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Release – Comtech Receives Additional Funding for U.S. Army Communications

Posted on February 7, 2023February 7, 2023 by aweinsoff@channelchek.com

Feb 7, 2023 9:45 AM

MELVILLE, N.Y. –
February 7, 2023– Comtech (NASDAQ: CMTL) announced today that it was awarded four Very Small Aperture Terminal (VSAT) III Satellite Systems and Services task order modifications exceeding $20 million dollars, under the Global Tactical Advanced Communication Systems (GTACS) IDIQ award, to support global U.S. Army operations.

“With the convergence of space and terrestrial communications, the seamless mobility of information is paramount to maintaining strategic advantage across today’s information dominant battlespace,” said Ken Peterman, President and CEO, Comtech. “Current events illustrate the significant advantage communications technologies provide to warfighters operating across all domains. As the United States Department of Defense (DOD) continues to allocate technology resources to deter adversaries and address a wide range of geopolitical challenges, Comtech is uniquely positioned to deliver resilient, battle-proven communications capabilities that will significantly enhance information dominance, and mission effectiveness in all domain operations.”

Comtech’s portfolio of defense and security technologies are uniquely positioned to deliver capabilities that will enhance Joint All Domain Command and Control (JADC2) operations. The company has extensive experience developing and deploying customized, interoperable, robust, and resilient communications systems for all branches of the DOD and coalition forces. Comtech’s expansive portfolio of defense and security technologies is designed to continuously evolve over time to meet emerging Command, Control, Computers, Communications, Cyber, Intelligence, Surveillance and Reconnaissance (C5ISR) use cases and enhance mission effectiveness in future all domain command and control operations.

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.

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.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230206005623/en/

Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Onconova Therapeutics Announces Additional Clinical Data Demonstrating Rigosertib’s Monotherapy Activity In Rdeb-Associated Squamous Cell Carcinoma

Posted on February 7, 2023February 7, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Two of two evaluable participants in an ongoing investigator-sponsored program of rigosertib in RDEB-associated squamous cell carcinoma (SCC) have achieved a complete response of all cancerous skin lesions

First evaluable participant has been in complete remission with no signs of metastatic disease for >18 months; the second patient has achieved a complete response in all squamous cell skin lesions following four cycles of treatment and remains on therapy with additional scans to follow to evaluate metastatic disease

Onconova plans to review initial data with regulators to gain insights on the optimal regulatory pathway for rigosertib in RDEB-associated SCC, an ultra-rare and invariably fatal condition

NEWTOWN, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the second of two evaluable participants in an investigator-initiated Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) achieved a complete response of all cancerous skin lesions following 4 treatment cycles and remains on oral rigosertib.

The Company previously announced that the RDEB-associated SCC program’s first evaluable participant achieved a RECIST-defined complete response. Both of the program’s evaluable participants remain on therapy, with the first participant in complete remission with no signs of metastatic disease for more than 18 months. Rigosertib continues to demonstrate a favorable safety profile in this indication that is similar to that displayed in prior studies in other indications.

“Though from only two participants, the emerging data from this Phase 2 program show rigosertib displaying a level of anti-cancer activity in RDEB-associated SCC that far exceeds what we have seen with currently available treatments,” said Professor Andrew P South from Sidney Kimmel Cancer Center, Thomas Jefferson University. “Given its ultra-orphan nature and the extremely high unmet need in RDEB-associated SCC, I believe regulatory discussions to enable rigosertib’s expeditious advancement to potential approval in this indication are warranted. In parallel, we plan to continue advancing this Phase 2 program and to report more detailed data at a future medical meeting.”

RDEB is caused by insufficient expression of type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by over expression of polo like kinase 1 (PLK1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively^1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC^1,3.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “We are pleased to be building on this Phase 2 program’s initial single-patient data with a second participant showing complete resolution of all cancerous skin lesions, with the most recent patient notably seeing this result after only four cycles of therapy. We look forward to reviewing our findings with the FDA to determine the most expeditious regulatory path for rigosertib in RDEB-associated SCC. In addition, these findings may have important implications beyond this orphan indication, as they and prior preclinical data demonstrate rigosertib’s activity against the PLK1 protein. Although the company is focusing its resources mainly on the lead narazaciclib program, preclinical studies exploring rigosertib’s activity in other PLK1-dependent tumors are underway and will hopefully open a broader regulatory path for rigosertib.”

Onconova and a program investigator plan to present more detailed data on the first two evaluable participants from the Phase 2 RDEB-associated SCC program at a future medical meeting. In addition, preclinical data on rigosertib’s mechanism of action have been accepted for presentation at the American Association for Cancer Research (AACR) Targeting RAS Conference, which is taking place in Philadelphia, Pennsylvania from March 5 – 8, 2023.

About Rigosertib

Rigosertib is an investigational product candidate with a multi-faceted mechanism of action targeting proteins containing the RAS binding domain, allowing it to modulate the PI3K and PLK-1 pathways, as well as the tumor immune microenvironment. It is currently being evaluated in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer refractory to pembrolizumab, the current standard of care for these patients, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

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 two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including 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, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

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

References

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

Forward-Looking Statements

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

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

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

MustGrow Biologics Corp. (MGROF) – Commercialization Is The Goal

Posted on February 7, 2023February 7, 2023 by cpereira@noblefcm.com

Tuesday, February 07, 2023

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

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

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

Conversation With CEO Giasson. We had an opportunity to speak with MustGrow Biologics CEO Corey Giasson about milestones and goals for 2023. In a nutshell, 2023 will be about moving towards commercialization of MustGrow’s organic mustard-derived crop protection and food preservation technology. We believe MustGrow continues to have ample capital to support the Company through commercialization.

Timing? While one cannot pinpoint an exact date, we believe commercialization of TerraMG could occur in 2023, resulting in revenue generation in 2024. The first commercial application likely will be for preplant soil biofumigation, an estimated $1.3 billion market in fruit and vegetables. Additional field trials are currently being conducted for bananas, canola, and pulse crops in this area.

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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.

Largo Inc. (LGO) – Coverage Initiated With a $11 Price Target

Posted on February 7, 2023February 7, 2023 by cpereira@noblefcm.com

Tuesday, February 07, 2023

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

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

Largo is a play on growing vanadium demand. We believe Largo, Inc. offers investors an attractive way to play an expected growth in the demand for vanadium due to its use in large-scale energy storage. Largo is the largest producer of vanadium outside of China and Russia. The high vanadium concentration of is Maracas Menchen Mine in Brazil makes Largo one of the lowest-cost producers of vanadium in the world.

Largo is involved with vanadium batteries. In addition to mining vanadium, Largo has formed a division to manufacture and install Vanadium Redox Flow Batteries (VRFB). VRFBs have key advantages over other battery types in terms of scalability, cost, and safety making them ideal for grid operations. VRFB can store energy for months and have operating duration periods of 6-10 hours. Vanadium used in VRFBs has little degradation and can be recovered and reused upon recycling.

Get the Full Report

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

How is the Economy Really Doing (Just the Facts)?

Posted on February 7, 2023February 7, 2023 by phoffman@channelchek.com

Do the Most Current Economic Measurements Suggest a Trend Toward Recession or Growth?

How is the US Economy Doing?

US GDP increased 2.1% in 2022 after increasing 5.9% in 2021.
Year-over-year inflation, the rate at which consumer prices increase, was 6.5% in December 2022.
The Federal Reserve raised interest rates seven times in 2022 and again on February 1, 2023 to curb inflation, increasing the target rate from near zero to 4.5-4.75%.
When accounting for inflation, workers’ average hourly earnings were down 1.7% in December 2022 compared to a year prior.
The ratio of unemployed people to job openings remained at or near record lows throughout 2022.
The unemployment rate was 4.0% at the beginning of 2022 and ended the year at 3.5%.
The labor force participation rate remains almost one percentage point below February 2020.
From January to November 2022, the US imported $889.9 billion more in goods and services than it exported. This is 7% higher than the trade deficit in 2021 for the same months.

US GDP increased 2.1% in 2022 after increasing 5.9% in 2021

Gross domestic product (GDP) fell in the first half of 2022 but grew in the second half. GDP reached $25.5 trillion in 2022.

Year-over-year inflation, the rate at which consumer prices increase, was 6.5% in December 2022

That’s down from June 2022’s rate of 9.1%, the largest 12-month increase in 40 years. Inflation grew at the beginning of the year partly due to rising food and energy prices, while housing costs contributed throughout 2022.

The Federal Reserve raised interest rates seven times in 2022 and again on February 1, 2023 to curb inflation, increasing the target rate from near zero to 4.5-4.75%

Rate increases make it more expensive for banks to borrow from each other. Banks pass these costs on to consumers through increased interest rates. Read more about how the Federal Reserve tries to control inflation here.

When accounting for inflation, workers’ average hourly earnings were down 1.7% in December 2022 compared to a year prior

Inflation-adjusted average hourly earnings fell in all industries except information and leisure and hospitality, where earnings were flat.

The ratio of unemployed people to job openings remained at or near record lows throughout 2022

In a typical month from March 2018 and February 2020, there were between 0.8 and 0.9 unemployed people per job opening. But after more than quadrupling in April 2020 at the onset of the pandemic, the ratio fell and settled from December 2021 to December 2022 to between 0.5 and 0.6 unemployed people per job opening, the lowest since data first became available in 2000.

The unemployment rate was 4.0% at the beginning of 2022 and ended the year at 3.5%

It decreased most for Black and Asian people, 1.2 and 1.1 percentage points, respectively. Black people still have unemployment rates higher than the rest of the nation.

The labor force participation rate remains almost one percentage point below February 2020

An additional 2.5 million workers would need to be in the labor force for the participation rate to reach its pre-pandemic level.

From January to November 2022, the US imported $889.9 billion more in goods and services than it exported. This is 7% higher than the trade deficit in 2021 for the same months

During this time, the goods trade deficit reached $1.1 trillion. Complete 2022 data is expected on February 7, 2023.

This content was republished from USAFacts. USAFacts is a not-for-profit, nonpartisan civic initiative making government data easy for all Americans to access and understand. It provides accessible analysis on US spending and outcomes in order to ground public debates in facts.

AI a New Favorite Among Retail Investors

Posted on February 7, 2023February 7, 2023 by phoffman@channelchek.com

Recent Investment Trends Include Small-Cap Artificial Intelligence Stocks

C3 AI, sometimes written C3.ai, is an artificial intelligence platform that provides services for companies to build large-scale AI applications. Its stock had the fifth highest traded shares among Fidelity’s retail investors on Monday (February 6). This included a record-breaking $31.4 million worth of shares traded among the broker’s individual self-directed traders. According to Reuters, “Retail investors are piling up on small-cap firms that employ artificial intelligence amid intensifying competition between tech titans.” The article points to Google and Microsoft as examples of companies that expect AI to be the next meaningful driver of growth.

Investors, for their part, are looking to get ahead of any acquisition spree that deep-pocketed companies may embark on, which could include buying the advanced technology by acquiring small-cap tech firms.

Focus Heightened by ChatGPT

The spotlight ChatGPT finds itself in, three months after its launch, is indicicative of the interest in this technology amongst investors and users. With applications as numerous than one can think up, the technology could outdate many services provided by tech companies like Alphabet (GOOGL), or Microsoft (MSFT) – big tech has catching up to do. This seems to have created a race by cash rich companies to not be disrupted and left behind.

Investor’s recent focus on small companies in this space prefer those that are concentrated in AI technology. One main reason is that small-cap or microcap firms in this space are likely to have AI as a more concentrated part of their business. The bet being that whether the small company continues to grow independently, or is acquired by a larger firm looking to instantly be par with current technology, doesn’t much matter, it is a win for the investor if either occurs.

And it is a win, C3 AI stock rallied 46% last week, and climbed another 6.5% on Monday. It is now up 146% year to date.

Other Companies Involved

SoundHound AI, provides a voice AI platform services, and Thailand-based security firm Guardforce AI have more than doubled so far this year, while analytics firm BigBear.AI has increased ninefold.

US-listed shares of Baidu Inc climbed after the Chinese search engine indicated it would complete an internal test of a ChatGPT-style project called “Ernie Bot” next month.

Shares of Microsoft, which supports ChatGPT parent OpenAI, had been ratcheting up over the past month. The company is expected to make an announcement on their AI gained 1.5% in premarket trading ahead of the AI plans this week.

Google-owner Alphabet Inc said this week it would launch Bard, a chatbot service for developers, alongside its search engine.

Take Away

Change in technology that leads to improvements in daily lives has always been a focus of investors betting on which companies will outlast the others with “the next big thing.” These companies start out as small growth companies as Apple (AAPL) did in 1976. Then, a number of paths lay ahead. They either grow on their own like the Jobs/Wozniak computer maker did, get acquired for an early payday for investors and other stakeholders, or they can be outcompeted leaving investors with a non-performing asset.

Channelchek is a platform that specializes in bringing data and research on small-cap companies, including many varieties of new technology, to the investors that insist on being informed before they place a trade. Discover more on the industries of tomorrow by signing up for notifications in your inbox from Channelchek by registering here.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.reuters.com/markets/us/retail-investors-flock-small-cap-ai-firms-big-tech-battles-share-2023-02-07/

https://www.barrons.com/articles/c3-ai-stock-rally-bull-wall-street-51675441248?mod=Searchresults

Release – FAT Brands Accelerates Organic Growth in 2022 with 362 Stores Added to Development Pipeline

Posted on February 6, 2023February 6, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FAT

FEBRUARY 06, 2023

Global Restaurant Franchising Company Builds Upon 1,000 Unit Pipeline

LOS ANGELES, Feb. 06, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., a leading global franchising company that owns a number of iconic restaurant brands, including Johnny Rockets, Fatburger, Round Table Pizza, Twin Peaks, Fazoli’s and 12 other concepts, announces it has experienced a historic year of growth, opening 142 new stores in 2022 and adding a total of 362 stores to its development pipeline which spans 29 states and 17 countries.

Leading the way in new store development amongst FAT Brands’ concepts was Fatburger and Buffalo’s Express with 86 stores, Fazoli’s with 61, Round Table Pizza with 56, and Twin Peaks with 50. Noteworthy franchise deals included a combined 80-store development agreement for 40 Fatburger and Buffalo’s Express locations and 40 Round Table Pizza restaurants in the state of Texas, a 32-store agreement for Twin Peaks in Mexico, and a10-store agreement for Johnny Rockets in Israel.

Other strategic deals included 10 Marble Slab Creamery locations in Egypt and a nine-store development deal for Fazoli’s in Phoenix, AZ. The record-breaking development activity by the company will also bring its iconic portfolio to highly anticipated areas, such as Fatburger arriving in Florida, Puerto Rico and Atlanta, GA, Fazoli’s landing in Louisiana and Dallas, TX, and Twin Peaks growing its presence in Chicago, IL.

“We are extremely proud of our organic growth and the performance of our team in 2022,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “Franchisee interest was at an all-time high from both new and existing franchisees, which speaks volumes to our robust portfolio of brands that continue to deliver strong same-store sales and attract new fans around the globe. This year, we will remain focused on converting our over 1,000-unit pipeline into new stores, approximately 175 of which are set to open in 2023, along with continuing to fuel our long-term growth with additional development deals.”

For more information on FAT Brands, visit www.fatbrands.com.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing and performance of new store openings, area development agreements, and growth in same-store sales. Forward-looking statements reflect expectations of FAT Brands Inc. (“we”, “our” or the “Company”) concerning the future and are subject to significant business, economic and competitive risks, uncertainties and contingencies, including but not limited to uncertainties surrounding the severity, duration and effects of the COVID-19 pandemic. These factors are difficult to predict and beyond our control, and could cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other factors. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

MEDIA C ONTACT :
Erin Mandzik, FAT Brands
emandzik@fatbrands.com
860-212-6509

Release – Direct Digital Holdings to Ring Nasdaq Closing Bell on Tuesday, February 14, 2023 to Celebrate One-Year Anniversary of Public Listing

Posted on February 6, 2023February 6, 2023 by aweinsoff@channelchek.com

Research News and Market Data on DRCT

February 06, 2023 9:00am EST

HOUSTON, Feb. 6, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company will ring the Nasdaq closing bell on Tuesday, February 14, 2023, in celebration of one year since the Company listed on The Nasdaq Capital Market under ticker “DRCT”.

Company attendees at the closing bell ceremony include:

Mark D. Walker, Chairman, Co-Founder & Chief Executive Officer
Keith Smith, Director, Co-Founder & President
Susan Echard, Chief Financial Officer
Anu Pillai, Chief Technology Officer
Maria Vilchez Lowrey, Chief Growth Officer
Kristie MacDonald, Chief Executive Officer, Huddled Masses
Lashawnda Goffin, Chief Executive Officer, Colossus SSP
Doug Mankiewicz, Chief Executive Officer, Orange142
Tonie Leatherberry, Director, Direct Digital Holdings
Richard Cohen, Director, Direct Digital Holdings
Misty Locke, Director, Direct Digital Holdings

The live broadcast will start at 3:45 PM Eastern Time on February 14, 2023 from the Nasdaq MarketSite Tower in New York City, New York. Please tune in to the broadcast by visiting www.nasdaq.com/marketsite/bell-ringing-ceremony.

Mark D. Walker commented on the occasion, stating, “As the ninth black-owned company to go public in the U.S., we are thrilled to be recognized by Nasdaq and thankful for the opportunity to ring the closing bell. To us, this ceremony will commemorate a year of tremendous growth and success since we first went public in February of 2022. We remain committed to delivering high-quality, technology-led digital advertising solutions to our clients and are excited for the further growth that access to the public markets allows us.”

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, video, CTV, in-app and other media channels. Direct Digital Holdings is the ninth black-owned company to go public in the U.S and was named a top minority-owned business by The Houston Business Journal.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to Direct Digital Holdings. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, of receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-to-ring-nasdaq-closing-bell-on-tuesday-february-14-2023-to-celebrate-one-year-anniversary-of-public-listing-301739353.html

SOURCE Direct Digital Holdings

Released February 6, 2023

Release – PDS Biotech Announces Abstract Accepted for Presentation at ESMO Targeted Anticancer Therapies Congress

Posted on February 6, 2023February 6, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Abstract, titled “HPV16-specific CD4 and CD8 T cell activation and functionality in patients receiving combination PDS0101 immunotherapy,” highlights data generated from VERSATILE-002 Phase 2 study

FLORHAM PARK, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that an abstract investigating the ability of PDS0101 in combination with KEYTRUDA^® (pembrolizumab) to induce HPV16-specific CD4 and CD8 T cell activation and functionality has been accepted for presentation at the ESMO Targeted Anticancer Therapies Congress 2023 (ESMO TAT) in Paris, March 6-8, 2023.

PDS Biotech’s HPV-targeted immunotherapy, PDS0101, is being studied in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in the Phase 2, VERSATILE-002 clinical trial (NCT04260126) in patients with advanced recurrent or metastatic HPV16-positive head and neck cancer. Measurement of antigen-specific activation of endogenous T cells is critical to understanding drug-induced, T cell based immunity and its association with observed clinical outcomes.

Abstract Number: 246
Abstract Title: HPV16-specific CD4 and CD8 T-cell activation and functionality in patients receiving combination PDS0101 immunotherapy
Authors: Dr. Lauren V. Wood, Dr. David Schaaf, Nathalie Riebel, and Sally Jones from PDS Biotech and Stephen McCarthy, Dr. Adam Cotty and Dr. Julie Bick from FlowMetric

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^®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune^® and PDS0301 based candidates 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 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. 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 our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, 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 – Alvopetro Announces January 2023 Sales Volumes, our Semi-Annual Natural Gas Price Redetermination, 2023 Capital Plans and an Operational Update

Posted on February 6, 2023February 6, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ALVOF

Feb 06, 2023

CALGARY, AB, Feb. 6, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces January 2023 sales volumes, our February 1, 2023 natural gas price redetermination, our 2023 capital plan and an operational update.

President and CEO, Corey Ruttan commented:

“Building on our record year in 2022 we are looking forward to our 2023 capital plan. Our focus this year is on adding production and reserves from our lower risk development opportunities. We have made the key infrastructure investments necessary to realize the full potential from our Murucututu natural gas project. This project has significant reserves and resources and our goal is to unlock this potential with a multi-year development plan starting this year.”

January 2023 sales volumes

January sales volumes averaged 2,754 boepd, including natural gas sales of 15.6 MMcfpd, associated natural gas liquids sales (condensate) of 141 bopd, and 5 bopd of oil sales, based on field estimates, a 1% increase from our Q4 average daily volumes.

Operational Update and 2023 Capital Plans

Murucututu (100% Alvopetro)

On our Murucututu project, we expect to commence the stimulation on our 197(1) well later this quarter. We have already completed the work to tie-in this well to our 183(1) facility and expect to commence production in the second quarter. We also plan to drill two “fit-for-purpose” Gomo development wells in 2023. One of these locations has additional uphole exploration potential in the Caruaçu and Marfim Formations. Total capital expenditures of $16 million are budgeted for Murucututu in 2023.

Caburé (49.1% Alvopetro)

Our 2023 capital budget includes an expansion of the unit facilities and drilling two additional development wells. Total expenditures of $3 million are budgeted for Alvopetro’s share of 2023 capital expenditures on our Caburé project.

Bom Lugar (100% Alvopetro)

In 2023, we plan to drill up to two development wells on our Bom Lugar oil field, targeting the Caruaçu Formation with additional potential in the deeper Gomo and Agua Grande Formations. Capital expenditures of up to $11 million are budgeted in 2023 for Bom Lugar, including the development wells and facility upgrades.

Mãe-da-lua (100% Alvopetro)

2023 capital expenditures include $0.5 million at our Mãe-da-lua field where we plan to complete a stimulation of our existing well to improve oil recovery rates.

Exploration (100% Alvopetro)

In 2022, Alvopetro drilled two exploration prospects, 182-C, and 183-B. We encountered thick, hydrocarbon saturated zones in the Sergi Formation which have demonstrated low permeability during testing operations. Alvopetro continues to evaluate alternatives to enhance permeability in the Sergi Formation in both wells and in the Agua Grande Formation of the 183-B1 well. We are evaluating alternatives to remediate possible permeability impacts from near wellbore damage. This work is expected to start with the 182-C2 well later this quarter. Capital costs of $0.4 million are currently budgeted on these projects in 2023, including final testing costs on 182-C2 incurred in January. Future capital expenditures will depend on these initial results.

Semi-Annual Natural Gas Price Redetermination

Effective February 1, 2023, our natural gas price under our long-term gas sales agreement with Bahiagás has been adjusted to BRL2.00/m³ or $11.88/Mcf (based on our average heat content to date and the January 31, 2023 BRL/USD foreign exchange rate of 5.10). This price represents an increase of 3.6% from our prior contracted price and will be effective for natural gas sales from February 1 to July 31, 2023. Including recently approved and enhanced sales tax credits, our realized gas price, net of sales taxes, is expected to be $12.40/Mcf (based on our average heat content to date and the January 31, 2023 BRL/USD foreign exchange rate of 5.10).

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation.

Social Media

Follow Alvopetro on our social media channels at the following links: Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltdYouTube –https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

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

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Abbreviations:

bbls	=	barrels
boepd	=	barrels of oil equivalent (“boe”) per day
bopd	=	barrels of oil and/or natural gas liquids (condensate) per day
BRL	=	Brazilian real
m³	=	cubic metre
Mcf	=	thousand cubic feet
MMcf	=	million cubic feet
MMcfpd	=	million cubic feet per day

BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward–looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning plans relating to the Company’s operational activities, proposed exploration and development activities and the timing for such activities, capital spending levels and future capital costs, and the expected natural gas price, gas sales and gas deliveries under the Company’s long-term gas sales agreement. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning the timing of regulatory licenses and approvals, equipment availability, the success of future drilling, completion, testing, recompletion and development activities, the performance of producing wells and reservoirs, well development and operating performance, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the outlook for commodity markets and ability to access capital markets, foreign exchange rates, general economic and business conditions, the impact of the COVID-19 pandemic, weather and access to drilling locations, the availability and cost of labour and services, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.

Release – Tonix Pharmaceuticals Initiates Enrollment in Phase 2 ‘PREVENTION’ Study of Potentiated Intranasal Oxytocin (TNX-1900) for the Prevention of Migraine Headaches in Chronic Migraineurs

Posted on February 6, 2023February 6, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 06, 2023 7:00am EST

Results from Planned Interim Analysis Expected Fourth Quarter 2023

Approximately Four Million in U.S. Suffer from Chronic Migraine

Development of TNX-1900 Also Planned for Treatment of Episodic Migraine

CHATHAM, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 ‘PREVENTION’ study of TNX-1900 (intranasal potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs.

The double-blind, placebo-controlled study has a target enrollment of 300 participants at approximately 25 sites across the U.S. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023.

“Despite several classes of migraine preventatives available, there remains an unmet need for novel approaches with an estimated four million individuals in the United States suffering from chronic migraine, often a seriously disabling condition,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1900 has a unique, multimodal mechanism of action, that includes an ability to inhibit the release of the trigeminal sensory neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining and the brainstem, and to suppress signaling in pain neurons. We believe that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine. TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition.”

Shashidar Kori, M.D., former Chief Medical Officer of Trigemina and consultant to Tonix added, “After a decade of development and optimization of our proprietary oxytocin formulation, it is very gratifying and exciting to enter the next stage of testing required to make TNX-1900 available to unfortunate chronic migraine sufferers who have few treatment options. This has the potential to improve the quality of life of people suffering from chronic migraine.”

About the Phase 2 PREVENTION Study

The Phase 2 PREVENTION study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 taken prophylactically on a daily basis to prevent chronic migraine. There are three arms: two treatment regimens of TNX-1900 and one placebo in a 1:1:1 ratio in a total of 300 participants across approximately 25 U.S. sites. After a four-week Run-In phase to confirm meeting chronic migraine criteria, there are 12-weeks of a double-blind Treatment phase with study drug, followed by a 2-week safety Follow-up phase. The primary efficacy endpoint is mean change in the number of migraine headache days between the 28-day Run-In phase and the last 28-days of the Treatment phase. Key secondary efficacy endpoints include proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days, mean change in the number of days using migraine abortive medications, and mean change in a migraine-specific quality of life measure. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of potential sample size re-estimation, currently anticipated in the fourth quarter of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05679908

About Migraine
Migraine is a neurological condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises¹. Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.² In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).² The current FDA approved drugs for migraine prevention in chronic migraine include Botox^® (onabotulinumtoxin), and the anti-CGRP/CGRP-R monoclonal antibodies Aimovig^® (erenumab), Vyepti^® (eptinezumab), Ajovy^® (fremanezumab) and Emgality^® (galcanezumab).

About TNX-1900
TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system³ resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.⁴ Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding⁵ as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models⁷. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children⁶. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies⁸. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

About TNX-2900
TNX-2900 is another intranasal potentiated oxytocin-based therapeutic candidate, being developed for the treatment of Prader-Willi syndrome, or PWS. The technology for TNX-2900 was licensed from the French National Institute of Health and Medical Research. PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite later in childhood.

¹The International Classification of Headache Disorders, 3^rd Edition. Cephalalgia. 2018. 38(1):1-211.
²Burch et al., Migraine: Epidemiology, Burden, and Comorbidity, Neurol Clin 37 (2019):631–649.
³Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
⁴Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
⁵Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
⁶Yeomans, DC et al. 2017. US patent US2017368095
⁷Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
⁸MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788

About Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. 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 second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, entered the clinic with a Phase 2 study in the first quarter of 2023 and interim data are expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600; humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals,TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)

Tonix Pharmaceuticals

investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners

Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)

ICR Westwicke

peter.vozzo@westwicke.com

(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released February 6, 2023

Newegg Commerce, Inc. (NEGG) – A Growth Company Not Fully Hatched

Posted on February 6, 2023February 13, 2023 by cpatches

Monday, February 06, 2023

Newegg Commerce, Inc. (NASDAQ: NEGG), founded in 2001 and based in the City of Industry, Calif., near Los Angeles, is a leading global online retailer for PC hardware, consumer electronics, gaming peripherals, home appliances, automotive and lifestyle technology. Newegg also serves businesses’ e-commerce needs with marketing, supply chain and technical solutions in a single platform. For more information, please visit Newegg.com.

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

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

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

Initiating coverage with an Outperform rating. We believe Newegg has a platform that is positioned to benefit from a fast-growing e-commerce vertical, namely, electronics. The company’s platforms serve both B2B and B2C customers on an international scale, reaching more than 20 countries. Moreover, the company has additional growth opportunities through expansion into other e-commerce verticals.

Growing e-commerce market. The global retail e-commerce market is expected to grow at 13.5% CAGR from 2019-2026. Notably, the North American technology e-commerce market, Newegg’s area of focus, is expected to grow even faster, at 25% CAGR over the same period.

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

Alliance Resource Partners (ARLP) – Growth from a Position of Strength

Posted on February 6, 2023February 6, 2023 by cpatches

Monday, February 06, 2023

ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Updating estimates. While our 2023 earnings per unit estimate is unchanged at $5.90, we have made several adjustments in our model resulting in a modest reduction in EBITDA to $1.14 billion from $1.18 billion. Operating, depreciation, depletion and amortization, and general and administration expenses were increased, while net interest expense and income tax expense were lowered. Estimates for certain line items are now more aligned with management guidance.

Attractive total return potential. In our view, the stock price did not respond in line with the partnership’s outstanding fourth quarter and full year 2022 financial results, along with the 40% increase in its quarterly cash distribution per unit to $0.70 or $2.80 on an annualized basis. The indicated distribution rate represents a 12.6% yield based on the recent closing price and an 8.75% yield based on our price target of $32 per unit implying total return potential of greater than 50%.

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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).