Month: June 2023

ChitogenX Inc. (CHNXF) – Non-Brokered Private Placement 2nd Tranche Closed; Clarification And Revision

Posted on by cpereira@noblefcm.com


Wednesday, June 07, 2023

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

2nd Tranche.  The Company announced Monday they had closed a 2nd tranche for $288,000 (currencies in Canadian $).  This tranche, on the back of the closed $3.86 million 1st tranche announced previously, consisted of gross cash proceeds of $41,250 and $241,141 in convertible debt conversions that had matured May 1, 2023.  In this 2nd tranche, 1.922608 million units at $0.15 per unit were issued.  Each unit consisted of one share of common and one purchase warrant exercisable at $0.35 per share.

Clarification To Company May 5, 2023 Press Release And Correction.  In the Company’s press release Monday June 5, 2023, it was clarified that the $3.86 million non-brokered 1st tranche placement, which closed early May, consisted of $1.267 million in gross cash proceeds and debt conversions of $2.589 million.  While the two tranches remove $2.84 million in liabilities, gross cash proceeds from the tranches totaled approximately $1.31 million. In our prior noted dated June 1, 2023, we indicated ChitogenX raised $5.3 million subsequent to its fiscal January 31, 2023 yearend. However, gross cash proceeds were approximately $3.0 million.


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*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. 

Can an Inexpensive, Repurposed Therapy Treat Brain Cancer?

Posted on by phoffman@channelchek.com

Brain Tumors are Cognitive Parasites – How Brain Cancer Hijacks Neural Circuits and Causes Cognitive Decline

Researchers have long known that brain tumors, specifically a type of tumor called a glioma, can affect a person’s cognitive and physical function. Patients with glioblastoma, the most fatal type of brain tumor in adults, experience an especially drastic decline in quality of life. Glioblastomas are thought to impair normal brain functions by compressing and causing healthy tissue to swell, or competing with them for blood supply.

What exactly causes cognitive decline in brain tumor patients is still unknown. In our recently published research, we found that tumors can not only remodel neural circuits, but that brain activity itself can fuel tumor growth.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Saritha Krishna, Postdoctoral Fellow in Neurological Surgery, University of California, San Francisco, and Shawn Hervey-Jumper, Associate Professor of Neurological Surgery, University of California, San Francisco.

We are a neuroscientist and neurosurgeon team at the University of California, San Francisco. Our work focuses on understanding how brain tumors remodel neuronal circuits and how these changes affect language, motor and cognitive function. We discovered a previously unknown mechanism brain tumors use to hijack and modify brain circuitry that causes cognitive decline in patients with glioma.

Brain Tumors in Dialogue with Surrounding Cells

When we started this study, scientists had recently found that a self-perpetuating positive feedback loop powers brain tumors. The cycle begins when cancer cells produce substances that can act as neurotransmitters, proteins that help neurons communicate with each other. This surplus of neurotransmitters triggers neurons to become hyperactive and secrete chemicals that stimulate and accelerate the proliferation and growth of the cancer cells.

We wondered how this feedback loop affects the behavior and cognition of people with brain cancer. To study how glioblastomas engage with neuronal circuits in the human brain, we recorded the real-time brain activity of patients with gliomas as they were shown pictures of common objects or animals and asked to name what they depicted while they were undergoing brain surgery to remove the tumor.

While the patients engaged in these tasks, the language networks in their brains were activated as expected. However, we found that the brain regions the tumors had infiltrated quite remote from known language zones of the brain were also activated during these tasks. This unexpected finding shows that tumors can hijack and restructure connections in the brain tissue surrounding them and increase their activity.

This may account for the cognitive decline frequently associated with the progression of gliomas. However, by directly recording the electrical activity of the brain using electrocorticography, we showed that despite being hyperactive, these remote brain regions had significantly reduced computational power. This was especially the case for processing more complex, less commonly used words, such as “rooster,” in comparison with simple, more commonly used words, such as “car.” This meant that brain cells entangled in the tumor are so compromised that they need to recruit additional cells to carry out tasks previously controlled by a smaller defined area.

We make an analogy to an orchestra. The musicians need to play in synchrony for the music to work. When you lose the cellos and the woodwinds, the remaining musicians can’t deliver the piece as effectively as when all players are present. Similarly, when brain tumors hijack the areas surrounding it, the brain is less able to effectively function.

Gabapentin as a Promising Drug for Glioblastoma

Now we understood that tumors can impair cognition by affecting neural connections. Next, we further examined their connections with each other and with healthy neurons using mouse models and brain organoids, which are clusters of brain cells grown in a Petri dish.

These experiments, led by one of us, Saritha Krishna, found that tumor cells secrete a protein called thrombospondin-1 that plays a key role in promoting the hyperactivity of brain cells. We wondered whether blocking this protein, which normally helps neurons form synapses, would halt tumor growth and extend the survival of mice with glioblastoma.

Glioma cells could potentially be treated by repurposing the anti-seizure drug gabapentin. Castro Lab, Michigan Medicine/NIH via Flickr, CC BY-NC

To test this hypothesis, we treated mice with a common anti-seizure drug called gabapentin that blocks thrombospondin-1. We found that gabapentin was able to keep the brain tumors from expanding for several months. These findings highlight the potential of repurposing this existing drug to control brain tumor growth.

Our study suggests that targeting the communication between healthy brain cells and cancer cells could offer another way to treat brain cancer. Combining gabapentin with other conventional therapies could complement existing treatments, helping mitigate cognitive decline and potentially improving survival. We are now exploring new ways to take advantage of this drug’s potential to halt tumor growth. Our goal is to ultimately translate the findings of our study to clinical trials in people.

Did IBM Just Flip-Flop on AI and Job Losses?

Posted on by phoffman@channelchek.com

Regulation on Artificial Intelligence Innovation is Dumb, Says IBM CEO

Is IBM’s CEO flip-flopping on the impact of artificial Intelligence on jobs? What are his thoughts on AI regulation? In an interview with Bloomberg last month, IBM’s CEO Arvind Krishna said his company would slow or suspend hiring because he expects about 30% of nearly 26,000 positions could be replaced by AI over a five-year period at his company, that was calculated as 7,800 supplanted by AI. In a new interview this month with Barron’s, Krishna addresses the expected impact on jobs and makes light of the idea that humanity is at great risk from AI technology.

Spoiler Alert, AI is Good

AI will actually create, not destroy jobs – and it is not going to destroy the world. This is the view of IBM’s CEO Krishna, discussing artificial Intelligence in a feature with Barron’s published in the most recent Tech Trader column.

Addressing AI job loss, which he has been quoted as expecting, at least for IBM, the blue-chip CEO says he’s somewhat irritated about a recent flurry of news stories that quoted him as saying that IBM could replace 7,800 workers with AI software. Krishna says his comments were taken out of context. He tried to set the record straight explaining, that he actually said was that over the next five years, 30% to 50% of repetitive white-collar jobs could be replaced by AI. He also added the bottom end of the range was most likely. The number used in the reporting came from his response to a follow-up question with the Bloomberg reporter. Krishna was asked how many IBM employees meet the description, he estimated 10%. The math, based on IBM’s workforce, was used to come up with 7,800 employees.

The IBM CEO says the calculation left out another key piece of information.

“I also said that AI is going to create more jobs than it takes away,” Krishna said, “the same way that the agricultural revolution and the services revolution created way more jobs than those that got taken away.” He says we will need new “prompt engineers” to lever AI tools, and more fact-checking to address the accelerated creation of misinformation that he thinks will inevitably accompany the creation of AI tools.

Are Their AI Risks?

On humanity’s risks from AI and potential regulation, the IBM CEO explained, the assertion by some that AI represents an existential threat to humanity—that there’s a risk that AI gets smarter than humans, and then somehow wipes us off the face of the Earth, is bunk – or highly unlikely.

“I’m not there fundamentally,” he said. “It seems like a pretty big stretch. These things are great at memorization and pattern matching. They don’t yet have a knowledge representation. They don’t have any symbolic manipulation. They do math by memory, not by understanding math. There are a lot of things that are yet to be done,” said Krishna.

It was noted in the interview that some people are using nightmare scenarios to make a case for strict regulation of artificial Intelligence and machine learning. While he agrees all should be careful about how and where they use AI, he doesn’t think aggressive regulation is called for. He even believes that any US regulation would cause cheaters within the States or competitive countries, without the imposition of US regulation, to move forward as they see appropriate.

“We don’t want to have regulation on innovation. That’s dumb actually,” said Krishna. “All you are going to do is give an advantage to those who choose to ignore the regulation and those who work outside the US boundaries.”

An AI Quantum Leap?

Quantum computing is a rapidly-emerging technology that harnesses the laws of quantum mechanics to solve problems too complex for classical computers. IBM is a leader in this field. As it relates to the potential combination of AI and quantum computing Krishna thinks we are close to the day when quantum computing will mesh with AI, and open new areas of computing power.

Krishna suggested that to explore benefits of this, one might want to consider the future of the chemical and pharmaceutical industry. “Maybe we go through reading all the literature—that’s AI—and we find some gaps in knowledge,” he says. “Today you fill in those gaps by doing a wet lab experiment which might take three to six months or more. In three to five years, a quantum computer will be able to simulate those experiments and fill in the gaps in a few minutes,” he said.

A key power of quantum computing is its ability to work on vast amounts of data at the same time. Looking further out, perhaps a decade, Krishna expects that quantum computers will be able to create AI models. “Current models with hundreds of billions of parameters can take two to three months to train on a very large cluster of GPUs. With a quantum computer, you’ll be able to train the same model overnight,” he said. His expectation is, “You’ll be able to solve problems that are far beyond what the biggest supercomputers in the world can do now.”

Take Away

As part of his position as CEO of IBM, Arvind Krishna has a window seat to much of the cutting-edge changes in computing technology, including artificial Intelligence. He suggests he was not fully quoted in the article that Bloomberg did covering AI and that the technology is expected to create jobs. It may, however alter available occupations while creating new needs.

He is not in the camp that massive regulation is needed to keep the innovative technology at bay; Krishna believes creative development is best when there is a level playing field.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.barrons.com/articles/ai-stocks-dividend-ibm-99e61b50?mod=article_inline

https://www.barrons.com/articles/ai-jobs-ibm-ceo-94a6537d?mod=Searchresults

https://www.ibm.com/topics/quantum-computing

Kratos Defense & Security (KTOS) – $46.7 Million Navy Award

Posted on by cpereira@noblefcm.com


Tuesday, June 06, 2023

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Navy Award. Yesterday, Kratos announced it was awarded a contract by the Naval Surface Warfare Center Dahlgren Division (NSWCDD) for thermo-mechanical and aerothermal ground testing of thermal protection system materials in ballistic reentry and reentry-like environments in its Kratos SRE business unit in Birmingham, Alabama. The five-year contract includes options with a total value up to $46.7 million, with an initial award of $8.6 million under a cost-plus-fixed-fee contract.

Details. Under the award, Kratos will test materials supporting technical efforts for the U.S. and the U.K. with direct oversight from the NSWCDD Reentry Systems Office. The contract enables Kratos SRE to conduct ground testing of thermal protection materials at external ground test facilities and produce flight hardware for the Navy. It requires the unique ability to test and collect data at maximum temperatures of 5,500 degrees Fahrenheit to properly test materials in reentry-like environments.


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

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

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

MustGrow Biologics Corp. (MGROF) – Setting Up the Seeds to Sprout

Posted on by cpereira@noblefcm.com


Tuesday, June 06, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New Agreement. MustGrow announced the Company has agreed to a Contract Services Agreement with Bio Ag Product Strategies to develop and commercialize MustGrow’s soil amendment and biofertility technologies, including TerraSante. The agreement is a non-exclusive contract, enabling MustGrow to seek out additional commercial collaborations and funding partnerships. Neither the length of the agreement nor any financials were disclosed.

Who is Bio Ag? Bio Ag Product Strategies is a consulting firm that provides consultation to manufacturers of microbial products for agriculture and support products including biostimulants and prebiotics. According to MustGrow, Bio Ag Product Strategies has tremendous knowledge and a great track record of working with organizations to help develop, market, and target key retailers and farmers.


Get the Full Report

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

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

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

Why Small Cap Stocks Started to Attract Mega Cap Investors

Posted on by phoffman@channelchek.com

Small Cap Companies Making June 2023 a Whole New Race

June is shaping up to be the month when small-cap stocks are the stocks to watch. This investment news is based on the huge lead they have taken since the opening bell on Friday June 2nd. The Russell 2000 index tracks U.S. small-cap stocks. While the index is up less than 3% in 2023, and the S&P 500 is up nearly 12%, and Nasdaq is up almost 27%, historically, the average return over time is expected to be greater for small-caps. In order for the averages to come back in line with historical norms, the large-cap stocks either have to begin trending down, the small-caps upward, or maybe a little of both. There is new reason to believe that now is the time that small-caps are finally getting back into the race.

The Russell Small-Cap Index, which is made up of the lowest 2,000 companies in terms of market cap of the broader Russell 3000, was up 3.6% on Friday, June 2nd; it gave up 1.1% on the following Monday, then rallied on Tuesday, June 6th by 2.8%. Meanwhile, the other indexes stalled. Friday’s gains were its largest one-day increase in six months, and Tuesday represents its biggest gain since early March.

Both large-cap indexes attribute their gains to the high-flying mega-cap tech stocks. Much of the non-tech portions of these indexes are not contributing to the year’s great performance. Some analysts are beginning to express concern that Nasdaq valuations are stretched. In contrast, price/earnings ratios on many small-cap stocks are below historical norms.

What’s more, is the earnings per share (EPS) is beginning to be revised upward, “small caps are finally starting to participate in the EPS revisions recovery,” said Lori Calvasina, head of U.S. equity strategy at RBC Capital Markets, in a research note Monday. “The rate of upward EPS estimate revisions has moved up to 50% for the Russell 2000,” she said, adding that more than half the sectors in the index are “now in positive revisions territory for both EPS and revenues.”

Source: Koyfin


Calvarisa highlighted these sectors: utilities, consumer staples, healthcare, industrials, communications services, information technology, and TIMT (technology, internet, media and telecommunications), saying they have both positive EPS and revenue revisions among the small-caps.

Another interesting reason for the promise of small-caps stealing the show in June, according to the RBC research, small-cap stocks usually bottom three to six months before EPS forecasts start rising again.

The introduction of artificial intelligence (AI), from primarily small market cap companies and how the new technology can help with online research and creative inspiration, has placed investors in megacap stocks like Google and Microsoft on notice. They now know that a younger superior technology may disrupt a large part of these tech giants’ business. Not dissimilar to what they had done as small companies a few decades earlier.

Take Away

June is always an exciting month for companies with small market cap as the Russell 3000 index reconstitution also reshapes the small-cap Russell 2000 during June. Many self-directed investors try to front-run the institutions that are required to own or eliminate stocks from their portfolios. Price movements can be large.

The excitement is being compounded by the fear creeping in among large-cap investors, EPS revisions, and of course the reversion to mean average performance of large-cap stocks, to small-caps.  

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.morningstar.com/news/marketwatch/20230606265/small-cap-stocks-are-surging-tuesday-as-broader-us-market-sleeps-heres-why

https://www.morningstar.com/news/marketwatch/20230605260/small-cap-stocks-lag-in-2023-but-heres-where-theyre-finally-starting-to-see-positive-earnings-revisions

https://www.cnbc.com/video/2023/06/02/small-caps-are-benefitting-from-the-value-trade-catchup-says-rbcs-lori-calvasina.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard

https://app.koyfin.com/share/09d4d3eaad

An Investor List of the Industries that Can be Improved With Blockchain Technology

Posted on by phoffman@channelchek.com

Blockchain Beyond Cryptocurrency: The Potential of Distributed Ledger Technology

Does blockchain have a future beyond crypto? Since its beginning as the underlying technology for Bitcoin (BTC) and later other cryptocurrencies, blockchain has been the necessary, behind-the-scenes, engine that allow these fintech currencies to function. Dogecoin (DOGE), Ethereum (ETH), and even the 18 G20 countries developing a central bank digital currency (CBDC) need blockchain to exist.  

But what non-finance industries are being impacted or will be disrupted by blockchain? It is not with exaggeration to say blockchain has the power to revolutionize various industries and redefine everyday transactions, manage data, and establish trust. Long-term investing requires knowledge of current trends and where the future may take them. Below we explore many of the possibilities of blockchain aside from cryptocurrency and delve into its promising future.

What is Blockchain?

At its core, blockchain is a decentralized (no single control) and immutable (unable to be changed) ledger that records activity across multiple computers. This distributed character replaces the need for institutional intermediaries to ensure transparency, security, and efficiency. A person or an entity can function, even across borders directly, without the need for a middleman. Verification of activity is recorded and remains a part of a blockchain ledger.

Uses beyond cryptocurrency, or the speculative investment that crypto and non-fungible tokens (NFT) have become, include health care, finance, voting, real estate titles, and smart communities.

Health Care

The HIPAA Privacy Rule sets national standards to protect individuals’ medical records and other identifiable health information. It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain medical transactions electronically. The purpose is to keep data ownership from improperly being passed and to maintain privacy in the industry. Current centralized systems are not able to meet the many needs of patients, health service providers, insurance companies, and governmental agencies. Blockchain technology enables a decentralized system for access control of medical records where all stakeholders’ interests are protected.

Blockchain systems not only allow healthcare service providers to securely share patients’ medical records but patients may also track who has accessed their records and determine who is authorized to do so. If blockchain-driven, all transactions can become transparent to the patient.

And blockchain-powered interoperability can enable the seamless sharing of medical data between healthcare organizations, improving patient care, research, and drug development.

Supply Chain Management

Complex global supply chains involve numerous stakeholders, some sending, others receiving, and others verifying the source of food or products. Verifying the authenticity and improving traceability of products can be a challenging task. Blockchain’s ability to create an immutable record of every transaction and movement along the supply chain enables transparency and accountability. A company will be able to securely track the origin, manufacturing process, and movement of goods. Consumers can be equipped with verified information, among other benefits, this will increase trust and reduce the risk of receiving counterfeit products.

Storing information regarding movement on a blockchain improves integrity, accountability and traceability. For example, IBM’s Food Trust uses a blockchain system to track food items from the field to retailers. The participants in the food supply chain record transactions in the shared blockchain, which simplifies keeping track.

Entertainment Products

As technology has allowed greater reproduction and distribution, including music and art, blockchain may provide creators with more control over their work. The whole entertainment industry may undergo a significant transformation with blockchain technology. Artists can tokenize their efforts, creating a digital certificate of ownership that can be bought, sold, and shared on blockchain platforms. This will enable artists to have tight control over their intellectual property, receive fair compensation, and even establish a direct connection with their followers. Beyond ownership infringement, blockchain can facilitate transparent royalty distribution, this could ensure that artists receive their rightful earnings without an intermediary and the cost that comes with anyone getting in the middle of a transaction.

The Energy Sector

Blockchain is likely to play a transformative role in all forms of energy. As renewable energy sources continue their trend, blockchain can enable peer-to-peer energy trading. Individuals and organizations will be able to directly exchange surplus energy with those expecting an energy deficit. This could create a decentralized energy market.

Smart contracts executed on the blockchain can automatically verify and settle transactions, ensuring transparency. This democratization of energy, if broadly implemented, could accelerate the adoption of sustainable practices, provide energy where needed, and reduce waste.

Governments

While the government is often the intermediary that the blockchain makes less needed or unneeded, recognizing the potential of blockchain to enhance transparency and efficiency in public services may become its greatest use. Land registries, taxation, voting systems, and identity certainty can all be improved through blockchain’s tracking and tamper-resistant design. Immutable records of land ownership can reduce disputes and increase trust in property transactions. Digital identities stored on a blockchain can streamline processes such as passport verification and border control, making them more secure and efficient. Blockchain-based voting systems have the potential to eliminate voter fraud, ensuring fair and transparent elections.

Potential

Much of what is described above has either barely been implemented or has not been put to use. This is a period in any technological advancement when most long-term investors would like to be involved. Efficiencies and improved products are poised to help the industries mentioned, and pure blockchain companies, large and small, can benefit from developing uses for their technology.

Despite its potential, blockchain technology still faces challenges. Scalability, energy consumption, and regulatory frameworks require further development and refinement. However, ongoing research and collaborations among businesses, academia, industry, and policymakers are actively finding avenues around these concerns, driving the maturation of blockchain technology.

Take Away

Blockchain is still in its infancy, and industries are just becoming aware of its power to help them. As the paradigm shifts, it could become a technology businesses could not imagine doing without. Blockchain’s decentralized, transparent, and secure nature makes it a powerful tool for revolutionizing healthcare, supply chain management, entertainment, governing, and energy sectors. As the technology evolves, we can expect innovative use and widespread adoption of blockchain that serves to elevate trust, efficiency, and transparency. And maybe the now-developed cryptocurrencies will survive within these changes.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.investopedia.com/tech/forget-bitcoin-blockchain-future/

https://www.hhs.gov/hipaa/for-professionals/privacy/index.html

https://www.ibm.com/products/supply-chain-intelligence-suite/food-trust

https://www.investopedia.com/10-biggest-blockchain-companies-5213784

Release – PDS Biotechnology Post-ASCO Conference Call Tomorrow, June 6, at 8 a.m. ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., June 05, 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 that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.

During the call, management will provide an in-depth review of the 2023 ASCO interim data.

Conference Call Information:
PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. ET to discuss the interim data being presented at the ASCO 2023 Annual Meeting. A live webcast of the event will be available online at PDS Biotech Post-ASCO Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Additionally, interested participants and investors may access the conference call by dialing either 877-407-3088 (US) or 201-389-0927 (International).

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

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

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

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

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Schwazze Completes Acquisiton to Manage Assets of New Mexico Cannabis Operator, Everest Apothecary, Inc.

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

June 5, 2023

NEO: SHWZ 
OTCQX: SHWZ

Acquisition Increases Schwazze’s New Mexico Retail Store Count to 32 and 
Provides Expanded Coverage Throughout State

DENVER, June 5, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announced it has acquired certain assets of Sucellus, LLC, pursuant to which the Company will manage Everest Apothecary, Inc. (“Everest“), a New Mexico not-for-profit corporation. The transaction includes retail dispensaries, cultivation, and manufacturing facilities.  

The acquisition of Everest increases the Company’s retail consumer base and furthers Schwazze’s growth strategy in the New Mexico market. Upon closing, Schwazze’s New Mexico operations will include 32 dispensaries, four cultivations, two manufacturing facilities and over 400 employees statewide.

The Everest brand complements Schwazze’s existing retail brand in New Mexico, R. Greenleaf.  Each serves a unique demographic, and both retail banners will continue to operate in the state.  

“This acquisition fits well within our growing portfolio of retail brands alongside R.Greenleaf, and firmly positions us as a top operator in the New Mexico market,” said Nirup Krishnamurthy, President of Schwazze.

“Collaborating on Schwazze’s operating playbook, we look forward to working with the Everest team members to continue to support the Everest customers with outstanding service and an even wider selection of quality products throughout the entire state. These really are two great teams coming together as one,” said Ken Diehl, New Mexico Division President of Schwazze.   

Established in 2016, Everest is a New-Mexico-based licensed medical and recreational cannabis provider that consists of 14 dispensaries, one cultivation facility and one manufacturing plant. The dispensaries are in Albuquerque, Santa Fe, Las Cruces, Los Lunas, Sunland Park, Belen, and Texico. Everest’s cultivation and manufacturing facilities are both located in Albuquerque.

Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as six operating cultivation facilities and three manufacturing plants across 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. To learn more about Schwazze, visit www.Schwazze.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. 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) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. 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 because of new information, future events or otherwise except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-completes-acquisition-to-manage-assets-of-new-mexico-cannabis-operator-everest-apothecary-inc-301842392.html

SOURCE Medicine Man Technologies, Inc.

Release – GameSquare Set to Join Russell Microcap Index

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GAME

06/05/2023

Inclusion in the Russell Microcap Index reflects significant growth in market cap over the past 12 months

FRISCO, TX / ACCESSWIRE / June 5, 2023 / GameSquare Holdings, Inc. (“GameSquare”, or the “Company”) (NASDAQ:GAME)(TSXV:GAME) announced today that it is set to join the Russell Microcap® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, according to a preliminary list of additions posted June 2.

Justin Kenna, Chief Executive Officer of GameSquare, stated, “Joining the Russell Microcap® Index is an important milestone for GameSquare. Our market cap has increased over 120% over the past 12 months, reflecting the successful execution of our growth strategies and record pipeline, as well as our recent merger with Engine Gaming and Nasdaq listing. We believe our awareness and exposure within the investment community will further increase as a member of the Russell Microcap® Index, and we are excited by the growing momentum underway across our business.”

Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12.1 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About GameSquare Holdings, Inc.

GameSquare Holdings, Inc. (NASDAQ:GAME | TSXV:GAME) is a vertically integrated, digital media, entertainment and technology company that connects global brands with gaming and youth culture audiences. GameSquare’s end-to-end platform includes GCN, a digital media company focused on gaming and esports audiences, Cut+Sew (Zoned), a gaming and lifestyle marketing agency, USA, Code Red Esports Ltd., a UK based esports talent agency, Complexity Gaming, a leading esports organization, Fourth Frame Studios, a creative production studio, Mission Supply, a merchandise and consumer products business, Frankly Media, programmatic advertising, Stream Hatchet, live streaming analytics, and Sideqik a social influencer marketing platform. www.gamesquare.com

About FTSE Russell:

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20.1 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group.

For more information, visit www.ftserussell.com.

Forward-Looking Information

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the Company’s future performance and revenue; continued growth and profitability; the Company’s ability to execute its business plan; and the proposed use of net proceeds of the Offering. These forward-looking statements are provided only to provide information currently available to us and are not intended to serve as and must not be relied on by any investor as, a guarantee, assurance or definitive statement of fact or probability. Forward-looking statements are necessarily based upon a number of estimates and assumptions which include, but are not limited to: the Company being able to grow its business and being able to execute on its business plan, the Company being able to complete and successfully integrate acquisitions, the Company being able to recognize and capitalize on opportunities and the Company continuing to attract qualified personnel to supports its development requirements. These assumptions, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: the Company’s ability to achieve its objectives, the Company successfully executing its growth strategy, the ability of the Company to obtain future financings or complete offerings on acceptable terms, failure to leverage the Company’s portfolio across entertainment and media platforms, dependence on the Company’s key personnel and general business, economic, competitive, political and social uncertainties including impact of the COVID-19 pandemic and any variants. These risk factors are not intended to represent a complete list of the factors that could affect the Company which are discussed in the Company’s most recent MD&A. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. GameSquare assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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

Media and Investor Relations

Andrew Berger
Phone: (216) 464-6400
Email: IR@gamesquare.com

SOURCE: GameSquare Holdings, Inc.

Release – Onconova Therapeutics Announces Poster Presentation At The American Society Of Clinical Oncology Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX


Jun 05, 2023

Trial in Progress poster detailed design of Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa

NEWTOWN, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the presentation of a Trials in Progress poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place June 2 – 6, 2023 in Chicago, Illinois and online.

The poster, which was presented on Saturday, June 3, 2023, during the “Melanoma/Skin Cancers” session, detailed the design of an investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A copy of the poster, titled “A pilot, open study to assess efficacy and safety of ON-01910 (rigosertib) in patients with recessive dystrophic epidermolysis bullosa associated locally advanced/metastatic squamous cell carcinoma,” is available on the “Scientific Presentations” section of the Onconova website.

About RDEB-associated SCC

RDEB is caused by insufficient expression of normal type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC1,3.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab metastatic melanoma.

For more information, please visit www.onconova.com.

References

  1. Mellerio et al. Br J Dermatol. 2016 Jan; 174(1):56-67. doi: 10.1111/bjd.14104.
  2. Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
  3. Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Navy Awards Kratos $46.7M Contract for Submarine Ballistic Missile Reentry Systems

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

June 5, 2023 at 8:00 AM EDT

SAN DIEGO, June 05, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, has been awarded a contract by the Naval Surface Warfare Center Dahlgren Division (NSWCDD) for thermo-mechanical and aerothermal ground testing of thermal protection system materials in ballistic reentry and reentry-like environments in its Kratos SRE business unit in Birmingham, Alabama. The five-year contract includes options with a total value up to $46.7 million, with an initial award of $8.6 million under a cost-plus-fixed-fee contract.

The effort will test materials supporting technical efforts for the U.S. and the U.K. with direct oversight from the NSWCDD Reentry Systems Office. The support includes sample preparation, instrumentation, testing and gathering thermo-mechanical data on materials at extremely high temperatures and in high heat flux/shear environments. The contract enables Kratos SRE to conduct ground testing of thermal protection materials at external ground test facilities and produce flight hardware for the Navy. It requires the unique ability to test and collect data at maximum temperatures of 5,500 degrees Fahrenheit to properly test materials in reentry-like environments.

Michael Johns, Senior Vice President of Kratos SRE, said, “We are honored to support NSWCDD for this important program and are proud that we have been able to do so for decades. We bring a unique capability to this program and through the hard work of our expert team, we look forward to helping our nation as part of the larger Navy team.”

Dave Carter, President of Kratos’ Defense & Rocket Support Services Division, said, “Our division has a long and valued relationship with the Navy supporting research rocket and ballistic missile target programs. The addition of the NSWCDD RSO work by adding KSRE to our division team is exciting, and we look forward to continuing our role as a trusted provider for the Navy.”

Kratos SRE, formerly part of Southern Research and acquired by Kratos in May 2022, is an advanced concept group within Kratos’ Defense & Rocket Support Services (KDRSS) Division. SRE currently employs about 175 engineers, technicians and program support professionals conducting work in support of the space community, the Department of Defense and other national security customers.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a Technology Company that develops and fields transformative, affordable systems, products and solutions for United States National Security, our allies and global commercial enterprises. At Kratos, Affordability is a Technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with actual products, systems and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being First to Market with our solutions, well in advance of competition. Kratos is the recognized Technology Disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. For more information, please visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Announces Presentation of Data Supporting Development of Racemic and Single (S)-Isomer Tianeptine, Plastogen Anti-Depressants, at the American Society of Clinical Psychopharmacology Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 05, 2023 7:00am EDT

Tianeptine’s Mechanism of Restoring Neuroplasticity and Neurogenesis by Dual PPAR-β/δ and PPAR-γ Agonism Supports Development as a First-in-Class Oral Therapy for Psychiatric and Neurodegenerative Diseases

Racemic Tianeptine, or TNX-601 ER, is Enrolling in a Potentially Pivotal Phase 2 Study for the Treatment of Major Depressive Disorder; Results from Interim Analysis Expected Fourth Quarter 2023

Single (S)-Isomer of Tianeptine, or TNX-4300, is Free from µ-Opioid Receptor Activity Associated with the (R)-Isomer

TNX-4300 is in Preclinical Development for Depression, Bipolar Disorder, Alzheimer’s Disease and Parkinson’s Disease

CHATHAM, N.J., June 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the presentation of data detailing the mechanism of action and pharmacokinetics of TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine) at the American Society of Clinical Psychopharmacology (ASCP) meeting in Miami, Fla. TNX-601 ER is being tested in a potentially pivotal Phase 2 trial for the treatment of major depressive disorder (MDD) for which results of a preplanned interim analysis are expected in the fourth quarter of 2023. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. The active ingredient of both products is the (S)-isomer of tianeptine.1 The (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and lacks µ-opioid liability. In contrast, the (R)-isomer of tianeptine lacks PPAR-β/δ activity and is an agonist at the µ-opioid receptor. The poster presentation is available on Tonix’s website: www.tonixpharma.com.

Tonix recently announced that the plastogen anti-depressant tianeptine, a drug marketed outside the U.S. for more than 30 years, acts on nuclear PPAR-β/δ and PPAR-γ in neurons and glia to restore neuronal connectivity in depression.2 The understanding that tianeptine bypasses the synapse and acts on the nucleus to exert its effects on restoring neuroplasticity and neurogenesis has direct applicability in a number of neurodegenerative diseases in which neuronal connections are atrophying.2 The newly reported mechanism also provides clarity on why tianeptine is not associated with sexual dysfunction, weight gain or several other treatment-limiting toxicities, which are associated with the antidepressants currently marketed in the U.S. for long-term use.

“Restoring atrophied neuronal connections in psychiatric and neurodegenerative diseases has the potential to achieve better and more durable outcomes,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The tianeptine marketed outside the U.S. for treating depression is a 1:1 racemic mixture of two mirror image isomers. Our team of scientists isolated and characterized the (S)-isomer of tianeptine, which is free from µ-opioid receptor activity and is now under development as TNX-4300 for treating psychiatric and neurodegenerative diseases. The (S)-isomer of tianeptine is responsible for tianeptine’s activity on PPAR-β/δ and restoring neuroplasticity and neurogenesis, while the (R)-isomer is responsible for any off-target activity on the µ-opioid receptor.”

The findings reported at the meeting show how the pharmacokinetics of oral TNX-601 ER in humans differ from intraperitoneal (i.p.) tianeptine in mice. In humans, after an oral dose of TNX-601 ER the half-life of tianeptine in the blood is approximately 5-7 hours. In contrast, in mice after an i.p. dose of tianeptine the half-life of tianeptine in the blood has been reported to be less than approximately 30 minutes and the behavioral effects appear dominated by the longer-lasting MC5 metabolite, which maintains µ-opioid receptor activity.3 The data Tonix presented also show that the (R)-isomer of tianeptine is responsible for the decrease in immobility in the mouse forced swim test after i.p. administration, which is consistent with previous reports that the effect of tianeptine on the forced swim test is a µ-opioid receptor-dependent phenomenon.3

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, said, “From our clinical studies on volunteers, after oral dosing with TNX-601 ER, the extended pharmacokinetics of parent tianeptine is consistent with tianeptine exerting activity on PPAR-β/δ and resulting in neurorestorative effects. In contrast, after i.p. dosing of tianeptine in mice, the exposure of tianeptine is brief and the behavioral effects appear dominated by the MC5 metabolite.3 While tianeptine’s MC5 metabolite has been reported to maintain µ-opioid receptor activity3, we found that MC5 metabolite lacks activity on either PPAR-β/δ or PPAR-γ in culture. Together, we believe these findings support the interpretation that the parent tianeptine and specifically, the (S)-isomer of tianeptine exert antidepressant effects in humans by interacting with PPAR-β/δ and PPAR-γ.”

Dr. Sullivan continued, “Our ongoing work on racemic tianeptine in depression is expected to inform and potentially accelerate the development of TNX-4300. The dose of tianeptine for treating depression is well-established from racemic studies, so we plan to test single isomer TNX-4300 at a dose equivalent to 50% of the racemic dose, which is expected to provide equivalent exposure of (S)-tianeptine as racemic tianeptine. Subsequently, we plan to test higher doses of (S)-tianeptine, because TNX-4300 lacks µ-opioid receptor activity, but such studies will require additional non-clinical studies.”

Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.

* TNX-601 and TNX-4300 are investigational new drugs and are not approved for any indication
1Tonix press release, May 23, 2023 https:// ir.tonixpharma.com/news-events/press-releases/detail/1392/tonix-pharmaceuticals-announces-the-isolation-and
2Tonix press release, May 17, 2023 https://ir.tonixpharma.com/news-events/press-releases/detail/1389/tonix-pharmaceuticals-announces-pharmacology-and-medicinal
3 Samuels et al., Neuropsychopharmacology. 2017, 42(10):2052-2063

About Tianeptine

Racemic tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.1 Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes its properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis).2 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 treated3 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 does not appear to result in dependence or withdrawal symptoms following 6-weeks4-8, 3-months9, or 12-months10 of treatment. (S)-tianeptine mimics naturally occurring polyunsaturated fatty acid ligands in binding PPAR-β/δ and PPAR-γ. (S)-tianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ receptors appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity than current therapies. Its proposed mechanism as a plastogen is consistent with its clinical effects in promoting cognition in Alzheimer’s disease and bipolar disorder11,12 in addition to posttraumatic stress disorder (PTSD) and corticosteroid-induced cognitive dysfunction. The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune diseases of the central nervous system13 and the concept that Alzheimer’s can be considered a form of diabetes that affects the CNS, or type-III diabetes.”14 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 (PTSD), and neurocognitive dysfunction associated with corticosteroid use.

1 McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
2 Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
3 Haute 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.
4 Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
5 Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
6 Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
7 Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
8 Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
9 Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
10 Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65.
11 García-Alberca JM, et al. J Alzheimer’s Dis 2022, 88 (2), 707-720.
12 Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510.
13 Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70
14 Nguyen et al., Int J Mol Sci. 2010, 21(9):3165

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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

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

Maddie Stabinski (media)
Russo Partners
Madeline.Stabinski@russopartnersllc.com
(212) 845-4273

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

Source: Tonix Pharmaceuticals Holding Corp.

Released June 5, 2023