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Release – Defense Metals Updates Metallurgical Test Work and Preliminary Feasibility Study Progress for its Wicheeda Rare Earth Elements Project

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DFMTF

13 Feb, 2024, 07:00 ET

VANCOUVER, BC, Feb. 13, 2024 /PRNewswire/ – Defense Metals Corp. (Defense Metals or the Company) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to provide an update on the metallurgical work programs, undertaken by SGS Canada Inc. (SGS) and the ongoing Preliminary Feasibility Study (PFS) work by SRK Consulting (Canada) Inc. (SRK) and Hatch Limited (Hatch), for its wholly-owned Wicheeda Rare Earth Element Project located in British Columbia, Canada.

Highlights of Metallurgical Test Work and PFS-related Matters

  1. The metallurgical test work required for the PFS has been completed. Multiple bench-scale flotation and flotation pilot plant test work resulted in the production of a high-grade mineral concentrate containing 50% Total Rare Earth Oxide (TREO) with an 80% recovery rate, which will be included in the PFS for the first 8 years of mine-life.

  2. Bench-scale and hydrometallurgical pilot plant test work shows that the planned acid bake process will deliver approximately 90% TREO extraction from the mineral concentrate to a Mixed Rare Earth Carbonate product.

  3. The PFS plant flowsheets are completed, based on the metallurgical test work, and equipment specifications have been issued to vendors for cost quotations. 

  4. The field-based geotechnical, geochemical and environmental test work required for the PFS has been completed and lab-based studies are in progress.

  5. Other PFS tasks, including open pit mine design and tailings storage trade-off studies, are well advanced.

  6. Economic evaluation and cashflow modelling are in progress.

  7. PFS report completion in the second quarter of 2024 is on schedule.

  8. Eleven mixed rare earth precipitate samples from the hydrometallurgical test work have been sent to potential partners, processors or end-users.

  9. Over the past 5 years, Defense Metals drilled 58 core holes totalling 12,073 metres (m; ~39,610 feet) to define the Wicheeda Rare Earth Element (REE) deposit and provide samples for metallurgical test work. This work resulted in measured and indicated (M+I) resources of 34.2 million tonnes, averaging 2.02% TREO1, inclusive of 17.8 million tonnes of high-grade dolomite carbonatite averaging 2.92% TREO, in addition to inferred resources of 11.1 million tonnes, averaging 1.02% TREO. This represents a 260% increase over the Defense Metals initial 2019 mineral resource estimate, and a conversion to M+I of 101% of the prior 2021 mineral resource estimate.

  10. Total expenditures on the Wicheeda REE Project since 2019, including costs for mineral resource estimate definition, all metallurgical test work, earlier studies and the remaining PFS-related costs are in excess of CAD $17.5 million.
     
  11. Defense Metals has entered into a strategic Co-Design Agreement with the McLeod Lake Indian Band (MLIB), the First Nations community having the traditional territory on which the Wicheeda Project sits.
____________________________________
1 TREO % is the sum of CeO2, La2O3, Nd2O3, Pr6O11, Sm2O3, Eu2O3, Gd2O3, Tb4O7, Dy2O3 and Ho2O3 percentages.

Craig Taylor, CEO of Defense Metals, stated:

“Continuing positive results from our technical studies suggest that our wholly-owned Wicheeda REE Project has the potential to become the next producer of rare earth elements in North America accounting for a significant amount of the rare earths needed for the western world’s future magnet metal production. We look forward to completing and filing the PFS for the Wicheeda REE Project in Q2-2024 and, subject to financing, moving directly into our feasibility study.”

Metallurgical Test Work

  • Extensive comminution, beneficiation, hydrometallurgical, and environmental tests have been completed and the resulting data have been applied in the PFS. These tests have studied development and optimization of milling and hydrometallurgical processes and the response of twenty-one variability samples representing different REE grades, lithologies and locations within the deposit.

  • From 2018 to date, about CAD$5 million has been spent on metallurgical test work and the development of the metallurgical flowsheets for the Wicheeda REE Project.

  • Thirty-one samples of deposit material, flotation and hydrometallurgical products have been subjected to detailed mineralogical examination.

  • Twenty-one samples have been subjected to Bond milling index and SMC comminution tests.

  • 210 open circuit flotation tests and seven locked cycle flotation tests, of samples ranging from 1 to 12 kilograms (kg), and a 26-tonne pilot flotation operation have been completed.

  • Sixty-three static acid bake tests, sixteen short-duration acid bake kiln runs with associated water leach tests were completed. Additionally, SGS completed a total of 15 days of continuous kiln operation (in one 5-day and one 10-day segment) as part of a fully integrated hydrometallurgical pilot plant operation that processed 560 kg of flotation concentrate.

  • Approximately 40 bench-scale impurity removal tests were done as well as about 40 rare earth precipitation tests and results incorporated in the integrated hydrometallurgical pilot plant operation and the project process design criteria.

  • Many other small-scale tests examined water recycle options and other aspects of the metallurgical flowsheets.

  • The liquid-solid separation characteristics of the flotation plant products and those of the hydrometallurgical plant have been determined through appropriate thickening and filtration tests.
____________________________
Technical Report for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated October 27, 2023, with an effective date of August 28, 2023, and prepared by APEX Geoscience Ltd. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR+ (www.sedarplus.com) and on the Company’s website at www.defensemetals.com.

PFS Plant Design 

Results from the metallurgical test work have been used to develop flowsheets for the planned comminution, beneficiation and hydrometallurgical plants. These flowsheets have been completed, reviewed and used to generate major equipment specifications for grinding mills, kilns, etc., which have been issued to equipment suppliers for quotes.

The metallurgical process design, engineering and costing is on track to allow completion of the PFS in Q2 of 2024.

Optimization of Open Pit Mining

Geotechnical investigation work for the mine design and pit optimization was performed by SRK and completed in December 2023. This work included sixteen geotechnical drill holes totaling 225.5 m, and twenty excavated overburden geotechnical test pits. Within the Wicheeda REE deposit pit shell, six diamond drill holes totaling 1,182 m were completed, inclusive of 4 open pit geotechnical drill holes totaling 920 m, and in-pit exploration holes totaling 262 m.

Pit design work is underway, incorporating the latest geotechnical information provided from the 2023 geotechnical drilling program.

Community Engagement

Defense Metals entered into a Co-Design Agreement with the McLeod Lake Indian Band (MLIB) (see news release dated January 17, 2024), thus solidifying a joint commitment to the successful advancement of the Wicheeda REE Project. The Co-Design Agreement emphasizes a joint planning approach, empowering MLIB to play an integral part in the design and decision-making process in the technical, social, engineering and environmental aspects of the Wicheeda REE Project. This agreement expands upon the Mineral Exploration Agreement Memorandum of Understanding previously entered into with MLIB.

The McLeod Lake Indian Band purchased an equity stake in Defense Metals, signalling their long-term commitment to the success of the Wicheeda REE Project.

Infrastructure and Tailings Management Studies

Tradeoff studies are being performed on the various options being considered for tailings management and infrastructure locations are being determined. 

The Wicheeda REE Project has excellent infrastructure and logistics, which are expected to allow for lower operating and capital costs, including:

  • The future mine site and beneficiation plant will be located:
    • along a permitted Forest Service Road approximately 38 km east from the paved John Hart Provincial Highway at the community of Bear Lake.
    • ~37 km from the Canadian National Railway mainline.
    • ~36 km from the main natural gas distribution pipeline..
    • ~34 km from high-voltage powerlines that supply BC with abundant green hydroelectric power.
    • ~ 110 km from an international airport in Prince George
  • British Columbia has a long history of mining and its industry participants are recognized worldwide as expert in open pit mining and mineral processing.
  • Prince George is a major industrial center supplying both the mining and wood products industries. Most of the equipment that will be required for the mining operation will be supplied by companies already established in the area.
  • Multiple options exist for location of the hydrometallurgical plant site close to reagent supply.
  • Easy access to the year-round port of Prince Rupert, the closest North American port to Asian markets.

Environmental Test Work and Field Studies 

Environmental and geochemical test work has been performed on both flotation and hydrometallurgical plant products and mixtures thereof. Data have been used by SRK in the design of facilities.

Surface water sampling and field investigations commenced in 2022 and will continue through 2024. The results of these and future environmental investigations will be used to inform siting, design, and mitigation planning as well as to prepare technical data reports to support Environmental Assessment and permitting processes. 

Qualified Persons

The scientific and technical information concerning metallurgy and processing contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by J.R. Goode, P.Eng., a metallurgical consultant to the Company and a “Qualified Person” as defined in NI 43-101. This news release has also been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), a technical consultant to the Company, a Principal and Consultant of APEX Geoscience Ltd. of Edmonton, Alberta, and a “Qualified Person” as defined in NI 43-101.

About Defense Metals Corp. and its Wicheeda Rare Earth Element Project

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned, 8,301-hectare (~20,534-acre) Wicheeda REE Project that is located on the traditional territory of the McLeod Lake Indian Band in British Columbia, Canada.

The Wicheeda REE Project, approximately 80 kilometres (~50 miles) northeast of the city of Prince George, is readily accessible by a paved highway and all-weather gravel roads and is close to infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.

Defense Metals Corp. trades on the TSX Venture Exchange under the symbol “DEFN”, in the United States, trading symbol “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”

Defense Metals is a proud member of Discovery Group. For more information please visit:
www.discoverygroup.ca .

For further information, please visit www.defensemetals.com or contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca

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

Cautionary Statement Regarding “Forward-Looking” Information or Statements

This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to completion of the PFS and the expected timelines, the completion of additional work and studies and the expected timelines, advancing the Wicheeda REE Project, completing the PFS and progressing towards a feasibility study, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR+ (www.sedarplus.com). While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain or obtain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical, engineering and pricing assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, restriction on labour and international travel and supply chains, loss of key employees, consultants, officers or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.

SOURCE Defense Metals Corp.

Release – Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 13, 2024 8:00am ESTDownload as PDF

Tonmya™ is a potential new first-line therapy, non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials

New Drug Application (NDA) submission to the FDA planned for second half of 2024

Fibromyalgia is a chronic pain condition affecting approximately 10 million U.S. adults that typically persists for years or decades

CHATHAM, N.J., Feb. 13, 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 that it has engaged Rho, Inc. (Rho), a global contract research organization (CRO), to support Tonix’s preparation and planned submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.

“We are excited by our most recent positive Phase 3 study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase 3 studies.”

Tonmya is a patented sublingual tablet 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.

“We are delighted in our continued support of Tonix and their Tonmya program,” said Tara Gladwell, President and COO at Rho. “We are hopeful that this work may result in a new treatment for the millions of Americans that suffer from this debilitating, chronic disorder.”

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 patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya 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 cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development fibromyalgia-type 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 Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

About Rho

Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. Since 1984, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on LinkedIn.

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’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to reduce the severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder. This trial is being sponsored by the University of North Carolina and received funding support from the U.S. Department of Defense. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA and received funding from the National Institute on Drug Abuse (NIDA). A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. 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. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. 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 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
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released February 13, 2024

New Inflation Data Shows Prices Still Rising, Clouding Path for Fed Rate Cuts

Posted on by slightbourne@noblecapitalmarkets.com

The latest inflation data released Tuesday shows consumer prices rose more than expected in January, defying forecasts for a faster slowdown. The Consumer Price Index (CPI) increased 0.3% over December and rose 3.1% over the last year, down slightly from December’s 3.4% pace but above economist predictions.

Core inflation, which excludes volatile food and energy costs, also came in hotter than anticipated at 0.4% month-over-month and 3.9% annually. Shelter prices were a major contributor, with the shelter index climbing 0.6% in January, accounting for over two-thirds of the overall monthly increase. On an annual basis, shelter costs rose 6%.

While used car and energy prices fell, persistent strength in housing and services indicates inflation remains entrenched in the economy. This could complicate the Federal Reserve’s plans to pivot to rate cuts this year after aggressively raising interest rates in 2023 to combat inflation.

Markets are currently pricing in potential Fed rate cuts beginning as early as May, with around five quarter-point decreases projected through end of 2024. However, Tuesday’s inflation data casts doubt on an imminent policy shift. Many Fed officials have signaled a more gradual approach, with only two or three cuts likely this year.

The hotter CPI print pushed stocks sharply lower in early trading, with the Dow Jones Industrial Average falling over 250 points. Meanwhile, Treasury yields surged higher on expectations for sustained Fed tightening.

Inflation-adjusted wages also fell 0.3% month-over-month when factoring in a decline in average workweek hours. While inflation may be peaking, price increases continue to erode household purchasing power.

Shelter costs present a tricky situation for policymakers. Rental and housing inflation tend to lag other price moves, meaning further gains are likely even if overall inflation slows. And shelter carries significant weighting in the Fed’s preferred core PCE index.

While annual PCE inflation has fallen below 4%, the six-month annualized rate remains near the Fed’s 2% target. Tuesday’s data provides a reality check that the battle against inflation is not yet won.

To tame housing inflation, the Fed may have to accept some economic pain in the form of job losses and supply chain stress. So far, the resilience of the labor market and strong consumer demand has kept the economy humming along.

But the cumulative impact of 2023’s aggressive tightening is still working its way through the economy. Eventually, restrictive policy normally triggers a recession as demand falls and unemployment rises.

The Fed is walking a tightrope, trying to curb price increases without severely damaging growth. But persistent inflationary pressures leave little room for a swift policy reversal.

Rate cuts later this year are still possible, but will depend on compelling evidence that core inflation is on a sustainable downward path toward the Fed’s 2% goal. Until shelter and services costs normalize, additional rate hikes can’t be ruled out.

Markets cling to hopes that falling goods prices and easing supply chain strains will open the door for Fed easing. But policymakers remain laser-focused on services inflation, particularly in housing.

Overall, the January inflation data signals the Fed’s inflation fight is far from over. While markets may yearn for rate cuts, persistent price pressures suggest a longer road ahead before policy can substantively turn dovish.

Release – DLH to Provide Information Technology Services at National Institute on Drug Abuse

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DLHC

 

February 13, 2024

ATLANTA, Feb. 13, 2024 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading Health IT provider of digital transformation and cybersecurity, science research and development, and systems engineering and integration, today announced that it has been awarded a contract to continue providing information technology services for the National Institutes of Health’s (“NIH”) National Institute on Drug Abuse (“NIDA”). NIDA is the lead federal agency supporting scientific research on drug use and addiction.

The new award extends a partnership that began with DLH’s first contract with NIDA in 2014. The contract includes a base period of one year with four one-year options, for a total value of approximately $23 million. Through this award, DLH will provide a host of information technology services for NIDA, including managing the operations of an integrated advanced clinical/research informatics series of systems which enables researchers to share data and resources in real time. Additionally, the Company will be responsible for the research, design, development, and maintenance of clinical and scientific informatics, Intranet applications, and public web pages, as well as IT infrastructure and desktop support. This work is 100% NIH funded.

“NIDA-supported research leads to the development of effective prevention and treatment interventions that affect the more than 40 million people in the United States with substance use disorders and their families,” said Diane Yarnell, President of DLH’s Health IT Operations Center. “That NIDA continues to choose DLH for this important work is a testament to our team’s superb execution and commitment to excellence.”

About DLH

DLH (NASDAQ:DLHC) delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions. For more information, visit www.DLHcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com

Release – ACCO Brands Corporation Announces Fourth Quarter and Full Year 2023 Earnings Webcast

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ACCO

02/13/2024

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that it will release its fourth quarter and full year 2023 earnings after the market close on February 22, 2024. The Company will host a conference call and webcast to discuss the results on February 23 at 8:30 a.m. EST. The webcast can be accessed through the Investor Relations section of www.accobrands.com and will be available for replay.

About ACCO Brands Corporation

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

Christopher McGinnis
Investor Relations
(847) 796-4320

Kori Reed
Media Relations
(224) 501-0406

Source: ACCO Brands Corporation

Beasley Broadcast Group (BBGI) – A Much Better Quarter Than The Stock Suggests

Posted on by cpereira@noblefcm.com


Tuesday, February 13, 2024

Beasley Broadcast Group, Inc. owns and operates 61 stations (47 FM and 14 AM) in 15 large- and mid-size markets in the United States. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text messaging, digital and web applications and email. The Overwatch League’s Houston Outlaws esports team is a wholly owned subsidiary. The Company also owns BeasleyXP, a national esports content hub, and AXLR-R8, a Rocket League Championship Series team, in its esports portfolio. For more information, please visit www.bbgi.com.

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.

Solid Q4 results. The company reported Q4 revenue of $65.7 million, in-line with our estimate of $66.1 million, and adj. EBITDA of $5.0 million, which was slightly below our estimate of $6.1 million. Notably, the company’s high growth digital businesses performed strongly in the quarter, and accounted for 18.4% of full year 2023 revenue. 

Favorable digital outlook. 2023 was a solid year for the company’s digital initiatives. Digital revenue increased a solid 11.4% year-over-year and accounted for 18.4% of total revenue for the year. Notably, we expect the company’s favorable digital revenue growth to continue in 2024, and account for 20% of total revenue. 


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Gilead Sciences Acquires CymaBay Therapeutics for $4.3 Billion in Cash

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences announced Monday that it will acquire clinical-stage biotech CymaBay Therapeutics for $4.3 billion, gaining seladelpar, an investigational treatment for primary biliary cholangitis (PBC) that is currently under FDA priority review.

PBC is a progressive autoimmune disease that damages the bile ducts in the liver, causing bile acid buildup that can lead to irreversible scarring and liver failure. An estimated 130,000 Americans live with PBC, which mostly affects women over 40.

CymaBay’s seladelpar is an oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that targets metabolic and inflammatory pathways involved in PBC. Data from late-stage studies demonstrate seladelpar’s potential as a best-in-class therapy for second-line PBC patients who don’t respond adequately to first-line treatment with ursodeoxycholic acid (UDCA).

The drug received breakthrough therapy and orphan drug designations from the FDA and EMA based on positive mid-stage results. In December 2022, CymaBay submitted a new drug application to the FDA, which was granted priority review last month. An approval decision is expected by August 14, 2024.

According to the phase 3 RESPONSE trial, seladelpar achieved significant improvements in reducing alkaline phosphatase levels and relieving itch symptoms compared to placebo. Nearly 62% of patients on seladelpar attained a biochemical response versus 20% on placebo.

Gilead aims to leverage its extensive experience in developing treatments for liver diseases like hepatitis C and nonalcoholic steatohepatitis (NASH) to advance seladelpar. The deal expands Gilead’s presence in the PBC space, complementing its existing medicine Ocaliva, which is approved as a second-line option.

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“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” commented Gilead CEO Daniel O’Day. “Building on the strong R&D work by the CymaBay team, we have the potential to address a significant unmet need for people with PBC.”

Under the terms of the agreement, Gilead will commence a tender offer to acquire all outstanding CymaBay shares at $32.50 per share in cash, representing a 27% premium over the stock’s closing price on February 9. Following the tender offer, Gilead will mop up any untendered shares via a second-step merger at the same price.

The deal is anticipated to close in the first quarter of 2024, subject to customary closing conditions and regulatory clearances. Once the transaction is completed, CymaBay will become a wholly owned subsidiary of Gilead.

Gilead expects the buyout will boost its top-line revenue growth, while being neutral to earnings per share in 2025 before turning significantly accretive thereafter.

For CymaBay, the takeover marks the culmination of years of effort advancing seladelpar into late-stage testing and regulatory review. “Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead can apply its expertise to bring seladelpar as quickly as possible to people with PBC,” noted CymaBay CEO Sujal Shah.

The profitable exit provides a major return for CymaBay investors, as the purchase price represents a substantial premium over the stock’s pre-announcement valuation. CymaBay shares have languished below $4 for much of the past two years.

Gilead has actively pursued M&A to augment its pipeline and product portfolio across therapeutic areas like oncology, inflammation, and antivirals. The company faces looming patent expiries on flagship HIV medicines. New growth drivers like seladelpar could help offset that impact.

PBC currently affects a relatively small patient population, but analysts project seladelpar could generate peak annual sales above $1 billion. Gilead likely sees potential to expand seladelpar’s utility to other cholestatic liver diseases.

Nonetheless, the deal does carry risks for Gilead. Seladelpar’s broad mechanism regulating gene expression raises safety concerns about potential side effects. Patients in late-stage testing experienced elevations in low-density lipoprotein cholesterol.

By acquiring CymaBay outright, Gilead shoulders all future R&D costs rather than opting for a partnership deal to share expenses. If seladelpar encounters any regulatory or commercial setbacks, Gilead lacks an immediate fallback option for its PBC program.

But with priority review underway and approval expected within six months, Gilead moved aggressively to lock up rights to a promising PBC candidate. Adding seladelpar provides another growth avenue beyond HIV and bolsters Gilead’s mission of delivering transformative medicines for underserved diseases.

Release – Marble Slab Creamery Strengthens Foothold in Canada with 40-Unit Development Deal

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

02/12/2024

Leading Ice Cream Chain to Grow Presence in Country to 140 Units

LOS ANGELES, Feb. 12, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Marble Slab Creamery and 17 other restaurant concepts, announces a new development deal set to open 40 new Marble Slab Creamery franchised locations throughout Canada in partnership with Canadian Ice Cream Company Inc. The Marble Slab Creamery locations are set to open over the next 10 years, with the first of the new locations slated to open by the end of 2024. The development deal will bolster the brand’s presence from approximately 100 stores that are operating today in the country to 140 units.

“We are very pleased with the continued market growth in Canada with our experienced master franchise partner, Canadian Ice Cream Company Inc.,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “Since entering the country nearly 20 years ago, Marble Slab Creamery has made a name for itself. Our homemade ice cream and unlimited mix-in philosophy resonate with fans and our franchisees as we continue to expand the concept across Canada and the world.”

For nearly 40 years, Marble Slab Creamery has been an innovator in the ice cream space, dreaming up the frozen slab technique and offering homemade, small-batch ice cream with free unlimited mix-ins, shakes in a variety of flavors, and ice cream cakes.

For more information on Marble Slab Creamery, visit www.marbleslab.com.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, 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 fatbrands.com.

About Marble Slab Creamery
Since dreaming up the frozen slab technique and serving fresh homemade, small-batch ice cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite ice cream possibilities to feed your curiosity and capture cravings. With our free unlimited mix-in philosophy, delicious ice cream and shakes in a variety of flavors, hand-rolled waffle cones, and ice cream cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Bangladesh, Canada, Kuwait, Pakistan, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing and performance of new store openings and area development agreements. Forward-looking statements reflect expectations of FAT Brands Inc. (“we” or “our”) concerning the future and are subject to significant business, economic and competitive risks, uncertainties and contingencies. These factors are difficult to predict and beyond our control, and could cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other factors. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

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

Source: FAT Brands Inc.

Release – Kratos Receives $877 Million Indefinite-Delivery/Indefinite-Quantity, Multiple Award Sounding Rocket Program-4 Contract Award

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

February 12, 2024 at 8:00 AM EST

Credit: NASA

A Kratos Terrier Terrier Oriole sounding rocket lifts off on March 3, 2021 from the Wallops Flight Facility in Virginia

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2194626f-98a6-4702-b83f-15e6b1d0d09a.

SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in Defense, National Security and Global Markets, announced today that its Kratos Space & Missile Defense Systems Inc., business unit has received a multiple-award, indefinite-delivery/indefinite-quantity, cost-plus-incentive-fee, cost-plus-fixed-fee, and firm-fixed-price contract with a combined maximum ceiling of $877 million with a nine-year ordering period for Sounding Rocket Program-4. This contract provides suborbital launch services and launch support services necessary to accomplish the Rocket Systems Launch Program’s suborbital mission. The primary locations of performance of the work will be at the contractor facilities and a variety of government launch sites, depending on mission requirements, and is expected to be completed by November 15, 2029. This contract was a competitive acquisition, and three offers were received. Space Systems Command, Kirtland Air Force Base, New Mexico, is the contracting activity.

Kratos Space & Missile Defense Systems is a leading provider of affordable rocket launch systems for ballistic missile target, ballistic missile defense, sub orbital, hypersonic and other missions.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

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

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

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 12, 2024 8:00am ESTDownload as PDF

Bedtime TNX-102 SL improves sleep quality in PTSD and is also being developed for the management of fibromyalgia for which NDA preparation is ongoing

Investigator-Initiated OASIS Trial at UNC is a Phase 2 180-patient, randomized, placebo-controlled trial in acute trauma patients following motor vehicle collisions

One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluation after trauma exposures

CHATHAM, N.J., Feb. 12, 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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL1 in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). The trial is sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).

“No medication is currently available at or near the point-of-care to treat patients suffering from traumatic events and support long-term health,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “There is an unmet need for treating ASR after traumatic events such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. Previous trials of TNX-102 SL in PTSD suggested activity on sleep and stress related symptoms in the first several weeks of treatment.2,3 The study is motivated by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms.”

The Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The trial will enroll approximately 180 trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention, and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.

“This innovative clinical trial and partnership will help address the need for safe and effective therapies to treat acute trauma,” said Samuel McLean, M.D., Professor of Psychiatry and Emergency Medicine at the UNC School of Medicine at UNC, School of Medicine, and lead principal investigator of the proposed study. “ASR and posttraumatic stress symptoms are common among civilian motor vehicle collision survivors. The AURORA initiative, which has collected thousands of data points from motor vehicle collisions, has allowed us to better investigate the correlation between motor vehicle collisions and the emergence of acute stress disorder or PTSD symptoms. In OASIS, we will test a pharmacological intervention in the immediate aftermath of trauma that has potential for fast relief of stress symptoms, improvement in coping and functioning, and preclusion of escalation to more severe conditions, ASD in the short term and PTSD thereafter.”

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives.4 In the U.S. alone, one-third of emergency department visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.5 Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.6

About Tonmya™ (also known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya 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 cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development for fibromyalgia-type 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 Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of cyclobenzaprine HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

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’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. 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 first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. 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. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. 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 product development candidates are investigational new drugs or biologics and have not been approved for any indication.

  1. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) has not been approved for any indication; (Tonmya™ is conditionally approved by FDA for the management of fibromyalgia)
  2. Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974.
  3. Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In Press). https://doi.org/10.1016/j.psychres.2024.115764
  4. Goldstein RB, et al. Soc Psychiatry Psychiatr Epidemiol. 2016. 51(8):1137-48
  5. Wisco BE, et al. J Clin Psychiatry. 2014. 75(12):1338-46
  6. Thompson M. Time. 2015;185(12):40-3

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 February 12, 2024

Release – Beasley Broadcast Group Reports Fourth Quarter Revenue of $65.7 Million and Diluted EPS of $0.21

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BBGI

February 12, 2024 07:00 ET|

Conference Call and Webcast
Today, February 12, 2024 at 11:00 a.m. ET
877-407-4018 or 201-689-8471, conference ID 13744073 or
www.bbgi.com
 
Replay information provided below

NAPLES, Fla., Feb. 12, 2024 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI) (“Beasley” or the “Company”), a multi-platform media company, today announced operating results for the three- and twelve-month periods ended December 31, 2023. For further information, the Company has posted a presentation to its website regarding the fourth quarter highlights and accomplishments that management will review on today’s conference call.

Summary of Fourth Quarter and Full Year Results


In millions, except per share data		Three Months Ended
December 31,		Twelve Months Ended
December 31,
 2023202220232022
Net revenue$65.7$72.0$247.1$256.4
Operating income (loss) 17.6(31.7)(82.0)(34.3)
Net income (loss) 16.4(24.5)(75.1)(42.1)
Net income (loss) per diluted share 1$0.21($0.83)($2.51)($1.43)
Adjusted EBITDA (non-GAAP)$4.7$9.9$20.6$25.1
1 Operating income (loss), net income (loss) and net income (loss) per diluted share in the three and twelve months ended December 31, 2023 include $1.0 million and $99.8 million, respectively, of non-cash impairment losses and a $6.0 million gain from the Overwatch e-sports league franchise fee extinguishment. Operating loss, net loss and net loss per diluted share in the three and twelve months ended December 31, 2022 include $42.4 million and $52.9 million, respectively, of non-cash impairment losses and a $3.4 million gain on exchange.


Net revenue during the three months ended December 31, 2023 reflects a year-over-year decrease in cyclical political advertising as well as in commercial advertising, related to continued softness in the agency business.

Beasley reported fourth quarter operating income of $7.6 million, an increase of $39.3 million compared to an operating loss of $31.7 million in the fourth quarter of 2022. The year-over-year improvement in fourth quarter 2023 operating income largely reflects a year-over-year decrease in operating expenses and non-cash impairment losses, as well as a $6.0 million gain from the Overwatch e-sports league franchise fee extinguishment, compared to a $3.4 million gain on exchange in the 2022 fourth quarter.

Beasley reported net income of $6.4 million, or $0.21 per diluted share, in the three months ended December 31, 2023, compared to a net loss of $24.5 million, or $0.83 per diluted share, in the three months ended December 31, 2022. The year-over-year improvement was primarily attributable to the impact of the aforementioned non-cash impairment losses in the comparable prior year period.

Adjusted EBITDA (a non-GAAP financial measure) was $4.7 million in the fourth quarter of 2023 compared to $9.9 million in the fourth quarter of 2022. The year-over-year decrease is primarily attributable to lower net revenue compared to the prior year period.

Please refer to the “Calculation of Adjusted EBITDA” and “Reconciliation of Net Income (Loss) to Adjusted EBITDA” tables at the end of this release.

Commenting on the financial results, Caroline Beasley, Chief Executive Officer, said, “Beasley’s fourth quarter and full year financial results reflect the impacts of cyclical political revenue and ongoing advertising market softness, partially offset by the continued success of our revenue diversification strategy and cost management initiatives. Net revenues for the 2023 fourth quarter and full year decreased by $6.3 million and $9.3 million, respectively. Excluding the impacts from a decrease in political advertising and the Company’s dispositions of WWWE-AM, WJBR-FM and the Houston Outlaws in 2023 and WWNN-AM and KDWN-AM in 2022, partially offset by the Company’s acquisitions of KXTE-FM and Guarantee Digital in 2022, revenues would have decreased by $0.2 million and $1.3 million in the 2023 fourth quarter and full year, respectively.

“For the 2023 fourth quarter and full year, net income (loss) was $6.4 million and $(75.1) million, respectively. We made meaningful progress throughout the year in lowering our operating expenses and growing our digital, network and other revenue sources, and generated fourth quarter and full year Adjusted EBITDA of $4.7 million and $20.6 million, respectively. Adjusted EBITDA for the 2023 fourth quarter and full year decreased by $5.1 million and $4.5 million, respectively. Excluding the impacts from a decrease in political advertising and the Company’s dispositions of WWWE-AM, WJBR-FM and the Houston Outlaws in 2023 and WWNN-AM and KDWN-AM in 2022, partially offset by the Company’s acquisitions of KXTE-FM and Guarantee Digital in 2022, Adjusted EBITDA would have increased by $0.1 million and $6.0 million in the 2023 fourth quarter and full year, respectively.

“For the better part of the year, we continued to execute on our successful growth agenda for our digital business that capitalizes on the value of our strong local brands, unique local business relationships and proven marketing capabilities. While macroeconomic pressures held fourth quarter digital revenue flat compared to the prior year, Beasley delivered meaningful full-year digital revenue growth, up 11.4% year-over-year. Our digital business represented 18.4% of full year 2023 revenue. We remain laser focused on prioritizing the growth of our digital platform as a means to diversify our revenue in a cash flow positive manner, and we expect digital revenue to account for between 20% and 25% of total revenue in 2024. Our dedicated sales teams also continue to leverage the tremendous audience reach and engagement of our local multi-platform content to attract new advertisers, resulting in fourth quarter and full year new local business revenue growth of 52% and 20%, respectively. Additionally, the actions we have taken to reduce costs drove a year-over-year decline in operating expenses of 3.3% in the fourth quarter and 2.3% for the full year.

“Throughout the year, we further refined our media platform and completed several strategic transactions in order to prioritize investments in key growth areas, with an emphasis on digital. In the fourth quarter, we closed the sale of WJBR-FM in Wilmington to a non-commercial buyer for $5.0 million. Upon the completion of Activision’s sale to Microsoft, the Overwatch e-sports league was discontinued, and our Houston Outlaws team was dissolved. In December, Activision paid Beasley $6.0 million in exchange for the return of our franchise license. As a result, we made the strategic decision to pivot our focus toward higher-margin gaming content creation under our new Outlaws Entertainment brand.

“Consistent with Beasley’s commitment to enhancing financial flexibility and cash flows through debt reduction, we used the proceeds from these transactions, along with cash on hand, to repurchase $20 million of our senior secured notes at a discount. In 2023, we reduced debt by $23.0 million, strengthening our balance sheet and lowering our quarterly interest expense. With the return of the political advertising cycle and expectations for further digital growth in 2024, we intend to continue to opportunistically repurchase our senior secured notes this year.

“In summary, we are proud of the commitment of our teams in delivering exceptional content and services to millions of listeners, advertisers, digital users and sports fans, and remain confident that the actions we are taking to transform our company are laying the foundation for future growth and success. While macroeconomic uncertainty persists, we are cautiously optimistic about our 2024 growth prospects given our solid foundation, including powerful brands, leading audience share, effective strategies, and anticipated strong political spending in the back half of the year.”

Conference Call and Webcast Information

The Company will host a conference call and webcast today, February 12, 2024, at 11:00 a.m. ET to discuss its financial results and operations. To access the conference call, interested parties may dial 877-407-4018 or 201-689-8471, conference ID 13744073 (domestic and international callers). Participants can also listen to a live webcast of the call at the Company’s website at www.bbgi.com. Please allow 15 minutes to register and download and install any necessary software. Following its completion, a replay of the webcast can be accessed for five days on the Company’s website, www.bbgi.com.

Questions from analysts, institutional investors and debt holders may be e-mailed to ir@bbgi.com at any time up until 9:00 a.m. ET on Monday, February 12, 2024. Management will answer as many questions as possible during the conference call and webcast (provided the questions are not addressed in their prepared remarks).

About Beasley Broadcast Group

Beasley Broadcast Group, Inc. (www.bbgi.com) was founded in 1961 by George G. Beasley and owns 59 AM and FM stations in 13 large- and mid-size markets in the United States. Beasley radio stations reach over 30 million unique consumers weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text, apps and email. For more information, please visit www.bbgi.com.

For further information, or to receive future Beasley Broadcast Group news announcements via e-mail, please contact Beasley Broadcast Group, at 239-263-5000 or email@bbgi.com, or Joseph Jaffoni, JCIR, at 212-835-8500 or bbgi@jcir.com.

Definitions

EBITDA is defined as net income (loss) before interest income or expense, income tax expense or benefit, depreciation, and amortization.

Adjusted EBITDA is defined as EBITDA further adjusted to exclude certain, non-operating or other items that we believe are not indicative of the performance of our ongoing operations, such as impairment losses, other income or expense, or equity in earnings of unconsolidated affiliates. See “Reconciliation of Net Income (Loss) to Adjusted EBITDA” for additional information.

Adjusted EBITDA can also be calculated as net revenue less operating and corporate expenses. We define operating expenses as cost of services and selling, general and administrative expenses. Corporate expenses include general and administrative expenses and certain other income and expense items not allocated to the operating segments.

Adjusted EBITDA is a measure widely used in the media industry. The Company recognizes that because Adjusted EBITDA is not calculated in accordance with GAAP, it is not necessarily comparable to similarly titled measures employed by other companies. However, management believes that Adjusted EBITDA provides meaningful information to investors because it is an important measure of how effectively we operate our business and assists investors in comparing our operating performance with that of other media companies. The Company also presents Net revenue, excluding the impacts of political advertising, acquisitions and dispositions, and Adjusted EBITDA, excluding the impacts of political advertising, acquisitions and dispositions, to provide meaningful information to investors regarding how political advertising and acquisition and disposition activity impacted certain key performance measures.

Note Regarding Forward-Looking Statements

Statements in this release that are “forward-looking statements” are based upon current expectations and assumptions, and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “looking ahead,” “intends,” “believes,” “expects,” “seek,” “will,” “should” or variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Key risks are described in the Company’s reports filed with the Securities and Exchange Commission (“SEC”) including its annual report on Form 10-K and quarterly reports on Form 10-Q. Readers should note that forward-looking statements are subject to change and to inherent risks and uncertainties and may be impacted by several factors, including:

  • our ability to comply with the continued standards of the Nasdaq Global Market;
  • external economic forces and conditions that could have a material adverse impact on our advertising revenues and results of operations;
  • the ability of our stations to compete effectively in their respective markets for advertising revenues;
  • our ability to develop compelling and differentiated digital content, products and services;
  • audience acceptance of our content, particularly our audio programs;
  • our ability to respond to changes in technology, standards and services that affect the audio industry;
  • our dependence on federally issued licenses subject to extensive federal regulation;
  • actions by the FCC or new legislation affecting the audio industry;
  • increases to royalties we pay to copyright owners or the adoption of legislation requiring royalties to be paid to record labels and recording artists;
  • our dependence on selected market clusters of stations for a material portion of our net revenue;
  • credit risk on our accounts receivable;
  • the risk that our FCC licenses and/or goodwill could become impaired;
  • our substantial debt levels and the potential effect of restrictive debt covenants on our operational flexibility and ability to pay dividends;
  • the potential effects of hurricanes on our corporate offices and stations;
  • the failure or destruction of the internet, satellite systems and transmitter facilities that we depend upon to distribute our programming;
  • disruptions or security breaches of our information technology infrastructure and information systems;
  • the loss of key personnel;
  • our ability to integrate acquired businesses and achieve fully the strategic and financial objectives related thereto and their impact on our financial condition and results of operations;
  • the fact that our Company is controlled by the Beasley family, which creates difficulties for any attempt to gain control of our Company; and
  • other economic, business, competitive, and regulatory factors affecting our businesses, including those set forth in our filings with the SEC.

Our actual performance and results could differ materially because of these factors and other factors discussed in our SEC filings, including but not limited to our annual reports on Form 10-K or quarterly reports on Form 10-Q, copies of which can be obtained from the SEC, www.sec.gov, or our website, www.bbgi.com. All information in this release is as of February 12, 2024 and we undertake no obligation to update the information contained herein to actual results or changes to our expectations.

CONTACT:  
B. Caroline Beasley Joseph Jaffoni, Jennifer Neuman
Chief Executive Officer JCIR
Beasley Broadcast Group, Inc. 212/835-8500 or bbgi@jcir.com
239/263-5000 or ir@bbgi.com  

Release – The GEO Group Delivers Notice of Redemption for Remaining Senior Notes Due 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GEO

February 12, 2024

PDF Version

BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 12, 2024– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) has delivered a notice of redemption for all of the remaining $23,253,000 in outstanding aggregate principal amount of its 5.875%Senior Notes due October 15, 2024 (CUSIP No. 36162JAA4) (the “2024 Senior Notes”). The redemption of the 2024 Senior Notes will occur on March 11, 2024 (the “Redemption Date”).

The redemption price for the 2024 Senior Notes will be equal to $1,000 per $1,000 original principal amount, plus any accrued and unpaid interest up to, but excluding, the Redemption Date. GEO has deposited with the trustee for the 2024 Senior Notes the redemption price for the 2024 Senior Notes, using available cash on hand, and the Indenture governing the 2024 Senior Notes has been satisfied and discharged as to the 2024 Senior Notes. Payment of the redemption price for the 2024 Senior Notes will be made through the Depository Trust Company.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements, including our ability to redeem the 2024 Senior Notes on March 11, 2024. Readers are strongly encouraged to read the full cautionary statements contained in GEO’s filings with the U.S. Securities and Exchange Commission. GEO disclaims any obligation to update or revise any forward-looking statements.

Pablo E. Paez, 1-866-301-4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Ocugen (OCGN) – Raising Price Target to $8 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, February 12, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

New Price Target Reflects Clinical Progress In Several Programs. We are raising our price target on OCGN to $8 from $5 to reflect the company’s recent progress. Its clinical programs now include retinitis pigmentosa (RP), dry age-related macular degeneration (dAMD), and Stargardt disease. Since OCU410 has recently begun clinical trials in dAMD, we have adjusted our probability of market entry to arrive at a new price target.

OCU400 Has Produced Meaningful Data In RP and Advanced Toward Phase 3. Ocugen is finalizing the design of the Phase 3 for OCU400 and expects to begin the trial in Q24. The Phase 1/2 trial has completed dosing of the RP patients and three LCA patients. Final LCA patient data could allow FDA approval for expansion to LCA patients in 2H24. Data reported during 2023 showed meaningful improvements in vision for patients with RP, leading to its RMAT designation from the FDA and an expanded access program.


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