Page 300 – Channelchek

Release – Direct Digital Holdings Announces Completion of Redemption of Outstanding Warrants

Posted on October 31, 2023October 31, 2023 by aweinsoff@channelchek.com

October 31, 2023 9:00am EDT

HOUSTON, Oct. 31, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that it completed the redemption of its outstanding warrants (the “Warrants”) to purchase shares of the Company’s Class A Common Stock, par value $0.0001 per share (the “Common Stock”) that remained outstanding following 5:00 p.m. New York City Time on October 30, 2023 (the “Redemption Date”), for a cash redemption price of $0.35 per Warrant. A notice of redemption was distributed on October 23, 2023 to the registered holders of outstanding Warrants announcing the redemption pursuant to the terms of the Warrant Agency Agreement, dated as of February 15, 2022, by and between the Company and Equiniti Trust Company, LLC (formerly known as American Stock Transfer and Trust Company, LLC), governing the Warrants. The redemption follows the expiration and closing of the Company’s offer to each holder of outstanding Warrants to purchase any and all outstanding Warrants for $1.20 in cash per Warrant, without interest.

The Warrants were listed for trading on the Nasdaq Capital Market (“Nasdaq”) under the symbol “DRCTW.” In connection with the redemption, the Warrants ceased trading on Nasdaq and were delisted, with the trading halt announced after close of market on October 30, 2023. The Common Stock continues to trade on Nasdaq under the symbol “DRCT.”

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 136,000 clients monthly, generating approximately 250 billion impressions per month across display, CTV, in-app and other media channels.

Contacts:
Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com

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SOURCE Direct Digital Holdings

Released October 31, 2023

Release – Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344

Posted on October 31, 2023October 31, 2023 by aweinsoff@channelchek.com

Research News and Market Data on COCP

OCTOBER 31, 2023

BOTHELL, Wash., Oct. 31, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with its broad-spectrum, oral PB2 inhibitor CC-42344 as a potential treatment for pandemic and seasonal influenza A. Cocrystal expects to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.

In late 2022 Cocrystal reported highly favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia. The Phase 2a single-site, double-blind, placebo-controlled human challenge trial will evaluate the safety, viral and clinical measurements of orally administered CC-42344 in subjects infected with influenza A.

“We are pleased to have met the regulatory requirements of the MHRA to begin this Phase 2a human challenge trial in the UK,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Influenza is a major global health threat that may become more challenging to treat due to emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. The need for new therapeutic and prophylactic treatments is clear. Our encouraging Phase 1 data demonstrated that CC-42344 has a favorable safety profile and is well-tolerated. CC-42344 has the potential to be a best-in-class antiviral treatment for pandemic and seasonal influenza infections.”

“We are closely working with a world leading clinical research organization that is experienced in testing infectious and respiratory disease antivirals using human challenge clinical trials,” said James Martin, Cocrystal’s CFO and Co-CEO. “Receiving authorization to move ahead with our Phase 2a trial is a major step in our quest to bring CC-42344 to market and make a meaningful contribution to improving health and reducing the cost of care.”

About Seasonal Influenza
Each year there are approximately one 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. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About CC-42344
CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology and is a novel approach to treating pandemic and seasonal influenza A. In vitro data show that CC-42344 is highly active against drug-resistant influenza A strains with a high barrier to resistance, while also demonstrating favorable pharmacokinetic and safety profiles.

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), hepatitis C viruses and noroviruses. 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 initiation and characteristics of a Phase 2a study for CC-42344 and the potential efficacy and clinical benefits of such product candidate and the demand for such a product. 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, the risks arising from manufacturing and research delays arising labor shortages and other factors, the ability of our Clinical Research Organization partner to recruit volunteers for, and to proceed with, the Phase 2a clinical study for CC-42344, general risks arising from conducting a clinical trial, receipt of regulatory approvals for future trials, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the governmental authorities, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we may develop. 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 October 31, 2023

Release – MustGrow Receives USDA Organic Approval for Biological Fertilizer and Soil Amendment Technology

Posted on October 31, 2023October 31, 2023 by aweinsoff@channelchek.com

Research News and Market Data on MGROF

USDA National Organic Program (OMRI Listed^®) has awarded MustGrow’s TerraSante^TM Crop Fertilizer and Soil Amendment technology with organic compliance.
TerraSante^TM is a mustard plant-based technolgy focused on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.
MustGrow plans to continue to advance its TerraSante^TM registration approval process in key U.S. states.

SASKATOON, Saskatchewan, Canada, October 31, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of organic compliance certification from the USDA National Organic Program for its TerraSante^TM crop fertilizer and soil amendment technology. TerraSante^TM is now OMRI Listed^® in the following Generic Material Listing(s): NOP: Plant Extracts, Class: Crop Fertilizers and Soil Amendments.

The organic certification from Organic Materials Review Institute (“OMRI”) (www.omri.org) may provide an opportunity for farmers to reduce synthetic chemical and fertilizer use while meeting growing market demand for organic biological products. The OMRI approval process includes a strict review of product ingredient composition and observance of manufacturing compliance standards required in organic production. Pending final registration of product approval from U.S. state agencies, TerraSante^TM will be marketed with the legend “OMRI listed for organic use”.

“We believe that organic compliance is a major milestone towards commercializing TerraSante^TM” commented MustGrow’s COO, Colin Bletsky. “Agriculture needs new organic innovations to support food production and this organic certification further supports our belief that MustGrow’s technologies could be impactful. The key U.S. agricultural regions are under constant pressure to eliminate or reduce synthetic products, so natural, OMRI certified technologies, like TerraSante^TM, have great promise for commercial-scale adoption.”

MustGrow believes this soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.

TerraSante^TM for Soil and Ecological Health

MustGrow’s soil amendment and biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Initially, the development work is anticipated to progress in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States.

Soil is a farmer’s most valuable and precious asset, and MustGrow’s plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

As a soil amendment in mixable form, TerraSante^TM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentionally improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSante^TM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.

MustGrow expects to initially pursue TerraSante^TM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets. The soil amendment and biofertility products will utilize multiple technologies derived from novel plant-based extracts from mustard and potentially other sources.

Soil Amendment and Biofertility Marketplace

The global fertilizer market is anticipated to reach US$242 billion by 2030, up from US$193 billion in 2021 (2.5% CAGR).⁽¹⁾ This aggregate fertilizer figure includes the following sub-markets, which MustGrow intends to target initially with TerraSante^TM and potentially other branded products:

Soil amendment: estimated market size in 2022 was US$3.5 billion and is expected to be US$8.0 billion by 2030 (11.0% CAGR).⁽²⁾
Biofertility: estimated market size in 2021 was US$2.7 billion and is estimated to be US$7.0 billion by 2030 (12.3% CAGR).⁽³⁾

Combined, these additional market segments have the potential to add over US$15 billion of target market opportunity globally for MustGrow by 2030, which is almost double from the initially targeted infield biocontrol market.⁽¹⁾

Alternatives to Synthetic Fertilizers are Needed

With the world’s population expanding, agriculture production and global food security are increasingly important. Fertilizers continue to play a critical role in agriculture, yet plans to reduce their use have been amplified in recent years to minimize the negative consequences of climate change through emission reduction strategies. Canada, for example, has set a voluntary national fertilizer emissions reduction target of 30% below 2020 levels by 2030 to lower greenhouse gas emissions.⁽²⁾ Sustainable, climate-friendly solutions may play a role in helping to offset this reduction while balancing the nation’s economic health. For example, Canada’s fertilizer industry directly and indirectly supports over 76,000 jobs and contributes nearly C$13 billion to Canadian GDP.⁽²⁾

The European Green Deal is targeting a 20% reduction in fertilizer use by 2030, while also ensuring no deterioration in soil fertility, as part of the European Commission’s aim to reduce nutrient losses by at least 50% by 2030.⁽³⁾ Fertilizer reduction is a key element of the broader Green Deal target of a minimum 55% net reduction in greenhouse gas emissions by 2030.⁽⁴⁾

Soil amendment and biofertifility innovations, such as MustGrow’s TerraSante^TM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Source:
1. Statista, Fortune Business, Polaris Market Research.
2. https://fertilizercanada.ca/our-focus/stewardship/emissions-reduction-initiative/
3. https://agriculture.ec.europa.eu/system/files/2022-02/factsheet-farmtofork-comparison-table_en_0.pdf
4. https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

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

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: its plans to continue to advance its TerraSante^TM registration approval process in key U.S. states; the opportunity that being OMRI listed for organic use may provide to farmers to reduce synthetic chemical fertilizer use while meeting growing market demand for organic biological products; the potential outcome of pending final registration product approvals; the planned marketing of TerraSante^TM with the legend, “OMRI listed for organic use”; the relevance of organic compliance towards commercializing TerraSante^TM; MustGrow’s belief that TerraSante^TM will complement its existing biocontrol programs; the expected focus of MustGrow’s soil amendment and biofertility development programs on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields; the anticipated progression of MustGrow’s development work in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States; MustGrow’s expectation that it will initially pursue TerraSante^TM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets; and the opportunity that soil amendment and biofertility innovations, such as MustGrow’s TerraSante^TM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

Release – Corinne Ross Joins Commercial Vehicle Group as President, Aftermarket & Accessories

Posted on October 31, 2023October 31, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CVGI

October 30, 2023

NEW ALBANY, Ohio, October 30, 2023 (Newswire.com) – Commercial Vehicle Group (CVG) (NASDAQ:CVGI), a global leader in the design and manufacturing of electrical systems, mechanical components, and vehicle accessories, announced today that Corinne Ross has been appointed President, Aftermarket & Accessories. Ross will oversee CVG’s global aftermarket and accessories business segment.

Ross comes to CVG after 16 years with German-based Freudenberg Sealing Technologies, a leading sealing technology company, where she served as Vice President, Corteco North America, Aftermarket Division. In that role, she led regional sales; marketing; supply chain management and operations; and product development and category

management. She began her career in human resources and served in a variety of HR roles of increasing responsibility in both corporate and manufacturing environments.

Ross will be responsible for both the strategic development and tactical execution of the annual and long-term business plans for Aftermarket & Accessories. She will lead the development and execution of commercial, operational, and product management strategies and action plans, and she will work closely with customers and focus on new business development. Ross will also have oversight of product innovation, design, development, and planning activities for the entire Aftermarket product portfolio.

“Corinne is a strong strategic leader who brings a unique blend of business and product aptitude, customer centricity, a big-picture vision and the ability to deliver results,” said Bob Griffin, Interim President and CEO and Chairman of the Board at CVG. “I am confident that she will be a strong strategic thought partner to our executive leadership team.”

“The Aftermarket business is poised for global growth with great potential for additional sales of existing and new products,” said Corinne. “I am excited to join CVG and accelerate growth in the Aftermarket segment.”

Ross holds a bachelor’s degree in business management and an MBA, both from the University of Findlay.

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 our company and products is available at www.cvgrp.com.

Source: Commercial Vehicle Group, Inc.

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 our company and products is available at www.cvgrp.com.

http://cvgrp.com

Release – Bitcoin Depot Schedules Third Quarter 2023 Conference Call for Monday, November 13th at 11:00 am ET

Posted on October 31, 2023October 31, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BTM

October 30, 2023 4:05 PM EDT

ATLANTA, Oct. 30, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, will hold a conference call and live audio webcast on Monday, November 13^th at 11:00 a.m. Eastern time (8:00 a.m. Pacific Time) to discuss its financial results for the third quarter ended September 30, 2023. Bitcoin Depot plans to release results before the market open on the same day.

Call Date: Monday, November 13, 2023
Time: 11:00 a.m. Eastern time (8:00 a.m. Pacific time)
U.S. dial-in: 646-307-1963
International dial-in: 800-715-9871
Conference ID: 8247570

The conference call will broadcast live and be available for replay here following the call.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

A replay of the call will be available beginning after 3:00 p.m. Eastern time on November 13, 2023 through November 20, 2023.

U.S. replay number: 609-800-9909
International replay number: 800-770-2030
Conference ID: 8247570

About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of June 30, 2023. Learn more at www.bitcoindepot.com.

Contacts:

Investors
Cody Slach, Alex Kovtun
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com

Media
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com

Source: Bitcoin Depot Inc.

Released October 30, 2023

Xcel Brands (XELB) – A License To Grow, Profitably

Posted on October 31, 2023October 31, 2023 by cpereira@noblefcm.com

Tuesday, October 31, 2023

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Initiating coverage with Outperform rating and $3.50 price target. Xcel Brands is a fashion apparel company, boasting several well-known and iconic brands, such as Isaac Mizrahi and Halston. In our view, the company is on the cusp of a new, profitable growth era, after its recent business model transformation to an asset-light, brand licensor.

Business model transformation. The new licensing business model is expected to significantly lower the company’s costs, eliminating warehousing and inventory costs as well as capital expenditure needs. We believe this repositioning of the business is a key catalyst for the company to swing towards positive cash flow generation later this year.

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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.

Great Lakes Dredge & Dock (GLDD) – Updating 3Q23 Estimates

Posted on October 31, 2023October 31, 2023 by cpereira@noblefcm.com

Tuesday, October 31, 2023

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

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

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

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

Updating 3Q23 Estimates. On the heels of Orion Group’s release late last week, we are adjusting our third quarter 2023 projections for Great Lakes downward. On its earnings call, Orion management noted the ongoing sluggishness in Army Corps of Engineers dredging awards. As a result, competition for business has increased. We suspect Great Lakes has been impacted to some degree by the market conditions.

Updated Projections. On the revenue side, we are lowering our estimate to $137 million from a prior $145 million. With reduced utilization, we also are decreasing our gross margin estimate. Net net, our projected quarterly net loss projection is now $6 million, or a loss of $0.09 per share, compared to a previous estimated loss of $3.0 million, or a loss of $0.04 per share. Our adjusted EBITDA estimate declines to $8 million from $11.5 million.

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

GeoVax Labs, Inc. (GOVX) – Clinical Trial Expansion Continues With A Stream Of Milestones

Posted on October 31, 2023October 31, 2023 by cpereira@noblefcm.com

Tuesday, October 31, 2023

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

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

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

Site Expansion Should Increase Rate Of Enrollment. GeoVax announced the additional of new clinical sites in the Phase 2 trial for CM04S1, its COVID-19 vaccine to protect patients who are immunocompromised due to treatment for hematological malignancies. Patients who receive treatments including allogenic/autologous stem cell transplant or CAR-T therapy have difficulty responding to the available COVID-19 vaccines, leaving them vulnerable.

Site Expansion Should Increase Speed of Enrollment. The trial is designed to compare the safety and immunogenicity of CM04S1 directly against the mRNA vaccines from Pfizer and Moderna. The trial began at the City of Hope Medical center in California and will begin treating patients at Wake Forest Baptist Medical Center (North Carolina), University of Massachusetts Medical Center, and Fred Hutchinson Cancer Research (Washington). Patient enrollment at these sites should increase the enrollment rate and number of patients in the study, providing greater statistical significance with shortened time to results.

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

Choppy Waters: S&P 500 Faces Longest Slump Since the 2020 Crash

Posted on October 31, 2023November 1, 2023 by slightbourne@noblecapitalmarkets.com

The S&P 500 is staring down a dubious milestone – its first 3-month losing streak since the COVID-19 pandemic upended markets back in early 2020.

Barring a dramatic turnaround this week, the index will log declines in August, September and October. That hasn’t happened since a brutal 5-month free fall ended in March 2020.

The benchmark index has sunk over 10% from peaks hit in late July. After four straight down weeks, the S&P 500 dipped into correction territory last Friday.

That marks a ten percent drop from all-time highs reached just three months ago in July. However, the index remains up around 8% year-to-date.

The S&P 500, and What It Represents

For context, the S&P 500 represents the broader U.S. stock market across major sectors of the economy. It tracks the stocks of 500 large American companies selected by a committee at S&P Dow Jones Indices.

The index covers around 80% of available market capitalization. Exposure spans mega-cap technology leaders like Apple, Microsoft and Amazon to energy giants like Exxon and Chevron.

The S&P 500 functions as a barometer for the country’s economic health. The performance and reactions within the index drive news cycles and often dictate investor sentiment.

Trillions in assets are benchmarked to the S&P 500. That includes huge passive funds like those offered by Vanguard and BlackRock’s iShares. The index is also a favorite benchmark for active managers trying to beat the market.

Given its stature and ubiquity, sustained declines in the S&P 500 raise investor fears and make headlines. Its ongoing slide has been driven largely by surging inflation, rising interest rates, and recession worries.

History of Late-Year Rebounds

While unpleasant, the S&P 500’s current slump isn’t out of the ordinary from a historical perspective. The index has averaged a 14% peak-to-trough decline in intra-year pullbacks since 1950 according to data from Carson Group’s Ryan Detrick.

And when the index falters during the late summer and early fall months, strong year-end rebounds have usually followed.

In the 5 prior years where August, September and October saw declines, the S&P 500 rose 4.5% on average over November and December. The lone exception was 1957 when it managed a slight loss.

So despite growing skittishness on Wall Street, historical trends bode decently for markets to close 2023 on a high note.

Drivers of the Current Decline

Like most substantial sell-offs, fears of slowing economic growth and a hawkish Federal Reserve have driven the current slide.

Surging inflation led the Fed to rapidly raise interest rates in order to cool down demand. Higher rates pressure different areas of the market like long-duration tech stocks.

Meanwhile, recession odds have climbed as housing and manufacturing data weakened. The strong U.S. dollar has also impacted multinational corporate earnings.

Geopolitical turmoil surrounding Russia’s war in Ukraine coupled with US-China tensions exacerbated volatility. It amounted to a deteriorating backdrop that sent the S&P 500 downhill fast.

Now with consumer prices potentially peaking, Fed rate hikes slowing, and earnings holding up, optimism is regrowing. Valuations also look more attractive after the steep pullback.

Many strategists see the negativity as overdone and expect a rally into year-end. However, tests likely remain until concrete evidence of an inflation or economic slowdown emerge.

S&P 500 Outlook and Implications

While disconcerting on the surface, the S&P 500’s bout of weakness isn’t unprecedented. The question is whether it represents a normal correction or the start of a bear market.

Broadly, analysts think major indices will close out 2023 with mid-single digit gains. But forecasts vary widely from low single digits to returns over 10% above current levels.

If historic trends repeat, odds favor a recovery once the calendar flips to November. Although with midterm elections ahead, politics could play an outsized role in market swings.

Regardless, the S&P 500 ending its 3-month rut would be welcomed by investors. Sustained declines often signal greater worries about the economy and corporate profits.

Given the importance of consumer and business confidence, ending 2023 on an upswing would bode well for preventing a deeper downturn. But the Fed’s moves to squash inflation will remain an overhang into 2024.

Weight Loss Drugs Shake Up Pharma Stocks, But Wider Impact Remains Unclear

Posted on October 31, 2023October 31, 2023 by slightbourne@noblecapitalmarkets.com

A new class of potent weight loss drugs has been shaking up the pharmaceutical sector, sending stocks of some major drug makers soaring. But the wider impact on other industries like food, retail, and medical devices remains uncertain amidst changing consumer behaviors.

Novo Nordisk and Eli Lilly have been riding high thanks to their injectable diabetes medications Ozempic and Mounjaro. Though only approved for diabetes, both drugs have shown dramatic weight loss potential in clinical trials.

Ozempic and Mounjaro belong to a drug class called GLP-1 agonists. They mimic a hormone that regulates appetite and food intake. Patients using the new drugs at high doses can lose up to a quarter of their body weight.

Predictions have emerged that these drugs could reshape industries from restaurants to airlines. But so far, the actual impact beyond pharma has been muted.

In the stock market, Novo Nordisk shares are up over 50% in the last year thanks to Ozempic. The drug’s sales hit $5.2 billion in the first 9 months of 2022. Mounjaro brought in $187 million for Lilly within just 2 months of its launch.

“The physiological benefits these treatments offer patients help address significant unmet needs,” said Josh Schimmer, senior analyst at Evercore ISI.

The market potential also has investors excited. If just 2% of obese Americans eventually use weight loss medications, it could swell into a $58 billion market according to Evercore forecasts.

Among other drug stocks involved, Amgen owns a portion of Mounjaro’s revenue due to a licensing deal with Lilly. Meanwhile, companies like Entera Bio and Novo Nordisk have oral pills in late stage testing that could expand the weight loss drug market substantially.

However, analysts caution growth depends on how insurers cover the drugs which can cost nearly $1,500 a month without insurance. Usage also remains low currently at around just 1% of the US population.

Beyond pharma, the impact is hazier. The consumer staples sector has been the worst performing segment of the S&P 500 this year as investors brace for potential fallout.

But so far, food and beverage leaders seem unfazed. PepsiCo, Hershey, and Constellation Brands recently reported strong quarters without seeing signs of slowing demand.

Retailers and restaurants have opportunities to adapt their offerings to court health-focused consumers. “Maybe the GLP-1 consumer looks very different three or five years from now,” said Goldman Sachs analyst Jason English.

Surprisingly, medical device makers also haven’t seen slowed growth yet either. In fact, continuous glucose monitoring usage grew right alongside Ozempic prescriptions, suggesting weight loss isn’t eliminating diabetes demand.

However, bariatric surgery has been slightly impacted according to comments from Johnson & Johnson’s CEO. Other discretionary categories like apparel and travel could eventually be impacted if behaviors change long term.

For now, the uncertainty leaves analysts split on whether these drugs are a fad or the beginning of a healthcare revolution. But Wall Street is clearly enamored with the weight loss leaders.

As more data emerges on usage and impact, it will determine whether stock declines are overdone for consumer staples beyond pharma. If wide adoption materializes, Novo and Lilly appear poised to dominate a blockbuster new drug market.

Breaking Boundaries: Lilly’s Investment in Base Editing for Heart Disease

Posted on October 31, 2023November 1, 2023 by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly is expanding its efforts in cardiovascular disease research through a new deal with Beam Therapeutics and Verve Therapeutics worth up to $600 million. The deal centers around base editing, an emerging gene editing technology that Beam and Verve are pioneering for new precision genetic medicines.

Under the agreement announced today, Lilly will acquire Beam’s opt-in rights to co-develop and co-commercialize several of Verve’s base editing programs targeting cardiovascular disease. This includes lead programs focused on PCSK9 and ANGPTL3 – two high profile genes involved in cholesterol regulation and metabolism. A third undisclosed target related to liver-mediated cardiovascular disease is also included.

In exchange, Beam will receive a hefty $200 million upfront payment along with a $50 million equity investment from Lilly. Beam is further eligible for up to $350 million in future milestone payments as the programs advance through clinical trials and regulatory approvals.

For Lilly, this deal provides access to a promising new approach to treating cardiovascular disease, an area where the company already has a major presence. Lilly has been a leader in cholesterol drugs like statins for decades, and more recently entered the PCSK9 market through its ownership of Repatha. But despite effective medications, cardiovascular disease remains a top killer globally.

Base editing offers a way to precisely and permanently modify disease-causing genes in order to lower cholesterol and potentially deliver stronger treatment effects than current options. Early human trials have already shown base editing of PCSK9 can lower LDL cholesterol. Verve recently initiated a clinical trial using base editors to target both PCSK9 and ANGPTL3 simultaneously.

Take a moment to take a look at Ocugen (OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines.

As a technology pioneer, Beam is widely considered the leader in base editing. The company has uncovered a series of natural enzymes that can be programmed to make single letter DNA changes at targeted sites without cutting the double strand like traditional CRISPR gene editing. This opens possibilities for more precise control while minimizing unintended effects.

Beam CEO John Evans highlighted base editing as a core strategic priority, and views creative partnerships as a key path to accelerate development. “Our initial collaboration with Verve and this new transaction with Lilly are exemplary of our execution of that strategy,” Evans said. “This deal provides meaningful upfront capital to advance our portfolio of clinical- and research-stage programs, with significant additional value achievable as the Verve programs advance.”

For Beam, the capital influx provides fuel to advance its broader base editing pipeline including programs in sickle cell disease, alpha-1 antitrypsin deficiency, and glycine encephalopathy. The company now expects its cash runway to extend into the second half of 2026.

Lilly’s history with Verve also preceded this acquisition. In 2021, Lilly led Verve’s $105 million Series B financing and took a stake in the company. That marked another early mover deal to tap into base editing. Verve CEO Sekar Kathiresan said “Lilly’s extensive capabilities in drug development and commercialization make them an ideal partner for Verve as we work together to advance base editing programs aimed at reducing CVD risk through genome editing.”

Beam and Verve join a short list of biotechs focused on realizing the promise of base editing. But Lilly’s involvement marks a huge vote of confidence from the pharma world. As base editing advances toward the clinic, deals like this suggest major players view the technology as more than just hype.

Lilly has been aggressively scouting the latest biotech innovations through both in-house R&D and external deals. The past year saw Lilly acquire hot companies like POINT Biopharma and Repare Therapeutics for large sums. Base editing adds a new tool in Lilly’s toolkit for next generation therapeutic approaches.

Cardiovascular disease also represents an attractive area for investment despite already having effective medications. Heart attacks, strokes and other complications remain a top cause of mortality globally. In the US alone, 1 in 4 deaths are attributable to heart disease each year. Even modest improvements in treatment can translate into major public health benefits.

The risk for Lilly and other major pharmaceutical companies is that base editing and gene editing fail to live up to their early promise in the clinic. However, most experts are optimistic the technology will usher in a new wave of therapies over the next decade. For a pharma giant like Lilly with over $28 billion in yearly revenue, the potential reward is well worth the investment risk to stay on the cutting edge.

President Biden’s Sweeping AI Executive Order: What Investors Need to Know

Posted on October 31, 2023October 31, 2023 by slightbourne@noblecapitalmarkets.com

On October 30th, President Biden signed a landmark executive order to increase oversight and regulation of artificial intelligence (AI) systems and technologies. This sweeping regulatory action has major implications for tech companies and investors in the AI space.

The order establishes new security and accountability standards for AI that companies must meet before releasing new systems. Powerful AI models from leading developers like Microsoft, Amazon, and Google will need to undergo government safety reviews first.

It also aims to curb harmful AI impacts on consumers by mandating privacy protections and anti-bias guardrails when algorithms are used in areas like housing, government benefits programs, and criminal justice.

For investors, this secures a leadership role for the U.S. in guiding AI development. It follows $1.6 billion in federal AI investments this fiscal year and supports American competitiveness versus China in critical tech sectors.

Here are the key takeaways for investors and industries affected:

Tech Giants – For AI leaders like Alphabet, Meta, and Microsoft, compliance costs may increase to meet new standards. But early buy-in by these companies helped shape the order to be achievable. The upfront reviews could also reduce downstream AI risks.

Chipmakers – Companies like Nvidia and Intel providing AI hardware should see continued demand with U.S. positioning as an AI hub. But if smaller competitors struggle with new rules, consolidation may occur.

Defense – AI has become vital for advanced weapons systems and national security. The order may add procurement delays but boosts accountability in this sensitive area. Northrop Grumman, Lockheed Martin and other defense contractors will adapt.

Automotive – Self-driving capabilities rely on AI. Mandating safety reviews for AI systems helps build public trust. Automakers investing heavily in autonomy like GM, Ford and Waymo will benefit.

Healthcare – AI holds promise for improving patient care and outcomes. But bias concerns have arisen, making regulation welcome. Medical AI developers and adopters such as IBM Watson Health now have clearer guidelines.

Startups – Early-stage AI innovators may face added hurdles competing as regulations rise. But they can tout adherence to government standards as a competitive advantage to enterprises adopting AI.

China Competition – China aims to lead in AI by 2030. This order counters with U.S. investment, tech sector support, and global cooperation on AI ethics. Investors can have confidence America won’t cede this key industry.

While adaptation will be required, investors can find opportunities within the AI landscape as it evolves. Companies leaning into the new rules and transparency demands can realize strategic gains.

But those lagging in ethics and accountability may see valuations suffer. disciplines like algorithmic bias auditing will now become critical enterprise functions.

Overall the AI executive order puts guardrails in place against unchecked AI harms. Done right, it can increases trust and spur responsible innovation. That’s a bullish signal for tech investors looking to deploy capital into this transformative sector.

UAW Strikes End as Detroit 3 Reach Deals

Posted on October 30, 2023October 30, 2023 by slightbourne@noblecapitalmarkets.com

Detroit automaker General Motors (GM) has reached a tentative labor agreement with the United Auto Workers (UAW) union, bringing an end to 6 weeks of strikes that idled tens of thousands of autoworkers across the United States.

The 4-year deal was announced Monday after marathon negotiating sessions over the weekend. It follows similar tentative agreements reached last week by the UAW with Ford Motor Co. and Fiat Chrysler Automobiles.

With contracts now in place with all Detroit Three automakers, the UAW can turn its focus to ratification votes. The agreements are expected to add hundreds of millions in new labor costs, but deliver significant gains to autoworkers who made concessions during the Great Recession to help stabilize the industry.

Key improvements include an accelerated path to top hourly wages of over $32, pay increases of 3-4% each year, cost of living adjustments, $11,000 ratification bonuses, and restored rights to strike over plant shutdowns. The deals also hold healthcare costs steady without increased worker premiums.

For the automakers, the additional labor expenses come as the industry already faces rising costs for technology investments in electric vehicles and autonomy. But the end of strikes brings relief after 6 extremely costly weeks of lost production.

Ford pegged the financial impact of the work stoppage at $1.3 billion. The company expects its new deal to increase per vehicle labor costs by $850-$900. GM lost about $2 billion according to estimates, over $1 billion of that in the United States.

The sacrifices by both sides reflect just how damaging an extended strike could have been. A 2-day strike last year cost GM an estimated $400 million alone. With U.S. auto sales plateauing, neither side could afford an extended plant shutdown.

For Wall Street, the end of uncertainty from the labor disputes will be welcomed. GM stock gained 0.75% Monday after details emerged, while Ford’s share price rose 1.2%. Investors see the short-term costs of the deals as outweighed by the benefits of resumed production and sales.

Moody’s auto analyst Bruce Clark said the deals are “credit negative but containable” for the automakers, allowing them to remain competitive. Labor peace also helps attract talent and productivity gains.

The question now is whether rank-and-file UAW members will ratify the tentative contracts. Ford and GM workers are expected to start voting within 2 weeks, once the agreements are finalized and presented to members.

UAW leaders face pressure to avoid the rejection they suffered in 2015, when Fiat Chrysler workers initially voted down a proposed deal. But the united front displayed by the UAW in pursuing coordinated strikes gives momentum.

With U.S. unemployment at historic lows, workers leveraged a tight labor market and the automakers’ need for labor stability into significant gains after years of minimal increases. For the UAW, it represents a big win and reprieve from scandal.

The new contracts set the stage for a productive new era of labor-management relations in the auto industry, vital to the American manufacturing sector. As the UAW’s most profitable bargaining partners, Detroit now aims to move beyond the strikes and shift focus to the future of transportation.