Release – ISG Announces Amended, $140 Million Credit Agreement

Research News and Market Data on III

2/23/2023

Firm improves financial flexibility, eliminates mandatory annual principal payments under new all-revolver facility with more favorable terms, extended maturity date

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced it has successfully amended its $140 million credit facility at more favorable terms, to improve the firm’s financial flexibility.

The new credit agreement amends the previous agreement entered into on March 10, 2020. Key updates include:

  • Converting the previous term and revolving loan into an all-revolving credit facility
  • Eliminating $4.3 million of mandatory annual principal payments due in 2023 and 2024
  • Extending the maturity date of the previous agreement by three years, to February 2028

“Our amended credit facility greatly enhances our financial flexibility and offers further validation of our robust business performance that enabled these enhancements,” said Michael P. Connors, chairman and CEO of ISG. “We thank our lenders for their partnership and confidence in our ability to deliver long-term sustainable growth and value for our shareholders.”

BofA Securities Inc. was the Sole Lead Arranger and Sole Bookrunner on the transaction.

Additional details about the amended credit agreement can be found in the Form 8-K ISG filed today with the U.S. Securities and Exchange Commission, a link to which can be found on ISG’s website.

Forward-Looking Statements

This communication contains “forward-looking statements” which represent the current expectations and beliefs of management of ISG concerning future events and their potential effects. Statements contained herein including words such as “anticipate,” “believe,” “contemplate,” “plan,” “estimate,” “target,” “expect,” “intend,” “will,” “continue,” “should,” “may,” and other similar expressions, are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future results and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. Those risks relate to inherent business, economic and competitive uncertainties and contingencies relating to the businesses of ISG and its subsidiaries including without limitation: (1) failure to secure new engagements or loss of important clients; (2) ability to hire and retain enough qualified employees to support operations; (3) ability to maintain or increase billing and utilization rates; (4) management of growth; (5) success of expansion internationally; (6) competition; (7) ability to move the product mix into higher margin businesses; (8) general political and social conditions such as war, political unrest and terrorism; (9) healthcare and benefit cost management; (10) ability to protect ISG and its subsidiaries’ intellectual property or data and the intellectual property or data of others; (11) currency fluctuations and exchange rate adjustments; (12) ability to successfully consummate or integrate strategic acquisitions; (13) outbreaks of diseases, including coronavirus, or similar public health threats or fear of such an event; and (14) engagements may be terminated, delayed or reduced in scope by clients. Certain of these and other applicable risks, cautionary statements and factors that could cause actual results to differ from ISG’s forward-looking statements are included in ISG’s filings with the U.S. Securities and Exchange Commission. ISG undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 800 clients, including 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 more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

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Company

Release – Baudax Bio Reports 2022 Fourth Quarter and Annual Financial Results and Provides Business Update

Research News and Market Data on BXRX

  February 23, 2023 8:00am EST

Company Focuses on Development of Neuromuscular Blocking Agents

Phase II Randomized Trial for BX1000 Initiated, Positive Interim Results Announced; Completion of Study Enrollment Expected Q1 2023, Top Line Results Expected Early Q2 2023

BX2000 Dose Escalation Study Progressing

$5 Million in Financing Secured through Public Offering

MALVERN, Pa., Feb. 23, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the fourth quarter and year ended December 31, 2022, updated the status of the neuromuscular blocking (NMB) agent development program, and provided an overview of other corporate and financial developments.

“During our fourth quarter we refocused our priorities on our NMB portfolio, initiating our Phase II trial for BX1000 and advancing our Phase I dose escalation trial for BX2000,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The encouraging interim data we announced from the BX1000 trial showed all patients treated to date have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that BX1000 has been generally well tolerated. We believe these data speak to the potential of our NMB portfolio to improve patient management and deliver cost efficiencies in procedures where NMB is required. We expect to complete enrollment in the BX1000 trial during the first quarter of 2023, and to announce top line data early in the second quarter of 2023. Concurrently, BX2000, our ultrashort acting NMB, is continuing through its dose escalation study, which we expect to complete by the end of 2023. BX3000, our NMB reversal agent, remains on track, and we expect to complete the nonclinical and manufacturing studies needed to support an IND filing for BX3000, the NMB reversal agent in the summer of 2023. Data from these trials will provide us with insight on the profiles of the two blocking agents, which will contribute to decisions to move forward later in 2023.”

“Due to persistent economic challenges facing hospitals, as previously disclosed, we have taken the strategic decision to discontinue commercialization of ANJESO,” continued Ms. Henwood. “We continue to believe in ANJESO’s advantages over other non-opioid pain therapies, as well as its potential to overcome many of the issues associated with commonly prescribed opioid therapeutics.”

Fourth Quarter 2022 and Recent Business Highlights

NMBs

  • BX1000 (IV Intermediate duration of action). Results for a planned interim analysis of the Phase II trial for BX1000 were announced in January 2023. This randomized, double-blind, active-controlled clinical trial comparing three different doses of BX1000 to a standard dose of rocuronium (rocuronium bromide 0.6 mg/kg IV Bolus) is planned to enroll a total of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia currently at a single clinical site in the U.S. The primary efficacy endpoint is the proportion of patients meeting criteria for Good or Excellent intubating conditions using a standardized scale. Additionally, the trial is evaluating the safety and tolerability profile of BX1000 and rocuronium in this patient population.
  • BX1000 Interim Data. The pre-planned interim analysis evaluated the intubating conditions for each randomized patient after administration of study drug in a blinded fashion. In the 20-patient cohort, 5 patients per group received one of the study medications. All 20 patients were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. Nineteen of the subjects were successfully intubated following the assessment at 60 seconds, with one remaining subject successfully intubated following the assessment at 90 seconds. Study treatments were generally well tolerated with no occurrence of severe or serious adverse events. This blinded interim analysis did not result in the decision to drop any of the four study groups nor any decision to adjust planned study enrollment numbers.
  • BX2000 (IV Ultra-short duration of action). Cohort enrollment is ongoing for the Phase I dose escalation study evaluating the safety, tolerability, and pharmacokinetics of BX2000 in intubated healthy volunteers. This study is comprised of likely seven or eight dosing cohorts and each cohort is planned to enroll eight patients. The first and second cohorts have been dosed and enrollment of the third cohort is underway. The Company expects to complete enrollment of the remaining cohorts in the study by the end of 2023.
  • BX3000 (Reversal agent). Baudax Bio expects to complete nonclinical studies and manufacturing data required to support the IND for BX3000 in the summer of 2023. Early single agent clinical trials of BX3000 will not require intubation and so would be expected to progress quickly once the IND is active, and trials are ready to initiate. The Company believes progress towards a reversal study using BX3000 in patients who have received BX1000 could begin before the end of 2023.
  • The Company believes the data from the ongoing clinical trials for BX1000 and BX2000 will contribute to decisions to move forward later in 2023.

ANJESO

  • ANJESO U.S. Commercialization Discontinued. Despite having distinct benefits as the first and only once-daily, non-opioid IV analgesic, market conditions are not favorable for the introduction and commercialization of a new pain management product in the hospital market. As a result, Baudax Bio has formally discontinued the commercialization of ANJESO and the product is currently on hold due to these business conditions.

Corporate and Financial

  • Closed $5 million public offering – on December 6, 2022 the Company closed a public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and expire five years from the date of issuance, and the Series A-4 warrants have an exercise price of $4.50 per share, are exercisable immediately and expire thirteen months from the date of issuance. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes. In January 2023, 961,787 warrants were exercised providing $4.3 million in cash to the Company.

Financial Results for the Three Months Ended December 31, 2022

As of December 31, 2022, Baudax had cash and cash equivalents of $5.3 million.

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the three months ended December 31, 2022 was $0.3 million. This compares to $0.4 million for the three months ended December 31, 2021, a decrease of $0.1 million, resulting from the impact of the reduction in our field staff in 2022 and the impact of our discontinuation of commercialization in the fourth quarter of 2022. While utilizing the title model of distribution, product revenue was recognized as shipments were made to the Company’s third-party logistics provider.

Cost of sales for the three months ended December 31, 2022 was $4.8 million, compared to $0.6 million for the three months ended December 31, 2021, an increase of $4.2 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The increase of $4.2 million was primarily a result of an increase in the non-cash charge for inventory reserve expense of $4.4 million, partially offset by the decrease in fixed personnel related costs of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the three months ended December 31, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods.

Research and development expense for the three months ended December 31, 2022 was $1.0 million compared to $0.5 million for the three months ended December 31, 2021, an increase of $0.5 million, which was a result of an increase in NMB clinical trial costs of $0.9 million, partially offset by a decrease in personnel costs of $0.3 million.

Selling, general and administrative expenses for the three months ended December 31, 2022 were $2.1 million, of which $0.2 million was attributable to selling expense and $1.9 million was attributable to general and administrative expense. This compares to $11.5 million for the same prior year period, of which $6.5 million was attributable to selling expense and $5.0 million was attributable to general and administrative expense. Selling expenses decreased $6.3 million, primarily as a result of a reduction in personnel costs of $4.4 million, a decrease in marketing costs of $1.6 million and a decrease in associated travel expenses of $0.3 million. The decrease of $3.1 million in general and administrative costs was primarily a result of a decrease in personnel costs of $2.2 million, a decrease in public company costs of $0.5 million and a decrease in both consulting costs and travel expenses of $0.2 million.

As a result of the discontinuation of commercialization of ANJESO, Baudax Bio evaluated the intangible asset carrying value attributed to ANJESO as of December 31, 2022 and recorded a non-cash impairment loss of $1.9 million to eliminate the carrying value of the asset. The value of its construction in progress related to the construction of an additional manufacturing suite for ANJESO was further reduced by $0.5 million.

Baudax Bio reported net loss of $9.2 million, or $(12.33) per share, including non-cash charges of $6.1 million (primarily related to the inventory reserve expense discussed above), for the three months ended December 31, 2022. Adjusted net loss* was $3.1 million for the three months ended December 31, 2022. Net income for the three months ended December 31, 2021 was $29.4 million, or $437.19 per diluted share, including a non-cash benefit of $41.3 million. Adjusted net loss* was $11.9 million for the three months ended December 31, 2021.

Financial Results for the Year Ended December 31, 2022

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the year ended December 31, 2022 was $1.3 million. This compares to $1.1 million for the year ended December 31, 2021, an increase of $0.2 million, which was attributable to increased demand at existing accounts. While utilizing the title model of distribution, product revenue was recognized as shipments were made to the Company’s third-party logistics provider.

Cost of sales for the year ended December 31, 2022 was $7.0 million, compared to $2.4 million for the year ended December 31, 2021, an increase of $4.6 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The increase of $4.6 million was primarily a result of the increase in the non-cash charge for inventory reserve expense of $5.2 million, partially offset by the reduction in personnel related costs of $0.4 million and the reduction in production and storage costs of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the year ended December 31, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods.

Research and development expenses for the year ended December 31, 2022 were $3.9 million compared to $3.1 million for the year ended December 31, 2021. The increase of $0.8 million was primarily due to the increase in the NMB portfolio clinical trial costs of $1.0 million and an increase of $0.2 million related to the pediatric clinical trial costs for ANJESO. These costs were partially offset by a decrease in personnel related costs of $0.4 million.

Selling, general and administrative expenses for the year ended December 31, 2022 were $24.1 million, of which $9.4 million was attributable to selling expense and $14.7 million was attributable to general and administrative expense. This compares to $45.3 million for the same prior year period, of which $22.4 million was attributable to selling expense and $22.9 million was attributable to general and administrative expense. Selling expenses decreased $13.0 million, primarily as a result of a reduction in personnel costs of $7.9 million, a decrease in marketing costs of $4.7 million and a decrease in travel expenses of $0.4 million compared to 2021. The decrease of $8.2 million in general and administrative expenses was primarily a result of a decrease in personnel costs of $4.7 million, a decrease in public company costs of $2.3 million, a decrease in consulting costs of $0.9 million and a decrease in other costs of $0.3 million.

As a result of the discontinuation of commercialization of ANJESO, Baudax Bio evaluated the intangible asset carrying value attributed to ANJESO as of December 31, 2022 and recorded a non-cash impairment loss of $19.7 million to eliminate the carrying value of the asset. Additionally, the value of its construction in progress related to the construction of an additional manufacturing suite for ANJESO was reduced by $4.2 million.

Baudax Bio reported net loss of $58.8 million, or $(177.30) per share, including net non-cash charges of $30.9 million, for the year ended December 31, 2022. Adjusted net loss* was $27.9 million for the year ended December 31, 2022. For the year ended December 31, 2021 net loss was $19.8 million, or $(361.16) per share, including net non-cash benefit of $26.4 million. Adjusted net loss* was $46.2 million for the year ended December 31, 2021.

Non-GAAP Financial Measures

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company is reporting certain non-GAAP information for its business, including adjusted net loss. Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, stock-based compensation, losses on impairment of construction in progress and intangible assets and the write off of inventory. The Company believes this non-GAAP financial measure is helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. This measure is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of non-GAAP adjusted net loss to its most directly comparable GAAP measure.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one undergoing a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACTS:

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company has disclosed in the tables below the following non-GAAP information about adjusted net loss.
Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, stock-based compensation, losses on impairment of construction in progress and intangible assets and the write off of inventory.
The Company believes that non-GAAP financial measures are helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. Adjusted net loss is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.

Source: Baudax Bio, Inc.

Released February 23, 2023

Biotechnology Industry Report: Webcast Highlights Long COVID Symptoms and Potential Treatments

Thursday, February 23, 2023

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the bottom of the report for important disclosures

Webinar. BIO (Biotechnology Innovation Organization, an industry group) sponsored a webinar titled, “Long COVID:  What Will It Take To Accelerate Therapeutic Progress?” Speakers included officials from government, academia, and drug development companies to discuss the scientific basis of the condition, its public health implications, and its potential treatments.  Presenting companies included Axcella Health (AXLA) and Tonix Pharmaceuticals (TNXP).

Long COVID Symptoms and Prevalence.  The program began with how Long COVID became recognized as a condition, its incidence, and its patient population. Scientific presentations showed the biological effects of the SARS-CoV-2 virus on cells in the body, including the connection between Long COVID and other chronic conditions such as CFS/ME (chronic fatigue syndrome/myalgic encephalomyelitis). Symptoms and their duration can vary widely, including inflammation, fatigue, organ dysfunction, and reactivation of latent viral reservoirs.  The presenters agreed that the range of symptoms and their variability will require numerous drugs.

Axcella Health Presented AXA1125. Chief Scientific Officer at Axcella Health, Dr. Margaret Koziel, presented the scientific basis for the use of AXA1125 in Long COVID, including its effects on inflammation, mitochondrial dysfunction, and fatigue.  Data from the Phase 2a trial was presented, showing improvements in function, and biomarkers that correlate with reductions in inflammation and mitochondrial dysfunction. The design of the Phase 2b/3 trial was also presented.

Tonix Pharmaceuticals Presented Data From TNX-102 SL. Tonix is currently enrolling patients in its Phase 2 PREVAIL trial testing TNX-102 SL, sublingual cyclobenzaprine, in Long COVID. This trial is based on common symptoms with fibromyalgia and chronic fatigue syndrome, such as pain, fatigue, and insomnia.  Projected enrollment is about 470 patients with a primary endpoint of change in daily pain score from baseline over the 14-week treatment period.

Conclusion. The BIO webinar speakers agreed that the high variability and large population would require several drugs to adequately treat patients. For Axcella, we believe the presentation could raise awareness of AXA1125 and its “Phase 2b/3 Ready” status, allowing it obtain trial funding through partnerships, government funding, or from investors.  Tonix was able to present how TNX-102 SL overlaps with other pain syndromes and how it could treat symptoms, as well as to highlight its clinical milestones in the coming year.

Summary. BIO (Biotechnology Innovation Organization, and industry group) sponsored a webinar titled, “Long COVID: What Will It Take To Accelerate Therapeutic Progress?” Speakers included officials from government, academia, and drug development companies to discuss the scientific basis of the condition, its public health implications, and its potential treatments.  Presenting companies included Axcella Health (AXLS) and Tonix Pharmaceuticals (TNXP).

The program began with the history of Long COVID, how it became recognized as a condition, and its prevalence. Scientific presentations discussed the SARS-CoV-2 viral infection and its effects on different organs, as well as the mechanisms of infection that lead to fatigue, cerebral effects (brain fog), and chronic pain.  The speakers pointed out that the range and severity of symptoms can vary widely, making it likely that numerous drugs will be needed.

The overlap between Long COVID and other chronic conditions, such as CFS/ME (chronic fatigue syndrome/myalgic encephalomyelitis), was also discussed. The common features in these conditions were cited in the “National Research Action Plan on Long COVID”, published by the Department of Health and Human Services in August 2022.

Axcella Health Spoke About AXA1125. Chief Scientific Officer at Axcella Health, Dr. Margaret Koziel, presented the scientific basis for the use of AXA1125 in Long COVID, including its effect on inflammation, mitochondrial dysfunction, epithelial dysfunction, and fatigue. Data from the Phase 2a trial was presented, showing improvements in physical and mental function.  These data included biomarkers that correlate with improvements in inflammation and mitochondrial function. The design of the Phase 2b/3 trial was also presented.

Tonix Pharmaceuticals Presented Data From TNX-102 SL. Tonix is currently enrolling patients in its Phase 2 PREVAIL trial testing TNX-102 SL, sublingual cyclobenzaprine, in Long COVID. This trial is based on common symptoms with fibromyalgia and chronic fatigue syndrome, such as pain, fatigue, and insomnia.  Projected enrollment is about 470 patients with a primary endpoint of change in daily pain score from baseline over the 14-week treatment period.

TNX-102 SL showed positive results in its Phase 3 RELIEF study in fibromyalgia, although the confirmatory Phase 3 RALLY missed its primary endpoint.  After analyzing the RALLY trial, the Phase 3 RESILIENT trial began.  An interim analysis from the RESILIENT trial is expected in 2Q23. 

Conclusion. The BIO webinar gave different perspectives on Long COVID and discussed different approaches to treatment. For Axcella, we believe the presentation could raise awareness of AXA1125 data and its “Phase 2b/3” ready status, allowing it obtain trial funding through partnerships, government funding, or from investors.  For Tonix, presentations on the common features of Long COVID and chronic pain syndromes support the use of Tonix’s TNX-102 SL, and show how its Phase 2 PREVAIL clinical trial design could become an effective treatment.

Companies Mentioned In This Report:

Axcella Health  (AXLA, Outperform)

Tonix Pharmaceuticals (TNXP, Outperform)

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All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

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Noble is not a market maker in any of the companies mentioned in this report. Noble intends to seek compensation for investment banking services and non-investment banking services (securities and non-securities related) with any or all of the companies mentioned in this report within the next 3 months

ANALYST CREDENTIALS, PROFESSIONAL DESIGNATIONS, AND EXPERIENCE

Senior Equity Analyst focusing on Basic Materials & Mining. 20 years of experience in equity research. BA in Business Administration from Westminster College. MBA with a Finance concentration from the University of Missouri. MA in International Affairs from Washington University in St. Louis.
Named WSJ ‘Best on the Street’ Analyst and Forbes/StarMine’s “Best Brokerage Analyst.”
FINRA licenses 7, 24, 63, 87

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transactions effected on the recipients behalf, details of which will be available on request in regard to a transaction that involves a personalized securities recommendation. Additional risks associated with the security mentioned in this report that might impede achievement of the target can be found in its initial report issued by Noble Capital Markets, Inc.. This report may not be reproduced, distributed or published for any purpose unless authorized by Noble Capital Markets, Inc..

RESEARCH ANALYST CERTIFICATION

Independence Of View
All views expressed in this report accurately reflect my personal views about the subject securities or issuers.

Receipt of Compensation
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appearance and/or research report.

Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.

3D-Printed Human Hearts (Patient Specific)

Image Credit: Melanie Gonick, MIT

Custom, 3D-Printed Heart Replicas Look and Pump Just Like the Real Thing

Jennifer Chu | MIT News Office

No two hearts beat alike. The size and shape of the heart can vary from one person to the next. These differences can be particularly pronounced for people living with heart disease, as their hearts and major vessels work harder to overcome any compromised function.

MIT engineers are hoping to help doctors tailor treatments to patients’ specific heart form and function, with a custom robotic heart. The team has developed a procedure to 3D print a soft and flexible replica of a patient’s heart. They can then control the replica’s action to mimic that patient’s blood-pumping ability.

The procedure involves first converting medical images of a patient’s heart into a three-dimensional computer model, which the researchers can then 3D print using a polymer-based ink. The result is a soft, flexible shell in the exact shape of the patient’s own heart. The team can also use this approach to print a patient’s aorta — the major artery that carries blood out of the heart to the rest of the body.

To mimic the heart’s pumping action, the team has fabricated sleeves similar to blood pressure cuffs that wrap around a printed heart and aorta. The underside of each sleeve resembles precisely patterned bubble wrap. When the sleeve is connected to a pneumatic system, researchers can tune the outflowing air to rhythmically inflate the sleeve’s bubbles and contract the heart, mimicking its pumping action.

The researchers can also inflate a separate sleeve surrounding a printed aorta to constrict the vessel. This constriction, they say, can be tuned to mimic aortic stenosis — a condition in which the aortic valve narrows, causing the heart to work harder to force blood through the body.

Doctors commonly treat aortic stenosis by surgically implanting a synthetic valve designed to widen the aorta’s natural valve. In the future, the team says that doctors could potentially use their new procedure to first print a patient’s heart and aorta, then implant a variety of valves into the printed model to see which design results in the best function and fit for that particular patient. The heart replicas could also be used by research labs and the medical device industry as realistic platforms for testing therapies for various types of heart disease.

“All hearts are different,” says Luca Rosalia, a graduate student in the MIT-Harvard Program in Health Sciences and Technology. “There are massive variations, especially when patients are sick. The advantage of our system is that we can recreate not just the form of a patient’s heart, but also its function in both physiology and disease.”

Rosalia and his colleagues report their results in a study appearing today in Science Robotics. MIT co-authors include Caglar Ozturk, Debkalpa Goswami, Jean Bonnemain, Sophie Wang, and Ellen Roche, along with Benjamin Bonner of Massachusetts General Hospital, James Weaver of Harvard University, and Christopher Nguyen, Rishi Puri, and Samir Kapadia at the Cleveland Clinic in Ohio.

Print and Pump

In January 2020, team members, led by mechanical engineering professor Ellen Roche, developed a “biorobotic hybrid heart” — a general replica of a heart, made from synthetic muscle containing small, inflatable cylinders, which they could control to mimic the contractions of a real beating heart.

Shortly after those efforts, the Covid-19 pandemic forced Roche’s lab, along with most others on campus, to temporarily close. Undeterred, Rosalia continued tweaking the heart-pumping design at home.

“I recreated the whole system in my dorm room that March,” Rosalia recalls.

Months later, the lab reopened, and the team continued where it left off, working to improve the control of the heart-pumping sleeve, which they tested in animal and computational models. They then expanded their approach to develop sleeves and heart replicas that are specific to individual patients. For this, they turned to 3D printing.

“There is a lot of interest in the medical field in using 3D printing technology to accurately recreate patient anatomy for use in preprocedural planning and training,” notes Wang, who is a vascular surgery resident at Beth Israel Deaconess Medical Center in Boston.

An Inclusive Design

In the new study, the team took advantage of 3D printing to produce custom replicas of actual patients’ hearts. They used a polymer-based ink that, once printed and cured, can squeeze and stretch, similarly to a real beating heart.

As their source material, the researchers used medical scans of 15 patients diagnosed with aortic stenosis. The team converted each patient’s images into a three-dimensional computer model of the patient’s left ventricle (the main pumping chamber of the heart) and aorta. They fed this model into a 3D printer to generate a soft, anatomically accurate shell of both the ventricle and vessel.

The team also fabricated sleeves to wrap around the printed forms. They tailored each sleeve’s pockets such that, when wrapped around their respective forms and connected to a small air pumping system, the sleeves could be tuned separately to realistically contract and constrict the printed models.

The researchers showed that for each model heart, they could accurately recreate the same heart-pumping pressures and flows that were previously measured in each respective patient.

“Being able to match the patients’ flows and pressures was very encouraging,” Roche says. “We’re not only printing the heart’s anatomy, but also replicating its mechanics and physiology. That’s the part that we get excited about.”

Going a step further, the team aimed to replicate some of the interventions that a handful of the patients underwent, to see whether the printed heart and vessel responded in the same way. Some patients had received valve implants designed to widen the aorta. Roche and her colleagues implanted similar valves in the printed aortas modeled after each patient. When they activated the printed heart to pump, they observed that the implanted valve produced similarly improved flows as in actual patients following their surgical implants.

Finally, the team used an actuated printed heart to compare implants of different sizes, to see which would result in the best fit and flow — something they envision clinicians could potentially do for their patients in the future.

“Patients would get their imaging done, which they do anyway, and we would use that to make this system, ideally within the day,” says co-author Nguyen. “Once it’s up and running, clinicians could test different valve types and sizes and see which works best, then use that to implant.”

Ultimately, Roche says the patient-specific replicas could help develop and identify ideal treatments for individuals with unique and challenging cardiac geometries.

“Designing inclusively for a large range of anatomies, and testing interventions across this range, may increase the addressable target population for minimally invasive procedures,” Roche says.

This research was supported, in part, by the National Science Foundation, the National Institutes of Health, and the National Heart Lung Blood Institute.

Reprinted with permission from MIT News ( http://news.mit.edu/ )

Three Regulators Provide Direction to Banks on Crypto

Image Credit: QuoteInspector.com (Flickr)

The Statement on Crypto Vulnerabilities by Regulators

A joint statement to banking organizations on “crypto-asset vulnerabilities” was just released by three bank regulatory agencies. Most banks in the U.S. fall under these three federal institutions overseeing them in a regulatory capacity. So when a statement regarding the health and stability of banks is made, it is often a joint statement from the three. At a minimum, statements include the Federal Reserve Bank (FRB), Office of the Controller of the Currency (OCC), and Federal Deposit Insurance Corp. (FDIC).

About the Statement

Issued on February 23rd, the multiple agencies felt a need to highlight liquidity risks presented by some “sources of funding” from crypto-asset-related entities, and practices they should be using to manage the risks.

The regulators remind banks that they are neither prohibited nor discouraged from offering banking services to this class of customer, but if they do, much of the existing risk management principles should be applied.

Related Liquidity Risks

Highlighted in the statement by the three bank regulatory bodies are key liquidity risks associated with crypto asset participants and crypto-asset organizations involved in banking and what they should be aware of.

This includes some sources of funding from crypto-asset-related entities that may pose heightened liquidity risks to those involved in banking due to the unpredictability of the scale and timing of deposit inflows and outflows, including, for example:

  • Deposits placed by a crypto-asset-related entity that is for the benefit of thecrypto-asset-related entity’s customers. The stability of the deposits, according to the statement, may be driven by the behavior of the end customer or asset sector dynamics, and not solely by the crypto-asset-related entity itself, which is the banking organization’s direct counterparty. The concern is the stability of the deposits may be influenced by, for example, periods of stress, market volatility, and related vulnerabilities in the crypto-asset sector, which may or may not be specific to the crypto-asset-related entity. Such deposits can be susceptible to large and rapid inflows as well as outflows when end customers react to crypto-asset-sector-related market events, media reports, and uncertainty. This uncertainty and resulting deposit volatility can be exacerbated by end customer confusion related to inaccurate or misleading representations of deposit insurance by a crypto-assetrelated entity.
  • Deposits that constitute stablecoin-related reserves. The stability of this type of  deposit may be linked to demand for stablecoins according to the agencies, along with the confidence of stablecoin holders in the coin arrangement, and the stablecoin issuer’s reserve management practices. These deposits can be susceptible to large and rapid outflows stemming from, for unanticipated stablecoin redemptions or dislocations in crypto-asset markets.

More broadly, when a banking organization’s deposit funding base is concentrated in crypto-asset-related entities that are highly interconnected or share similar risk profiles, deposit fluctuations may also be correlated, and liquidity risk therefore may be further heightened, according to the statement.

Effective Risk Management Practices

In light of these hightened risks, agencies think it is critical for banks that use certain sources of funding from crypto-asset-related entities, as described earlier, to actively monitor the liquidity risks inherent in these sources of funding and to establish and maintain effective risk management and controls commensurate with the level of liquidity risks from these funding sources. Effective practices for these banking organizations could include:

  • Understanding the direct and indirect drivers of the potential behavior of deposits from crypto-asset-related entities and the extent to which those deposits are susceptible to unpredictible vulnerability.
  • Assessing potential concentration or interconnectedness across deposits from crypto-asset-related entities and the associated liquidity risks.
  • Incorporating the liquidity risks or funding volatility associated with crypto-asset-related deposits into contingency funding planning, including liquidity stress testing and, as appropriate, other asset-liability governance and risk management processes.
  • Performing significant due diligence and monitoring of crypto-related-entities that establish deposit accounts, including assessing the representations made by those crypto-asset-related entities to their end customers about the accounts – if innaccurate they could lead to to unexpected or rapid outflows.

Additionally, banks and banking organizations are required to comply with applicable laws and regulations.  For FDIC insured institutions, this includes compliance with rules related to brokered deposits and Call Report filing requirements.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/newsevents/pressreleases/files/bcreg20230223a1.pdf

Release – FAT Brands Inc. Reports Fourth Quarter and Full Year 2022 Financial Results

Research News and Market Data on FAT

FEBRUARY 22, 2023

Conference call and webcast today at 5:00 p.m. ET

LOS ANGELES, Feb. 22, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT) (“FAT Brands” or the “Company”) today reported fourth quarter and full year 2022 financial results for the fiscal year ended December 25, 2022.

Andy Wiederhorn, President and CEO of FAT Brands, commented, “The fourth quarter marked yet another strong performance for FAT Brands, as evidenced by our robust unit development and profitable revenue growth. After a very active acquisition strategy in 2021, I am particularly pleased with the momentum of our organic growth strategy during 2022.”

“With over 140 store openings during 2022, we achieved a new milestone for FAT Brands, including 44 that opened in the fourth quarter. We plan to continue this robust unit growth with between 150 and 175 units slated to open in 2023. We are seeing strong new franchisee activity as well as continued demand from existing franchise partners to develop other brands within our portfolio, which is very encouraging as we look beyond our current unit development pipeline of over 1,000 locations representing 60% EBITDA growth over the next several years.”

“We are extremely impressed with how our 2021 acquisitions have seamlessly fit into our portfolio and the demand we are experiencing for them from our franchisee base. In addition to our organic growth momentum, we will lean into the expansion of our high-growth brands, particularly our sports lodge category, and continue to expand our factory business.”

“We also continue to work on reducing our cost of capital and are pursuing strategies to significantly reduce our leverage ratio over the next 24 to 36 months.”

Fiscal Fourth Quarter 2022 Highlights

  • Total revenue improved 39.9% to $103.8 million compared to $74.2 million in the fourth quarter of 2021
    • System-wide sales growth of 22.1% in the fourth quarter of 2022 compared to the prior year quarter
    • Year-to-date system-wide same-store sales growth of 2.7% in the fourth quarter of 2022 compared to the prior year
    • 44 new store openings during the fourth quarter of 2022 and over 140 openings during the year
  • Net loss of $70.8 million, or $4.29 per diluted share, compared to $19.6 million, or $1.38 per diluted share, in the fourth quarter of 2021
  • Adjusted EBITDA(1) of $19.6 million compared to $10.4 million in the fourth quarter of 2021
  • Adjusted net loss(1) of $43.0 million, or $2.60 per diluted share, compared to $16.5 million, or $1.16 per diluted share, in the fourth quarter of 2021

Fiscal Year 2022 Highlights

  • Total revenue increased 242.5% to $407.2 million compared to $118.9 million in 2021
    • System-wide sales growth of 108.0% compared to 2021
    • Year-to-date system-wide same-store sales growth of 6.0% in 2022 compared to 2021
    • Over 140 new store openings during 2022
  • Net loss of $126.2 million, or $7.66 per diluted share, compared to $31.6 million, or $2.15 per diluted share, in 2021
  • Adjusted EBITDA(1) of $88.8 million compared to $21.1 million 2021
  • Adjusted net loss(1) of $80.9 million, or $4.91 per diluted share, compared to $20.6 million, or $1.41 per diluted share, in 2021

(1)   EBITDA, Adjusted EBITDA and adjusted net loss are non-GAAP measures defined below, under “Non-GAAP Measures”. Reconciliation of GAAP net loss to EBITDA, adjusted EBITDA and adjusted net loss are included in the accompanying financial tables.

Summary of Fourth Quarter 2022 Financial Results

Total revenue increased $29.6 million, or 39.9%, in the fourth quarter of 2022, to $103.8 million compared to $74.2 million in the same period of 2021. The increase reflects revenue from the acquisition of Twin Peaks in October 2021, the acquisitions of Fazoli’s and Native Grill & Wings in December 2021 (collectively, the “2021 Acquisitions”) and the continuing recovery from the negative effects of the COVID-19 pandemic on royalties from restaurant sales.

Costs and expenses increased $59.5 million, or 77.3%, in the fourth quarter of 2022 to $136.4 million compared to $77.0 million in the same period in the prior year, primarily due to the 2021 Acquisitions.

General and administrative expense increased $17.6 million, or 81.4%, in the fourth quarter of 2022 compared to the same period in the prior year, primarily due to the 2021 Acquisitions, increased compensation costs, professional fees related to pending litigation and government investigations, and travel, reflecting the significant expansion of the organization.

Cost of restaurant and factory revenues totaled $61.7 million in the fourth quarter of 2022 and was related to the operations of the company-owned restaurant locations and our dough factory associated with the 2021 Acquisitions.

Depreciation and amortization increased $1.6 million, or 30.6% in the fourth quarter of 2022 compared to the same period in the prior year, primarily due to depreciation of company-owned restaurant property and equipment and amortizing intangible assets related to the 2021 Acquisitions.

Refranchising losses in the fourth quarter of 2022 were $3.1 million and were comprised of restaurant costs and expenses, net of food sales. Refranchising losses in the fourth quarter of 2021 were $1.0 million and were comprised of $2.1 million restaurant operating costs, net of food sales, partially offset by $1.1 million in net gains related to refranchised restaurants.

Advertising expenses increased $1.6 million in the fourth quarter of 2022 compared to the prior year period. These expenses vary in relation to advertising revenues and reflect advertising expenses related to the 2021 Acquisitions and the increase in customer activity as the recovery from COVID continues.

Total other expense, net for the fourth quarters of 2022 and 2021 was $24.2 million and $17.1 million, respectively, primarily comprised of net interest expense of $25.6 million and $16.4 million, respectively.

Adjusted net loss was $43.0 million, or $2.60 per diluted share, in the fourth quarter of 2022 compared to $16.5 million, or $1.16 per diluted share, in the fourth quarter of 2021.

Key Financial Definitions

New store openings – The number of new store openings reflects the number of stores opened during a particular reporting period. The total number of new stores per reporting period and the timing of stores openings has, and will continue to have, an impact on our results.

Same-store sales growth – Same-store sales growth reflects the change in year-over-year sales for the comparable store base, which we define as the number of stores open and in the FAT Brands system for at least one full fiscal year. For stores that were temporarily closed, sales in the current and prior period are adjusted accordingly. Given our focused marketing efforts and public excitement surrounding each opening, new stores often experience an initial start-up period with considerably higher than average sales volumes, which subsequently decrease to stabilized levels after three to six months. Additionally, when we acquire a brand, it may take several months to integrate fully each location of said brand into the FAT Brands platform. Thus, we do not include stores in the comparable base until they have been open and in the FAT Brands system for at least one full fiscal year. For 2022, the comparable store base does not include concepts acquired during the fourth quarter of 2021.

System-wide sales growth – System wide sales growth reflects the percentage change in sales in any given fiscal period compared to the prior fiscal period for all stores in that brand only when the brand is owned by FAT Brands. Because of acquisitions, new store openings and store closures, the stores open throughout both fiscal periods being compared may be different from period to period.

Conference Call and Webcast

FAT Brands will host a conference call and webcast to discuss its fiscal fourth quarter 2022 financial results today at 5:00 PM ET. Hosting the conference call and webcast will be Andy Wiederhorn, President and Chief Executive Officer, and Ken Kuick, Chief Financial Officer.

The conference call can be accessed live over the phone by dialing 1-877-704-4453 from the U.S. or 1-201-389-0920 internationally. A replay will be available after the call until Wednesday, March 1, 2023, and can be accessed by dialing 1-844-512-2921 from the U.S. or 1-412-317-6671 internationally. The passcode is 13735781. The webcast will be available at www.fatbrands.com under the “Investors” section and will be archived on the site shortly after the call has concluded.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses and franchises and owns approximately 2,300 units worldwide. For more information, please visit www.fatbrands.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 future financial and operating results of the Company, estimates of future EBITDA, the timing and performance of new store openings, future reductions in cost of capital and leverage ratio, our ability to conduct future accretive acquisitions, our pipeline of new store locations, and the recovery of our business from the COVID-19 pandemic. Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results 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 risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this press release.

Non-GAAP Measures (Unaudited)

This press release includes the non-GAAP financial measures of EBITDA, adjusted EBITDA and adjusted net loss.

EBITDA is defined as earnings before interest, taxes, and depreciation and amortization. We use the term EBITDA, as opposed to income from operations, as it is widely used by analysts, investors, and other interested parties to evaluate companies in our industry. We believe that EBITDA is an appropriate measure of operating performance because it eliminates the impact of expenses that do not relate to business performance. EBITDA is not a measure of our financial performance or liquidity that is determined in accordance with generally accepted accounting principles (“GAAP”), and should not be considered as an alternative to net income (loss) as a measure of financial performance or cash flows from operations as measures of liquidity, or any other performance measure derived in accordance with GAAP.

Adjusted EBITDA is defined as EBITDA (as defined above), excluding expenses related to acquisitions, refranchising gain or losses, impairment charges, and certain non-recurring or non-cash items that the Company does not believe directly reflect its core operations and may not be indicative of the Company’s recurring business operations.

Adjusted net loss is a supplemental measure of financial performance that is not required by or presented in accordance with GAAP. Adjusted net loss is defined as net loss plus the impact of adjustments and the tax effects of such adjustments. Adjusted net loss is presented because we believe it helps convey supplemental information to investors regarding our performance, excluding the impact of special items that affect the comparability of results in past quarters to expected results in future quarters. Adjusted net loss as presented may not be comparable to other similarly titled measures of other companies, and our presentation of adjusted net loss should not be construed as an inference that our future results will be unaffected by excluded or unusual items. Our management uses this non-GAAP financial measure to analyze changes in our underlying business from quarter to quarter based on comparable financial results.

Reconciliations of net loss presented in accordance with GAAP to EBITDA, adjusted EBITDA and adjusted net loss are set forth in the tables below.

Investor Relations:

ICR
Michelle Michalski
ir-fatbrands@icrinc.com
646-277-1224

Media Relations:

Erin Mandzik
emandzik@fatbrands.com
860-212-6509

Release – CVG Announces Fourth Quarter And Full Year 2022 Earnings Call

Research News and Market Data on CVGI

FEBRUARY, 22, 2023

NEW ALBANY, Ohio, Feb. 22, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI) will hold its quarterly conference call on Tuesday, March 7, 2023, at 10:00 a.m. ET, to discuss fourth quarter and full year 2022 financial results. CVG will issue a press release and presentation prior to the conference call.

Toll-free participants dial (888) 396-8049 using conference code 33489158. International participants dial (416) 764-8646 using conference code 33489158. This call is being webcast and can be accessed through the “Investors” section of CVG’s website at ir.cvgrp.com where it will be archived for one year.

A telephonic replay of the conference call will be available until March 21, 2023. To access the replay, toll-free callers can dial (877) 674-7070 using access code 489158.

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Source: Commercial Vehicle Group, Inc.

Release – Defense Metals starts construction of Hydrometallurgical Pilot Plant with commissioning at SGS Lakefield scheduled for March 2023

Research News and Market Data on DFMTF

Feb 22, 2023, 09:00 ET

VANCOUVER, BC, Feb. 22, 2023 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“; (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that construction of the hydrometallurgical pilot plant has started and commissioning is scheduled to start in the second half of March. 

Craig Taylor, CEO of Defense Metals, stated:

“We are excited to enter this important milestone of building and running the hydrometallurgical pilot plant, which is scheduled to be commissioned in late March.  Pilot operations will be done in two segments and should be completed by the end of April. A successful pilot plant program will be essential for the completion of the engineering design and economics of the planned pre-feasibility study.”

Following the successful completion of laboratory flotation and acid bake tests from December 2021 to date, Defense Metals is now ready to build a hydrometallurgical pilot plant. It is important to note that the Independent Preliminary Economic Assessment1 was based on a different hydrometallurgy flowsheet, the gangue-leach – caustic-crack process (see the Company’s March 31, 2022 news release).  However, after numerous laboratory tests the Company decided to pursue piloting of the less complex acid bake process, which has, in initial test-work, yielded better recovery rates, is an industry standard, and has the potential for improved economics.

The objective of the pilot plant is to demonstrate at a larger scale, and with continuous operation, the processing of Wicheeda flotation concentrate to produce rare earths using the acid bake flowsheet, to help confirm the quality of the project, and to gather data required for the pre-feasibility study.

The pilot plant will be configured to produce a high-purity rare earth precipitate suitable as feed for a separation plant. Samples produced from the pilot plant will also be shared with potential end-users for product development and qualification.

Methodology

The plant is being built at SGS Lakefield, Ontario and will run in two segments for approximately two weeks. The feed for the plant will total approximately 600 kg of mineral concentrate that was generated from a flotation pilot plant operated on a bulk sample from the Wicheeda deposit.

Qualified Person

The scientific and technical information contained in this news release, as it relates to the Wicheeda Rare-Earth Project, has been reviewed and approved by John Goode, P. Eng., a metallurgical consultant to the Company, and who is a Qualified Person as defined by National Instrument 43-101 and who has provided the technical information relating to metallurgy in this news release. Kristopher J. Raffle, P.Geo. (BC), a director of the Company, is the Qualified Person as defined in National Instrument 43-101 for the information relating to resources in this news release.

About the Wicheeda REE Property

Defense Metals 100% owned, 4,262-hectare (~10,532-acre) Wicheeda REE property is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near 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.

The 2021 Wicheeda REE Project Preliminary Economic Assessment technical report (“PEA”) outlined a robust after-tax net present value (NPV@8%) of $517 million and an 18% IRR[1]. This PEA contemplated an open pit mining operation with a 1.75:1 (waste:mill feed) strip ratio providing a 1.8 Mtpa (“million tonnes per year”) mill throughput producing an average of 25,423 tonnes REO annually over a 16 year mine life. A Phase 1 initial pit strip ratio of 0.63:1 (waste:mill feed) would yield rapid access to higher grade surface mineralization in year 1 and payback of $440 million initial capital within 5 years.

About Defense Metals Corp.

Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power markets, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

For further information, please 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

This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, starting and completing the hydrometallurgical pilot plant including anticipated timeline and expected results and outcomes, the Company’s plans for its Wicheeda REE Project, expected results and outcomes, completion of the PFS, 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 at www.sedar.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 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 and engineering 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, an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to, the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, 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.

__________________________
1 Independent Preliminary Economic Assessment for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated January 6, 2022, with an effective date of November 7, 2021, and prepared by SRK Consulting (Canada) Inc. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR (www.sedar.com).

SOURCE Defense Metals Corp.

Release – Kratos Introduces the Satellite Industry’s First Open Edge Terminal for Satellite Communications and Other Applications

Research News and Market Data on KTOS

February 22, 2023 at 8:00 AM EST

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Virtualized software apps bring more power and flexibility to the edge by replacing dedicated hardware

SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider, released the first of its new OpenEdge™ products, the industry’s first open standards-based and software-enabled satellite terminals. Part of Kratos’ OpenSpace® Platform, OpenEdge is the first generally available family of satellite network edge devices employing a modern, software-defined approach for a range of communications, observation, sensing and TT&C uses. OpenEdge is the next step in Kratos’ ongoing effort to support the mainstreaming of satellite services by enabling satellite ground systems to operate seamlessly with today’s wireless and terrestrial networks.

Until OpenEdge, satellite terminals─ the devices that end users employ at the far edge of a satellite ground network to transmit and receive data─ have been purpose-built hardware devices that seriously restrict functionality and flexibility at the network’s edge. OpenEdge disrupts these limitations by:

  • employing virtualized software modems that can run on general purpose, off-the-shelf compute, and
  • adding far more power and versatility by enabling additional apps to run at the network’s edge, fully orchestrated across service delivery

Bringing Flexibility to the Network’s Edge
Today’s satellite terminals consist of purpose-built hardware components that are limited to performing a dedicated function, for example a satellite modem performing modulation/demodulation functions. OpenEdge uses a different model for operating at the edge, one that employs standards already widely adopted across the larger global telecommunications industry to expand terminal functions and make them more flexible. These standards are what enable mobile devices such as smartphones to support roaming, use cloud-based functions, interoperate with other networks and do much more. While satellites present a more complex technology challenge, the goal of OpenSpace and OpenEdge is to help satellite operators make their services as mainstream as cellular communications and to capitalize on new services such as 5G.

“OpenEdge satellite terminals extend the dynamic operations of the OpenSpace Platform beyond the core and gateway out to the network’s far edge,” said Greg Quiggle, Senior Vice President of Space Product Management at Kratos, “As a result, signal processing and other value-added network functions happen closer to the end user. This enables satellite service providers to deploy new services in minutes while dramatically reducing the overall lifecycle cost of their network.

Intelsat, one of the world’s largest commercial satellite operators, will be among the first to supplant traditional satellite terminals with OpenEdge capabilities.

“OpenEdge technology powers Intelsat’s family of smart edge satellite terminals providing a highly dynamic and application-optimized customer experience. Through this open and virtualized platform, we are able to deliver new services and features to the customer edge on-demand,” commented Blane Boynton, VP Product Development at Intelsat. “We expect this technology to benefit customers across multiple industries and applications, from fixed cellular backhaul and enterprise connectivity, to inflight and maritime applications. In the near future, we’ll rely on OpenEdge technology to help us be the first to transition to 5G, standards based, service delivery for non-terrestrial applications.”

Adding Power at the Edge
The OpenEdge advantage starts with Kratos’ virtual modem, replacing the traditional hardware box with software that can run on off-the-shelf x86 compute devices, such as a generic server, a laptop or in the cloud. It can interface directly with a digitally-enabled antenna or be configured with a built-in digitizer that converts the satellite’s analog RF signals into standard Internet Protocol (IP) packets that can be operated upon digitally.

Because OpenEdge effectively turns the traditional, purpose-built terminal into a generic, off-the-shelf computer─ sometimes referred to as universal customer premises equipment (uCPE)─ it can incorporate any x86 applications into operations at the edge. For example, a spectrum monitoring app can be loaded so that end users in the field can quickly find alternate routes for avoiding interference or intentional jamming of satellite signals. In fact, operators or mission controllers can actually turn the terminal into a remote hub in minutes simply by remotely enabling additional software directly into the terminal.
The Value of Orchestration
At a time when satcom equipment vendors are still struggling to virtualize even basic network functions, Kratos has done that and more by delivering orchestrated virtual network functions today. Orchestration is the ability to specify and automate how network functions will interoperate with each other to support specific services, missions, customer requirements and satellite payloads, and to intelligently configure and reconfigure themselves in real time as needs and demands change. While common across the global communications infrastructure, orchestration has not been employed to great degree in satellite networks, in part due to the challenge of virtualizing unique satcom functions. However, traditional hardware-based ground systems and terminals simply can no longer keep up with the increasingly dynamic advances in both the space layer, such as software-defined satellites and constellations of smallsats, nor in the world’s global communications networks, such as automated provisioning and mobility. In contrast, OpenSpace can ably support these necessary dynamic operations.

Additional OpenEdge Advantages
The dynamic advances in OpenEdge support additional benefits to network operators and their customers with more power and flexibility at the edge, including:

  • Support for Multiple Missions and Markets. OpenEdge terminals simultaneously support a variety of fixed and mobile satellite use cases, including two-way Satellite Communication (satcom), Earth Observation and Remote Sensing (EO/RS), and Telemetry, Tracking & Command (TT&C). Additionally, they can deliver complementary end-user services in the same way that a terrestrial network does, such as enterprise network extension, cellular backhaul, telecom trunking and defense and government applications.
  • Lower Hardware Cost, Smaller Footprint. OpenEdge terminals reduce the overall hardware footprint to a single box. As a generic x86 device, it both costs less than proprietary units while enabling more power simply by adding complementary software apps. Because the digitizer can be built in, OpenEdge terminals can work with virtually any mission-suitable antenna.
  • Enhanced Security at the Edge. Any x86-based app can be loaded on the OpenEdge terminal, including firewalls, encrypters and more advanced or custom security applications for highly sensitive uses.
  • Eliminate Vendor Lock-In. Today’s purpose-built terminals all employ proprietary architectures which lock customers into their equipment for given services, especially in satcom. In contrast, OpenEdge, and the entire OpenSpace Platform, embrace commonly accepted industry interoperability standards, enabling OpenEdge terminals to work side-by-side with standards compliant devices from other companies. In addition, network operators will find much greater success integrating their space-based offerings into the global communications mainstream, expanding their reach, services and revenue.

For more information about OpenEdge visit: https://www.KratosDefense.com/OpenEdge
For more about OpenSpace dynamic ground visit: https://www.KratosDefense.com/OSP

About Kratos OpenSpace
Kratos’ OpenSpace family of solutions enables the digital transformation of satellite ground systems to become a more dynamic and powerful part of the space network. The family consists of three product lines: OpenSpace SpectralNet for converting satellite RF signals to be used in digital environments; OpenSpace quantum products, which are virtual versions of traditional hardware components; and the OpenSpace Platform, the first commercially available, fully orchestrated, software-defined ground system. These three OpenSpace lines enable satellite operators and other service providers to implement digital operations at their own pace and in ways that meet their unique mission goals and business models. For more information about the OpenSpace family visit http://KratosDefense.com/OpenSpace.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms and systems for United States National Security related customers, allies and commercial enterprises. Kratos is changing the way breakthrough technology for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training, combat systems and next generation turbo jet and turbo fan engine development. For more information go to 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 26, 2021, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

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

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Describes Emerging Research on the Incidence of Multi-Site Pain Symptoms in Long COVID Patients During Event Titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”

Research News and Market Data on TNXP

February 22, 2023 7:00am EST

Symptoms of Long COVID, Like Multi-Site Pain, Fatigue and Insomnia, are the Hallmarks of Chronic Pain Syndromes Like Fibromyalgia and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

Event Co-Hosted by the Biotechnology Innovation Organization (BIO) and Solve M.E., an Advocacy Group for CFS/ME

CHATHAM, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that during a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, presented emerging research describing the role of infections in triggering fibromyalgia or CFS/ME and other fibromyalgia-type illnesses, and discussed Tonix’s ongoing Phase 2 study of TNX-102 SL in fibromyalgia-type Long COVID. Symptoms of Long COVID, like multi-site pain, fatigue and insomnia, are the hallmarks of chronic pain syndromes like fibromyalgia and CFS/ME.

“The U.S. Department of Health and Human Services National Research Action Plan on Long COVID1, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central sensitization,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Furthermore, a recent survey2 found comparable pain, fatigue and function between Long COVID, fibromyalgia and CFS/ME.”

Enrollment continues in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for patients with Long COVID syndrome whose symptoms overlap with fibromyalgia. PREVAIL is a randomized, double-blind, placebo-controlled study in the U.S. that is expected to enroll approximately 470 patients. One unblinded interim analysis is anticipated based on the first 50% of randomized participants.

Dr. Lederman’s presentation is available under the Presentations tab of the Tonix website at www.tonixpharma.com.

1Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201.

2Haider S, et al. Pain. 2023;164(2):385-401.

About Solve M.E.

Solve M.E. is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for CFS/ME, Long COVID and other post-infection conditions.

About BIO

BIO is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in approximately 19% of people who recover from COVID.1 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.2 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2021.3 While the vaccines available in the U.S. under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600; and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

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

1https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm – Accessed Feb. 21, 2023

2Briggs, Andrew, and Anna Vassall. “Count the cost of disability caused by COVID-19.” (2021): 502-505.

3The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

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

Forward Looking Statements

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

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released February 22, 2023

Schwazze (SHWZ) – Here We Grow Again


Wednesday, February 22, 2023

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

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

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

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

New Acquisitions. Continuing to build out its Colorado dispensary network, Schwazze has announced definitive documents to acquire certain assets of Cannabis Care Wellness Centers, LLC and Green Medicals Wellness Center #5, LLC (d/b/a “Smokey’s”). The proposed transaction includes the adult use Smokey’s dispensaries located at 2515 7th Avenue in Garden City as well as 5740 S. College Ave. in Fort Collins. These two vibrant cannabis markets have limited licenses and present Schwazze with more opportunities to serve customers in northern Colorado.

Details. The consideration for the proposed acquisition is $7.5 million and will be paid as $3.75M in cash and $3.75M in stock at closing. The acquisition is expected to close in the second quarter of 2023 after Colorado Marijuana Enforcement Division and local licensing approvals.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Kelly Services (KELYA) – Fourth Quarter and Full Year Results for 2022


Wednesday, February 22, 2023

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

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

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

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

4Q22. Revenue of $1.23 billion was down 1.3% year-over-year (up 0.7% in constant currency). We were at $1.25 billion. Kelly took a $10.3 million asset impairment charge related to its RocketPower acquisition during the quarter. As a result, GAAP EPS loss was $0.02 compared to EPS of $1.80 in 4Q21. Adjusted EPS for the fourth quarter was $0.18 versus $0.65 last year. We had projected adjusted EPS of $0.29.

Quarterly Drivers. Kelly saw top line growth in its SET, Education, and OCG business, and International, if we exclude the sold Russian operations from the y-o-y comparison. Once again, the gross profit rate improved in all five business units, a testament to Kelly’s specialty talent focus.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Defense Metals Corp. (DFMTF) – Entering an Important New Phase


Wednesday, February 22, 2023

Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

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

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

Pilot plant commissioning. Defense Metals has commenced construction of a hydrometallurgical pilot plant which is expected to be commissioned in March. Pilot plant operations will run in two segments and be completed by the end of April. The feed for the plant will total approximately 600 kilograms of mineral concentrate that was processed from a Wicheeda deposit bulk sample.

The proof will be in the precipitate. The pilot plant is being configured to produce a high-purity rare earth precipitate suitable as feed stock for a rare earths element (REE) separation plant. The objective of the pilot plant is to demonstrate, at a larger scale, the processing of Wicheeda flotation concentrate to produce rare earths using the acid bake hydrometallurgy process and to collect data for a preliminary feasibility study which is expected to be completed in the first quarter of 2024. Samples produced from the pilot plant will be shared with potential end-users for product qualification.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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.