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PDS Biotechnology Corp (PDSB) – PDS0101 To Advance To Phase 3 In First Indication

Posted on by cpatches


Tuesday, October 04, 2022

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.

PDS Biotech Announces FDA Meeting Results.  PDS Biotech announced the outcome of an End-of-Phase 2 meeting with the FDA to determine the clinical development pathway for PDS0101.  In the meeting, data from the interim analysis of the VERSATILE-002 trial testing PDS0101 in HPV-positive head-and-neck cancer was evaluated and regulatory guidance provided.  Although the trial is still ongoing, the efficacy and safety data will allow moving into a Phase 3 pivotal study ahead of schedule during 2023.

VERSATILE-002 Showed Strong Response Rates.   The VERSATILE-002 Phase 2 trial was designed to test PDS0101 in HPV-positive cancer of the head and neck in combination with the checkpoint inhibitor pembrolizumab (Keytruda, from Merck).  As discussed in our Research Note reviewing the data at the ASCO conference last May 31, the tumor response rate (shrinkage of 30% or more) was 41.2% (7 out of 17 patients).  This compares with published data showing 19% response rate for checkpoint inhibitors alone.  Progression-free survival (PFS) at nine months was 55.2% and overall survival (OS) was 87.2%.


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Energy Industry Report – Oil prices have fallen but its not because of supply

Posted on by cpatches

Tuesday, October 04, 2022

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

Refer to the bottom of the report for important disclosures

Energy stocks, as measured by the XLE Energy Index, were essentially flat during the third quarter rising 0.1%. The performance was impressive given overall market weakness. The S&P Composite Index declined 5.0% during the quarter.  What makes the performance even more impressive is the fact that spot oil prices declined 25% during the quarter. We believe energy stocks remain an attractive investment and are an important part of a diversified investment portfolio.

WTI prices peaked at $120 per barrel in the first week of June. Since then, prices have declined in response to signs of a global economic slowdown. Near month oil future contracts are now below $80 per barrel. We believe recent weakness largely reflects demand concerns and foreign currency changes but is not a condition of oversupply. The domestic rig count remains at less than half peak levels. What’s more, rig count has leveled off in recent months in response to the decline in oil prices.

Production has risen to 90% of peak, but it has been done by harvesting the low-hanging fruit. When oil prices began falling early in 2020, there was an increase in Drilled Uncompleted (DUC) wells. When prices rose, drillers focused on completing DUCs. With the number of DUCs having fallen in half, future supply increases will be more difficult. If demand does not decrease in reaction to a slowing economy, domestic production may be hard pressed to meet demand. If worries about a recession are overblown and demand increases, there’s a good chance oil prices will be back at a price of $120 or even higher.

Energy industry fundamentals remain strong. The recent drop in oil prices does not concern us as long-term prices are still 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 are reluctant to initiate/raise dividends in case the industry goes into a down cycle forcing them to reverse course. Share repurchase remains a viable option especially if energy stocks continue to be weak alongside the overall market.

Energy Stocks

Energy stocks, as measured by the XLE Energy Index, were essentially flat during the third quarter rising 0.1%. The performance was impressive given overall market weakness. The S&P Composite Index declined 5.0% during the quarter.  What makes the performance even more impressive is the fact that spot oil prices declined 25% during the quarter. We believe energy stocks remain an attractive investment and are an important part of a diversified investment portfolio.

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. Since then, prices have declined in response to signs of a global economic slowdown as governments raise interest rates to fight inflation. Near month oil future contracts are now below $80 per barrel.

Figure #1

We believe recent weakness largely reflects demand concerns and foreign currency changes but is not a condition of oversupply. Historically, oil prices are lower when the dollar is stronger. This is because most oil suppliers, including international suppliers, demand payments in dollars.

The domestic rig count remains at less than half peak levels. According to Baker Hughes, there were 764 active rigs as of September 23, 2022, as compared to 1600 in 2015. What’s more, rig count has leveled off in recent months in response to the decline in oil prices.

Figure #2

Rig count is one way to forecast future supply. While only half the peak number of rigs are active, that does not mean that production is half of peak levels. In fact, as the chart below shows, domestic daily production surpassed 2015 peak rig production levels in 2018. Production declined sharply when oil prices fell in 2020 but have recovered to a point where production has reached 90% of peak production. The increased production demonstrates an improved productivity per well as drillers better tailor drilling techniques to individual formations.

Figure #3

But before we chalk up increased production to improved technology, let’s look at one more chart. The chart below shows the number of drilled but uncompleted (DUC) wells against active rigs. The chart shows that the number of uncompleted wells has declined sharply the last two years as the active rig count has grown. When oil prices began falling early in 2020, drillers continued drilling but often did not complete the wells. This led to a large increase in the number of DUC wells. When prices started rising in the summer of 2020, drilling returned. However, drilling was largely focused on completing or reworking wells.

 Figure #4

 The implication of a declining DUC count is that the industry is running out of low hanging fruit. Future drilling will need to focus on wells that are likely to have a lower production rate per rig than what we have witnessed recently. Declining production could exasperate already low inventory levels (see chart below). Thus, if demand does not decrease in reaction to a slowing economy, domestic production may be hard pressed to meet demand. If worries about a recession are overblown and demand increases, there’s a good chance oil prices will be back at a price of $120 or even higher.

Figure #5

Natural Gas 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. As the chart below shows, natural gas prices do not seem to be affected by recession concerns as compared to oil prices.—-

Figure #6

Source: Natural Gas Intelligence

Summer is usually a quiet time for natural gas prices. Wells are producing more gas than is demanded, and gas is put in inventory. As is the case with oil, inventory levels are running below historical averages as we approach the point of withdrawing from inventory. This bodes well for natural gas prices remaining at current historical high levels and perhaps even rising higher.———- page break ———-

Figure #7

Outlook

Energy industry fundamentals remain strong. The recent drop in oil prices does not concern us as long-term prices are still 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 are reluctant to initiate/raise dividends in case the industry goes into a down cycle forcing them to reverse course. Share repurchase remains a viable option especially if energy stocks continue to be weak alongside the overall market.

We also believe the case for smaller cap energy stocks is strong. Major oil companies are facing increasing pressure to focus on renewable energy. While the majors are increasing drilling, they are doing so in a controlled manner as they also invest in green energy. 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.

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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

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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..

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Orion Group Holdings (ORN) – Ian Impact

Posted on by cpatches


Tuesday, October 04, 2022

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.

Lowering 4Q Projections. We are taking a more conservative view of the fourth quarter given the impact of Ian on Florida. Orion has a number of projects in the area and we expect to see a push back given the need for more humanitarian efforts. We are now forecasting revenue of $165 million for the quarter, down from a prior $168 million estimate, adjusted EBITDA of $8.55 million, down from $10.55 million, and breakeven EPS, down from a prior $0.03 EPS estimate. For the full year, we are now at revenue of $709.5 million and adjusted EBITDA of $28.1 million.

But More Future Work? The devastation wrought by Ian is undeniable, not just in Florida but also in the Carolinas. This unfortunate event, however, could create substantial future work for Orion. While it is way too early yet to determine, typically such storms end up being a net positive in terms of new work.


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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. 

CoreCivic, Inc. (CXW) – Updating FFO projections

Posted on by cpatches


Tuesday, October 04, 2022

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for nearly 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

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.

FFO, NFFO, and AFFO Projections. We modestly adjusted our projections for Funds From Operations, Normalized Funds From Operations, and Adjusted Funds From Operations. Our prior estimates reflected a larger estimate for depreciation and amortization and other than we are now using. We are now projecting third quarter FFO at $0.31 per share, versus a prior $0.36, NFFO of $0.31 versus $0.37, and AFFO of $0.31 versus a prior $0.32.

No Change in Business Outlook.  We are not currently expecting any major change in the business environment and our projections for revenue and EPS remain unchanged. ICE ADP has risen from below 20,000 in the spring to nearly 26,000 in September, while Southwest Border encounters exceeded 200,000/mth since March and likely will be up over 32% from the full fiscal year 2021.


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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. 

Musk, The Art of the Deal

Posted on by aweinsoff@channelchek.com
OnInnovation (Flickr)

Musk Plans to Go Ahead with Original Price of $54.20 a Share

All successful businessmen have their own style of negotiating. Elon Musk is better known as a whiz-kid/idea-man than a wheeler-dealer negotiator. But, he didn’t become the wealthiest person on planet Earth without being a master persuader. There’s no telling how much the on-again, off-again deal to buy Twitter was a “chess match” the entrepreneur was playing to accomplish a goal. Or if he backed himself into a corner that he could not get out of. In the end, Twitter had initially been fighting hard not to be bought for 54.20 a share, Twitter later wound up suing to be taken private for $54.20 a share. Assuming the final deal is near, this is either masterful brilliance or a costly mistake for the entrepreneur.

Will the Musk Twitter Deal Finally be Consummated?

Elon Musk, according to multiple news outlets, wrote to Twitter on Tuesday and offered to follow through with the deal to buy the company. The terms were the same as the original offer by the billionaire. If this is the final chapter of the interplay between Musk, who heads several companies, and Twitter, it will end the seven-month-long legal saga. It will also be the only company Musk owns that he has not built from the ground up.

Not coming to an agreement now would be difficult. Musk and Twitter are scheduled to meet in a Delaware court on October 17 as Twitter is looking to force the billionaire to purchase the company for the same terms Musk is said to have proposed in his letter.

As of 2:30 on Tuesday, the shares of Twitter are up 12.67%. The price is 11.50% below Musk’s per-share offering price.

Key Details

Twitter accepted Musk’s unsolicited takeover bid on April 25, three weeks after the billionaire disclosed he purchased a 9.2% stake in the company. This followed a short period where Twitter employees and a number of advocacy groups with names like Stop the Deal campaigned to prevent the purchase.

Musk is a uses the microblogging social media platform to communicate with his 108 million followers. However, he loathes the platform’s content moderation policy and wishes to change it to a more open, less moderated social media site. This was the reason given to his followers as to why he’d buy Twitter, to “fix it.”

He later said he was backing out of his offer, the reason was his due diligence allegedly uncovered a large number of fake and spam accounts on Twitter. Elon formally requested to be let out of the deal on July 8, using the reason Twitter lowballed the number of bot accounts in its public filings.

Twitter sued Musk four days later and argued his reasons for backing out of the deal were invalid. The company filed at a state court in Delaware to force Musk to buy Twitter at the originally agreed-upon terms. As the trial date drew nearer, more revelations about both Twitter and Musk emerged. One high drama event was Musk’s lawyers suggesting his case was strengthened by a whistleblower complaint from Twitter’s former head of security. The complaint alleged the company knowingly misled regulators and investors about the number of bots on the site.

The suit, if it had proceeded in two weeks, may have gotten messy as Musk’s texts between himself and  public figures like Twitter co-founder Jack Dorsey, popular podcaster Joe Rogan, and Florida Governor DeSantis were to be part of the suit.

Other Impacted Stocks

Late afternoon on Tuesday, Tesla (TSLA) stock was trading 2.25% higher on the day but off its highs from before the news. Digital World Acquisition Corp., the SPAC that has agreed to merge with Trump Media and its platform, Truth Social, is down 3.16% on the day, having fallen sharply as word spread about Musk’s plans to buy Twitter.

Paul Hoffman

Managing Editor, Channelchek

Will the Rally in Silver and Gold Stay in High Gear?

Posted on by cpatches
Image Credit: Pixabay (Pexels)

The Fundamental Reasons the Strength in Precious Metals May Continue

What’s happening with precious metals? Silver has been outshining gold the past few days as the rally in both precious metals (PM) has grabbed the attention of investors and perhaps caught those that were short silver off guard. Why are the metals rising, can the strength last, and what is the longer-term outlook for PM?

Silver reached a six-week high in the first week of October, and gold is at its highest level in three weeks. As financial markets are becoming more uncertain, the two metals are showing they never really lost their safe-haven status. The concerns have just not been high enough for many to rotate out of the investments they were in. The move to what has always been viewed as the highest level of safe, gold and silver. This rotation follows months of movement to $ U.S. dollar-denominated securities. The heightened level of safety was inspired by the media being focused on a potential financial crisis in Europe and discussions of Russia unleashing a nuclear weapon in Putin’s attempt to annex Ukraine.

Silver, Gold and Copper performance since September 1. Source: Koyfin

As if the words “nuclear bomb” aren’t enough to send some investors taking a larger allocation in safe-haven assets, there are rumors circulating that the global investment bank Credit Suisse may be in serious financial trouble. For many market participants, the rumblings about an investment bank having problems are reminiscent of 2007, the rumors of Bear Stearns, and the market troubles that followed. Revisiting the activity of the precious metals market that followed in 2008, silver outperformed copper, which outperformed gold.

As silver and gold rise, many speculators that were comfortable with short positions are finding themselves forced with the decision to decide to purchase to close out their short positions. Active hedge funds and other money managers will often play precious metals against the U.S. dollar. With the dollar at a 20-year high, the sentiment around metals was negative. If this is the beginning of a longer rotation into PM, the rotation could build into a strong short squeeze. Short covering serves to strengthen prices.

Other Fundamentals

Prior to Monday’s 7% increase in the price of silver and the 3% increase in gold, both with strong follow-up on Tuesday, some analysts were becoming more positive on the metals and miners category. In his quarterly Metals & Mining Review and Outlook, released on Channelchek pre-market Monday, Mark Reichmann, Sr. Research Analyst, wrote, “While higher rates and a strong U.S. dollar pose significant headwinds for gold, an inflection point may be reached as investors seek to preserve value amid deteriorating economic conditions, increasing geopolitical uncertainty, and market volatility.”

Reichmann seems to be long-term positive on metals, thinking gold and silver may turn first; he wrote, “Precious metals prices may strengthen in advance of industrial metals. Therefore, investors may desire to lean into precious metals mining names to benefit from a positive shift in investor sentiment.” He continued, “While it may take longer for industrial metals to recover, an eventual return to economic growth could result in strong prices due to potential supply and demand imbalances.”

For a complete list and the most current research reports of producers of precious and industrial metals companies covered by Mark Reichmann,  visit his analyst webpage here.

Take Away

The move earlier this year toward U.S. dollar denominated assets, to capture higher yields and low sovereign risk has been an ongoing investment trend since at least March. With the newly recognized potential of additional turmoil entering the market psyche, including Russia and whether they would use the bomb, and whether the recent about-face for England’s monetary policy indicates deep trouble beneath the financial world’s surface has created further allocations to precious metals.

The suddenness of the move may have caught some large investors who have been bearish on silver and gold to make unexpected decisions on short positions they had been carrying. This short-squeeze is likely contributing to the strength of both gold and silver as it plays out.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.kitco.com/commentaries/2022-10-04/Where-are-the-stops-Tuesday-October-4-gold-and-silver.html

https://www.marketwatch.com/story/gold-adds-to-gains-from-last-week-as-treasury-yields-pull-back-11664801679?mod=search_headline

https://schiffgold.com/key-gold-news/central-banks-add-gold-for-fifth-straight-month/

https://www.kitco.com/news/2022-10-03/Safe-haven-buying-boosts-gold-silver-prices-sharply-higher.html

Release – Cocrystal Pharma Announces a 1-for-12 Reverse Stock Split

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on COCP

OCTOBER 03, 2022

BOTHELL, Wash., Oct. 03, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces that its Board of Directors has approved a 1-for-12 reverse stock split of the Company’s common stock. Cocrystal’s common stock is expected to begin trading on a split-adjusted basis at commencement of trading on Tuesday, October 11, 2022.

The reverse stock split will support maintenance of the Company’s Nasdaq Capital Market’s listing. On November 16, 2021, Nasdaq Capital Markets LLC notified the Company that the Company was not compliant with Nasdaq Rule 5550(a)(2) by failing to be above $1.00 per share for 30 consecutive trading days. The purpose of the reverse split is to regain compliance with Nasdaq’s Rule and avoid delisting of its common stock.

The reverse stock split will reduce the number of shares of Cocrystal’s common stock outstanding from approximately 97.5 million shares to approximately 8.1 million shares, but will not change the authorized number of shares of common stock, which will remain at 150 million shares of common stock. The Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol “COCP.”

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Fractional shares resulting from the reverse split will be rounded up to the nearest whole share. Holders of the Company’s common stock held in book-entry form or through a bank, broker or other nominee do not need to take any action in connection with the reverse stock split. Stockholders of record will be receiving information from the Company’s transfer agent regarding their common stock ownership post-reverse stock split.

In addition, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under all of the Company’s outstanding equity awards, and the number of shares authorized and reserved for issuance pursuant to the Company’s equity incentive plans will be reduced proportionately.

Furthermore, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under all of the Company’s outstanding warrants.

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

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

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

Source: Cocrystal Pharma, Inc.

Released October 3, 2022

Release – Digerati Announces Appointment of Derek Gietzen to President

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on DTGI

SAN ANTONIO, October 3, 2022 (GLOBE NEWSWIRE) Digerati Technologies, Inc. (OTCQB: DTGI) (“Digerati” or the “Company”), a provider of cloud services specializing in UCaaS (Unified Communications as a Service) solutions for the small to medium-sized business (“SMB”) market, today announced that Derek Gietzen has been named as the Company’s President. Currently, Mr. Gietzen is President of NextLevel Internet (“NextLevel”), a Digerati subsidiary.

Mr. Gietzen is an experienced 20-year telecommunications executive with a track record of managing successful high-growth companies. In addition to achieving consistent double-digit growth at NextLevel, Mr. Gietzen’s passion for creating amazing corporate cultures led NextLevel to be recognized as a certified ‘Great Place to Work in the U.S’, for each of the last three years.

“Since our acquisition of NextLevel earlier this year, Derek has been instrumental in the operational integration of Digerati’s various subsidiaries,” said Arthur L. Smith, Chief Executive Officer. “Derek is an inspirational leader who perfectly aligns with our core values and brings the added skills necessary to successfully execute our business plan and ongoing M&A strategy. We are confident his contribution will enhance our ability to deliver on our corporate goals and assist us with creating long-term shareholder value.”

“This is an exciting time for Digerati, and I am thrilled to be taking on the role of President of the combined operations,” said Derek Gietzen. “We have an amazing leadership team, and I look forward to all we can accomplish.”

About Digerati Technologies, Inc.

Digerati Technologies, Inc. (OTCQB: DTGI) provides cloud services specializing in UCaaS (Unified Communications as a Service) solutions for the business market. Through its operating subsidiaries NextLevel Internet (NextLevelinternet.com), T3 Communications (T3com.com), Nexogy (Nexogy.com), and SkyNet Telecom (Skynettelecom.net), the Company is meeting the global needs of small businesses seeking simple, flexible, reliable, and cost-effective communication and network solutions including, cloud PBX, cloud telephony, cloud WAN, cloud call center, cloud mobile, and the delivery of digital oxygen on its broadband network. The Company has developed a robust integration platform to fuel mergers and acquisitions in a highly fragmented market as it delivers business solutions on its carrier-grade network and Only in the Cloud™. For more information, please visit www.digerati-inc.com and follow DTGI on LinkedIn, Twitter, and Facebook.

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the applicable securities laws. Forward-looking statements generally are accompanied by words such as “confident,” “accomplish,” “enhance,” “ability,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements like ‘we are confident his contribution will enhance our ability to deliver on our corporate goals and assist us with creating long-term shareholder value,’ are not intended to serve as and must not be relied on by any investor or other person as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Digerati. These forward-looking statements are subject to a number of risks and uncertainties, including but not limited to general economic, financial, legal, political and business conditions and changes in domestic and foreign markets.

Facebook: Digerati Technologies, Inc.
Twitter: @DIGERATI_IR
LinkedIn: Digerati Technologies, Inc.

Investors
ClearThink
Brian Loper
bloper@clearthink.capital
(347) 413-4234

Release – Tier-1 MNO Awards Multimillion-Dollar Award to Comtech for Large Messaging Contract

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CMTL

MELVILLE, N.Y.–(BUSINESS WIRE)–Oct. 3, 2022– October 3, 2022– Comtech (NASDAQ: CMTL), announced today that it has been awarded a contract for over $30 million with a multinational data networking and telecommunications equipment company for their text messaging platform.

As a pioneer in the SMS industry providing messaging solutions globally since 1996, Comtech has deep experience with its customers’ networks, use cases, and messaging features. Comtech’s messaging solutions have 99.999% reliability, minimize costs to customers and increase end-user loyalty and satisfaction.

“We have been working with this customer of over 20 years to supply reliable text messaging services. In 2019, we started working on migration of our in-network messaging application to a cloud-native, architecture-based messaging platform,” said Jay F. Whitehurst, President of Comtech Trusted Location. “We are pleased to announce that we have entered into a global licensing agreement with our partner and have inked a multi-year deal to provide a containerized messaging platform to a major tier-1 US-based mobile network operator.”

Comtech’s containerized Short Messaging Service Center (cSMSC) is a highly reliable, multi-protocol SMS delivery cloud-native platform that enables common use cases including person-to-person text messaging, application-to-person, machine-to-machine/Internet of Things (IoT), and various other advanced applications in legacy 4G and 5G networks. Comtech’s cSMSC solution is a containerized architecture-based messaging application, which complies with various worldwide telecommunications standards, Network Functions Virtualization (NFV), as well as Management and Orchestration (MANO) Requirements. The cSMSC will be deployed as a Containerized Network Function (CNF).

“At Comtech, I aim to combine our terrestrial and wireless expertise with our space and satellite technologies to exploit emerging opportunities arising from the convergence of communications infrastructure. I believe the need for constant connectivity will create ongoing demand to blend terrestrial, wireless, and satellite networks. This convergence of terrestrial and satellite communications networks will truly enable IoT connectivity on a global scale and aligns exceptionally well with Comtech’s core technologies. The launch of the cSMSC is an important step towards delivering on that roadmap,” said Ken Peterman, Comtech’s Chairman, President and CEO.

About Comtech

Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies to commercial and government customers around the world. Headquartered in Melville, New York and with a passion for customer success, Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations
Robert Samuels
631-962-7102
robert.samuels@comtech.com

Source: Comtech Telecommunications Corp.

Release – Vera Bradley To Donate Percentage Of Sales To Breast Cancer Research For National Breast Cancer Awareness Month

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Research, News, and Market Data on VRA

Oct 3, 2022

Company To Donate 100% Of Primary Net Proceeds From 1982 Collection NFTs, 100% Of Net Proceeds From Limited-Edition Hope Charity Pouch, And 20% Of Purchase Price From “Rose Toile” And “Happiness Returns Pink” Prints To The Vera Bradley Foundation For Breast Cancer

FORT WAYNE, Ind., Oct. 03, 2022 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (NASDAQ: VRA) today announced that Vera Bradley, its iconic American bag and luggage lifestyle brand, will donate 100% of primary net proceeds from its second NFT drop; 100% of net proceeds from its limited-edition Hope Charity Pouch; and 20% of the purchase price of its new Rose Toile and Happiness Returns Pink patterns, to the Vera Bradley Foundation for Breast Cancer (the “Foundation”) in support of National Breast Cancer Awareness Month.

Vera Bradley’s second NFT drop, the 1982 Collection, is now available for purchase through The World of Vera Bradley, the brand’s new metaverse concept, or via OpenSea. The 1982 Collection is comprised of 1,982 generative backgrounds derived from 40 archived prints to commemorate the year the company was founded. Priced at $19.82 USD*, the 1982 Collection appeals to crypto lovers and breast cancer awareness supporters alike, with 100% of Vera Bradley’s primary net proceeds benefiting the Foundation, focusing its unique utility on advocacy and fundraising.

Designed to honor and give hope to those affected by breast cancer, Vera Bradley’s limited-edition Hope Charity Pouch features the word “HOPE,” surrounded by delicate floral embellishments and boldly emblazoned on a canvas zip-closure pouch. The Hope Charity Pouch, available online at www.verabradley.com and in Vera Bradley Full Line Stores nationwide, is priced at $20, with 100% of net proceeds directed to the Foundation.

Vera Bradley’s newest prints with a purpose, Rose Toile and Happiness Returns Pink, also support the critical, life-saving research taking place at the Vera Bradley Foundation Center for Breast Cancer Research at Indiana University School of Medicine in Indianapolis. For every purchase of a style in Rose Toile and Happiness Returns Pink through October 31, 2022, Vera Bradley will donate 20% of the purchase price (up to a maximum contribution of $100,000) to the Foundation. Styles range in price from $4 – $155 and are available now in Vera Bradley Full Line Stores, participating Vera Bradley retailers nationwide, and online at www.verabradley.com.

“Vera Bradley has championed breast cancer research since 1993 when our co-founders Barbara Bradley Baekgaard and Patricia R. Miller established the Vera Bradley Foundation for Breast Cancer in memory of their dear friend, Mary Sloan,” noted Daren Hull, Vera Bradley Brand President. “With support from Vera Bradley’s customers and communities, the Foundation has since donated more than $38 million to fund research pursuing innovative and improved treatments that enable women and men to thrive, not just survive, after a breast cancer diagnosis. We invite our customers to join us in funding even more progressive research this October by purchasing Vera Bradley’s breast cancer awareness items or donating to the Vera Bradley Foundation for Breast Cancer.”

*Please Note: The exact USD retail price will depend on gas prices at time of purchase.

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

ABOUT VERA BRADLEY FOUNDATION FOR BREAST CANCER
The Vera Bradley Foundation for Breast Cancer raises funds for breast cancer research to find a cure and to improve the lives of the many affected by this disease. The Foundation has contributed $38.6 million to the Vera Bradley Foundation Center for Breast Cancer Research at the Indiana University School of Medicine and has pledged to raise a total of $50 million. The Center is focused on developing and dramatically improving therapies for some of the most difficult-to-treat types of breast cancer. Funds are raised through special events, partner events, and individual donations. For more information, visit www.verabradley.org.

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

Hunter PR for Vera Bradley
verabradley@hunterpr.com

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/ef5b555c-eb53-4e47-a57e-5ce7237887cd
https://www.globenewswire.com/NewsRoom/AttachmentNg/77e55081-cd84-4b7e-b96a-47409b8e7cc4

Release – Engine Gaming’s, Frankly Media and Aggregated Media Announce Partnership

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Research, News, and Market Data on GAME

10/03/2022

Frankly initiates monetization of Aggregated Media’s A8 Esports Digital Linear Channel while maximizing target audience reach

NEW YORK, NY / ACCESSWIRE / October 3, 2022 / Frankly Media (“Frankly”), a digital publishing platform used to create, distribute and monetize content across all digital channels and wholly-owned subsidiary of Engine Gaming and Media, Inc. (NASDAQ:GAME)(TSXV:GAME), today announced a partnership with Aggregated Media (“A8”), an esports and video game culture media company. The partnership enables Frankly to monetize A8’s content via their premium yield advertising services and maximize their audience reach through Frankly’s video streaming platform, mobile apps and OTT/CTV.

“We’ve been extremely impressed with Frankly’s highly skilled Programmatic Advertising and SaaS resources. The team is very hands on, helping us every step of the way. We’re also utilizing their video streaming and app platforms to assist our content creators to easily ingest and distribute our esports and gaming content to an ever-increasing esports and gaming audience,” commented Erik Reynolds, President of Aggregated Media.

Frankly Media offers an integrated suite of gaming, news and entertainment solutions that help its customers modernize their digital ecosystem, maximize their audience reach and engagement, and fully monetize their display, audio and video content. Frankly’s fully integrated solution suite includes premium yield advertising solutions that include ad sales, ad operations, audience insights and performance analytics, website/cms, video streaming for Live, VOD and FAST Channels, Mobile Apps, OTT/CTV Apps, and Audience Engagement widgets.

“Aggregated Media is a perfect partnership for the Engine Gaming & Media family. We are thrilled to be serving their team and are working hard to optimize the monetization of their content, maximize their audience reach and modernize their digital ecosystem,” offered Lou Schwartz, CEO, Engine Gaming & Media.

About Aggregated Media

Backed by Nations Ventures and Stadia Ventures (Spring 2022 Accelerator Program), Aggregated Media or A8 for short, is an esports content platform of 30+ Twitch, Youtube, podcast, and social media shows reaching more than 6.5 million unique esports fans that has solved the challenge of delivering the higher engagement of microinfluencers at the same scale as some of the biggest influencers in the world. A8 partners with world class content creators, esports teams, networks and tournament organizers to co-produce, broadcast, distribute and monetize content across multiple media platforms. For more information: info@aggregatedmedia.com.

About Frankly Media

Frankly Media provides a complete suite of solutions that give publishers a unified workflow for creating, managing, publishing, and monetizing digital content to any device while maximizing audience value and revenue. Frankly delivers publishers and their audiences the solutions to meet the dynamic challenges of a multi-screen content distribution world.

Frankly’s comprehensive advertising services maximize ROI for our customers, including direct sales and programmatic ad support. With the release of our server-side ad insertion (SSAI) platform, Frankly is well-positioned to help video producers take full advantage of the growing market in addressable advertising.

Frankly’s technology products include a ground-breaking online video platform for Live, VOD, and Live-to-VOD workflows, a full-featured CMS with rich storytelling capabilities, and native apps for iOS, Android, Apple TV, Fire TV, and Roku. The company is headquartered in New York, with offices in Atlanta. Frankly Media is a Subsidiary of Engine Media and Media, Inc.

About Engine Gaming and Media, Inc.

Engine Gaming and Media, Inc. (NASDAQ:GAME) (TSX-V:GAME) provides unparalleled live streaming data and social analytics, influencer relationship management and monetization, and programmatic advertising to support the world’s largest video gaming companies, brand marketers, ecommerce companies, media publishers and agencies to drive new streams of revenue. The company’s subsidiaries include Stream Hatchet, the global leader in gaming video distribution analytics; Sideqik, a social influencer marketing discovery, analytics, and activation platform; and Frankly Media, a digital publishing platform used to create, distribute, and monetize content across all digital channels. Engine generates revenue through a combination of software-as-a-service subscription fees, managed services, and programmatic advertising. For more information, please visit www.enginegaming.com.

For more information, please contact:

Engine Gaming Investor Relations
Shannon Devine
MZ Group
Email: shannon.devine@mzgroup.us

SOURCE: Engine Gaming & Media Holdings, Inc.



View source version on accesswire.com:
https://www.accesswire.com/718145/Engine-Gamings-Frankly-Media-and-Aggregated-Media-Announce-Partnership

Release – Lineage Establishes New R and D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel

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Research, News, and Market Data on LCTX

October 3, 2022 at 8:00 AM EDT

Expansions Expected to Support Process Development and Production of Current and Future Cell Transplant Programs

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 3, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineage’s new Carlsbad facility will broaden the Company’s R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineage’s Israel-based facility will increase the Company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen®), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California,” stated Brian M. Culley, Lineage CEO. “These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs.”

Mr. Culley added, “Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success.”

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential benefits of the new and expanded facilities to the Company and its operations, including the broadening of the Company’s R&D capabilities, increasing development and optimization of larger-scale clinical manufacturing processes, the expansion of the Company’s process development and analytical testing capabilities and ability to conduct exploratory work on future programs, the increase in the Company’s manufacturing facilities, the decreased reliance on certain vendors, the reduction in costs and risks of timeline uncertainty and supply chain disruption, and the improvement in the Company’s position of greater readiness for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221003005286/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-601 ER as a Potential Treatment for Major Depressive Disorder

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

October 03, 2022 7:00am EDT

TNX-601 ER, Tianeptine Hemioxalate, is an Extended-Release Tablet for Once-a-Day Dosing

Phase 2 Clinical Trial of TNX-601 ER Expected to Start First Quarter 2023

CHATHAM, N.J., Oct. 03, 2022 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD)1. Tianeptine is a new molecular entity in the U.S. that is being developed under the 505(b)(1) pathway. Tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America for the treatment of depression over more than three decades since it was first marketed in France in 1989. Tianeptine’s activity is mechanistically distinct from traditional monoaminergic treatments for depression available in the U.S. including the selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants (TCAs).

“This is an important milestone as we advance TNX-601 ER into clinical development,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-601 ER is a novel, oral, extended-release once-daily tablet. Studies from across the globe conducted over more than 30 years show that immediate-release (IR) tianeptine sodium formulations have comparable efficacy to SSRIs and TCAs, fewer drug-drug interactions, and are associated with a lower incidence of sexual dysfunction compared with SSRIs, SNRIs and TCAs. We expect that our new once-daily formulation will maintain these properties while also providing convenience and adherence advantages over the three-times-a-day dosing of these IR tianeptine sodium products. We expect to initiate the Phase 2 trial in MDD in the first quarter of 2023, with the potential for additional future indications in posttraumatic stress disorder and neurocognitive dysfunction from corticosteroids.”

TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD. No tianeptine-containing product has been approved by the FDA. The proposed mechanism of action of TNX-601 ER is distinct from traditional monoaminergic antidepressants, in that its principal mechanism in MDD is believed to be through indirect modulation of glutamatergic neurotransmission. It is notable that in multiple placebo-controlled and comparative studies that tianeptine demonstrates efficacy on par with both SSRIs and tricyclic antidepressants, while showing a more favorable tolerability profile, lacking the sedative, autonomic, cardiovascular and side effects on memory and attention of TCAs and a low incidence of sexual side effects, nausea, and sleep disruption as compared with SSRIs.2,3

In addition to its glutamatergic properties, tianeptine has weak µ-opioid receptor agonist properties and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD4. Previously, Tonix was developing a naloxone-containing tablet, TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse. TNX-601 ER is also designed with abuse deterrent properties but without the µ-opioid receptor antagonist naloxone. The abuse-deterrent properties include gel forming polymers which impede extraction for illicit misuse. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which hinders efforts to misuse by nasal insufflation or intravenous route.

1TNX-601 ER is an investigational new drug and is not approved for any indication.
2McEwen, B.S., et al. Neurobiological properties of the antidepressant tianeptine. Molecular Psychiatry 2010, 15, 237-249.
3Paparrigopoulos, T.J., et al. Sleep and antidepressant medication. WPA Bulletin on Depression 2007, 11 (33), 7-11.
4Lauhan, R., et al. Tianeptine abuse and dependence: case report and literature review. Psychosomatics 2018, 59 (6), 547–553.

About the Phase 2 Study

Tonix is proposing to conduct a registration-quality, potentially pivotal, Phase 2, 6-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy in male and female subjects aged 18 to 65 years (inclusive), with current MDD as defined by DSM-5 criteria at screening and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 25 at baseline. A total of 300 participants are planned to be randomized to two treatment arms across approximately 30 clinical trial sites in the U.S. The study is expected to have a single unblinded interim analysis for sample size re-estimation when the study has results of the first 50% of efficacy evaluable patients, pending agreement on the comprehensive statistical analysis plan with the FDA.

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

1Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml.
2IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.
3Kubitz N, et al. (2013) PLOS One,. 8(10):e76882. doi: 10.1371/journal.pone.0076882. PMID: 24204694.
4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER
TNX-601 ER is a novel oral formulation of tianeptine hemioxalate designed for once-daily daytime dosing that is now in the IND (Investigational New Drug) stage of development for the treatment of MDD. Tianeptine sodium (amorphous) immediate release (dosed three times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel hemioxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restoring hippocampal long-term potentiation and reversing the neuroplastic changes from stress and corticosteroid exposure. Tianeptine and its MC5 metabolite are also weak µ-opioid receptor agonists, that present a potential abuse liability if illicitly misused in large quantities (8-80 times the therapeutic dose for depression). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated1 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine did not appear to result in dependence or withdrawal symptoms following 6-weeks2,3,4–6, 3-months7, or 12-months8 of treatment. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder. TNX-601 ER is expected to have patent protection through 2037.

1Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
2Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
3Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.4Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
5Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
6Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
7Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
8Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

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 first half 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 fourth quarter of 2022. 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 consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. 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 first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*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 October 3, 2022