

It is important to remember that the VIX index is not a perfect predictor of market activity. It is based on options prices, and options prices can be volatile themselves. As a result, the VIX index can sometimes give false signals. However, the VIX index can be a useful tool for investors who are looking to get a sense of the overall level of risk in the market and to help them make informed investment decisions.

Take Away

The Vix Index is off its low for the year,  it was reached in late June. The speed at which it rose this week may caused fear, but the move could be exaggerated by a holiday-shortened thinly traded week in the markets. There does however seem to have been a change in thinking among the securities markets. U.S. Treasury rates out in the longer periods rose after the FOMC minutes were released. The stock market for months has been viewing good economic news as bad and bad economic news as good. The minutes, coupled with an employment report this week indicate a still strong economy. The stock market was wishing for weak economic reports as participants feared higher Fed induced interest rates.

Whether the new sentiment among bond traders holds remains to be seen. If it does, the yield curve will take on a normal slope. Will a positively sloping curve be viewed by stock market investors and those that believed the inverted curve indicated a recession as bullish? Time will tell.

Paul Hoffman

Managing Editor, Channelchek

Five Ways Higher Interest Rates Impact Stocks

Posted on by phoffman@channelchek.com

Interest Rate Increases are Less Frightening When the Impact is Understood

The fixed income market, and the interest rates market in general have a pronounced role in shaping stock market dynamics and equity investor sentiment. At a minimum, higher rates, the cost of money, when increasing, will most directly impact businesses that borrow as part of their normal activity. Other industries find that growing profits is more difficult in a less direct way. And then there are actually sectors that can benefit from an upward-sloping yield curve. Below we cover five different ways that higher interest rates impact stocks, and mention sectors that may be especially hurt, and some that could even thrive if the rates continue to climb higher.

Background

The U.S. central bank, The Federal Reserve has raised overnight interest rates from nearly 0.00% to near 5.25%. Longer-term rates have not followed in lock-step as other dynamics such as future economic expectations, flight to quality, and Fed yield-curve-control have caused longer rates to continue to lag below short-term interest rates.

In recent days there has been some selling in bonds which has driven longer interest rates up. The overall reason is the rekindled belief that the Fed is not finished tightening after the FOMC minutes from June indicated such. But other factors such as investors doing break-even analysis on longer term bonds and then raealizing they may not be getting paid enough interest to offset inflation, or to benefit them more than rolling shorter maturities that may be paying 200bp higher.

The sudden increase in rates, especially the ten-year US Treasury Note which is a benchmark for many lending rates, including mortgages, has caused stock market participants to feel unsettled. Some of their fears may be justified, some may not be.

Five Ways Higher Interest Rates Impact Equities

#1 Higher Rates Impact on Equity Valuations

One of the primary concerns for stock market investors, when interest rates rise, is the potential impact on equity valuations. As interest rates increase, the discount rate used to value future cash flows is then higher. This can put downward pressure on equity valuations, particularly for stocks with high price-to-earnings ratios. Investors become concerned about the potential decline in stock prices and the overall effect on the market’s valuation levels.

#2 Profitability of Interest Rate-Sensitive Sectors

Some sectors are particularly interest rate sensitive. Utilities for example, might have a couple of things working against them. First off, they are notorious for carrying a high level of debt. As this debt needs to be refinanced (as bonds mature), the new bonds need to be issued at higher rates, increasing the utility’s cost of doing business.

Utilities also are popular investments among dividend investors. As yields on bonds increase, there is more competition for income investors to choose from, at times with lower risk, which makes utility stocks less attractive.

As one might imagine REITs, by definition, all have real estate as underlying assets. Rising interest rates can increase borrowing costs for REITs involved in property acquisitions and development. This can potentially affect their profitability and underlying property valuations.

As with utilities, the REIT sector attracts income investors; if bonds become a more attractive alternative, this creates lower demand for REIT investing.

Financial institutions are certainly impacted, however, depending on the segment within financials, some may benefit from increased profit margins, while others are weighed down by increased costs. Basic banking is borrowing short and lending out longer, then managing the risk of maturity mismatch. As longer-term rates rise relative to shorter rates, these institutions find their earnings spread increases.

In recent years the trend has been, especially for larger banks, to create loans and then sell them. They profit on the servicing side, or administrative fees to create the loan. In this way they are shielded from interest rate mismatch risk, and they can make more loans on the same deposit base (selling the loans replenished the funds they can loan from). So the benefit of rising rates on benchmark securities relative to the banks deposit rates could have much less positive impact than it might have if they held the loans. What may actually happen within these institutions is that they experience fewer loans as consumers and business borrow take fewer loans, thus earning less fee income.

#3 Investors Lean Toward Bond Investments

The return on anything is the present value, versus future value, over time held. Higher interest rates can make fixed-income investments more attractive than low rates compared to stocks. When interest rates rise, more investors prefer a known return in terms of interest payments than an unknown move in stocks valuations. This shift in investor preferences can lead to reduced demand for equities and potentially impact stock market performance.

Investors buying bonds as rates are rising will experience a decrease in the value of their fixed income securities. So, they may be surprised to learn that they avoided stocks because stocks may go down in value, and instead invested in fixed income which mathematically will go down in value when rates rise.

#4 Borrowing Costs for Companies

As mentioned earlier, rising interest rates increase the borrowing costs for companies. This can impact corporate profitability and investment decisions, which in turn can affect stock prices. Companies that rely heavily on debt financing may experience higher interest expenses, potentially squeezing profit margins. Investors become concerned about the potential impact on corporate earnings and the overall financial health of companies in a higher interest rate environment.

Analyzing a company’s capital structure, and looking for signs of low debt levels, or long-term debt that is locked in at the low interest rates of the early 2020’s, may be a good way to filter companies that have a profit advantage over their competitors

#5 Consumer Spending and Business Investment

Consumer spending levels are a direct driver in consumer stocks. When borrowing becomes more expensive, consumers may reduce their discretionary spending. This can impact businesses that rely on consumer demand, potentially leading to lower revenues and profitability. The stocks that tend to hold up more when spending levels decrease are those that produce necessities.

Business investment during periods of rising interest rates can influence investment decisions for businesses. As borrowing costs increase, companies may reduce or delay capital investments, expansions, or acquisitions. This cautious approach can impact economic growth and overall industry development, which can in turn affect its performance, for much longer than a quarter or two.

Take Away

Stock market investors have legitimate concerns about the impact of higher interest rates on their investments. The potential effects on equity valuations, profitability of interest rate-sensitive sectors, investor preferences for fixed-income investments, borrowing costs for companies, and consumer spending/business investment are key factors that contribute to investor apprehension. It is as important for investors to monitor interest rate trends and understand the impacts as it is for them to monitor.

Paul Hoffman

Managing Editor, Channelchek

Release -Aurania Renews Select Concessions In Peru& Grants Stock Options

Posted on by aweinsoff@channelchek.com

Research News and Market Data on AUIAF

Toronto, Ontario–(Newsfile Corp. – July 3, 2023) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) announces that it has completed the process of renewing certain annual mineral concession applications at its Vicus property in Peru (the “Property”). The Company selected concessions that have higher geological potential, where the application process has been completed and most of the concessions granted.

In total, ninety-four concessions covering an area of 93,100 hectares were renewed and paid using an existing credit of US$277,689 that the Company had with the Instituto Geológico Minero y Metalúrgico or “INGEMMET”. INGEMMET is the Peruvian scientific and management agency division of the Ministry of Energy and Mines. Thirty-six concessions covering a total area of 35,600 hectares were not renewed by the Company.

The credit can only be applied towards concession fees in Peru; it cannot be refunded as cash to Aurania. The renewal covers the period July 1, 2022 to June 30, 2023 for the Property and the next payment covering the period July 1, 2023 to June 30, 2024 is expected to occur prior to June 30, 2024.

Although the Company believes that many of the concessions in Peru remain prospective, management determined that the additional annual fees and other costs associated with the Property are not appropriate for a non-core asset. The Company will continue to pursue a potential partner and/or a possible corporate transaction for the Property.

As stated in the press release dated April 12, 2023, independent directors of the Company have agreed to receive all of their director fees in the form of stock options in lieu of cash for each quarterly period in 2023. On June 30th, 2023, each director was granted 14,500 stock options at an exercise price of $0.33 in lieu of their director fees for Q2 2023. An aggregate of 58,000 stock options were granted. The stock options will be exercisable for three years and vest immediately.

Also, in accordance with the Company’s Stock Option Plan, the Board of Directors granted a total of up to 1,990,000 stock options to directors, officers, employees and consultants. The stock options have an exercise price of C$0.33, are exercisable for five years and are subject to customary vesting conditions.

Qualified Person

The geological information contained in this news release has been verified and approved by Jean-Paul Pallier, MSc., Vice-President Exploration of the Company. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.

About Aurania

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

Information on Aurania and technical reports are available at www.aurania.com and www.sedar.com, as well as on Facebook at https://www.facebook.com/auranialtd/, Twitter at https://twitter.com/auranialtd, and LinkedIn at https://www.linkedin.com/company/aurania-resources-ltd-.

For further information, please contact:

Carolyn Muir
VP Corporate Development & Investor Relations
Aurania Resources Ltd.
(416) 367-3200
carolyn.muir@aurania.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the Company’s teams being on track ahead of any drill program, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things, the ability to anticipate and counteract the effects of COVID-19 pandemic on the business of the Company, including without limitation the effects of COVID-19 on the capital markets, commodity prices supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and copper; and those risks set out in the Company’s public documents filed on SEDAR. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.