Month: October 2023

Aurania Resources (AUIAF) – Ecuador Elects a New President; Positive Implications for Business

Posted on by cpereira@noblefcm.com


Tuesday, October 17, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Presidential election in Ecuador. Mr. Daniel Noboa was elected President of Ecuador following a run-off election held on October 15th. He will be sworn in on November 25th and will govern until the next presidential election in 2025. He is completing the term of the outgoing president, Guillermo Lasso, who dissolved the Congress in May and called for snap Presidential and Legislative elections.

A positive outcome for investors. At 35 years of age, Mr. Noboa will be the youngest president in Ecuador’s history and is the scion of a wealthy Ecuadorian family. He is well-educated with several graduate degrees, including a degree in public administration from Harvard University. He campaigned on strengthening the economy, attracting greater foreign investment, and restoring law and order. As a candidate, Mr. Noboa met with the Ecuador Chamber of Mines and is expected to be supportive of the mining industry given its economic importance.


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Surprisingly Strong September Retail Sales Raises Hopes for Soft Landing

Posted on by slightbourne@noblecapitalmarkets.com

U.S. retail sales rose an unexpectedly robust 0.7% in September, surpassing economist forecasts of a flat or negative number. The solid spending data provides a dose of optimism that the economy can achieve a soft landing amidst high inflation and aggressive Fed rate hikes.

September’s gains were broad-based across categories like autos, gasoline, furniture, clothing, hobbies, and food services. The growth comes even as inflation persists at elevated levels, with the September Consumer Price Index report showing prices climbed 8.2% year-over-year.

However, the 0.4% monthly CPI increase was smaller than anticipated. This potentially indicates inflationary pressures are beginning to gradually ease.

Markets rallied on the retail sales beat, interpreting it as a sign of consumer resilience despite inflation chipping away at budgets. Stocks rose on hopes a soft landing—where the Fed engineers an economic cooldown without triggering a recession—appears more plausible.

Retail spending has seesawed in recent months, decreasing 0.4% in August as high prices at the pump drained consumer budgets. But gas prices have since moderated, alleviating some of this pressure. This freed up disposable income in September, evidenced by solid auto sales and increases in discretionary categories.

The better-than-expected data implies consumers still have some power to prop up the economy, though inflation remains a challenge. Prices dipped from the previous month’s 8.3% annual increase but continue running severely above the Fed’s 2% target. This explains why the central bank is almost certain to enact another large interest rate hike in early November.

Fed officials assert they will continue raising rates aggressively until inflation is convincingly tamed. This risks going too far and sparking a recession. But if inflation keeps gradually trending downwards, it raises confidence the Fed can stick the landing.

Firms are bracing for a potential downturn, with many announcing hiring freezes and cost cuts. However, the job market has yet to take a significant hit, which would severely impair consumer spending power. As long as individuals keep spending reasonably well, it makes a soft landing more feasible.

Looking ahead, the path for retail sales and inflation remains highly uncertain. More data will be required to determine if September’s retail boost was an anomaly or the start of more sustainable momentum. Inflation similarly needs to keep dropping before proclaiming victory.

But for now, September’s numbers provide a dose of positivity that the economy is not yet on the brink of cratering into recession. Consumers are weathering the inflation storm better than feared, aided by falling gas prices and healthy job gains.

This means the Fed can continue ratcheting up interest rates with less risk of immediately crashing growth. However, policymakers are unlikely to declare mission accomplished and halt hikes anytime soon.

For the soft landing narrative to play out, retail strength and inflation moderation will need to persist over coming months. September offered promising signs, but more evidence is required to confidently say a harsh recession is avoidable. The Fed will be monitoring data closely to ensure its forceful actions steer the economy in the right direction.

Gilead Partnership Provides Boost to Assembly Bio’s Antiviral Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Clinical-stage biotech Assembly Biosciences gained a powerful ally in developing next-generation antivirals through a new collaboration with pharma giant Gilead Sciences. The deal provides Gilead access to Assembly Bio’s portfolio of early-stage assets while giving Assembly funding and expertise to advance its programs.

Under the 12-year partnership announced Monday, Gilead will provide $100 million upfront, including an equity investment at a premium. Assembly Bio gains potential milestone payments, royalties, and profit-sharing as programs progress.

For investors, the collaboration validates Assembly Bio’s antiviral pipeline and represents significant long-term revenue potential. The deal also propels Assembly closer to becoming a fully integrated biotech firm.

Assembly’s current clinical assets target major viral diseases like hepatitis B virus (HBV) and herpes simplex virus (HSV). Its preclinical pipeline holds promise against hepatitis D virus (HDV), human cytomegalovirus, and more.

Take a look at other emerging biotechnology companies by taking a moment to look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

Gilead brings extensive experience developing and commercializing leading antiviral drugs in HIV and hepatitis C. The pharma giant now doubles down on virology via Assembly’s early-stage assets.

Opting into a program after proof-of-concept could cost Gilead at least $45 million, signaling confidence in Assembly’s science. The biotech leads R&D initially, with Gilead taking over once assets transition to late-stage trials and commercialization.

For Assembly investors, this deal structure provides valuable de-risking of the pipeline. The company secures funding to advance programs while sharing in the upside if Gilead opts in to lucrative late-stage development and sales.

Assembly is eligible for up to $330 million per program in milestones post opt-in. Royalties range from high single digits to high teens. The biotech can also opt into U.S. profit-sharing.

These economics help offset the risk of clinical failure for Assembly’s shareholders. Meanwhile, Gilead pays for the privilege of accessing Assembly’s innovating antiviral pipelines.

The partnership enhances Assembly’s financial position and extends its operating runway. This enables advancing other preclinical programs beyond the leads Gilead can opt into.

For example, Assembly recently unveiled a promising pan-herpesvirus asset that could treat multiple herpes infections from one oral pill. Such follow-on compounds ensure future revenue potential.

Meanwhile, major progress by Gilead with Assembly’s lead assets could generate substantial royalties and profit-sharing income. Upside from the deal should become clearer as Gilead opts to license drugs entering late-stage testing over the 12-year term.

With a strengthened balance sheet and veteran partner at its side, Assembly Bio seems poised for a breakthrough as a developmental biotech focused on next-gen antivirals.

The Gilead deal provides third-party validation of Assembly’s science and a critical launchpad toward integrated status combining R&D, late-stage trials, and commercialization.

For Assembly investors, these benefits significantly de-risk the journey to having approved antiviral products on the market. If clinical programs pan out as hoped, the payoff from this partnership could be huge.

Release – Aurania Announces Preliminary Election Results And Loan Agreement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on AUIAF

Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) announces that Mr. Daniel Noboa is the elected President of Ecuador following a runoff election held on October 15th.  Mr. Noboa is a graduate of the Harvard Kennedy school and is expected to be sworn in on November 25. He will be in power for approximately 18 months – completing the term of outgoing President, Guillermo Lasso until the next scheduled presidential election in the first half of 2025.  Noboa’s campaign was focused on the economy and creating jobs, attracting foreign investment and safety/security.  It is the Company’s view that this result may restore political stability and the confidence of international investors in the country. Mr. Noboa is also expected to be supportive of responsible exploration and mining.

The Company also announces that its Chairman, President and Chief Executive Officer, Dr. Keith Barron (the “Lender”) has agreed to provide a loan of up to C$1,000,000 to the Company to be advanced from time to time in principal amounts as agreed by the parties (the “Loan”).

The Loan is unsecured, bears interest at 2% per annum and matures upon notice of twelve months and one day from the Lender.  The Loan will help fund the Company’s working capital and general corporate purposes as well as any exploration expenses in Ecuador.  As of the date hereof, C$50,000 has been advanced under the Loan. 

Dr. Keith Barron is a related party of the Company by virtue of the fact that he is the Chairman, the President and Chief Executive Officer, a promoter and a principal shareholder of the Company, and as a result, each advance and repayment under the Loan constitutes a “related party transaction” for the purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying upon an exemption from the formal valuation and minority shareholder approval requirements under MI 61-101 in respect of the Related Party Transactions, in reliance on Sections 5.5(a) and 5.7(1) of MI 61-101, respectively, as the fair market value of the Related Party Transaction, collectively, does not exceed 25% of the Company’s market capitalization, as determined in accordance with MI 61-101. The Company did not file a material change report related to the Loan more than 21 days before the expected closing of the Loan as required by MI 61-101, as the Company wished to organize the Loan on an expedited basis for sound business reasons.

The Loan was approved by the members of the board of directors of the Company who are independent for purposes of the related party transaction, being all directors other than Dr. Barron. No special committee was established in connection with the Loan, and no materially contrary view or abstention was expressed or made by any director of the Company in relation thereto. 

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

What Are Small-Cap Stocks and Are They a Good Investment?

Posted on by slightbourne@noblecapitalmarkets.com

For many individuals, investing in the stock market is a pathway to financial growth and security. And while familiar large-cap names like Amazon, Apple and Microsoft may first come to mind when building a portfolio, small-cap stocks represent another promising segment of the market.

Today, we’ll take an in-depth look at the world of small-cap stocks and examine whether they can make a wise addition to your investment strategy. Whether you’re a seasoned investor looking to broaden your portfolio or someone new to stock market investing, this article will answer all your questions about what a small-cap stock is and much more.

Defining Small-Cap Stocks

First, let’s start with a quick definition – what exactly are small-cap stocks?

Small-cap stocks refer to companies that have a relatively small market capitalization, generally between $300 million and $2 billion. Market capitalization (or market cap) is calculated by multiplying the total number of company shares outstanding by the current market price per share.

So a company with 10 million shares trading at $20 per share would have a market cap of $200 million, landing it in the small-cap category.

In contrast, large-cap stocks like Apple, Microsoft, and Amazon are valued in the hundreds of billions. Small-cap stocks represent companies in earlier developmental stages with significant room for expansion ahead of them before reaching the scale of the market leaders. Some well-known examples of small-cap companies across different sectors are The ODP Corporation, Bassett Furniture, The Geo Group and Maple Gold Mines.

Small-cap stocks sit in the middle between micro-cap stocks (under $300 million market cap) and mid-cap stocks ($2 billion to $10 billion market cap). At the higher end are large-cap stocks (over $10 billion) and mega-cap stocks like Apple that exceed $200 billion in market value.

For many growth-oriented investors, small-cap stocks represent an opportunity to invest early in a company with potential for rapid expansion before they become household names. The early-stage status means small-cap companies have ample runway to grow their market share and establish themselves as industry leaders over time. With the right investments, small-cap stocks can deliver exponential returns compared to slow and steady large-cap stocks that have less growth potential ahead.

However, the smaller size and scale of these companies also leads to higher volatility and risk compared to large-caps with firmly entrenched market positions. We’ll explore these trade-offs more in the sections ahead.

Key Characteristics of Small-Cap Stocks

Now that we’ve defined what a small-cap stock is, let’s dive deeper into some of the typical characteristics of these types of companies:

Greater Growth Potential

With small-cap companies still in relatively early phases of their lifecycle, their products and services often have significant room for wider adoption and expansion. Small-cap stocks are laser focused on growing their market share rapidly during the critical early innings before competitors emerge. They pour capital into product development, sales and marketing, and geographic expansion while large-caps aim to protect and defend their existing turf.

Higher Volatility

With smaller financial resources and operational scale, small-cap stocks tend to be more vulnerable to market swings and changing economic conditions. As a result, their share prices can fluctuate wildly in short periods of time as sentiment shifts. On the other hand, large-cap stocks boast stability and steady, predictable growth.

Less Analyst Coverage

Wall Street banks and financial media outlets tend to devote the bulk of their research and coverage to large, established companies that dominate their industries. Meanwhile, small-cap stocks fly under the radar in comparison. This lack of attention results in opportunities for diligent individual investors to uncover small companies poised for growth before they gain widespread analyst and investor attention. This is where Channelchek comes in. Our market research is specific to small cap stocks and completely free as long as you join our community

Potential for Undervaluation

The limited analyst coverage and lack of institutional investor interest in small-cap stocks can at times lead to mispricing opportunities where the stocks trade at valuations that do not fully reflect their growth prospects and upside potential. Savvy investors can find hidden gems trading at deep discounts relative to their future earnings power. Of course, finding these diamonds in the rough requires rolling up your sleeves and digging into financial statements.

Liquidity Challenges

The total number of outstanding shares is far lower for small-cap companies versus large-caps, which leads to lighter trading volumes and thinner liquidity. This results in wider bid-ask spreads, premiums and heightened volatility when entering and exiting positions. Large-cap stocks benefit from abundant liquidity and tight spreads, allowing large trades to be executed seamlessly.

In summary, while small-cap stocks carry additional risk factors, their lower valuations, lack of analyst coverage and undiscovered status provide significant upside potential for enterprising investors willing to conduct their own due diligence.

The Pros and Cons of Small-Cap Stocks

Now that we understand the typical traits of small-caps relative to large-caps, let’s examine the key potential benefits and drawbacks of adding these types of companies to your investment portfolio:

Potential Benefits of Small-Cap Stocks

– Outsized Growth Potential – With the right stock picks, small-cap companies can deliver exponential returns over a relatively short timeframe that mature large-cap stocks simply cannot match. Just look at Amazon’s meteoric rise over the past decade when it was still a small-cap. 

– Undervaluation Opportunities – Due to the lack of widespread analyst coverage, small-cap stocks can become underpriced or neglected relative to their growth prospects. Dedicated investors can find hidden gems trading at compelling valuations before market awareness builds.

– Portfolio Diversification – Because small-cap stocks behave differently than large-caps with lower correlation, adding small-cap exposure can improve the overall risk-adjusted return profile of a portfolio heavy in stable large-cap names.

– Inflation Hedge – During periods of rising inflation, small-cap stocks have historically outperformed as they are more nimble in passing on price increases to customers. Large-cap names are slower to react.

Potential Drawbacks of Small-Cap Stocks

– Higher Volatility – The amplified swings in small-cap share prices require mental fortitude during periods of market stress. Their risk profile means small-caps are better suited for those with higher risk tolerance.

– Liquidity Risk – The lower trading volumes inherent with small-caps necessitates close monitoring of bid-ask spreads and liquidity when entering or exiting a position. Sudden moves can lead to dislocation.

– Fewer Resources – Compared to the robust balance sheets of large-caps, small-cap companies have less financial flexibility and capital reserves which can leave them vulnerable during recessions.

– Lack of Institutional Coverage – Minimal Wall Street research coverage means individual investors must conduct their own due diligence. Those relying purely on analyst reports will be late to the party.

All in all, while small-cap stocks carry some additional risks and challenges, their return potential merits inclusion for at least a portion of growth-oriented investors’ portfolios.

Researching and Investing in Small-Caps

Here are some key factors for investors to weigh before adding small-cap exposure:

– Assess your personal risk tolerance – The inherent volatility of small-cap stocks means they are better suited for those investors with higher risk appetites and ability to withstand routine price swings. Make sure your temperament aligns.

– Consider investment timeframe – The long-term growth trajectories of small-caps make them ideal picks for investors with longer time horizons of at least 5-10 years rather than short-term trading mentality. Have patience.

– Conduct extensive due diligence – There’s far less third-party Wall Street research available on small-caps compared to large-caps. You’ll need to thoroughly comb through financial filings, growth prospects, competitive dynamics and management track records.

– Diversify across multiple small-caps – Build a basket of small-cap stocks across different sectors to smooth volatility and avoid concentration risk. Layer in large-cap and mid-cap holdings.

– Monitor liquidity trends – Keep an eye on trading volumes and bid-ask spreads of small-caps you own to ensure ample liquidity exists when entering and exiting positions. Liquidity shrinks rapidly during downturns.

Taking these elements into account allows you to make informed decisions before venturing into small-caps.

Investing Strategies for Small-Cap Stocks

If small-cap stocks fit your risk tolerance, goals and research diligence, here are some effective approaches:

– Seek out promising sectors – Target high-growth sectors like technology, healthcare and consumer discretionary where disruption potential is highest rather than diversified small-cap funds.

– Identify company-specific catalysts – Look for upcoming product launches, partnerships, FDA approvals or expansion plans that could serve as catalysts for a sharp rise in sales, earnings and sentiment.

– Take a long-term perspective – Tune out the noise and stick to your original investment thesis during temporary price swings. Have conviction in your small-cap picks.

– Utilize stop-loss orders – Use stop-loss orders to automatically sell positions if prices breach certain thresholds as a risk management tactic. Re-enter when volatility subsides.

– Reinvest dividends for compounding – Many small-caps pay dividends despite early-stage status. Reinvesting dividends turbocharges long-term total returns. 

– Consider small-cap index funds – For diversification, consider cost-effective small-cap index funds from leading providers like Vanguard, Schwab and iShares.

– Limit overall allocation – Given the amplified risk, small-caps should likely account for no more than 10% of your total portfolio assets. Size positions accordingly.

With rigorous research and prudent strategy, small-cap stocks can boost returns for enterprising investors willing to accept the higher volatility profile.

The Bottom Line on Small-Cap Stocks

In the high-growth small-cap arena, there will inevitably be huge winners and unfortunate flameouts. But for risk-tolerant investors, the profit potential justifies the bumpy ride. By taking a selective approach, diversifying across multiple small-caps, and holding for long time horizons, much of the volatility smoothes outs while allowing winners time to fully capture market share.

While individual small-cap stocks require diligence, broad exposure can be gained cost-effectively through small-cap index funds and ETFs. Overall, small-cap stocks fill an important niche in balanced portfolios, providing a return boost that slow-changing large-caps cannot match. For investors willing to accept fluctuations in the pursuit of superior long-term returns, small-cap stocks warrant consideration.

Join the Channelchek community to keep up with the latest small-cap insights and start making informed investment decisions!

Release – QuoteMedia Powers Stirlingshire Investments Trading Platform

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QMCI

PHOENIX, Oct. 16, 2023 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, announced an agreement with Stirlingshire Investments.

Stirlingshire is an exciting market disruptor with a groundbreaking Hybrid Broker-Dealer framework that brings together the most advantageous aspects of the Full-Service Broker-Dealer and Discount Broker-Dealer models, while removing their limitations. By utilizing technology, Stirlingshire is able to dramatically reduce overhead and liability, while tying compensation much closer to performance. The result? A revolutionized industry that is Better for Clients, Better for Advisors.

Pursuant to the agreement QuoteMedia will be incorporating Quotestream® Trader, QuoteMedia’s streaming data application complete with trade integration, into Stirlingshire’s innovative trading platform. This allows Stirlingshire’s network of broker representatives and their retail clients to access real time market data, as well as comprehensive news, research, charting and analysis as part of their trading experience.

“Stirlingshire is dedicated to innovation, and QuoteMedia’s leading edge offerings are a perfect fit with our goals,” said Steven Woods, Stirlingshire’s Founder & CEO. “Our clientele quite justifiably expects best-in-class products and services from us, and the platform is receiving rave reviews. QuoteMedia’s applications and delivery technologies provide up-to-the-second market data and research information, and ensure our correspondent brokers and their customers are able to identify and capitalize on great investment opportunities.”

The partnership is a significant opportunity for QuoteMedia as well, according to QuoteMedia, Ltd. CEO Dave Shworan.

“Stirlingshire’s approach is truly innovative, and they are enjoying tremendous early success and growth,” said Shworan. “We are thrilled that they have chosen to incorporate our data and technology solutions, and that we can join them as they revolutionize the brokerage and investment industry. We look forward to a long and exciting partnership.”

About QuoteMedia

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Avantax, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, The Goldman Sachs Group, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Credential Qtrade Securities, CNW Group, iA Private Wealth, Ally Invest, Inc., Suncor, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Equisolve, Stock-Trak, Mergent, Cision and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com .

QuoteMedia Investor Relations

Brendan Hopkins
Email: investors@quotemedia.com
Call: (407) 645-5295

Stirlingshire Media Relations

Nicole Cox
Email: Nicole@stirlingshire.com
Call: 647-500-2763

News Provided by GlobeNewswire via QuoteMedia

Release – RNC to Partner with NBC News, Salem Radio Network, Republican Jewish Coalition, and Rumble for Third Republican Presidential Primary Debate in Miami

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

 Download as PDFOctober 16, 2023 8:15am EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that the Republican National Committee (RNC) has selected NBC News, Salem Radio Network, the Republican Jewish Coalition, and Rumble as partners for the third Republican presidential primary debate, which will take place at the Adrienne Arsht Center for the Performing Arts of Miami-Dade County on November 8, 2023. As with the first and second debates, Rumble will be the exclusive RNC livestream provider and the RNC’s exclusive online home for the third debate.

“I am eager to announce that the RNC has selected NBC News, Salem Radio Network, the Republican Jewish Coalition, and Rumble as our partners for the third Republican primary debate in Miami. The partners for our third debate will offer our candidates an excellent opportunity to meet the moment and contrast their plans and vision with the failures of the Biden White House.” – RNC Chairwoman Ronna McDaniel

“NBC News has a long history of fostering conversations with the leaders that seek to shape domestic politics and foreign policy. For us, there is no higher responsibility. We look forward to continuing our leading reporting on the 2024 presidential race and spotlighting the issues that matter most to voters as they head to the polls.” – Rebecca Blumenstein, President of NBC News Editorial

“Salem Media Group and the Salem Radio Network are honored to be chosen by the Republican National Committee to be a part of this historic Republican presidential primary debate. Salem is an experienced partner of the RNC, having co-moderated four RNC debates in 2015-2016. We look forward to working closely with NBC News and other selected partners to deliver an event that will shine a light on the candidates and educate voters ahead of the primary.”– David Santrella, Salem Media Group CEO

“We are honored to partner with the RNC in the upcoming GOP Presidential debate. As the horrific events of the last week have unfolded in Israel, the issue of American foreign policy has taken on an even greater role. American strength and American resolve – and our candidates’ vision for America’s role in the world – are more important than ever.” – RJC Chairman, Sen. Norm Coleman

ABOUT SALEM MEDIA GROUP:

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20231016018491/en/

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

Source: Salem Media Group, Inc.

Released October 16, 2023

Release – Johnny Rockets Opens First Location in Iraq

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

October 16, 2023

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Classic Burger Concept Celebrates Nine International Openings This Year

LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Johnny Rockets and 17 other restaurant concepts, announces nine openings for Johnny Rockets. The most recent new opening, in Baghdad, marks the first Iraqi location, and is operated by Alanwar Alarabiya.

Since February, Johnny Rockets has also opened international locations in the following cities: Fortaleza, Brazil, Cumbica International Airport in Sao Paulo, Brazil, Santiago, Chile, Lima, Peru, Dubai, United Arab Emirates, Abu Dhabi, United Arab Emirates, Talca, Chile, and one ghost kitchen in the United Arab Emirates. Johnny Rockets around the world serve the classic fare that put the brand on the map over 35 years ago, including juicy, made-to-order burgers and hand-spun shakes.

“Johnny Rockets is a timeless concept that we are proud to see succeed across many borders and formats,” said Jake Berchtold, COO of FAT Brands’ Fast Casual Division. “We look forward to continued growth in Iraq, where we see the opportunity to capitalize on an impressive customer base.”

The first Johnny Rockets restaurant opened June 6, 1986, on Melrose Avenue in Los Angeles. Since that time, the chain’s timeless all-American brand has connected with customers across the U.S. and in more than 25 other countries around the globe. The Johnny Rockets team’s passion for delivering fresh, classic American fare is only equaled by their commitment to providing a superb guest experience.

The new Johnny Rockets in Baghdad is located in the Alyarmouk neighborhood at The Four Streets, Allay 616, Ste. 17 Bldg. 105 Baghdad, Iraq and is open 12 p.m. to 12 a.m. seven days a week. The new location’s menu includes halal-friendly cooked-to-order burgers, indulgent, hand-spun real ice cream shakes, crispy fries, chicken options and more.

For more information on Johnny Rockets, visit www.johnnyrockets.com.

###

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Smokey Bones, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Johnny Rockets
Founded in 1986 on Melrose Avenue in Los Angeles, Johnny Rockets is a world-renowned international franchise that offers high-quality, innovative menu items including Certified Angus Beef® cooked-to-order hamburgers, veggie burgers, chicken sandwiches, crispy fries, and rich, delicious hand-spun shakes and malts. With over 325 locations in over 25 countries around the globe, this dynamic lifestyle brand offers friendly service and upbeat music contributing to the chain’s signature atmosphere of relaxed, casual fun.
For more information, visit www.johnnyrockets.com. 

MEDIA C ONTACT :
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Source: FAT Brands Inc.

Release – Harte Hanks Announces CFO Transition Plan

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HHS

Interim appointment of seasoned executive supports the growth-phase strategic plan launched earlier this year

CHELMSFORD, MA / ACCESSWIRE / October 16, 2023 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced the appointment of David Garrison, an experienced finance executive with more than 20 years of public company CFO experience, as Interim Chief Financial Officer, effective October 23, 2023. Lauri Kearnes is stepping down as CFO but will continue to advise the Company as needed through year end to support a smooth transition. Kearnes’ departure is not related to any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

Garrison brings 20 years of public company CFO experience, with particular expertise in cost containment, streamlining operations, and ERP implementations. He joins Harte Hanks from Digital Lumens Incorporated, an IoT lighting fixture and factory automation technology company that was spun out of Osram Sylvania, where he served as CFO for the last two years. As part of this role, he was instrumental in selling a product line to a strategic buyer and selling the remaining operating entity to a foreign company. Previously, he spent three years as Chief Financial Officer for Sensera, Inc., an Australian listed medical and IoT technology company, where he played an important role in turning around operations to facilitate a sale. Previously, he served as Managing Director of IW Ventures LLC, a financial consultant, and TTcogen LLC, a joint venture between Tecogen Inc. and TEDOM a.s. From 2014 to 2017, Garrison served as CFO of Tecogen Inc., a NASDAQ-listed company that designs, manufactures, and sells industrial and commercial cogeneration systems, where he supported growth with cost controls to drive margin expansion and profitability. He has an MBA from Boston University and has led several Greater Boston-based companies through successful growth-driven integrations, transactions, and implementations.

“Lauri has been a valued, long-standing member of our team and we appreciate all of her contributions as Harte Hanks has evolved over the years,” said Kirk Davis, Chief Executive Officer. “She played an instrumental role in providing the company with stability through restructuring and implementing a foundation for profitable growth. David is a proven financial and operational leader who will help advance the next phase of our comprehensive business plan. He brings a deep background in all facets of SEC reporting, compliance, and governance. Importantly, he brings specific and relevant expertise in information technologies and integration, data analytics, customer satisfaction, and expense management.”

Harte Hanks has already initiated a formal search process to select a permanent Chief Financial Officer to advance the company’s current growth plans and new market goals. Garrison’s interim appointment supports the strategic direction and growth-phase plan launched earlier this year after Harte Hanks celebrated its 100-year anniversary. The plan, which kicked off with the appointment of industry-veteran Kirk Davis as new CEO, is strategically designed to help Harte Hanks continue to adapt, change, and modernize, as it has done successfully for a century in business.

The company’s strategic plan includes a collaboration with the Kearney organization, a highly respected global management consulting firm. “I’ve had previous experience working with Kearney and am confident in their ability to help us mitigate inflation, benefit from their excellence in procurement and for our team to gain a deeper understanding of our profit potential,” said Davis. “Our engagement with Kearney is underway and will conclude before year end. The goal is to achieve the flexibility to not only drive profitability, but also make strategic investments that will support growth and further our technical aptitude.”

The company has also hired a new SVP of Sales and Marketing, with a formal announcement on this role to occur later this month.

“Having just completed my first full quarter with Harte Hanks, I am confident these actions will support our ambitions to have a strong 2024,” said Davis. Davis also noted that he remains comfortable with the most recently disclosed revenue baseline for fiscal 2023.

“Harte Hanks has a proud heritage, and the momentum we have right now is a very positive sign for our next 100 years,” continued CEO Kirk Davis. “We have a highly capable team in place, including many key long-term members of our management team and a creative, smart, motivated group of employees across all departments. We are very enthusiastic about the future and see profitable opportunities ahead for Harte Hanks.”

About Harte Hanks:

Harte Hanks (NASDAQ: HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.



View source version on accesswire.com:
https://www.accesswire.com/793221/harte-hanks-announces-cfo-transition-plan

Release – Technical Directions, Inc. and Boeing Sign Memorandum of Understanding for Kratos TDI Engines

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

October 16, 2023 at 8:00 AM EDT

PDF Version

SAN DIEGO, Oct. 16, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. [Nasdaq: KTOS], a Technology Company in the Defense, National Security and Global Markets, today announced a Memorandum of Understanding between Technical Directions, Inc. (TDI), a business unit within Kratos Unmanned Systems Division, and Boeing [NYSE: BA] for the TDI-J85 turbine engine to provide propulsion for the Powered Joint Direct Attack Munition (JDAM).

Boeing’s Powered JDAM combines a 500-pound ordnance, the conventional JDAM guidance kit, with a wing kit and a Kratos TDI-J85 engine to deliver high-end range at an affordable price. The cost savings is in part due to the low-cost turbine engine technology developed and enhanced by TDI over four decades. Powered JDAM will provide low-cost stand-off capability against land and maritime threats. Leveraging the JDAM family of weapons, it is designed to be produced at scale, exportable to any of the 35 JDAM partner nations, at a cost-point that enables affordable mass.

“We are proud that Boeing has selected our TDI-J85 engine for the Powered JDAM system. Incredible potential exists for this long-range, precision strike capability,” said Joseph Kovasity, Senior Vice President for TDI. “At Kratos TDI, we have been singularly focused on producing small, low-cost, military-grade turbine engines at quantity in the United States with U.S. suppliers and partners. With the Kratos acquisition of TDI, we have substantially invested in manufacturability for production scale resulting in an incredibly high engine performance-to-cost ratio, while ensuring we can meet the large quantity deliveries predicted for the Powered JDAM system and program.”

“Powered JDAM is the next step in the modular evolution of the JDAM and JDAM Extended Range family of weapons systems. Its ability to complement exquisite weapons system with low-cost stand-off capability will add new weapons capacity to the U.S. defense industrial base to support the current fight and deter future fights,” said Bob Ciesla, Vice President of Boeing Precision Engagement Systems.

The TDI-J85 straightforward architecture is capable of producing 200-lbf of net thrust at Sea-Level Static conditions. Specific Powered JDAM requirements are met with design adjustments achieving the desired thrust output at design point. The TDI-J85 is compatible with commercial and/or military kerosene-grade turbine fuels. The TDI-J85’s shaft-integral permanent magnet generator will produce up to 1.5 kW of AC power, from idle through maximum engine speeds, for P-JDAM’s onboard power requirements.

About Technical Directions Inc.
TDI has developed and refined turbine engine technologies for military applications in Michigan since 1983—providing unique features in support of low-cost, expendable turbojet engine applications, such as miniature cruise missiles and other Unmanned Aerial Vehicles (UAVs). With the engineering, manufacturing, and system integration employees in the Oxford, Michigan facility, TDI’s subject matter experts have experience that encompasses all aspects of this turbine engine class, from clean-sheet design, through performance testing, vehicle integration, flight testing, and production manufacturing. TDI is a wholly owned subsidiary of Kratos Defense & Security Solutions. For more information, visit www.TDI-Engines.com.

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 the 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, visit http://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.

Kratos Press Contact:
Yolanda White
858-812-7302 Direct

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

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 UPLIFT Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 16, 2023 7:00am EDTDownload as PDF

Topline Results Expected Early November 2023

Tianeptine, the Active Ingredient in TNX-601 ER, is Not Associated with Sexual Dysfunction or Weight Gain Which are Treatment-Limiting Side Effects of Many Traditional Antidepressants

Tianeptine Acts by Directly Restoring Neuroplasticity and Neurogenesis and Limiting the Effects of Oxidative Stress in the Brain

CHATHAM, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 potential registration-quality, double-blind, randomized, multicenter, placebo-controlled UPLIFT1 study of TNX-601 ER2 (tianeptine hemioxalate extended-release tablets) as a potential treatment for major depressive disorder (MDD). Topline results from the intention-to-treat (ITT) sample (N=132) are expected in early November 2023.

TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD and works by a distinct mechanism of action as compared to traditional monoaminergic antidepressants. Tonix recently reported that tianeptine activates peroxisome proliferator-activated receptors PPAR-β/δ and PPAR-γ. These activities on intracellular molecular targets in neurons and glia in the brain are believed to relate to tianeptine’s ability to restore connectivity between neurons that atrophy under conditions of stress, in animal models.3,4 Tianeptine is the active ingredient of an antidepressant that has been marketed as a three-times-a-day medicine outside the U.S. for more than 30 years. Tonix has developed a novel, patented once-daily oral formulation.

“Because of its unique mechanism, tianeptine avoids some of the treatment-limiting side effects of traditional antidepressants, including sexual dysfunction and weight gain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tianeptine restores connectivity between neurons, or neuroplasticity, and limits the effects of oxidative stress in the brain in animal models of depression. In contrast to traditional antidepressants which alter the levels of neurotransmitters in the synapse, tianeptine directly induces mature neurons to sprout new connections and also induces formation of new neurons.”

“With the last patient now treated, we look forward to analysis of the results of this registration-quality study, which will help to inform our plans as we discuss next steps with the U.S. Food and Drug Administration (FDA),” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We would like to thank the participants, their families, and all the investigators and researchers who have been an important part of this journey so far.”

  1. Clinical Trials.gov I.D. NCT05686408
  2. TNX-601 ER is an investigational new drug and is not approved for any indication.
  3. McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249
  4. Sullivan, GM et al. June 1, 2023. Poster presentation at the American Society of Clinical Psychopharmacology, Miami, FL. https://www.tonixpharma.com/wp-content/uploads/2023/06/ASCP-Poster-2023-A-Randomized-Placebo-Controlled-Multicenter-Trial-of-Monotherapy-with-TNX-601-ER.pdf

About the Phase 2 UPLIFT Study

The Phase 2 UPLIFT study, TNX-TI-M201, is a potential registration-quality, double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken by mouth once-daily for 6 weeks for the treatment of moderate-to-severe MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 132 participants were randomized in a 1:1 ratio into the two arms across approximately 27 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).

For more information, see ClinicalTrials.gov Identifier: NCT05686408.

About Major Depressive Disorder (Depression)

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

1 Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults 2020. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

2 IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.

3 Kubitz N, et al. PLoS One 2013, 8 (10), e76882.

4 Rush AJ, et al. Am J. Psychiatry 2007, 163 (11), 1905-1917.

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine designed for once-daily daytime dosing in development as a candidate for the treatment of MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. 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. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. 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 TNX-601 ER’s 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 basis2). 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. The ER formulation of TNX-601 includes several potentially abuse deterrent ingredients, such as gel forming polymers which impede extraction. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which potentially hinders efforts to misuse by insufflation or intravenous routes. 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. TNX-601 ER is expected to have patent protection through 2037.

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. 

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released October 16, 2023

Orion Group Holdings (ORN) – Additional Detail On New Award

Posted on by cpereira@noblefcm.com


Monday, October 16, 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.

Detail. Orion released some additional info regarding the new awards announced in its September 28th 8-K filing. The over $100 million design/build award was awarded by Grand Bahama Shipyard Limited for the turnkey design-build of the Grand Bahama Shipyard Dry Dock Replacement Project. The $121 million of other awards was split into $50.8 million of new Concrete business and $68.5 million of new Marine business.

Dry Dock. Grand Bahama Shipyard Dry Dock award was a competitive bid/negotiation process. The scope of work includes marine works and infrastructure construction, dredging, creating new mooring facilities, and providing enhancements to shore stability. In addition, Orion will modify and extend service piers for the installation of two cutting-edge floating dry docks, which are among the largest in the western hemisphere. The project is set to commence immediately and will conclude in late 2025.


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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. 

MAIA Biotechnology (MAIA) – Journal Publishes THIO Data In Pediatric Brain Cancer Models

Posted on by cpereira@noblefcm.com


Monday, October 16, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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

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Data Shows Efficacy In An Aggressive Pediatric Brain Cancer. MAIA announced that preclinical data on the use of THIO, its lead product for multiple cancers, was published in the journal Neuro-Oncology. The presentation tested THIO in diffuse intrinsic pontine glioma, an aggressive form of brain cancer in which radiotherapy is the only treatment but has only marginal efficacy. The data shows that THIO was able to activate immune pathways in the tumors, sensitizing the tumors to radiotherapy. In addition to a potential new indication, we see this as consistent with the theorized mechanism of action and provides further proof of concept for THIO.

THIO’s Mechanism Of Action Improved Responses To Radiotherapy. THIO targets the telomers of dividing cancer cells, causing damage that leads to cell death. As discussed in our report on February 21, the DNA released from the dead cancer cells is detected by a protective pathway known as cGAS-STING that activates the immune system pathways and produces an anti-tumor response. The study found that the THIO treatment also sensitized the tumors to radiotherapy, leading to improved efficacy.


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