Release – Salem Media Group to Present at the Upcoming 17th Annual Singular Research Best of the Uncovered Investor Conference

Research, News, and Market Data on SALM

December 01, 2022 9:00am EST

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM), announced today that it will present at the 17th annual Singular Research Best of the Uncovered Investor Conference in San Francisco on December 8, 2022 at 3:45 PM Central Time. The presentation will be available on the investor relations portion of the company’s website www.salemmedia.com prior to the company’s presentation.

ABOUT SINGULAR RESEARCH:

Singular Research aims to be the most trusted supplier of independent, trusted, single-sources research on small-to-micro cap companies to the small-to-medium sized Hedge Fund manager. Singular Research provides quarterly updates for 40 to 70 companies and makes recommendations.

Singular strives to achieve goals by finding under or overvalued securities. Singular’s goal is to provide initiation reports and quarterly updates for approximately 40 micro to small cap companies. In most cases, Singular analysts research companies that are not covered by any other firms.

Singular provides honest advice. Independent analysts have no financial interest in the stocks covered. Analysts are compensated based on the accuracy of their research calls not through trading commissions or potential deal flow.

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.comFacebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221129006018/en/

Evan D. Masyr
Executive Vice President and Chief
Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released December 1, 2022

Release – Tonix Pharmaceuticals Presents Development Update on Potential Smallpox and Monkeypox Vaccine TNX-801 in an Oral Presentation at the World Vaccine and Immunotherapy Congress

Research, News, and Market Data on TNXP

December 01, 2022 7:00am EST

TNX-801 is Based on the Sequence of a Natural Isolate of Horsepox and is Believed Closer in Structure to Edward Jenner’s 1798 Vaccine than Modern Vaccinia Virus Vaccines Against Smallpox

Live-Virus Vaccine Platform Leverages Tonix’s Expanding Internal Development and Manufacturing Capabilities for Biologics

CHATHAM, N.J., Dec. 01, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, presented data from the Company’s TNX-801 (live horsepox virus vaccine) smallpox and monkeypox vaccine development program in an oral presentation at the World Vaccine and Immunotherapy Congress 2022, being held in San Diego, Calif., November 28 – December 1, 2022. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com

“TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox,” said Seth Lederman, M.D., President and Chief Executive Officer. “Recent global outbreaks of monkeypox have highlighted the need to be prepared with a vaccine that provides durable immunity and blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes.”

The oral presentation titled, “Live Virus Smallpox and Monkeypox Vaccine,” describes the history of live virus vaccines and rationale for the development of the Company’s Recombinant Pox Virus (RPV) platform, including TNX-801 to protect against monkeypox and smallpox. The presentation describes the origins of immunization, beginning with the first live virus vaccine invented by Dr. Edward Jenner in 1798. The inoculation procedure was called “vaccination” and the inoculum material was initially obtained from lesions on cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses8,which led to immunization using material directly obtained from horses. This procedure was sometimes called “equination”. Equination and vaccination were practiced side-by-side in Europe13,14. Today, molecular analysis of DNA sequences from archaic smallpox vaccines suggests that TNX-801 is closer than modern smallpox vaccinia vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner6-8.

As presented at the Canadian Society for Virology in June 2022, non-human primates vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox.

In July 2022, the Company announced a collaboration with the Kenya Medical Research Institute (KEMRI) to seek regulatory approval for conducting a Phase 1 clinical study in Kenya to develop TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.

About TNX-801 and TNX-1850

TNX-801 is a live virus vaccine based on synthesized horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix is also developing TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1850 is designed to express the spike protein from the BA.2 variants of SARS-CoV-2. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain5. Tonix’s TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.11 The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses8. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’13. Equination and vaccination were practiced side-by-side in Europe13,14.

About the Recombinant Pox Virus (RPV) Platform

Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.

About Monkeypox and Smallpox

Monkeypox15 and smallpox16 are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases have been identified outside of Africa.17 Smallpox is considered eradicated, but there are concerns about malicious reintroduction.

About Tonix Pharmaceuticals Holding Corp.1

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. 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 first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the 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.

1All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

2Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

3Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536

4Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference – January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)

5Tonix Press Release March 16, 202a https://ir.tonixpharma.com/news-events/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine

6Schrick L et al. N Engl J Med. (2017) 377:1491.

7Qin et al. J. Virol. 89:1809 (2015).

8Jenner E. “An Inquiry Into the Causes and Effects of the Variolae Vaccinae: A Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire, and Known by the Name of the Cow Pox.” London: Sampson Low, 1798.

9Brinkmann A et al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0

10Duggan A et al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z

11Tonix press release. Dec 4, 2020 https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity

12Trindale GS et al. Viruses (2016) (12). Pii: E328. PMID:27973399

13Esparza E, et al Vaccine. (2017) 35(52):7222-7230.

14Esparza J et al. Vaccine. (2020); 38(30):4773-4779.

15www.cdc.gov/poxvirus/monkeypox/about.html

16www.cdc.gov/smallpox/research/

17Mandavilli, A. The New York Times. May 26, 2020. “Who is protected against monkeypox”

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

Forward Looking Statements

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

Contacts

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

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

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

Source: Tonix Pharmaceuticals Holding Corp.

Released December 1, 2022

Release – Comstock Announces Dayton Mineral Resource Report Significantly Expands Gold and Silver Resources

Research, News, and Market Data on LODE

VIRGINIA CITY, Nev., Dec. 01, 2022 (GLOBE NEWSWIRE) — Comstock Inc. (NYSE: LODE) (“Comstock” or the “Company”) today announced the publication of the initial technical report for the Company’s Dayton Consolidated Project. Behre Dolbear authored the independent, initial assessment of the Dayton Consolidated Project mineral resources, as of November 1, 2022, compliant with current SEC S-K 1300 guidelines. The full report is available on the Company’s website, at www.comstock.inc/investors.

The estimated mineral resource is constrained within an open pit economic shell based on a gold price of $1,800 per ounce and reported at a cutoff grade of 0.007 ounce gold per ton. The estimate includes Measured and Indicated resources containing 293,000 ounces of gold and 2,120,000 ounces of silver, plus an additional Inferred resource containing 90,000 ounces of gold and 480,000 ounces of silver.

The Dayton resource is located approximately one mile south of the Company’s Lucerne mining area, along State Route 342 and State Route 341. It includes the historic Dayton, Alhambra, Metropolitan, and Kossuth mines. Additional Comstock exploration areas located northwest, southwest, and south of the Dayton Project include Oest, Amazon Extension of Oest, and Spring Valley, respectively.

The Dayton project has long been known for high grade assays, with gold assays as high as 2.95 ounces per ton, and silver assays as high as 6.68 ounces per ton. Drilling by Comstock has also encountered significant thicknesses of mineralization, including 135 feet averaging 0.218 ounces per ton Au and 0.685 ounces per ton Ag (hole D11-21), 145 feet averaging 0.056 ounces per ton Au and 0.352 ounces per ton Ag (hole D11-33), 50 feet averaging 0.030 ounces per ton Au and 1.072 ounces per ton Ag (hole D94-17), 295 feet averaging 0.027 ounces per ton Au and 0.087 ounces per ton Ag (hole D10-01), and 235 feet averaging 0.031 ounces per ton Au and 0.102 ounces per ton Ag (hole SV12-05).

The report reflects a newly developed geologic model based on highly detailed and methodical identification and correlation of structural and lithological controls for mineralization.

Behre Dolbear’s conclusions include,

  • The Dayton Project represents an early stage but well-explored, epithermal, precious metal deposit within an historic world-class mining district.
  • The geology of the project area, particularly in the Dayton resource area, is well described and understood through vigorous surface and underground mapping and drill hole logging.
  • Based upon drilling, continuity of the mineralized zone appears to be good.
  • The QP opines that potentially higher-grade mineralization may exist in previously un-drilled areas in the Dayton resource where northeast striking faults intersect.
  • The deposit is hosted in structurally prepared rocks within the southerly striking east dipping Silver City fault zone extension. Grades and extent of mineralization are enhanced where this fault zone is intersected by north-south, northwest, and northeast striking faults and in particular where N50°E faults intersect N75°E faults.
  • At Spring Valley, high-grade or bonanza-style mineralization may be present as much of the area is covered by post-mineral gravel and historic mining is minimal.

“These results confirm the quality and growth potential of our Dayton resource,” stated Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “When combined with the results of the recent technical report published on our Lucerne resource, Comstock controls significant, district-wide mineral resources with outstanding potential for further gold and silver mineral resource growth.”

Comstock plans to develop the Dayton resource systemically, through the deployment of more advanced mineral discovery technologies and a series of phased drilling programs and engineering studies. A first phase of drilling, recommended by Behre Dolbear, includes 70 RC holes totaling 31,500 feet that will, among other objectives, test for high grade mineralization and step out exploration into Spring Valley.

About Behre Dolbear
Behre Dolbear is a one of the oldest mineral industry advisory firms in the world, continuously operating since 1911. Behre Dolbear authored the Technical Report Summary, Dayton Consolidated Project, Lyon County, Nevada as an independent third-party, following the United States Security and Exchange Commission’s mining rules under subpart 1300 of Regulation S-K.

About Comstock
Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complementary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Forward-Looking Statements 
This press release and any related calls or discussions may include 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. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future industry market conditions; future explorations or acquisitions; future changes in our exploration activities; future prices and sales of, and demand for, our products; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital, costs, revenues, business opportunities, debt levels, cash flows, margins, taxes, earnings and growth. These statements are based on assumptions and assessments made by our management considering their experience and their perception of historical and current trends, current conditions, possible future developments, and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; ability to achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology, quantum computing and advanced materials development, and development of cellulosic technology in bio-fuels and related carbon-based material production; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.

Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Contact information:

Comstock Inc.
P.O. Box 1118
Virginia City, NV 89440
www.comstock.inc
Corrado De Gasperis
Executive Chairman & CEO
Tel (775) 847-4755
degasperis@comstockinc.com
Zach Spencer
Director of External Relations
Tel (775) 847-5272 Ext.151
questions@comstockinc.com

Item 9 Labs (INLB) – A Management Change


Thursday, December 01, 2022

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by up to 640,000-plus square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit https://investors.item9labscorp.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.

New CEOYesterday, Item 9 Labs announced Mike Weinberger, the Company’s Chief Franchise Officer, has assumed the CEO mantle, replacing Andrew Bowden. Given the upcoming transformational acquisition of Sessions Cannabis, we view the change in leadership as a positive for the Company.

Franchise Experience. As Item 9 Labs goes full bore in cannabis franchising, Mr. Weinberger’s long background in the franchising industry will become even more valuable, in our opinion. A 20-plus year franchise industry veteran, Mr. Weinberger launched Item 9 Labs Corp.’s dispensary franchise, Unity Rd., in 2018 and grew the brand to more than 20 entrepreneurial groups driving development across 10 states before the sale of Unity Rd. to Item 9 Labs. Mr. Weinberger also led 500 unit Maui Wowi, a global coffee and smoothie franchise.


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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. 

Garibaldi Resources Corp. (GGIFF) – Looking Ahead to 2023


Thursday, December 01, 2022

Garibaldi Resources Corp. is an active Canadian-based junior exploration company focused on creating shareholder value through discoveries and strategic development of its assets in some of the most prolific mining regions in British Columbia and Mexico.

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

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

Private placement. Garibaldi announced a private placement to raise gross proceeds of up to C$4 million to advance its flagship E&L nickel-copper-cobalt project and other British Columbia properties, along with funding working capital. The offering consists of the sale of up to 10 million flow-through units (FT) at a price of C$0.30 per FT Unit for gross proceeds of up to C$3 million, and 4 million non-flow-through-units (Unit) at a price of C$0.25 per unit for gross proceeds of up to C$1.0 million. Proceeds from the sale of FT Units will be used to fund exploration, while proceeds from the sale of Units will fund working capital needs. See the body of this note for offering details.

2022 drilling program. The 2022 drill program at E&L tested targets from the 2021 Geotech deep penetrating Z-Axis Tipper Electromagnetic (ZTEM) survey. Of four holes drilled, two were successful, including Hole EL-22-97b, a deep hole which intersected two intervals of E&L gabbro more than 200 meters down plunge from previous drilling and intersected nickel-bearing disseminated and semi-massive sulphide mineralization. The two successful drill holes are lined with polyvinyl chloride (PVC) and Garibaldi intends to conduct a geophysical borehole electromagnetic (BHEM) survey to better plan future drill holes.


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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. 

Commercial Vehicle Group, Inc. (CVGI) – A Business Transformation


Thursday, December 01, 2022

Joe Gomes, Senior Research Analyst, 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.

Initiation. We are initiating research coverage of Commercial Vehicle Group, Inc. (CVG) with an outperform rating and a $10.00 price target. CVG is in the midst of a business transformation to drive top line revenue and overall margin improvements, with a goal of doubling revenue and increasing adjusted operating margin by 300 basis points by the 2025-2027 time frame.

Attractive End Markets. Long-term prospects for CVG’s key end markets are attractive. Demand for class 8 trucks exceeds supply and, with an aging fleet, is likely to continue. The ongoing switch to electric vehicles is opening a massive opportunity for CVG. And while the warehouse automation vertical is currently challenging, longer term we expect to see significant growth. 


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. 

Baudax Bio (BXRX) – Curing the Deficiency: Reverse Stock Split


Thursday, December 01, 2022

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Stock split approved at November 3, 2022 shareholder meeting. Shareholders of record September 29, 2022, approved the 1-for-40 stock split. The stock split will become effective for December 1, 2022, Nasdaq trading. The Company’s common stock will also commence trading under a new CUSIP number (07160F404).

Curing the deficiency.  Baudax Bio received Nasdaq notice that the minimum $1.00 bid price requirement was not being met and had until January 2, 2023, to cure the issue, unless they sought to obtain an additional 180 days to regain compliance.  The reverse split should bring the Company into listing compliance.


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In the Womb a Genetic Battle Sometimes Rages

Rotterdams Ballonenbed (Flickr)

Pregnancy is a Genetic Battlefield – How Conflicts of Interest Pit Mom’s and Dad’s Genes Against Each Other

Baby showers. Babymoons. Baby-arrival parties. There are many opportunities to celebrate the 40-week transition to parenthood. Often, these celebrations implicitly assume that pregnancy is cooperative and mutually beneficial to both the parent and the fetus. But this belief obscures a more interesting truth about pregnancy – the mother and the fetus may not be peacefully coexisting in the same body at all.

At the most fundamental level, there is a conflict between the interests of the parent and fetus. While this may sound like the beginning of a thriller, this genetic conflict is a normal part of pregnancy, leading to typical growth and development both during pregnancy and across an individual’s lifetime – something my research focuses on.

However, even though genetic conflict is normal during pregnancy, it can play a role in pregnancy complications and developmental disorders when left unchecked.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Jessica D. Ayers, Assistant Professor of Psychological Science, Boise State University.

What is Genetic Conflict?

Pregnancy is generally thought of as a period when a new individual is created from a unified blend of genes from their parents. But this is not quite right.

The genes a fetus gets from each parent carry slightly different instructions for development. This means there are contrasting and sometimes conflicting blueprints for how to build the new individual. Conflict over which blueprint to follow for fetal growth and development is the essence of the genetic conflict that occurs during pregnancy.

Moms have to use their bodies to help the fetus grow during pregnancy while dads don’t. This means that the genes the fetus inherits from mom have to not only provide for the current fetus, but also try to keep mom alive and healthy and make sure there are resources left over for a potential future pregnancy. These reserves include both biological resources like glucose, protein, iron and calcium, as well as the time and energy needed to help her children after birth as they grow and develop.

Dad’s genes don’t have this same pressure because they don’t use their bodies to help the fetus grow during pregnancy. A dad’s genes, then, don’t need to ensure that anyone other than the current fetus thrives.

To better understand this situation, pretend that all of the resources a mom can give her children come in the form of a milkshake. Once the milkshake runs out, mom has nothing left to give her children. Maternal genes, therefore, want each child to drink only as much as they need to grow and develop. This ensures that the milkshake can be “shared” across all current and future children.

Paternal genes, on the other hand, have no such guarantee of representation in this mother’s other children – the father of the current child may not be the father of the mother’s potential future children. This lack of guaranteed genetic representation means there is no pressure on the father to “share” the milkshake. The best strategy when it comes to paternal genes, then, is for the fetus to drink as much of the milkshake as they can.

These two strategies play a figurative game of tug of war throughout pregnancy. Both sides are trying to pull fetal development slightly more toward their side. Paternal genes encourage the fetus to grow and develop quickly and take more resources, while maternal genes encourage the fetus to grow and use only what’s necessary for proper development. Conflict over how deeply the embryo implants in the uterus and how quickly the placenta and fetus grow are just a few areas where researchers have documented this tug of war during pregnancy.

The milkshake problem helps researchers determine where to look for genetic conflict by simplifying where trade-offs may take place during pregnancy. Because fetal growth is at the heart of genetic conflict, researchers have focused on processes where conflict over resource transfers from mother to fetus can be observed. These investigations have found that the placenta, a fetal organ responsible for all resource transfers during pregnancy, is dominated by paternally-expressed genes. It releases paternally-derived insulin-like growth factors that make mom less sensitive to her own insulin and hormones that increase maternal blood pressure, both of which ultimately increase the amount of resources the fetus can use to grow during pregnancy but have the potential to harm the mother’s health.

Genetic Conflict and Pregnancy Complications

If genetic conflict goes uncontrolled, it can cause pregnancy complications for the mother and developmental disorders for the child. In fact, there is a growing consensus among researchers that some of the most well-known pregnancy complications like preeclampsia, gestational diabetes, miscarriages and preterm births may best be explained by unchecked genetic conflict.

Despite the potential role that genetic conflict plays in pregnancy complications, current medical treatments are reactive rather than proactive. A pregnant person must show signs of experiencing complications before medical interventions and treatments can take place.

Knowing how unchecked genetic conflict contributes to pregnancy complications could provide researchers another way to develop treatments that are proactive and, ideally, preventive. However, there are currently no treatments for pregnancy complications that consider genetic conflict. Though gestational diabetes can be attributed to underlying genetic conflict, a pregnant person must present with elevated blood sugar levels before doctors can treat underlying conflict over insulin production and blood sugar.

Pregnancy During the COVID-19 Pandemic has Been Challenging for Many

The experiences of pregnant people during the COVID-19 pandemic provide an example of why more research on genetic conflict is needed. During the pandemic, doctors saw both a dramatic decrease in the number of preterm births as well as an increase in the number of stillbirths and miscarriages. Both types of complications are influenced by genetic conflict, but the reasons behind these opposing trends are unclear.

As a woman who was pregnant early in the pandemic, my pregnancy was scary and stressful, spent at home away from the pressures of “normal” life. More research on the complex process of pregnancy and genetic conflict’s role in complications could help researchers better understand how the changes brought by the pandemic produced such wildly different pregnancy outcomes.

The Success Rate of Noninvasive Transcranial Magnetic Stimulation for Depression

Image Credit: NIH (Flickr)

Patients Suffering with Hard-to-Treat Depression May Get Relief from Noninvasive Magnetic Brain Stimulation

Not only is depression a debilitating disease, but it is also widespread. Approximately 20 million adult Americans experience at least one episode of depression per year.

Millions of them take medication to treat their depression. But for many, the medications don’t work: Either they have minimal or no effect, or the side effects are intolerable. These patients have what is called treatment-resistant depression.

One promising treatment for such patients is a type of brain stimulation therapy called transcranial magnetic stimulation.

This treatment is not new; it has been around since 1995. The U.S. Food and Drug Administration cleared transcranial magnetic stimulation in 2008 for adults with “non-psychotic treatment-resistant depression,” which is typically defined as a failure to respond to two or more antidepressant medications. More recently, in 2018, the FDA cleared it for some patients with obsessive-compulsive disorder and smoking cessation.

Insurance generally covers these treatments. Both the psychiatrist and the equipment operator must be certified. While the treatment has been available for years, the equipment to perform the procedure remains expensive enough that few private psychiatry practices can afford it. But with the growing recognition of the potential of transcranial magnetic stimulation, the price will likely eventually come down and access will be greatly expanded.

Does it Work?

Transcranial magnetic stimulation is a noninvasive, pain-free procedure that has minimal to no side effects, and it often works. Research shows that 58% of once treatment-resistant patients experience a significant reduction in depression following four to six rounds of the therapy. More than 40 independent clinical trials – with more than 2,000 patients worldwide – have demonstrated that repetitive transcranial magnetic stimulation is an effective therapy for the treatment of resistant major depression.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Patricia Junquera, Associate Professor and Vice Chair of Clinical Services, Florida International University.

As a professor and psychiatrist who has used transcranial magnetic stimulation to treat some of my patients, I have seen depression symptoms decrease even within the first two weeks of treatment. What’s more, the effects continue after the treatment has ended, typically for six months to a year. After that, the patient has the option of maintenance treatment.

About the Procedure

For the patient, the procedure is easy and simple. One sits in a comfortable chair with a snug pillow that holds their head in place, puts on earplugs and can then relax, check their phone, watch TV or read a book.

A treatment coil, which looks like a figure 8, is placed on the patient’s head. A nearby stimulator sends an electrical current to the coil, which transforms the current into a magnetic field.

The field, which is highly concentrated, turns on and off rapidly while targeting a portion of the prefrontal cortex – the area of the brain responsible for mood regulation.

Researchers know that people suffering from depression have reduced blood flow and less activity in that part of the brain. Transcranial magnetic stimulation causes increases in both blood flow and in the levels of dopamine and glutamate – two neurotransmitters that are responsible for brain functions like concentration, memory and sleep. It’s the repeated stimulation of this area – the “depression circuit” of the brain – that brings the antidepressant effect.

It is Not ‘Electroshock’ or Deep Brain Stimulation

Some people confuse transcranial magnetic stimulation with electroconvulsive therapy, a procedure used for patients with severe depression or catatonia. With electroshock therapy, the anesthetized patient receives a direct electrical current, which causes a seizure. Typically, people who undergo this procedure experience some memory loss after treatment.

Transcranial magnetic stimulation is very different. It doesn’t require anesthesia, and it doesn’t affect memory. The patient can resume daily activities right after each treatment. Dormant brain connections are reignited without causing a seizure.

It should also not be confused with deep brain stimulation, which is a surgical procedure used to treat obsessive-compulsive disorder, tremors, epilepsy and Parkinson’s disease.

Side Effects and Access

Transcranial magnetic stimulation patients undergo a total of 36 treatments, at 19 minutes each, for three to six weeks. Research has concluded that this is the best protocol for treatment. Some patients report that it feels like someone is tapping on their head. Others don’t feel anything.

Some very minor side effects may occur. The most common is facial twitching and scalp discomfort during treatment, sensations that go away after the session ends. Some patients report a mild headache or discomfort at the application site. Depending on how effective the therapy was, some patients return for follow-ups every few weeks or months. It can be used in addition to medications, or with no medication at all.

Not everyone with depression can undergo this type of brain stimulation therapy. Those with epilepsy or a history of head injury may not qualify. People with metallic fillings in their teeth are OK for treatment, but others with implanted, nonremovable metallic devices in or around the head are not. Those with pacemakers, defibrillators and vagus nerve stimulators may also not qualify, because the magnetic force of the treatment coil may dislodge these devices and cause severe pain or injury.

But for those who are able to use the therapy, the results can be remarkable. For me, it is amazing to see these patients smile again – and come out on the other side feeling hopeful.

Release – Permex Petroleum Corporation Interview to Air on Bloomberg U.S. on the RedChip Money Report®

Research, News, and Market Data on OILCD

November 30, 2022 07:30 ET | Source: Permex Petroleum Corporation

DALLAS, Nov. 30, 2022 (GLOBE NEWSWIRE) — RedChip Companies will air a new interview with Permex Petroleum Corporation (CSE: OIL) (OTCQB: OILCD) (FSE: 75P) (“Permex” or the “Company”), an independent energy company engaged in the acquisition, exploration, development, and production of oil and natural gas properties on private, state, and federal land in the United States, on The RedChip Money Report® on Bloomberg TV, this Saturday, December 3, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.

Interview highlights:

In the exclusive RedChip Money Report interview, Permex Petroleum’s CEO, President, and Director Mehran Ehsan discusses the Company’s 78 oil and gas wells, the recompletion of oil and gas wells in Eddy County, New Mexico and Marin County, Texas, the Company’s acquisition strategy, and much more.

Access this interview in its entirety at https://www.oilcfinfo.com/interview_access

About The RedChip Money Report®

The RedChip Money Report® is produced by RedChip Companies Inc., an international Investor Relations and media firm with 30 years’ experience focused on Discovering Tomorrow’s Blue Chips Today™. “The RedChip Money Report®” delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

About Permex Petroleum Corporation

Permex Petroleum is a uniquely positioned junior oil and gas company with assets and operations across the Permian Basin of West Texas and the Delaware Sub-Basin of New Mexico. The Company focuses on combining its low-cost development of Held by Production assets for sustainable growth with its current and future Blue-Sky projects for scale growth. The Company, through its wholly-owned subsidiary, Permex Petroleum US Corporation, is a licensed operator in both states, and owns and operates on private, state and federal land. For more information, please visit www.permexpetroleum.com.

About RedChip Companies

RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on microcap and small-cap companies. For 30 years, RedChip has delivered concrete, measurable results for its clients. Our newsletter, the RedChip Money Report is delivered online weekly to 60,000 investors. RedChip has developed the most comprehensive service platform in the industry for microcap and small-cap companies. These services include the following: a worldwide distribution network for its stock research; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated millions of unique investor views; investor webinars and group calls; a television show, “The RedChip Money Report,” which airs weekly on Bloomberg US; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more.

To learn more about RedChip’s products and services, please visit:

https://www.redchip.com/corporate/investor_relations

“Discovering Tomorrow’s Blue Chips Today”™

Forward Looking Statements

Statements in this press release may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws as well as applicable Canadian securities laws. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Company’s reports that it files from time to time with the U.S. Securities and Exchange Commission and the Canadian securities regulators which you should review. When used in this press release, words such as “will,” “could,” “plan,” “estimate”, “expect”, “intend”, “may”, “potential”, “believe”, “should” and similar expressions, are forward-looking statements. Forward-looking statements may include, without limitation, statements relating to the Company’s plans to list on NYSE American, financial condition and operating results, legal, economic, business, competitive and/or regulatory factors affecting Permex’s businesses and any other statements regarding events or developments Permex believes or anticipates will or may occur in the future. These forward-looking statements should not be relied upon as predictions of future events, and the Company cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by the Company or any other person that it will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation to publicly update or release any revisions to these forward- looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Contact:

Permex Petroleum Corporation

Mehran Ehsan
President, Chief Executive Officer & Director
(469) 804-1306

Gregory Montgomery
CFO & Director
(469) 804-1306

Or for Investor Relations, please contact:

Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447)
Or 407-491-4498
OILCF@redchip.com

Release – Kelly to Participate in the Sidoti Virtual Investor Conference

Research, News, and Market Data on KELYA

November 30, 2022

TROY, Mich., Nov. 30, 2022 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading specialty talent solutions provider, today announced it will participate in the Sidoti Virtual Investor Conference on Wednesday, December 7, 2022.

Peter Quigley, president and CEO, Olivier Thirot, executive vice president and chief financial officer, and James Polehna, chief investor relations officer and corporate secretary, will participate in virtual one-on-one meetings. A copy of Kelly’s investor presentation is also available at kellyservices.com.

About Kelly®

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

KLYA-FIN

ANALYST & MEDIA CONTACT: 
James Polehna
(248) 244-4586
james.polehna@kellyservices.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kelly-to-participate-in-the-sidoti-virtual-investor-conference-301686539.html

SOURCE Kelly Services, Inc.

Release – Tonix Pharmaceuticals Announced Data from its Fully Human anti-SARS-CoV-2 Monoclonal Antibody Platform in an Oral Presentation at the World Antiviral Congress

Research, News, and Market Data on TNXP

November 30, 2022 7:00am EST

Research Being Conducted in Collaboration with Scientists at Columbia University

SARS-CoV-2 Variants have Evaded Antibody Therapeutics Previously Granted FDA Emergency Use Authorization, but which are No Longer Recommended for Use by the NIH COVID-19 Guidelines Panel

Immunocompromised Individuals, Including Organ Transplant Recipients, are at Increased Risk of Severe COVID-19 and Poor Outcomes

Therapeutic Antibody Platform Leverages Tonix’s Expanding Internal Development and Manufacturing Capabilities for Biologics

CHATHAM, N.J., Nov. 30, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced data from its fully human anti-SARS-CoV-2 monoclonal antibody platform in an oral presentation delivered by Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, at the World Antiviral Congress 2022 in San Diego, Calif. The project is part of a broader research collaboration and option agreement with scientists at Columbia University designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The presentation titled, “Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies” highlights the need for a broad array of monoclonal antibodies (mAbs) which can be scaled up quickly and potentially combined with other mAbs to treat or prevent COVID-19.

“We believe that the development of these fully human mAbs strengthens our pipeline of next-generation therapeutics to treat Covid-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and bad outcomes1. Although five mAb products, containing 7 distinct mAbs, have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, only a single product, Evushield® is still recommended for use as a prophylaxis by the NIH COVID Guidelines panel or FDA2,3. Moreover, concerns have been raised about the ongoing ability of Evushield to serve as a prophylaxis against COVID-19 in the face of new variants4. For these reasons, we believe there is a need for second generation mAb treatments and prophylactics for COVID-195. Generating fully human mAbs starting from recovered patient blood samples has the potential to reduce the time required to create novel therapeutics in response to newly identified COVID-19 variants.”

Ilya Trakht, Ph.D., Associate Research Scientist at Columbia and principal investigator of the sponsored research agreement said, “We are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. As new variants emerge, anti-spike mAbs that were highly effective against older variants of SARS-CoV-2, may quickly lose their place in the treatment landscape. To protect immunocompromised people, we are committed to assembling a diverse inventory of monoclonal antibodies to keep pace with circulating mix of SARS-CoV-2 variants. Our proprietary technology is based on CD40-ligand promoted B-cell expansion and the MFP-2S human hybridoma system”

Seth Lederman added, “This potential therapeutic antibody platform leverages our expanding internal development and manufacturing capabilities for biologics.”

1Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397

2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ – accessed Nov 3, 2022

3“FDA Updates on Bebtelovimab” – “This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.” – www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab– Accessed Nov 4, 2022

4Wu, K.J. October 29, 2022. The Atlantic. “The End of Evusheld: If you’re immunocompromised, this … isn’t great. www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/

5Madison Muller, M. November 16, 2022 Bloomberg. “Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.” www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?

Tonix Pharmaceuticals Holding Corp.*

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

*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) 904-8182

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

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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 30, 2022

Release – Garibaldi Announces $4.0 Million Financing

Research, News, and Market Data on GGIFF

Vancouver, British Columbia, November 29, 2022 – Garibaldi Resources (TSXV: GGI) (the “Company” or “Garibaldi”) is pleased to announce a non-brokered private placement (the “Offering”) of up to 10,000,000 flow-through units (each, a “FT Unit”) at a price of $0.30 per FT Unit for gross proceeds of up to CDN $3.0 million and 4,000,000 non-flow-through units (each, a “Unit”) at a price of $0.25 per Unit for gross proceeds of up to CDN $1.0 million.

Each FT Unit will consist of one common share of the Company issued on a “flow-through” basis pursuant to the Income Tax Act (Canada) and one-half of one common share purchase warrant (each whole warrant, a “FT Warrant”), with each FT Warrant entitling the holder to purchase one common share (on a non-flow-through basis) at a price of $0.45 per common share for a period of three years following the closing of the Offering.

Each Unit will consist of one common share of the Company (on a non-flow-through basis) and one-half of one common share purchase warrant (each whole warrant, a “Warrant”), with each Warrant entitling the holder to purchase one common share (on a non-flow-through basis) at a price of $0.40 per common share for a period of three years following the closing of the Offering.

All of the proceeds from the offering of FT Units will be used to further advance Garibaldi’s 100% owned flagship E&L nickel-copper-cobalt project on Nickle Mountain and other British Columbia properties. All proceeds from the offering of Units will be used for working capital purposes.

All securities issued in connection with the Offering will be subject to a statutory hold period expiring four months and one day after closing of the Offering. The Offering may include finder’s fees commission’s payable in cash and/or securities and is subject to approval of the TSX Venture Exchange (the “Exchange”). Insiders may participate in the Offering.  Any participation by insiders in the Offering will constitute a related party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) but is expected to be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101.

None of the securities sold in connection with the Offering will be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Garibaldi

Garibaldi Resources Corp. is an active Canadian-based junior exploration company focused on creating shareholder value through discoveries and strategic development of its assets in some of the most prolific mining regions in British Columbia and Mexico.

GARIBALDI RESOURCES CORP.

Per: “Steve Regoci”
Steve Regoci, President

Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or the accuracy of this release

Cautionary Statement Regarding Forward-Looking Statements

This news release includes certain “forward-looking statements” under applicable Canadian securities legislation that are not historical facts. Forward-looking statements involve risks, uncertainties, and other factors that could cause actual results, performance, prospects, and opportunities to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements with respect to the expectations of management regarding the proposed Offering, the expectations of management regarding the use of proceeds of the Offering, closing conditions for the Offering, the expiry of hold periods for securities distributed pursuant to the Offering, and Exchange approval of the proposed Offering. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements including that: the Company may not complete the Offering on terms favorable to the Company or at all; the Exchange may not approve the Offering; the proceeds of the Offering may not be used as stated in this news release; the funds raised from the sale of the FT Units and the Units may not be renounced in favour of the shareholders of the Company; the Company may be unable to satisfy all of the conditions to the Closing; and those additional risks set out in the Company’s public documents filed on SEDAR at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements are reasonable, undue reliance should not be placed on these statements, which only apply as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. Except where required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.