Great Lakes Dredge & Dock (GLDD) – More New Business


Wednesday, August 21, 2024

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

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

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

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

Recent DOD Awards. Great Lakes has been awarded over $120 million in two new contracts since August 9th, according to the Department of Defense daily contract release. We believe the additional awards highlight the amount of opportunity available to Great Lakes.

Mobile Harbor. Yesterday, Great Lakes was awarded a $65.9 million firm-fixed-price contract to deepen and widen Mobile Harbor, with an estimated completion date of April 27, 2025. Fiscal 2020 civil construction funds and fiscal 2024 civil operation and maintenance funds in the amount of $65.9 million were obligated at the time of the award. The U.S. Army Corps of Engineers, Mobile, Alabama, is the contracting activity.


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

Bit Digital (BTBT) – Focused On Computing


Wednesday, August 21, 2024

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

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

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

HPC Focus. Management is placing greater emphasis on the HPC segment given the near-term potential of the business, its higher margin profile, and growing pipeline of opportunity. Management continues to believe the business could obtain a $100 million annualized revenue run rate by the end of 2024.

Realization of Pipeline. The Company is adding staff in its HPC segment, including a head of sales, to realize more of the Company’s growing pipeline in the segment. It has already come to fruition with the Boosteroid agreement announcement and management noted that other potential clients are not far behind. We expect the addition of more salespeople in the near term and won’t be surprised to see more agreement announcements sooner rather than later.


Get the Full Report

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

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

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

Gold Bars Reach New Historic High of $1 Million

In a remarkable milestone, gold bars have for the first time ever reached a value of $1 million per bar. As reported by Bloomberg, this historic event occurred on Friday when the spot price of gold surpassed $2,500 per troy ounce, setting an all-time high. With standard gold bars typically weighing around 400 troy ounces, this works out to each bar being worth over $1 million.

This astronomical rise in the value of gold is the result of a perfect storm of factors driving up the precious metal’s price. One of the key drivers has been increased buying from central banks around the world. In the first half of 2024 alone, central banks purchased a net total of 483.3 metric tons of gold, equivalent to almost 40,000 standard bars. This voracious central bank demand has been a major factor underpinning gold’s meteoric ascent.

Beyond central bank purchases, the gold price has also been boosted by expectations of looser monetary policy from the US Federal Reserve. With inflation remaining stubbornly high, the Fed is widely anticipated to cut interest rates further in the coming months, making gold a more attractive asset compared to yield-bearing instruments. The easy money policies of major central banks have been a boon for gold, which is often seen as a hedge against inflation and currency debasement.

While the $1 million gold bar is certainly a milestone, it’s worth noting that the figure comes with some important caveats. The 400-ounce standard cited in the article represents bars traded on the London Bullion Market, but individual bars can actually range from 350 to 430 ounces of pure gold. Additionally, smaller gold bars aimed at retail investors, such as those sold by Costco, are much more affordable at just a fraction of the million-dollar price tag.

Nevertheless, the sheer magnitude of gold’s ascent is remarkable. Just a decade ago, gold was trading below $1,300 per ounce. To have reached the point where a single bar is worth over $1 million is a testament to gold’s enduring appeal as a safe-haven asset in times of economic uncertainty.

The implications of $1 million gold bars are significant. For central banks and other large institutional investors, allocating to gold has become an even more crucial part of portfolio diversification strategies. The high price may also spur increased exploration and mining activity, as producers seek to capitalize on gold’s lofty valuation.

At the same time, the astronomical price tag puts physical gold further out of reach for many individual investors. While gold-backed ETFs and other derivative products provide more affordable exposure, the dream of owning a tangible gold bar worth over $1 million remains firmly in the realm of the ultra-wealthy.

Overall, the milestone of $1 million gold bars is a remarkable development that underscores gold’s status as a premier store of value in the modern global economy. As central banks and investors continue to flock to the precious metal, it will be fascinating to see how high gold’s price can climb in the years ahead.

Powering the Future: The $5.2 Billion Merger that Reshapes the U.S. Coal Landscape

Key Points:
– Creation of a $5.2 billion domestic coal powerhouse
– Enhanced operational and financial flexibility to navigate industry headwinds
– Potential to extend the lifespan of the U.S. coal industry amid global energy shifts

The announcement of the merger between Consol Energy and Arch Resources marks a significant development in the U.S. coal industry. This $5.2 billion all-stock transaction will create a powerhouse player in the domestic coal market, poised to navigate the challenging landscape ahead.

At the core of this deal is the synergy between the two companies’ operations and market positions. Consol Energy and Arch Resources both specialize in high-quality bituminous coal, with a strong presence in the Appalachian region. By combining their resources, the merged entity, to be named Core Natural Resources, will control 11 mines, including some of the largest, lowest-cost, and highest-calorie domestic assets.

This consolidation is a strategic move to enhance competitiveness and resilience in the face of mounting pressures. The coal industry has faced a tumultuous year, with Consol Energy’s share price dropping 5.8% and Arch Resources’ declining 24%. The growing competition from renewable energy sources has put significant strain on the sector, underscoring the need for a more robust and adaptable player.

The merger is poised to deliver a range of operational and financial benefits. The companies expect to generate $110 to $140 million in synergies through cost reductions and enhanced market reach. Additionally, the larger scale and improved financial flexibility of the combined entity could better equip it to navigate the evolving energy landscape.

Notably, both Consol Energy and Arch Resources have maintained conservative balance sheets, with debt-to-equity ratios around 10% and sizeable cash reserves. This financial prudence suggests that the merged company will be well-positioned to weather any future industry headwinds.

The timing of this merger is particularly noteworthy, as it comes amid a backdrop of shifting global energy dynamics. While the long-term outlook for coal remains uncertain, the International Energy Agency (IEA) has reported that global coal demand is expected to remain stable in 2023 and 2024, driven primarily by continued growth in electricity demand from major economies like China and India.

This trend suggests that the phase-out of coal may not be as immediate as some have anticipated. The creation of a larger, more diversified domestic coal player through the Consol Energy-Arch Resources merger could help to bolster the industry’s position and provide a more robust foundation for its future.

Ultimately, this merger represents a strategic response to the challenges facing the coal industry. By combining their strengths, Consol Energy and Arch Resources aim to create a premier North American coal producer with enhanced capabilities and a stronger market presence. As the energy landscape continues to evolve, this merger could be a critical step in securing the long-term viability of domestic coal production.

Release – Published Findings Highlight Tecarfarin’s Potential and Reinforce Need for Better Anticoagulation Therapy in LVAD Patients

Research News and Market Data on CVKD

  • 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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/published-findings-highlight-tecarfarins-potential-and-reinforce-need-for-better-anticoagulation-therapy-in-lvad-patients-302225967.html

SOURCE Cadrenal Therapeutics, Inc.

Release – Hemisphere Energy Announces 2024 Second Quarter Results, Declares Quarterly Dividend, and Provides Operations Update

Research News and Market Data on HMENF

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”)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.

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Release – Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 CATALYST Study of TNX-1300 for the Treatment of Cocaine Intoxication

Research News and Market Data on TNXP

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.58 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 and Overdose

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 alA 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.

2 https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates; August 18, 2024

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.

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 alThermostable variants of cocaine esterase for long-time protection against cocaine toxicity. Mol Pharmacol. 2009. 75(2):318-23.

9 https://www.cdc.gov/drugoverdose/deaths/other-drugs.html; accessed August 18, 2024

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.

Investor Contact

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

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

Media Contact

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 20, 2024

Release – Bit Digital, Inc. Announces Second Quarter of Fiscal Year 2024 Financial Results

Research News and Market Data on BTBT

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.

Release – Bit Digital, Inc. Announces Binding Term Sheet with New HPC Customer Representing a More Than $700 Million Revenue Opportunity Over Five-Year Term

Research News and Market Data on BTBT

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.

Bit Digital (BTBT) – First Look at the Second Quarter


Tuesday, August 20, 2024

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

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

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

Results. Revenue for the quarter totaled $29.0 million, a 220% increase from last year of $9.0 million due to the inclusion of the HPC business. We estimated revenue of $24.9 million. Driven by an $11.5 million unrealized loss on digital assets, adjusted EBITDA was a negative $3.8 million from a positive $1.9 million last year. Net loss for the quarter was $12.0 million, or $0.09/sh, from a loss of $2.4 million, or $0.03/sh, the prior year.

A Temporary Setback. The Company’s anchor HPC client is temporarily delaying its purchase order to potentially upgrade the servers to have newer generation Nvidia GPUs. The contract may be amended to provide for the newer GPUs. We believe the delay to only be temporary as Nvidia’s new Blackwell architecture is expected to be released later in the year or in early 2025.


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Fed’s Balancing Act: Jackson Hole 2024

Key Points:
Unemployment Rises: Fed officials consider rate cuts as jobless numbers climb.
– Inflation Eases: With inflation near target, focus shifts to avoiding job market fallout.
– Powell’s Key Address: Expectations build for guidance on balancing economic risks.

As the Federal Reserve officials convene for their annual central banking conference in Jackson Hole, Wyoming, the economic landscape is under intense scrutiny. With the U.S. unemployment rate currently at 4.3%, the Fed faces a delicate balancing act: managing inflation while avoiding a significant downturn in the job market. This year’s gathering, a key event for central bankers worldwide, is marked by growing unease about the potential weakening of the U.S. labor market and the implications for future monetary policy.

Historically, the U.S. has enjoyed periods of low unemployment, often below the long-term average of 5.7%. However, these periods have been punctuated by sharp spikes in joblessness during economic downturns, a pattern that Federal Reserve officials are keen to avoid. The current trend, with unemployment gradually increasing from 3.7% in January 2023 to 4.3% by July 2024, has raised concerns among policymakers. The rise in unemployment has been accompanied by an influx of 1.2 million people into the labor force, a typically positive sign that can paradoxically push the unemployment rate higher as more individuals actively seek work.

The Federal Reserve has maintained its benchmark policy rate in the 5.25%-5.50% range for over a year, the highest level in 25 years. However, with signs of a cooling job market, the conversation among Fed officials has shifted towards the possibility of cutting rates. Minneapolis Fed President Neel Kashkari, in a recent interview, noted that the balance of risks has shifted, making a debate about rate cuts at the upcoming September policy meeting appropriate. This sentiment has been echoed by other Fed officials, including San Francisco Fed President Mary Daly, who expressed growing confidence that inflation is returning to the Fed’s 2% target.

Indeed, the progress on inflation has been significant. The personal consumption expenditures (PCE) price index, a key measure tracked by the Fed, peaked at an annual rate of 7.1% in June 2022 but had dropped to 2.5% by July 2024. This progress suggests that the worst of the inflationary surge may be behind us, leading some policymakers to argue for a loosening of credit conditions to ensure a “soft landing” for the economy.

However, the labor market presents a more complicated picture. Recent data indicates that job growth is slowing, with only 114,000 positions added in July 2024, a figure that fell below expectations and pulled the three-month average below pre-pandemic levels. The unemployment rate’s rise, coupled with longer job search durations and a growing number of workers moving from employment to unemployment, signals potential weaknesses that the Fed must carefully navigate.

Despite these concerns, unemployment claims have not surged dramatically, and consumer spending remains robust. This mixed economic picture has led to a cautious stance among Fed officials, who are not yet ready to declare a crisis but are vigilant about the risks of keeping monetary policy too tight for too long. As Fed Chair Jerome Powell prepares to address the Jackson Hole conference, his remarks are expected to clarify the central bank’s approach to managing these risks, with an emphasis on avoiding a destabilizing spike in unemployment while ensuring that inflation remains under control.

The Jackson Hole conference, therefore, comes at a critical juncture. As the Fed weighs the potential for rate cuts against the backdrop of a slowing labor market and moderating inflation, the decisions made here could shape the trajectory of the U.S. economy in the months and years to come.

Mpox Resurgence: Biotech Sector Sees Renewed Interest Amid Global Health Concerns

Key Points:
– Mpox outbreaks boosts biotech stocks, especially those with related vaccines or treatments
– Small biotech firms see volatile, dramatic gains, prompting caution from analysts
– Renewed focus on infectious diseases may reshape biotech industry investments and partnerships

As the world grapples with a new outbreak of mpox, formerly known as monkeypox, the biotech sector is experiencing a surge of investor interest and market activity. The recent declaration of a global public health emergency by the World Health Organization (WHO) has thrust several biopharma companies into the spotlight, particularly those with potential treatments, vaccines, or diagnostic capabilities related to the virus.

The current outbreak, primarily driven by the more severe clade I variant, has already claimed over 1,100 lives in the Democratic Republic of Congo since January 2024. Unlike the 2022 outbreak, which was largely confined to specific communities, the new clade Ib variant appears to spread more easily through routine close contact, raising concerns about its potential for wider transmission.

This evolving situation has created a ripple effect across the biotech marketplace. Companies with mpox-related products or research pipelines have seen significant stock price movements. Danish biotech firm Bavarian Nordic, known for its mpox vaccine, has experienced a substantial surge in share value as it announces plans to ramp up production. Similarly, Emergent BioSolutions, with its approved smallpox treatment, has seen notable gains.

The diagnostic sector is also benefiting from the outbreak. Companies like Co-Diagnostics, which offers testing solutions, have seen increased investor interest. More dramatically, several smaller biotech firms focusing on infectious diseases have experienced explosive growth. Tonix Pharmaceuticals, Virax Biolabs, GeoVax, and Applied DNA Sciences have all seen their stock prices skyrocket, with some gaining over 100% in a single trading session.

However, industry analysts caution that such rapid gains may be unsustainable and could be subject to equally swift corrections. The volatile nature of biotech stocks, especially during disease outbreaks, is well-documented. Investors are advised to approach these opportunities with caution, considering both the potential for breakthrough developments and the risks associated with speculative investments.

The mpox outbreak is also rekindling interest in the broader infectious disease sector. Many investors and industry observers are drawing parallels to the early days of the COVID-19 pandemic, which saw unprecedented growth in vaccine and therapeutic development. This has led to increased funding and research initiatives across the biotech industry, not just for mpox-specific solutions, but for a wide range of potential emerging infectious diseases.

Large pharmaceutical companies are also taking notice. While they may not experience the same dramatic stock movements as smaller, more specialized firms, many are reassessing their infectious disease portfolios and considering new investments or partnerships in this area.

The outbreak is also highlighting the importance of preparedness and rapid response capabilities in the biotech sector. Companies with flexible platforms for developing vaccines or therapeutics are gaining attention from both investors and potential government partners.

As the situation continues to evolve, the biotech marketplace is likely to see ongoing volatility and opportunities. The mpox outbreak serves as a reminder of the critical role the sector plays in global health security and its potential for both scientific advancement and financial growth.

While the immediate focus remains on addressing the current health emergency, the long-term implications for the biotech industry could be significant. The outbreak may lead to increased investment in infectious disease research, new partnerships between academia and industry, and a renewed emphasis on global health preparedness – all factors that could shape the biotech landscape for years to come.

Take a moment to take a look at more emerging growth biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

AMD’s Acquisition of ZT Systems: A Strategic Play in the AI Arena

Key Points:
Strategic Move: AMD acquires ZT Systems for $4.9 billion to bolster its AI and server capabilities.
AI Focus: The acquisition targets the growing demand for AI-driven data centers, positioning AMD to challenge Nvidia.
– Future Plans: AMD aims to offload the server manufacturing business post-acquisition, streamlining its focus on AI hardware.

Advanced Micro Devices (AMD) has taken a significant step in its strategic push into the artificial intelligence (AI) market by announcing the acquisition of server builder ZT Systems for $4.9 billion. This bold move is designed to expand AMD’s portfolio of AI chips and hardware, positioning the company to compete more aggressively against industry leader Nvidia.

The acquisition deal, which AMD plans to fund 75% with cash and the remaining 25% in stock, reflects the company’s strong financial footing. As of the second quarter, AMD held $5.34 billion in cash and short-term investments, providing the liquidity necessary to pursue such a sizable transaction. The acquisition of ZT Systems comes at a time when the computing power required for AI applications is growing exponentially. Companies in the tech sector are increasingly focused on stringing together thousands of chips in large clusters to achieve the necessary data processing capabilities. This trend has elevated the importance of the server systems that house these chips, making the acquisition of ZT Systems a strategic move for AMD.

Lisa Su, AMD’s CEO, emphasized the importance of AI in the company’s long-term strategy. “AI systems are our number one strategic priority,” Su said in an interview with Reuters, highlighting the critical role AI plays in AMD’s growth plans. The integration of ZT Systems’ engineering talent will allow AMD to accelerate the development and deployment of its AI-focused graphics processing units (GPUs), particularly for large-scale cloud computing providers like Microsoft. The acquisition is expected to enable AMD to sell more GPUs, a key component in AI data centers, which are rapidly becoming the backbone of modern computing infrastructure.

While the acquisition is primarily about enhancing AMD’s AI capabilities, the company has no intention of entering the server manufacturing business on a permanent basis. Su made it clear that AMD plans to spin off ZT Systems’ server manufacturing operations once the deal is finalized. The company is currently focused on leveraging ZT Systems’ expertise to scale its AI hardware offerings and does not plan to compete with established server manufacturers like Super Micro Computer. As part of the acquisition, ZT Systems’ Chief Executive Frank Zhang will join AMD and report directly to Forrest Norrod, AMD’s head of data centers. This leadership transition is expected to ensure that the integration process is smooth and that AMD can quickly begin reaping the benefits of the acquisition. Out of ZT Systems’ approximately 2,500 employees, AMD plans to retain around 1,000 engineers, underscoring the value AMD places on the engineering talent that ZT Systems brings to the table.

ZT Systems, which generates about $10 billion in annual revenue, is a closely held company that has built a reputation for its expertise in server manufacturing and systems integration. The addition of ZT Systems to AMD’s portfolio is expected to strengthen the latter’s position in the competitive AI hardware market. The deal is anticipated to close in the first half of 2025, after which AMD plans to sell the server manufacturing business within the following 12 to 18 months. This approach aligns with AMD’s strategy of focusing on high-value, high-growth segments of the market, particularly AI hardware, rather than diversifying into lower-margin businesses.

The acquisition of ZT Systems also comes as AMD continues to face stiff competition from Nvidia, which has dominated the AI hardware market. Nvidia, once primarily known as a designer of gaming chips, has successfully pivoted to become a leading provider of AI hardware, including entire data center solutions. This year, Nvidia’s data center segment, which includes AI chips, is expected to generate $105.9 billion in revenue, far outpacing AMD’s AI chip revenue, which is projected to be around $4.5 billion. By acquiring ZT Systems, AMD is positioning itself to close this gap and capture a larger share of the AI market.

AMD’s customers, including tech giants like Microsoft and Meta Platforms, are increasingly reliant on advanced AI chips to power their data centers. The acquisition of ZT Systems is expected to enhance AMD’s ability to meet the growing demand for AI hardware and to compete more effectively with Nvidia in this critical area. Moreover, the deal is expected to contribute positively to AMD’s adjusted financial performance by the end of 2025, marking a significant milestone in the company’s ongoing transformation.

As the tech industry continues to evolve, the race to dominate the AI hardware market is heating up. AMD’s acquisition of ZT Systems is a clear signal that the company is serious about becoming a major player in this space. By strategically acquiring key assets and talent, AMD is positioning itself to capitalize on the rapid growth of AI and to challenge Nvidia’s dominance in the market. With the acquisition expected to close in 2025, all eyes will be on how AMD integrates ZT Systems and leverages this acquisition to drive its AI ambitions forward.