Month: November 2024

Nvidia’s Q3 Earnings in Focus: AI Boom Continues, But Challenges Loom

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Nvidia’s Data Center revenue expected to hit $29 billion, doubling year-over-year.
– Demand for Blackwell chips outstrips supply as production challenges persist.
– Proposed tariffs on Taiwan-made chips threaten Nvidia’s costs and margins.

Nvidia, the world’s largest publicly traded company by market cap, is set to report its third-quarter earnings today, and investors are bracing for what could be another blockbuster performance fueled by artificial intelligence (AI). Analysts project Nvidia will report earnings per share (EPS) of $0.74 on revenue of $33.2 billion, a staggering 83% year-over-year increase. This incredible growth highlights Nvidia’s position as a market leader in the rapidly expanding AI sector, where demand for cutting-edge chips continues to skyrocket.

Nvidia’s dominance in the AI chip market has driven its meteoric rise throughout 2024, with its stock up an impressive 192% year-to-date. As companies across industries increasingly adopt AI-driven solutions, Nvidia’s technology has become indispensable, powering advancements in areas ranging from autonomous vehicles to generative AI tools like ChatGPT. Investors are eager to see if the company can maintain its momentum while navigating the challenges posed by geopolitical and supply chain issues.

The company’s Data Center segment has been a key driver of its success and is expected to deliver $29 billion in revenue for Q3, representing a remarkable 100% increase compared to the same period last year. Nvidia’s GPUs are the backbone of AI computing, enabling the training and deployment of sophisticated AI models. This has made the company a go-to provider for enterprises and tech giants seeking to harness the transformative power of AI.

While AI-related revenue has been the cornerstone of Nvidia’s growth, its gaming segment remains an important contributor, with revenue projected to reach $3 billion, up 7% year-over-year. The sustained demand for GPUs among gaming enthusiasts and professionals demonstrates the versatility and widespread application of Nvidia’s technology. Yet, the spotlight remains firmly on the AI sector, where Nvidia’s innovations continue to lead the industry.

However, the company faces looming uncertainties that could impact its future trajectory. Nvidia’s reliance on Taiwanese chipmaker TSMC for the production of its cutting-edge chips exposes it to geopolitical risks. President-elect Donald Trump’s proposal to impose tariffs on Taiwan-made chips could result in higher production costs for Nvidia, potentially squeezing margins or forcing the company to pass on the additional costs to customers. These potential tariffs come amid broader efforts to bolster domestic semiconductor production in the United States through initiatives like the CHIPS Act. Investors will be watching closely for any guidance from Nvidia’s CEO, Jensen Huang, on how the company plans to address these challenges.

Adding to these concerns are supply chain issues affecting Nvidia’s latest Blackwell chips, which are designed to meet the surging demand for AI applications. Reports of overheating servers have delayed shipments, creating uncertainty about the timeline for broader adoption of these next-generation chips. Despite these setbacks, Nvidia remains optimistic about the future of Blackwell and expects substantial revenue contributions from the line in the coming quarters.

Even with these challenges, Nvidia continues to dominate Wall Street’s attention. Analysts expect strong guidance for Q4, with projected revenues of $37 billion. Whether Nvidia’s stock continues its impressive ascent will depend on how effectively the company manages its challenges while capitalizing on the tremendous growth opportunities presented by the AI revolution.

Release – Ocugen Announces European Medicines Agency Grants Orphan Medicinal Product Designation for Modifier Gene Therapy Candidate OCU410ST for Treatment of ABCA4-Associated Retinopathies including Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 20, 2024

MALVERN, Pa., Nov. 20, 2024 (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 the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD3).

“We are deeply honored to receive orphan medicinal product designation from the EMA for OCU410ST. This recognition brings us one step closer to providing a much-needed option for Stargardt patients who currently have no therapies available,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of R&D at Ocugen. “We are committed to advancing this treatment with urgency and dedication, with the hope of making a meaningful impact on the lives of those affected by this challenging disease.”  

The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to OCU410ST in April 2023. Stargardt disease affects approximately 100,000 people in the U.S. and Europe combined.

Orphan medicinal product designation in Europe offers certain benefits to drug developers while they develop drugs intended for safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that impact fewer than 5 in 10,000 patients in the European Union. Benefits include protocol assistance, reduced regulatory fees, research grants, and 10 years of market exclusivity following regulatory approval.

Dosing in the first phase of the Phase 1/2 OCU410ST GARDian trial for Stargardt disease is complete and the Data and Safety Monitoring Board (DSMB) has recommended moving forward with Phase 2. To date, the safety and tolerability profile of OCU410ST appears to be very favorable.

Preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410ST GARDian clinical trial was recently presented at Ocugen’s Clinical Showcase. Data from evaluable subjects at six months demonstrated a remarkable 84% reduction in atrophic lesion growth in treated eyes versus untreated fellow eyes.

“We are encouraged by the preliminary efficacy data showing stabilization or improvement in visual function and retinal structure outcomes in OCU410ST treated eyes,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “These positive clinical and regulatory milestones continue to support the potential for OCU410ST to address inherited retinal diseases with a one-time therapy for life.”

OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene and further represents the impact of Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptors (NHRs) that regulate diverse physiological functions such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks.

Ocugen intends to pursue an accelerated marketing authorization application (MAA) for OCU410ST.

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 patient’s 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.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and 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 – Comstock Fuels Executes Commercial Agreement for Fourth Site

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

VIRGINIA CITY, Nev., Nov. 20, 2024 (GLOBE NEWSWIRE) — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced execution of a binding amendment to an existing agreement between Comstock Fuels Corporation (“Comstock Fuels”) and SACL Pte. Limited (“SACL”), a Singapore-based renewable fuel project developer, under which Comstock Fuels agreed to grant SACL an exclusive marketing agreement for Comstock Fuels’ advanced lignocellulosic biomass refining processes in Vietnam. The amendment was executed to increase SACL’s territory to facilitate the financing, construction, and operation of SACL’s first planned site in Vietnam, in addition to three existing sites currently under development in Australia, now totaling over 460 million gallons of renewable fuels, with an emphasis on sustainable aviation fuel (“SAF”).

Early Adopter License Terms

SACL and its stakeholders previously identified three qualified sites for the construction of three Bioleum™ Refineries based on Comstock Fuels’ industry leading yields and decarbonizing impact, including (1) a 250,000 metric ton per year (“MTPY”) refinery located near Portland, Victoria, Australia, (2) a 250,000 MTPY refinery located near Moree, New South Wales, Australia, and (3) a 750,000 MTPY refinery located near Mackay, Queensland, Australia. However, SACL is actively evaluating additional projects for development in the Pacific Rim, including SACL’s now-planned new 750,000 MTPY Bioleum Refinery in Quang Tri Province, Vietnam.

Under the terms of Comstock Fuels’ agreement with SACL, Comstock Fuels will contribute site specific technology rights in exchange for a 20% equity stake in each Bioleum Refinery, plus a royalty fee equal to 6% of each refinery’s sales of licensed products, and engineering fees equal to 6% of total construction costs. At least one of the Bioleum Refineries will initially start with a capacity of 75,000 MTPY prior to scaling-up to 250,000 MTPY or more, with early adopter royalty fees of 3% of sales and engineering fees equal to 3% of construction costs until scaling-up to 250,000 MTPY, with an initial upfront payment of $2,500,000 payable upon execution of each applicable site-specific license agreement for each refinery.

Together, all four Bioleum Refineries will have an estimated total construction cost of over $4.0 billion and produce approximately 280 million gasoline gallon equivalent basis (“GGE”) of sustainable aviation fuel, and other renewable fuels from lignocellulosic biomass, and about another 180 million GGE from vegetable oils, with over $3.0 billion per year in sales at current prices.

Best-in-Class Yield and Carbon Intensity

Comstock Fuels offers advanced lignocellulosic biomass refining solutions that produce market-leading yields of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel, and other renewable fuels at extremely low carbon intensities. The Comstock Fuels process generally involves: (1) digestion and fractionation of lignocellulosic biomass, (2) bioconversion of cellulose into Cellulosic Ethanol, (3) esterification of lignin and other derivatives into Bioleum Oil, (4) hydrodeoxygenation of Bioleum Oil into Hydrodeoxygenated Bioleum Oil, (5) refining of these extremely low carbon oils and fuels into ASTM compliant renewable fuels, and (6) gas-to-liquids emissions capture and fuel conversion. The first five of these processes are proven to produce up to 125 GGE per dry metric ton of feedstock on a gasoline gallon equivalent basis, depending on feedstock, lignin content, site conditions, and other process parameters, with extremely low carbon intensity scores of 15.

Wide Open Market, Unprecedented Results

“Comstock Fuels’ breakthrough yields unlock an abundant, available and efficient feedstock source that enables extraordinary new opportunities for renewable fuels project developers, especially given the ongoing global surge in demand for sustainable aviation fuel,” said Garry Millar, SACL’s founder and director. “The Comstock Fuels’ patented and patent-pending process uses reliable, available equipment and standard refining processes to convert woody biomass, such as purpose grown eucalyptus in our case, into renewable intermediates and fuels that leverage existing supply chains. We are excited by this collaboration, and we are looking forward to working with the Comstock Fuels’ team and our local stakeholders to develop each of our projects as we continue assessing additional sites for qualification.”

“SACL’s team has rapidly advanced their projects, and we look forward to accelerating their objectives with our leading global solution for sustainable and extremely low carbon renewable fuels,” stated David Winsness, president of Comstock Fuels. “We are concurrently executing on our own plan to build, own, and operate our first four facilities in the U.S., including an initial 75,000 MTPY demonstration scale facility followed rapidly by three additional 75,000 MTPY facilities, each of which would then be scaled-up to 1,000,000 MTPY commercial scale Bioleum Refineries. Collectively, our first four planned U.S. facilities will produce more than 920 million GGE per year of renewable fuels, including about 560 million GGE from woody biomass and another 360 million GGE from vegetable oils. Between SACL and our initial plans alone, we are planning for over 1.38 billion GGE per year of initial renewable fuel production from our solutions before considering all other licensees and projects in our pipeline.”

About SACL Pte. Limited

SACL is a Singapore-based project development and management company that intends to develop renewable energy projects in Australia, New Zealand, and Vietnam. To learn more, please visit www.saclimited.com.

About Comstock Fuels Corporation

Comstock Fuels delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 125 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, lignin content, site conditions, and other process parameters. Comstock Fuels plans to directly build, own, and operate a network of Bioleum Refineries in the U.S. to refine 50 million tons of biomass annually into 8 billion gallons of renewable fuel by 2035, corresponding to 50% of the U.S. renewable fuel mandate. Comstock Fuels is currently evaluating several U.S. sites for construction of its Demonstration Scale Facility to validate its fully integrated process at 75,000 tons per year, paving the way for rapid full-scale commercialization. Comstock Fuels also licenses its advanced refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to global decarbonization and the clean energy transition by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its Twitter, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

For media inquiries or questions:
Comstock Inc., Tracy Saville
Tel (775) 847-7573
questions@comstockinc.com

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

QuoteMedia Inc. (QMCI) – Working Through A Rough Patch

Posted on by cpereira@noblefcm.com


Wednesday, November 20, 2024

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

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

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

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

In-line results. The company reported Q3 revenue of $4.7 million, a decrease of 1.4% from the prior year period and largely in line with our estimate of $4.8 million. Q3 adj. EBITDA of $0.4 million, was modestly lighter than our estimate of $0.7 million, as illustrated in Figure #1 Q3 Results. The adj. EBITDA miss was driven by a modestly higher cost of revenue and increased sales headcount.

Lackluster near term outlook. Management indicated that Q4 revenue will be relatively flat compared to Q3 despite a solid business pipeline. Management highlighted that it lost a significant client and that some of its clients are experiencing financial hardship, leading to a lower volume and higher bad debt expenses. We believe the company should be able to offset lower volume and the loss of clients with its building business pipeline.


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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. 

Ocugen (OCGN) – Interim Data From The Clinical Showcase Highlighted

Posted on by cpereira@noblefcm.com


Wednesday, November 20, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

Summary Of Data Announced For Products In Clinical Trials. Ocugen summarized some of the major points presented at its Clinical Showcase on November 12. As discussed in our Research Note on November 13, speakers reviewed the products’ mechanisms of action, reviewed OCU400 data from the Phase 1/2 trial, the design of the OCU400 Phase 3 liMeliGhT trial, and presented new interim data from the Phase 1/2 ArMaDa trial for OCU410.

Mechanism of Action For The Modifier Gene Therapy (MGT) Detailed. Ocugen is developing gene therapies for retinal diseases that deliver a regulatory gene to control other genes and regulate downstream pathways. Products in development are for inherited diseases that result from multiple gene mutations or conditions that result from several dysfunctional pathways.


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. 

Kelly Services (KELYA) – Enhancing Education through Children’s Therapy Center Acquisition

Posted on by cpereira@noblefcm.com


Wednesday, November 20, 2024

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

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

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

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

Adding On. Expanding on the Company’s Pediatric Therapy Services (PTS) portfolio in the Education segment, yesterday Kelly announced the acquisition of Children’s Therapy Center (CTC). Notably, the acquisition increases the current network’s scale of licensed therapists to Kelly, enabling practice flexibility between clinics and schools. The terms of the acquisition were not disclosed, but we do not believe it will impact fourth quarter results.

CTC Overview. Headquartered in Eagan, Minnesota, CTC specializes in occupational, physical, and speech therapy for children from birth to 18 years old. The company was founded in 1999 and has two office locations, one in Eagan and the other in Apple Valley, MN. Various disorders that are treated through CTC include motor or speech delays, sensory processing disorders, Cerebral Palsy, Autism Spectrum Disorders, and Attention Deficit Disorder.


Get the Full Report

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

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

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

GeoVax Labs (GOVX) – Interim Analysis Shows CM04S1 Outperforms mRNA Vaccines

Posted on by cpereira@noblefcm.com


Wednesday, November 20, 2024

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

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

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

CM04S1 Continues In Phase 2 As DSMB Determines mRNA Vaccine Arm Failed Primary Endpoint. CM04S1 is in Phase 2 testing as a COVID-19 booster against an approved mRNA vaccine in patients with chronic lymphocytic leukemia (CLL). An interim analysis conducted by an independent Data Safety Monitoring and Review Board (DSMB) determined that the mRNA arm did not meet its specified primary endpoint, but the trial will continue with the CM04S1 arm.

Study Tests CM04S1 In Immunocompromised Patients. The Phase 2 study enrolled patients that are immunocompromised due to CLL and its therapies, which often leaves them unable to mount a sufficient immune response and vulnerable to COVID-19 infection. The trial was designed to determine the immune response with Pfizer’s mRNA vaccine as the control and comparator arm. Patients were randomized at 1:1 into two arms, receiving either two injections of CM04S1 three months apart or the mRNA vaccine. 


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. 

EuroDry (EDRY) – Third Quarter Performance Falls Short Amid a Weak Market

Posted on by cpereira@noblefcm.com


Wednesday, November 20, 2024

EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd. into a separate listed public company. EuroDry was spun-off from Euroseas Ltd. on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY. EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day- to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters and under pool agreements.

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

Hans Baldau, Research Associate, Noble Capital Markets, Inc.

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

Third quarter financial results.  Eurodry Ltd. reported an adjusted third-quarter net loss to controlling shareholders of $3.9 million or ($1.42) per share compared to an adjusted net loss of $675 thousand or ($0.24) per share during the prior year period. Adjusted EBITDA declined to $474 thousand compared to $3.1 million during the prior year period. The year-over-year decline was driven by a heavier-than-expected dry-docking quarter, a decline in charter rates due to a weakening Chinese economy and the reopening of trade routes.

Updating 2024 and 2025 estimates. We have lowered our 2024 adjusted EBITDA and earnings per share estimates to $14.7 million and $(2.46), respectively, from $23.0 million and ($0.85). Similarly, we have lowered our 2025 adjusted EBITDA and earnings per share to $30.8 million and $3.28, respectively, from $37.3 million and $5.65. Our revisions are primarily the result of a weak market outlook and corresponding rates.


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Release – Kelly Enhances Pediatric Therapy Services with Strategic Acquisition of Children’s Therapy Center, Bolstering Market Leadership

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on KELYA

  • Kelly’s acquisition of Children’s Therapy Center (CTC) further expands growth opportunities in the high-margin, high-demand therapeutic services segment.
  • The integration of CTC into Kelly Education’s Pediatric Therapy Services will bolster service delivery, offering Minnesota school districts access to comprehensive therapy solutions to address the increasing demand arising from student special education needs.
  • The addition of CTC brings increased scale to the current network of licensed therapists, enabling flexible practice in clinics or schools.

TROY, Mich., Nov. 19, 2024 (GLOBE NEWSWIRE) — Today, Kelly (Nasdaq: KELYA, KELYB) announced that it has acquired Children’s Therapy Center (CTC). Specializing in occupational, physical, and speech therapy for children from birth to eighteen, CTC operates from its headquarters in Eagan, MN, with an additional office in Apple Valley, MN. This acquisition will integrate CTC into Kelly Education’s Pediatric Therapy Services (PTS) portfolio. This provides opportunities for Minnesota school districts, including those who currently partner with Teachers On Call (TOC), a Kelly Education Company, to integrate PTS’s related therapy services to meet the growing demand of student special education needs. The terms of the acquisition were not disclosed.

“Children’s Therapy Center’s people-focused culture aligns well with Kelly’s values,” said Nicola Soares, president of Kelly Education. “CTC’s therapist-focused model emphasizes provider-child relationships and is dedicated to achieving positive outcomes for children. This expansion also enables us to bring value to the Center’s strong therapist retention practices by offering flexibility to practice in either school or clinical settings, underscoring our commitment to growth and comprehensive service delivery.”

CTC offers diverse interventions supported by continuous professional development for its therapists. Focused on delivering best-in-class service and ensuring the highest standards of care, CTC is committed to strong compliance, implementing robust processes to ensure adherence to federal, state, and local regulations.

“I am excited about the direction of this innovative adoption by Kelly Education’s PTS specialty brand, bringing together our unique strengths to advance holistic care for children,” said Sue Fuller, founder of Children’s Therapy Center. “This collaboration represents a unified vision and offers a remarkable opportunity to transform how we deliver services, ensuring that every child receives the support necessary for their growth and well-being.”

About Kelly

Kelly (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners, we connect job seekers around the world with meaningful work. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Visit kellyservices.com.

About Kelly Education

Kelly Education powers the future of learning through customized workforce solutions, including hiring and recruiting, business management, professional development, academic and social-emotional support across the full continuum of education––from PreK-12, special education, and therapeutic services to executive search and beyond. Kelly Education is a business of Kelly (Nasdaq: KELYA, KELYB), a global workforce solutions provider that connects businesses and individuals with limitless opportunities through meaningful work. Learn more at kellyeducation.com or connect with us on LinkedIn, Facebook, and X. 

Forward-Looking Statements

This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vi) our future business development, results of operations and financial condition, (vii) damage to our brands, (viii) dependency on third parties for the execution of critical functions, (ix) conducting business in foreign countries, including foreign currency fluctuations, (x) availability of temporary workers with appropriate skills required by customers, (xi) cyberattacks or other breaches of network or information technology security, and (xii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

KLYA-FIN

Contact Information

Media Contact:
Danielle Nixon
816-737-8414
danielle.nixon@kellyservices.com		          Analyst Contact:
Scott Thomas
(248) 251-7264
scott.thomas@kellyservices.com

Release – GeoVax Announces Positive Interim Data Review for Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 19 November 2024
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GEO-CM04S1 Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, November 19, 2024 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, as a booster vaccine for patients with chronic lymphocytic leukemia (CLL).

Based on the interim analysis of immune responses from the patients enrolled to date, the DSMB determined that, while the mRNA control arm of the study failed to meet the predetermined primary endpoint, the study should continue enrollment of the experimental arm utilizing GeoVax’s Next-Generation GEO-CM04S1 vaccine. The Phase 2 trial is an investigator-initiated clinical study (ClinicalTrials.gov Identifier: NCT05672355) being conducted at City of Hope National Medical Center. The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in CLL patients, with an mRNA vaccine as the control arm. Thus far, participants have been randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the mRNA control vaccine.

“This is very exciting news,” commented David Dodd, GeoVax President and CEO, “The outcome of the DSMB interim review appears to support our view of GEO-CM04S1 as a potentially superior COVID-19 vaccine booster within the CLL patient population. Within the CLL and other immune-compromised patient populations, more robust and durable protective immunity is needed, as provided by potential next-generation vaccines such as GEO-CM04S1 that induce both strong T cell and antibody responses.”

Individuals with CLL, regardless of their treatment status, typically exhibit less predictable and often insufficient immune responses to the currently authorized COVID-19 vaccines; therefore, such patients may be at higher risk of a lethal COVID-19 infection. GEO-CM04S1 uses a modified vaccinia virus (MVA) viral vector backbone, containing both the Spike (S) and Nucleocapsid (N) antigens of the SARS-CoV-2 virus.  Inclusion of both the S and N antigens may be more effective at inducing COVID-19 immunity in patients exhibiting poor antibody responses following receipt of an mRNA vaccine containing only the S antigen as MVA also induces strong T cell expansion, even in the background of immunosuppression. By targeting both the S and N protein antigens, GEO-CM04S1 offers the potential to both broaden the specificity of the immune responses as well as protect against the loss of efficacy associated with current vaccines due to the significant sequence variation observed within the S antigen.

Dodd continued, “This ongoing trial is providing important information about the potential use of GEO-CM04S1 in one of many immune-compromised patient populations. It is also complementary to the pending start of a BARDA-funded 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine as a booster in healthy individuals. We look forward to sharing further progress reports on each of these programs.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, 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.comaustin.murtagh@precisionaq.com                   sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Release – Comtech Appoints Daniel Gizinski as New President of Satellite & Space Communications Segment

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

CHANDLER, Ariz. – November 19, 2024– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global technology leader, announced today the appointment of Daniel Gizinski as President of the Company’s Satellite & Space Communications (“S&S”) segment. With extensive industry leadership experience and a collaborative, hands-on approach to solving customer challenges, Gizinski will play a central role in advancing Comtech’s S&S strategy, including its expanding portfolio of next-generation satellite solutions and vision as a pure-play satellite and space communications company.

Gizinski brings over 15 years of experience in satellite communications engineering, operations, product strategy and executive management to his new role as President of the S&S segment, including key leadership positions throughout the Comtech organization. With a proven track record of driving growth and fostering innovation, he will oversee all aspects of the S&S segment, including product development, operations, and market expansion.

Gizinski will also lead new initiatives to strengthen Comtech’s global partnerships and enhance the Company’s S&S offerings to meet the evolving demands of government, commercial, and international markets.

“I am honored to have Daniel’s proven and trusted leadership in this critical executive role, as he guides Comtech’s space and satellite business and confidently creates and capitalizes on new opportunities to deliver on our commitments to customers, partners, and shareholders around the world,” said John Ratigan, President and CEO of Comtech. “Daniel’s appointment as President of S&S will also be central to helping Comtech realize our vision as a pure-play satellite and space communications company. His deep customer relationships and unique understanding of industry growth trajectories will help ensure Comtech continues to drive innovation and meet the needs of customers for decades to come.”

Gizinski’s appointment underscores Comtech’s ongoing commitment to delivering trusted, resilient multi-orbit connectivity and communications solutions to some of the world’s most demanding customers.

“Comtech’s S&S business is well positioned to capitalize on our ongoing industry transformation,” said Daniel Gizinski, President of Comtech’s S&S segment. “I am a firm believer in having a customer-first mentality, and as a trusted ally of our partners, I will continue to roll up my sleeves and collaborate with our commercial and government customers to solve their toughest challenges. I look forward to leading this team as we execute on John’s vision and plan to make Comtech a pure-play satellite and space company, ensuring we have the right people, processes, and solutions needed to rapidly deliver on the growing demands we’re seeing from our customers.”

Prior to his appointment as President of the Company’s S&S segment, Gizinski served as Chief Strategy Officer and President of the Comtech Satellite Network Technologies (“CSNTI”) division. Gizinski also held prior appointments as the Company’s Chief Strategy Officer from 2022-2024 and President of CSNTI in 2022.

During his tenure at Comtech, he has held various senior management positions, including serving as Vice President of Product and Strategy for Comtech Systems, Inc. Earlier in his career, Gizinski held program management and leadership roles at General Electric, Sierra Nevada Corporation, and L3Harris Technologies. Gizinski holds a bachelor’s degree in electrical engineering from the University of Virginia and a master’s degree from Duke University.

Comtech’s S&S segment is a U.S.-based, leading provider of advanced modems and high-power amplifier technologies, and a market leader in troposcatter technologies. The S&S segment has an innovative portfolio of these mission-critical technologies and serves some of the world’s largest defense contractors and allied foreign governments, as well as multiple U.S. government agencies, including branches of the U.S. Armed Forces, U.S. Department of Defense and U.S. Space Force, among others.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

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

Investor Relations Comtech

Maria Ceriello

631-962-7115

Maria.Ceriello@comtech.com

Media Contact Comtech

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Cadrenal Therapeutics Named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Recognized as innovative biopharma developing a potentially safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions

PONTE VEDRA, Fla., Nov. 19, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, has been recognized as the 2024 “Anticoagulation Therapy Company of the Year” by Pharma Tech Outlook, an industry publication focused on breakthrough pharmaceutical technologies. The award underscores Cadrenal’s commitment to addressing the significant unmet needs of patients with implanted left ventricular assist devices (LVADs) and other rare cardiovascular conditions who require chronic anticoagulation. Cadrenal aims to develop a better VKA blood thinner for these warfarin-dependent patients.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation. (PRNewsfoto/Cadrenal Therapeutics, Inc.)


In addition to receiving the award, Cadrenal was featured in the current edition of Pharma Tech Outlook. Entitled Pioneering Innovation in Anticoagulation for Rare Cardiovascular Conditions, the article highlights tecarfarin, Cadrenal’s lead candidate that is being developed to potentially overcome many of the challenges associated with warfarin anticoagulation therapy including drug-drug interactions and wide variability requiring frequent dosing changes. Unlike VKA warfarin, tecarfarin uses a unique metabolic pathway that is less affected by drug-drug interactions and kidney impairment. By providing a stable, once-daily, and reversible therapeutic, Cadrenal seeks to improve patient outcomes and ease the burden on patients and healthcare providers who face the complex anticoagulation management needs of this population.

“We are honored to receive this recognition from Pharma Tech Outlook,” said Quang X. Pham, founder and CEO of Cadrenal Therapeutics. “Our goal is to provide a safer and superior blood thinner option for patients who rely on chronic anticoagulation but are underserved by current treatments. Warfarin, the first VKA anticoagulant, was approved more than 70 years ago yet no significant advancements in oral VKA drugs have occurred since then.”

“Cadrenal Therapeutics has demonstrated a commitment to filling a serious gap in anticoagulation therapy,” said Lisa Winget, Managing Editor at Pharma Tech Outlook. “We are pleased to recognize Cadrenal’s innovative approach to developing a new treatment to serve patients with LVADs and other rare cardiovascular conditions.”

With orphan drug and fast-track designations, tecarfarin is uniquely positioned to fill the gap in chronic anticoagulation treatment options for patients with LVADs and rare cardiovascular conditions such as end-stage kidney disease (ESKD) with atrial fibrillation.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) to provide potentially safer and superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Cadrenal is focused on evaluating tecarfarin versus warfarin in reducing adverse events such as strokes, heart attacks, and bleeds in these patients. With tecarfarin, Cadrenal aims to address many of warfarin’s challenges such as drug interactions, frequent dosing adjustments, and kidney impairment effects, which are common in these patients. Tecarfarin has an orphan drug designation for left ventricular assist device (LVAD) patients and both orphan drug and fast-track designations for end-stage kidney disease patients with atrial fibrillation. Cadrenal is advancing a pivotal trial and pursuing clinical and commercial partnerships, with plans to study mechanical heart valve patients facing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

Safe Harbor

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding Cadrenal’s anticoagulant being a potentially safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions; Cadrenal developing a better VKA blood thinner for warfarin-dependent patients; Cadrenal’s lead candidate potentially overcoming many of the challenges associated with warfarin anticoagulation therapy including drug-drug interactions and wide variability requiring frequent dosing changes; Cadrenal improving patient outcomes and easing the burden on patients and healthcare providers who face the complex anticoagulation management needs of this population; Cadrenal providing a safer and superior blood thinner option for patients who rely on chronic anticoagulation but are underserved by current treatments; and tecarfarin being uniquely positioned to fill the gap in chronic anticoagulation treatment options for patients with LVADs and rare cardiovascular conditions such as end-stage kidney disease (ESKD) with atrial fibrillation; and advancing a pivotal trial and pursuing clinical and commercial partnerships, with plans to study mechanical heart valve patients facing anticoagulation difficulties. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to be a safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions and being a better VKA blood thinner for warfarin-dependent patients, the ability of the Company to advance tecarfarin in a pivotal trial and to advance tecarfarin with patients with LVADs and those with AFib and ESKD, the ability to advance commercial partnerships and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-named-anticoagulation-therapy-company-of-the-year-by-pharma-tech-outlook-302309432.html

SOURCE Cadrenal Therapeutics, Inc.

Release – Comstock Fuels Amends License With RenFuel

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

Expands Territory in Advance of Accelerating Project Development in Pacific Rim

VIRGINIA CITY, NEVADA, November 19, 2024 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the execution by its subsidiary, Comstock Fuels Corporation (“Comstock Fuels”), of an amendment to its exclusive license agreement with RenFuel K2B AB (“RenFuel”) for use of RenFuel’s patented catalytic esterification process to refine Comstock Fuels’ proprietary BioleumTM biointermediates. The amendment expanded the territory from North America, Central America, and South America to include Australia, New Zealand and Vietnam to facilitate ongoing project development by licensees of Comstock Fuels broader lignocellulosic biomass refining process.  

Johan Löchen, RenFuel’s chief executive officer, stated, “Comstock and its licensees are making great and rapid progress developing sites for construction of demonstration and commercial scale facilities based on Comstock’s Bioleum refining process, including RenFuel’s patent catalytic esterification process. Our partnership with Comstock has been productive in many ways and we are pleased with the rapid progress and the mutual benefits of expanding the scope of our collaboration and our license.”

David Winsness, Comstock Fuels’ president, added, “Our patented and patent-pending technologies integrate proven systems from multiple industries in new ways to create a new class of petroleum refinery – a Bioleum Refinery, to refine abundant woody biomass into renewable fuels at market-leading yields and profitability. The RenFuel process is a key enabling step in that integration and we continue to be excited to work with the RenFuel team on our combined commercialization efforts.”

About RenFuel K2B AB

RenFuel innovates technologies that contribute to decarbonization and circularity by effectively turning under-utilized biomass waste and residues into renewable fuels and materials. To learn more, please visit www.renfuel.se.

About Comstock Fuels Corporation

Comstock Fuels delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 125 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, lignin content, site conditions, and other process parameters.

Comstock Fuels plans to directly build, own, and operate a network of Bioleum Refineries in the U.S. to refine 50 million tons of biomass annually into 8 billion gallons of renewable fuel by 2035, corresponding to 50% of the U.S. renewable fuel mandate. Comstock Fuels is currently evaluating a number of U.S. sites for construction of its demonstration scale facility to validate its fully integrated process at 75,000 tons per year, paving the way for rapid full-scale commercialization. Comstock Fuels also licenses is advanced refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to global decarbonization and the clean energy transition by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its Twitter, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

For media inquiries or questions:
Comstock Inc., Tracy Saville
Tel (775) 847-7573
questions@comstockinc.com

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.