Month: July 2023

Release – Salem Media Announces the Passing of its Co-founder Stuart Epperson Sr.

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

July 17, 2023 4:56pm EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) with a heavy heart, announced today the passing of co-founder, Stuart Epperson. He was 86. Stuart, along with his brother-in-law, Edward Atsinger, founded Salem Communications (now Salem Media Group) in 1986 and expanded Salem’s influence with Christian and politically conservative News Talk formatted radio stations and media assets nationwide. Mr. Epperson was a longtime leader in Christian radio as a former member of the board of directors of the National Religious Broadcasters Association. In 2005, Time Magazine named him one of the 25 most influential evangelicals in America. Stuart was involved in several other conservative organizations dedicated to preserving Judeo Christian values in our culture through public policy. He was a member and the past president of the conservative Council for National Policy (“CNP”). In 1984 and 1986, Epperson was the Republican nominee for the fifth Congressional district of North Carolina.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230717970556/en/

Stuart Epperson Sr. (Photo: Business Wire)

Epperson attended Bob Jones University in Greenville, South Carolina, where he received a bachelor’s degree in radio/television broadcasting and a master’s degree in communications. Epperson is survived by his wife, Nancy, his four children, daughters Kristy, Karen, and Kathy, and son Stuart Jr. and by 21 grandchildren, 1 great grandchild and 2 more on the way, as well as a sister, Mary Lee King.

Salem Media Group Executive Chairman Ed Atsinger commented: “Stuart will be greatly missed by many. I will miss him, but I take comfort in realizing that he is already receiving his reward for a life well-lived. A life that personifies the words of the Apostle Paul in 2 Timothy 4:7-8: ‘I have fought the good fight. I have finished the race. Now there Is in store for me the crown of righteousness, which the Lord, the righteous Judge, will award to me on that day and not only to me, but also to all who have longed for his appearing.’”

ABOUT SALEM MEDIA GROUP:

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20230717970556/en/

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

Source: Salem Media Group, Inc.

Released July 17, 2023

PDS Biotechnology Corp. (PDSB) – New PDS0301 Combination Data To Be Presented

Posted on by cpereira@noblefcm.com


Tuesday, July 18, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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.

First Data From Prostate Cancer. PDS announced that it will present interim data from its first trial testing PDS301 with docetaxel (Taxotere) in prostate cancer patients. The presentation will be at the International Cytokine and Interferon Society annual meeting in October 2023. We see acceptance of the PDS0301 data for presentation as positive sign for proof-of-concept and expansion into new indications.

Data Will Be From A Dose-Finding Trial To Establish Responses and Safety. The trial tests the combination of PDS0301 with docetaxel in metastatic prostate cancer. The regimen was given in 3-week cycles consisting of a standard dose of docetaxel with one of three dose levels of PDS0301. The presentation abstract is based on safety, immune responses, and clinical activity data from 18 patients.


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Goldman’s Chief Economist More Optimistic

Posted on by phoffman@channelchek.com

Jan Hatzius Thinks the U.S. Will Avoid a Recession

The July hike in rates will be their last, according to a new forecast by Goldman Sachs’ chief economist, Jan Hatzius. In an analyst note dated July 17, Mr. Hatzius reduced his forecast for a recession over the next 12 months to only 20% from an already lower tha peers 25%, citing inflation that has dropped precipitously over the past year.

“We are cutting our probability that a US recession will start in the next 12 months further, from 25% to 20%,” Hatzius wrote. “The main reason for our cut is that the recent data have reinforced our confidence that bringing inflation down to an acceptable level will not require a recession.”

The forecast follows the previous weeks CPI and PPI reports that show both had decelerating price increases from previous periods, with consumer prices up just 3% from a year ago.  The report pointed to a faster-than-expected decline in core inflation, which showed to a 4.8% increase from a year earlier. Core inflation readings don’t include food or energy prices that may be up or down based on factors unrelated to economic strength or weakness.  

With inflation on the run, economists don’t expect the Fed to stop short of finishing the job. On July 25-26 next week the Federal Reserve is widely expected to adjust rates up another quarter-percentage point. Goldman’s Hatzius wrote he expects this will be the final increase in the Fed’s tightening cycle.

“We do expect some deceleration in the next couple of quarters, mostly because of sequentially slower real disposable personal income growth — especially when adjusted for the resumption of student debt payments in October — and a drag from reduced bank lending,” he wrote.

Monetary policymakers have raised interest rates sharply over the past year, approving 10 straight rate hikes in the span of one year to lower inflation that was as high as 9%. In a little over a year, the base overnight bank lending rate was pushed up from near zero to near 5.25%, the fastest pace of tightening since the 1980s. If Hatzius and many other economists are correct, Officials are expected to approve an 11th rate hike at the conclusion of their two-day meeting next week, the FOMC did not raise rates at the June meeting, choosing to assess the economy for a longer period before deciding.

Increased interest rates elevates costs on consumer and business loans, which then slows the economy by forcing employers to cut back on spending. Higher rates have helped push the average rate on 30-year mortgages above 7% from half that level a couple of years back. Borrowing costs for everything from home equity lines of credit to auto loans and credit cards have also spiked. This helps slow demand, less demand is less inflationary.

The labor market has remained strong despite the Fed’s assault on business conditions. Taken all together Goldman Sachs is more bullish on a soft landing for the US economy.

“The main reason for our cut is that the recent data have reinforced our confidence that bringing inflation down to an acceptable level will not require a recession,” he wrote. For context the average recession expectation has been 15% since WWII. Hatzius’ adjusted forecast is still above the average of 15%, but well below the median forecast on Wall Street, of 54%. 

According to the note, encouraging CPI data is not a trend set to fizzle out, as fundamental signals highlight further disinflation to come, “Used car prices are sliding on the back of higher auto production and inventories, rent inflation still has a long way to fall before it catches up with the message from median asking rents, and the labor market has continued to rebalance with an ongoing downtrend in job openings, quits, reported labor shortages, and nominal wage growth,” wrote Goldman’s Hatzius.

Take Away

No economist has a crystal ball, but when Goldman Sachs issues a note, the markets pay attention. In its note this week it reports expectations that the odds of a recession in the next year have fallen to just 20%, citing encouraging economic data, including, employment, consumer sentiment and slowing inflation. Goldman’s senior economist expects just one remaining interest rate hike in the Federal Reserve’s tightening cycle, and that is expected in July.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.goldmansachs.com/about-us/people-and-leadership/leadership/management-committee/jan-hatzius.html

https://www.bloomberg.com/news/articles/2023-07-17/goldman-s-hatzius-cuts-odds-of-us-recession-in-next-year-to-20?srnd=premium#xj4y7vzkg

https://www.foxbusiness.com/economy/goldman-sachs-trims-us-recession-odds-next-year

Professional Investment Managers Do This, Are You?

Posted on by phoffman@channelchek.com

The Basics of Creating an Investment Plan

One investment tool used by professionals far more often than self-directed investors could prove beneficial to individual retail investors to prevent their portfolio from chasing stocks that may have already had their run, or holding for too long, or even selling just as the company is about to rise. And it’s created by the investors themselves, at times with the help of a wealth advisor. A written Investment Policy Statement (IPS) even at the most basic level, can go a long way to commit to building a portfolio to fit one’s purpose and in ways true to that purpose.

What is an IPS?

An Investment Policy Statement (IPS) is a detailed framework that outlines an individual’s approach to investing to achieve their financial goals. Put another way, it’s a compass that helps investors keep their bearings and make sober decisions about their investments based on their risk tolerance, time horizon, financial objectives, and other relevant factors.

What’s Included in an IPS?

Financial Goals: Clearly define short-term and long-term financial objectives, such as saving for retirement, buying a home, funding education, or starting a business is the best starting point.

Risk Tolerance: Everyone wants the best of both worlds, but risk can work against you. Assessing one’s risk appetite or willingness to tolerate market volatility and potential losses should be an honest conversation with oneself. It should then be defined and adhered to when determining the proportion of investments exposed to higher-risk versus lower-risk assets.

Asset Allocation: Asset allocation can help the investor balance risk using non-correlated assets so the positions don’t all tend to move together, up and especially down. Determining the optimal mix of asset classes like stocks, bonds, real estate, gold, or cash based on risk tolerance, time horizon, and financial goals is just the beginning. A person with long-term goals may wish to review the history of small-cap stocks to large-cap stocks and allocate more of their stocks to the more historically volatile, but better performing small-caps. Similarly, someone with a short time horizon may determine a larger allocation of bonds suits their financial goals best, and then perhaps choose shorter duration or higher quality bonds.

Diversification: Spreading investments across different asset classes, industries, geographies, and investment vehicles to reduce risk and enhance portfolio stability. Diversification minimizes the impact of adverse events on the overall investment performance.

Investment Selection: Identify specific investments, such as individual stocks, exchange-traded funds (ETFs), or bonds, that align with the chosen asset allocation and meet the criteria for risk, return, and other preferences. Resources available to individuals today, including from retail brokers and online research and data from sources like Channelchek can provide insights into risk and reward.

Monitor and Review: The IP document should define how often you’ll assess the investment portfolio’s performance, making adjustments as needed while staying true to your stated financial goal. Staying informed about changes in market conditions and investment opportunities along the way will help the review.

Benefits and Importance of IPS for Individuals

Clarity and Focus: An IPS takes the fuzziness out of investing in a world with so many options. It helps individuals define and articulate their financial goals and align their investment decisions with those objectives. It may not be a precise roadmap, but it can serve as a compass helping to reduce costly impulsive or emotional investment decisions.

Risk Management: By assessing risk tolerance and designing an appropriate asset allocation, an IPS helps individuals manage risk effectively and avoid overexposure to any single investment or asset class. Risk management can include rebalancing your portfolio, selling a bond if it drops below a certain investment grade, and making sure any stock you purchase trades with ample volume for better execution and timing.

Consistency and Discipline: An IPS encourages individuals to maintain a long-term perspective and stay committed to their investment strategy, even during periods of market volatility or short-term fluctuations.

Maximizing Returns: An IPS may even help remind you that you have too much money sitting in low yielding bank accounts. Through diversification and thoughtful investment selection, an IPS aims to optimize investment returns while minimizing unnecessary risks that don’t match your goals.

Adaptability: An IPS is not a static document. It should be periodically reviewed and adjusted to accommodate changes in personal circumstances, market conditions, and financial goals.

Downside Risk of an IPS

The problem with the idea of creating an IPS is that so few take the time to actually write one. It requires thinking through your goals, and determining what expected returns are in different asset classes, and then breking those down further for security selection. While this may seem like a lot of work, if it improves the outcome toward meeting a goal, or provides confidence one will meet the goal, it is worth the investment in time.

If it seems overwhelming, don’t get lost in too many details to start, just include the basics. The following may help take the mystery out of what a basic Investment Policy Statement can look like:

Financial Goals:

Short-term goal: Save $35,000 for a down payment on a house within the next three years.

Long-term goal: Build a retirement nest egg of $1 million over the next 30 years.

Risk Tolerance:

Moderate risk tolerance: Willing to accept some market volatility in pursuit of higher returns.

Asset Allocation:

Equities (stocks): 60% of the portfolio for long-term growth potential.

Fixed Income (bonds): 30% of the portfolio for stability and income generation.

Cash and Cash Equivalents: 10% of the portfolio for liquidity and emergency funds.

Diversification:

Within equities: Include 60% index large-cap funds, 20% large-cap individual stocks (no more than 5% of portfolio each). Include 20% small-cap stocks, 10% in a small cap index fund and 10% in individual stocks diversified across different sectors (technology, healthcare, finance, etc.). All equities U.S. based companies.  

Within fixed income: Ladder maturities evenly out to seven years maturity. Include bonds rated BB or above, no municipal bonds.  

Monitoring and Review:

Regularly review the portfolio’s performance and make adjustments as needed. Seek to rebalance quarterly beginning September 15, 2023.

Stay informed about market trends, economic indicators, and any changes in the individual investments. Subscribe to trsuted news sources like no-cost Channelchek daily emails.

Reassess the investment strategy periodically to ensure it remains aligned with financial goals and changing circumstances.

Please note that this example is generalized and should not be considered personalized investment advice.

Take Away

Overall, a written investment policy can provide individuals with a structured approach to investing, increase their chances of achieving their financial objectives, and help them navigate the complexities of the investment landscape more effectively.

Paul Hoffman

Managing Editor, Channelchek

Release – ZyVersa Therapeutics Announces Publication in the Journal, Hepatology, Highlighting the Role of NLRP3 Inflammasome-Mediated IL-18 in Development of Liver Fibrosis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 17, 2023

  • Liver fibrosis is a progressive form of chronic liver injury mediated by persistent NLRP3 inflammasome activation in liver cells called hepatic stellate cells (“HSCs”), which leads to the development of cirrhosis and liver cancer
  • Inflammasome NLRP3 activation leads to production of the proinflammatory cytokines, IL-1β and IL-18, and IL-18 activates HSCs resulting in liver fibrosis
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation through ongoing production of IL-1β and IL-18

WESTON, Fla., July 17, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Hepatology, demonstrating the role of NLRP3 inflammasome-mediated IL-18 in the development of liver fibrosis.

In the paper titled, “Interleukin‐18 signaling promotes activation of hepatic stellate cells in mouse liver fibrosis,” the authors evaluated serum levels of IL-18 in patients diagnosed with liver fibrosis/cirrhosis, and they conducted studies in three different mouse models of liver fibrosis. Following are key findings reported in the paper:

  • Levels of circulating IL‐18 and IL‐18 binding protein were elevated in patients with liver fibrosis/cirrhosis in comparison to healthy controls
  • Data in liver fibrosis mouse models provided strong evidence that IL-18 signaling and its downstream effects have a pivotal role in the development of liver fibrosis (fibrogenesis)
  • The pivotal role of IL-18 signaling in liver fibrosis was confirmed in IL-18 deficient mice, which showed protection from fibrotic liver changes

The authors stated, “Our results highlight the pivotal role of IL-18 signaling in liver fibrogenesis through the activation of HSCs in vitro and in vivo in three different mouse models.” To read the article, Click Here.

“The research published in the Hepatology demonstrated that NLRP3 inflammasome-mediated activation of IL-18 has a pivotal role in liver fibrosis, providing support for inflammasome inhibition as a promising treatment. Unlike NLRP3 inhibitors, which only inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, Inflammasome ASC inhibitor IC 100 inhibits formation of multiple types of inflammasomes, and it uniquely inhibits ASC specks to block perpetuation of damaging inflammation,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

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

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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

Release – Century Lithium Appoints New Director

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

July 17, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce the appointment of Dr. Corby G. Anderson to its Board of Directors, effective July 14, 2023.

Dr. Anderson is a Licensed Professional Chemical Engineer with over 40 years of global experience in engineering, design, industrial plant operations, corporate level management, education, research, and professional service. He holds degrees of BSc in Chemical Engineering from Montana State University, an MSc in Metallurgical Engineering from Montana Tech, and a PhD in Mining Engineering and Metallurgy from the University of Idaho. He most recently assisted Century Lithium as its Technical Advisor, Metallurgy.

“We are pleased to welcome Dr. Anderson to the Company’s Board of Directors” said Bryan Disher, Chair of Century Lithium. “As Technical Advisor, Dr. Anderson has been instrumental in the advancement of our Clayton Valley Lithium Project, and we look forward to his continued contribution to the Company in his new role on the Board of Directors”.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com 
centurylithium.com  

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

Release – PDS Biotech Announces Acceptance of Abstract on Combination of PDS0301 with Docetaxel in Metastatic Prostate Cancer for Oral Presentation by the National Cancer Institute at Cytokines 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB



First clinical study of immunocytokine with docetaxel in prostate cancer patients

FLORHAM PARK, N.J., July 17, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T cell activating technologies, today announced that an abstract reporting on interim data from a first-in-human clinical trial evaluating the combination of PDS0301, an IL-12-based immunocytokine, with the chemotherapy medication docetaxel has been accepted for oral presentation at the 11th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023).

The abstract, titled, “Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data”, will report interim safety and immune data on 18 patients in the clinical trial being led by the National Cancer Institute (NCI), part of the National Institutes of Health. The trial is investigating the safety, immune responses and clinical activity of PDS0301 and docetaxel in metastatic castration-sensitive and castration-resistant prostate cancer patients. The study is designed to evaluate three dose levels of PDS0301 (8 mcg/kg, 12 mcg/kg, and 16.8 mcg/kg) in combination with docetaxel (75 mg/m2) administered every three weeks.

“We look forward to Dr. Ravi Madan’s presentation of the interim safety, clinical outcomes and immune correlates for PDS0301 administered in combination with standard of care docetaxel in patients with advanced prostate cancer,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “This clinical trial provides an important opportunity to investigate the potential of PDS0301 combined with docetaxel chemotherapy to offer improved treatment options for patients with metastatic castration-sensitive and castration-resistant forms of prostate cancer. The results of this study could provide insight into the potential use of PDS0301 with chemotherapy across multiple solid tumors.”

Abstract Title: Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data
Paper Number: 249
Presenting Author: Head, Prostate Cancer Clinical Research Section, Ravi A. Madan
Authors: Renee Donahue, Yo-Ting Tsai, Mohammad O. Atiq, Elias Chandran, Luke Meininger, Fatima Karzai, Marijo Bilusic, Jennifer Marte, Philip M. Arlen, Lisa Cordes, Megan Hausler, Amy Hankin, Nikki Williams, William D. Figg, Jeff Schlom, James L. Gulley, Ravi A. Madan
Session Details: Plenary 3: Cytokines in Cancer Immunity and Immunotherapy, Mittwoch; Olympia A+B
Session Date and Time: October 18, 2023, 10:00-10:15

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615) and/or the Web site:  https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer (NK) cells in the tumor microenvironment. PDS0301 is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Eric Reiss
Phone: +1 (802) 249-1136
ereiss@tiberend.com

Release – Tonix Pharmaceuticals Announces Agreement and Initiation of Enrollment in Phase 2 Trial with the University of Washington to Study TNX-1900 (Potentiated Intranasal Oxytocin) for Social Anxiety Disorder

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 17, 2023 7:00am EDT

Social Anxiety Disorder Affects 15 Million U.S. Adults and is More Common Among Women than Men

CHATHAM, N.J., July 17, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company, today announced that the first participant has been enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 (potentiated intranasal oxytocin) for enhancing social safety learning in social anxiety disorder (SAD). Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 with Angela Fang, Ph.D., Assistant Professor, Department of Psychology, University of Washington as the principal investigator.

“We are excited to collaborate with the University of Washington and Dr. Fang on the development of TNX-1900 for social anxiety disorder,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In the past decade, there has been an increase in studies examining oxytocin’s effects on social cognition and behavior in animals and humans due to translational discoveries showing that intranasal oxytocin appears to reach central nervous system targets1. Specifically, evidence suggests that oxytocin may enhance the importance of social cues or have anti-anxiety properties2,3. These studies have shown that intranasal oxytocin may hold therapeutic promise for psychiatric disorders involving social deficits3-5. TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition.”

“For psychiatric disorders characterized by severe social avoidance, such as social anxiety disorder, social learning has been disproportionately understudied despite its role in the acquisition of fear in models of anxiety,” said Dr. Fang. “Social anxiety disorder is a disabling psychiatric disorder. Past research has focused on the observational, or vicarious, acquisition of fears, but little is known about how social information (such as observing others experiencing safety) can promote safety learning. To address this issue, we will study the effects of vicarious extinction learning on the recovery of conditioned fear.”

The Phase 2 study is a randomized, double-blind, placebo-controlled trial, such that all participants will be randomized to receive a single dose of either TNX-1900 or matching placebo nasal spray. 100 subjects are planned to enroll: 50 with a primary diagnosis of SAD, and 50 demographically-matched healthy controls. The primary objective of the Phase 2 study is to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.

About Social Anxiety Disorder

Social anxiety disorder (SAD) is characterized by persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. The individual fears that he or she will act in a way (or show anxiety symptoms) that will be embarrassing and humiliating1. SAD affects 15 million adults or 7.1% of the U.S. population, is more common among women than men, and typically begins around age 135-8. Individuals with SAD report experiencing symptoms for 16 years before seeking help9.

1Lee MR, et al. Nat Commun. 2020. 11, 2783.
2Smith AS, et al. Pharmacol Res. 2019. 146, 104324.
3Domes G, et al. Biol Psychiatry. 2007. 62(10), 1187-90.
4Shamay-Tsoory SG, et al. Biol Psychiatry. 2016. 79(3), 194-202.
5Meyer-Lindenberg A, et al. Nat Rev Neurosci. 2011. 12, 524–538.
6Asher M & Aderka IM. J Clin Psychol. 2018. 74(10), 1730-1741.
7Asher M, et al. Clin Psychol Rev. 2017. 56, 1-12.
8Xu Y, et al. J Anxiety Disord. 2012. 26(1), 12-19.
9Wang PS, et al. Arch Gen Psychiatry. 2005. 62, 603-613.

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system3 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.4 Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding5 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models7. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children6. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies8. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

1NIH, National Institute of Mental Health
2Anxiety & Depression Association of America
3Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388
4Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
5Antoni FA & Chadio SE. Biochem J. 1989. 257(2):611-4
6Yeomans DC, et al. 2017. US patent US2017368095
7Cai Q, et al. Psychiatry Clin Neurosci. 2018. 72(3):140-151
8MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788

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 17, 2023

Release – Orion Group Holdings, Inc. to Report Second Quarter 2023 Financial Results on Wednesday, July 26

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ORN

Jul 17, 2023

Conference Call to be held Thursday, July 27 at 8:00 a.m. Central Time

HOUSTON, July 17, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today announced that it will issue its financial results for the second quarter ended June 30, 2023 on Wednesday, July 26, 2023, after the close of the stock market.

A conference call and audio webcast with analysts and investors will be held the next day, July 27, at 8:00 a.m. Central Time to discuss the results and answer questions.

Live conference call: 800-715-9871

Live and archived webcast: https://edge.media-server.com/mmc/p/t24hfk9r or the Company’s website at Orion Group Holdings, Inc. – Investor Relations & Shareholder Contact (oriongroupholdingsinc.com)

About Orion Group Holdings, Inc.

Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design, and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas.

Contact:

Financial Profiles, Inc.
Margaret Boyce
310-622-8247
mboyce@finprofiles.com

Release – Alliance Resource Partners, L.P. Announces Second Quarter 2023 Earnings Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

Company Release – 7/17/2023 7:00 AM ET

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its second quarter 2023 financial results before the market opens on Monday, July 31, 2023. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “investor relations” section of ARLP’s website at www.arlp.com.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13739987.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

FAT Brands Inc. (FAT) – Flexibility

Posted on by cpereira@noblefcm.com


Monday, July 17, 2023

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 17 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, 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.

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.

Debt Raise. In an 8-K filing from late last week, FAT Brands reported the sale of an aggregate principal amount of $105.8 million of notes issued by its special purpose, wholly-owned subsidiary, FB Resid Holdings I, LLC, comprised of $52.9 million of Series 2023-1 10.00% Fixed Rate Senior Secured Notes, Class A-1 and $52.9 million of Series 2023-1 10.00% Fixed Rate Senior Subordinated Secured Notes, Class A-2. An additional $22.1 million in Class A-1 Notes and $22.1 in Class A-2 Notes were issued to a direct subsidiary of the Company and will be held pending sale to third party investors.

Cost. For both the Class A-1 Notes and A-2 Notes, the 10.00% interest rate is comprised of a 6.00% per annum nondeferrable interest portion and a 4.00% per annum deferrable interest portion. According to management, of the $105.8 million, about $60 million was used to swap out existing bonds, lowering overall required payments.


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Gold Could Get Much Stronger from BRICS Plans

Posted on by phoffman@channelchek.com

The BRICS Currency Project Picks Up Speed

On Friday, July 7, 2023, news broke in the financial market media that the “BRICS” (that is, Brazil, Russia, India, China, and South Africa) will implement their plan to create a new international currency for trading and financial transactions, and that this new currency will be “gold-backed”. Most recently, on June 2, 2023, the foreign ministers of the BRICS – as well as representatives from more than 12 countries – met in Cape Town, South Africa (interestingly at the “Cape of Good Hope”). Among other things, it was emphasized that they wanted to create an international trading currency. Undoubtedly, this is an undertaking that could have consequences of epic proportions.

After all, the BRICS countries represent about 3.2 billion people, approximately 40 percent of the world’s population, with a combined economic output nearly the size of the economy of the United States of America. And there are also many other countries (such as Saudi Arabia, United Arab Emirates, Egypt, Iran, Algeria, Argentina, and Kazakhstan) that might want to join the BRICS club.

The goal of the BRICS countries is to reduce their economic and political dependence on the US dollar, challenging “US dollar imperialism”. To this end, they want to create a new international currency for commercial and financial transactions, replacing the US dollar as the means of transaction unit.

The reason is obvious. The US administration has on many occasions used the greenback as a “geopolitical weapon” and engaged in a kind of “financial warfare”: Washington sanctions enemy countries by denying them access to the US dollar capital market, but above all, it shuts them off from the international US dollar-centric payment system.

The freezing of Russia’s currency reserves (the equivalent of almost 600 billion US dollars is currently at stake) has set off alarm bells in many non-Western countries. It has reminded a number of them that holding US dollars comes with a political risk. This, in turn, has prompted many to restructure their international foreign reserves: holding fewer US dollars, switching to other (smaller) currencies, but above all, buying more gold.

But how might the BRCIS manage to swim away from the US dollar? While no details are available yet about how the new BRICS currency might be structured, it should not stop us from speculating about what lies ahead.

The BRICS could establish a new bank (the “BRICS-Bank”), funded by gold deposits from BRICS central banks. The physically deposited gold holdings would be shown on the asset side of the BRICS bank’s balance sheet – and could be denominated, for example, “BRICS-Gold”, where 1 BRICS-Gold represents 1 gram of physical gold.

The BRICS-Bank can then grant loans denominated in BRICS-Gold (for example, to exporters from BRICS countries and/or to importers of goods from abroad). To fund the loans, the BRICS-Bank makes a credit contract with the holders of BRICS-Gold: The holders of BRICS-Gold agree to transfer their deposit to the BRICS-Bank for, say, one month, or one or two years, against receiving an interest rate. What is more, the BRICS-Bank, and it can also accept further gold deposits from international investors, who can hold (interest-bearing) BRICS-Gold deposits this way.

BRICS-Gold could henceforth be used by the BRICS countries and their trading partners as international money, as an international unit of account in global trade and financial transactions. Incidentally, the new de facto gold currency would not even have to be physically minted but could be and remain an accounting-only unit while being redeemable on demand.

The exporters from the BRICS countries and the other member countries would, however, have to be willing to sell their goods against BRICS-Gold instead of US dollars and other Western fiat currencies, and the importers from the Western countries would have to be willing and able to pay their bills in BRICS gold.

How do you get BRICS-Gold? Those demanding BRICS-Gold must either get a BRICS-Gold loan from the BRICS-Bank or purchase gold in the market and deposit it with the BRICS-Bank or a designated custodian, and the gold deposit is then credited to his account in the form of BRICS-Gold.

For example, in payment transactions, the goods importer’s BRICS-Gold deposits (held, for example, at the BRICS-Bank) are credited to the account of the exporter of goods (also held at the BRICS-Bank or at a correspondent bank or gold custodian).

However, the transition, the use of BRICS-Gold as an international trade and transaction currency, would most likely have far-reaching consequences:

(1.) It would presumably lead to a (sharp) increase in the demand for gold compared to current levels, with not only gold prices measured in US dollars, euros, etc. but also in the currencies of the BRICS countries increasing (substantially).

(2.) Such an increase in the gold price would devalue the purchasing power of the official currencies – not only the US dollar but also the BRICS currencies – against the yellow metal. Also, the prices of goods in terms of the official fiat currencies would most likely skyrocket, debasing the purchasing power of presumably all existing fiat currencies.

(3.) The BRICS countries would build up gold reserves to the extent that they run, or will run, trade surpluses. They would presumably be the winners of the “currency switch”, while the countries with trade deficits (first and foremost, the US) would lose out.

BRICS official gold holdings, in billion US dollars, Q1 2023

 Source: Refinitiv; The BRICS’ gold reserves amounted to 5452.7 tons in the first quarter of 2023 (market value currently around 350 billion US Dollars).

These few considerations already show how disrupting the topic of “creating a new gold-backed international trading currency” could be: The BRICS could well trigger landslide-like changes in the global economic and financial structure. Still, it will be interesting to see how the BRICS countries intend to proceed at their August 22-24 meeting in Johannesburg, South Africa.

About the Author:

Dr. Thorsten Polleit is Chief Economist of Degussa and Honorary Professor at the University of Bayreuth. He also acts as an investment advisor.

The Ripple XRP Case Creates Many Questions

Posted on by phoffman@channelchek.com

Who Will Regulate Crypto if not the SEC?

The cryptocurrency developer Ripple Labs just won a legal victory against the U.S. Securities and Exchange Commission (SEC) that should provoke cheers from the entire industry, at least those that prefer that digital currency not be treated as a security. If crypto is not viewed as a security, the jurisdiction which the SEC has been pushing hard to cement, may fall apart. This ruling may eventually lead to any future legal framework for digital tokens being designed by the U.S. Congress.

Background

Ripple is a technology company that uses cryptocurrency and blockchain technology to offer financial solutions. Ripple and XRP are two distinct entities. Ripple is a fintech company that builds global payment systems, while XRP is an independent digital asset that can be used by anyone for a variety of reasons.

In 2020, Ripple was charged by the SEC on the grounds that the company illegally raised $1.38 billion in unregistered securities offerings. In a ruling on July 13 of this year, it was decided by a Federal court that Ripple Labs did not violate securities law by selling its XRP tokens on its exchange.  This is being seen as the first major setback for the SEC in a decade of enforcement against the cryptocurrency industry. Other crypto firms accused of illegally operating digital asset exchanges can now explore ways to take advantage of the ruling.

This is an important decision that may alter the expected path of the entire industry. The SEC and the cryptocurrency industry which includes exchanges, crypto-mining, and the tokens themselves, have been at odds, with increasing heat on the industry, mainly by the SEC. Gary Gensler, who chairs the SEC, has described the crypto market as a “Wild West” riddled with fraud. He claims that most crypto tokens are securities. The regulator has been cracking down on crypto exchanges, including the top U.S. exchange Coinbase. If crypto is considered a security, it will fall under the commission’s oversight.

What this Means for the Crypto Industry

Crypto firms have long disputed the SEC’s jurisdiction but until last week had no supporting precedence from a court. This win provides much needed ammunition for the industry to reassert its claims.  

U.S. District Judge Analisa Torres in New York ruled that sales on public cryptocurrency exchanges were not offers of securities because purchasers did not have a reasonable expectation of profit that depended on anything Ripple did. This profit expectation was used as a key in determining if XRP was a security at the time.

Crypto supporters are viewing the decision as a watershed and the judge’s reasoning as a new line of defense for the others being targeted by the SEC, such as Coinbase, Binance, and Bittrex.

SEC APPEAL?

It remains to be seen whether the SEC will challenge the ruling in the 2nd U.S. Court of Appeals which could cause judges to delay hearing other pending and new cases that other crypto assets sold on exchanges are not securities.

Ripple Chief Legal Officer Stuart Alderoty said in an interview with Reuters that the company “wouldn’t shy away from an appeal, because the judge was right on her core findings,” adding: “I believe any appellate court looking at this would amplify and endorse those rulings, which would certainly be welcome.”

An appeal is somewhat risky for the SEC. If the 2nd Circuit, whose rulings are binding on federal courts in New York, Connecticut and Vermont, adopts the logic in the Ripple ruling, other cases like the SEC vs. Coinbase case would leave the SEC without much of an argument. This could permanently eliminate any claim the Commission has to regulation over the industry.

With the district court having taken a sledgehammer to the main claim the SEC had to oversight,  the industry may find itself subject to a legislative agreement. Especially with an SEC deprived of the argument that their legal cases were sound, there’s nothing to stop an acceleration of efforts to find a bipartisan agreement on a regulatory framework for crypto assets by the legislative branch.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.coindesk.com/policy/2023/07/14/what-ripples-partial-xrp-win-means-for-other-crypto-firms-fighting-sec/

https://www.reuters.com/technology/crypto-firms-facing-us-sec-charges-find-hope-ripple-ruling-experts-say-2023-07-17/

https://www.fnlondon.com/articles/why-the-ripple-ruling-wont-spell-the-end-of-the-secs-crypto-crackdown-20230717?mod=hp_LATEST&adobe_mc=MCMID%3D04828691964107368544310185344499067435%7CMCORGID%3DCB68E4BA55144CAA0A4C98A5%2540AdobeOrg%7CTS%3D1689601964