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Release – Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia

Posted on March 11, 2024March 11, 2024 by aweinsoff@channelchek.com

March 11, 2024 8:00am EDT

Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes on sleep, fatigue, FIQ-R symptoms and FIQ-R function ranging from 0.3 to 0.5

Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p=0.001) where the patients rated their level of memory problems

NDA submission expected in the second half of 2024 following pre-NDA meeting with FDA scheduled for the second quarter of 2024

CHATHAM, N.J., March 11, 2024 (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 presentation of additional efficacy data from RESILIENT, the second positive Phase 3 study evaluating Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at the 6^th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024.

In presenting more detailed data from the RESILIENT study, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, said, “We previously reported statistically significant and clinically meaningful results in all six key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. We now report that the effect sizes of the five continuous key secondary outcomes measures ranged from 0.3 to 0.5. The results also showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or ‘brain fog’, measured by the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a p=0.001 and effect size of 0.31. Together, we believe the activity of Tonmya on pain, sleep quality, fatigue and brain fog are indicative of broad-spectrum activity of Tonmya and suggest that Tonmya treats fibromyalgia at a syndromal level.”

As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. RELIEF, the first Phase 3 trial of Tonmya 5.6 mg in fibromyalgia, was completed in December 2020. It also met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010). Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 and has scheduled a pre-NDA meeting with FDA in the second quarter of 2024.

Tonmya was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects in the RESILIENT trial. In addition, when systematically investigated using the Changes in Sexual Functioning Questionnaire short form (CSFQ-14), women who received study drug had a higher CSFQ-14 total score relative to those who received placebo, which is consistent with improved sexual function.

Dr. Gregory Sullivan, Chief Medical Officer of Tonix Pharmaceuticals said, “These are important tolerability factors for fibromyalgia patients on long-term treatment with the three FDA-approved drugs, since weight gain and fatigue are associated with gabapentinoids, and negative sexual side effects, increased blood pressure and insomnia are associated with SNRIs.”

Dr. Lederman added, “We believe that the data from our two positive Phase 3 studies, with clinically meaningful separation from placebo on pain, sleep disturbance, and fatigue, supports the conclusion that fibromyalgia may be successfully treated with Tonmya 5.6 mg, and may provide the opportunity for Tonix to launch the first FDA-approved drug for fibromyalgia in more than a decade. We are excited to bring forward a new first-line treatment to fibromyalgia patients that offers broad symptom relief with favorable tolerability attributes for chronic use and adherence, which provides hope for the 6-12 million affected adults in the U.S.”

Dr. Sullivan added, “We believe that these broad-spectrum efficacy results will be important to fibromyalgia patients who struggle not only with pain, but also multiple other symptoms. We also believe the favorable tolerability and side effect profiles will be important to patients and doctors managing this debilitating condition on a long-term basis.”

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 Tonmya (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial randomized 457 participants in the U.S. across 33 sites. The first two weeks of treatment consist of a run-in period in which participants start on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to Tonmya 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 (Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. The results showed that Tonmya treatment resulted in an improvement in cognitive dysfunction or ‘brain fog’ measured by the change in the FIQ-R memory item. The FIQ-R cognition item showed improvement in Tonmya treated patients vs placebo treated patients (LS mean (SE) difference of −0.8 (0.23); nominal p=0.001; effect size 0.31, no correction for multiple comparisons, mixed model repeated measures analysis). The Cohen’s d effect sizes (ESs) of the five continuous key secondary outcomes measures were: Fibromyalgia Impact Questionnaire-Revised (FIQ-R) – Symptoms domain ES = 0.44, FIQ-R-Function ES =0.30, PROMIS sleep disturbance ES =0.50, PROMIS Fatigue ES = 0.37 and Daily Sleep quality rating ES = 0.32. The most common adverse events were local administration site reactions that were transient and self-limited.

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 million to 12 million adults in the U.S., the majority 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 Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*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. 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
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released March 11, 2024

ATHA Energy and Latitude Uranium Complete Merger to Create Uranium Powerhouse

Posted on March 11, 2024March 11, 2024 by slightbourne@noblecapitalmarkets.com

In a major development in the uranium mining sector, ATHA Energy Corp. and Latitude Uranium Inc. announced the successful completion of their merger on March 7, 2024. Through this strategic transaction, ATHA has acquired 100% of the outstanding common shares of Latitude Uranium, making the latter a wholly-owned subsidiary.

The merger brings together two promising uranium players, combining their complementary assets and expertise to create a formidable force in the industry. Latitude Uranium shareholders received 0.2769 ATHA common shares for each share held, resulting in ATHA issuing approximately 64.4 million new shares.

This deal marks a significant milestone for ATHA, adding historical resources to its portfolio and expanding its reach across multiple high-grade uranium jurisdictions. The combined company now boasts a diverse range of exploration catalysts, including the Angilak and CMB uranium discoveries, with historical resource estimates of 43.3 million lbs and 14.5 million lbs U3O8, respectively.

Moreover, ATHA now holds the largest cumulative exploration package in both the Athabasca Basin and Thelon Basin, two of the world’s most prominent basins for uranium discoveries, with a total of 6.5 million acres. Additionally, the company has a 10% carried interest in a portfolio of claims in the Athabasca Basin operated by industry leaders NexGen Energy Ltd. and IsoEnergy Ltd.

Troy Boisjoli, CEO of ATHA, expressed enthusiasm about the merger, stating, “This acquisition marks a significant milestone for the Company by adding historical resource to our portfolio and enabling us to expand the reach of our robust balance sheet across a diverse range of exploration catalysts.”

The Resurgence of Uranium Mining

The ATHA-Latitude Uranium merger comes at a time when the uranium mining industry is experiencing a resurgence, driven by the global push towards clean energy and the pivotal role of nuclear power in achieving carbon neutrality goals.

As countries around the world seek to reduce their reliance on fossil fuels and transition to more sustainable energy sources, the demand for uranium is expected to increase significantly. Nuclear power plants, which generate electricity without emitting greenhouse gases, are attracting renewed interest as a viable solution to meet energy needs while addressing climate change concerns.

This resurgence has sparked a flurry of activity in the uranium mining sector, with companies scrambling to secure promising exploration projects and develop new mines to meet the anticipated demand. Established players and emerging companies alike are vying for a share of this lucrative market, fueled by the potential for substantial returns on investment.

However, the uranium mining industry is not without its challenges. Stringent regulations, environmental concerns, and the need for significant capital investment present hurdles that companies must navigate cautiously. Responsible exploration and mining practices, combined with robust risk management strategies, are crucial for long-term success in this sector.

Nonetheless, the ATHA-Latitude Uranium merger positions the combined entity as a formidable player in the uranium mining landscape. With a diverse portfolio of assets, historical resources, and strategic partnerships, the company is well-positioned to capitalize on the growing demand for uranium and contribute to the global transition towards a more sustainable energy future.

As the world grapples with the twin challenges of meeting energy needs and addressing climate change, the uranium mining industry is poised to play a pivotal role. Companies like ATHA, armed with extensive resources and a solid growth strategy, may emerge as key players in this exciting and rapidly evolving sector.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Mark Reichman’s coverage list.

Unicycive Therapeutics (UNCY) – Trial Meets Milestone With Complete Enrollment

Posted on March 11, 2024March 11, 2024 by cpereira@noblefcm.com

Monday, March 11, 2024

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

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

Pivotal Trial Enrollment Complete. Unicycive announced that it has completed enrollment in the pivotal trial testing OLC (oxylanthanum carbonate), its phosphate binder, in ESRD patients on renal dialysis. This is a milestone for the trial that also confirms the timeframes we had expected for the trial results, NDA application, and product launch.

Data and NDA Expected Later In 2024. The pivotal trial is an open-label single arm study. Its primary endpoint is tolerability, with secondary endpoints of safety and pharmacokinetics. Statistical analysis is not required. The trial has a target enrollment of 60 patients and is expected to announce data in late 2Q24/mid2024.

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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.

Onconova Therapeutics (ONTX) – Onconova To Present Data At American Association of Cancer Research Meeting

Posted on March 11, 2024March 11, 2024 by cpereira@noblefcm.com

Monday, March 11, 2024

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.

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

Onconova Announces Presentation At AACR. Onconova announced the scheduling of a poster presentation at the American Association for Cancer Research Annual Meeting scheduled for April 8, 2024, in San Diego. The abstract provides additional details on rigosertib’s multiple mechanisms of action that include effects on cell signaling, interruption of cell division, and inflammation within the tumor environment to improve efficacy of checkpoint inhibitors.

Mechanisms Are Consistent With Rigosertib Clinical Trials. Rigosertib is currently in a Phase 1/2 trial testing the combination of rigosertib with nivolumab (Opdivo, an anti-PD-1 checkpoint inhibitor) in patients with KRAS-positive non-small cell lung cancer (NSCLC) and in a Phase 2 trial with pembrolizumab (Keytruda, an anti-PD-1 checkpoint inhibitor) in metastatic melanoma.

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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).

Information Services Group (III) – Waiting Out the Delays

Posted on March 11, 2024March 11, 2024 by cpereira@noblefcm.com

Monday, March 11, 2024

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com

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

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

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

Continued Challenging Environment. Client decision making drove a decrease in performance for ISG in the fourth quarter. However, it was not just the Company experiencing this, the IT and business services industry felt the squeeze as well. We believe the Company’s recurring revenues (now 43% of total sales) and the expansion of its AI services will allow ISG to push through an expected challenging first half in 2024.

Full Year Results. Revenue increased 2% to $291.1 million for the year, with the Americas segment showing growth while Europe and Asia Pacific decreased from last year. Net income was $9.8 million, or $0.20 per share excluding a bad debt reserve. Adjusted EBITDA was $37.7 million or a margin of 12.9%.

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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).

FAT Brands (FAT) – Reports Fourth Quarter Results

Posted on March 11, 2024March 11, 2024 by cpereira@noblefcm.com

Monday, March 11, 2024

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

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

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

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

4Q23 Results. FAT Brands reported 4Q23 revenue of $158.6 million, up 52.8% y-o-y, driven by the Smokey Bones acquisition. System-wide sales growth was 16.5%. FAT reported adjusted EBITDA of $27 million in the quarter, compared to $19.6 million in 4Q23. Net loss for the quarter was $26.2 million, or $1.68/sh, compared to a net loss of $70.8 million, or $4.39/sh last year. Adjusted net loss for the quarter was $17.3 million, or $1.15/sh, compared to a net loss of $43 million, or a loss of $2.70/sh, last year. We had projected revenue of $150 million and a net loss of $25.9 million, or a loss of $1.55/sh.

New Locations. During the quarter, FAT Brands saw 29 store openings, bringing the full year count to 125 locations, somewhat below the original expectation of 150 new locations. Management expects another 125+ new openings in 2024. The current 1,100 store pipeline will add some $60 million of adjusted EBITDA once built out.

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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).

Biden’s Scrutiny of Private Equity Healthcare Deals: A New Hurdle for Investors?

Posted on March 11, 2024March 11, 2024 by slightbourne@noblecapitalmarkets.com

The healthcare industry has long been a fertile ground for private equity investments, with firms eagerly scooping up stakes in hospitals, physician practices, and ancillary service providers. However, a recent move by the Biden administration to scrutinize these deals more closely could signal turbulent times ahead for investors eyeing opportunities in the healthcare space.

In February 2024, the White House announced plans to establish an interagency taskforce dedicated to investigating the effects of private equity ownership on healthcare costs, quality, and workforce compensation. This move comes amid growing concerns from lawmakers and advocacy groups about the potential negative impacts of private equity firms’ profit-driven strategies on patient care and healthcare affordability.

The taskforce’s mandate is broad, encompassing a comprehensive examination of how private equity business models influence everything from staffing levels and worker wages to service availability and pricing dynamics across various healthcare sectors. While the specific policy implications remain uncertain, the heightened scrutiny alone could cast a cloud of uncertainty over future private equity healthcare deals, particularly smaller acquisitions of physician practices, nursing homes, and ancillary service providers.

For investors, this development represents a potential new hurdle in an already challenging regulatory landscape. Private equity firms have long been drawn to the healthcare sector due to its recession-resistant nature, steady cash flows, and the potential for operational improvements and consolidation plays. However, the increased regulatory oversight could make it more difficult for these firms to execute their traditional playbook of cost-cutting, leveraged buyouts, and aggressive growth strategies. Nathan Cali, Head of Healthcare Investment Banking at Noble Capital Markets said, “Certainly, government oversight never means more business to be done, and alternatively may result in fewer healthcare services, healthcare innovations and reduce opportunities for patients. Private equity typically fuels great innovation with the necessary growth funds to already thriving good businesses. Government regulations and oversight may reduce these types of activities.”

One area likely to face heightened scrutiny is the acquisition of physician practices by private equity firms. These deals have been a contentious issue, with critics arguing that private equity ownership can lead to higher healthcare costs, a focus on profitable procedures over patient needs, and potential conflicts of interest. If the taskforce recommends additional regulations or restrictions on such acquisitions, it could dampen private equity firms’ appetite for these investments, potentially limiting exit opportunities for investors.

Similarly, private equity ownership of nursing homes and long-term care facilities has been a subject of intense debate, with concerns over staffing levels, quality of care, and the diversion of resources towards profit maximization. Increased oversight in this sector could lead to stricter requirements for private equity firms, potentially impacting their ability to implement cost-cutting measures and limiting the financial returns on these investments.

Beyond the direct impact on private equity firms, the taskforce’s findings and recommendations could also have broader implications for the healthcare sector as a whole. If the investigation uncovers evidence of harmful practices or negative outcomes associated with private equity ownership, it could prompt lawmakers to pursue more comprehensive regulatory changes or industry-wide reforms.

Such changes could include enhanced transparency requirements, stricter oversight of billing practices, or even limitations on the types of healthcare entities that can be acquired by private equity firms. These measures could potentially level the playing field between private equity-owned and non-profit healthcare providers, but could also create additional compliance burdens and operational challenges for all industry participants.

For investors, navigating this shifting landscape will require a keen eye for regulatory risks and a deep understanding of the potential impacts on specific healthcare subsectors. While the taskforce’s ultimate recommendations remain uncertain, investors should be prepared for potential changes in valuations, deal structures, and exit strategies for private equity healthcare investments.

Noble Capital Markets’ Senior Research Analyst Robert Leboyer states, “The Administration’s provisions for Medicare price negotiations in the Inflation Reduction Act have added uncertainty to a high-risk business, causing reduction in the value of future drugs and discontinuation of some drugs in development. Small company valuations were reduced and many were unable to raise capital. Additional regulation for healthcare facilities would add administrative costs and reduce profitability, reducing the incentives and competition in providing the best care for patients.”

Additionally, investors may need to reassess their due diligence processes to scrutinize not only the financial and operational aspects of potential investments but also the potential regulatory and reputational risks associated with private equity ownership in the healthcare space.

Despite the challenges, the healthcare sector remains an attractive target for private equity firms due to its resilience, growth potential, and the ongoing need for operational efficiencies and consolidation. However, the Biden administration’s heightened scrutiny serves as a reminder that the pursuit of profits must be balanced against the broader societal impact and responsibilities inherent in the healthcare industry.

As the taskforce’s work unfolds, investors would be wise to closely monitor developments and adapt their strategies accordingly. Those who can navigate this new reality adeptly may find themselves well-positioned to capitalize on the enduring opportunities in the healthcare sector, while those who fail to adjust could face significant headwinds in a rapidly evolving regulatory and political landscape.

Release – NN Announces First Steps In Balance Sheet Optimization Plan

Posted on March 8, 2024March 11, 2024 by aweinsoff@channelchek.com

Research News and Market Data on NNBR

Will reduce term loan balance, reduce cash interest, and strengthen balance sheet

CHARLOTTE, N.C., March 08, 2024 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced that on March 5, 2024, it entered into a Purchase and Sale and Escrow Agreement to sell and lease back three facilities, for an aggregate purchase price of a $16.8 million that is expected to close on or around March 15, 2024 with no impact to EBITDA. The net proceeds from the transaction will be used to repay a portion of the outstanding balance under the company’s term loan, lowering ongoing cash interest expenses. In addition, the company has reduced its corporate headquarters footprint by approximately two-thirds through a separate sublease transaction, lowering ongoing operating costs.

“These actions mark another strong step forward in the execution of our transformation plan and helps us further strengthen and strategically de-risk our balance sheet,” said Mike Felcher, Senior Vice President and Chief Financial Officer of NN, Inc. “We are taking actions in line with a multi-step 2024 plan to reduce our cost of capital, and to position ourselves for future refinancing when market conditions are favorable. Combined with our continued efforts to drive consistent free cash flow generation through our operations, this is as an important strategic pillar as we align our capital resources for a stronger, more focused long-term growth program.”

NN will continue to operate at these facilities. There will be no impact to NN employees or customers.

About NN, Inc.
NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.

FORWARD-LOOKING STATEMENTS
Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. (the “Company”) based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises, on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, military conflict, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, the availability of labor and labor disruptions along the supply chain; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures, as well as expansion of end markets and product offerings; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; new laws and governmental regulations; the impact of climate change on our operations; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Investor & Media Contacts:
Joseph Caminiti, CFA, or Stephen Poe, Investors
Tim Peters or Emma Brandeis, Media
NNBR@alpha-ir.com
+1 312 445 2870

Source: NN, Inc.

Release – Onconova Therapeutics’ Rigosertib Poster Selected for AACR 2024

Posted on March 8, 2024March 8, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Mar 08, 2024

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Translational science to characterize pathways impacted by rigosertib may help to guide future clinical studies and combination treatment regimen for difficult-to-treat cancers

NEWTOWN, Pa., March 08, 2024 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will present an abstract related to preclinical studies conducted by the Company and its collaborators to further characterize the mechanism of rigosertib at the American Association for Cancer Research Annual Meeting 2024 (AACR 2024), taking place April 5-10, 2024 in San Diego, CA.

“The ability to impact multiple targets is an important characteristic of Onconova’s two lead clinical programs, rigosertib and narazaciclib. We are pleased to present new preclinical studies that explore the molecular targets for rigosertib, in clinical development through a series of investigator initiated studies (IIS),” commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova. “The studies provide additional prospective on the main cellular pathways impacted by rigosertib, including RAS-MAPK signaling and reactive oxygen species (ROS)-related proteins. In addition, the studies highlight rigosertib’s impact on the tumor microenvironment through the activation of inflammation–related targets, such as an NLRP3. We hope to apply this translational science to help guide the clinical program to enable the potential use of rigosertib in difficult-to-treat cancers.”

*Poster Information:*
Poster Title:	*Rigosertib promotes anti-tumor activity of cancer cells via CETSA revealed novel targets and activates NLRP3-dependent inflammatory responses* (2033/16)
Session:	Microenvironment, Immunity, and DNA Repair in Therapeutic Response (PO.ET05.02)
Date/Time:	Monday, April 8 9:00a-12:30p PT

Brief Overview: Onconova and its collaborators conducted a series of biochemistry and molecular and cell biology assays to study rigosertib’s molecular and inflammation-based targets. The team used a specialized mass spectrometry assay (a Cellular Thermal shift Assay or CETSA-MS) as one of the tools to identify new targets which were then validated as novel targets of rigosertib.

Conclusions: This work identified a series of cellular and inflammatory targets that may be affected by rigosertib. In particular, the research highlighted target activity through RAS-MAPK signaling, ROS-mediation JNK activation, and tumor microenvironment reprogramming through NLRP3 activation, which may contribute to preclinical and clinical synergistic effects with checkpoint inhibitors. The identification of these targets and signaling pathways may be helpful in the design of clinical trials to address difficult-to-treat cancers.

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’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, multiple myeloma, and mantle cell lymphoma.

Rigosertib is being studied through an IIS strategy to evaluate the product candidate in multiple indications, 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 (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

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

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position including the potential to initiate IISs in metastatic breast cancer and relapsed/refractory multiple myeloma, and initiate enrollment in H2 2024 and potential that the results will provide data on new treatment options for patients with metastatic breast cancer and relapsed/refractory multiple myeloma. 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

Xcel Brands (XELB) – Updates Investors With Preliminary Q4 Results

Posted on March 8, 2024March 8, 2024 by cpereira@noblefcm.com

Friday, March 08, 2024

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

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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Provides preliminary Q4 estimates. The company provided Q4 revenue and adj. EBITDA preliminary estimates that are slightly below our expectations. The preliminary revenue estimate was $2.13 million versus our estimate of $2.80 million. In addition, the adj. EBITDA preliminary estimate of a loss of $1.07 million was somewhat higher than our loss estimate of $451,000.

Preliminary full year results. Total company revenue for 2023 is expected to be $17.7 million and EBITDA of $5.1 million. The preliminary results are slightly below our $18.5 million and loss of $5.4 million, respectively.

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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).

Saga Communications (SGA) – Regains Its Crown

Posted on March 8, 2024March 8, 2024 by cpereira@noblefcm.com

Friday, March 08, 2024

Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.

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

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

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

Delivers good Q4 results. Total company revenues of $29.1 million was slightly better than our $28.5 million estimate. The Q4 revenue decline of a modest 3.3% was due to the absence of Political advertising. However, it was among the best in an industry which reflected revenue declines between 6% to 14% among its peers. Adj. EBITDA was $4.5 million versus our $4.0 million estimate.

Announces special dividend. The company declared its first variable dividend of $0.60 per share to be paid on April 5, 2024 with a record date of March 18, 2024. The dividend will be funded by cash on the company’s balance sheet. This variable dividend is in addition to the regular quarterly dividend and a recent $2 per share special dividend.

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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).

QuantaSing Group Limited (QSG) – Quietly Executing Its Growth Strategy

Posted on March 8, 2024March 8, 2024 by cpereira@noblefcm.com

Friday, March 08, 2024

QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners under a variety of brands, including QiNiu, JiangZhen and QianChi, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services, the Company has also expanded its services to corporate clients including, among others, marketing services and enterprise talent management services.

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 results. The company reported strong fiscal Q2 revenue and adj. EBITDA for the period ended December 31. Revenue of RMB980.5 million and adj. EBITDA of RMB 98.6 million outperformed our estimates of RMB 930.0 million and RMB 83.0 million, respectively.

User growth. Total registered users grew roughly 45% to 112.4 million users, up from 77.8 million users at the end of the prior year period. Total paying learner grew to 0.4 million, up 24% from the prior year period.

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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).

Information Services Group (III) – First Look into the Fourth Quarter

Posted on March 8, 2024March 8, 2024 by cpereira@noblefcm.com

Friday, March 08, 2024

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

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

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

Growth in a Down Industry. For the year, the IT and business services industry has been down 6% in revenue while ISG grew its topline by 2%. We believe the growth is a testament to the Company’s focus on recurring revenues with such revenues being $125 million for the year, up 16% compared to last year, through its platforms such as ISG GovernX and ISG ProBenchmark. Recurring revenues now represent 43% of ISG’s overall revenue, up 500 basis points from the prior year.

Fourth Quarter Results. Management reported revenues of $66.2 million for the quarter, below last year’s revenue of $74.2 million and below our estimate of $69.0 million. Slower decision making from clients resulted in revenue being pushed to the right for the Company. Driven by a $4.8 million bad-debt reserve taken in 4Q23, net loss was $2.9 million, or $0.06/sh, versus net income of $4.3 million, or $0.09/sh in 4Q22. We estimated net income of $2.6 million, or $0.05/sh.

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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).