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Release – Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 01, 2024 8:00am EDT Download as PDF

Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad-spectrum oral antiviral program TNX-4200 for medical countermeasures

CHATHAM, N.J., July 01, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

Tonix’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “The DoD announced in December 2022 that they are moving beyond a ‘one bug, one drug’ approach and are seeking broad-spectrum drugs since one cannot predict which or how many viruses may be deployed.1 This funding provides important validation for our ongoing research and current in-house capabilities, and will enable Tonix to advance its antiviral discovery program.”

The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

1 “Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products.” 2022. Chemical and Biological Defense Program. U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF (accessed March 5, 2024)

About Defense Threat Reduction Agency (DTRA)

The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com  
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 1, 2024

Release – Unicycive Therapeutics Joins Russell Microcap® Index

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

July 01, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., July 01, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced it was included in the Russell Microcap Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024.

The annual Russell US Indexes reconstitution captures the 4,000 largest US stocks as of Tuesday, April 30th, ranking them by total market capitalization. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.

“Inclusion in the Russell Microcap Index represents the latest milestone as a public company and validates the progress we have made over the last year,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Inclusion in the Index continues our strong momentum following our positive clinical trial results for oxylanthanum carbonate (OLC) announced last week. We believe our addition to this index will benefit our shareholders by increasing our visibility within the investment community.” 

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell’s US indexes serve as the benchmark for about $10.5 trillion in assets as of the close of December 2023. Russell indexes are part of FTSE Russell, a leading global index provider.

Fiona Bassett, CEO of FTSE Russell, An LSEG Business, comments, “Russell indexes–now in their 40th year–continue to evolve to reflect the dynamic US economy. Annual rebalancing plays a vital role in establishing accurate benchmarks, ensuring they correctly mirror their designated market segments and remain unbiased in terms of size and style.”

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About FTSE Russell:

FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their investment process. A comprehensive range of reliable and accurate indexes provides investors worldwide with the tools they require to measure and benchmark markets across asset classes, styles, or strategies.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. ​​​​​​​

FTSE Russell is focused on applying the highest industry standards in index design and governance, employing transparent rules-based methodology informed by independent committees of leading market participants. FTSE Russell fully embraces the IOSCO Principles, and its Statement of Compliance has received independent assurance. Index innovation is driven by client needs and customer partnerships, allowing FTSE Russell to continually enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit https://www.lseg.com/en/ftse-russell.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released July 1, 2024

Release – CoreCivic Announces 2024 Second Quarter Earnings Release and Conference Call Dates

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CXW

BRENTWOOD, Tenn., July 01, 2024 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2024 second quarter financial results after the market closes on Wednesday, August 7, 2024. A live broadcast of CoreCivic’s conference call will begin at 10:00 a.m. central time (11:00 a.m. eastern time) on Thursday, August 8, 2024.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BIdd7601382fc644b791a9a7cfbbe4f556. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.

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 one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for over 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.

Contact:Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957
 Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – FAT Brands Announces Jordan Chirico as Executive Vice President and Head of Debt Capital Markets

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on FAT

Experienced Financial Executive Joins Fast-Growing Global Franchising Company

LOS ANGELES, July 01, 2024 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. announces the hiring of Jordan Chirico as Executive Vice President and Head of Debt Capital Markets. Mr. Chirico joins FAT Brands with nearly 20 years of Wall Street experience and will be focused on the Company’s balance sheet including its $1.2 billion Whole Business Securitization portfolio, additional acquisition financings, preferred stock, and other debt related strategies.

Mr. Chirico spent the first half of his career in structured finance at Bank of America, Robert W. Baird and Credit Suisse before pivoting to the asset management side of the business, holding senior Portfolio Management roles at Robert W. Baird, Brigade Capital Management, and 3|5|2 Capital.

“We are so pleased to welcome Jordan to FAT Brands with his strong background in capital markets,” said Rob Rosen, Co-CEO of FAT Brands. “FAT Brands is uniquely positioned to continue its growth trajectory and Jordan’s expertise will be beneficial as we look to both bolster the balance sheet and be efficient in our financings to build upon our positioning as one of the largest restaurant companies in the U.S.”

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

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza®, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Native Grill & Wings, Pretzelmaker, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit http://www.fatbrands.com.

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

Townsquare Media (TSQ) – Virtual Conference Highlights

Posted on by cpereira@noblefcm.com


Monday, July 01, 2024

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, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

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

Virtual conference highlights. On June 26, the company’s CEO Bill Wilson and CFO Stuart Rosenstein presented at Noble’s Virtual Consumer/TMT conference. Mr. Wilson highlighted the company’s transformation to a digital first business, unique value proposition, favorable growth outlook and sizeable return of capital to shareholders. A replay of the company’s presentation can be viewed here.

Favorable outlook. With Q2 nearly finished, Mr. Wilson highlighted the company is on track to hit Q2 guidance, experience sequential revenue growth over Q1, and expectation to hit full year revenue and adj. EBITDA guidance. Notably, we anticipate the company will gain positive momentum and experience sequential growth in the back half of the year, as high margin political revenue kicks in.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Schwazze (SHWZ) – Noble Consumer Virtual Conference

Posted on by cpereira@noblefcm.com


Monday, July 01, 2024

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

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

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

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

Conference. We hosted Schwazze Chairman Justin Dye at the Noble Capital Emerging Growth Conference on June 27th. The entire presentation with Q&A can be found at https://www.channelchek.com/videos/schwazze-shwz-noble-capital-markets-virtual-consumer-tmt-conference-replay. The following are key highlights of the presentation.

Improving Outlook. Schwazze is seeing improvement in both Colorado and New Mexico from a competitive standpoint. In Colorado, pricing continues to stabilize, which will prove positive to both the top line and gross margin dollars. In New Mexico, enhanced enforcement of illegal operators and the illicit market is beginning to produce results, which will benefit Schwazze over the longer-term, in our view.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Haynes International (HAYN) – Key U.S. Regulatory Approval; Updating Estimates

Posted on by cpereira@noblefcm.com


Monday, July 01, 2024

Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Key U.S. regulatory approval. Haynes International announced that clearance has been obtained from the Committee on Foreign Investment in the United States (CFIUS) related to the planned merger with North American Stainless, Inc. The merger remains subject to approvals from regulatory authorities in the United Kingdom and Austria. All other regulatory approvals and clearances have been obtained where the applicable authorities have asserted jurisdiction. The company continues to expect that the merger will close in the fourth calendar quarter of 2024.

Chief Operating Officer appointment. Mr. Marlin (Marty) Losch has been named Chief Operating Officer, a newly created role, and will have responsibility for all commercial and operational activities. Mr. Losch joined the company in 1988 and previously served as Vice President of Sales and Distribution. Mr. Losch has held various positions of increasing responsibility in marketing, quality engineering, and production. Mr. Losch’s expanded role should be helpful to Mr. Michael Shor, President and CEO, as Mr. Shor focuses more attention on closing the company’s merger with North American Stainless Inc, a division of Acerinox S.A. Additionally, we expect the appointment to enhance post transaction integration.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 28, 2024 4:05pm EDTDownload as PDF

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 28, 2024

Beyond the Big Names: Inside the Russell 3000’s Crucial Annual Update

Posted on by slightbourne@noblecapitalmarkets.com

Today marks a significant event in the financial world as the annual reconstitution of the Russell indexes takes effect after the market closes. This process, particularly for the Russell 3000 index, is a crucial moment for investors of all experience levels to pay attention to, as it can have far-reaching implications for both individual stocks and the broader market landscape.

The Russell 3000 index, which encompasses the largest 3,000 U.S. stocks by market capitalization, serves as a comprehensive barometer of the U.S. equity market. Its annual rebalancing is a carefully orchestrated event that reflects the evolving dynamics of the market, capturing the rise of emerging companies and the decline of others.

As the closing bell rings today, a new roster of companies will join the Russell 3000, while others will bid farewell. This shift is not merely a technicality but a reflection of changing market realities. Companies that have grown in value over the past year may find themselves newly included, signaling their ascent in the business world. Conversely, those that have fallen out of favor or experienced significant market cap declines may be removed, highlighting the cyclical nature of market success.

For investors, both novice and seasoned, this reconstitution presents a unique opportunity to gain insights into market trends and potential investment prospects. The companies being added to the index often represent growth stories or emerging sectors that are gaining traction. By paying close attention to these additions, investors can identify potential up-and-coming stars in the market before they become household names.

This year’s reconstitution has seen some notable changes, with several companies making their debut on the Russell 3000. Among the newcomers are Graham Corp(GHM), Lifeway Foods (LWAY), and Ocugen (OCGN), DLH Holdings Corp (DLHC), and NN Inc (NNBR). These additions reflect the dynamic nature of the market and highlight emerging trends across different sectors.

The inclusion of these companies in the Russell 3000 index is likely to bring significant benefits. For Graham Corporation, a company specializing in critical equipment for the defense, energy, and chemical industries, this recognition could attract more investor attention to the industrial technology sector and its role in key infrastructure. Lifeway Foods, a leading probiotic and fermented food company, may see increased interest in the growing health food sector. Ocugen, a biotechnology company focused on developing gene therapies and vaccines, could draw more eyes to the innovative potential in healthcare and pharmaceutical. DLH Holdings Corp, a provider of technology-enabled business process outsourcing and program management solutions, highlights the growing importance of efficient business services and government contracting. NN Inc, a diversified industrial company producing high-precision components and assemblies, underscores the continued significance of advanced manufacturing in various industries.

The impact of today’s reconstitution extends beyond individual stock picks. Index funds and ETFs that track the Russell 3000 will need to adjust their holdings to reflect the new composition. This rebalancing can lead to increased trading volumes and potential short-term price volatility for the affected stocks. For active traders, this volatility can create opportunities, while for long-term investors, it underscores the importance of understanding the underlying mechanisms that drive market movements.

It’s worth noting that while the Russell 3000 includes smaller companies compared to more famous indexes like the S&P 500, its comprehensive nature makes it a valuable tool for investors looking to gauge the health of the broader U.S. equity market. The index captures approximately 98% of the investable U.S. equity market, making it a more inclusive representation of the economy than narrower large-cap focused indexes.

As the day unfolds, investors would do well to keep an eye on the final list of additions and deletions published by FTSE Russell. This information can provide valuable insights into sector rotations, emerging trends, and potential investment opportunities. Moreover, understanding the methodology behind these changes can help investors make more informed decisions about their portfolios.

In conclusion, today’s Russell 3000 reconstitution is more than just a reshuffling of an index. It’s a snapshot of the current state of the U.S. equity market and a glimpse into its future direction. For investors of all levels, from novices just starting their journey to experienced market veterans, paying attention to these changes can offer valuable insights and potentially lucrative opportunities. As the market closes today and the new index composition takes effect, remember that even in the world of smaller companies, massive value awaits those who know where to look.

For more detailed information about the Russell reconstitution process and its implications, investors can visit the official FTSE Russell website at https://www.lseg.com/en/ftse-russell/russell-reconstitution. This resource provides comprehensive insights into the methodology, timelines, and impacts of the annual reconstitution, helping investors stay informed about this crucial market event.

Release – Graham Corporation Set to Join Russell 2000® and 3000® Indexes

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GHM

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries, today announced it will be added to the Russell 2000® and Russell 3000® Indexes, effective after the close of financial markets on June 28, 2024.

“The inclusion in the Russell Indexes marks another milestone for GHM, recognizing the meaningful progress we have made in executing our strategy to drive revenue growth and enhance profitability,” commented Dan Thoren, President and Chief Executive Officer. “We believe that being part of the Russell indexes will increase our visibility within the investment community, improve our liquidity, and attract a broader range of investors.”

Membership in the U.S. Russell 3000® Index, which remains in place for one year, means automatic inclusion in the small-cap Russell 2000® Index, as well as the appropriate growth and value style indexes. The annual Russell indexes reconstitution captures the largest U.S. stocks by market capitalization.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9.1 trillion in assets are benchmarked against Russell’s U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About Graham Corporation

GHM is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. The Graham Manufacturing and Barber-Nichols’ global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

Safe Harbor Regarding Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “believe,” “will,” and other similar words. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission, including under the heading entitled “Risk Factors,” its quarterly reports on Form 10-Q, and other filings it makes with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Deborah K. Pawlowski
Kei Advisors LLC
Phone: (716) 843-3908
dpawlowski@keiadvisors.com

Source: Graham Corporation

Released June 28, 2024

Release – MustGrow Biologics Corp. Announces Results of Shareholder Meeting

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, June 27, 2024 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), is pleased to announce the results of its 2024 annual meeting of shareholders (the “Meeting“) held on June 27, 2024. At the Meeting, shareholders approved all director nominees listed in the Company’s management information circular dated May 28, 2024 were elected as directors of the Company on a vote held by ballot. The results of the ballot were as follows:

DirectorVote TypeNumber of VotesPercentage of Votes
Corey GiassonFor9,778,10299.76%
Withheld23,2000.24%
Colin BletskyFor9,778,10299.76%
Withheld23,2000.24%
Brad MunroFor9,777,80299.76%
Withheld23,5000.24%
Thomas FlowFor9,777,80299.76%
Withheld23,5000.24%
Matt KowalskiFor9,778,10299.76%
Withheld23,2000.24%
David BoreckyFor9,794,00299.93%
Withheld7,3000.07%
Laura WestbyFor9,798,00299.76%
Withheld3,3000.24%

In addition, shareholders approved the reappointment of Ersnt & Young LLP, Chartered Professional Accountants, as the Company’s auditors and authorized the directors of the Company to fix their remuneration, and reapproved the Company’s omnibus equity incentive plan (the “Omnibus Plan“). Having received shareholder approval, the Company’s Omnibus Plan remains subject to final approval from the TSX Venture Exchange. 

The formal report on voting results with respect to all matters voted upon at the Meeting will be filed on SEDAR+ under www.sedarplus.ca. 

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation.  Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its Organic Materials Review Institute (OMRI Listed®) and California’s Organic Input Material (OIM) Program registered biofertility product, TerraSanteTM, in key U.S. states including California.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  MustGrow has approximately 51.6 million basic common shares issued and outstanding and 54.1 million shares fully diluted.  For further details, please visit www.mustgrow.ca. 

ON BEHALF OF THE BOARD 
“Corey Giasson”
Director & CEO 
Phone: +1-306-668-2652
info@mustgrow.ca 

© 2024 MustGrow Biologics Corp. All rights reserved.

MustGrow Forward-Looking Statements

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

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements are described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2023 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

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

FreightCar America (RAIL) – Poised for Greater Scale and Margin Expansion

Posted on by cpereira@noblefcm.com


Friday, June 28, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Initiating coverage with an Outperform rating. FreightCar America, Inc. is a diversified manufacturer of railroad cars and rail car components. The company designs and manufactures a broad variety of railroad car types for the transportation of bulk commodities and containerized freight products primarily in North America. These include open top hoppers, covered hoppers, gondolas, and intermodal and non-intermodal flat cars. FreightCar America and its predecessors have been manufacturing railroad cars since 1901.

Unique competitive advantages. FreightCar America is a pure play manufacturer that has unique manufacturing capabilities that allow it to respond to customer orders with short lead times due to its ability to set up a production line to batch produce orders and quickly change over to the next line for a different product type. Its engineering capabilities allow it to offer tailored solutions in areas unmet by competitors.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GeoVax Labs (GOVX) – CRO Partnership For Clinical Trial Allows Sponsored Phase 2b Trial To Move Forward

Posted on by cpereira@noblefcm.com


Friday, June 28, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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

Partnership For BARDA-Funded Trial Announced. GeoVax announced a partnership with Allucent, a global clinical management organization (CRO), to conduct the Phase 2 clinical trial for CM04S1. The trial has been awarded approximately $357 million in funding through Project NextGen, with about $24.3 million going to GeoVax and the balance to fund the clinical trial costs. We see the partnership as an important step toward the start of the clinical trial, as well as another scientific validation for CM04S1 and the GeoVax manufacturing technologies.

The Partnership Allows The Trial To Begin As Expected. Under the grant, GeoVax is the trial sponsor with responsibility for manufacturing and providing vaccine supplies. The grant also requires a CRO to conduct the trial and manage its clinical operations. The announcement of the partnership with Allucent, a global CRO that can provide these services, allows the trial to move forward with a possible starting date during summer 2024.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.