Month: November 2024

Release – GeoVax Reports Third Quarter 2024 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Progress in GEO-CM04S1 BARDA/Project NextGen Phase 2b trial; multiple data readouts of existing COVID-19 vaccine Phase 2 trials expected during fourth quarter 2024

 Gedeptin® on track to advance into Phase 2 clinical trial for first recurrent head and neck cancer in the first half of 2025

 GEO-MVA Mpox vaccine advancing with cGMP clinical batch anticipated during fourth quarter 2024 

 Company to host conference call and webcast today at 4:30 p.m. ET

ATLANTA, GA, November 12, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

David Dodd, GeoVax’s Chairman and CEO, stated, “2024 has shaped up to be a year of steady progress and execution across our development programs. Following the BARDA/RRPV award of nearly $400 million in support of evaluating GEO-CM04S1 in the Project NextGen program, we continue to collaborate closely with the BARDA Project NextGen team and our CRO, Allucent, preparing for the activation of the 10,000-patient Phase 2b clinical study. The necessary sites are confirmed, and we are working closely with Oxford Biomedica (“OXB”), our manufacturing partner, to produce the vaccine product required for study activation. We look forward to sharing further updates related to this exciting Phase 2b study.”

“In the third quarter, we also strengthened our balance sheet with additional funding, enabling us to confirm plans towards initiating a Phase 2 trial of Gedeptin in conjunction with an immune checkpoint inhibitor, as therapy for first recurrent head and neck cancer patients,” Dodd continued. “We anticipate initiating this study during the first half of 2025. We have also made significant progress with GEO-MVA, our vaccine candidate for Mpox, and expect to achieve production of a cGMP clinical batch during the fourth quarter. With GEO-MVA, we intend to create the first U.S.-based source for a Mpox vaccine, an important biodefense goal.”

“Supported by our recent progress, we believe we are well-positioned to advance our priority programs in support of developing innovative solid tumor therapies and infectious disease vaccines. Our commitment to advancing life-changing treatments continues to drive us in our mission to improve patient care worldwide through innovative developments.”

Third Quarter Business Achievements and Updates

GEO-CM04S1

  • BARDA Project NextGen Phase 2b trial: Target sites are confirmed, and activities are underway in support of initiating the 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA) approved mRNA COVID-19 vaccine.
  • Existing Phase 2 clinical studies: During the fourth quarter of 2024, GeoVax anticipates reporting interim results from (a) the comparative trial among Immunocompromised/Chronic Lymphocytic Leukemia (CLL) patients and (b) the booster trial among healthy adults. For the Immunocompromised/Stem Cell Transplant patient trial, additional sites have been added and patient enrollment continues.

Gedeptin®

  • Activities underway in support of Phase 2 study of Gedeptin combined with an immune checkpoint inhibitor as therapy among patients with first recurrent head and neck cancer.
  • This trial is anticipated to be a single-cycle trial in approximately 36 patients with a pathologic response rate as the primary endpoint. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer.

Mpox and Smallpox Vaccine Platform

  • GEO-MVA is GeoVax’s vaccine candidate in development for protection against Mpox and Smallpox.
  • A cGMP Master Seed Virus has been successfully manufactured and released by OXB and a cGMP clinical batch is currently in production, anticipated to be completed during Q4.
  • MVA is the vaccine recommended by both WHO and the CDC against both Mpox and Smallpox, recognized for its safety and efficacy among all patient populations, including pregnant women, children and immunocompromised individuals. MVA is the vaccine currently used and stockpiled in the United States Strategic National Stockpile for immunization against potential bioterrorism threats based on the smallpox virus.

 Continuous Cell-line MVA Manufacturing Process Development

  • Development activities are underway in support of the AGE.1 continuous MVA manufacturing process. Additional progress is expected to be reported during Q4.

Corporate Updates

  • GeoVax Scientific Advisory Board: Appointed Teresa Lambe, PhD, OBE, FMedSci, professor of Vaccinology and Immunology at the Oxford Vaccine Group within the University of Oxford, to the Scientific Advisory Board.

Third Quarter 2024 Financial Results 

  • Net Loss: Net loss for the three-month period ended September 30, 2024, was $5,815,468, or $0.91 per share, as compared to $8,408,818, or $4.75 per share, for the comparable period in 2023. For the nine months ended September 30, 2024, the Company’s net loss was $16,729,642, or $4.52 per share, as compared to $18,374,354, or $10.42 per share, in 2023.
  • Revenue: During the three-month and nine-month periods ending September 30, 2024, the Company reported $2,789,484 and $3,090,161 of government contract revenues associated with the BARDA/RRPV Project NextGen award. There were no revenues reported during the comparable 2023 periods.
  • R&D Expenses: Research and development expenses were $7,402,884 and $16,105,480 for the three-month and nine-month periods ended September 30, 2024, compared with $6,947,979 and $14,486,896 for the comparable period in 2023, with the changes primarily due to costs of manufacturing materials for use in our clinical trials of GEO-CM04S1 and other costs associated with the BARDA Contract.
  • G&A Expenses: General and administrative expenses were $1,241,176 and $3,784,559 for the three-month and nine-month periods ended September 30, 2024, compared to $1,651,775 and $4,562,293 for the comparable periods in 2023, with the changes primarily due to lower stock-based compensation expense, consulting costs, legal and patent costs and franchise tax cost.
  • Cash Position: GeoVax reported cash balances of $8,592,523 at September 30, 2024, as compared to $6,452,589 at December 31, 2023.

Summarized financial information is attached. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

Conference Call Details

Management will host a conference call and live audio webcast to discuss third quarter 2024 financial results and provide a business update today, November 12, 2024, at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

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

FINANCIAL TABLES

Release – SKYX Reports Record Sales of $22.2 Million for Third Quarter Compared to $21.6 Million for Third Quarter 2023 as it Continues to Grow its Market Penetration of its Advanced and Smart Platform Products in the U.S and Canadian Markets

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

November 12, 2024 16:05 ET

    MIAMI, Nov. 12, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 97 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the third quarter ended September 30, 2024.

    Third Quarter 2024 Highlights and Recent Events

    • Generated record third quarter revenues of $22.2 million compared to $21.6 million for the third quarter of 2023,
    • Prior to the completion of the $11 million equity raise in October 2024, as of September 30, 2024, Company reported $13.0 + million in cash, cash equivalents, and restricted cash, as compared to $15.6 million as of June 30, 2024.
    • In October 2024, SKYX Secured $11 million equity preferred stock investment representing $2.00 per share of common stock with NO warrants, led by global Marriott Hotel chain developer/owner (of over 70 hotels) Lance Shaner, and included significant insider investing by SKYX’s President Steve Schmidt, who invested $500,000, Co-CEO Lenny Sokolow, who invested $250,000, and Co-CEO John Campi, who invested $250,000.
    • Net cash used in operating activities for the third quarter ending September 30, 2024, decreased sequentially by 39% to $2.6 million compared to $4.2 million in net cash used in the second quarter of 2024.
    • Company’s gross profit for the third quarter ending September 30, 2024, increased sequentially by 4% to $6.8 million compared to the quarter ending June 30, 2024.
    • As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company leverages its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
    • Management emphasizes that it has sufficient cash to achieve its goals including being cash flow positive in 2025.
    • The Company continues to grow its market penetration of its advanced and smart plug & play products and expects its products to be in close to 15,000 U.S. and Canadian homes by the end of 2024.
    • Company expects its products to be in tens of thousands of homes, incrementally in 2025.
    • Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe plug & play products it will start being recommended by insurance companies.
    • Product range is currently in production and is expected to arrive by the end of 2024. Products will comprise advance and smart plug & play lighting including recessed lights, down lights, EXIT signs, emergency lights, ceiling fans, chandeliers/pendants, holiday/kids/themes lights, indoor/outdoor wall lights among other.
    • Company’s plug & play technology enables an installation of lighting, fans, and smart home products in high-rise buildings and hotels within days rather than months. Company expects to start delivering products to buildings and hotels in Q-1 of 2025.
    • Company’s total addressable market (TAM) in the U.S. is roughly $500 billion with over 4.2 billion ceiling applications in the U.S. alone. Expected revenue streams from retail and professional segments include product sales, royalties, licensing, subscription, monitoring, and sale of global country rights.
    • Company continues to utilize its e-commerce platform of over 60 websites for lighting and home décor to educate and enhance its market penetration to both retail and professional segments.

    Recent Collaborations:

    • Announced a Collaboration with Home Depot for the retail and professional markets. Company started shipping and products are already in 100 stores. Company has also started to sell product on Home Depot website and ultimately expects to have hundreds of advanced smart plug & play products on Home Depot’s website.
    • Announced a Collaboration with world leading home décor website, Wayfair, for its advanced and smart plug & play products, and ultimately expects to have hundreds of its advanced smart plug & play products on Wayfair’s website.
    • Signed with General Electric / GE Licensing a 5-year global licensing agreement to license its advanced and smart technologies with a goal to create an advanced smart global ceiling standard.
    • Collaboration with a world-leading Chinese Lighting supplier and manufacturer Ruee Appliances. The collaboration with Ruee includes SKYX’s advanced and smart products to both professional and retail markets and provides SKYX substantial backing in several areas including financial, mass production manufacturing capabilities, and distribution to global markets, including China and Europe. The collaboration is expected to substantially enhance gross margins on SKYX’s product sales and favorably impact its cash conversion cycle.
    • Collaboration with world leading lighting company Kichler for online and builder segments.
    • Collaboration with U.S. leading lighting company Quoizel including for online and builder segments.
    • Collaboration with European leading lighting company EGLO for online and builder segments.
    • Future Collaborations: Management is in the process of working on additional collaborations with leading strategic companies.
    • Companies collaborating with SKYX are expected to leverage the fast and easy interchangeability capabilities of the technology to enhance sales of smart fixtures and fixture replacements for seasonality, energy savings, holidays, smart capabilities and renovations for both retail and professional segments.
    • SKYX smart home technology wins 7 CES Awards (Consumer Electronics Show).
    • Company started production of its new global patented advanced, smart, plug & play recessed light. The global recessed light market is a multi-billion-unit market. SKYX’s new Plug & Play recessed light global patents include the U.S., China, Canada, Hong-Kong and Mexico. As billions of recessed lights are installed globally with hazardous electrical wires, SKYX’s recessed light solution enables an advanced, simple Plug & Play installation that saves time, cost and lives. SKYX’s Plug & Play recessed lights can be controlled through SKYX’s App, Voice Control and Phone and works with Apple’s Siri, Amazon Alexa, Google Home and Samsung.
    • New Global Smart Home and AI Related Patents. SKYX’s new and existing patents, including the new global patented advanced, smart, plug & play recessed light, enable and enhance performance of smart home and AI sensors in addition to home safety sensors bringing the Company’s intellectual property portfolio to a total of over 97 issued and pending patents, 36 of which are issued patents covering SKYX’s advanced plug and play and smart home platform technologies for the smart home, AI, electrical, and lighting industries in the U.S. and internationally including China, Europe, Mexico and 2 patents in India. This also includes the recent issuance of 6 additional patents in the U.S. and internationally, in China, India, Europe, Canada, and Mexico for its advanced smart Plug & Play Ceiling Fan & Heater. The 6 additional patent issuances cover SKYX’s advanced plug-and-play smart ceiling fan and heater, enabling an all-in-one all-season product providing cool air for summertime and hot air for wintertime.
    • The Company entered into an agreement to supply approximately 1,000 homes with its advanced smart home platform technologies and is expected to deliver approximately 30,000 units representing a variety of its advanced and smart platform technology products to the developer’s upcoming projects.

    Safety Standardization Highlights

    Based on the safety aspects of the Company’s ceiling outlet receptacle, in the past 12 years, the Company’s product was voted into 10 segments in the NEC Code Book. Management believes that its standardization process, including it’s the NEC votes and its product specification significant approval voting by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturing Association) meet the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings. Voting decisions are at the discretion of the NEC voting members.

    The Company’s code team is led by Mark Earley – former head of the National Electrical Code (NEC) and former Chief Electrical Engineer of the National Fire Protection Association (NFPA) – as well as Eric Jacobson, former President and CEO of The American Lighting Association (ALA). Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries.

    Select Third Quarter 2024 Financial Results

    Revenue in the third quarter of 2024 increased sequentially 3% to a record $22.2 million, including E-commerce sales as well as smart and standard plug and play products, as compared to $21.6 million in the third quarter of 2023.

    The gross profit for the third quarter ending September 30, 2024, increased sequentially by 4% to $6.8 million compared to the quarter ending June 30, 2024.

    Net cash used in operating activities for the third quarter ending September 30, 2024, decreased sequentially by 39% to $2.6 million compared to $4.2 million in net cash used in the second quarter of 2024.

    Prior to the completion of the $11 million equity raise in October 2024, we reported $13.0 million in cash, cash equivalents, and restricted cash, as of September 30, 2024, as compared to $15.5 million as of June 30, 2024. As common with companies such as ours when their sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, we leverage our trades payable to finance our operations to enhance our cash position and lower our cost of capital.

    Loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments (“adjusted EBITDA”), a non-GAAP measure, to $2.6 million, in the third quarter of 2024, as compared to $2.1 million, in the second quarter of 2024.

    Adjusted EBITDA loss, a non-GAAP measure, amounted to $2.6 million, or $(0.03) per share, as compared to $2.9 million, or $(0.03) per share, in the third quarter of 2023. 

    The Company’s financial statements for the quarter ended September 30, 2024, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/

    Management Commentary

    Company’s Management, Board members, and Senior Advisors include former CEO’s and executives from Fortune 100 companies including Nielsen, Microsoft, Disney, GE, Home Depot, Office Depot, Chrysler, among others.

    The third quarter of 2024 was highlighted by our continued market penetration and positioning that includes our announced collaboration with Home Depot and Wayfair which we believe can be significant for our growth to both retail and professional markets. Additionally, the Ruee Appliances collaboration will assist us with product variety, gross margins, future distribution channels, and sales and marketing programs with key stakeholders in such channels. We believe we have accelerated our cadence of sales, notably managing our cash burn, while our e-commerce platform with over 60 websites is providing additional cash flow to the Company, which, when combined with our existing cash enhanced by our $11 Million equity raise in October 2024, enhances our cash position to continue executing our business plan. We believe we will be cash flow positive during 2025.

    We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.

    Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, licensing and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies.

    About SKYX Platforms Corp.

    As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

    Forward-Looking Statements

    Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

    Non-GAAP Financial Measures

    Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

    Investor Relations Contact:

    Jeff Ramson
    PCG Advisory
    jramson@pcgadvisory.com

    Release – Direct Digital Holdings Reports Q3 2024 Financial Results

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on DRCT

    November 12, 2024 4:01 pm EST Download as PDF

    Earnings Webcast

    Audio

    Company Launches Colossus Connections to Accelerate Direct Integration Efforts with Leading Demand-Side Platforms

    New Unified Buy-Side Operating Structure Creates Additional Business Lines and Revenue Opportunities

    Company to Host Conference Call at 5:00 PM ET Today 

    HOUSTON, Nov. 12, 2024 /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”) and Orange 142, LLC (“Orange 142”), today announced financial results for the third quarter ended September 30, 2024.

    Mark D. Walker, Chairman and Chief Executive Officer, commented, “The past few quarters have presented significant challenges for our company due to a targeted and defamatory disinformation campaign. We describe this as disinformation not only because it contained factual inaccuracies, but also because it omitted key insights and context that would have clarified our business practices. As a result, Direct Digital Holdings experienced an unexpected business disruption among our partners, advertisers, and clients, including a major customer who paused its connection with our supply-side platform, Colossus SSP, which led to a temporary reduction in our revenues.”

    Walker continued, “We moved swiftly to address these claims, working closely with all of our partners to ensure they understood the truth of our practices and taking legal action against the author of the defamatory claims. Our paused customer has since restored its connection, with volumes through our sell-side platform steadily increasing, though not yet fully returned to previous levels. Throughout this, we have been working diligently with our multi-national HoldCo agencies, our Fortune 500 brand partners, and demand-side partners, to resume business, which many already have. While we are confident we will return the Company to normalcy, it will take time to rebuild. We are grateful for the resiliency and focus of our employees as they work to position us to rebound from these challenges.”

    Revenues for the third quarter of 2024 were $9.1 million, consisting of $2.2 million in our sell-side advertising segment and $6.9 million in our buy-side advertising segment. The key driver for the reduction of our revenue from prior periods was the pause by our customer as described above.

    Keith Smith, President, commented, “Our recently announced $20 million Equity Reserve Facility with New Circle Principal Investments provides us with enhanced financial flexibility to execute on our strategic initiatives while also strengthening our balance sheet. This new financing source will support both our technology investments and growth objectives as we continue to evolve our platform capabilities and position Direct Digital Holdings for sustainable, long-term growth.”

    Walker added, “Over these past few months, we have innovated and optimized our business and are now in a position of strength, well-situated to capitalize on several of our key growth initiatives. Direct Digital Holdings’ technology platform, diversified client base, optimized cost structure and new financing sources allow us to expand into new industry verticals, accelerate our direct integrations with leading demand-side platforms, advance our technological capabilities across our business and maintain our commitment to bringing underrepresented publishers into the programmatic ecosystem.”

    Advancing Innovation for Colossus SSP

    The Company expects to make investments to drive technological advancements for Direct Digital Holdings’ supply-side platform, Colossus SSP, including the launch of Colossus Connections, an aggressive initiative the Company is already executing to accelerate direct integrations with leading demand platforms. This initiative will aim to unlock direct access to more demand partners and revenue, while optimizing transaction costs and efficiency for Colossus SSP and its clients. As a result of Colossus Connections, the Company has already signed two of the leading demand-side partners, with those direct connections expected to go live in 2025.

    Additionally, for Colossus SSP, the Company is developing new curation and segment-based products in areas such as carbon, attention, and media quality, which are in high-demand among advertisers. The Company is also expanding efforts to bring underrepresented publishers and creators into the programmatic ecosystem, with their unique and premium inventory available through Colossus SSP.

    Enhancing Growth on the Demand Side

    On the demand-side, the Company expects that funding will support the recently announced unification of Direct Digital Holdings’ buy-side divisions, Orange 142 and Huddled Masses. This will enable the delivery of new capabilities, particularly in helping clients navigate emerging technologies, such as artificial intelligence and machine learning, as well as emerging, high-growth channels such as marketing-enabled services, connected TV, social media and retail media. Small- and mid-sized clients will be a key focus for the combined entity, as these clients are increasingly shifting advertising budgets to digital and require support to navigate its complexities and optimize their ad spend. Currently, the Company serves hundreds of small- and mid-sized clients, enabling over 2,000 campaigns each year.

    Third Quarter 2024 Financial Highlights:

    • For the third quarter of 2024, revenue was $9.1 million, a decrease of $50.4 million, or an 85% decline compared to the $59.5 million in the same period of 2023.
      • Sell-side advertising segment revenue fell to $2.2 million compared to $51.6 million in the same period of 2023, 96% decrease year-over-year. As described above, the key driver for this reduction was the suspension by one of our large customers following the defamatory article against the Company, and this customer has since restored its connection.
      • Buy-side advertising segment revenue fell to $6.9 million compared to $7.9 million in the same period of 2023, a 12% year-over-year decline.
    • Gross profit was $3.5 million, or 39% of revenue, in the third quarter of 2024 compared to $11.8 million, or 20% of revenue, in the same period of 2023.
    • Operating expenses were $7.2 million in the third quarter of 2024, a decrease of $0.1 million, or 1%, over $7.3 million in the same period of 2023.
    • Consolidated operating loss was $3.7 million, compared to operating income of $4.5 million in the same period of 2023, a decrease of $8.2 million or 181%.
    • Net loss was $6.4 million in the third quarter, compared to net income of $3.4 million in the same period of 2023.
    • Adjusted EBITDA(1) was a loss of $2.9 million in the third quarter of 2024, compared to positive Adjusted EBITDA of $5.4 million in the same period of 2023.
    • As of September 30, 2024, the Company held cash and cash equivalents of $4.1 million compared to $5.1 million as of December 31, 2023.
    (1) “Adjusted EBITDA” is a non-GAAP financial measure. The section titled “Non-GAAP Financial Measures” below describes our usage of non-GAAP financial measures and provides reconciliations between historical GAAP and non-GAAP information contained in this press release.

    Financial Outlook

    Assuming the U.S. economy does not experience any major economic conditions that deteriorate or otherwise significantly reduce advertiser demand, and subject to certain uncertainties related to the ramp-up of our businesses and general market conditions, Direct Digital Holdings is providing full-year revenue guidance of $60 million to $70 million for FY 2024 and full-year revenue guidance of $90 million to $110 million for FY 2025 as the Company rebuilds to previous levels.

    Diana Diaz, Chief Financial Officer, stated, “As we move forward, we are pleased to return to a normal cadence of reporting our financial results which will provide our investors with the timely and accurate information they deserve. We’re committed to delivering sustainable growth for our investors while offering our partners industry-leading marketing and advertising capabilities.”

    Smith added, “While Direct Digital Holdings is working to overcome these recent challenges, defamatory disinformation attacks go far beyond the advertising technology industry, distorting public perception, manipulating stock prices, often to the disadvantage of everyday investors, and stifling innovation. The weaponization of disinformation is posing a profound risk to small and up-and-coming businesses such as ours, and calls for a deeper dive into this pernicious and increasingly ubiquitous issue and an appropriate systemic response.”

    Conference Call and Webcast Details 

    Direct Digital will host a conference call on Tuesday, November 12, 2024 at 5:00 p.m. Eastern Time to discuss the Company’s third quarter 2024 financial results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/. Please access the website at least fifteen minutes prior to the call to register, download and install any necessary audio software. For those who cannot access the webcast, a replay will be available at https://ir.directdigitalholdings.com/ for a period of twelve months.

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10 K (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).

    The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.

    Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: conditions to our ability to sell Class A common stock under our equity reserve facility; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; failure to remedy any listing deficiencies noted in the deficiency letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC; the risk that the Listing Qualifications Department of The Nasdaq Stock Market LLC does not accept the Company’s plan to regain compliance with applicable rules to maintain its listing on The Nasdaq Capital Market; costs, risks and uncertainties related to the restatement of certain prior period financial statements; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.

    Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. 

    About Direct Digital Holdings

    Direct Digital Holdings (Nasdaq: DRCT) 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 the general market and multicultural media properties. The Company’s buy-side platform, Orange 142, delivers 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. Combined, Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app and other media channels.

    NON-GAAP FINANCIAL MEASURES

    In addition to our results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), including, in particular operating income, net cash provided by operating activities, and net income, we believe that earnings before interest, taxes, depreciation and amortization (“EBITDA”), as adjusted for loss on early termination of line of credit, revaluation of tax receivable agreement liability and stock-based compensation (“Adjusted EBITDA”), a non-GAAP financial measure, is useful in evaluating our operating performance. The most directly comparable GAAP measure to Adjusted EBITDA is net income (loss).

    In addition to operating income and net income, we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-GAAP financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

    • Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as depreciation and amortization, interest expense, provision for income taxes, stock-based compensation, revaluation of tax receivable agreement liability and certain one-time items such as acquisition costs, losses from early termination or redemption of credit agreements or preferred units and gains from settlements or loan forgiveness that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired;
    • Our management uses Adjusted EBITDA in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and
    • Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.

    Our use of this non-GAAP financial measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under GAAP. The following table presents a reconciliation of Adjusted EBITDA to net income (loss) for each of the periods presented:

    Contacts: 

    Investors:
    Brett Milotte, ICR
    investors@directdigitalholdings.com

    Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

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    SOURCE Direct Digital Holdings

    Released November 12, 2024

    Release – Eledon Pharmaceuticals Announces Recent Business Highlights and Third Quarter 2024 Financial Results

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ELDN

    November 12, 2024

    Completed enrollment of Phase 2 BESTOW trial of tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025

    Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

    Announced oversubscribed $85 million underwritten offering, with proceeds expected to extend cash runway to the end of 2026

    IRVINE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its third quarter 2024 operating and financial results and reviewed recent business highlights.

    “We believe tegoprubart has best-in-class potential as a novel immunosuppressive treatment option to prevent transplant rejection, with promising clinical results across kidney, xenograft, and now islet transplantations,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Recent encouraging data from the UChicago Medicine trial in type 1 diabetes, combined with our accelerated enrollment in the Phase 2 BESTOW trial and our strong capital position following our recent oversubscribed financing, has put us in a strong position to advance tegoprubart’s development. We look forward to sharing results from our BESTOW trial in the fourth quarter of 2025.”

    Recent Business Highlights

    • Completed enrollment for the Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than originally planned.
    • Announced positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppressive regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplantation Institute. The first two subjects achieved insulin independence and remain insulin free, with glucose control in the normal range; the third subject was recently transplanted and remains on a trajectory to also achieve insulin independence. Treatment with tegoprubart was generally well tolerated in all subjects with no unexpected adverse events. The data demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppressive therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
    • Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million, or net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing leading healthcare investors.

    Anticipated Upcoming Milestones

    • Mid-2025: Report updated interim clinical data from the ongoing Phase 1b and long-term safety and efficacy extension studies of tegoprubart in kidney transplantation.
    • 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
    • 2025: Report longer-term follow up from the investigator-led clinical trial with the UChicago Medicine Transplant Institute for pancreatic islet transplantation in subjects with type 1 diabetes.

    Third Quarter 2024 Financial Results

    Cash, cash equivalents and short-term investments totaled $78.2 million as of September 30, 2024, which does not include net proceeds of approximately $79.5 million received in the October 2024 underwritten offering. The company expects current cash, cash equivalents and short-term investments, together with the net proceeds from the October 2024 underwritten offering, to fund operations to the end of 2026.

    Research and development (R&D) expenses for the third quarter of 2024 were $16.5 million, compared to $7.9 million for the comparable period in 2023, an increase of $8.6 million. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b and Phase 2 BESTOW studies, an increase in employee compensation and benefits related to increased headcount, and greater chemistry, manufacturing and controls (CMC) expenses related to the production of clinical trial materials.

    General and administrative expenses for the third quarter of 2024 were $4.0 million, compared to $3.3 million for the comparable period in 2023, an increase of $0.7 million. The increase was primarily driven by a rise in professional services and an increase in general operating expenses.

    Net income for the third quarter of 2024 was $77.0 million, or $1.05 per basic share, compared with a net loss of $9.9 million, or $0.33 per basic share, for the comparable period in 2023, an increase of $86.9 million. The increase in net income was primarily driven by a non-cash gain of $96.4 million related to changes in the fair value of warrant liabilities and the fair value of financial instruments issued in excess of proceeds, recorded in the third quarter ending September 30, 2024. Excluding this gain, the company would have recorded a net loss of $19.5 million for the third quarter of 2024.

    About Eledon Pharmaceuticals and tegoprubart

    Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

    Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Stephen Jasper
    Gilmartin Group
    (858) 525 2047
    stephen@gilmartinir.com

    Media Contact:

    Jenna Urban
    Berry & Company Public Relations
    (212) 253 8881
    jurban@berrypr.com

    Source: Eledon Pharmaceuticals

    Release – Cadrenal Therapeutics Highlights Presentation at European Association For Cardio-Thoracic Surgery (EACTS) Medical Congress

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CVKD

    Leading heart failure specialist features tecarfarin data and Cadrenal’s proposed clinical trial protocol at 8th EACTS Mechanical Circulatory Support Summit

    PONTE VEDRA, Fla., Nov. 12, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, today highlighted a key opinion leader presentation at the November 2024 European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit that featured tecarfarin historical data and Cadrenal’s proposed clinical trial protocol to evaluate tecarfarin versus warfarin in patients with the Abbott HeartMate3 (HM3) left ventricular assist device (LVAD).

    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.)


    The presentation, titled Tecarfarin and Hemocompatibility with LVAD Therapy (TECH-LVAD), took place in Prague, Czech Republic and outlined Cadrenal’s proposed clinical trial protocol recently submitted to the U.S. Food and Drug (FDA). Dr. Mandeep R. Mehra, who holds the William Harvey Chair in Advanced Cardiovascular Medicine and is Executive Director, Center for Advanced Heart Disease, Brigham and Women’s Hospital, developed and delivered the TECH-LVAD presentation. In the presentation Dr. Mehra highlighted data from past trials demonstrating the inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients, and evidence from prior studies indicating tecarfarin’s potential ability to improve TTR. He included data from a trial in end-stage kidney disease (ESKD) patients showing that ESKD does not alter tecarfarin exposure while warfarin exposure is increased, explaining that this is one of the critical differentiators for tecarfarin because many LVAD patients have kidney impairment.

    Dr. Mehra, who also chaired Abbott’s ARIES-HM3 study in LVAD patients and is a Professor of Medicine, Harvard University, commented, “In the proposed TECH-LVAD trial, we plan to study a much-needed VKA option with the expectation of reducing bleeding events that accompany use of the HM3 LVAD in advanced heart failure. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation.”

    “As our team progresses discussions with the FDA and Abbott about a tecarfarin study in LVAD patients, increasing tecarfarin data visibility will help us to continue accelerating our development as we plan for investigator outreach and patient recruitment for our tecarfarin trial,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics.

    ABOUT CADRENAL THERAPEUTICS, INC.

    Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin’s superiority to warfarin in these patients where direct oral anticoagulants (DOACs) are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

    Safe Harbor Statement

    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 our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, tecarfarin’s potential ability to improve TTR; the plan to study a much-needed VKA option with the expectation to reduce bleeding events that accompany use of the HM3 LVAD in advanced heart failure; tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation and advancing the visibility of tecarfarin data helping to continue to accelerate the Company’s development as it plans for investigator outreach and patient recruitment for its tecarfarin trial. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “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 improve TTR and anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs) and those with ESKD with AFib, the collaborative efforts with Abbott being successful 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-highlights-presentation-at-european-association-for-cardio-thoracic-surgery-eacts-medical-congress-302301951.html

    SOURCE Cadrenal Therapeutics, Inc.

    Release – Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    November 12, 2024 8:00am EST Download as PDF

    Related Documents

    Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies

    Granted Fast Track Designation by FDA in July 2024 for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women

    Expect FDA decision in December 2024 on TNX-102 SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibromyalgia in more than 15 years

    Presented new data on potential mpox vaccine, TNX-801, in September and October 2024, demonstrating tolerability in immunocompromised animals; Previously reported studies showed a single-dose provided immune protection against a monkeypox challenge

    Awarded U.S. Department of Defense (DoD) contract for up to $34 million over five years in July 2024 to develop a broad-spectrum antiviral drug; Received first payment from DTRA

    CHATHAM, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the third quarter ended September 30, 2024, and provided an overview of recent operational highlights.

    “With our recent NDA submission to the U.S. Food and Drug Administration (FDA), Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in more than 15 years for the roughly 10 million adults in the U.S. suffering from fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “FDA awarded TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite FDA review of important new drugs to fill unmet needs for serious conditions. We look forward to next steps with FDA. If the NDA filing is accepted in December, we expect a decision on the marketing approval of TNX-102 SL for fibromyalgia in 2025.”

    Dr. Lederman continued, “As we continue to advance key pipeline products through a capital efficient strategy, we are excited to have announced collaborations with world-class institutions to advance the development of TNX-801, a potential mpox vaccine whose single-dose administration and other characteristics align closely with The World Health Organization’s preferred target product profile (TPP) criteria for mpox vaccines. The World Health Organization (WHO) previously announced the growing number of mpox cases constitutes a public health emergency of international concern (PHEIC), with clade 1b mpox strains now detected in 16 countries in Africa as well as in Sweden, Thailand, Singapore, India, England and Germany.”

    Key Product Candidates* — Recent Highlights

    Central Nervous System (CNS) Pipeline

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.

    • In October 2024, Tonix announced submission of the TNX-102 SL New Drug Application (NDA) for fibromyalgia to the FDA. The submission was based upon two Phase 3 studies of TNX-102 SL in fibromyalgia that showed statically significant reduction in the chronic, widespread pain associated with fibromyalgia. If approved by the FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years. Fibromyalgia affects more than 10 million adults in the U.S., most of whom are women.
    • In September 2024, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024), the Company announced data highlighting the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, including composition and methods patents based on the proprietary eutectic1 formulation of TNX-102 SL that are expected to provide market exclusivity until at least 2034 in the U.S., EU, Japan, China and other jurisdictions. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, improve pain and other fibromyalgia symptoms, while reducing the risk of daytime somnolence.
    • In August 2024, at both the DoD’s 2024 Military Health System Research Symposium (MHSRS), and at the International Association for the Study of Pain’s (IASP’s) 2024 World Congress on Pain, Tonix announced additional data and analyses of TNX-102 SL for the management of fibromyalgia. TNX-102 SL had met the pre-specified primary endpoint in the Phase 3 RESILIENT study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while demonstrating broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints, including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals were observed.
    • In July 2024, Tonix noted that, based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM), fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID. The Company believes that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL following approval as compared to market estimates from before the COVID-19 pandemic.

    TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

    • In August 2024 at the DoD’s MHSRS conference, the Company presented clinical data and rationale supporting the potential for TNX-102 SL to be studied for the treatment of ASR and prevention of PTSD. Prior studies showed that treatment with TNX-102 SL showed effects on sleep and PTSD symptoms in PTSD patients at two and four weeks1. This supportive data on the effects of TNX-102 SL on reducing PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential to reduce ASR/ASD symptoms which are similar to those of PTSD2,3. Data from these trials support testing of TNX-102 SL within 24 hours of index trauma for effects on ASR symptoms and the subsequent incidence of PTSD.
    • The DoD-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial will be conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application. The OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department (ED) after a motor vehicle collision. Fourteen days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The results may ultimately provide military personnel with a new treatment option that, when administered in the early aftermath of a traumatic event to individuals with ASR symptoms, improves warfighter function.

    TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

    • Tonix announced the first patient in the Phase 2 CATALYST study of TNX-1300 for the treatment of cocaine intoxication was enrolled in August 2024. CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department. Topline results are expected in the first half of 2025.
    • The National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) previously awarded Tonix a Cooperative Agreement grant for approximately $5 million from to support development of TNX-1300.
    • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

    Infectious Disease Pipeline

    TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.

    • In September 2024, at the DoD’s MHSRS conference and in October 2024 at the World Vaccine Congress in Barcelona, Spain, Tonix presented new data on potential mpox vaccine, TNX-801, demonstrating tolerability and no evidence of spreading to blood or tissues, even at high doses, in immunocompromised animals. TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge. After a single-dose vaccination, TNX-801 prevented clinical disease and lesions, and also decreased shedding in the mouth and lungs of non-human primates after a lethal challenge with Clade Ia monkeypox. These findings are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission.
    • In August 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC), the second such declaration in the past two years in response to transmission of the virus. Mpox cases of the new clade 1b mpox have since also been detected in Sweden, Thailand, Singapore, India, Germany and England.
    • In September 2024, the Company announced that the WHO’s preferred TPP aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.

    Footnotes:

    1. The TNX-102 SL eutectic is a composition of matter based on co-penetration of cyclobenzaprine HCl and mannitol crystals and protected by 5 issued U.S patents: Nos. 9,636,408; 9,956,188; 10,117,936; 10,864,175; 11,839,594; 9,918,948; 11,826,321.
    2. Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974.
    3. Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In Press). https://doi.org/10.1016/j.psychres.2024.115764

    Corporate and Partnerships – Recent Highlights

    • In November 2024, the Company announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix is expected be the sponsor and KEMRI is expected to lead the execution of the proposed clinical trial.
    • In October 2024, the Company announced it entered into an artificial intelligence and machine learning drug discovery collaboration with X-Chem, Inc., a leader in small molecule drug discovery, to accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures. Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families.
    • In September 2024, Tonix announced the appointment of Thomas Englese as its new Executive Vice President, Commercial Operations. Mr. Englese brings significant leadership to Tonix across several functions, including commercial operations, sales and marketing, and launching and managing major brands through all stages of commercialization.  
    • In August 2024, the Company announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801 as a potential mpox vaccine. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.  
    • In July 2024, Tonix announced it had been awarded a DoD contract with a potential for up to $34 million over five years by DoD’s Defense Threat Reduction Agency (DTRA). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an IIND submission and to fund a first-in-human Phase 1 clinical study.

    Marketed Products – Recent Highlights

    • In September 2024, Tonix announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,097,183 to the Company, claiming use of a pre-filled autoinjector comprising a composition of Zembrace® SymTouch® for treating migraines via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to fortify protection and market exclusivity into 2036.
    • Tonix announced that the USPTO issued U.S. Patent No. 12,090,139 to the Company, claiming a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for Tosymra®. This patent is expected to fortify protection and market exclusivity into 2030.

    Tonix Medicines launched a national educational campaign focusing on the link between migraine, gastroparesis, and the need for non-oral acute migraine therapies. Tonix Medicines is the only manufacturer with both a branded injectable and nasal spray indicated for the acute treatment of migraine with or without aura in adults.

    Financial – Recent Highlight

    As of September 30, 2024, Tonix had approximately $28.2 million of cash and cash equivalents, compared to approximately $24.9 million as of December 31, 2023. Additionally, Tonix had inventory totaling approximately $7.9 million as of September 30, 2024. Net cash used in operations was approximately $46.3 million for the nine months ended September 30, 2024, compared to approximately $79.7 million for the same period in 2023. Cash used in investing activities for the nine months ended September 30, 2024 was approximately $117,000 compared to $28.6 million for the same period in 2023.

    In July 2024, Tonix received net proceeds of approximately $3.5 million in a securities offering with certain institutional and retail investors. Additionally, during the three months ended September 30, 2024, Tonix sold approximately 134.5 million shares of common stock under the 2024 ATM Sales Agreement for net proceeds of approximately $41.8 million.

    Third Quarter 2024 Financial Results

    Net product revenue for the third quarter 2024 was approximately $2.8 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of sales for the third quarter 2024 was approximately $1.6 million.

    During the three months ended September 30, 2024, Tonix received its first payment from DTRA as part of its previously announced award from DTRA for up to $34 million over five years.

    Research and development expenses for the third quarter 2024 were approximately $9.1 million, compared to $21.0 million for the same period in 2023. This decrease is predominantly due to lower clinical, non-clinical and manufacturing expenses aligned with the Company’s capital efficient strategy.

    Selling, general and administrative expenses for the third quarter 2024 were approximately $7.7 million, compared to $8.7 million for the same period in 2023. The decrease was primarily due to lower employee-related expenses, transactional services and sales and marketing expenses partially offset by an increase in professional fees.

    Net loss available to common stockholders was approximately $14.2 million, or $0.23 per share, basic and diluted, for the third quarter 2024, compared to net loss available to common stockholders of $28.0 million, or $38.63 per share, basic and diluted, for the same period in 2023. The basic and diluted weighted average common shares outstanding for the third quarter 2024 was 62,122,283 compared to 724,190 shares for the same period in 2023.

    Tonix Pharmaceuticals Holding Corp.*
    Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in 2025. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

    Forward Looking Statements

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

    Investor Contact

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

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

    Media Contact

    Ray Jordan
    Putnam Insights
    ray@putnaminsights.com
    (949) 245-5432

    Primary Logo

    Source: Tonix Pharmaceuticals Holding Corp.

    Released November 12, 2024

    Release – Snail, Inc. to Report Third Quarter 2024 Financial Results

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on SNAL

    November 12, 2024 at 8:01 AM EST

    PDF Version

    CULVER CITY, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, announced today that it will report financial results for the third quarter ended September 30, 2024 on Wednesday, November 13, 2024. Management will host a conference call and webcast on the same day at 4:30 p.m. ET to discuss the results.

    Participants may listen to the live webcast and replay on the Company’s investor relations website at https://investor.snail.com/.

    About Snail, Inc.
    Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

    Contacts:

    Investors:
    investors@snail.com

    Press:
    media@snail.com

    Release – Noble Capital Markets Initiates Equity Research Coverage on Zomedica

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ZOM

    ANN ARBOR, MI / ACCESSWIRE / November 12, 2024 / Zomedica Corp. (NYSE American:ZOM), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is pleased to announce that Noble Capital Markets has initiated company-sponsored equity research coverage on the Company. The full report by Noble Capital Markets Research Analyst Robert LeBoyer, as well as news and advanced market data on Zomedica Corp., is available on Channelchek.

    About Zomedica

    Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet ® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi ® Loop line of therapeutic devices and the TRUFORMA ® diagnostic platform, the TRUVIEW ® digital cytology system, and the VetGuardian ® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $78 million in liquidity as of September 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

    Follow Zomedica

    About Noble Capital Markets

    Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com

    About Channelchek

    Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.com

    Investor Relations Contact:
    Zomedica Investor Relations
    investors@zomedica.com
    1-734-369-2555

    SOURCE: Zomedica Corp.

    View the original press release on accesswire.com

    Release – Grubhub Grows its Marketplace Offerings to Include Office Supplies with Office Depot

    Posted on by dburczyk@noblecapitalmarkets.com

    Research News and Market Data on ODP

    Office Depot is the first office supplies retailer on Grubhub and is available for on-demand delivery from more than 800 locations

    CHICAGO & BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 12, 2024– Grubhub announced today that it is adding office supplies to its marketplace in partnership with Office Depot, an operating company of The ODP Corporation and a leading omnichannel retailer dedicated to supporting small business, home office, and education customers live more productive and organized lives. More than 6,000 items are available for on-demand delivery, including laptops, printers, ink, paper products, writing supplies, tech accessories and more. Office Depot is Grubhub’s first office supplies retail partner.

    The addition of Office Depot provides even greater convenience for Grubhub Corporate Accounts clients — many of whom are office administrators responsible for restocking supplies. A recent survey found that more than 80 percent of administrators have encountered situations where they run out of essential supplies they need the same day. Furthermore, 67 percent said they would prefer supplies to be delivered the same day they place an order. Office Depot is also part of Grubhub+, Grubhub’s loyalty program that provides unlimited $0 delivery fees on eligible orders.* This offers significant value for corporate clients, with those surveyed ranking $0 delivery fees as their most important consideration.**

    “Whether they’re a student preparing for finals, an office administrator who needs to restock supplies, or a working professional setting up their home office, we’re excited about all of the ways our customers can benefit from having access to office supplies on Grubhub,” said Craig Whitmer, vice president of new verticals at Grubhub. “Adding office supplies to our marketplace reflects our commitment to being a platform where customers can get more of what they need.”

    “Partnering with Grubhub enhances our distribution reach and empowers us to better serve our customers’ unique needs,” said Kevin Moffitt, executive vice president of The ODP Corporation and president of Office Depot. “We are excited to join a dynamic marketplace where consumers can effortlessly shop for their office and personal essentials, ultimately fostering a more productive lifestyle.”

    More than 800 locations across 42 states are available for customers to order from. Office supplies is the latest category available for order on Grubhub, joining restaurants, convenience, grocery, and pet supplies.

    About Grubhub

    Grubhub is part of Just Eat Takeaway.com (LSE: JET, AMS: TKWY), and is a leading U.S. food ordering and delivery marketplace. Dedicated to connecting diners with the food they love from their favorite local restaurants, Grubhub elevates food ordering through innovative restaurant technology, easy-to-use platforms, and an improved delivery experience. Grubhub features 375,000 merchants in over 4,000 U.S. cities.

    About Office Depot

    Office Depot, LLC, an operating company of The ODP Corporation, is a leading specialty retailer providing innovative products and services delivered through a fully integrated omnichannel platform of Office Depot and OfficeMax retail stores and an award-winning online presence, OfficeDepot.com, to support the productivity and organization of its small business, home office and education clients. Office Depot is committed to enabling its clients’ success, strengthening local communities and providing equal opportunities for all. For more information, visit officedepot.com, download the Office Depot app on your iPhone or Android and follow @officedepot on Facebook, X, Instagram and TikTok.

    Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc

    *Terms and additional fees apply. Learn morehere.

    **Data points are based on an internal survey of Grubhub Corporate clients (2024)

    Office Depot Media Contact:
    MediaRelations@officedepot.com

    Grubhub Media Contact:
    press@grubhub.com

    Source: Office Depot

    Release – FreightCar America, Inc. Reports Third Quarter 2024 Results

    Posted on by dburczyk@noblecapitalmarkets.com

    Research News and Market Data on RAIL

    Company delivers 83% year-over-year revenue growth with strong gross margin

    Raises mid-point of full year Adjusted EBITDA guidance

    CHICAGO, Nov. 12, 2024 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (“FreightCar America” or the “Company”), a diversified manufacturer and supplier of railroad freight cars, railcar parts and components, today reported results for the third quarter ended September 30, 2024.

    Third Quarter 2024 Highlights

    • Revenues of $113.3 million on 961 railcar deliveries, compared to revenues of $61.9 million on 503 railcar deliveries in the third quarter of 2023, up 83% and 91% respectively
    • Gross margin of 14.3% with gross profit of $16.2 million, compared to gross margin of 14.9% with gross profit of $9.2 million in the third quarter of 2023
    • Net loss of ($107.0) million, or ($3.57) per share and Adjusted net income of $7.3 million, or $0.08 per share, driven by a ($110.0) million non-cash loss on warrant liability due to a significant appreciation in share price
    • Adjusted EBITDA of $10.9 million, compared to Adjusted EBITDA of $3.5 million in the third quarter of 2023, up 211%
    • Ended the quarter with a backlog of 3,611 units valued at $372 million

    “We again demonstrate the power of our disciplined approach to growth and operational excellence. Delivering another solid quarter, that continues the momentum for a record-setting year out of our operating facility. Our team has consistently followed through on our commitments, with robust product shipments and adaptable operating capabilities. This reinforces our ability to meet our customers’ needs while improving our gross margins, and further demonstrates the power of our value proposition. We continue to showcase our ability to secure business through innovative solutions, and our ease of doing business which has led to a consistent higher quality of earnings,” commented Nick Randall, President and Chief Executive Officer of FreightCar America.

    Randall continued, “Our pipeline is invigorated, with consistent demand across a broad range of railcar types. As we head into the fourth quarter, we are well positioned to sustain this momentum through our differentiated offerings and unique market approach. Our commitment to innovation and operational flexibility sets us apart in the industry, ensuring that we deliver long-term value for our customers and shareholders.”

    Fiscal Year 2024 Outlook

    The Company has updated its outlook for fiscal year 2024 as follows:

    Mike Riordan, Chief Financial Officer of FreightCar America, commented, “Given our strong order activity and delivery performance year to date, we are narrowing and raising the mid-point of our previously issued full-year EBITDA guidance to between $37 million and $39 million while reaffirming our previously stated revenue and delivery guidance. As we move forward, I am confident in our ability to achieve profitable growth and cash generation across the enterprise with an even stronger financial profile.”

    Third Quarter 2024 Conference Call & Webcast Information

    The Company will host a conference call and live webcast on Tuesday, November 12 at 11:00 a.m. (Eastern Time) to discuss its third quarter 2024 financial results. FreightCar America invites shareholders and other interested parties to listen to its financial results conference call via the following live and recorded methods:

    Live Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1693396&tp_key=feca4932b6

    Recorded Webcast: A recorded webcast will be available until Tuesday, November 26, 2024, on FreightCar America’s website following the conference call date at:   https://investors.freightcaramerica.com/news-events/event-calendar/

    Teleconference: Dial-in numbers for the live Conference Call are (877) 407-0789 or (201) 689-8562. Please call in at least 10 minutes prior to the start time of the call. An audio replay may be accessed at (844) 512-2921 or (412) 317-6671; Passcode: 13749627.

    About FreightCar America

    FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.

    Forward-Looking Statements

    This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials including steel and aluminum; future changes in U.S. tax laws and regulations or interpretations thereof; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion, delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings, and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

    Non-GAAP Financial Measures

    This press release includes measures not derived in accordance with generally accepted accounting principles (“GAAP”), such as EBITDA, Adjusted EBITDA, Adjusted net income (loss) and Adjusted EPS. These non-GAAP measures should not be considered in isolation or as a substitute for any measure derived in accordance with GAAP and may also be inconsistent with similar measures presented by other companies. Reconciliations of these measures to the applicable most closely comparable GAAP measures, and reasons for the Company’s use of these measures, are presented in the attached pages.

    Investor Contact:RAILIR@Riveron.com

    Click Here for Full Report

    Release – Bit Digital, Inc. Announces Date for Third Quarter 2024 Financial Results and Conference Call

    Posted on by dburczyk@noblecapitalmarkets.com

    Research News and Market Data on BTBT

    NEW YORK, November 11, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York, announced today that it will release its Third Quarter 2024 results on Monday, November 18, 2024, before the stock market opens. Senior management will host a live webcast and conference call to review the results on Monday, November 18, 2024, at 10:00 a.m. ET.

    To register for the earnings call, please click here. Additionally, participants can join the conference call by dialing 1-800-289-0462 (passcode: 781205).

    The Company will issue a press release regarding Third Quarter 2024 earnings prior to the conference call. The press release will be posted on the Bit Digital website at www.bit-digital.com.

    About Bit Digital

    Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. The Company has established a business line, Bit Digital AI, that offers infrastructure services for artificial intelligence applications. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com. 

    Investor Notice 

    Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our most recent Annual Report on Form 20-F for the fiscal year ended December 31, 2023. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors.

    Safe Harbor Statement 

    This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

    FOMO Frenzy: Small-Caps Are Outperforming, But Is It Safe to Invest?

    Posted on by slightbourne@noblecapitalmarkets.com

    In the wake of recent elections, the stock and cryptocurrency markets have surged as investor optimism is fueled by FOMO (Fear of Missing Out). While this bullish momentum brings opportunities, it also signals caution, especially given the high volatility seen across markets. For investors, understanding the potential and risks in this unique environment is key to making wise decisions.

    One notable trend is the recent outperformance of the Russell 2000 index, an index that tracks small-cap stocks, which has shown greater gains compared to larger indices like the S&P 500 and Nasdaq. This trend hints at potential opportunities within small-cap companies, but it’s crucial for investors to recognize the volatile backdrop surrounding these gains.

    The Russell 2000 index, composed primarily of small-cap stocks, has experienced a significant uptick in recent weeks, outpacing some of the larger, more familiar indices. Small-cap stocks historically perform well during economic recoveries, as investors tend to favor companies with high-growth potential. Smaller companies often have greater room for expansion compared to established giants, which can lead to impressive returns if these firms capitalize on their growth potential.

    For investors who can tolerate a higher level of risk, small-cap stocks within the Russell 2000 may offer appealing opportunities. However, even in an optimistic market, it’s essential to approach these investments carefully, as smaller companies tend to be more volatile and sensitive to economic shifts.

    Post-election optimism isn’t unusual, and investors often flock to markets anticipating favorable policies or economic changes that could benefit various sectors. This year, that optimism is even more pronounced as both traditional and digital markets see upward momentum. The crypto markets are also surging, with certain tokens like Bitcoin reaching new highs alongside the rally in stocks. These gains across both asset types contribute to the FOMO effect, where investors feel compelled to jump in quickly, potentially without due diligence.

    However, FOMO can lead to hasty decisions, as investors rush to capture potential gains without fully evaluating the risks. In the current climate, it’s critical to remember that the same forces driving prices up can lead to sudden drops as market conditions shift.

    Despite these upward trends, the high volatility in both stock and crypto markets should serve as a caution flag. Small-cap stocks, while promising, are known for their vulnerability to rapid price swings. They’re also more likely to be affected by liquidity issues, which can amplify losses during sell-offs. Similarly, cryptocurrencies are notoriously volatile and subject to external forces such as regulatory changes, technological developments, and shifts in investor sentiment.

    For those considering investments in these areas, being prepared for sudden price changes and being comfortable with the associated risks is essential.

    To navigate these volatile waters successfully, investors should keep the following tips in mind:

    • Risk Assessment – Understanding your personal risk tolerance is crucial, especially with small-cap stocks and cryptocurrencies. Not every portfolio is suited for high-risk, high-volatility assets, so evaluate carefully before diving in.
    • Diversification – A diversified portfolio can help manage risk by balancing small-cap and cryptocurrency investments with more stable assets. This approach can soften the impact of any single asset’s fluctuations, creating a more resilient portfolio.
    • Due Diligence – For investors interested in small-cap stocks, doing thorough research is essential. Look for companies with solid fundamentals, promising growth potential, and innovative offerings that set them apart from competitors.
    • Stay Informed – Markets can shift quickly, especially during periods of economic or political change. Following relevant news and trends can help investors stay ahead of potential risks and make informed decisions when the market moves.

    The post-election market surge brings both promise and caution. Investors looking to take advantage of small-cap stock outperformance or capitalize on crypto market gains should do so with a clear understanding of the risks. In a market driven by FOMO, a balanced approach that includes careful research, risk management, and diversification is key. With these strategies, investors can navigate today’s volatility effectively, capturing opportunities without losing sight of the inherent risks.

    Release – Aurania Nickel Samples from Corsica Yield Precious Metals as Well as Cobalt and Copper

    Posted on by dburczyk@noblecapitalmarkets.com

    Research News and Market Data on AUIAF

    Toronto, Ontario–(Newsfile Corp. – November 11, 2024) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) has received preliminary results from ongoing mineral processing, laboratory assay and metallurgical studies conducted by SGS Laboratories (Lakefield) Ltd. (“SGS”) on a sample of magnetic sand taken from Nonza Beach, Corsica, under independent supervision by Mr. John Rae, P. Geo. of Ontario, Canada. The nickel-bearing mineral in the black magnetic sand is awaruite, a naturally occurring nickel-iron alloy, which is both of high specific gravity (dense) and of high magnetic susceptibility (magnetic).

    Project Highlights:

    • Black beach sands from Nonza Beach, Corsica, contain the magnetic nickel-iron mineral awaruite transported by longshore drift from a nearby historic mine.
    • The beach is approximately 1350 metres long and up to 350 metres wide, with the beach material extending on the seabed up to at least an additional 600 metres offshore. The maximum beach thickness is estimated at 14 metres but this has yet to be tested by drilling.
    • Preliminary studies indicate the beach is 40% sand, up to 31.7% of which is magnetic, and a magnetic concentrate of the sand (containing awaruite+magnetite) yielded 40.1% nickel. 98% of the awaruite reports to the ˂ 1 mm fraction
    • New assays of an awaruite flotation concentrate yielded 71.4% nickel, 0.98% cobalt, 0.65% copper, 0.58 g/t gold, 0.09 g/t platinum and 0.39 g/t palladium
    • Further metallurgical studies are underway to determine the potential marketability of the mixed awaruite-magnetite as nickel-matte feedstock versus pure awaruite as a polymetallic product
    • Study of identical sands at the nearby Albo Beach are also underway

    SGS was able to isolate a nearly pure awaruite concentrate using a combination of grinding and flotation of magnetic sand collected in a traverse of Nonza Beach using a high field strength rare earth magnet. The awaruite flotation concentrate assayed 71.4% nickel, 0.98% cobalt, 0.65% copper, 0.58 g/t gold, 0.09 g/t platinum and 0.39 g/t palladium. The flotation method was able to recover 83.8% of the nickel contained in the magnetic sand, which had a head grade of 6% nickel. Using reverse flotation, a second product of nearly pure (93%) magnetite was obtained. This process has not been optimised and is a “first pass” only. It is believed that the recovery of nickel from the raw magnetic sand can be improved.

    An examination of the literature shows that platinum group metal (“PGM”) enrichment in awaruite is quite rare. The only other occurrence documented being in the Kamchatka Peninsula of Russia[1] The Company had previously determined that the Corsican awaruite contains PGMs by electron microprobe analysis carried out at Western University in Canada, and these new assay results by SGS confirm and quantify this.

    As presented in the Company’s press release dated October 3, 2024, a Mozley gravity table concentrate of magnetic beach sand generated by SGS yielded 40.1% nickel. The Company believes that an “impure” awaruite-magnetite gravity concentrate by itself could be potentially saleable as feedstock for a nickel-matte furnace. However, recovery and isolation of a pure awaruite product may allow for the extraction of cobalt, copper, and precious metals in a “value-added” scenario. Hydrometallurgical studies using an atmospheric leach on the remainder of the sample recovered by flotation is in progress with encouraging early results. The Company has no plan at this time to build a refinery or manufacture any battery grade materials but would like to explore all possibilities for commerciality.

    The Company notes that it has not done sufficient work to determine a compliant resource at this juncture.

    Qualified Persons:
    The geological information contained in this news release has been verified and approved by Aurania’s VP Exploration, Mr. Jean-Paul Pallier, MSc. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.

    About Aurania
    Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

    Information on Aurania and technical reports are available at www.aurania.com and www.sedarplus.ca, as well as on Facebook at https://www.facebook.com/auranialtd/, Twitter at https://twitter.com/auranialtd, and LinkedIn at https://www.linkedin.com/company/aurania-resources-ltd-.

    For further information, please contact:

    Carolyn Muir
    VP Corporate Development & Investor Relations
    Aurania Resources Ltd.
    (416) 367-3200
    carolyn.muir@aurania.com

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

    Forward-Looking Statements
    This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the tonnage and grade of mineralization which has the potential for economic extraction and processing, the merits and effectiveness of known process and recovery methods, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the Company’s teams being on track ahead of any drill program, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: failure to identify mineral resources; failure to convert estimated mineral resources to reserves; the inability to complete a feasibility study which recommends a production decision; the preliminary nature of metallurgical test results; the inability to recover and process mineralization using known mining methods; the presence of deleterious mineralization or the inability to process mineralization in an environmentally acceptable manner; commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.