HOUSTON, Aug. 29, 2024 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) (NASDAQ: GLDD), the largest provider of dredging services in the United States, announced today that the Company’s issuer credit rating has been upgraded to “B-” from “CCC+” by S&P Global Ratings (“S&P”).
S&P based its ratings upgrade in part due to the Company’s improved revenue and profitability in the first half of 2024. S&P also cited that the Company’s strong backlog and recent awards gives visibility into improved cash flows through 2025. The stable rating reflects S&P’s expectation that the Company will continue to expand revenue and improve profitability throughout the remainder of 2024 and into 2025.
Great Lakes’ Senior Vice President and CFO Scott Kornblau commented, “We are pleased with the recent credit rating upgrade from S&P, which further demonstrates the improvements we have made this year to our balance sheet, cash flows and overall performance. This upgrade not only validates our efforts but also positions us for future growth and success.”
The Company Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 134-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.
Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking” statements as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future events.
Although Great Lakes believes that its plans, intentions and expectations reflected in this press release are reasonable, actual events could differ materially. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.
For further information contact: Tina Baginskis Director, Investor Relations 630-574-3024
MCLEAN, Va., Aug. 27, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) has appointed Jeremy Nance as General Counsel. In this role, Nance will be responsible for managing all legal matters related to V2X’s operations, transactions, and business practices. He will also join the executive team and report directly to President and Chief Executive Officer, Jeremy C. Wensinger.
Nance has served on V2X’s legal team since July 2018, and most recently as Vice President, Deputy General Counsel and Chief Compliance Officer for the company. “Jeremy Nance brings a wealth of experience and a deep understanding of the legal landscape that will benefit V2X as we continue to grow in our industry,” said Jeremy C. Wensinger, President and CEO of V2X.
In a related move, V2X’s Sarita Malakar has been named Corporate Secretary and Sustainability Officer, assuming responsibility for ensuring the efficient and compliant operation of the Board of Directors. Malakar, who has been an essential part of V2X since July 2022, currently serves as Vice President and Deputy General Counsel and Assistant Secretary, bringing a strong legal background and governance expertise to her new role.
These appointments follow Kevin Boyle’s departure, who is departing after six years of valuable service to V2X. The company expresses its gratitude for Boyle’s contributions and wishes him well in this future endeavors.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA IR@GOv2x.com 719-637-5773
MCLEAN, Va., Aug. 26, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) announces that it has been awarded a single award indefinite-delivery/indefinite-quantity contract valued at $747 million. The F-5 aircraft play a crucial role in training naval pilots by providing adversary combat tactics and simulation capabilities. This advanced training environment ensures that pilots are well-prepared for real-world scenarios, enhancing their combat readiness and proficiency. The use of F-5s in an aggressor-training role contributes significantly to the overall readiness of our armed forces, ensuring they are equipped with the skills and experience needed to protect the nation effectively.
This contract underscores V2X’s commitment to supporting our nation’s military readiness and ensuring the sustainability of these essential assets.
“We are honored to have been selected for this critical endeavor, further solidifying our dedication to providing industry leading support for our nation’s defense,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “We look forward to leveraging our expertise and capabilities to ensure the operational excellence of the F-5 aircraft and, by extension, the readiness of the U.S. Navy and Marine Corps.”
V2X will be responsible for delivering critical support and operational readiness of the F-5 Adversary aircraft. The work will encompass multiple locations across the United States.
Under this firm-fixed price contract, the comprehensive scope of services is projected to continue through November 2028 on the base contract, with three one-year options that could extend through November 2031, bringing the overall contract value to more than $747 million.
About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
CHATHAM, NJ / ACCESSWIRE / August 23, 2024 / Following an upsurge of cases in the Democratic Republic of the Congo and several other countries in Africa, the World Health Organization (WHO) declared mpox a public health emergency of international concern on Aug. 14 – the second such declaration in two years. The WHO has called on vaccine manufacturers to step up efforts to curb the spread of a new, more deadly strain of the virus.
The WHO also is asking companies and organizations to bring in their vaccines, inviting developers of mpox vaccines to submit an Expression of Interest for Emergency Use Listing (EUL).
Amid this backdrop, Tonix Pharmaceuticals (NASDAQ:TNXP) is developing a vaccine candidate, called TNX-801, that could play a role in combating this escalating global health crisis. Tonix has successfully completed non-human primate studies showing protection from challenge with lethal doses of the Clade 1 monkeypox virus that is driving the new epidemic.
Clearly more testing is ahead for TNX-801, but the technology behind it is rooted in the science of Edward Jenner’s smallpox vaccine of the late 1700s, the only vaccine to successfully eradicate a contagious viral pathogen.
These credentials have earned the vaccine technology platform upon which TNX-801 is based a competitive spot in the NIH’s NextGen program for a more effective, single-dose COVID-19 vaccine to potentially provide durable protection instead of the every-six month booster strategy of mRNA vaccines.
Last month, another of Tonix’s technologies was awarded a contract for up to $34 million by the U.S. Department of Defense to develop a single broad spectrum antiviral that would work against multiple potential biowarfare agents.
An Historical Approach to Modern Challenges The current mpox crisis can be traced back to a decision made in the 1970s to discontinue routine smallpox vaccinations after smallpox was successfully eradicated. Research shows that the smallpox vaccine also provided immunity against mpox. In retrospect, smallpox vaccination kept mpox out of the human population in Africa. So an unintended consequence of stopping vaccinations for smallpox meant that mpox, then known as monkeypox (which is still the name of the virus), was able to reemerge in the human population.
Tonix’s mpox vaccine is believed to be closely related to the original smallpox vaccine invented by British physician Edward Jenner in 1796. Jenner’s vaccine is credited with being the first and only vaccine to successfully eradicate a viral pathogen. This triumph depended on several important attributes of the vaccine, including that it was generally well-tolerated, provided long-term immunity with a single dose, prevented forward transmission and provided a simple biomarker confirmation of protective immunity known as a “take”.
TNX-801 is designed to have these same attributes; it is delivered in a single dose that provides protective immunity to animals that is marked by a “take”. It is believed to have a high likelihood of providing durable immunity and preventing forward transmission. Furthermore, unlike many other vaccines, TNX-801 does not require complex ultra cold-chain storage, making it a strong candidate for global distribution.
The Science Behind TNX-801 Unlike mRNA vaccines, which primarily elicit an antibody response that requires frequent booster shots, TNX-801 is designed to trigger a robust T-cell response. T-cells have the ability to recognize and remember internal parts of viral proteins, not just those on the surface. T-cell memory lasts for years – even decades – providing long-term immunity and potentially eliminating the need for repeated boosters.
In preclinical trials, Tonix says TNX-801 demonstrated the ability to prevent death, clinical disease and lesions caused by a lethal challenge of monkeypox virus in non-human primates. Similar to Jenner’s smallpox vaccine, TNX-801 also significantly reduced viral shedding, suggesting that it can block forward transmission,. Tonix is rushing to manufacture vaccine suitable for Phase 1 human trials.
Beyond Mpox: A Platform for Future Pandemics The vaccine platform on which TNX-801 is based has potential applications beyond mpox. The company says the TNX-1800 version of the platform, for example, is designed to protect against COVID-19 and has shown promise in preclinical studies. The U.S. National Institute of Health has recognized the potential of Tonix’s platform by selecting it for Project NextGen, aimed at developing next-generation COVID-19 vaccines and pandemic platform technologies.
As the world faces the growing threat of mpox and other infectious diseases, Tonix Pharmaceuticals is not only attempting to address the current crisis with TNX-801, but also potentially contributing to a future where pandemics can be more predictably contained.
PONTE VEDRA, Fla., Aug. 22, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it will be engaging with the U.S. Food and Drug Administration (FDA) in early September for a Type-B meeting to discuss its clinical trial for tecarfarin in LVAD patients.
“This upcoming meeting with the FDA is a crucial step in developing tecarfarin as we prepare for our pivotal trial. We look forward to discussing the development program for tecarfarin in LVAD patients,” said Quang Pham, Chief Executive Officer of Cadrenal Therapeutics.
ABOUT LVAD PATIENTS
Left Ventricular Assist Devices (LVADs) are mechanical pumps to support heart function in patients with advanced heart failure. These devices are vital for patients awaiting heart transplants or those who are ineligible for transplants. However, LVAD patients face an increased risk of thromboembolic events, such as strokes, which necessitates ongoing anticoagulation therapy. The current anticoagulation therapy, warfarin, presents challenges, including variability in dosing, a narrow therapeutic window, and potential interactions with other medications, making effective management crucial to reducing complications and ensuring patient safety.
ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices. Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in 11 human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
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 the Company engaging with the FDA in early September for a Type-B meeting to discuss its clinical trial for tecarfarin in LVAD patients and the planned pivotal 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 anticoagulation treatment in patients, the success of the Type-B meeting, the ability of the Company to commence and complete a pivotal trial and commercialize tecarfarin with patients with left ventricular assist devices (LVADs), 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 SEC, 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
MustGrow has received the Arizona Department of Agriculture approval to commence sales of TerraSanteTM, an organic biofertility product, in the State of Arizona.
Mustard-derived TerraSanteTMfocuses on soil and soil microbiome health, nutrient/water use efficiencies, and plant yields.
SASKATOON, Saskatchewan, Canada, August 22, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of the Arizona Department of Agriculture registration approval for its mustard plant-based TerraSanteTM, an organic biofertility product. The Arizona organic certification is included under MustGrow’s existing Organic OMRI Listed® certifications in Idaho, Oregon, and Washington State.
MustGrow’s Arizona registration and organic certification is a key pillar in the commercialization strategy with BioAg Product Strategies. Notably, several large California agriculture companies utilize Arizona’s winter climate for winter farming production. In addition to Arizona, and recently-awarded Idaho, California, Oregon and Washington State, MustGrow expects to continue its efforts towards further state-level registrations in other pertinent U.S. states.
With over 25 million acres of farmland, Arizona farms produced US$3.0 billion in agricultural crop products in 2022.1 The Vegetable/Melon/Potatoes category led with US$1.43 billion in sales.2 Arizona is ranked 2nd in the U.S. production for head lettuce, leaf lettuce, romaine lettuce, cauliflower, broccoli, spinach, and cantaloupe. Yuma County is considered the winter lettuce capital of the world, also highly regarded for its leafy greens, broccoli, and cauliflower.3
TerraSanteTM for Soil and Ecological Health
MustGrow’s soil amendment and biofertility development programs focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.
As an organic biofertilizer in soluble mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed the soil and soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.
MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation. Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its Organic Materials Review Institute (OMRI Listed®) and California’s Organic Input Material (OIM) Program registered biofertility product, TerraSanteTM, in key U.S. states including California. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. MustGrow has approximately 51.6 million basic common shares issued and outstanding and 54.1 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: its commercialization strategy; its continuing efforts towards further state-level registrations; TerraSanteTM ability to improve beneficial microbial activity; the ability of TerraSanteTM to increase plant vigor and yields; and the ability of TerraSanteTM to improve crop nutrient uptake. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2023 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
MCLEAN, Va., Aug. 21, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) announces a mission critical win to provide readiness capabilities to the U.S. Army worldwide under the Warfighter-Training Readiness Solutions (W-TRS) task order. Valued at $3.7 billion over five years, including option periods, this task order further solidifies V2X’s leading role in enabling full spectrum readiness for every soldier and unit across the U.S. Army.
At the heart of this initiative is the mission enablement services for the Army’s expansive network of Training Aids Devices Simulations and Simulators (TADSS). V2X will provide a flexible enterprise solution that will seamlessly support hundreds of thousands of these critical devices worldwide, evolving warfighter training needs.
“We are leading Army readiness with solutions that incorporate technology, techniques, and integration for a rapidly changing operational environment. W-TRS empowers the Army to harness cutting-edge innovation swiftly, making sure our forces remain agile and prepared against all threats,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. Wensinger reaffirmed V2X’s dedication to the strategic readiness of the Army, “This comprehensive effort ensures our warfighters are properly prepared to keep the nation safe and that our customers are enabled to execute missions around the globe.”
“V2X has a proven track record of providing high-consequence mission readiness to the Army, and we are honored the Army has continued to put their trust in V2X to ensure every soldier and unit in the Army has the tools they need to conduct realistic training so they are prepared whenever called upon to deploy,” said Ken Shreves, Senior Vice President of Global Mission Solutions at V2X. “This win underscores V2X’s commitment to delivering comprehensive, end-to-end solutions throughout the entire mission lifecycle.”
For decades, V2X has partnered with the U.S. Army at two of its four Combat Training Centers: the National Training Center in Fort Irwin, California, and the Joint Multinational Readiness Center in Germany. We continue to provide solutions to U.S. Army Central Command in Kuwait. V2X’s dedication to supporting the U.S. Army extends beyond operational excellence to safeguarding national security through robust mission critical initiatives. As the premier mission solution partner for the Army, V2X ensures readiness across all global theaters, reinforcing our nation’s defenses during both peacetime and active operations.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Analysis features the growing need to evolve anticoagulation therapy beyond warfarin to avoid gastrointestinal bleeding, a significant and common complication for left ventricular assist device (LVAD) patients resulting in expensive hospitalizations
Tecarfarin, a novel vitamin K antagonist (VKA), uses a different metabolic pathway than warfarin, the most commonly used anticoagulant for LVAD patients, and may offer more stable and effective anticoagulation
PONTE VEDRA, Fla., Aug. 20, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation VKA oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices or rare cardiovascular conditions, today highlighted a manuscript that was recently peer-reviewed and published in the Journal of Cardiac Failure evaluating the relationship between time in therapeutic range, or TTR, management quality and LVAD patient clinical outcomes. These findings focus on the potential role of investigating new VKA agents beyond warfarin in improving clinical outcomes in LVAD patients.
In the manuscript co-authored by Mandeep R. Mehra, MD, MSc, FRCP, Brigham and Women’s Hospital Heart and Vascular Center, Center for Advanced Heart Disease, titled “Antithrombotic Strategies with Left Ventricular Devices,” the findings conclude that although the current generation of LVAD pumps has largely overcome hemocompatibility-related adverse events there is a continuing need to evolve the anticoagulant therapy to avoid persistent gastrointestinal bleeding, which leads to frequent hospital admissions, procedures, blood transfusions, decreased quality of life and increased cost of care.1
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, commented, “Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
A secondary analysis of the ARIES-HM3 trial, sponsored by Abbott, evaluated the relationship between VKA management quality and clinical outcomes, wherein a median TTR for VKAs of 56% was achieved. This analysis found an inverse relationship between TTR and bleeding events, with a 47% reduction in bleeding risk for patients with a TTR above the median. Lower TTRs were associated with threefold more sub-therapeutic INRs than supra-therapeutic INRs, with no clear correlation between higher INRs and bleeding events.
“These findings provide us with increased confidence that tecarfarin has the potential to address the LVAD patients’ critical unmet anticoagulation needs more effectively,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “We are excited to work with the LVAD community to potentially bring our next-generation VKA to patients.”
About Tecarfarin Tecarfarin is the only oral anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions. It has been uniquely designed to overcome many of the challenges patients experience with warfarin. Tecarfarin is metabolized using carboxyl esterase rather than the cytochrome P450 system, which allows the drug to avoid interactions with many other commonly used medications and may offer more stable anticoagulation, including those patients with renal dysfunction, which is common in LVAD patients. In a Phase II study with 66 patients with atrial fibrillation switched from warfarin to tecarfarin, the mean interpolated TTR was 71.4% within three weeks, with minimal time spent in extreme INR ranges (<1.5 and >4.0). If approved, tecarfarin has the potential to be the only on-label drug for LVAD patients in the U.S.
In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage kidney disease and atrial fibrillation or those with mechanical heart valves and hard-to-control International Normalized Ratio, which measures how long it takes the blood to clot.
On August 6, 2024, Cadrenal Therapeutics announced that it had been in discussions with Abbott about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. LVAD patients require lifelong anticoagulation to protect against thromboembolic events. The only LVAD available in the U.S. is Abbott’s HeartMate 3TM.
On April 9, 2024, Cadrenal Therapeutics announced that the U.S. Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the LVAD.
About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics Is Developing Tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has an orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome. Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in 11 human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
Safe Harbor Statement Any statements 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 tecarfarin offering more stable and effective anticoagulation than warfarin, the potential role of investigating new VKA agents beyond warfarin in improving clinical outcomes in LVAD patients, the continuing need to evolve the anticoagulant therapy to avoid persistent gastrointestinal bleeding and tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin, tecarfarin having the potential to address the LVAD patients’ critical unmet anticoagulation needs more effectively and potentially bringing the Company’s r next-generation VKA to patients 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 anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), 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 SEC, 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
Vancouver, British Columbia–(Newsfile Corp. – August 20, 2024) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) is pleased to provide its financial and operating results for the three and six months ended June 30, 2024, declare a quarterly dividend payment to shareholders, and provide an operations update.
Q2 2024 Highlights
Achieved record quarterly production of 3,628 boe/d (99% heavy oil), a 26% increase over the same quarter last year.
Attained quarterly revenue of $28.9 million, a 52% increase from the second quarter of 2023.
Delivered operating netback1 of $17.7 million or $53.58/boe for the quarter.
Realized quarterly adjusted funds flow from operations (“AFF”)1 of $13.6 million or $41.13/boe.
Invested $3.0 million of capital expenditures in the Company’s Marsden and Atlee Buffalo properties.
Achieved quarterly free funds flow1 of $10.6 million or $0.11/share.
Exited the second quarter with a positive working capital1 position of $11.6 million.
Distributed $2.5 million or $0.025/share in dividends to shareholders during the quarter.
Announced a special dividend of $0.03/share to shareholders that was paid subsequent to the quarter on July 26, 2024.
Purchased and cancelled 1,054,200 shares under the Company’s Normal Course Issuer Bid (“NCIB”).
Renewed the Company’s $35 million two-year extendible credit facility.
(1) Operating netback, adjusted funds flow from operations (AFF), free funds flow, capital expenditures, and working capital are non-IFRS measures, or when expressed on a per share or boe basis, non-IFRS ratio, that do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other entities. Non-IFRS financial measures and ratios are not standardized financial measures under IFRS and may not be comparable to similar financial measures disclosed by other issuers. Refer to the section “Non-IFRS and Other Specified Financial Measures”.
Selected financial and operational highlights should be read in conjunction with Hemisphere’s unaudited consolidated interim financial statements and related notes, and the Management’s Discussion and Analysis for the three and six months ended June 30, 2024 which are available on SEDAR+ at www.sedarplus.ca and on Hemisphere’s website at www.hemisphereenergy.ca. All amounts are expressed in Canadian dollars unless otherwise noted.
CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department
More than 27,569 individuals in the U.S. died from drug overdose deaths involving cocaine in 2022; there is currently no FDA-approved product for cocaine intoxication
Topline results are expected in the first half of 2025
CHATHAM, N.J., Aug. 20, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the first patient has been dosed in the Phase 2, single-blind, placebo-controlled, proof of concept trial of TNX-1300 (double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of acute cocaine intoxication in the emergency department (ED). TNX-1300 is a recombinant enzyme that rapidly and efficiently degrades and metabolizes cocaine in cocaine users, as demonstrated in a prior Phase 2a randomized, double-blind, placebo-controlled, laboratory-based clinical study, providing support for the use of TNX-1300 as a treatment for life-threatening cocaine intoxication.1
Tonix has been awarded a Cooperative Agreement Grant from National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300 for the treatment of cocaine intoxication. In addition, TNX-1300 has been granted Breakthrough Therapy designation by the U.S Food and Drug Administration (FDA).
“Cocaine abuse and dependence are major problems in the U.S. However, there is currently no FDA-approved treatment indicated for cocaine intoxication, a life-threatening state characterized by acute symptoms including agitation, hyperthermia, tachycardia, arrhythmias, hypertensive crisis, myocardial infarction, stroke, and seizures,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In 2022, the number of overdose deaths involving cocaine reached 27,569 individuals.2 With approximately 505,000 emergency room visits annually involving cocaine use and approximately 61,000 of the visits involving detox services to treat cocaine overdose,3,4 we believe TNX-1300 has the potential to help address the morbidity and mortality caused by cocaine intoxication. By targeting the cause rather than the symptoms of cocaine intoxication, TNX-1300 may offer significant advantages to the current standard of care for cocaine overdose.”
The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 to placebo injection plus standard of care alone for the treatment of signs and symptoms of acute cocaine intoxication. The study is being conducted in the EDs of six academic medical centers in the U.S. It will include approximately 60 subjects presenting to the ED with cocaine intoxication. During the treatment period, subjects randomized to receive TNX-1300 will receive a single i.v. injection of TNX-1300 administered over two minutes or less; whereas subjects randomized to receive standard of care alone will receive a single i.v. saline injection over two minutes or less. For both study arms, signs and symptoms of cocaine intoxication will be assessed at pre-determined time points after treatment. After randomization, blood samples will be drawn at specific time points to assess the pharmacokinetics of TNX-1300 and levels of cocaine and its metabolites in the plasma. The primary endpoint of the study is reduction of systolic blood pressure associated with acute cocaine intoxication identified at study baseline comparing TNX-1300 to placebo with standard of care after 60 minutes. A variety of secondary endpoints will be measured, including reduction of circulating cocaine and levels of its metabolites at multiple post-baseline timepoints.
For more information, see ClinicalTrials.gov Identifier: NCT06045793
About TNX-1300
TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. TNX-1300 is a recombinant protein enzyme produced through recombinant DNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine esterase (CocE) was identified in bacteria (Rhodococcus) that uses cocaine as its sole source of carbon and nitrogen and that grows in soil surrounding coca plants.5 The gene encoding CocE was identified and the protein was extensively characterized.5–8 CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at human body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours at body temperature.8 In a Phase 2 laboratory-based study in volunteers who use cocaine, TNX-1300, at 100 mg or 200 mg i.v. doses, was well tolerated and rapidly reduced cocaine effects after cocaine 50 mg i.v. challenge.1
About Cocaine Intoxication andOverdose
Cocaine is an illicit recreational drug which is taken for its pleasurable effects and associated euphoria. In 2022, over 5 million individuals in the U.S. reported current cocaine use, almost 2% of the population.9 Pharmacologically, cocaine blocks the reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within the synapse and an amplification of dopamine signaling and its capacity to produce euphoric mood states. With the continued use of cocaine, however, intense cocaine cravings occur resulting in a high potential for abuse and addiction (dependence), as well as the risk of acute cocaine intoxication. Cocaine intoxication refers to the deleterious effects on several body systems, especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication are sent immediately to the emergency department (ED), preferably by ambulance in case cardiac arrest occurs during transit. The standard of care for treating cocaine intoxication in the ED focuses on symptom management, preventing complications, and supporting cardiovascular, respiratory, and neurological function, e.g. benzodiazepines for agitation, seizures, and sympathetic overdrive; antihypertensives for extremely elevated blood pressure; aspirin and nitroglycerine for cardiac ischemia. There are approximately 505,000 emergency room visits for cocaine abuse each year in the U.S., of which 61,000 require detoxification services.3,4 According to the National Institute on Drug Abuse, in 2022 the number of overdose death involving cocaine reached 27,569 individuals.2 In 2019, Black Americans experienced the highest death rate for overdoses involving cocaine, at 10.7 per 100,000.10
References
1 Nasser et al. A randomized, double-blind, placebo-controlled trial of RBP-8000 in cocaine abusers: pharmacokinetic profile of rbp-8000 and cocaine and effects of RBP-8000 on cocaine-induced physiological effects. J Addict Dis. 2014;33(4):289-302.
3 Substance Mental Health Services Administration, Drug Abuse Warning Network, 2011: National Estimates of Drug- Related Emergency Department Visits. HHS Publication No. (SMA) 13-4760, DAWN Series D-39. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.
4 Drug Abuse Warning Network, 2011: Selected Tables of National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Center for Behavioral Health Statistics and Quality, SAMHSA, 2013.
5 Bresler, et al. Gene cloning and nucleotide sequencing and properties of a cocaine esterase from Rhodococcus sp. strain MB1. Appl Environ Microbiol. 2000. 66(3):904-8.
6 Larsen, et al. Crystal structure of a bacterial cocaine esterase. Nat Struct Biol. 2002. 9(1):17-21.
7 Turner, et al. Biochemical characterization and structural analysis of a highly proficient cocaine esterase. Biochemistry. 2002. 41(41):12297-307.
8 Gao, et al. Thermostable variants of cocaine esterase for long-time protection against cocaine toxicity. Mol Pharmacol. 2009. 75(2):318-23.
10 Kariisa, et al. Drug overdose deaths involving cocaine and psychostimulants with abuse potential among racial and ethnic groups – United States, 2004-2019. Drug Alcohol Depend. 2021. 1;227:109001.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. 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 the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) 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, instrumental in progressing this development. 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 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.
NEW YORK, August 19, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City, today announced its unaudited financial results for the Second Quarter ended June 30, 2024.
Financial Highlights for the Second Quarter of 2024
Total revenue was $29.0 million for the Second Quarter of 2024, a 220% increase compared to the Second Quarter of 2023. The increase was primarily driven by the commencement of our high performance computing services (“HPC”) business and by a higher realized bitcoin price.
Revenue from bitcoin mining was $16.1 million for the Second Quarter of 2024, an 80% increase compared to the prior year’s quarter. The Company’s HPC recognized $12.5 million of revenue during the quarter compared to nil the prior year.
The Company had cash, cash equivalents and restricted cash of $61.4 million, and total liquidity (defined as cash, cash equivalents and restricted cash, USDC, and the fair market value of digital assets) of approximately $191.9 million1, as of June 30, 2024.
Total assets were $315.5 million and Shareholders’ Equity amounted to $295.3 million as of June 30, 2024.
Adjusted EBITDA2 was $(3.8) million for the Second Quarter of 2024 compared to $1.9 million for the Second Quarter of 2023. Adjusted EBITDA includes an $11.5 million unrealized loss on digital assets.
GAAP loss per share was $0.09 on a fully diluted basis for the Second Quarter of 2024 compared to a loss per share of $0.03 for the Second Quarter of 2023.
Operational Highlights for the Second Quarter 2024
The Company earned 244.2 bitcoins during the Second Quarter of 2024, a 23% decrease from the prior year. The decline was primarily driven by a reduction in block rewards following the halving event in April 2024 and by an increase in network difficulty.
The Company paid approximately $0.047 per kilowatt hour to its hosting partners for electricity consumed during the Second Quarter of 2024.
The average fleet efficiency for the active fleet was approximately 27.9 J/TH as of June 30, 2024.
The Company earned 109.4 ETH from native staking in the Second Quarter of 2024.
Treasury holdings of BTC and ETH were 585.6 and 27,226.23, respectively, with a fair market value of approximately $36.7 million and $93.5 million on June 30, 2024, respectively.
The BTC equivalent4 of our digital asset holdings as of June 30, 2024 (defined as if all ETH and USDC holdings were converted into BTC as of that date) was approximately 2,082.1 BTC5, or approximately $130.5 million.
As of June 30, 2024, we had 50,044 miners owned or operating (in Iceland) for bitcoin mining with a total maximum hash rate of 4.3 EH/s.
The Company’s active hash rate of its bitcoin mining fleet was approximately 2.6 EH/s as of June 30, 2024.
The Company purchased approximately 1,146 bitcoin mining units during the Second Quarter of 2024.
Approximately 86% of our fleet’s run-rate electricity consumption was generated from carbon-free energy sources as of June 30, 2024. These figures are based on data provided by our hosts, publicly available sources, and internal estimates, demonstrating our commitment to sustainable practices in the digital asset mining industry.
The Company had approximately 17,184 ETH actively staked in native staking protocols as of June 30, 2024.
In the second quarter of 2024, the Company finalized an agreement to supply its existing customer with an additional 2,048 GPUs over a three-year period. To help finance this operation, the Company entered into a sale-leaseback agreement with a third party, agreeing to sell 128 AI servers (equivalent to 1,024 GPUs) and lease them back for three years. In late July, at behest of the customer, the Company and the customer mutually agreed to temporarily delay the purchase order so that the customer could evaluate potentially upgrading the purchase order to include newer generation Nvidia GPUs. Accordingly, the Company and manufacturer mutually agreed to delay the Company’s purchase pending the contractual outcome with the Company’s customer. The Company expects to provide additional details about the revised deployment timeline in the coming weeks. The Company’s contract with the customer remains fully in effect, but may have to be amended to provide for newer generation GPUs. In early August, the Company received $30.0 million as a non-refundable prepayment from its customer, half of which will be distributed to the Company’s leasing partner.
Subsequent Events
On August 19, 2024, Bit Digital announced that it had signed a binding term sheet with Boosteroid Inc. (“Boosteroid”), the world’s third-largest cloud gaming provider. Upon signing a master service agreement (“MSA”), Boosteroid will place an initial purchase for a starting quantity of GPU servers with a five-year service duration. Bit Digital will provide Boosteroid with options to draw down additional servers in multiples of 100, up to a total of 50,000 GPU servers within five years after signing the MSA, depending on their deployment plans and subject to market conditions. The entire 50,000 GPU deployment represents an aggregate revenue opportunity to Bit Digital in excess of $700 million over the five-year term. The initial purchase includes GPU-servers based on AMD EPYC 4th Gen CPUs and RX7900XT GPUs, customized by ASUSTeK Computer Inc. (“ASUS”) and AMD for Boosteroid. Deployment is planned across a network of more than 10 data centers in the U.S. and Europe. The initial deployment is scheduled to begin over the next two to three months and is expected to generate approximately $13 million in revenue to Bit Digital over the five-year term, or approximately $2.6 million per year. Bit Digital’s entry into a MSA is conditioned upon further diligence of Boosteroid, customary legal and business reviews, internal approvals, and execution of an acceptable MSA.
Management Commentary
“The second quarter of 2024 was an important step in the evolution of Bit Digital. Despite the reduction in block rewards from the April ‘halving event’, our total revenue more than doubled from the prior year, principally aided by the first full quarter of revenue from our HPC services business. Our balance sheet remains a key strength that will enable us to withstand recent market volatility and deploy growth capital into high-return opportunities.
Mining economics remain challenging, and in the absence of a material improvement in expected payback periods for mining equipment, it is unlikely that we will reach our active hash rate target of 6.0 EH/s by year-end 2024. From the onset of the year, we have been cautious in terms of exahash growth, preferring to wait for the post-halving mining environment before enacting material growth. In the interim, we will focus on high grading our existing fleet while reserving the right to make opportunistic growth purchases should the returns profile justify the expenditure.
We continue to view the HPC business as the most attractive use of incremental growth capex in the current environment. Our pipeline remains strong and the main bottleneck to date has been a lack of personnel and man hours to bring contracts to the finish line. We have started to solve this issue, making our first key hire for this business earlier this month with a plan to further expand our personnel and improve our tech stack. Our growth pipeline remains strong, and we continue to believe we will be able to reach our $100 million annualized revenue target by year-end 2024 even if the 2,000 GPU expansion deployment with our existing customer is pushed into 2025.”
About Bit Digital
Bit Digital, Inc. is a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. 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 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. See “Safe Harbor Statement” below.
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.
NEW YORK, August 19, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York, announced today that it has signed a binding term sheet with Boosteroid Inc. (“Boosteroid”), a new customer for its high-performance computing (“HPC”) business.
Key Highlights
Initial Agreement: Upon signing a master service agreement (“MSA”), Boosteroid will place an initial purchase for a starting quantity of GPU servers with a five-year service duration. Bit Digital’s entry into a MSA is conditioned upon further diligence of Boosteroid, customary legal and business reviews, internal approvals, and execution of an acceptable MSA.
Revenue Impact: This initial order is expected to generate approximately $13 million in revenue to Bit Digital over the five-year term, or approximately $2.6 million per year.
Scalability: Bit Digital will provide Boosteroid with options to draw down additional servers in multiples of 100, up to a total of 50,000 GPU servers within five years after signing the MSA, depending on their deployment plans. The entire 50,000 GPU deployment represents an aggregate revenue opportunity to Bit Digital in excess of $700 million over the five-year term, depending on the deployment plan and subject to market conditions.
Technology and Deployment: The initial purchase includes GPU-servers based on AMD EPYC 4th Gen CPUs and RX7900XT GPUs, customized by ASUSTeK Computer Inc. (“ASUS”) and AMD for Boosteroid. Deployment is planned across a network of more than 10 data centers in the U.S. and Europe. The initial deployment is scheduled to begin over the next two to three months.
Sam Tabar, Bit Digital’s CEO, commented: “We are excited to expand our HPC business and provide mission-critical computing solutions to Boosteroid, a customer in a new end-market for our HPC offerings. We are impressed with Boosteroid’s business model and look forward to supporting their ambitious growth plans. We aim to deliver exceptional service quality and execution, laying the foundation for a long-term and growing partnership between our companies.”
Ivan Shvaichenko, Founder and President of Boosteroid, commented: “This collaboration between Boosteroid and Bit Digital enhances our existing partnerships with AMD and ASUS, creating a powerful synergy that will drive us toward our goal of becoming the leader in the global cloud gaming market. By leveraging the advanced computing power provided by Bit Digital and the cutting-edge technology from AMD and ASUS, we are poised to deliver an unparalleled gaming experience to millions of users worldwide. This partnership not only strengthens our GPU-based infrastructure, already one of the widest in the world, but also sets the foundation for long-term innovation and growth within the cloud gaming industry.”
About Boosteroid
Boosteroid is the world’s third-largest cloud gaming provider, following Microsoft and Nvidia. With a GPU-based infrastructure network spanning 22 data centers and 10 more expected to launch by the end of 2024, Boosteroid serves over 5.7 million users across Europe, North America, and South America. It partners with major brands like Google for cloud gaming on Chrome OS, and collaborates with Microsoft, Samsung, LG, Hisense, Philips, Sharp, etc. Boosteroid uses custom hardware solutions designed by ASUS, AMD, and other companies tailored specifically for their platform.
About Bit Digital
Bit Digital, Inc. is a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure 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.
The Collaboration Provides for the Joint Exploration and Product Development Potential for European and International markets for leveraging SKYX’s Technology, Product and Manufacturing Expertise of the Two Companies
MIAMI, Aug. 19, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart platform technology company with more than 97 issued and pending patents globally and over 60 lighting and home décor websites, announces a new collaboration with EGLO, an international market leading designer and manufacturer of decorative and functional lighting and ceiling fans.
The collaboration provides for the two companies to explore and evaluate the development of products that integrate SKYX’s technology for European and global markets, and the product driven needs of EGLO’s international customer base.
The collaboration is expected to further enhance SKYX’s U.S. and global market penetration through online, retail and builder segments.
SKYX’s advanced and smart technologies make homes and buildings smart and safe, while saving time, cost, and creating significant value for property developers and homeowners.
Rani Kohen, Founder and Executive Chairman of SKYX, said: “This collaboration opportunity is just another step in expanding the applicability and penetration of our technology to European and global markets and distribution channels. Aligning with industry leaders who support our vision for growth and innovation in smart home and lighting sectors is significant to our global expansion strategy.
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.
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