Bit Digital, Inc. (BTBT) – Into the Digital Mines


Thursday, June 15, 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.

Initiating Coverage. We are initiating research coverage on Bit Digital, Inc. with an Outperform rating and a $4.50 price target. Bit Digital is an asset-light, sustainability-focused digital asset mining company with mining and staking operations in the US, Canada, and Iceland. We believe the Company provides an opportunity for investors to invest in cryptocurrency mining and staking operations through two blue chip tokens in Bitcoin (BTC) and Ethereum (ETH).

Asset-Light Mining. Bit Digital’s primary revenue source is through BTC mining. The Company manages to keep an asset-light model through multi-year contracts with facilities to host the Company’s miners, enabling Bit Digital to exclusively focus on mining. The Company is currently at a hash rate of 1.2 EH/s with a goal of 2.6 EH/s by the end of 2023. We believe Bit Digital is capable of reaching its goal through increased utilization of the existing fleet as well as various miner purchases.


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

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

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

CoreCivic, Inc. (CXW) – Two Sides of a Coin


Thursday, June 15, 2023

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, 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.

A Renewal. CoreCivic entered into a lease agreement with the Oklahoma Department of Corrections (ODOC) for the company-owned, 1,670-bed Davis Correctional Facility (DCF), which the Company currently operates under a management contract with ODOC that is currently scheduled to expire on June 30, 2023. The new lease agreement includes a base term commencing October 1, 2023, with a scheduled expiration date of June 30, 2029, and unlimited two-year renewal options.

But. While CoreCivic retained a client, it went from a management contract to a lease. Previously, under the May 2021 management contract terms, we estimate the facility was generating north of $30 million in annual revenue (assuming full occupancy), while the under the lease agreement this declines to $7.5 million. However, gross margins on Properties segment agreements run in the high 70% range, compared to gross margins in the low 20% range for Safety segment managed locations.


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

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

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

Onconova Therapeutics (ONTX) – New Leukemia Data Presented Supports Wide Range Of Action


Thursday, June 15, 2023

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 two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data In Mantle Cell Lymphoma Updated. Onconova presented new data testing narazaciclib in mantle cell lymphoma (MCL) at the annual International Conference on Malignant Lymphoma, adding to data presented at the AACR meeting in April 2023. The preclinical studies tested the combination of narazaciclib as a single agent or in combination with ibrutinib (Imbruvica from AbbVie, an inhibitor of BTK or Bruton tyrosine kinase), a drug widely used to treat mantle cell lymphoma. Narazaciclib also was tested against approved CDK4/6 inhibitors and showed superior efficacy. 

Presentation Expands On Previous Data. Narazaciclib was tested with ibrutinib in multiple cell lines that are sensitive or resistant to ibrutinib. The combination showed anti-tumor activity that was synergistic compared with either drug alone. The drugs were shown to use separate pathways to downregulate cell cycle checkpoints and lead to G1 cell cycle arrest. This stops the cancer cells reproduction cycle, causing the cell to die. The combination inhibited tumor growth and reduced infiltrations of malignant B-cells in the bone marrow.


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. 

Unhyped Information to Improve Investment Success

Retail Traders Looking in the Right Place, Never Had it So Good

Do you feel like every time you buy a stock, it goes down? You’re not alone, it’s a common complaint. Yet there’s a large universe of industries, companies, and ideas to choose to invest in. And at the same time, a flood of people who make a living telling you where you should invest. So why do so many investors buy after a run-up, perhaps even at the high, then watch their holdings languish?

Part of the problem may be in how the self-directed investor, consumes information. Watching investment news, digesting a fast-talking influencer’s words, or being told which moving average to rely on is, at best a good start to knowing what the masses are seeing, but taking time away from the hype, and absorbing well-presented material, data, and other information will provide a better look at companies in a way that could help prevent the late-in-the-trade buys that retail investors are known for.

Multiple Sources of Investment Information

When it comes to making investment decisions, the probability of success should increase if you take a look from different angles by using a few sources of trusted information. Beginner investors learn quickly that, if success was as easy as just buying your favorite TV stock pickers love of day, viewers of shows like Mad Money on CNBS would all be rich. It clearly doesn’t work that way.

But if you’re not prone to acting on hype, watching stockpickers fall in and out of love, every show is entertaining. If you are prone to hype, as most humans are, you have to be suspicious of anyone who has to come up with a stock or two for each show (or article). Then speak or write about it with a convincing and engaging style. Keep in mind, viewers or readers are their customers, they lose customers if they’re boring, they gain customers by instilling hope. Yet, as a person who managed billions in institutional funds, I can attest to you that most days, it is best to sit on your hands, monitor your current holdings, and keep scouring resources for high-probability stocks to watch.

Celebrity CEOs

Another problem with mainstream media’s financial news is the coverage universe is typically only familiar household names. You can turn on Fox Business, read the Wall Street Journal, or even Yahoo Finance and expect that on any given day there will be information on Apple, Tesla, and Microsoft, and they’ll be highlighting celebrity CEOs of similar companies. As mentioned earlier, there is a large universe of stocks to choose from. If the only stocks that have your attention are the huge names, largely held by funds and transacted by Wall Street’s most powerful, you could be in the same position you’d be in if you came down from the stands at a pro basketball game and played for a couple of quarters. You’re considered lucky if you put any points on the board.

Broadening your watchlist stocks to include companies that you have to search for, because they aren’t hyped, may include making a few additions to your stock market news, information, and analysis regimen.

News Information and Analysis

In addition to the traditional sources for investment ideas, including TV market analysts, stock picking columnists, and any paid-for advertorial seen on even big name financial websites and publications. You may wish to explore lesser-known companies and review emotionless equity investment research. Outside of stock research, you may find an appealing company you never heard of by viewing videos that invite you to “Meet the CEO” and listen to someone who knows the company better than anyone. If you’re in a metropolitan area, you may get on an email list to see what roadshows are within driving distance so you can attend and better understand an opportunity. Investors who aren’t near financial hubs that attract roadshows can still benefit from face-to-face presentations, including questions and answers at an investor conference geared toward their interests.

Investment Research

Receiving up-to-date research from analysts that never forget they have a reputation to maintain used to be difficult for retail investors. It was expensive to subscribe to financial firms’ research, and with good reason. Large investor’s could afford it because they stood to benefit most from the insights, justifying the cost. And the firm doing the research and setting the price was justified because maintaining a staff of analysts is expensive. But it kept a lot of good info from smaller players. This has evolved recently and become more fair.

The availability of quality stock research began to fall off last decade as regulatory bodies began making rules on who can provide valuable research, based on financial licenses, company registrations, and compensation arrangements.

Equity research that was once paid for by subscribers, has now taken a similar path as “free” trading apps. Retail customers, or institutional are not the ones paying for it, in many cases, the company that wants to be evaluated is. This is called company-sponsored research or CSR.

There are a number of firms that now provide this investor service, Channelchek, with the expertise of the equity analysts at Noble Capital Markets, is the largest provider of CSR in North America.

So no hype investment research is available, and more companies are recognizing how it helps interest in their stock if investors have trusted sources evaluating their business.

Video Presentations

While it isn’t hard to find the CEO of Tesla or many other mega-cap companies talking about their plans, the CEO’s of the thousands of less celebrated, often higher potential, companies have to be sought out and there has to be a means to understand their plans, ideas, and expectations. Technology has helped solve some of this. In fact YouTube and similar platforms has opened the floodgates to information on everything from fixing your air conditioner, to how to braid hair. While there are many video presentations best avoided, presentations direct from company management, in a six months or younger video, can provide tremendous insight, and confidence to pull the buy trigger, or even confidence to decide not to.

A large selection of content of this type can be found in Channelchek’s Video Library.  

In-Person Roadshows

A roadshow is essentially management of a company, getting out of their office and meeting in different towns with investors. This could be done individually, perhaps at a financial institutions office, or in a reserved area in a public restaurant or other venue. This is particularly interesting as not only do investors get to look the person presenting directly in the eye, they benefit from questions being asked from all the other interested investors – they often have a great question you hadn’t thought of.

While every firm that conducts road shows has its own way of getting the word out, Noble Capital Markets organized roadshows list their calendar of roadshows on Channelchek.

Investment Conferences

While roadshows are great if it’s a company you want to hear from, and if it is convenient, a conference with many interesting companies, and perhaps in a vacation destination, can really help investors in a few short days hear many management presentations, ask questions and listen to other’s questions, and meet and network with investors of all levels. These events tend to be held in vacation destinations, so self-directed investors tend to bring family members, and professionals can spend a productive day of work enjoying a beautiful change of scenery.

I won’t even try to hide that I have a favorite conference.

Each year Noble Capital Markets puts on a popular two or three day investor event called NobleCon. Now in its 19th year, it attracts companies with interesting stories and business models from various industries, and professional and retail investors from three continents.

Now in its 19th year, NobleCon19 will be held in Late Fall 2023. The plans are pretty hush, but the opportunities for presenting companies and those looking to enhance their portfolios, I’m told, will be even greater than previous NobleCons. That’s a high hurdle.

Take Away

Understanding that the person on TV saying a stock is a buy, sell, or hold is, in a way, part of a reality TV show that needs to entertain to retain an audience, could improve your investment performance. Much of what is written is the same. Frankly, most days, there is little or nothing worth acting on, but they aren’t going to tell you this – it’s just not in their best career interest.

Alternative sources of ideas and information involve less hype and include, company- sponsored research, management discussions on video, roadshows, and investment conferences.

Most years there are many opportunities, most of these are under the radar companies that, even after they do well, are still under the radar. The ability to find these companies is becoming easier to all investors, but not if they are not looking for it.

Paul Hoffman

Managing Editor, Channelchek

Copper Market Poised for Unprecedented Growth

New Projections for Copper Demand High, Price Seen as Still “Muted”

The copper market could see an “unprecedented” inflow in the coming years as investors seek to profit from the metal’s anticipated surge in value, driven by growing demand for electric vehicles (EVs) and renewable energy, according to Citigroup.

In an interview with Bloomberg last week, Max Layton, Citi’s managing director for commodities research, said he believes now is an ideal time for investors to buy, as the price of copper is still muted on global recession concerns. The red metal is currently trading around $8,300 a ton, down approximately 26% from its all-time high of nearly $11,300, set in October 2021.

According to Layton, copper could top out at $15,000 a ton by 2025, a jump that would “make oil’s 2008 bull run look like child’s play.”

Citi also pointed out that copper may dip further in the short-term but could begin to rally in the next six to 12 months as the market fully recognizes the massive imbalance between supply and demand, a gap that’s expected to widen as demand for EVs and renewables expands.

This article was republished with permission from Frank Talk, a CEO Blog by Frank Holmes of U.S. Global Investors (GROW).

Find more of Frank’s articles here – Originally published June 12, 2023.

Internal Combustion Vehicle Sales Set To Peak This Decade: BloombergNEF

As I’ve mentioned before, electric vehicles (EVs) require up to three times more copper compared to traditional internal combustion engine (ICE) vehicles. This presents a challenge because the number of newly discovered copper deposits is decreasing, and the time it takes to go from discovery to production has been increasing due to rising costs. According to S&P Global, out of the 224 copper deposits found between 1990 and 2019, only 16 have been discovered in the last decade.

Meanwhile, EV sales continue to rise. Last year, these sales reached a total of 10.5 million, and projections by Bloomberg New Energy Finance (NEF) suggest that they could escalate to around 27 million by 2026. Bloomberg predicts that the global fleet of ICE vehicles will peak in as little as two years, after which the market will be dominated primarily by EVs and, to a lesser extent, hybrids. By 2030, EVs might constitute 44% of all passenger vehicle sales, and by 2040, three could account for three quarters of all vehicle sales.

Tesla Stock Supported By String Of Positive News

Tesla, which remains the world’s largest EV manufacturer, has seen its stock increase over 100% year-to-date in 2023, making it the third best performer in the S&P 500, following NVIDIA (+166%) and Meta (120%). In fact, shares of Tesla have now fully recovered (and then some) from October 2022, when CEO Elon Musk purchased Twitter for $44 billion. This raised concerns among investors about Musk’s ability to run the EV manufacturer while taking on a new, time-intensive project, not to mention also juggling SpaceX.

Friday marked the 12th straight day that shares of Tesla have advanced, representing a remarkable winning streak that we haven’t seen since January 2021.

The Austin-based carmaker got a huge boost last week after it announced that its popular Model 3 now qualifies for a $7,500 EV consumer tax credit. This action means that in California, which applies its own $7,500 tax rebate for EV purchases, a brand new Tesla Model S is cheaper than a Toyota Camry.

To qualify for the U.S. tax credit, Tesla had to make changes to how it sourced materials for its batteries in accordance with the Inflation Reduction Act (IRA), signed into law in August 2022. The IRA stipulates that 40% of electric vehicle battery materials and components must be extracted or processed in the U.S. or in a country that has a free trade agreement with the U.S. This manufacturing threshold will increase annually, and by 2027, 80% of the battery must be produced in the U.S. or a partner country to qualify for the full rebate.

Tesla stock also benefited from last Thursday’s announcement that drivers of EVs made by rival General Motors (GM) would be able to use Tesla’s North American supercharger network starting next year. The deal not only gives GM customers access to an additional 12,000 charging stations across the continent, but it also vastly increases Tesla’s market share of the essential charging infrastructure.

Musk’s Copper Quest

Thinking ahead, Musk reportedly met virtually last month with L. Oyun-Erdene, prime minister of Mongolia. The details of their discussion were not fully disclosed, but it’s worth pointing out that Mongolia is a copper-rich country, home to the world’s fourth-largest copper mine, operated jointly by Rio Tinto and the Mongolian government. In May, Rio Tinto announced that production had finally begun at the mine, which sits 1.3 kilometers (0.8 miles) below the Gobi Desert.

With access to this copper, perhaps Tesla is planning to build a metals processing plant in Mongolia? This would make sense, as the company maintains a factory in Shanghai, China.

US Global Investors Disclaimer

Holdings may change daily. Holdings are reported as of the most recent quarter-end. The following securities mentioned in the article were held by one or more accounts managed by U.S. Global Investors as of (03/31/2023): Tesla Inc.

All opinions expressed and data provided are subject to change without notice. Some of these opinions may not be appropriate to every investor. By clicking the link(s) above, you will be directed to a third-party website(s). U.S. Global Investors does not endorse all information supplied by this/these website(s) and is not responsible for its/their content.

Release – Comtech, E-Space Team Up to Make Space-Powered Connectivity Services Available and Actionable Anywhere

Research News and Market Data on CMTL

MELVILLE, N.Y. & LOS GATOS, Calif. – June 14, 2023– Comtech (NASDAQ: CMTL) and E-Space, the company bridging Earth and space to enable hyper-scaled deployments of Internet of Things (IoT) solutions and services, today announced a teaming agreement to collaborate, develop and deploy innovative space-based communications solutions and IoT services to support predominantly government and targeted commercial customers.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230613091149/en/

The collaboration will leverage Comtech’s vast portfolio of industry leading technologies and strategic partnerships, coupled with E-Space’s future advanced space system, inclusive of its global low Earth orbit (LEO) constellation and unique device capabilities, to provide customers with secure, resilient global connectivity services. The E-Space space system, optimized with edge Artificial Intelligence (edge AI), will enable the delivery of new smart applications, real-time actionable insights and suggested courses of action.

“Continuous connectivity is a fundamental need in today’s information-driven society that will generate ongoing demand to blend terrestrial, wireless and satellite networks,” said Ken Peterman, President and CEO, Comtech. “By teaming with E-Space, we will provide end users with reliable, global connectivity to enable near real-time predictive insights that will drive efficiency, reduce operator burden and empower individuals by providing access to new technologies.”

Greg Wyler, founder, chairman and CEO of E-Space, added, “Combining the expertise and resources from Comtech and E-Space will help revolutionize the way defense and commercial companies leverage space-powered data to connect, communicate and put intelligence into action. From providing warfighters up-to-the-minute situational awareness to ensuring logistics providers have incredible insights into every asset in a shipment – we will be able to provide unique information sets that will enable smarter operations.”

E-Space is building a satellite infrastructure that will blur the line between satellite and terrestrial communications network capabilities for delivering IoT connectivity. E-Space’s advanced technology will enable a new class of ubiquitous, real-time communications capabilities, which is expected to reduce device costs and increase coverage.

Comtech delivers innovative approaches to automate workflows, enhance safety, improve reliability and reduce system downtime. The Company holds hundreds of patents spanning terrestrial and satellite communications as well as location-based services, and its technologies are currently fielded in over 200 countries. Comtech is expanding its already vast portfolio of solutions and services through EVOKE, Comtech’s Innovation Foundry, as well as through strategic partnerships with world class innovators, like E-Space. These relationships provide customers with unprecedented access to data and insights that deliver meaningful value and uncover a number of new economic growth opportunities in diverse global markets.

About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

About E-Space
E-Space is bridging Earth and space to enable hyper-scaled deployments of Internet of Things (IoT) solutions and services. The Company is fundamentally changing the design, economics, manufacturing, coverage limitations and service delivery of space-powered IoT connectivity. Its advanced, sustainable low Earth orbit (LEO) space infrastructure will blur the line between satellite and terrestrial communications networks, creating a new class of ubiquitous, real-time communications capabilities that enable end-users to connect, track, sense and act on edge AI optimized data, gathered from billions of novel E-Space devices deployed planet-wide. Learn more about E-Space at: e-space.com and follow the Company on LinkedIn and Instagram.

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 and performance 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.

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

Media Relations
Jamie Clegg
480-532-2523
jamie.clegg@comtech.com

E-Space:
PR & Communications
Chris Phillips
917-974-1667
chris.phillips@e-space.com

Release – US Navy and Gaming Community Network Host Never Before Seen STEM Competition for High School Students

Research, News and Market Data on GAME

06/14/2023

Three talented high school STEM students will win the opportunity to play their custom Fortnite maps with the U.S. Navy’s Goats & Glory Team and the chance at $30,000 in cash prizes.

FRISCO, TX / ACCESSWIRE / June 14, 2023 / GameSquare Holdings, Inc. (“GameSquare”, or the “Company”) (NASDAQ:GAME)(TSXV:GAME) announced today that the U.S. Navy, the most highly skilled and technologically advanced military force in the world, with over half of all jobs in STEM fields, has partnered with Gaming Community Network (GCN) to create an exciting new STEM competition for high school students. In this unique competition, students will use their STEM skills to create new and innovative islands in the recently released Unreal Editor for Fortnite.The islands must incorporate a Navy inspired nautical theme where the player experiences and challenges such as scavenger hunts, puzzles or speed runs are happening on, or under, the water.

According to a Naval spokesperson, “This competition offers a first-of-its-kind opportunity for high school students to showcase their STEM skills and creativity in a fun, engaging way. By taking part in the competition, students not only will develop valuable skills, but also gain exposure to potential opportunities in Navy STEM fields.”

The qualifying competition will be judged by four well-known gaming influencers, who also will drive the conversation surrounding the different paths and STEM opportunities available in America’s Navy. These influencers will judge each map submitted by the students and help promote them to the gaming community.

This is the first time GCN will launch a campaign using the Unreal Editor for Fortnite.

According to Epic, this application is created for “designing, developing, and directly publishing games and experiences into Fortnite.” This implementation grants players greater artistic license, as well as access to innovative Unreal Engine 5 tools that will allow for expanded capabilities and more efficient workflow for creators.

The maps will be played and promoted by the Navy’s own Esports team, Goats & Glory. The top three finalists will be invited to a final map judging event by Goats & Glory team members. GCN will award the grand prize winner with $30,000 in scholarships.

“We’re thrilled to partner with America’s Navy and offer this exciting opportunity to high school students,” said Drew Brunson, President at Gaming Community Network. “We believe that this competition will help inspire students to pursue careers in Navy STEM fields and show them the endless possibilities that await them.”

The competition opens today, June 14th and runs until July 31st. To enter, high school students should visit operationoceanodyssey.com.

###

About the U.S. Navy
With more than 330,000 active-duty Sailors, 290 deployable ships, more than 3,700 aircraft and dozens of bases in the U.S. and across the globe, America’s Navy is the largest, most powerful naval force in the world. The opportunities available in today’s Navy are as boundless as the sea itself. You can learn more about these opportunities at Navy.com, and on FacebookTwitterInstagramYouTube, and LinkedIn.

About Gaming Community Network
GCN is the only independent media group completely dedicated to gaming and esports across community sites, content producers, influencers and tournament/event operators. Bridging the gap between traditional media and gaming with a “Gamer First” promise, GCN’s aggregated & integrated proprietary media network reaches 65M+ MAUs in the US and 115M+ MAUs globally, driving scale for premium content designed to provoke and share conversations. GCN builds bespoke strategy solutions from content creation to full-scale tournaments for any endpoint, be it social, broadcast TV or live stream. GCN collaborates with its partners to deliver memorable experiences for gamers and brands. Learn more at GCN.gg or follow on LinkedIn.

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.

SOURCE: GameSquare Holdings, Inc.



View source version on accesswire.com:
https://www.accesswire.com/761123/US-Navy-and-Gaming-Community-Network-Host-Never-Before-Seen-STEM-Competition-for-High-School-Students

Release – Covers Pulled Off Le Mans Ultimate Game at Centenary 24 Hours Of Le Mans

Research News and Market Data on MSGM

JUNE 14, 2023

LE MANS, France, June 14, 2023 (GLOBE NEWSWIRE) — Le Mans Ultimate – the official game of the 24 Hours of Le Mans and FIA World Endurance Championship – was announced ahead of the eagerly-anticipated Centenary edition of the 24 Hours of Le Mans (June 10/11), with a first look available for fans to play during the build-up to the ultimate endurance race.

An early version of the game developed by Studio 397 and Motorsport Games Inc. (the “Company” or “Motorsport Games”) was available in the Family Fan Village for race goers of all ages to try an early build preview presented by Thrustmaster. The free to play activation allowed over 3,200 fans to get behind the wheel of either the Porsche 963 Hypercar or Ferrari 488 GTE on full rig set-ups. The session around a virtual Circuit de la Sarthe gave drivers a chance to echo the real-life action taking place race around the legendary venue, using with the latest products from Thrustmaster, including the entry-level T248 wheel or bespoke sim racing Direct Drive T818.

Among those sampling an early version of the PC-based game was factory Porsche Penske Motorsport driver Matt Campbell and Porsche Coanda Esports Racing Team star Joshua Rogers who put the Porsche 963 Hypercar through its paces. Ferrari was also represented, as Scuderia Ferrari Esports drivers Timotej Andonovski and Alex Siebel were on hand to give feedback on the Ferrari 488 GTE machine.

Further to the presence in the fan zone, the traditional pre-event press conference organised by the Automobile Club de l’Ouest (ACO) saw the premiere of the first teaser video for the game [LINK], alongside the news of the 2024 FIA World Endurance Championship calendar and Hydrogen prototype plans from Toyota, the first manufacturer to announce plans for the new-for-2026 category.

In conjunction with the week-long activation, the Le Mans Ultimate Steam store went live. This will enable PC gamers to add the title to their Wishlist, so they can be kept up to date with the latest developments ahead of the expected release in December 2023 – bit.ly/LeMansUltimateOnSteam

Stephen Hood, CEO Motorsport Games commented, “After months of planning, it was fantastic to see the reaction for Le Mans Ultimate, from not only the gaming, but the motorsport community – a welcome surprise for many during the build-up to the 100th anniversary of the 24 Hours of Le Mans. We were able to show the public an early version of the game as well as listening to their stories of the iconic event, and gather feedback for the game; its vitally important we do that as often as we can in the run up to release. We want to make this experience as realistic and enjoyable as possible and we will be taking feedback onboard from the public as well as working closely with the manufacturers, FIA WEC and the ACO to bring the ultimate experience to the game.”

More information, news and updates on Le Mans Ultimate can be found on the website, lemansultimate.com or @LeMansUltimate on social media channels.

About Motorsport Games:

Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.

Forward-Looking Statements:

Certain statements in this press release which are not historical facts are forward- looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are provided pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected Le Mans Ultimate and/or Studio 397’s attributes, performance, benefits and features, the benefits and positive attributes of competing or playing Le Mans Ultimate game, that Motorsport Games will be successful in bringing the ultimate experience to Le Mans Ultimate game. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Motorsport Games and are difficult to predict. Examples of such risks and uncertainties include, without limitation: difficulties, delays in or unanticipated events that may impact the timing and expected benefits of the new Le Mans Ultimate game and/or related products and features, such as due to unexpected release delays, whether the reveal of Le Mans Ultimate will be well received and/or successful, whether the final product will meet the expectations of the fans, users and spectators and/or whether Studio 397 and Motorsport Games will produce the positive experience for gamers and motorsport fans. Factors other than those referred to above could also cause Motorsport Games’ results to differ materially from expected results. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in Motorsport Games’ filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, its Quarterly Reports on Form 10-Q filed with the SEC during 2023, as well as in its subsequent filings with the SEC. Motorsport Games anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Motorsport Games assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing Motorsport Games’ plans and expectations as of any subsequent date. Additionally, the business and financial materials and any other statement or disclosure on, or made available through, Motorsport Games’ website or other websites referenced or linked to this press release shall not be incorporated by reference into this press release.

Website and Social Media Disclosure:

Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):

WebsitesSocial Media
   motorsportgames.comTwitter: @msportgames & @traxiongg
   traxion.ggInstagram: msportgames & traxiongg
   motorsport.comFacebook: Motorsport Games & traxiongg
 LinkedIn: Motorsport Games
 Twitch: traxiongg
 Reddit: traxiongg

The contents of these websites and social media channels are not part of, nor will they be incorporated by reference into, this press release.

Contacts:

Investors:

investors@motorsportgames.com

Media:

pr@motorsportgames.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83b2a5eb-afd0-447e-b9cb-6e31ffd20445

Release – PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

Research News and Market Data on PDSB

  • 14 patients in the immune checkpoint inhibitor naïve arm of VERSATILE-002 have experienced either a complete response or partial response on two consecutive scans, thus constituting a confirmed objective response
  • Efficacy and safety continue to be monitored as additional patients have yet to undergo imaging evaluation

FLORHAM PARK, N.J., June 14, 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, announced today the Company achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023. The threshold for efficacy, as defined in the clinical protocol, was achieved when 14 out of the 54 immune checkpoint inhibitor (ICI) naïve patients enrolled achieved a confirmed objective response. Additional patients in the trial have yet to undergo imaging evaluation. 

Per RECIST 1.1, the standard to classify oncologic imaging outcomes in clinical trials, patients are considered to have achieved an objective response when imaging studies document tumor shrinkage of 30% or more. In VERSATILE-002, the primary endpoint requires two consecutive scans 9 to 12 weeks apart, rather than one, to be considered a confirmed objective response. Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1.

At the recent 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, we presented data showing 9 confirmed responses among 34 evaluable patients.  Median progression-free survival (PFS) of 10.4 months was also presented at the 2023 ASCO Annual Meeting along with a 12-month overall survival (OS) rate of 87.1% for patients with a CPS≥1. Additional patients have been assessed since data was presented at the 2023 ASCO Annual Meeting. With these additional data, a total of 14 patients have now achieved a confirmed response to date.   The achievement of this endpoint suggests an additive effect of PDS0101 over published results with ICI monotherapy and is based on statistical calculations using the appropriate power and alpha.

The primary endpoint in the VERSATILE-002 study is the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1. The key secondary endpoints are progression-free survival (PFS), OS at 12 and 24 months, safety, and tolerability. The study utilizes a Simon’s 2-stage optimum design.

“We are highly encouraged by the growing set of PDS0101 efficacy and safety data being generated in multiple independent trials by leading experts in the field,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “The consistency in PDS0101 induced HPV16-specific immune responses, the response rates and survival benefit observed in multiple types of HPV cancer and at different stages of disease, aligns with both the preclinical and Phase 1 monotherapy results. Multiple studies have demonstrated the induction of high levels of active and potent, HPV16-specific CD4 and CD8 T cells, as well as long-lasting memory CD8 T cells by PDS0101.” 

“Achieving the efficacy threshold in VERSATILE-002 is an important milestone for the Company, especially as it has been achieved ahead of the full efficacy evaluation for this cohort,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “With our Phase 2 trial near completion, and our planned global Phase 3 confirmatory randomized, controlled trial, VERSATILE-003, actively advancing, we believe we are closer to our goal of providing a well-tolerated, safe and effective therapy for those who suffer from head and neck cancer, a critical unmet medical need.”

PDS Biotech plans to initiate the VERSATILE-003 as a result of the successful completion of an End-of-Phase 2 meeting in the third quarter of 2022 with the FDA, during which PDS Biotech received guidance on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). The planned primary endpoints for VERSATILE-003 are OS and PFS. In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in the third quarter of 2023.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002 

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.   

Interim efficacy and safety data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients (PR link). Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.

 About VERSATILE-003 

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

About Versamune®
Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

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

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

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

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

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

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

Release – CoreCivic Enters Into New Lease Agreement With the State of Oklahoma for the Davis Correctional Facility

Research News and Market Data on CXW

June 14, 2023

BRENTWOOD, Tenn., June 14, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (CoreCivic or the Company) announced today it has entered into a lease agreement with the Oklahoma Department of Corrections (ODOC) for the company-owned, 1,670-bed Davis Correctional Facility (DCF), which the Company currently operates under a management contract with ODOC that is currently scheduled to expire on June 30, 2023. CoreCivic expects to enter into a 90-day contract extension for the current management contract, after which time operations will transfer from CoreCivic to ODOC in accordance with the new lease agreement. The new lease agreement includes a base term commencing October 1, 2023, with a scheduled expiration date of June 30, 2029, and unlimited two-year renewal options.

Terms of the 90-day contract extension are expected to remain consistent with the existing management contract at the DCF. Annual rental revenue generated from the ODOC at the DCF under the new lease agreement will be $7.5 million during the base term and will be reported in the CoreCivic Properties business segment upon lease commencement.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. CoreCivic provides 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. CoreCivic is the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. CoreCivic has been a flexible and dependable partner for government for 40 years. CoreCivic’s 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.

Forward-Looking Statements

This press release contains statements as to CoreCivic’s beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with executing a contract extension of the current management contract under substantially the same terms as the existing management contract, the successful transition of operations from CoreCivic to ODOC, and the financial impact of the new lease agreement.

CoreCivic takes no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

Contact:  Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
  Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204

Release – Onconova Therapeutics Presents Preclinical Data On Narazaciclib At The 17th International Conference On Malignant Lymphoma

Research News and Market Data on ONTX

Jun 14, 2023

Narazaciclib demonstrated significant synergistic anti-cancer activity in multiple in vivo models of mantle cell lymphoma (MCL) when combined with ibrutinib, the current standard-of-care

NEWTOWN, Pa., June 14, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today presented preclinical data on narazaciclib at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17, 2023.

Data from the Josep Carreras Leukaemia Research Institute expanded on a prior presentation at the recent American Association for Cancer Research (AACR) Annual Meeting, showing that narazaciclib’s antitumor activity against mantle cell lymphoma (MCL) cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Combining narazaciclib with the FDA-approved Bruton’s tyrosine kinase inhibitor ibrutinib led to synergistic increases in antitumor activity against both ibrutinib-sensitive and ibrutinib-resistant MCL cell lines. In addition, treatment with narazaciclib combined with ibrutinib led to significant inhibition of tumor growth and significant reductions in malignant B cell infiltration into the bone marrow in multiple chicken embryo chorioallantoic membrane xenograft models of MCL.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “The data being presented at ICML provide further evidence of narazaciclib’s potential to combine synergistically with a wide range of therapeutic classes, derived from its ability to inhibit CDK 4, 6, and additional kinases involved in cancer cell survival and metastasis. This differentiated kinase inhibitory profile also confers expansive therapeutic potential across a variety of indications and may enable narazaciclib to overcome the efficacy limitations and safety concerns of currently marketed CDK 4/6 inhibitors. Given ibrutinib is the standard-of-care in mantle cell lymphoma, the preclinical results showing narazaciclib improving antitumor responses in combination represents a promising development that speaks to its potential therapeutic utility in this high unmet need indication. We look forward to discussing our data throughout ICML as we continue to evaluate additional opportunities for clinical studies with narazaciclib and advance our ongoing Phase 1/2a combination trial of narazaciclib plus estrogen blockade in endometrial cancer.”

The ICML poster, titled, “Prolonged cell cycle arrest by the CDK 4/6 antagonist narazaciclib restores ibrutinib response in preclinical models of BTKi-resistant mantle cell lymphoma,” is currently available to registered attendees of ICML via the conference’s e-poster gallery. The poster will also be displayed during the in-person poster sessions being held throughout the conference. A copy of the poster will be available on the “Scientific Presentations” section of the Onconova website following the conclusion of the conference.

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 in patients with metastatic melanoma.

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

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

MustGrow Biologics Corp. (MGROF) – Growing Production


Wednesday, June 14, 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.

Completed Run. Yesterday, MustGrow filed a press release stating the Company successfully completed its initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer. The run-rate of the production reached greater than 5,000 litres per day of the biocontrol liquid.

Revenue Translation. The production of the mustard plant-based biocontrol liquid technology is estimated to equal approximately USD$25 million of annual revenue at a retail level, along with creating zero residual waste through generating a high protein ingredient for animal feed. Based on the trial run, we believe the estimated annual production of the liquid would cover a fraction of the demand, and we estimate the trial run annual production liquid would cover some 25,000-50,000 acres.


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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. 

June’s FOMC Announcement Shows No Immediate Change, But Expects More Hikes

Source: Federal Reserve (Flickr)

The FOMC Left Policy the Same in June, But Became More Hawkish

The Federal Open Market Committee (FOMC) voted to hold its target rate steady on overnight interest rates at  5.00% – 5.25% after the June 2023 meeting. This is considered a pause, not a halt to a hawkish stance as indicated by the post-meeting announcement. The announcement indicated FOMC members, on average, expect Fed Funds to be 50bp higher by year-end. This could come about as two 25bp moves. The lack of policy shift was in overnight bank lending rates and the quantitative tightening cycle previously announced. However, a slightly more hawkish Fed includes statements that are more certain that rates will still be pushed up, and member projections of where funds will be at year-end, which include one member seeing as high as 6.25% for the first time.

The vote was unanimous.

The minutes discuss that indicators suggest that economic activity has continued to expand at a modest pace. Job gains have been robust in recently, and the unemployment rate has remained low. However, they are concerned that inflation remains well above its targeted range.

After the meeting, the Fed says it believes the U.S. banking system is sound and resilient. They expect tighter household and business credit conditions are likely to weigh on economic activity, hiring, and inflation. The extent of these effects remains uncertain.

“The Committee seeks to achieve maximum employment and inflation at the rate of 2 percent over the longer run. In support of these goals, the Committee decided to maintain the target range for the federal funds rate at 5 to 5-1/4 percent,” according to the Fed’s announcement. “Holding the target range steady at this meeting allows the Committee to assess additional information and its implications for monetary policy,” it continued.

 The Fed indicated that it will continue to assess “incoming information for the economic outlook.” The FOMC’s said its assessments will take into account readings on labor market conditions, inflation pressures and inflation expectations, financial and international developments, as well as other data.

The Summary of Economic Projections (SEP), relative to previous meetings, makes clear that Fed members are on average expecting to have to do more to combat inflation tan they had previously forecast.

Image: June’s SEP

Fed Chair Powell generally shares more thoughts on the matter during a press conference beginning at 2:30 PM EST after the statement.

Paul Hoffman

Managing Editor, Channelchek

Source

https://www.federalreserve.gov/newsevents.htm