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Release – Tonix Pharmaceuticals Completes Clinical Stage of Phase 3 RESILIENT Study of TNX-102 SL for the Management of Fibromyalgia

Posted on November 15, 2023November 15, 2023 by aweinsoff@channelchek.com

November 15, 2023 7:00am EST

Topline results expected late December 2023

RESILIENT is expected to be the final efficacy trial required for submission of a New Drug Application to FDA; first successful Phase 3 trial, RELIEF, achieved statistical significance (p=0.010)

Preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8% which compares favorably with prior studies: RELIEF 6.0% and RALLY 10.7%

TNX-102 SL is a centrally acting, non-opioid analgesic

CHATHAM, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT¹ study of TNX-102 SL² (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

“There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia. We believe TNX-102 SL works by improving sleep quality, which leads to improvement of other symptoms. In previous studies, TNX-102 SL showed broad coverage across the symptoms of fibromyalgia, including chronic widespread pain, fatigue and sleep disturbance.”

“The preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8%,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “This compares favorably to the blinded AE-related discontinuation rates in our two previous Phase 3 trials: 6.0% in RELIEF which achieved statistical significance on the primary endpoint (p=0.010), and 10.7% in RALLY which was stopped at the interim analysis. We later learned that an unexpectedly high rate of AE-related discontinuations in RALLY contributed to missing the primary endpoint. The study was conducted during the Delta wave of the COVID pandemic, which we believe may have contributed to patient discontinuations. AE-related discontinuations are treated as negative outcomes in the ‘missing data’ multiple imputation approach that is part of the analysis of the primary endpoint.”

In December 2020, Tonix reported positive results from the first Phase 3 RELIEF study of TNX-102 SL 5.6 mg for the management of fibromyalgia.³ TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.010) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints, demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies. The most common treatment-emergent adverse events were oral hypoesthesia, oral paresthesia, and product taste abnormal.

¹Clinical Trials.gov I.D. NCT05273749
²TNX-102 SL is an investigational new drug and is not approved for any indication.
³Lederman S, et al. Arthritis Care Res. 2023. 75(11):2359-2368.

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial randomized 457 participants across 33 sites in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores) for TNX-102 SL 5.6 mg vs. placebo, analyzed by mixed model repeated measures with multiple imputation.

For more information, see ClinicalTrials.gov Identifier: NCT05273749.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

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-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been 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, bone health in autism, 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, including TNX-1800, in development as a vaccine to protect against COVID-19. 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 November 15, 2023

Release – MustGrow Receives Registration Approval for TerraSanteᵀᴹ in Washington State

Posted on November 15, 2023November 15, 2023 by aweinsoff@channelchek.com

Research News and Market Data on MGROF

Washington State Department of Agriculture Fertilizer Registration Certificate received to commence sales of TerraSante^TM crop fertilizer and soil amendment product in Washington State.
MustGrow’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to this Registration.
Mustard-derived TerraSante^TM focuses on soil microbiome health, nutrient/water use efficiencies, and plant yields.
MustGrow is committed to launching mustard-derived innovative, sustainable, and regenerative agriculture products.

SASKATOON, Saskatchewan, Canada, November 15, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of the Washington State Department of Agriculture Fertilizer Registration Certificate for its mustard plant-based TerraSante^TM crop fertilizer and soil amendment product. TerraSante^TM’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed^®) will apply to TerraSante^TM product sales in Washington State.

TerraSante^TM product sales can now commence in Washington State, with a sales & marketing commercialization strategy already forming in conjunction with BioAg Product Strategies for the 2024 planting season. In addition to Washington State, registration work is progressing rapidly in other key U.S. states.

“With our first state government registration approval, we have cleared the final requirement to commence TerraSante^TM commercial sales,” commented MustGrow’s President & CEO, Corey Giasson. “Agriculture needs new organic innovations to support food production and MustGrow has answered the call. This product approval demonstrates our ability to execute and also have a meaningful impact on the key U.S. agricultural regions that are under constant pressure to eliminate or reduce synthetic products and increase the use of natural biologics such as TerraSante^TM.”

In 2019, Washington State agriculture production totaled USD $9.49 billion. Washington State’s rich soils, diverse climates, and large-scale irrigation nurtures production of over 300 different crops in one of the most world’s productive agricultural regions. For example, Washington State is the nation’s largest producer of apples, blueberries, hops, pears, spearmint oil, and sweet cherries; and the number two producer of apricots, asparagus, dry onions, grapes, potatoes, raspberries, and winter wheat. Organic acres total 105,660, representing USD $652 million in total farm gate sales, with another 7,824 acres in certified organic transition.⁽¹⁾

MustGrow believes this soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.

TerraSante^TM for Soil and Ecological Health

MustGrow’s soil amendment and biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable and precious asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

As a soil amendment in mixable form, TerraSante^TM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSante^TM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.

To learn more about TerraSante^TM, visit www.mustgrow.ca.

Sources:
(1) https://agr.wa.gov/washington-agriculture

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the Company’s commitment to launching mustard-derived innovative, sustainable, and regenerative agriculture products; the formation of sales & marketing commercialization strategy for Washington State; the expected progression of registration work in other key U.S. states; and whether the soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

Seanergy Maritime (SHIP) – September-quarter results in line with expectations

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of approximately 12 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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Seanergy 2023-3Q results were generally in line with expectations. Shipping rates declined as expected but were offset by better-than-expected available shipping days. Operating costs and bottom-line results were also near expectations.

The company has fixed additional rates for the upcoming quarter and realized rates should rise. The company has locked in 60% of expected shipping days at an average rate that is roughly 25% above the average realized rate for the most recent quarter. Available days will go up with a new charter-in.

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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.

PDS Biotechnology Corp. (PDSB) – Clinical Milestones For 2024 Announced With 3Q23 Financial Results

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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

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Several Data Presentations With New Trials Expected In 2024. PDS Biotech reported a 3Q loss of $10.8 million or $(0.35) per share, ending the quarter with $54.3 million in cash. The company reviewed several clinical data presentations made during the quarter and gave updates on the expected milestones for its clinical trials and pipeline products.

VERSATILE-003 Is On Schedule To Begin In 1Q24. The Phase 3 VERSATILE-003 trial has received FDA comments on the amended IND and final study design. Clinical supplies have been made for the trial to start in 1Q23. The trial will test the combination of PDS0101 with Keytruda (pembrolizumab, from Merck) against Keytruda alone in patients with HPV16+ recurrent or metastatic head and neck cancer.

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Onconova Therapeutics (ONTX) – 3Q23 Reported With Several 2024 Milestones Announced

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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

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Clinical Milestones For Narazaciclib and Rigosertib Expected In 2024. Onconova reported a 3Q23 loss of $4.7 million or $(0.23) per share. Cash on hand at the end of the quarter was $25.2 million, which we believe is sufficient to fund operations through 3Q24. The company reviewed several recent data presentations and the clinical milestones ahead for 2024.

An Additional Dose Level Has Been Added To The Narazaciclib Phase 1/2 Study. As expected, Onconova announced that an additional dosing cohort has been added to the Phase 1/2 dose-escalation trial in solid tumors. The maximum tolerated dose (MTD) was not reached in the first 6 cohorts, and did not show neutropenia and diarrhea commonly seen in other CDK4/6 inhibitors. This allows a higher dose level to be tested. The Phase 1/2 trial is expected to continue into 1Q23, followed by Phase 2 dose selection.

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Snail Inc. (SNAL) – A Positive Flip Side To The ARK Delay?

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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Strong Q3 results. The company reported Q3 revenue of $9.0 million, exceeding our forecast of $5.8 million. Adj. EBITDA for the quarter was a loss of $5.1 million, in line with our forecast.

Impressive launch. In October, the company launched ARK: Survival Ascended, which was the #1 selling game on the PC gaming platform, Steam, on launch day. Management noted that, so far, the game is performing 60% better than expectations, in terms of units sold.

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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).

One Stop Systems (OSS) – A New Contract and a New Client

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays, and Ion Accelerator™ SAN, NAS, and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles, and rugged entertainment applications. OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge,’ especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training, and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.

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

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

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New Win. One Stop Systems, Inc. (OSS), has won a multi-million-dollar program with Leidos’ Dynetics, a provider of mission-critical solutions for the U.S. government. The new award with a new client illustrates management’s focus on broadening end markets and client relationships, in our view.

Contract Details. Valued at approximately $2.5 million to $3.5 million over the next three years, with an initial award of $500,000, the award is the first multi-year win OSS has secured with this prime contractor. OSS will provide its proprietary transportable compute and storage technology designed to power an emerging specialized mobile AI signal collection application.

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Blackboxstocks (BLBX) – Reports Third Quarter Results

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

Blackboxstocks, Inc. is a financial technology and social media hybrid platform offering real-time proprietary analytics and news for stock and options traders of all levels. Our web-based software employs “predictive technology” enhanced by artificial intelligence to find volatility and unusual market activity that may result in the rapid change in the price of a stock or option. Blackbox continuously scans the NASDAQ, New York Stock Exchange, CBOE, and all other options markets, analyzing over 10,000 stocks and up to 1,500,000 options contracts multiple times per second. We provide our users with a fully interactive social media platform that is integrated into our dashboard, enabling our users to exchange information and ideas quickly and efficiently through a common network. We recently introduced a live audio/video feature that allows our members to broadcast on their own channels to share trade strategies and market insight within the Blackbox community. Blackbox is a SaaS company with a growing base of users that spans 42 countries; current subscription fees are $99.97 per month or $959.00 annually. For more information, go to: www.blackboxstocks.com .

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

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

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3Q2023 Results. Revenue for the Company was $728,468 compared to $1.2 million last year. Average monthly revenue per user was $76.37 for the quarter compared to $78.19 in the prior year period. Operating expenses totaled $1.3 million compared to $1.9 million last year. Blackboxstocks reported a net loss of $671,745 or EPS loss of $0.21, compared to a net loss of $1.3 million or $0.40 EPS loss last year. Adjusted EBITDA was a negative $513,026 versus a negative $1.1 million in the prior year.

Member Count. Blackboxstocks had an average member count of 3,174 at the end of the quarter, down from 3,937 at the end of the second quarter and 5,197 last year. This continues a trend of decreasing users experienced by the company on its products for the year. The Company is exploring strategic marketing partnerships to increase the growth of its products.

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Alliance Resource Partners (ARLP) – Refining Estimates; Outlook Remains Favorable

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 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, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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Refining estimates. We have increased our 2023 EBITDA and EPU estimates to $4.96 and $975.2 million from $966.2 million and $4.89. We decided to increase our total coal sales estimates which are now at the midpoint of guidance instead of at the low end. We also modestly increased our coal sales price per ton estimate to $65.15 from $65.00 but still within the guidance range of $64.50 to $66.00. We have lowered our 2024 EBITDA and EPU estimates to $998.1 million and $5.05 from $1.0 billion and $5.15 based on modestly lower commodity prices.

Why the revisions? Alliance has committed and priced 35.0 million tons in 2023, including 29.7 million tons in the domestic market and 5.3 million tonnes in export markets. While a portion of higher priced export volumes could be deferred into 2024, we think our previous estimate was too conservative. As part of our review, we also adjusted quarterly and full year 2024 estimates and refined both years’ estimates associated with equity method investments.

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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).

QuoteMedia Inc. (QMCI) – Another Quarter of Solid Growth

Posted on November 15, 2023November 15, 2023 by cpereira@noblefcm.com

Wednesday, November 15, 2023

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, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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Solid Q3 results. The company reported Q3 revenue of $4.7 million, which was in-line with our estimate of $4.8 million and adj. EBITDA of $719,547, which was modestly below our estimate of $849,000, illustrated in Figure #1 Q3 Results. The slight adj. EBITDA miss was attributed to revenue mix and slightly higher than expected operating expenses. Notably, revenue and adj. EBITDA increased by 8.5% and 7.3%, respectively, from the prior year period.

Interactive Growth. The company’s interactive business had a strong quarter as revenue increased 16% from the prior year period, and does not include deferred revenue which increased 76% over the same period. Management attributed the favorable increase in revenue to large contracts that were recently signed. The company remains focused on signing larger clients, and has increased its headcount in its sales and marketing departments to support that goal.

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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).

Microsoft Makes Waves with New AI and ARM Chips

Posted on November 15, 2023November 15, 2023 by slightbourne@noblecapitalmarkets.com

Microsoft made waves this week by unveiling its first ever custom-designed chips at the Ignite conference. The tech giant introduced two new processors: the Maia 100 chip for artificial intelligence workloads and the Cobalt 100 chip for general computing purposes. These new silicon offerings have the potential to shake up the chip industry and cloud computing markets.

The Maia 100 is Microsoft’s answer to the AI accelerators from rivals like Nvidia and Amazon. It is tailored to boost performance for AI tasks like natural language processing. During Ignite, Microsoft demonstrated Maia handling queries for its Bing search engine, powering the Copilot coding assistant, and running large OpenAI language models.

Microsoft has been collaborating closely with OpenAI and is a major investor in the AI research company. OpenAI’s popular ChatGPT was trained on Azure using Nvidia GPUs. By designing its own chip, Microsoft aims to reduce reliance on third-party silicon for AI workloads.

Though performance details remain unclear, Microsoft stated that Maia handles AI tasks with high throughput and low latency. It emphasized efficiency as a key design goal. The chip was engineered in close consultation with Microsoft’s internal AI teams to ensure it fits their requirements.

Microsoft has created novel liquid cooling technology called Sidekicks to work alongside Maia server racks. This advanced thermal management unlocks Maia’s full processing capacity while avoiding the overheating issues that often plague GPU-powered data centers.

When available on Azure, Maia will provide customers access to specialized AI hardware on demand instead of buying dedicated GPUs. Microsoft did not provide a timeline for Maia’s availability or pricing. But offering it as a cloud service instead of a physical product sets Maia apart from AI chips from Intel, Nvidia and others.

The second new chip announced at Ignite was the Cobalt 100 ARM-based processor for general computing. It is expected to deliver a 40% performance boost over existing Azure ARM chips from Ampere.

Microsoft believes Cobalt will provide a compelling alternative to Intel’s server CPUs for cloud workloads. Companies like Amazon have already demonstrated success in cloud data centers by transitioning from Intel to custom ARM chips.

Virtual machines powered by Cobalt will become available on Azure in 2024. Microsoft is currently testing it for key services like Teams and Azure SQL database. More efficient ARM servers can translate to lower costs for cloud customers.

The Cobalt announcement highlights Microsoft’s growing reliance on ARM architecture across its cloud infrastructure. ARM chips are known for power efficiency in mobile devices, but companies like Amazon, Microsoft and Apple now recognize their benefits for data centers too.

By designing its own server-class ARM processor, Microsoft can optimize performance and features specifically for its cloud services. With both Maia and Cobalt, Microsoft aims to give Azure a competitive edge over rivals like AWS and Google Cloud.

Microsoft has lagged behind in cloud infrastructure market share, but introducing unique silicon could help close the gap. Its vertically integrated approach produces chips tailor-made for AI and its cloud platform. With demand for AI compute and cloud services booming, Microsoft’s gambit on custom chips could soon pay dividends.

Congress Averts Government Shutdown, But Fight Over Debt Limit Looms

Posted on November 15, 2023November 15, 2023 by slightbourne@noblecapitalmarkets.com

With a government shutdown set to hit at the end of this week if new funding legislation wasn’t passed, Congress has acted swiftly to approve a short-term spending bill. The so-called “continuing resolution” will keep federal agencies open and running until January 19 for some programs and February 2 for others.

The bill easily cleared the Democratic-controlled House on Tuesday with bipartisan support. This followed the backing of Republican House Speaker Mike Johnson, who had proposed the novel “laddered” approach to stagger program expiration dates. The bill now heads to the Senate, where both Majority Leader Chuck Schumer and Minority Leader Mitch McConnell have voiced support. With President Biden also signaling he will sign it, a shutdown appears to have been averted.

For investors, the passage of this stopgap bill means reduced short-term economic uncertainty. A shutdown would have disrupted many key government services as hundreds of thousands of federal workers are furloughed. This can dampen consumer and business sentiment. While the stock market has mostly shaken off prior shutdowns, an extended one could still eventually take a toll.

Yet longer-term risks remain on the horizon, especially regarding the fast-approaching debt ceiling. Come June, the government will hit its statutory borrowing limit, which could set up an intense fiscal battle. If the ceiling isn’t raised or suspended in time, the U.S. could default on its debt for the first time ever. Such an unprecedented event would surely roil markets.

With Speaker Johnson facing pressure from the right flank of his Republican caucus to extract steep spending cuts and other concessions in exchange for lifting the borrowing cap, the stage is set for a high-stakes showdown. Democrats have adamantly opposed using the debt limit as a bargaining chip.

For now, investors may breathe a small sigh of relief. But the reprieve could be short-lived. Once the government funding issue is settled, focus will shift to addressing the debt ceiling well before the June deadline. Otherwise, a far more damaging crisis than a temporary shutdown could be on tap, potentially threatening the full faith and credit of the United States along with the stability of financial markets.

Beyond the recurring fiscal battles, investors will continue monitoring the overall health of the U.S. economy amid rising interest rates and stubborn inflation. Though job growth and consumer spending have been bright spots, risks of recession still loom. Stock market volatility reflects these crosscurrents. For long-term investors, diversification and temperance remain key as policy uncertainty persists.

Looking ahead, the specter of a government default looms large. The debt ceiling debate is a critical juncture that could have widespread implications not just for the financial markets but for the broader economy. The potential fallout from a failure to raise the debt ceiling includes disruptions in government payments, increased borrowing costs, and a loss of confidence in the U.S. financial system.

The debt ceiling has been a recurrent point of contention in recent years, with temporary agreements often reached to avert a crisis. However, the underlying issues of fiscal responsibility, spending priorities, and partisan gridlock persist. The consequences of a protracted deadlock on the debt ceiling could be severe, with ripple effects felt globally.

In the midst of these challenges, investors must navigate an environment marked by uncertainty. While the short-term resolution of the government funding issue provides a momentary sense of stability, the underlying risks and complexities of fiscal policy remain. As the nation grapples with these fiscal challenges, market participants should remain vigilant and adapt their strategies to navigate potential shifts in the economic landscape.

In conclusion, the recent passage of the short-term spending bill averted an immediate government shutdown, providing a respite for investors. However, the focus now turns to the looming debt ceiling debate, introducing a new set of challenges and uncertainties. As events unfold, market participants will need to carefully assess the evolving situation and make informed decisions to mitigate risks in an ever-changing economic and political landscape.

Release – Snail, Inc. to Report Third Quarter 2023 Financial Results

Posted on November 14, 2023November 14, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SNAL

November 14, 2023 at 7:02 AM EST

CULVER CITY, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL), a leading, global independent developer and publisher of interactive digital entertainment, announced today that it will report financial results for the third quarter ended September 30, 2023, today, November 14, 2023, after the U.S. stock market closes. Management will host a conference call and webcast today at 5:00 p.m. ET to discuss the results.

Participants may listen to the live webcast and replay on the Company’s investor relations website at https://investor.snail.com/.

About Snail, Inc.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices.

Contact:
Investors: investors@snail.com