Month: November 2023

Release – Cocrystal Pharma Highlights its Novel Inhaled and Oral Influenza A Antiviral CC-42344 at the World Vaccine Congress West Coast

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

NOVEMBER 29, 2023

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BOTHELL, Wash., Nov. 29, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces the presentation of favorable data demonstrating activity of its potent broad-spectrum PB2 inhibitor CC-42344 against pandemic and seasonal influenza A strains at the World Vaccine Congress West Coast. Cocrystal has initiated a Phase 2a human challenge trial with oral CC-42344 in the UK in subjects infected with influenza A, and plans to begin a Phase 1 trial with inhaled CC-42344 as a potential influenza A treatment and prophylaxis in Australia in the first half of 2024.

In his presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344,” Cocrystal President and co-CEO Sam Lee, PhD discussed the potential prevention and therapy of influenza infection using inhaled CC-42344. Dr. Lee commented that CC-42344 exhibits superior antiviral activity compared with oseltamivir (Tamiflu®) and demonstrates a novel mechanism of action with high barrier of resistance. He noted that Cocrystal discovered and developed CC-42344 utilizing the Company’s proprietary structure-based drug discovery platform technology, which is proving successful in delivering multiple broad-spectrum antiviral leads for influenza and other viral diseases.

“We are excited to accomplish another important milestone with the influenza antiviral CC-42344. Based on our recent preclinical data, CC-42344 exhibits superior lung exposure, a favorable safety profile, and efficacy in influenza-infected human lung epithelia. We also demonstrated highly efficient delivery of inhaled CC-42344 into the lung,” he said. “Inhaled CC-42344 could be developed for both therapeutic and prophylactic influenza treatment. We are encouraged by this potential breakthrough influenza treatment option.”

Slides from the presentation are available on the Company’s website.

About CC-42344
CC-42344 is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to certain approved influenza antivirals, while also demonstrating favorable pharmacokinetic and safety profiles.

About Seasonal Influenza
Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. Influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s ongoing Phase 2a human challenge trial for CC-42344 as a product candidate for oral treatment of influenza A, and the planned initiation of a Phase 1 clinical trial in the first half of 2024 for CC-42344 as a product candidate for inhaled treatment of influenza A, and the potential efficacy and clinical benefits of, and market for, such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the Phase 2a and Phase 1 studies referred to above including recruiting volunteers for and procuring or manufacturing materials for such studies by our clinical research organizations and vendors, and the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released November 29, 2023

Release – Ocugen CEO To Present at Noblecon19 – Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 29, 2023

MALVERN, Pa., Nov. 29, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will present at NobleCon19 – Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL—taking place December 3 – 5, 2023.

Details regarding the presentation and moderated Q&A are as follows:

Date: Monday, December 4, 2023

Location: Presentation Room 1

Time: 2 p.m. ET  

Following the presentation, there will be an opportunity to meet with the Company’s management team in a breakout session at 2:30 p.m. ET—Breakout Table 1 (located directly across from the presentation room). Also, Ocugen will conduct one-on-one meetings with registered investors to showcase the Company’s business and clinical development strategy across its unique gene therapy, cell therapy, and vaccine platforms, and highlight recent corporate and pipeline-related achievements.

A webcast of the presentation will be available the following day in the Events section of the Company’s website and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website and on Channelchek—the investor portal created by Noble. The webcast will be archived on the Company’s website, the NobleCon website, and on Channelchek.com for 90 days following the event. 

About Ocugen, Inc. 
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. 

Contact: 
Tiffany Hamilton 
Head of Communications 
Tiffany.Hamilton@ocugen.com

Release – AZZ Inc. to Present and Host Meetings at the 19th Annual Noble Capital Markets Conference on December 4, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on AZZ

28 Nov, 2023, 16:30 ET

Investor Presentation to be held at 1:00 p.m. Eastern Time

FORT WORTH, Texas, Nov. 28, 2023 /PRNewswire/ — AZZ Inc. (NYSE: AZZ) the leading independent provider of hot-dip galvanizing and coil coating solutions in North America, today announced that David Nark, Senior Vice President, Marketing, Communications, and Investor Relations, will present at the 19th Annual Noble Capital Markets Emerging Growth Equity Conference at the campus of Florida Atlantic University on Monday, December 4, 2023 at 1:00 p.m. ET. Investors interested in meeting with management may attend a breakout session scheduled immediately following the presentation or schedule a one-on-one meeting during the conference on December 4th or December 5th.

A high-definition video webcast of the presentation will be available the day following the event on the Company’s website at www.azz.com/investor-relations, on Noble Capital Markets’ Conference website at www.nobleconference.com and at www.channelchek.com the investor portal created by Noble. The webcast will be archived on each website for 90 days following the event.

AZZ’s management will host one-on-one investor meetings during the event. Investors interested in arranging one-on-one meetings should contact Amanda Weinsoff at aweinsoff@channelchek.com.

About AZZ Inc.

AZZ Inc. is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end-markets. Collectively, our business segments provide sustainable, unmatched metal coating solutions that enhance the longevity and appearance of buildings, products and infrastructure that are essential to everyday life. For more information on AZZ Inc. please visit https://www.azz.com/about-us/.

Safe Harbor Statement

Certain statements herein about our expectations of future events or results constitute forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by terminology such as “may,” “could,” “should,” “expects,” “plans,” “will,” “might,” “would,” “projects,” “currently,” “intends,” “outlook,” “forecasts,” “targets,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Such forward-looking statements are based on currently available competitive, financial, and economic data and management’s views and assumptions regarding future events. Such forward-looking statements are inherently uncertain, and investors must recognize that actual results may differ from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made and are subject to risks that could cause them to differ materially from actual results. Certain factors could affect the outcome of the matters described herein. This press release may contain forward-looking statements that involve risks and uncertainties including, but not limited to, changes in customer demand for our products and services, including demand by the construction markets, the industrial markets, and the metal coatings markets. We could also experience additional increases in labor costs, components and raw materials including zinc and natural gas, which are used in our hot-dip galvanizing process; supply-chain vendor delays; customer requested delays of our products or services; delays in additional acquisition opportunities; an increase in our debt leverage and/or interest rates on our debt, of which a significant portion is tied to variable interest rates; availability of experienced management and employees to implement AZZ’s growth strategy; a downturn in market conditions in any industry relating to the products we inventory or sell or the services that we provide; economic volatility, including a prolonged economic downturn or macroeconomic conditions such as inflation or changes in the political stability in the United States and other foreign markets in which we operate; acts of war or terrorism inside the United States or abroad; and other changes in economic and financial conditions. AZZ has provided additional information regarding risks associated with the business, including in Part I, Item 1A. Risk Factors, in AZZ’s Annual Report on Form 10-K for the fiscal year ended February 28, 2023, and other filings with the SEC, available for viewing on AZZ’s website at www.azz.com and on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully when evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. These statements are based on information as of the date hereof and AZZ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Relations and Company Contact:
David Nark, Senior Vice President of Marketing, Communications, and Investor Relations
AZZ Inc.
(817) 810-0095
www.azz.com

Investor Contact:
Sandy Martin / Phillip Kupper
Three Part Advisors
(214) 616-2207
www.threepa.com

SOURCE AZZ Inc.

Defense Metals Corp. (DFMTF) – On a Positive Trajectory Going Into 2024

Posted on by cpereira@noblefcm.com


Wednesday, November 29, 2023

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

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

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

Mineral resource update. Defense Metals recently filed a NI 43-101 compliant mineral resource estimate (MRE) technical report for the Wicheeda Rare Earth Element (REE) Project. The 2023 mineral resource estimate, discussed in our research note dated September 13, represents an 18.2% increase in total rare earth oxide (TREO) and a 31.3% in tonnage compared to the 2021 MRE. Total measured and indicated mineral resources of 34.2 million tonnes, averaging 2.02% TREO is a significant upgrade compared to the previous estimate and can be included in the mine plan for the preliminary feasibility study that is expected to be completed in the first half of 2024.

Laying the ground work for off-take agreements. On Defense Metals’ behalf, SGS Canada shipped samples of mixed rare earth oxide and mixed rare earth carbonate to select processors, refiners, and metals traders in North America (2), Europe (2), and Asia (2). The shipments represent an important step toward future off-take agreements or strategic partnership opportunities. The company estimates a universe of 10 to 12 potential customers and so another set of shipments is expected.


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. 


Wednesday, November 29, 2023

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

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

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

Mineral resource update. Defense Metals recently filed a NI 43-101 compliant mineral resource estimate (MRE) technical report for the Wicheeda Rare Earth Element (REE) Project. The 2023 mineral resource estimate, discussed in our research note dated September 13, represents an 18.2% increase in total rare earth oxide (TREO) and a 31.3% in tonnage compared to the 2021 MRE. Total measured and indicated mineral resources of 34.2 million tonnes, averaging 2.02% TREO is a significant upgrade compared to the previous estimate and can be included in the mine plan for the preliminary feasibility study that is expected to be completed in the first half of 2024.

Laying the ground work for off-take agreements. On Defense Metals’ behalf, SGS Canada shipped samples of mixed rare earth oxide and mixed rare earth carbonate to select processors, refiners, and metals traders in North America (2), Europe (2), and Asia (2). The shipments represent an important step toward future off-take agreements or strategic partnership opportunities. The company estimates a universe of 10 to 12 potential customers and so another set of shipments is expected.


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 – Alliance Resource Partners, L.P. to Participate in Noble Capital Markets 19th Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

November 28, 2023

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TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) today announced that the Company will attend the NobleCon19 – Noble Capital Markets 19th Annual Emerging Growth Equity Conference in Boca Raton, FL on Monday, December 4, 2023.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
918-295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – CVG Announces Participation in the NobleCon19 Investor Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVGI

November 28, 2023

NEW ALBANY, Ohio, Nov. 28, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI) announced today that Andy Cheung, Executive Vice President and Chief Financial Officer, will present at NobleCon19 – Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex on Monday, December 4 at 12:00 p.m. ET. There is also the opportunity to meet management at our breakout session scheduled immediately following our presentation. A link to the webcast and associated presentation materials can be accessed through the investor section of the Company’s website at cvgrp.com the following day.

For further information, please contact CVGI@alpha-ir.com

About CVG

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

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

Source: Commercial Vehicle Group, Inc.

Release -Entravision Announces Participation in NobleCon19 – Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on EVC

November 28, 2023

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced its participation in NobleCon19, Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference, to be held December 3-5, 2023, in Boca Raton, FL. Chris Young, Chief Financial Officer and Treasurer, is scheduled to present on Monday, December 4th, 2023 at 11:30 a.m. ET and will participate in meetings with investors throughout the day.

The presentation will be webcast live over the Internet, and links to the live webcast and replay will be available on Entravision’s Investor Relations website at investor.entravision.com.

About Entravision Communications Corporation

Entravision is a global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services in 40 countries. We have commercial partnerships with Meta, X Corp. (formerly known as Twitter), TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

Christopher T. Young
Chief Financial Officer
Entravision
310-447-3870

Kimberly Orlando
Addo Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – GeoVax COVID-19 Vaccine Clinical Data Presented at World Vaccine Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 28 November 2023 14:00
  • Created: 28 November 2023 14:49
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Presentation of Data from Phase 2 Open-Label Study of GEO-CM04S1

Next-Generation COVID-19 Vaccine Demonstrates Potent Antibody and

Cellular Immunity in Immunocompromised Patients

Atlanta, GA, November 28, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of data from the active development program for its next-generation COVID-19 vaccine (GEO-CM04S1), including Phase 2 clinical trial data. The data include some of which was recently published in the journal Vaccines and can be accessed here: GEO-CM04S1 Publication.

The data were presented during the World Vaccine Congress, West Coast conference, being held in Santa Clara, CA from November 27-30, 2023. The presentation, titled “COVID-19 Vaccines for Immunocompromised Patients,” was delivered by Don Diamond, PhD, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center.

David Dodd, GeoVax Chairman and CEO, commented, “Safeguarding individuals at the highest risk in our society requires the development of next-generation COVID-19 vaccines. Ideally, these vaccines should induce enhanced immune responses after the first dose, provide long-lasting protection, and effectively address the ongoing emergence of new variants. Current mRNA vaccines and monoclonal antibody therapies often fall short in quickly delivering sufficient protective immunity to immunocompromised patients. Given the persistent evolution of variants, the public health community faces a continuous challenge to mitigate the impact of infections, ultimately minimizing the risks of severe illness, hospitalizations, and mortality. Vaccines like GEO-CM04S1, designed to be “variant-agnostic,” are becoming increasingly vital in addressing these risks, protecting the most vulnerable populations, and bolstering our ability to combat infectious threats effectively.”

In his presentation, Dr. Diamond described the immune response analyses conducted on the open-label portion of the Phase 2 trial, indicating that GEO-CM04S1 is highly immunogenic in these immunocompromised patients, inducing potent humoral (antibody) and cellular (T cell) responses, including neutralizing antibodies against SARS-CoV-2 ancestral virus and variants of concern and the highly immune-evasive Omicron XBB 1.5 variant.

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. These patients have significantly compromised immune system function as the result of their treatment and are at exceptionally high risk for COVID. They must be re-vaccinated and will benefit greatly from the types of immune responses induced by the GEO-CM04S1 vaccine, both the antibodies and T cells.

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. First-generation SARS-CoV-2 vaccines based on the spike (S) protein have demonstrated that they induce neutralizing antibodies, providing effective, albeit short-term levels of immune protection. Unfortunately, with the existing authorized vaccines, efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring continuous updating and booster doses. To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials.  GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating. Moreover, GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in support of patients with compromised immune systems, for whom the current authorized vaccines can be inadequate in providing protective immunity.

GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently announced clinical site expansion for this trial.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.

About GeoVax

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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:           Investor Relations Contact:           Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – Onconova Therapeutics To Present At NobleCon19, Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX


Nov 28, 2023

NEWTOWN, Pa., Nov. 28, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will present at NobleCon19, Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference, being held December 3-5, 2023 at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL.

Presentation Details

Date/Time:Monday, December 4, 2023, 10:30 AM ET followed by a Breakout Session
Speaker:Steven Fruchtman, M.D., President & CEO
1X1 meetings:The Onconova Management Team will be available for 1X1 meetings during the conference. Those interested in requesting a meeting should contact their Noble Capital Markets representative.

A webcast of the presentation will be available the following day on the “Corporate Events and Presentations” section of the Onconova website, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website www.nobleconference.com, and on Channelchek www.channelchek.com. The webcast will be archived on the Onconova website, the NobleCon website, and on Channelchek.com for 90 days following the event.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer and mantle cell lymphoma.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Orion Group Holdings, Inc. Names Chip Earle as General Counsel

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ORN

Nov 28, 2023

HOUSTON, Nov. 28, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, announced today the appointment of Edward Chipman (“Chip”) Earle as Executive Vice President, General Counsel, Chief Administrative Officer, Chief Compliance Officer and Corporate Secretary, effective November 27th. Mr. Earle will succeed Executive Vice President Peter R. Buchler, who is retiring from Orion after 15 years of service.

Mr. Earle joins Orion from Newpark Resources, Inc. (NYSE: NR), a service provider to the industrial and energy sectors, where he was Vice President – General Counsel, Chief Administrative Officer, Chief Compliance Officer, and Corporate Secretary. Prior to Newpark, Mr. Earle held executive leadership roles at Transocean (NYSE: RIG) and Bristow Group (NYSE: VTOL).

“We are excited to welcome Chip to our senior leadership team. With over 20 years in worldwide legal, compliance, and risk management, Chip brings valuable experience to Orion. We look forward to his leadership and guidance in these areas that are critical to the successful execution of our long-term strategy. I also want to thank Pete Buchler for his many years of dedicated service and wish him all the best in his well-earned retirement,” said Travis Boone, Chief Executive Officer of Orion Group Holdings, Inc.

Mr. Earle holds a Bachelor of Arts degree from Middlebury College. He received his Master Degree in Business Administration (MBA) with a focus in Energy Finance from the University of Texas McCombs School of Business and his Juris Doctor (JD) from the University of Texas School of Law.

About Orion Group Holdings
Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design, and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. https://www.oriongroupholdingsinc.com.

Contacts:
Financial Profiles, Inc.
Margaret Boyce 310-622-8247
mboyce@finprofiles.com

Release – Tonix Pharmaceuticals to Present at Two Upcoming Investor Conferences in December

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 28, 2023 7:00am EST

CHATHAM, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix Management will present and host investor meetings at the following December investor conferences:

NobleCon 19, Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference

Presenter:Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals
Date:Monday, December 4, 2023
Place:Florida Atlantic University, Boca Raton, Fla.
Room:Presentation Room 1
Time:11:00 a.m. ET


December 2023 Virtual Investor Summit

Presenter:Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals
Date:Thursday, December 7, 2023
Time:12:00 p.m. ET
Webcast Link:HERE


Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators. Replays of both webcasts of the Company’s presentations at NobleCon 19 and the Virtual Investor Summit will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following each presentation.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development 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 development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released November 28, 2023

Strong Business Spending and Government Demand Drive Upward Q3 GDP Revision

Posted on by slightbourne@noblecapitalmarkets.com

US economic output grew at a faster pace than initially estimated in the third quarter, according to revised GDP data released Wednesday by the Commerce Department. The upgraded third quarter growth paints a picture of resilient business and government spending offsetting slowing consumer demand.

GDP expanded at an annualized rate of 5.2% during the July to September period, topping the advance reading of 4.9% growth. Upward revisions were fueled primarily by fixed business investment and government expenditures proving stronger than expected.

Corporate Investments Defy Recession Fears
As rising rates threaten housing and construction, many economists feared companies would pull back on equipment investments amid an uncertain outlook. However, nonresidential fixed investment, encompassing structures, equipment, intellectual property and more, rose 1.3% in Q3.

While this marked a steep decline from 6.1% growth in Q2, business spending has moderated far less than feared. Companies seem focused on funding promising productivity enhancements even as they trim costs elsewhere. Tech and machinery upgrades that drive efficiency and cut costs over the long term remain attractive.

Surprisingly resilient corporate investment provided vital ballast for growth last quarter. Coupled with still-healthy consumer spending, albeit revised down slightly, business capital outlays appear sufficient to keep the US out of recession territory for now.

Government Spending Spikes
In addition to business investment, government expenditures at the federal, state and local levels increased 5.8% in Q3, meaningfully higher than early readings. Surging defense spending as well as state investments in education drove elevated government consumption.

With Democrats in control of Congress and the White House, pandemic-era support programs also continued stimulating significant public sector demand.

Consumer Engine Slows but Remains Solid
Although personal consumption spending fell short of initial 4% growth estimates and instead rose a still-strong 3.6%, households continue underpinning US growth. A super-tight jobs market, rising wages and abundant savings for higher-income Americans seem sufficient to maintain solid consumer demand.

However, with borrowing costs jumping and inflation eating away at incomes, an evident slowdown in spending ahead of the crucial holiday season presents economic risks. Any further erosion of consumption could spur layoffs and trigger recessionary conditions. For now at least, consumers appear positioned to continue carrying the torch.

Strong Growth But Uncertainty Lingers
Thanks to business and government resilience, Q3 expansion topped already lofty expectations. This provides a sturdy launching pad heading into year-end. But with the Fed aggressively tightening policy and key trading partners teetering on the brink of recession, clouds linger on the horizon. Another quarter of solid growth could be the high water mark before a challenging 2024.

GM Launches $10 Billion Buyback to Appease Shareholders

Posted on by slightbourne@noblecapitalmarkets.com

Facing mounting criticism after production setbacks and labor unrest rattled investor confidence this year, automaker General Motors (GM) is opening the corporate coffers to initiate a massive $10 billion share repurchase program. The move aims to regain Wall Street’s trust by returning billions to shareholders.

Accelerating Buybacks to Prop Up GM Stock

GM shares have sputtered in 2023, down 14% year-to-date heading into Wednesday’s announcement. The stock dove nearly 5% in October when contract negotiations with the United Auto Workers (UAW) broke down into nationwide strikes, forcing GM to suspend guidance. With electric vehicle launches also lagging internal targets, GM hopes to stop the bleeding and inject positive sentiment through shareholder payouts.

The accelerated buyback comes after GM already spent $3.3 billion repurchasing shares so far this year. By expanding repurchases to $10 billion, GM moves aggressively to reduce outstanding shares and boost key per-share metrics like earnings-per-share.

How The $10 Billion GM Buyback Will Work

Rather than spacing out buybacks over several years, GM is frontloading the program to have maximum near-term impact. The company will immediately receive $6.8 billion worth of its shares from the banks underwriting the plan – Bank of America, Goldman Sachs, Barclays and Citibank.

These banks will then repurchase GM shares on the open market over the next six months. The final tally of shares bought back depends on GM’s average share price during that period. If shares remain around current levels in the $37 range, the full $10 billion could retire nearly 270 million shares – almost 20% of GM’s float.

Such large buybacks often drive share prices higher by soaking up excess supply. It also means per-share financial metrics like earnings, cash flow and dividends appear larger with fewer shares outstanding. For GM to hit the upper end of its newly reinstated earnings-per-share guidance range this year, solid buyback execution will be key.

GM Shareholders Get More Cash Too

In tandem with turbocharging buybacks, GM also announced a 33% dividend hike from 9 cents to 12 cents per share annually. Together, these moves signal a shareholder-friendly turn for the automaker after delays in its electric and autonomous programs led to executive departures.

Rather than flashy visionary promises, GM looks to deliver tangible returns now in the form of cold hard cash. These initiatives could take center stage heading into 2024 as leadership emphasizes financial consistency through a period of technological transition.

For income-focused investors and funds, juicier dividends make GM appear more attractive relative to other automakers and electric vehicle pure plays. Combined with reduced shares outstanding, GM’s 4.2% dividend yield will rise even higher, bringing in more potential shareholders.

Outlook Still Uncertain Beyond 2023

An open question is whether GM can sustain enhanced shareholder returns in the years ahead while simultaneously investing billions in next-generation manufacturing and technology. Many bears argue spreading cash so liberally now leaves GM vulnerable to economic shocks down the road.

But with UAW deals running into 2028 and strains from this year mostly wiped clean, GM can campaign on hitting its earnings guidance in 2024 and rewarding loyal shareholders along the way. Where GM goes from there, however, remains clouded in uncertainty.