DLH Holdings (DLHC) – Another Solid Quarter

Wednesday, August 03, 2022

DLH Holdings (DLHC)
Another Solid Quarter

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, Senior Research 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.

3QFY22 Results. Revenue totaled $66.4 million, up from $61.6 million in 3Q21. The short-term FEMA business has been completed, with the increase in the quarter’s revenues due to expanded work across the Company’s existing contracts. Earnings were $4.9 million, or $0.34 per diluted share, compared to $2.9 million, or $0.21 per diluted share last year. EBITDA was $9.0 million, or 13.5% of revenue, compared to $7.0 million and 11.3% last year. We had projected revenue of $67 million, EBITDA of $7.0 million, and EPS of $0.23.

Debt Paydown Continues. During the quarter, DLH reduced the outstanding term loan to $28.5 million from the $37.5 million at the end of March. Mandatory principal amortization on the loan has now been satisfied. We expect debt reduction to continue to be a focus of management, all else being equal. With the rapid paydown, additional M&A, which remains a key aspect of the Company’s growth strategy, may move to the forefront….

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. 

Axcella Therapeutics (AXLA) – Phase 2a Data In Long COVID-19 Shows Improvements In Fatigue and Function

Wednesday, August 03, 2022

Axcella Therapeutics (AXLA)
Phase 2a Data In Long COVID-19 Shows Improvements In Fatigue and Function

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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

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

Phase 2a Trial In Long COVID-19 Shows Benefits.  Accella announced preliminary results from its Phase 2a trial testing AXA1125 in Long Covid-19.  After previous AXA1125 data had shown effects on mitochondrial function, inflammation, and bioenergetics, the Phase 2a trial was designed to test AXA1125 in treating symptoms of fatigue and mental fatigue that follow COVID-19 infection.

Patients had improvements in their fatigue scores.  The trial was a double-blind, placebo-controlled trial that enrolled 41 patients with Long COVID-19.  Patients were randomized to receive either 67.8 grams per day of AXA1125 (n=21) or placebo (n=20) for 28 days.  Trial endpoints included validated clinical fatigue measurements such as the Chalder Fatigue Questionnaire (CHQ-11), 6-minute walk test (6MWT), and other biomarkers….

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. 

Great Lakes Dredge & Dock (GLDD) – When It Rains…..

Wednesday, August 03, 2022

Great Lakes Dredge & Dock (GLDD)
When It Rains…..

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Joe Gomes, Senior Research 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.

2Q22 Operating Results. Revenue of $149.3 million fell short of our $185 million estimate and consensus $181 million. Gross margin declined to 7.0% versus our 21.6% expectation. Adjusted EBITDA for the quarter was $10.15 million versus our $35.8 million estimate. The Company reported a loss of $4.0 million, or $0.06 per share, for the quarter, compared to our estimate of net income of $15.4 million, or $0.23 per share.

It Pours. Just about anything that could go wrong during the quarter did: supply chain delays which impacted ship availability, inflationary pressures, which impacted margins on previously won business, adverse weather conditions, with three times as many weather days during the quarter during the same period in 2021, and atypical dredging project challenges at three projects.

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. 

The GEO Group (GEO) – Continuing to Outperform Expectations

Wednesday, August 03, 2022

The GEO Group (GEO)
Continuing to Outperform Expectations

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Joe Gomes, Senior Research 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.

2Q22 Results. Sounding like a broken record, GEO posted above expected operating results for 2Q22. Revenue for the quarter came in at $588.2 million, up from $565.4 million a year ago. Adjusted EBITDA totaled $132.3 million, AFFO was $0.69 per diluted share, EPS was $0.37, and adjusted net income $0.42 per share. In the year ago period, GEO reported $118.4 million, $0.71, $0.29, and $0.41, respectively. We had forecast $560 million, $98.5 million, $0.58, $0.32, and $0.32, respectively. GEO’s results highlight the resiliency of the business model, in our opinion.

Drivers. Many parts of GEO’s business continue to show operating strength, driving the better than expected performance. BI continues to be an exceptional performer, while the Secured Services continues to perform even in the face of various headwinds….

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. 

Alliance Resource Partners (ARLP) – Stellar Second Quarter Results; Outlook Remains Favorable

Wednesday, August 03, 2022

Alliance Resource Partners (ARLP)
Stellar Second Quarter Results; Outlook Remains Favorable

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

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

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

Banner second quarter performance. Alliance reported second quarter net income of $161.5 million, or $1.23 per unit compared to $44.0 million, or $0.34 per unit, during the prior year period. The company generated EBITDA of $243.8 million compared to $118.6 million during the prior year period and free cash flow increased 5.1% to $83.5 million. Revenue and gross margin were above our estimates. Second quarter financial results reflected higher coal sales prices and volumes which increased 43.3% and 13.9%, respectively, along with greater oil & gas royalty prices and volumes which rose 64.7% and 27.6%.

Updating estimates. We have increased our 2022 EBITDA and adjusted EPU estimates to $945.3 million and $4.85 from $759.2 and $3.45, respectively. Our estimates reflect continued strength in commodity prices and greater oil and gas royalty volumes. We have also increased our 2023 EBITDA and adjusted EPU estimates to $1.1 billion and $5.75. What stands out are visible sources of volume growth and margin expansion potential through at least 2024 which support return of capital to unit holders in the form of cash distributions and/or buybacks.

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. 

Townsquare Media (TSQ) – The Undervalued Industry Standard Bearer

Wednesday, August 03, 2022

Townsquare Media (TSQ)
The Undervalued Industry Standard Bearer

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

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

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

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

Strong Q2 results. The company reported record quarterly revenue of $121.9 million, 3.6% higher than our estimate of $117.7 million. Adj. EBITDA of $32.4 million compared favorably to our estimate of $32.2 million. The quarter demonstrated the resiliency of local advertising and the success of Townsquare’s digital businesses.

Holding up to economic headwinds. Broadcast advertising revenue of $56.9 million was slightly up from $56.4 million in the prior year period. The continued steady Broadcast revenue is attributable to the company’s local market focus. While national advertising was down double-digits, it only accounts for roughly 7% of the company’s revenue. Management noted that local advertising, a more meaningful component of the business, continues to pace up.  

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. 

Release – Comtech to Showcase 911 Solutions for States and Local Jurisdictions at APCO



Comtech to Showcase 911 Solutions for States and Local Jurisdictions at APCO

Research, News, and Market Data on Comtech Telecommunications

MELVILLE, N.Y.–(BUSINESS WIRE)–Aug. 2, 2022– 
Aug. 2, 2022— 
Comtech Telecommunications Corp. (NASDAQ: CMTL), a global leading provider of next-generation 911 emergency systems and secure wireless communications technologies, announced today that it will be showcasing all of the Company’s Next Generation 911 (“NG911”) solutions at the annual 
Association of Public-Safety Communications Officials-International (“APCO”) Conference & Expo, 
August 7-10, 2022
, at the 
Anaheim Convention Center in 
Anaheim, CA.

With decades of experience, 
Comtech has developed an extensive portfolio of emergency call routing, call handling, location data delivery and text messaging solutions, and has strengthened its one-stop-shop NG911 capabilities for state and local jurisdictions. 
Comtech is the only company in the industry offering a single-source, next-generation 911 approach that includes comprehensive in-house capabilities spanning the entire deployment and ongoing systems management.

Comtech invites attendees to visit booth 519, meet its team of 911 industry experts, and learn more about the following:

  • Call Routing and
    Location Delivery

    Comtech designs, implements, and operates secure, highly available, carrier agnostic Emergency Services IP Networks (“ESInets”) across 
    the United States. Our NENA i3 NG911 Next
    Generation Core Services
     (“NGCS”) applications enable end-to-end Internet Protocol (“IP”) call completion and data delivery, and our multiple operational models put our customers in control of their regional or statewide deployment.
  • Call Handling and
    Management Solutions
    : Purpose-built with more than 30 years of research and innovation, Comtech Solacom’s line of NG911 solutions leverage advanced hardware and software technologies that are trusted to streamline processes and enable a more efficient collection of critical information in emergency situations. Live demonstrations for our industry-leading 911 solutions include Guardian Call
    Handling
    Map, and our latest workload planning and management application, Insights.
  • Cybersecurity: Comtech’s CyberStronger™ 
    solutions include up-skill, re-skill, and training systems to increase the cybersecurity skills of any mission-critical workforce or public safety staff. These solutions provide education, hands-on training, and live online knowledge assessment and skills-building programs in all cybersecurity areas.
  • Situational
    Awareness
    : Comtech’s SmartResponse™ situational awareness platform is an in-cloud geospatial solution with real time, contextual, and actionable intelligence for public safety answering points (“PSAPs”) and security agencies. This powerful application collates human and device-generated data into a flexible mapping interface, providing actionable insights into emergency situations for efficient and effective management of crisis situations.
  • Text Messaging
    Capabilities

    Comtech offers multiple options for Text to 911, including an interim web-based solution (“
    EMedia®”) and Session Initiation Protocol (“SIP”) Message Session Relay Protocol (“MSRP”) 
    connectivity from the 
    Comtech Text Control Center (“TCC”) to PSAPs’ call handling equipment (“CHE”). Additionally, Messenger readies call takers with the ability to collect, process and share previously unavailable live incident information such as text, photos, and video via short message service (“SMS”)/multimedia messaging service (“MMS”), from one integrated desktop.

About Comtech

Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies to commercial and government customers around the world. Headquartered in 
Melville, New York and with a passion for customer success, 
Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtech.com.

Forward-Looking
Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s 
Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such 
Securities and Exchange Commission filings.

PCMTL

Investor Relations Robert Samuels 631-962-7102
robert.samuels@comtech.com

Source: 
Comtech Telecommunications Corp.


Release – CoreCivic Reports Second Quarter 2022 Financial Results



CoreCivic Reports Second Quarter 2022 Financial Results

Research, News, and Market Data on CoreCivic

Increases Share Buyback
authorization

BRENTWOOD, Tenn., Aug. 02, 2022 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today its financial results for the second quarter of 2022 and provided an update on several significant transactions, including an increase in its share buyback program.

Damon T. Hininger, CoreCivic’s President and Chief Executive Officer, said, “We are pleased to have entered into an agreement during the second quarter to sell our 1,978-bed McRae Correctional Facility for a sale price of $130.0 million. This sale, which is expected to close later in the third quarter, will result in a gain on sale of $75.0 million to $80.0 million. The sale price represents approximately $66,000 per bed which, when used to approximate the value of our over 70,000 company-owned correctional beds, indicates a real estate value in excess of $4 billion, demonstrating the value of our portfolio. Monetizing this asset will generate additional liquidity, which we can use for general corporate purposes, including for our share repurchase program, which our board just increased to $225.0 million, and/or for additional debt reduction.

Hininger continued, “Our second quarter operations were affected by short-term earnings disruptions from transitioning populations at our La Palma Correctional Center in Arizona from an ICE population to an Arizona population, as a result of the previously announced state contract award, and a challenging labor market. Despite the short-term earnings disruption at the La Palma facility that we expect to normalize in the first quarter of 2023, we continue to make great strides in improving the position of our balance sheet, and we were able to begin returning capital to shareholders through our share repurchase authorization. We are pleased with our operational and financial performance and are confident in the long-term outlook for returning to earnings growth.”

Financial Highlights – Second Quarter 2022

  • Total revenue of $456.7 million
    • CoreCivic
      Safety
       revenue of $416.4 million
    • CoreCivic
      Community 
      revenue of $25.8 million
    • CoreCivic
      Properties 
      revenue of $14.5 million
  • Net Income of $10.6 million
  • Diluted earnings per share of $0.09
  • Adjusted diluted EPS of $0.13
  • Funds From Operations per diluted share of $0.28
  • Normalized Funds From Operations per diluted share of $0.34
  • Adjusted EBITDA of $78.8 million

Second Quarter 2022 Financial Results Compared With Second
Quarter 2021

Net income in the second quarter of 2022 totaled $10.6 million, or $0.09 per diluted share, compared with net income in the second quarter of 2021 of $15.6 million, or $0.13 per diluted share. Adjusted for special items, adjusted net income in the second quarter of 2022 was $16.2 million, or $0.13 per diluted share (Adjusted Diluted EPS), compared with adjusted net income in the second quarter of 2021 of $31.1 million, or $0.25 per diluted share. Special items for each period are presented in detail in the calculation of Adjusted Diluted EPS in the Supplemental Financial Information following the financial statements presented herein.   The decline in adjusted per share amounts was primarily the result of transitioning to a new contract with the state of Arizona at our 3,060-bed La Palma Correctional Center in Arizona, the non-renewal of contracts in 2021 with the United States Marshals Service (USMS) at the 1,033-bed Leavenworth Detention Center in Kansas and the 600-bed West Tennessee Detention Facility, and the expiration of a managed-only contract with Marion County, Indiana at the Marion County Jail, which the County replaced with a newly constructed facility. We have two remaining direct contracts with the USMS expiring in 2023 and 2025, and we will work with the USMS to enable it to continue to fulfill its mission. Our renewal rate on owned and controlled facilities remained high at 95% over the previous five years. We believe our renewal rate on existing contracts remains high due to a variety of reasons including the aged and constrained supply of available beds within the U.S. correctional system, our ownership of the majority of the beds we operate, and the cost effectiveness of the services we provide.

Earnings before interest, taxes, depreciation and amortization (EBITDA) was $71.1 million in the second quarter of 2022, compared with $82.1 million in the second quarter of 2021. Adjusted EBITDA was $78.8 million in the second quarter of 2022, compared with $101.7 million in the second quarter of 2021. Adjusted EBITDA decreased from the prior year quarter primarily due to the sale of five non-core properties in our Properties segment and two under-utilized facilities in our Community segment, which generated $4.4 million in Adjusted EBITDA in the second quarter of 2021, the aforementioned transition of offender populations at our La Palma Correctional Center, which resulted in a reduction in EBITDA of $10.8 million, and the aforementioned non-renewal of contracts at three facilities that collectively resulted in a reduction in EBITDA of $4.5 million from the second quarter of 2021 to the second quarter of 2022.  

Funds From Operations (FFO) was $34.3 million, or $0.28 per diluted share, in the second quarter of 2022, compared to $11.4 million, or $0.09 per diluted share, in the second quarter of 2021. Normalized FFO, which excludes special items, was $40.7 million, or $0.34 per diluted share, in the second quarter of 2022, compared with $56.0 million, or $0.46 per diluted share, in the second quarter of 2021.   Normalized FFO was negatively impacted by the same factors that affected Adjusted EBITDA.

Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO, and, where appropriate, their corresponding per share amounts, are measures calculated and presented on the basis of methodologies other than in accordance with generally accepted accounting principles (GAAP). Please refer to the Supplemental Financial Information and related note following the financial statements herein for further discussion and reconciliations of these measures to net income, the most directly comparable GAAP measure.

New Bank Credit Facility

On May 12, 2022, we entered into a Third Amended and Restated Credit Agreement (New Bank Credit Facility) in an aggregate principal amount of $350.0 million, consisting of a $100.0 million Term Loan A and a revolving credit facility with a borrowing capacity of $250.0 million, which remains undrawn. The New Bank Credit Facility matures in May 2026 and replaced an existing facility (Previous Bank Credit Facility), which was scheduled to expire in April 2023.   The interest rates applicable to the New Bank Credit Facility are tiered based on the then-current total leverage ratio. Based on our current total leverage ratio, loans under the New Bank Credit Facility currently bear interest at a base rate plus a margin of 2.25% or at the Bloomberg Short-Term Bank Yield Index (BSBY) rate plus a margin of 3.25%. In connection with obtaining the New Bank Credit Facility, we paid-down the previous Term Loan A by $67.5 million, and recorded a charge of $0.8 million for the write-off of deferred loan costs associated with the Previous Bank Credit Facility.

Additional Debt Repayments

On May 19, 2022, we announced we voluntarily repaid the remaining $124.1 million outstanding principal balance under our Term Loan B, and satisfied all of our outstanding debt obligations under the agreement. We did not incur any prepayment penalties in connection with the repayment of the Term Loan B, which had a scheduled maturity of December 18, 2024. In connection with the prepayment, we recorded a charge of $6.0 million for the write-off of deferred loan costs, original issue discount and fees and expenses associated with the prepayment of the Term Loan B. The prepayment was made in full with cash on hand.

During the second quarter of 2022, we also purchased an additional $3.6 million of our 4.625% Senior Notes at a weighted average price approximately equal to par in open market purchases, reducing the outstanding balance of the 4.625% Senior Notes to $170.1 million.

Share Repurchases

On August 2, 2022, our Board of Directors authorized an increase in our share repurchase program of up to an additional $75.0 million in shares of our common stock. As a result of the increased authorization, the aggregate authorization under our share repurchase program increased from the original authorization of up to $150.0 million in shares of our common stock to up to $225.0 million shares of our common stock. Since May 16, 2022 through August 1, 2022, we have repurchased 4.2 million shares of our common stock at an aggregate purchase price of $50.6 million, excluding fees, commissions and other costs related to repurchases.

We currently have approximately $174.4 million remaining under the Board authorized share repurchase plan. Additional repurchases of common stock will be made in accordance with applicable securities laws and may be made at management’s discretion within parameters set by the Board of Directors from time to time in the open market, through privately negotiated transactions, or otherwise. The share repurchase program has no time limit and does not obligate us to purchase any particular amount of our common stock. The authorization for the share repurchase program may be terminated, suspended, increased or decreased by our Board in its discretion at any time.

Business Updates

Asset Sales. On July 25, 2022, we entered into a Purchase & Sale Agreement with the Georgia Building Authority to purchase our 1,978-bed McRae Correctional Facility in McRae, Georgia for a price of $130.0 million. We currently have a management contract with the Federal Bureau of Prisons (BOP) at the McRae Facility, which expires November 30, 2022.  As previously disclosed, we do not expect the contract at the McRae facility to be renewed upon its expiration.  We also entered into an agreement to lease the McRae facility from the Georgia Building Authority through November 30, 2022. We expect the sale, which is subject to customary closing conditions, to be completed during the third quarter of 2022. On July 19, 2022, we completed the sale of our Stockton Female Community Corrections Facility and our Long Beach Community Corrections Center, both located in California, to a third-party that resulted in net sales proceeds of $10.9 million. On July 20, 2022, we also completed the sale of an undeveloped parcel of land in California that resulted in net sales proceeds of $4.8 million.

We currently intend to use the net proceeds from the sales for general corporate purposes, which may include making repurchases under our share repurchase plan and/or reducing our outstanding indebtedness.

CoreCivic Safety and Community Contract Renewals. During the second quarter of 2022, we successfully renewed contracts with multiple government partners:

  • A local government agency exercised a two-year renewal option at our 2,672-bed Tallahatchie County Correctional Facility in Tutwiler, Mississippi, that allows the USMS to continue utilizing available capacity, extending the contract until June 30, 2024. This contract also has an indefinite number of two-year renewal options.
  • The BOP provided notice of its intent to renew our contract for residential reentry and home confinement services at our 60-bed South Raleigh Reentry Center in Raleigh, North Carolina.
  • The BOP provided notice of its intent to renew our contract for residential reentry and home confinement services at our 84-bed James River Residential Reentry Center and 36-bed Ghent Residential Reentry Center in the State of Virginia.
  • The Colorado Department of Public Safety notified us of its intent to award a contract to provide intensive residential treatment and sex offender supervision and treatment services across five of our residential reentry facilities located in the state.
  • The City of Mesa, Arizona renewed our contract to house approximately 120 inmates at our 4,128-bed Central Arizona Florence Correctional Complex in Florence, Arizona.

2022 Financial Guidance

Based on current business conditions, the Company is providing the following update to its financial guidance for the full year 2022:

 

Guidance

Full Year 2022

Prior Guidance

Full Year 2022

  • Net Income

$106.6 million –
$118.2 million

$77.1 million –
$94.4 million

  • Adjusted Net Income

$52.0 million –
$60.0 million

$75.5 million –
$92.8 million

  • Diluted EPS

$0.89 – $0.99

$0.64 – $0.79

  • Adjusted Diluted EPS

$0.44 – $0.50

$0.63 – $0.77

  • FFO per diluted share

$1.19 – $1.26

$1.45 – $1.60

  • Normalized FFO per diluted share

$1.25 – $1.32

$1.45 – $1.60

  • EBITDA

$375.2 million –
$386.2 million

$336.1 million –
$351.4 million

  • Adjusted EBITDA

$299.0 million –
$305.0 million

$333.9 million –
$349.1 million

Our updated 2022 guidance reflects a delay in the reversal of Title 42, a public health order that has been used since March 2020 to deny entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of COVID-19. On April 1, 2022, the Center for Disease Control and Prevention terminated Title 42 with an effective date of May 23, 2022. However, on April 25, 2022, a federal judge issued a temporary restraining order blocking its termination, and on May 20, 2022, ruled that the administration violated administrative law when it announced that it planned to cease Title 42. That ruling is under appeal with a decision unlikely before the first quarter of 2023.   The termination of Title 42 is expected to result in an increase in the number of undocumented people permitted into the United States to claim asylum, and could result in an increase in the number of people apprehended and detained by ICE, our largest government customer. However, it is difficult to predict when Title 42 will be terminated.   Our prior guidance anticipated higher occupancy levels from ICE from the potential termination of Title 42, which is no longer contemplated in our current guidance.

Our updated 2022 guidance also reflects a larger earnings disruption at our La Palma Correctional Center than previously estimated. During the second quarter of 2022, we agreed with the state of Arizona to extend the transition period from the fourth quarter of 2022 to the first quarter of 2023. However, we still expect the final ICE detainees to be transferred out of the La Palma facility during the third quarter of 2022.   Our 2022 guidance also reflects the continuation of a challenging labor market, including above average wage inflation.

During 2022, we expect to invest $79.5 million to $84.0 million in capital expenditures, consisting of $33.5 million to $34.0 million in maintenance capital expenditures on real estate assets, $30.0 million to $32.0 million for capital expenditures on other assets and information technology, and $16.0 million to $18.0 million for facility renovations.  

Supplemental Financial Information and Investor Presentations

We have made available on our website supplemental financial information and other data for the second quarter of 2022.   Interested parties may access this information through our website at http://ir.corecivic.com/ under “Financial Information” of the Investors section.   We do not undertake any obligation and disclaim any duties to update any of the information disclosed in this report.  

Management may meet with investors from time to time during the third quarter of 2022.   Written materials used in the investor presentations will also be available on our website beginning on or about August 12, 2022.   Interested parties may access this information through our website at http://ir.corecivic.com/ under “Events & Presentations” of the Investors section.

Conference Call, Webcast and Replay Information

We will host a webcast conference call at 10:00 a.m. central time (11:00 a.m. eastern time) on Wednesday, August 3, 2022, and will be accessible through the Company’s website at 
www.corecivic.com under the “Events & Presentations” section of the “Investors” page. The live broadcast can also be accessed by dialing 888-221-3881 in the U.S. and Canada, including the confirmation passcode 8733680. An online replay of the call will be archived on our website promptly following the conference call. In addition, there will be a telephonic replay available beginning at 1:15 p.m. central time (2:15 p.m. eastern time) on August 3, 2022, through 1:15 p.m. central time (2:15 p.m. eastern time) on August 11, 2022. To access the telephonic replay, dial 888-203-1112 in the U.S. and Canada. International callers may dial +1 719-457-0820 and enter passcode 8733680.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for nearly 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Forward-Looking Statements

This press release contains statements as to our beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with: (i) changes in government policy (including the United States Department of Justice, or DOJ, not renewing contracts as a result of President Biden’s Executive Order on Reforming Our Incarceration System to Eliminate the Use of Privately Operated Criminal Detention Facilities, or the Private Prison EO) (two agencies of the DOJ, the United States Federal Bureau of Prisons and the United States Marshals Service utilize our services), legislation and regulations that affect utilization of the private sector for corrections, detention, and residential reentry services, in general, or our business, in particular, including, but not limited to, the continued utilization of our correctional and detention facilities by the federal government, and the impact of any changes to immigration reform and sentencing laws (our company does not, under longstanding policy, lobby for or against policies or legislation that would determine the basis for, or duration of, an individual’s incarceration or detention); (ii) our ability to obtain and maintain correctional, detention, and residential reentry facility management contracts because of reasons including, but not limited to, sufficient governmental appropriations, contract compliance, negative publicity and effects of inmate disturbances; (iii) changes in the privatization of the corrections and detention industry, the acceptance of our services, the timing of the opening of new facilities and the commencement of new management contracts (including the extent and pace at which new contracts are utilized), as well as our ability to utilize available beds; (iv) general economic and market conditions, including, but not limited to, the impact governmental budgets can have on our contract renewals and renegotiations, per diem rates, and occupancy; (v) fluctuations in our operating results because of, among other things, changes in occupancy levels; competition; contract renegotiations or terminations; inflation and other increases in costs of operations, including a continuing rise in labor costs; fluctuations in interest rates and risks of operations; (vi) the duration of the federal government’s denial of entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of COVID-19, a policy known as Title 42 (On April 1, 2022, the Center for Disease Control and Prevention, or CDC, terminated Title 42, and began preparing for a resumption of regular migration at the United States southern border, effective May 23, 2022; however, on April 25, 2022, a judge issued a temporary restraining order blocking the termination of Title 42 and on May 20, 2022, ruled that the administration violated administrative law when it announced that it planned to cease Title 42.); (vii) government and staff responses to staff or residents testing positive for COVID-19 within public and private correctional, detention and reentry facilities, including the facilities we operate; (viii)  restrictions associated with COVID-19 that disrupt the criminal justice system, along with government policies on prosecutions and newly ordered legal restrictions that affect the number of people placed in correctional, detention, and reentry facilities, including those associated with a resurgence of COVID-19; (ix) whether revoking our REIT election, effective January 1, 2021, and our revised capital allocation strategy can be implemented in a cost effective manner that provides the expected benefits, including facilitating our planned debt reduction initiative and planned return of capital to shareholders; (x) our ability to successfully identify and consummate future development and acquisition opportunities and realize projected returns resulting therefrom; (xi) our ability to have met and maintained qualification for taxation as a REIT for the years we elected REIT status; and (xii) the availability of debt and equity financing on terms that are favorable to us, or at all. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.

CoreCivic takes no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

CORECIVIC, INC. AND SUBSIDIARIES

CONSOLIDATED
BALANCE SHEETS

(UNAUDITED AND AMOUNTS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

ASSETS

 

June 30,

2022

 

December 31,
2021

 

 

 

 

 

Cash and cash equivalents

 

$

115,611

 

 

$

299,645

 

Restricted cash

 

 

11,794

 

 

 

11,062

 

Accounts receivable, net of credit loss reserve of $8,946 and $7,931,         respectively

 

 

273,839

 

 

 

282,809

 

Prepaid expenses and other current assets

 

 

42,413

 

 

 

26,872

 

Assets held for sale

 

 

61,587

 

 

 

6,996

 

Total current assets

 

 

505,244

 

 

 

627,384

 

Real estate and related assets:

 

 

 

 

Property and equipment, net of accumulated depreciation of $1,671,088 and $1,657,709, respectively

 

 

2,197,463

 

 

 

2,283,256

 

Other real estate assets

 

 

213,164

 

 

 

218,915

 

Goodwill

 

 

4,844

 

 

 

4,844

 

Other assets

 

 

355,815

 

 

 

364,539

 

 

 

 

 

 

Total assets

 

$

3,276,530

 

 

$

3,498,938

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

294,435

 

 

$

305,592

 

Current portion of long-term debt

 

 

180,378

 

 

 

35,376

 

Total current liabilities

 

 

474,813

 

 

 

340,968

 

 

 

 

 

 

Long-term debt, net

 

 

1,148,679

 

 

 

1,492,046

 

Deferred revenue

 

 

25,070

 

 

 

27,551

 

Non-current deferred tax liabilities

 

 

91,828

 

 

 

88,157

 

Other liabilities

 

 

167,200

 

 

 

177,748

 

 

 

 

 

 

Total liabilities

 

 

1,907,590

 

 

 

2,126,470

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Preferred stock ? $0.01 par value; 50,000 shares authorized; none issued and outstanding at June 30, 2022, and December 31, 2021, respectively

 

 

 

 

 

 

Common stock ? $0.01 par value; 300,000 shares authorized; 118,620 and 120,285 shares issued and outstanding at June 30, 2022, and December 31, 2021, respectively

 

 

1,186

 

 

 

1,203

 

Additional paid-in capital

 

 

1,836,949

 

 

 

1,869,955

 

Accumulated deficit

 

 

(469,195

)

 

 

(498,690

)

Total stockholders’ equity

 

 

1,368,940

 

 

 

1,372,468

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

3,276,530

 

 

$

3,498,938

 

 

 

 

 

 

 

 

 

 

CORECIVIC, INC. AND SUBSIDIARIES

CONSOLIDATED
STATEMENTS OF OPERATIONS

(UNAUDITED AND AMOUNTS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

 

For the Three Months Ended

June 30,

 

2022

 

2021

 

 

 

 

REVENUE:

 

 

 

Safety

$

416,354

 

 

$

419,880

 

Community

 

25,775

 

 

 

24,929

 

Properties

 

14,526

 

 

 

19,732

 

Other

 

42

 

 

 

30

 

 

 

456,697

 

 

 

464,571

 

 

 

 

 

EXPENSES:

 

 

 

Operating

 

 

 

Safety

 

324,261

 

 

 

307,280

 

Community

 

21,282

 

 

 

20,024

 

Properties

 

3,377

 

 

 

5,668

 

Other

 

80

 

 

 

98

 

Total operating expenses

 

349,000

 

 

 

333,070

 

General and administrative

 

31,513

 

 

 

33,228

 

Depreciation and amortization

 

32,259

 

 

 

34,084

 

Shareholder litigation expense

 

1,900

 

 

 

2,550

 

Asset impairments

 

 

 

 

2,866

 

 

 

414,672

 

 

 

405,798

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

Interest expense, net

 

(21,668

)

 

 

(23,222

)

Expenses associated with debt repayments and refinancing transactions

 

(6,805

)

 

 

(52,167

)

Gain on sale of real estate assets, net

 

1,060

 

 

 

38,766

 

Other income (expense)

 

(37

)

 

 

(8

)

 

 

 

 

 

 

 

 

INCOME BEFORE INCOME TAXES

 

14,575

 

 

 

22,142

 

 

 

 

 

Income tax expense

 

(4,013

)

 

 

(6,519

)





NET INCOME





$




   
 10,562

 

 




$




15,623

 

 

 

 

 

 

 

 

 

BASIC EARNINGS PER SHARE

$

0.09

 

 

$

0.13

 

 

 

 

 

DILUTED EARNINGS PER SHARE

$

0.09

 

 

$

0.13

 

 

 

 

 

 

 

 

 

CORECIVIC, INC. AND SUBSIDIARIES

SUPPLEMENTAL
FINANCIAL INFORMATION

(UNAUDITED AND AMOUNTS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

CALCULATION OF ADJUSTED NET INCOME AND ADJUSTED DILUTED EPS

 

For the Three Months Ended

June 30,

 

2022

 

2021

 

 

 

 

Net income

$

10,562

 

 

$

15,623

 

 

 

 

 

Special items:

 

 

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

52,167

 

Expenses associated with COVID-19

 

 

 

 

836

 

Gain on sale of real estate assets, net

 

(1,060

)

 

 

(38,766

)

Shareholder litigation expense

 

1,900

 

 

 

2,550

 

Asset impairments

 

 

 

 

2,866

 

Income tax benefit for special items

 

(2,041

)

 

 

(4,185

)

Adjusted net income

$

16,166

 

 

$

31,091

 

Weighted average common shares outstanding – basic

 

120,529

 

 

 

120,283

 

Effect of dilutive securities:

 

 

 

Restricted stock-based awards

 

817

 

 

 

434

 

Non-controlling interest – operating partnership units

 

 

 

 

1,342

 

Weighted average shares and assumed conversions – diluted

 

121,346

 

 

 

122,059

 

Adjusted Earnings Per Diluted Share

$

0.13

 

 

$

0.25

 

 

 

 

 

 

 

 

 

CORECIVIC, INC. AND SUBSIDIARIES

SUPPLEMENTAL
FINANCIAL INFORMATION

(UNAUDITED AND AMOUNTS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

CALCULATION OF FUNDS FROM OPERATIONS AND NORMALIZED FUNDS FROM
OPERATIONS

 

For the Three Months Ended

June 30,

 

2022

 

2021

 

 

 

 

Net income

$

10,562

 

 

$

15,623

 

Depreciation and amortization of real estate assets

 

24,501

 

 

 

24,926

 

Gain on sale of real estate assets, net

 

(1,060

)

 

 

(38,766

)

Income tax expense for special items

 

283

 

 

 

9,641

 

Funds From Operations

$

34,286

 

 

$

11,424

 

 

 

 

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

52,167

 

Expenses associated with COVID-19

 

 

 

 

836

 

Income taxes associated with change in corporate tax structure and other special tax items

 

 

 

 

 

Shareholder litigation expense

 

1,900

 

 

 

2,550

 

Goodwill and other impairments

 

 

 

 

2,866

 

Income tax benefit for special items

 

(2,324

)

 

 

(13,826

)

Normalized Funds From Operations

$

40,667

 

 

$

56,017

 

 

 

 

 

Funds From Operations Per Diluted Share

$

0.28

 

 

$

0.09

 

Normalized Funds From Operations Per Diluted Share

$

0.34

 

 

$

0.46

 

 

 

 

 

 

 

 

 

CORECIVIC, INC. AND SUBSIDIARIES

SUPPLEMENTAL
FINANCIAL INFORMATION

(UNAUDITED AND AMOUNTS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

CALCULATION OF EBITDA AND ADJUSTED EBITDA

 

For the Three Months Ended

June 30,

 

2022

 

2021

 

 

 

 

Net income

$

10,562

 

 

$

15,623

 

Interest expense

 

24,292

 

 

 

25,843

 

Depreciation and amortization

 

32,259

 

 

 

34,084

 

Income tax expense

 

4,013

 

 

 

6,519

 

EBITDA

$

71,126

 

 

$

82,069

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

52,167

 

Expenses associated with COVID-19

 

 

 

 

836

 

Gain on sale of real estate assets, net

 

(1,060

)

 

 

(38,766

)

Shareholder litigation expense

 

1,900

 

 

 

2,550

 

Asset impairments

 

 

 

 

2,866

 

Adjusted EBITDA

$

78,771

 

 

$

101,722

 

 

 

 

 

 

 

 

 

GUIDANCE — CALCULATION OF ADJUSTED NET INCOME, FUNDS FROM
OPERATIONS, EBITDA & ADJUSTED EBITDA

 

For the Year Ending

December 31, 2022

 

Low End of Guidance

 

High End of Guidance

Net income

$

106,610

 

 

$

118,235

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

6,805

 

Gain on sale of real estate assets, net

 

(84,921

)

 

 

(89,921

)

Shareholder litigation expense

 

1,900

 

 

 

1,900

 

Income tax expense for special items

 

21,606

 

 

 

22,981

 

Adjusted net income

$

52,000

 

 

$

60,000

 

 

 

 

 

Net income

$

106,610

 

 

$

118,235

 

Depreciation and amortization of real estate assets

 

97,000

 

 

 

97,500

 

Gain on sale of real estate assets, net

 

(84,921

)

 

 

(89,921

)

Income tax expense for special items

 

23,356

 

 

 

24,731

 

Funds From Operations

$

142,045

 

 

$

150,545

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

6,805

 

Shareholder litigation expense

 

1,900

 

 

 

1,900

 

Income tax expense for special items

 

(1,750

)

 

 

(1,750

)

Normalized Funds From Operations

$

149,000

 

 

$

157,500

 

Diluted EPS

$

0.89

 

 

$

0.99

 

Adjusted diluted EPS

$

0.44

 

 

$

0.50

 

FFO per diluted share

$

1.19

 

 

$

1.26

 

Normalized FFO per diluted share

$

1.25

 

 

$

1.32

 

 

 

 

 

Net income

$

106,610

 

 

$

118,235

 

Interest expense

 

98,000

 

 

 

97,000

 

Depreciation and amortization

 

128,000

 

 

 

128,000

 

Income tax expense

 

42,606

 

 

 

42,981

 

EBITDA

$

375,216

 

 

$

386,216

 

Expenses associated with debt repayments and refinancing transactions

 

6,805

 

 

 

6,805

 

Gain on sale of real estate assets, net

 

(84,921

)

 

 

(89,921

)

Shareholder litigation expense

 

1,900

 

 

 

1,900

 

Adjusted EBITDA

$

299,000

 

 

$

305,000

 

 

 

 

 

 

 

 

 

NOTE TO SUPPLEMENTAL FINANCIAL INFORMATION

Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO, and, where appropriate, their corresponding per share metrics are non-GAAP financial measures. The Company believes that these measures are important operating measures that supplement discussion and analysis of the Company’s results of operations and are used to review and assess operating performance of the Company and its properties and their management teams. The Company believes that it is useful to provide investors, lenders and security analysts disclosures of its results of operations on the same basis that is used by management.  

FFO, in particular, is a widely accepted non-GAAP supplemental measure of performance of real estate companies, grounded in the standards for FFO established by the National Association of Real Estate Investment Trusts (NAREIT).   NAREIT defines FFO as net income computed in accordance with GAAP, excluding gains (or losses) from sales of property and extraordinary items, plus depreciation and amortization of real estate and impairment of depreciable real estate and after adjustments for unconsolidated partnerships and joint ventures calculated to reflect funds from operations on the same basis.   EBITDA, Adjusted EBITDA, and Normalized FFO are useful as supplemental measures of performance of the Company’s properties because such measures do not take into account depreciation and amortization, or with respect to EBITDA, the impact of the Company’s tax provisions and financing strategies. Because the historical cost accounting convention used for real estate assets requires depreciation (except on land), this accounting presentation assumes that the value of real estate assets diminishes at a level rate over time.   Because of the unique structure, design and use of the Company’s properties, management believes that assessing performance of the Company’s properties without the impact of depreciation or amortization is useful. The Company may make adjustments to FFO from time to time for certain other income and expenses that it considers non-recurring, infrequent or unusual, even though such items may require cash settlement, because such items do not reflect a necessary or ordinary component of the ongoing operations of the Company.   Normalized FFO excludes the effects of such items. The Company calculates Adjusted Net Income by adding to GAAP Net Income expenses associated with the Company’s debt repayments and refinancing transactions, and certain impairments and other charges that the Company believes are unusual or non-recurring to provide an alternative measure of comparing operating performance for the periods presented.

Other companies may calculate Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO differently than the Company does, or adjust for other items, and therefore comparability may be limited.   Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO and, where appropriate, their corresponding per share measures are not measures of performance under GAAP, and should not be considered as an alternative to cash flows from operating activities, a measure of liquidity or an alternative to net income as indicators of the Company’s operating performance or any other measure of performance derived in accordance with GAAP.   This data should be read in conjunction with the Company’s consolidated financial statements and related notes included in its filings with the Securities and Exchange Commission.

Contact:

Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024


Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204




Fewer Quitters and Fewer Job Openings Suggest a Move Toward Normalcy



Image Credit: Brenda Gottsabend


Labor Market Statistics are Pointing to Lower Wage Inflation

The job market may be returning to normalcy; this is a good sign for lower inflation. The
JOLTS
report, which is released by The Labor Department, is similar to a supply chain measure for how adequate the economy’s labor and jobs match up. It tracks monthly changes in job openings and job offer rates on hiring and also quits. Overall, the movement toward what was considered normal and even desirable before the pandemic has accelerated. JOLTS is an acronym for Job Openings and Labor Turnover Survey.

The Numbers

Job openings fell to 10.7 million from 11.3 million in June, according to the data released Tuesday (August 2). The median estimate from economists was 11 million, which means jobs fell short of expectations. It was the largest one-month drop since the pandemic. This gives hope that shortages of labor have decreased.

Largest among the drop are positions in retail. Retailers accounted for more than half of the decline in openings. The sector shed 343,000 openings in June. Wholesalers followed with the next largest drop of 82,000 openings. Public education was third, with openings reduced to 62,000.

The industry seeing the most gains in job listings was the finance and insurance category; this sector added 31,000 openings. And while positions in public education were down, positions in educational services increased by 22,000 openings.


Source: St.
Louis Federal Reserve

The number of unemployed Americans per job opening climbed to 0.6 in June from 0.5. This added to signs that the labor market is normalizing. However, 0.6 people for every 1.0 position is still a challenging mismatch for employers. However, it is the first move toward having at ample people looking, even if they may not be an adequate fit for each role. The JOLTS report had a three-month streak of record-low workers-per-openings ratios. This is good for employers and helps taper wage pressures.


Source: US
Bureau of Labor Statistics

There is still plenty of room for further movement toward normalcy. Labor force participation, that is,  the percentage of Americans either working or actively seeking work, dropped in June to 62.2%. Pre-pandemic, the participation rate was 63.4%.

Resignations or quits data also point to the labor market’s imbalance moving towards normal. The total quits in June dropped to 4.2 million from 4.3 million. This is the lowest level since October. Quits have now fallen for three straight months straight after breaking records last year.

Take Away

When labor markets are not tight, wage earners are less likely to require higher wages to stay. One of the factors contributing to the year-long inflation spike in the U.S. is a shortage of labor. The lower number of job openings and reduced quit rates now suggest the supply and demand of workers may be moving toward better alignment.

A healthy economy requires willing and suitable workers and adequate positions for those workers. June was a good sign that this is beginning to occur.

Paul Hoffman

Managing Editor, Channelchek

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Taiwan Trip Turmoil May Create Investment Opportunities



Image Credit: Jimmy Liao (Pexels)


Investors’ Interest in Taiwan Being Highlighted with House Speaker’s Trip

Chinese President Xi Jinping holds the position that Taiwan is a Chinese territory that needs to be reunited with the mainland. When U.S. House Speaker Nancy Pelosi announced an official visit to the island, an important U.S. trading partner, Beijing, threatened to possibly intercept the plane, and members of the media there suggested they had the right to even shoot it down.

Regardless of geopolitical considerations and ignoring memes suggesting how husband Paul Pelosi may have positioned his portfolio holdings, investors should pay attention to the unfolding market swings for their own portfolios.  

Background

Speaker Pelosi had cancelled her plans to visit Taiwan last April as she was said to have been infected with Covid-19. She then rescheduled her trip for August. These plans were confirmed in late July, at which time President Biden said, “the military thinks it’s not a good idea right now.” There has been concern within the White House that China may go as far as to ground her travel by implementing a no-fly zone over Taiwan. This would put the two nuclear powers in direct conflict.

Taiwan is an important trading partner with the U.S. The announcement caused Taiwan technology stocks to dip, and the Taiwanese dollar and other Asian currencies are also off. While saber-rattling may be as far as mainland China takes their disapproval, the trip serves as a reminder of the significant risk that Taiwan represents for the U.S. technology sector. Most of the world’s advanced chips are made in Taiwan.

 

Investor Considerations

In assessing whether the dip is a buying opportunity or if this is the beginning of a need to sell and invest in domestic chip makers remains to be seen. It has certainly stirred up many semi-dormant issues between China, Taiwan, and U.S. relations. Investors should not underestimate the inherently unpredictable nature of global politics, positioning, and egos. Just as a war in Europe seemed improbable last December, this may play out differently than anticipated. One can never gauge based on the current state of relations. Analysts believe that if the U.S. and China do confront each other militarily, Taiwan would be the likely cause.

That there is genuine chatter and news reports discussing the chance of a war between China and the U.S. deserves serious attention. While the normal horrors of war first come to mind, as investors we can’t help but to contemplate all the industries this could impact.

Most of the advanced chips critical for military defense systems and corporate computing services are made in Taiwan. Taiwan represents more than 90% of the world’s most complex chip manufacturing (South Korea is at 8%). .

A large portion of this production is from Taiwan Semiconductor Manufacturing (TSM), which makes unique chips for external customers. TSM had total revenue of $57 billion last year and is the world’s largest third-party foundry, dominating the market for high-end chips. The products include the main processors inside Apple’s (AAPL) iPhones, the smartphone chips used by Qualcomm (QCOM), and computer processors for Advanced Micro Devices (AMD).


Source: Koyfin

Since the last days in July when the trip by the House Speaker seemed to be back on, shares of Taiwan Semiconductor Manufacturing have dropped 5% or more. It is expected that a military conflict over Taiwan would halt production and shipments. This would disrupt the completion of production of everything from cars, aircraft, and most anything else with onboard computing capabilities.

U.S.-Taiwan Trade Stats

• In 2020, Taiwan GDP was an estimated $635.5 billion (current market exchange rates); real GDP was up by an estimated 0.0 percent; and the population was 24 million. (Source: IMF)

 • U.S. goods and services trade with Taiwan totaled an estimated $105.9 billion in 2020. Exports were $39.1 billion; imports were $66.7 billion. The U.S. goods and services trade deficit with Taiwan was $27.6 billion in 2020.

 • Taiwan is currently our 9th largest goods trading partner with $90.6 billion in total (two-way) goods trade during 2020. Goods exports totaled $30.2 billion; goods imports totaled $60.4 billion. The U.S. goods trade deficit with Taiwan was $30.2 billion in 2020.

 • Trade in services with Taiwan (exports and imports) totaled an estimated $15.2 billion in 2020. Services exports were $8.9 billion; services imports were $6.3 billion. The U.S. services trade surplus with Taiwan was $2.6 billion in 2020.

 • According to the Department of Commerce, U.S. exports of goods and services to Taiwan supported an estimated 188,000 jobs in 2019 (latest data available) (133,000 supported by goods exports and 55,000 supported by services exports).

 

Take Away

The situation where the U.S. relations with Taiwan are separate from Beijing isn’t new. The expected trip has just highlighted and stirred up undefined boundaries. Washington recognizes one Chinese government based in Beijing and doesn’t officially support Taiwanese independence. Yet the U.S. also is opposed to China’s claim over Taiwan. These murky lines have been the unchallenged status quo for decades.

This trip may help to define the lines that China have drawn as Speaker Pelosi is being told that she is crossing them. At the same time, in her position (third in line from the President) she is defining where the U.S. believes those lines are.

From a pure investors’ point of view, we have our own lines, some of them are on the charts of the companies that are affected as this plays out. As with any disruption, there will be unusual price movement; this movement could allow for opportunity.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://ustr.gov/countries-regions/china/taiwan#:~:text=U.S.%20imports%20from%20Taiwan%20account,and%20plastics%20(%242.2%20billion).

https://apnews.com/article/china-beijing-international-law-south-china-sea-4370828e295d2eec9a4804bba9940273

https://www.speaker.gov/

https://www.ft.com/content/09669099-1565-4723-86c9-84e0ca465825

https://www.cbsnews.com/news/biden-us-military-not-a-good-idea-pelosi-visit-taiwan-now/

https://www.cbsnews.com/news/biden-us-military-not-a-good-idea-pelosi-visit-taiwan-now/

https://www.semiconductors.org/news-events/latest-news/

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Release – Axcella Announces Highly Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID



Axcella Announces Highly Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID

Research, News, and Market Data on Axcella Therapeutics

Subjects with Long COVID receiving AXA1125 experienced a
clinically and statistically significant improvement in mental (p=0.0097) and
physical (p=0.0097) fatigue scores compared to placebo subjects

Responders to AXA1125 demonstrated significantly improved scores
during a 6 minute walk test

No emergent adverse events (AEs) or serious adverse events
(SAEs) occurred

Regulatory meetings are planned to discuss a path to
registration trial

Axcella to host a conference call today at 8:00 a.m. ET; To
register, click 
here

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 2, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today reported topline results from the Phase 2a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.

Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide with fatigue as the most common symptom reported. The recent Congressional subcommittee on Long COVID stated that one million Americans have been pushed out of work due to Long COVID. Additionally, it was stated that Long COVID contributed to approximately $1 trillion in lost earnings and $529 billion in increased medical spending.

We believe effective treatment of this complex and often debilitating disease requires addressing the underlying dysregulation of multiple biological pathways. Given the lack of therapeutic options for Long COVID patients and based on our understanding of AXA1125’s positive impact on mitochondrial function, bioenergetics, and inflammation, Axcella conducted a placebo-controlled interventional study in collaboration with clinical researchers at University of Oxford as an exploratory trial to test the hypothesis that administration of AXA1125 could ameliorate fatigue symptoms of Long COVID. Bill Hinshaw, CEO of Axcella, remarked, “At Axcella, once we understood we had a potential Long COVID intervention we acted rapidly to test the hypothesis that we could address the high and growing need that exists for patients living with debilitating Long COVID fatigue. We are delighted to report that we have meaningful clinical results as well as an increased understanding on the best endpoints for future, potentially registrational studies and look forward to engaging with the regulatory authorities around the next steps in clinical development.”

Since established endpoints for Long COVID do not exist, the study incorporated multiple endpoints for prioritization, selection, and use in a future registration trial to assess the effects of AXA1125 compared to placebo in subjects with moderate to severe fatigue. Safety and tolerability were also studied.

In the study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 (N=21) or a matched placebo (N=20) in two divided doses for 28 days, with a one-week safety follow-up period. All 41 subjects who started the study remained in the study to completion. Endpoints included phosphocreatine recovery time (PCr?) following moderate exercise as assessed by 31P-magnetic resonance spectroscopy (MRS), which was included to assess mitochondrial function, and most importantly, clinically relevant endpoints including self-reported mental and physical fatigue as assessed by the Chalder Fatigue Questionnaire (CFQ-11), 6 minute walk test (6MWT) as well as serum lactate levels. The CFQ-11 is a validated patient reported outcome measure of fatigue that has been used in measuring patient impact in fatigue states such as chronic fatigue syndrome.

Subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared to those who received placebo. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively. Clinically meaningful shifts in the severity of physical and mental fatigue were also noted in subjects who received AXA1125 compared to those who received placebo. There was a statistically significant correlation of improvement in fatigue score and greater distance achieved in the 6MWT (p=0.0027), an objective measure of physical ability, only observed in subjects who received AXA1125.

Baseline PCr? among all subjects was significantly higher and had a higher degree of inter-subject variability (92.46 Seconds + 35.3 Seconds) than previously reported in the literature. These findings support the hypothesis that there is significant mitochondrial dysfunction in these patients but limits the utility of this parameter in a clinical trial. There was no significant difference on the primary outcome measure of PCr? following moderate exercise between subjects receiving AXA1125 and placebo. There was a notable trend toward significant improvement in serum lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and well tolerated with no significant adverse events reported by study subjects.

“The statistically significant improvement in reported mental and physical fatigue among study participants receiving AXA1125 is a very encouraging finding for Long COVID patients, who often experience extreme and constant fatigue throughout their day,” said study leader, Dr. Betty Raman, Associate Professor of Cardiovascular Medicine at the Radcliffe Department of Medicine, University of Oxford.

Karim Azer PhD, Axcella’s VP, Platform and Discovery stated, “The results of this trial encourage us to further evaluate the multi-targeted effects of AXA1125 on mitochondrial and related biomarkers to advance our understanding of the benefits AXA1125 delivers to Long COVID patients. Preliminary analysis including mitochondrial, inflammatory, and endothelial environment biomarker work provides additional data strengthening the core rationale for AXA-1125’s compelling clinical benefits.”

Dr. Jason Maley, Director of Beth Israel Deaconess Medical Center Critical Illness and COVID-19 Survivorship Program, remarked that, “This is the first pharmaceutical agent to demonstrate improved outcomes for patients with Long COVID in a randomized controlled trial and suggests that AXA1125 may play an important part in the long-term treatment of these patients as they seek to return to the life they had before the infection. On behalf of the innumerable patients urgently seeking therapies for the debilitating symptoms of Long COVID, I am excited to see the continued development of AXA1125.”

Conference Call
Information
Register for the call by clicking here.
A live webcast of the call, as well as a replay, will be available on the Events and Presentations section on the Company’s website: https://ir.axcellatx.com/events-and-presentations.

Internet Posting of
Information
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella
Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Forward-Looking
Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding interest that may ensue in the Company’s product candidates or securities following announcement of the Company’s recent clinical trial results and the timing of the Company’s clinical trial data readouts and next steps for its clinical programs, including a potential registration trial of AXA1125 for the treatment of Long COVID. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the belief that mitochondrial dysfunction is a key driver of Long COVID induced fatigue, potential impact of COVID-19 on the Company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the Company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the Company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the Company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the Company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the Company’s target indications, and other risks identified in the company’s SEC filings, including Axcella’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.

Dr. Maley receives compensation as a consultant for the Company.

View source version on 
businesswire.comhttps://www.businesswire.com/news/home/20220802005461/en/

Company
Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics


Release – Tonix Pharmaceuticals Receives Federal Grant from the National Institute on Drug Abuse (NIDA) to Advance Development of TNX-1300 as a Treatment for Cocaine Intoxication



Tonix Pharmaceuticals Receives Federal Grant from the National Institute on Drug Abuse (NIDA) to Advance Development of TNX-1300 as a Treatment for Cocaine Intoxication

Research, News, and Market Data on Tonix Pharmaceuticals

There is No
FDA-Approved Product for Cocaine Intoxication

TNX-1300 Has Been Granted
Breakthrough Therapy Designation by the FDA

Phase 2 Single-Blind,
Placebo-Controlled, Potential Pivotal Study Expected to Start in Fourth Quarter
2022, Pending FDA Agreement

CHATHAM, N.J., Aug. 02, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine. Cocaine intoxication refers to a state in which cocaine has deleterious effects on several body systems, especially the cardiovascular system. TNX-1300 demonstrated activity on reversing the physiological effects of i.v. cocaine challenge in people who use cocaine in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study.1

The grant is intended to support continued development of TNX-1300 as a treatment for life threatening cocaine intoxication. In 2021, more than 24,900 individuals in the U.S. died from drug overdose deaths involving cocaine2.

“This grant award underscores the unmet need for safe and effective treatments for cocaine intoxication and validates the progress we have achieved to date with TNX-1300,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Cocaine intoxication remains a serious issue in the U.S. where there is currently no specific pharmacotherapy indicated treatments. By targeting the cause rather than the symptoms of cocaine intoxication, we believe TNX-1300 may offer significant advantages to the current standard of care for cocaine intoxication.”

Tonix recently announced the design of a new single-blind, open-label, placebo-controlled, randomized Phase 2 clinical trial of TNX-1300 for the treatment of cocaine intoxication. The Phase 2 study, which has the potential to serve as a pivotal trial, is anticipated to start in the fourth quarter of 2022, pending U.S. Food and Drug Administration (FDA) agreement. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. As a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in addition to expected patent protection through 2029.

“The research Tonix is pursuing is a bright light in our shared goal of reducing overdose deaths and harm as we continue to battle the crisis in substance use disorders in New Jersey and across the country, which has only been compounded by the pandemic. This targeted treatment could bring down healthcare costs and, most importantly, loss of life due to cocaine overdose,” said Representative Mikie Sherrill (NJ-11). “With this federal grant, Tonix will be able to move one step closer to FDA authorization and getting this potentially life-saving treatment into the hands of emergency room doctors and nurses, as well as EMS and other first responders. I am proud to have Tonix’s headquarters based here in NJ-11.”

“Tonix has been an incredible partner and job creator in Maryland, and I commend their efforts in fighting against the substance use disorder crisis that our nation continues to face. With over 100,000 Americans killed by drug overdoses just last year, we need to work together to curb the loss and set our sights on prevention, harm reduction, treatment and recovery. That starts with medical innovation in our own communities and reliable investment in our country’s brightest leaders. This funding from the National Institute on Drug Abuse will do just that,” said Representative David Trone (MD-06).

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA056245. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About TNX-1300

TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug (IND) application for the treatment of cocaine intoxication. TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine esterase (CocE) was identified in bacteria (Rhodococcus) that uses cocaine as its sole source of carbon and nitrogen and that grows in soil surrounding coca plants.
3 The gene encoding CocE was identified and the protein was extensively characterized.3-6 CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours at body temperature.6 In a Phase 2 study, TNX-1300, at 100 mg or 200 mg i.v. doses, was well tolerated and rapidly reduced cocaine effects after a cocaine 50 mg i.v. challenge.1

About Cocaine
Intoxication

Cocaine is an illegal recreational drug which is taken for its pleasurable effects and associated euphoria, as well as mental alertness, in some cases. Pharmacologically, cocaine blocks the reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within the synapse and an amplification of dopamine signaling which reinforces the drug taking. With the continued use of cocaine, however, intense cocaine cravings can occur, resulting in a high potential for continued use and addiction, as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects of cocaine on several body systems, especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest occurs during transit. According to the U.S. Centers for Disease Control and Prevention (CDC), in 2021 the number of overdose death involving cocaine reached 24,900 individuals.2 Also according to a recent report by the CDC, among all 2020 U.S. drug overdose deaths, approximately nearly 1 in 5 involved cocaine.7 In 2020, Black Americans experienced the highest death rate for overdoses involving cocaine, at 14 per 100,000.7

References

1 Nasser AFFudala PJZheng BLiu YHeidbreder C. A randomized, double-blind,
placebo-controlled trial of RBP-8000 in cocaine abusers: pharmacokinetic
profile of rbp-8000 and cocaine and effects of RBP-8000 on cocaine-induced
physiological effects. 
J Addict Dis. 2014;33(4):289-302.

2 Centers
for Disease Control and Prevention (CDC) – 
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

3 Bresler MMRosser SJBasran ABruce NC. Gene cloning and nucleotide sequencing
and properties of a cocaine esterase from Rhodococcus sp. strain MB1. 
Appl Environ Microbiol. 2000. 66(3):904-8.

4 Larsen NATurner JMStevens JRosser SJBasran ALerner RABruce NCWilson IA. Crystal structure of a bacterial
cocaine esterase. 
Nat Struct Biol. 2002. 9(1):17-21.

5 Turner JMLarsen NABasran ABarbas CF 3rdBruce NCWilson IALerner RA. Biochemical characterization and
structural analysis of a highly proficient cocaine esterase. 
Biochemistry. 2002. 41(41):12297-307.

6 Gao DNarasimhan DLMacdonald JBrim RKo MCLandry DWWoods JHSunahara RKZhan CG. Thermostable variants of cocaine
esterase for long-time protection against cocaine toxicity. 
Mol Pharmacol. 2009. 75(2):318-23.

7 National
Institute on Drug Abuse 
https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates#:~:text=Overall%2C%20drug%20overdose%20deaths%20rose,overdose%20deaths%20reported%20in%202020

About Tonix
Pharmaceuticals Holding Corp.
*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate 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 that is mid-Phase 2 with a new potentially pivotal Phase 2 study expected to be initiated in the fourth quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. 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 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 first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. 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 Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

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

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

Forward
Looking Statements

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

Contacts

Jessica Morris
(corporate)

Tonix Pharmaceuticals
investor.relations@tonixpharma.com

(862) 799-8599

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

 


Release – Sierra Metals Subsidiary in Peru, Sociedad Minera Corona Reports Q2 2022 Financial Results



Sierra Metals Subsidiary in Peru, Sociedad Minera Corona Reports Q2 2022 Financial Results

Research, News, and Market Data on Sierra Metals

All metal prices reported in
USD)

TORONTO–(BUSINESS WIRE)– 
Sierra Metals Inc. (TSX: SMT) (BVL or Bolsa de Valores de Lima: SMT) (NYSE AMERICAN: SMTS) (“Sierra Metals” or “the Company”) announces the filing at the BVL by its subsidiary, Sociedad Minera Corona S.A. (“Corona”) of its unaudited Financial Statements and the Management’s Discussion and Analysis (“MD&A”) for the second quarter of 2022 (“Q2 2022”).

The Company holds an 81.8% interest in Corona. The unaudited Financial Statements and MD&A can be viewed at:

SMV — Superintendencia
del Mercado de Valores — Información Financiera

Sierra Metals will be releasing its Q2 2022 consolidated financial statements on Thursday August 11th, 2022 with an investor conference call taking place on August 12th, 2022.

About Sierra Metals

Sierra Metals Inc. is a diversified Canadian mining company with Green Metal exposure including increasing copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. Sierra Metals has recently had several new key discoveries and still has many more exciting brownfield exploration opportunities at all three Mines in Peru and Mexico that are within close proximity to the existing mines. Additionally, the Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.

The Company’s Common Shares trade on the Toronto Stock Exchange and the Bolsa de Valores de Lima under the symbol “SMT” and on the NYSE American Exchange under the symbol “SMTS”.

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Watch our progress:

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Forward-Looking Statements

This press release contains forward-looking information within the meaning of Canadian and United States securities legislation. Forward-looking information relates to future events or the anticipated performance of Sierra and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra to be materially different from any anticipated performance expressed or implied by such forward-looking information.

Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 16, 2022 for its fiscal year ended December 31, 2021 and other risks identified in the Company’s filings with Canadian securities regulators and the United States Securities and Exchange Commission, which filings are available at www.sedar.com and www.sec.gov, respectively.

The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.

For further information regarding Sierra Metals, please visit www.sierrametals.com or contact:

Investor Relations
Sierra Metals Inc.
Tel: +1 (416) 366-7777
Email: 
info@sierrametals.com

Luis Marchese
CEO

Sierra Metals Inc.
Tel: +1 (416) 366-7777

Source: Sierra Metals Inc.