Page 425 – Channelchek

Tokens.com Corp. (SMURF) – An Acquisition for the New Year

Posted on January 4, 2023January 4, 2023 by cpereira@noblefcm.com

Wednesday, January 04, 2023

Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.

Joe Gomes, Senior Research Analyst, 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.

A New Acquisition. Yesterday, Tokens.com’s subsidiary Metaverse Group announced the acquisition of CocoNFT. As part of the acquisition, Coco’s co-founders Mark Allen and Brody Berson will be joining the Metaverse Group as Chief Technology Officer and Chief Product Officer respectively and will be focused with building further tools and products for both NFT and virtual world applications. No financial details were given for the transaction.

Detail on CocoNFT. CocoNFT is a software platform that allows users to connect their Instagram to mint NFTs, leveraging the blockchain and a web3 wallet. In acquiring the company, Metaverse Group will work to advance Coco’s technology offering and integrate the products with its virtual world B2B offerings. The acquisition will leverage Coco’s strategic partnerships in Opensea and Rarible and online communities with over 45,000 followers across TikTok and Twitter.

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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.

PDS Biotechnology Corp. (PDSB) – PDS Licenses Merck’s IL-12 Used In Its Combination Studies

Posted on January 4, 2023January 4, 2023 by cpereira@noblefcm.com

Wednesday, January 04, 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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

License Gives Exclusive Rights To M9241. PDS Bio announced a licensing agreement with Merck KGaA covering M9241, the proprietary IL-12 tumor-targeting cytokine used in its Phase 2 Triple Therapy combination study. As discussed in our Research Note on December 29, most recent results have shown significant improvement in outcomes for these patients. Since PDS did not have commercial rights to M9241 before the licensing agreement, we believe this is a highly positive development.

Licensing Terms Are Favorable For Both Companies. The license agreement gives PDS exclusive worldwide rights to M9241. PDS will take over all development, manufacturing, and commercialization, while Merck continues to supply the drug during the transition. PDS will pay Merck a licensing fee of $5 million in cash and $5 million in its common stock, consisting of 378,787 shares or about 1.3% of the shares outstanding. Merck will receive development and regulatory milestones of up to $11 million for the first two indications, as well as commercial milestones of up to $105 million plus 10% royalties on initial sales.

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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).

Entravision Communications (EVC) – Loses Its Visionary

Posted on January 4, 2023January 4, 2023 by cpereira@noblefcm.com

Wednesday, January 04, 2023

Entravision Communications Corporation is a diversified Spanish-language media company utilizing a combination of television and radio operations to reach Hispanic consumers across the United States, as well as the border markets of Mexico. Entravision owns and/or operates 53 primary television stations and is the largest affiliate group of both the top-ranked Univision television network and Univision’s TeleFutura network, with television stations in 20 of the nation’s top 50 Hispanic markets. The Company also operates one of the nation’s largest groups of primarily Spanish-language radio stations, consisting of 48 owned and operated radio stations.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

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

Founder & CEO, Walter Ulloa passes. The company announced that founding CEO and Chairman of the Board of Directors, Walter Ulloa, died on December 31, 2022, of a sudden heart attack. The board appointed CFO Chris Young as interim CEO while it begins its search for a new CEO.

Legacy of dynamic leadership. Mr. Ulloa served as chairman and CEO since cofounding the company in 1996. He led the company’s expansion as a Spanish language broadcaster and oversaw its more recent transition to a digital media company with a global presence.

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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).

Energy Industry Report – Energy Stocks Resume Their Upward Trend – Is $80 Oil The New Norm?

Posted on January 4, 2023January 4, 2023 by cpatches

Wednesday, January 04, 2023

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the bottom of the report for important disclosures

Energy Stocks Were Strong. Energy stocks rose 21.5% in the fourth quarter far outpacing a 7.1% rise for the S&P 500 Index. For the year, energy stocks were up an impressive 57% versus a 20% decline in the overall market. The strength can largely be attributed to rising energy prices, although we would note that energy prices have largely leveled out after a strong first half of the year.

Oil prices are near $80. Near month oil future contracts are now almost $80 per barrel, below peak prices but significantly higher than historic prices. At $80 per barrel, most energy companies are very profitable and generating significant excess free cash flow. Despite the favorable economics, energy companies have been slow to drill new wells, and modest production increases have come mainly from improved efficiencies. In addition, there is a growing belief that OPEC’s spare capacity is declining questioning its ability to meet demand increases. As time passes, $80 oil is starting to feel like the new equilibrium level with $40-$60 oil prices a thing of the past.

Gas prices are rising even more than oil prices. Natural gas prices have risen steadily over the last two years even as production levels have been steady. Storage levels, which were running below historical levels, have improved in recent months.

Energy industry fundamentals remain strong. Oil and gas prices are near historical highs and above the levels assumed in our financial and valuation models. Energy company cash flow generation is high, and companies are facing the envious position of trying to decide what to do with the cash. Debt levels have been pared down and managements have been raising dividend levels and repurchasing shares. Drilling is increasing but at a controllable pace that doesn’t seem likely to put prices into a downcycle. We believe the case for smaller cap energy stocks is especially strong. If our belief that a world-wide recession is already factored into energy prices is correct, small cap energy companies will be in the best position to take advantage of any price increase.

Energy Stocks

Energy stocks, as measured by the XLE Energy Index, rose sharply in the most recent quarter after logging in a flat third quarter. In the fourth quarter, energy stocks rose 21.5% far outpacing a 7.1% rise for the S&P 500 Index. For the year, energy stocks were up an impressive 57% versus a 20% decline in the overall market. This year’s strong performance comes after last year’s 50% rise. The strength can largely be attributed to rising energy prices, although we would note that energy prices have largely leveled out after a strong first half of the year.

Oil Prices

Oil prices rose steadily over a two-year period beginning the spring of 2020. WTI prices peaked at $120 per barrel in the first week of June. Prices declined in the third quarter but seem to have leveled off in recent months. Near month oil future contracts are now almost $80 per barrel, below peak prices but significantly higher than historic prices. At $80 per barrel, most energy companies are very profitable and generating significant excess free cash flow. As time passes, $80 oil is starting to feel like the new equilibrium level with $40-$60 oil prices a thing of the past.

Figure #1

Despite the favorable economics, energy companies have been slow to drill new wells. U.S. rig count, as reported by Baker Hughes, crept up to 779 rigs by the end of the year. This compares to a peak level of 1,600 in 2014. The disparity between increased profitability and increased capital expenditures is shown in the chart below. Operating cash flow has soared over the last two years, but capital expenditures have barely increased. The result has been a large increase in dividend payments, share repurchases and debt reduction.

Figure #2

While capital expenditures have not increased in line with cash flow, it would be unfair to say that oil production has not increased. Indeed, current production levels are above that during peak drilling periods in 2014. The implication is that drilling has become more productive. While drilling advances such as the use of horizontal drill and fracking in shale deposits may be old hat, it is worth noting that drillers have been refining drilling techniques for individual drilling locations. Drillers continue to perfect the ideal number of fracking targets and the materials used to frack. In addition, as we discussed in our September quarter comments, there has been a sharp increase in the number of well recompletions, which are less expensive to complete but not a long-term solution.

Figure #3

Meanwhile, OPEC has been increasing production in recent years after making sharp reductions during the COVID years. However, there are growing concerns that OPEC’s overall capacity is declining and that its spare capacity has consequentially declined. If this is indeed true, OPEC’s ability to fulfill increased demand for oil may be limited. This would bode well, not only for oil prices, but for the role domestic producers will have in meeting demand.

Figure #4

Natural Gas Prices

The chart below shows natural gas prices against production levels. As the chart shows, natural gas prices have risen steadily over the last two years even as production levels have remained steady. To that extent, natural gas prices are acting like oil prices. Natural gas prices tend to track oil prices but with a few distinctions. Natural gas demand and supply is less global than oil. Imports (and now exports) of liquefied natural gas represent a small portion of domestic supply and demand. Secondly, natural gas is used primarily for space heating. That means demand is more seasonal. It also means demand can be affected by weather conditions. On the other hand, natural gas demand is less affected by general economic conditions than oil.

Figure #5

Storage levels, which were running below historical levels, have improved in recent months. We would note that the most recent storage numbers do not reflect the cold snap across the country during the last week of the year. Cold temperatures may send storage levels lower than is reflected in the chart below.

Figure #6

Outlook

Energy industry fundamentals remain strong. Oil and gas prices are near historical highs and above the levels assumed in our financial and valuation models. Energy company cash flow generation is high, and companies are facing the envious position of trying to decide what to do with the cash. Debt levels have been pared down and managements have been raising dividend levels and repurchasing shares. Drilling is increasing but at a controllable pace that doesn’t seem likely to put prices into a downcycle.

We believe the case for smaller cap energy stocks is strong. Major oil companies are facing increasing pressure to focus on renewable energy instead of producing more carbon-based fuel. Smaller cap energy companies are less tethered and often able to acquire and exploit properties being ignored by the majors. If our belief that a world-wide recession is already factored into energy prices is correct, small cap energy companies will be in the best position to take advantage of any price increase.

GENERAL DISCLAIMERS

All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

This publication is intended for information purposes only and shall not constitute an offer to buy/sell or the solicitation of an offer to buy/sell any security mentioned in this report, nor shall there be any sale of the security herein in any state or domicile in which said offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or domicile. This publication and all information, comments, statements or opinions contained or expressed herein are applicable only as of the date of this publication and subject to change without prior notice. Past performance is not indicative of future results. Noble accepts no liability for loss arising from the use of the material in this report, except that this exclusion of liability does not apply to the extent that such liability arises under specific statutes or regulations applicable to Noble. This report is not to be relied upon as a substitute for the exercising of independent judgement. Noble may have published, and may in the future publish, other research reports that are inconsistent with, and reach different conclusions from, the information provided in this report. Noble is under no obligation to bring to the attention of any recipient of this report, any past or future reports. Investors should only consider this report as single factor in making an investment decision.

IMPORTANT DISCLOSURES

This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part, copies circulated, or discussed to another party, without the written consent of Noble Capital Markets, Inc. (“Noble”). Noble seeks to update its research as appropriate, but may be unable to do so based upon various regulatory constraints. Research reports are not published at regular intervals; publication times and dates are based upon the analyst’s judgement. Noble professionals including traders, salespeople and investment bankers may provide written or oral market commentary, or discuss trading strategies to Noble clients and the Noble proprietary trading desk that reflect opinions that are contrary to the opinions expressed in this research report.
The majority of companies that Noble follows are emerging growth companies. Securities in these companies involve a higher degree of risk and more volatility than the securities of more established companies. The securities discussed in Noble research reports may not be suitable for some investors and as such, investors must take extra care and make their own determination of the appropriateness of an investment based upon risk tolerance, investment objectives and financial status.

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Noble is not a market maker in any of the companies mentioned in this report. Noble intends to seek compensation for investment banking services and non-investment banking services (securities and non-securities related) with any or all of the companies mentioned in this report within the next 3 months

ANALYST CREDENTIALS, PROFESSIONAL DESIGNATIONS, AND EXPERIENCE

Senior Equity Analyst focusing on Basic Materials & Mining. 20 years of experience in equity research. BA in Business Administration from Westminster College. MBA with a Finance concentration from the University of Missouri. MA in International Affairs from Washington University in St. Louis.
Named WSJ ‘Best on the Street’ Analyst and Forbes/StarMine’s “Best Brokerage Analyst.”
FINRA licenses 7, 24, 63, 87

WARNING

This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs. Prior to making any investment decision, recipients should assess, or seek advice from their advisors, on whether any relevant part of this report is appropriate to their individual circumstances. If a recipient was referred to Noble Capital Markets, Inc. by an investment advisor, that advisor may receive a benefit in respect of
transactions effected on the recipients behalf, details of which will be available on request in regard to a transaction that involves a personalized securities recommendation. Additional risks associated with the security mentioned in this report that might impede achievement of the target can be found in its initial report issued by Noble Capital Markets, Inc.. This report may not be reproduced, distributed or published for any purpose unless authorized by Noble Capital Markets, Inc..

RESEARCH ANALYST CERTIFICATION

Independence Of View
All views expressed in this report accurately reflect my personal views about the subject securities or issuers.

Receipt of Compensation
No part of my compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public
appearance and/or research report.

Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.

Golden Rule of Successful Trading/Investing

Posted on January 4, 2023January 5, 2023 by phoffman@channelchek.com

One Should Never feel Forced to Trade or Get Involved Because They are Bored

Most start off a New Year with great intentions. These often include saving money, starting a family, or finding a better job. A co-worker of mine is intent on skydiving before year-end – whatever. To each their own. For many involved in the markets, 2023 has become the year they want to further improve their trading. This usually begins with stepping back, reminding themselves of trading basics, then not falling into old habits weeks later. Another step is developing new understanding and new companies. It also includes not trading with the need to make back last year’s losses in a hurry.

There is one trading basic that is often ignored because it feels like it conflicts with other goals. But it doesn’t. It is knowing when being uninvolved is the best decision. Doing nothing without feeling you may be missing something takes practice for most. It may take more practice for those that have experienced the thrill of a mostly green trading account.

Trade No Stock Before its Time

Over the holidays, family members would ask, “should I buy Tesla?” or “should I be buying Apple down here?” My mom would instead ask, something that in my mind is a similar question. She’d ask, “when are you going to get married?” These are all similar because Tesla and Apple, when considering the whole universe of stocks, are probably not the best fit for the accounts of these people. Similarly, in the absence of finding a good personal fit, unless someone is holding a gun to one’s head, I believe in waiting for circumstances with a high probability of a positive outcome. Don’t get involved because you’re bored, or because you think you have to is the message.

If your win rate is over 50%, you’re doing better than average, this is as true in trading as it is in relationships. If you force either, your success rate goes down, and you’ve wasted time, money, and invited frustration. Yet so many investor/traders willy-nilly jump into something because they are bored, feel they are missing out, or are told it is what they are supposed to be doing.

Forcing trades, no matter how tempting it may be, how bored you are, or how much FOMO you’re experiencing, has a lower chance of being successful than if you wait for your perfect setup. Sitting on your hands so you can’t press the “Buy” button is preferable to being in the situation of trying to unwind a trade you spent too little time waiting to come to you. Good opportunity doesn’t always arrive on schedule, but if you have capital tied up in a mistake, you may not be able to jump at a real match for your portfolio later on.

Trading is Not Glamorous

The definition of booyah is “expressing triumphant exuberance.” If you yearn to say “booyah” or do any other kind of touchdown dance, you may find you will pull the sell trigger too early. A main key to trading is knowing what you want, then patience. Patience is one of the most important skills you can have as a trader. You need to have the control and the discipline to wait for a quality setup according to your individual strategy. It may take a while, but confidence the trades will come helps. Develop a trading strategy so you know the guidelines you will adhere to; abandoning that strategy just to be involved, over time, will cause you to be worse off.

Consistently successful traders will tell you that one of the most important things to remember with trading is that you should never let your emotions control your actions. If you can’t think rationally if you aren’t planning your trade and trading your plan, sit on your hands until you can. Really, defund your account, find another way to get your thrills. Because if you force a trade and it works out anyway, you have reinforced a bad habit. Many trading accounts of good people got fried in 2022 because they did the wrong thing in 2021, but in 2021 they were bailed out by the markets. Doing the wrong thing and succeeding is costly because you tend to repeat it.

A hail Mary pass sometimes meets the desired goal in a football game, swinging for a home run in baseball and connecting certainly can lead to exuberance and even a winning game. But most often, these are low-probability irrational plays if you actually want to win. Increase your time on base, work on your short plays, study your opponent, or whatever other kind of reference helps convey this thinking. Because saying “I do” to a stock without successful due diligence is like asking to eventually lose. If you just want excitement, then maybe you could consider skydiving.

Final Thoughts

We’re all always learning. Channelchek is a good way to discover less explored companies and to either learn or be reminded of things that may enhance your positive outcomes. Sign up now, there’s no paywall, just good info not found on more mainstream investment sites. Go here.

Paul Hoffman

Managing Editor, Channelchek

Newly Released FOMC Minutes Cause Concern

Posted on January 4, 2023January 4, 2023 by phoffman@channelchek.com

New Year, Same Old Fed – A Synopsis of the Last FOMC Meeting

Interest rate moves orchestrated by the Federal Reserve or, more specifically, monetary policy as formed at each Federal Open Market Committee (FOMC) meeting have recently taken a front seat in driving markets. This includes the stock market, real estate prices, and more directly, bond values. In what direction is the FOMC likely to push rates in 2023, and at what pace? Some hints have been uncovered in the just-released December meeting minutes. The minutes describe the views expressed by policymakers and explain the reasons for the Committee’s decisions. While voting member thinking can change from one meeting to the next, it is seldom dramatic. This new set of minutes offered only subtle clues as to whether change is in store.

Fed Minutes Present a Case for Continued Rate Hikes

The minutes from the December 2022 Federal Open Market Committee (FOMC) meeting showed that the Fed remains committed to bringing inflation back to its defined 2% target. But the pace of rate hikes should taper in 2023. There was no discussion at all as to whether rates may be cut during 2023.

On the progression of the economy, the Committee members noted that GDP was increasing at a modest pace in the fourth quarter after expanding strongly in the third quarter. Labor markets had eased but remained tight enough to be trouble from an inflation point of view. Both Consumer Price Inflation (CPI) and Personal Consumption Expenditures (PCE) readings moved lower, but continued well above the target inflation range.

Jobs increased at a slower pace in October and November. Both the labor force participation rate and the employment-to-population ratio declined a little over the period of time between meetings. The private-sector job openings rate, as measured by the Job Openings and Labor Turnover Survey, moved back down in October but remained higher than would seem consistent with dramatically lower inflation.

Wage growth continued higher than a pace expected to be consistent with the the two percent monetary policy target. Average hourly earnings rose 5.1% over the 12 months ending in November. Compensation per hour (CPH) in the business sector rose 4.0 percent over the four quarters ending in the third quarter, but the reported increase likely understated the true pace of increase in CPH, as the lower second-quarter employment data from the Quarterly Census of Employment and Wages had not yet been incorporated in the CPH measure.

Foreign economic activity grew in the third quarter, but some recent data point to weakening growth, weighed down by the economic fallout of Russia’s war with Ukraine and a COVID-19-related slowdown in China. High inflation continued to contribute to a decline in real disposable incomes, which, together with disruptions to energy supplies, depressed economic activity, especially overseas. In China, authorities began to ease social restrictions even as COVID cases surged, raising the prospect of significant disruptions to economic activity in the near term but also a faster reopening. Weaker global demand and high interest rates also weighed on activity in emerging market economies. Despite tentative signs of easing in foreign headline inflation, core inflationary pressures remained elevated in many countries. In response to high inflation, many central banks further tightened monetary policy.

Implications

The December 2022 minutes confirmed that reining in inflation remains the principal concern of the Fed. No members spoke of a scenario where they may lower rates this year, there is concern that the cost of money is getting easier despite the Fed’s tightening efforts. The expected path of the federal funds rate implied by financial market quotes ended, showing the market anticipates lower rates. This is likely reflective of the larger-than-expected moderation in inflation. Medium-to-longer-term nominal Treasury yields declined substantially over the intermeeting period. This was driven primarily by lower-than-expected inflation data releases, which appeared to prompt a substantial reduction in investors’ concerns about the possibility that inflation would remain high for a long period.

What Do the Minutes Say About Stocks?

Broad stock price indexes increased. This likely reflected reduced concerns about the inflation outlook and the associated implications for the future path of policy. On balance, the one-month option-implied volatility on the S&P 500 (VIX) decreased and was around the middle of its range since mid-2020. This makes sense because of reduced investor concerns about the inflation outlook, spreads of interest rates on corporate debt, mortgage-backed securities, and municipal bonds to comparable-duration Treasury yields, which all narrowed since the last meeting.

Inflation Worries Deflated

With inflation still well above the Committee’s longer-run goal of two percent, participants agreed that inflation was unacceptably high. Participants agreed that the inflation data received for October and November showed welcome reductions in the monthly pace of price increases, but they stressed that it would take substantially more evidence of progress to be confident that inflation was on a sustained downward path.

Participants noted that core goods prices declined in the October and November CPI data, consistent with easing supply bottlenecks. Some participants also noted that, by some measures, firms’ markups were still elevated and that a continued subdued expansion in aggregate demand would likely be needed to reduce the remaining upward pressure on inflation. Regarding housing services inflation, many participants observed that measures of rent based on new leases indicated a deceleration, which would be reflected in the measures of shelter inflation with some lag. Participants noted that, in the latest inflation data, the pace of increase for prices of core services excluding shelter—which represents the largest component of core PCE price inflation—was high. They also remarked that this component of inflation has tended to be closely linked to nominal wage growth and, therefore would likely remain persistently elevated if the labor market remained very tight. Consequently, while there were few signs of adverse wage-price dynamics at present, they assessed that bringing down this component of inflation to mandate-consistent levels would require some softening in the growth of labor demand to bring the labor market back into better balance.

Rates Moving Forward

In discussing the policy outlook, participants continued to anticipate that ongoing increases in the target range for the federal funds rate is appropriate to achieve the Committee’s objectives. In determining the pace of future increases in the target range, participants judged that it would be appropriate to take into account the cumulative tightening of monetary policy, the lags with which monetary policy affects economic activity and inflation, and economic and financial developments.

With inflation staying above the Committee’s two percent goal and the labor market remaining very tight, all participants had raised their assessment of the appropriate path of the federal funds rate relative to their assessment at the time of the September meeting. No participants anticipated that it would be appropriate to begin reducing the federal funds rate target in 2023. Participants generally observed that a restrictive policy stance would need to be maintained until the incoming data provided confidence that inflation was on a sustained downward path to two percent. Which would likely take some time.

In view of the persistent and unacceptably high level of inflation, several participants commented that historical experience cautioned against prematurely loosening monetary policy.

In light of the heightened uncertainty regarding the outlooks for both inflation and real economic activity, most participants emphasized the need to retain flexibility and optionality when moving policy to a more restrictive stance. Participants generally noted that the Committee’s future decisions regarding policy would continue to be informed by the incoming data and their implications for the outlook for economic activity and inflation and that the Committee would continue to make decisions meeting by meeting.

Take Away

It’s a new year, it’s the same Fed, inflation is still quite elevated, policymakers are surprised at how quickly some inflation measures did drop, but the drop wasn’t enough for them to reverse course.

The FOMC reserves the right to be data-dependent and change its pace or direction when the data changes. Until then, they still have more rate hikes they expect to unleash early this year.

Scheduled FOMC Meetings in 2023

January/February 31-1

March 21-22

May 2-3

June 13-14

July 25-26

September 19-20

October/November 31-1

December 12-13

The Policy announcements have been at PM on the second meeting date after they have adjourned.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/monetarypolicy/fomcminutes20221214.htm

https://www.federalreserve.gov/faqs/minutes-federal-open-market-committee-fomc.htm

Will Three Bank Regulators Kill Cryptocurrency in 2023?

Posted on January 4, 2023January 4, 2023 by phoffman@channelchek.com

Lack of Crypto Governance, Oversight, Standards, and Risk Management Frightens Feds

Three Federal Agencies have warned banks about the dangers of dealing with digital assets. On the first banking day of the new year, the Federal Reserve (Fed), the FDIC, and the Office of the Controller of the Currency (OCC), the three banking regulators in the US, issued a three-page joint warning to banks. It points to eight risks that banking organizations should not let migrate to the US banking system. And highlights processes to mitigate these risks while the three agencies develop frameworks to oversee the ever-changing asset class.

The Joint Statement on Crypto-Asset Risks to Banking Organizations is for the consumption of banks of all types and sizes through the US that have or may adopt policies. It warns the events of 2022 have “been marked by significant volatility,” and that vulnerabilities in the crypto-asset sector have surfaced.

The joint statement explains that banking organizations that have in the past seeked to engage in activities that involve crypto-assets. Have been taken on a case-by-case basis. “The agencies continue to build knowledge, expertise, and understanding of the risks crypto-assets may pose to banking organizations, their customers, and the broader U.S. financial system.” The statement says that the significant risks “highlighted by recent failures of several large crypto-asset companies,” will cause the three agencies to take a careful and cautious approach.

The agencies highlighted eight risks that they wanted banking organizations engaged in crypto-assets to understand may not be in accordance with safe and sound banking practices:

Risk of fraud and scams among crypto-asset sector participants.
Legal uncertainties related to custody practices, redemptions, and ownership rights, some of which are currently the subject of legal processes and proceedings.
Inaccurate or misleading representations and disclosures by crypto-asset companies, including misrepresentations regarding federal deposit insurance, and other practices that may be unfair, deceptive, or abusive, contributing to significant harm to retail and institutional investors, customers, and counterparties.
Significant volatility in crypto-asset markets, the effects of which include potential impacts on deposit flows associated with crypto-asset companies.
Susceptibility of stablecoins to run risk, creating potential deposit outflows for banking organizations that hold stablecoin reserves.
Contagion risk within the crypto-assetsector resulting from interconnections among certain crypto-asset participants, including through opaque lending, investing, funding, service, and operational arrangements. These interconnections may also present concentration risks for banking organizations with exposures to the crypto-asset sector.
Risk management and governance practices in the crypto-asset sector exhibiting a lack of maturity and robustness.
Heightened risks associated with open, public, and/or decentralized networks, or similar systems, including, but not limited to, the lack of governance mechanisms establishing oversight of the system; the absence of contracts or standards to clearly establish roles, responsibilities, and liabilities; and vulnerabilities related to cyber-attacks, outages, lost or trapped assets, and illicit finance.

Take Away

In 2022 the young crypto asset class took a beating similar to high-tech stocks. There is a reason banks are limited to their stock market activity. It seems that these three federal agencies, which do not include work being done by the SEC (or CFTC), are now working hard to regulate what banks can do involving these assets; in the meantime, they want to let banking organizations know that crypto-assets need to be dealt with extreme caution, perhaps moderation, and know that as far as the regulators are concerned, if they still want to serve crypto customers, they should discuss all planned activities with the appropriate regulator prior to filing an application and should ensure that risk management, including board oversight, policies, procedures, risk assessments, controls, gates and guardrails, and monitoring, are in place to effectively identify and manage risks.

Paul Hoffman

Managing Editor, Channelchek

Source

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Release – FAT Brands Inc. Announces Participation in the 2023 ICR Conference

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on FAT

LOS ANGELES, Jan. 03, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 12 other restaurant concepts, today announced their participation in the 2023 ICR Conference. Andy Wiederhorn, President and CEO, and Jim Neuhauser, Executive Chairman of the Board of Directors, will host a fireside chat on Monday, January 9th, 2023 at 4:00 PM ET. Institutional investors interested in scheduling a 1×1 meeting with management should contact their ICR representative.

The fireside chat will be webcast live and available for replay for 90 days. It can be accessed under the Events & Presentations section of the FAT Brands Investor Relations website at https://ir.fatbrands.com/.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, casual and polished casual dining restaurant 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, Native Grill & Wings, Pretzelmaker, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit http://www.fatbrands.com.

Investor Relations:
ICR
Michelle Michalski
IR-FATBrands@icrinc.com
646-277-1224

Media Relations:

Erin Mandzik
emandzik@fatbrands.com
860-212-6509

Release – Seanergy Maritime Announces Acquisition of a Scrubber-Fitted Capesize Vessel with Immediate Period Employment and the Sale of the two Oldest Vessels of the Fleet

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on SHIP

January 3, 2023 – Glyfada, Greece – Seanergy Maritime Holdings Corp. (the “Company” or “Seanergy”) (NASDAQ: SHIP) announced today the acquisition of a 2012-built Capesize vessel (the “Vessel”) from a major Japanese company and the simultaneous commencement of its period employment.

In addition, the Company has entered into definitive agreements to sell the 2005-built M/V Goodship and the 2006-built M/V Tradership, the oldest vessels in its fleet, to United Maritime Corporation (“United”), a related party.

The Company expects to record a profit of approximately $8 million in connection with the sale of the two vessels in the first quarter of 2023. In addition, the aforementioned transactions will reduce the average age of Seanergy’s fleet.

Stamatis Tsantanis, the Company’s Chairman & Chief Executive Officer, stated:

“We are pleased to announce the acquisition of another high-quality Japanese Capesize vessel, which will effectively replace the older M/V Goodship and M/V Tradership. The sale of the two oldest vessels in our fleet will result in a substantial profit of more than $8 million for Seanergy, whilst benefiting the average age of our fleet.

“The M/V Paroship will increase the number of the scrubber-fitted vessels in our fleet to nine, enhancing our cash-flow generating capacity based on the significant differential between high and low-sulfur fuel prevailing currently.

“The delivery of the M/V Paroship and the underlying T/C agreement are well-timed, considering the recent improvement in the freight market and what we believe to be strong fundamentals in our sector.

“Seanergy remains committed to the Capesize sector with a solid operational structure and consistent capital allocation, focusing predominantly on shareholder rewards and sustainable growth.”

Acquisition of a modern Japanese Capesize vessel & Period Employment

The Vessel was built in 2012 at a reputable shipyard in Japan, with a cargo-carrying capacity of approximately 181,415 deadweight tons and has been renamed M/V Paroship. The Vessel is fitted with an exhaust gas cleaning system (scrubber).

The M/V Paroship was delivered to the Company on December 27, 2022 and its gross purchase price of US$31 million was funded through a combination of cash on hand and a new senior credit facility.

The Vessel has been fixed on a time charter (“T/C”) with a leading European operator, which is an existing charterer of Seanergy, for a period of minimum ten (10) months to maximum December 31, 2023. The T/C commenced promptly, upon finalization of the customary transition process. The gross daily rate is set at a premium over the Baltic Capesize Index, while the Company has the option to convert the daily hire from index-linked to fixed for a period of minimum three (3) months to maximum nine (9) months based on the prevailing Capesize Freight Futures Agreements curve. In addition, the T/C includes a scrubber profit sharing scheme with the majority of the benefit from the differential between high sulfur and low sulfur fuel being attributed to Seanergy.

Sale of our two oldest Capesize vessels

The aggregate sale price of the two vessels is US$36.25 million and was agreed upon on the basis of the average of three independent broker valuations. The transaction was made pursuant to United’s exercise of a right of first offer granted by the Company on its Capesize vessels pursuant to an agreement entered into between the Company and United on July 5, 2022. The sale of the M/V Tradership and the M/V Goodship was approved by a special independent committee of the Company’s Board of Directors. The deliveries of the two vessels are expected to be concluded by the end of the first quarter of 2023, subject to the satisfaction of certain customary closing conditions.

Financing facility for the M/V Paroship

Seanergy concluded a new senior credit facility with an existing lender of the Company, a major European bank, secured by the M/V Paroship. The US$16.5 million loan bears interest of SOFR + 2.90% per annum and has a four-year tenor. The principal amount will be amortized through 16 consecutive quarterly installments averaging approximately US$0.43 million each, and a US$9.6 million final balloon payment at maturity.

About Seanergy Maritime Holdings Corp.

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. Including the newly delivered M/V Paroship and upon completion of the sale of the M/V Goodship and M/V Tradership, the Company’s operating fleet will consist of 16 Capesize vessels with an average age of 11.9 years and an aggregate cargo carrying capacity of approximately 2,846,965 dwt.

The Company is incorporated in the Republic of 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”.

Please visit our company website at: www.seanergymaritime.com.

Link to press release: https://www.capitallink.com/press/seanergy010323.pdf

Seanergy Investor Relations
Tel: +30 213 0181 522
E-mail: ir@seanergy.gr

This information is distributed by Capital Link, Inc. – Investor Relations
230 Park Avenue, Suite 1540
New York, NY 10169
Tel: (212) 661-7566
Email: pressrelease@capitallink.com

Release – Entravision Announces the Unexpected Passing of Chairman and Chief Executive Officer Walter F. Ulloa

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on EVC

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced that Walter F. Ulloa, the Company’s Chairman and Chief Executive Officer, passed away of a sudden heart attack on December 31, 2022. He was 74 years old.

Entravision’s Board of Directors issued the following statement:

“We are profoundly saddened by the sudden passing of Walter Ulloa and extend our heartfelt condolences to Walter’s wife, son and entire family. Since founding Entravision more than 25 years ago, Walter has been an exceptional leader who transformed the company from a traditional multi-linear Spanish-language company that currently owns and operates approximately 100 domestic television and radio stations, to a global digital media powerhouse with a footprint that today reaches across more than 40 countries. Well-known and respected throughout the media industry, Walter’s passion, energy, and devotion to our company will be greatly missed. We have lost a leader and a friend.

Thanks to Walter’s dynamic leadership, Entravision has assembled an experienced management team that will continue to drive the company’s long-term growth strategy as we serve our customers, our partners, and our shareholders.”

The Board also announced today that it has appointed Chris Young, Chief Financial Officer and Treasurer, as Interim Chief Executive Officer, effective immediately. Mr. Young has over two decades of experience in banking and corporate finance across the media, advertising and technology industries and has served as Treasurer and CFO of Entravision since 2008. He originally joined Entravision in August 2000 as CFO of the Company’s outdoor advertising division, of which he became President in February 2004 prior to the division’s sale in May 2008.

The Board of Directors will continue to meet to discuss matters related to the orderly transition and is currently conducting a search for a full-time replacement for the role of Chief Executive Officer.

Mr. Ulloa was a visionary in Spanish language broadcasting with nearly five decades of experience in television, radio and digital media. He co-founded Entravision in 1996, becoming the Chairman and Chief Executive Officer of the Company, roles he held until his passing. Mr. Ulloa served as director and Chairman of Entravision’s Board of Directors since February 2000. From 1976 to 1989, Mr. Ulloa worked at KMEX-TV, Los Angeles, California as Operations Manager, Production Manager, News Director, Local Sales Manager and Account Executive. This was followed by seven successful years in development, management and ownership of Entravision’s predecessor entities.

About Entravision

Entravision is a leading global advertising, media and ad-tech solutions company connecting brands to consumers by representing top platforms and publishers. Our dynamic portfolio includes digital, television and audio offerings. Digital, our largest revenue segment, is comprised of four business units: our digital sales representation business; Smadex, our programmatic ad purchasing platform; our branding and mobile performance solutions business; and our digital audio business. Through our digital sales representation business, we connect global media companies such as Meta, Twitter, TikTok and Spotify with advertisers in primarily emerging growth markets worldwide. Smadex is our mobile-first demand side platform, enabling advertisers to execute performance campaigns using machine learning. We also offer a branding and mobile performance solutions business, which provides managed services to advertisers looking to connect with global consumers, primarily on mobile devices, and our digital audio business provides digital audio advertising solutions for advertisers in the Americas. In addition to digital, Entravision has 49 television stations and is the largest affiliate group of the Univision and UniMás television networks. Entravision also manages 45 primarily Spanish-language radio stations that feature nationally recognized, Emmy award-winning talent. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements. These forward-looking statements, which are included in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results and performance in future periods to be materially different from any future results or performance suggested by the forward-looking statements in this press release. Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that actual results will not differ materially from these expectations, and the Company disclaims any duty to update any forward-looking statements made by the Company. From time to time, these risks, uncertainties and other factors are discussed in the Company’s filings with the Securities and Exchange Commission.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230103005225/en/

Christopher T. Young
Interim Chief Executive Officer
Entravision
310-447-3870

Kimberly Esterkin
Addo Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – Schwazze Ends 2022 Strong With Additional Cannabis Dispensary Opening In New Mexico, Bringing R.Greenleaf Dispensary Store Count To 16

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on SHWZ

DENVER, Jan. 3, 2023 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its adult-use dispensary, R.Greenleaf, located in Alamogordo, New Mexico. The new store, located at 101 N. White Sands Blvd in Alamogordo, officially opened its doors for business on December 29, 2022. Store operating hours are 9a to 9p Monday through Saturday; 9a to 8p on Sunday.

The Alamogordo R.Greenleaf store opening continues the intentional expansion throughout the state of New Mexico and comes on the heels of a total of five R.Greenleaf store openings since Schwazze’s acquisition in February 2022. This brings R.Greenleaf’s total number of New Mexico retail dispensaries to 16. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“We are excited to open up our sixth R.Greenleaf dispensary since late September, this one specifically in Alamogordo. The team has been hard at work to get this completed in time for the holiday season to serve this local community,” said Steve Pear, New Mexico Division President for Schwazze. “R.Greenleaf, offering a wide variety of quality products serviced by top-notch, knowledgeable staff, has grown from 10 locations to now 16 in New Mexico since Schwazze purchased the retail banner earlier this year.”

R.Greenleaf Alamogordo will also offer introductory pricing on flower, edibles, and vapes. Enrollment in the Gratify Rewards customer loyalty program, which can be used at any Schwazze-owned retail dispensary in either New Mexico or Colorado, is already open.

Alamogordo Store Location

R.Greenleaf
101 N. White Sands Blvd
Alamogordo, NM 88310

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 41 cannabis retail dispensaries as well as seven cultivation facilities and two manufacturing plants in Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Release – PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on PDSB

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.
79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

88% (7/8) of CPI naïve patients had an objective response.
38% (3/8) of responders had a complete response.
In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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.

About PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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 our 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; the success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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.

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:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

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

Release – Tonix Pharmaceuticals to Present at Biotech Showcase 2023

Posted on January 3, 2023January 3, 2023 by cpatches

Research News and Market Data on TNXP

CHATHAM, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at Biotech Showcase 2023 being held January 9-11, 2023, at the Hilton San Francisco Union Square.

Details of the Tonix presentation are as follows:

Event:	Biotech Showcase 2023
Date:	Tuesday, January 10, 2023
Time:	3:00 p.m. PT (6:00 p.m. ET)
Location:	Hilton San Francisco Union Square
Track:	Yosemite C (Ballroom Level)

A live webcast and subsequent archived recording of the Company presentation will be available under the IR Events tab of the Investors section of the Tonix Pharmaceuticals website at www.tonixpharma.com or can be found here. Investors interested in arranging a meeting with the Company’s management during the conference should contact Brandon.Weiner@Westwicke.com.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS 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 a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third 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 first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease 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 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released January 3, 2023