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Release – Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the 2024 Military Health System Research Symposium (MHSRS)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 28, 2024 7:00am EDT

Oral presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality

NDA submission on track for second half 2024; Fast Track designation granted by FDA; FDA decision expected 2025

TNX-102 SL is a potential non-opiod analgesic targeting non-restorative sleep in fibromyalgia: Post hoc analyses highlight strong correlations between improvements in nociplastic pain and sleep quality

Nociplastic pain originates from altered pain perception in the brain and is the type of pain that manifests in fibromyalgia and other chronic overlapping pain conditions (COPCs)

CHATHAM, N.J., Aug. 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, 2024, in Kissimmee, Fla. A copy of the Company’s presentation, titled “Assuaging Agony: Novel Pain Therapeutics”, is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. TNX-102 SL demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. A post hoc analysis showed strong correlations between improvements in pain and sleep quality at Week 14, supporting the concept that targeting sleep quality has the potential to achieve syndromal improvement in fibromyalgia. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.

“Traditional analgesics like NSAIDs or opioids often prove ineffective, if not deleterious, as strategies for treating fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In contrast, TNX-102 SL provided broad-spectrum symptom relief in the Phase 3 RESILIENT study and was designed as a bedtime treatment to target non-restorative sleep and improve sleep quality. With the statistically significant results of two positive Phase 3 studies of TNX-102 SL in fibromyalgia we believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”

Dr. Lederman continued, “Fibromyalgia is the prototypic nociplastic syndrome and chronic overlapping pain condition (COPC)3,4,5. Our results in fibromyalgia suggest potential for TNX-102 SL in treating other COPCs like post-concussive syndrome6, in which sleep disturbances correlate with persistence and severity. In addition, we expect to begin enrolling this quarter in a trial of TNX-102 SL for acute stress disorder/acute stress reaction in the immediate aftermath of motor vehicle collision in the U.S. Department of Defense (DoD)-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application.

Tonix remains on track to submit a new drug application (NDA) to the FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. A decision on approval is expected in 2025.

1Moldofsky H, et al. Psychosom Med. 1975;37:341-51

2Moldofsky H, Scarisbrick P. Psychosom Med. 1976;38:35-44

3Fitzcharles MA, et al. Lancet. 2021;397:2098-110

4Clauw DJ. Ann Rheum Dis. Published Online First: 2024

5Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363

6Kureshi S et al. Healthcare (Basel) 2024 12(3): 289. 

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of TNX-102 SL for the management of fibromyalgia. In the study, TNX-102 SL met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of TNX-102 SL in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). TNX-102 SL was recently granted Fast Track Designation by the FDA for the management of fibromyalgia and remains on track to submit an NDA to FDA in the second half of 2024.

About Nociplastic Pain

Nociplastic pain is the third category of pain distinct from nociceptive pain and neuropathic pain. Nociplastic pain is characterized by pain arising from altered nociception despite no evidence of actual or threatened tissue damage causing activation of peripheral nociceptors or somatosensory system disease or lesion. Its underlying pathophysiology involves altered pain processing by the central nervous system (CNS). Nociplastic syndromes, officially recognized by the International Association for the Study of Pain (IASP) in 2017, also include several other chronic overlapping pain conditions: myalgic encephalomyelitis/chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, forms of chronic back pain and chronic headache. The pathophysiology of nociplastic pain involves central sensitization (CS), where neurons of the CNS become hyperexcitable, amplifying pain signals. CS can be triggered by peripheral pain stimuli, emotional stress, or other factors, leading to persistent pain despite no peripheral nociceptive input.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. DoD, Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. The company also owns a Good Manufacutring Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA, which was purpose-built to manufacture TNX-801, a potential mpox vaccine, and the GMP suites are ready to be reactivated in case of a national emergency. Tonix’s development portfolio is focused on CNS disorders. Tonix’s priority is to submit an 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 designed to treat cocaine intoxication that has Breakthrough Therapy designation, which is enrolling in a potential pivotal Phase 2 trial. 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 and infectious disease. 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

Lisa DeScenza
LaVoieHealthScience
ldescenza@lavoiehealthscience.com
(617) 351-0243

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 28, 2024

Release – Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 28, 2024

PDF Version

MALVERN, Pa., Aug. 28, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease affects approximately 100,000 people in the United States (U.S.) and Europe.

“With all patients dosed in cohort 3 (high dose), Phase 1 of the dose-escalation portion of the trial is complete,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “We will continue to advance the trial as efficiently as possible, and work toward fulfilling an unmet medical need for Stargardt patients.”

Three subjects received a single subretinal injection of the highest dose (2.25×1011 vg/mL) being tested. The GARDian clinical trial is being performed at six leading retinal surgery centers across the U.S.

“OCU410ST is a novel modifier gene therapy that has the potential to be a one-time treatment given by subretinal injection in the operating room,” said Charles Wykoff, MD, PhD, Director of Research, Retina Consultants of Texas, lead investigator in the study. “The safety and tolerability profile of OCU410ST remains encouraging as the clinical trial progresses and brings hope to patients with Stargardt disease, who have no FDA-approved treatment options.”

The GARDian clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410ST in subjects with Stargardt disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (3.75×1010 vg/mL), medium dose (7.5×1010 vg/mL), and high dose (2.25×1011 vg/mL)].

Ocugen remains committed to advancing treatments for blindness, focusing on innovative gene therapy solutions that aim to provide lasting benefits to patients.

The Company will continue to provide clinical updates on a periodic basis.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Berkshire Hathaway Joins the Trillion-Dollar Club

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– First non-tech U.S. company to reach $1 trillion market cap
– Demonstrates strength of diversified, old-economy focused business model
– Milestone achieved despite Buffett’s recent defensive market stance

Berkshire Hathaway has become the first non-technology company in the United States to achieve a market capitalization of $1 trillion. This milestone, reached on August 28, 2024, just days before Buffett’s 94th birthday, underscores the enduring success of the Oracle of Omaha’s investment philosophy and business acumen.

Berkshire Hathaway’s ascent to the trillion-dollar club is particularly noteworthy given its stark contrast to the other members of this exclusive group. While tech giants like Apple, Nvidia, Microsoft, Alphabet, Amazon, and Meta dominate the list, Berkshire stands out with its focus on traditional, old-economy sectors. The conglomerate’s diverse portfolio includes BNSF Railway, Geico Insurance, and Dairy Queen, among many others, showcasing the potential for substantial growth and value creation in industries often overlooked by modern investors.

The company’s shares have surged more than 27% in 2024, significantly outpacing the S&P 500’s performance. This impressive rally has been driven by the strength of Berkshire’s core businesses and strategic investments, including a substantial stake in Apple, which has contributed to recent gains.

Buffett’s journey with Berkshire Hathaway is a testament to his long-term vision and value investing principles. Taking control of what was initially a struggling textile business in the 1960s, Buffett transformed Berkshire into a sprawling empire with interests spanning insurance, railroads, retail, and energy. The company’s success is built on a foundation of prudent capital allocation, operational excellence, and an unmatched balance sheet.

Interestingly, this milestone comes at a time when Buffett has adopted a notably defensive stance in the market. Recent moves include divesting a significant portion of Berkshire’s stock holdings, including half of its Apple stake, while simultaneously building the company’s cash reserves to a record $277 billion as of June 2024. This cautious approach has raised eyebrows among market watchers, with some interpreting it as a signal of Buffett’s concerns about current economic conditions and market valuations.

Berkshire’s conservative cash management strategy is evident in its substantial holdings of short-term Treasury bills, valued at $234.6 billion at the end of the second quarter – a figure that exceeds even the U.S. Federal Reserve’s holdings. This approach reflects Buffett’s emphasis on capital preservation and readiness to act on potential opportunities.

One unique aspect of Berkshire Hathaway is the astronomical price of its Class A shares, which have never been split. This policy, according to Buffett, attracts and retains long-term, quality-oriented investors. The introduction of more affordable Class B shares in 1996 has allowed smaller investors to participate in Berkshire’s success while maintaining the exclusivity of the Class A shares.

As Berkshire Hathaway joins the trillion-dollar club, it serves as a powerful reminder of the potential for value creation in traditional industries. The milestone validates Buffett’s long-standing investment philosophy and demonstrates that patient, principled investing can yield extraordinary results, even in an era dominated by high-growth technology companies.

Looking ahead, market observers will be keenly watching how Berkshire navigates the evolving economic landscape. With its robust balance sheet, diverse portfolio, and Buffett’s legendary acumen, the company is well-positioned to continue its remarkable journey, potentially paving the way for other non-tech companies to follow in its footsteps.

Release – Bowlero to Report Fourth Quarter and Full Year 2024 Financial Results on September 5, 2024

Posted on by aweinsoff@channelchek.com

News Research and Market Data on BOWL

08/27/2024

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location-based entertainment, will report financial results for the fourth quarter and full year fiscal 2024 on Thursday, September 5, 2024, after the U.S. stock market closes. Management will discuss the results via webcast at 4:30 PM ET on the same day.

The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/ .

About Bowlero Corp.

Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

IRSupport@BowleroCorp.com

Source: Bowlero Corp

GDEV Inc. (GDEV) – Shedding Its SPAC Image

Posted on by cpereira@noblefcm.com


Wednesday, August 28, 2024

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

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

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

Reverse split. On August 21, the company announced a one for ten reverse stock split on its ordinary shares. Notably, the reverse split will be effective following the market close on August 28, and will be adjusted for the split when trading opens on August 29. We view the move favorably as the company sheds its SPAC image.

Positive implications. Management highlighted that the reverse split could improve the marketability and attractiveness of its shares, as an investment grade company that it is. We believe the higher share price could improve investor perception, liquidity and marketability of the GDEV shares and open the company to more institutional interest, with the shares trading above single digit price points. 


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

*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. 

Nvidia Earnings Report: A $300 Billion Market Swing in the Balance

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Options market predicts unprecedented 9.8% stock move post-earnings
– Potential $305 billion market value swing, largest in history
– Nvidia’s earnings crucial for broader market performance

As Nvidia prepares to release its latest earnings report, the options market is bracing for what could be the largest earnings-related market value swing in history. Traders are anticipating a potential $305 billion fluctuation in Nvidia’s market capitalization, underscoring the chipmaker’s critical role in the artificial intelligence (AI) boom and its impact on the broader market.

Options pricing data from analytics firm ORATS indicates that traders expect Nvidia’s shares to move by approximately 9.8% on the day following its earnings announcement. This projected movement significantly surpasses the company’s average post-earnings move of 8.1% over the past three years and represents the largest expected swing for any Nvidia earnings report during this period.

The magnitude of this potential move is staggering when considering Nvidia’s current market capitalization of about $3.11 trillion. A 9.8% swing would translate to a market value change of around $305 billion – a figure that exceeds the entire market capitalization of 95% of S&P 500 companies, including giants like Netflix and Merck.

Nvidia’s outsized influence on the market is not limited to its own stock performance. The company’s chips, widely regarded as the gold standard in AI, have propelled its shares up by approximately 150% year-to-date. This remarkable growth has contributed to about a quarter of the S&P 500’s 18% gain in 2024, making Nvidia a critical driver of overall market performance.

Steve Sosnick, chief strategist at Interactive Brokers, aptly described Nvidia as “the Atlas holding up the market,” highlighting its substantial contribution to the S&P 500’s profitability. This analogy underscores the weight of expectations resting on Nvidia’s shoulders as it prepares to release its financial results.

Interestingly, the options market reveals a bias towards optimism among traders. Analysis from Susquehanna Financial indicates that traders are assigning a 7% probability to the stock rising more than 20% by Friday, compared to only a 4% chance of a 20% or greater decline. This sentiment suggests that investors are more concerned about missing out on potential gains than hedging against losses.

Christopher Jacobson, a strategist at Susquehanna Financial Group, attributes this phenomenon to the “continued uncertainty/optimism with regards to AI and the ultimate size of the opportunity.” The heightened interest in Nvidia among both institutional and retail investors has contributed to its elevated volatility compared to other trillion-dollar market cap companies.

The anticipation surrounding Nvidia’s earnings report reflects broader market dynamics and the pivotal role of AI in shaping investor sentiment. As the company prepares to unveil its latest financial results, the potential for a record-breaking market value swing serves as a testament to Nvidia’s position at the forefront of the AI revolution and its significance in the current investment landscape.

The outcome of Nvidia’s earnings report will likely have far-reaching implications, not only for the company’s shareholders but also for the broader technology sector and the overall market. As investors and analysts alike await the results, the unprecedented level of options activity surrounding Nvidia underscores the high stakes and intense scrutiny facing this AI chip giant.

Energy Fuels Acquires RadTran: A Strategic Move into Medical Radioisotopes for Cancer Treatment

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Energy Fuels expands capabilities in medical isotope production
– Acquisition addresses global shortage of crucial radioisotopes
– Potential for repurposing existing process streams for cancer treatments

Energy Fuels Inc., a leader in uranium and rare earth elements production, has made a strategic move to address the growing demand for medical radioisotopes used in cancer treatments. On August 16, 2024, the company announced its acquisition of RadTran LLC, a private firm specializing in the separation of critical radioisotopes.

This acquisition marks a significant step for Energy Fuels in its plans to develop and produce medical isotopes, particularly radium-226 (Ra-226) and radium-228 (Ra-228). These isotopes are crucial components in the production of actinium-225 (Ac-225) and lead-212 (Pb-212), which are used in emerging targeted alpha therapies (TAT) for cancer treatment.

The global shortage of Ra-226 and Ra-228 has been a major hurdle in the advancement and commercialization of these potentially life-saving therapies. Energy Fuels’ move to acquire RadTran is aimed at addressing this shortage and positioning the company as a leader in this developing industry.

Mark Chalmers, President and CEO of Energy Fuels, emphasized the synergy between the two companies. The acquisition combines Energy Fuels’ processing capabilities at the White Mesa Mill – the only permitted and operating uranium mill in the United States – with RadTran’s intellectual property and expertise in radionuclide separation and concentration.

One of the most innovative aspects of this initiative is Energy Fuels’ potential to recover valuable isotopes from its existing process streams. This approach would essentially recycle material that would otherwise be lost to disposal, repurposing it for use in producing cancer treatments. This not only adds value to Energy Fuels’ operations but also contributes to more sustainable practices in the industry.

The acquisition builds upon a Strategic Alliance Agreement between Energy Fuels and RadTran that has been in place since July 2021. Under this agreement, the companies have been evaluating the feasibility of recovering Ra-226 and Ra-228 from existing uranium process streams at Energy Fuels’ White Mesa Mill in Utah.

Energy Fuels has already made significant progress in this area, receiving regulatory approval and licensing in 2023 for the concentration of R&D quantities of Ra-226 at the Mill. The company is currently completing engineering on its research and development pilot facility for Ra-226 production. In 2024, Energy Fuels plans to set up the first stages of the pilot facility and expects to produce R&D quantities of Ra-226 for testing by end-users.

Looking ahead, Energy Fuels aims to develop capabilities for commercial-scale production of Ra-226 and potentially Ra-228 in 2026-2028. This timeline is contingent on completing engineering design, securing sufficient offtake agreements, and receiving all required regulatory approvals.

The acquisition terms include an initial payment of $1.5 million in cash and $1.5 million in Energy Fuels common shares, along with a 2% royalty on future revenues from radium sales. Additional performance-based milestones could lead to up to $14 million more in cash and shares.

As part of the deal, Saleem Drera PhD, President and CEO of RadTran, will join Energy Fuels as Vice President of Radioisotopes, Radiological Systems, and Intellectual Property. Dr. Drera will lead efforts to integrate RadTran’s proprietary technology and drive innovation in medical radioisotope production.

The urgency of this acquisition is underscored by the extensive clinical research currently underway. Over 30 clinical trials are evaluating Ac-225, with several reaching final pre-approval stages for treating neuroendocrine tumors and leukemia. The current shortfall in Ac-225 production is delaying trials and challenging the transition to full commercial and clinical availability of these promising cancer therapies.

Energy Fuels’ strategic acquisition of RadTran represents a significant step towards addressing critical supply chain issues in the medical radioisotope industry. By leveraging existing facilities and expertise, the company is poised to play a crucial role in supporting the development of innovative cancer treatments, potentially improving outcomes for patients worldwide.

Release – V2X Names Jeremy Nance to General Counsel

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on VVX

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

Media Contact
Angelica Spanos Deoudes
Communications@GOv2x.com
571-338-5195

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-names-jeremy-nance-to-general-counsel-302231047.html

SOURCE V2X, Inc.

Shift4’s Acquisition of Givex: A Game-Changer in the Global Payment and Loyalty Solutions Market

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Expansion of global reach with 130,000+ new locations
– Enhanced offering with advanced gift card and loyalty programs
– Strategic alignment for increased customer value and retention

Shift4, the leading integrated payments and commerce technology company, is set to make waves in the global market with its latest acquisition announcement. The company has signed a definitive arrangement agreement to acquire Givex Corp., a renowned provider of gift cards, loyalty programs, and point-of-sale solutions. This strategic move is poised to reshape the landscape of payment processing and customer engagement technologies.

The acquisition, expected to close in the fourth quarter of this year, will significantly expand Shift4’s global footprint. With Givex’s impressive network of over 130,000 active locations across more than 100 countries, Shift4 is positioning itself as a major player in the international payments arena. This expansion not only increases Shift4’s customer base but also opens up new markets and opportunities for growth.

One of the most compelling aspects of this acquisition is the enhancement of Shift4’s service offerings. Givex brings to the table a suite of robust gift card and e-gift solutions, along with customizable loyalty programs that have been adopted by industry giants such as Nike, Marriott, and Wendy’s. These additions will allow Shift4 to offer a more comprehensive package to its existing clients, potentially increasing customer retention and attracting new business.

The synergy between the two companies is evident in their complementary technologies. Shift4’s end-to-end payment solution, combined with Givex’s value-added engagement services, creates a powerful toolkit for businesses looking to streamline their operations and enhance customer relationships. This integration is expected to deliver an unparalleled package to both companies’ customer bases, setting a new standard in the industry.

From a financial perspective, this acquisition aligns perfectly with Shift4’s capital deployment strategy. By acquiring a company with an established customer base, Shift4 is effectively lowering its customer acquisition costs while simultaneously expanding its service portfolio. This approach is likely to contribute positively to Shift4’s bottom line and create long-term value for shareholders.

The merger also presents exciting opportunities for innovation. As the payments industry continues to evolve, the combined expertise of Shift4 and Givex could lead to the development of cutting-edge solutions that address emerging market needs. This potential for innovation could be a key differentiator in a highly competitive market.

As businesses increasingly prioritize customer engagement and loyalty, the timing of this acquisition couldn’t be better. The integration of Givex’s loyalty and gift card solutions into Shift4’s existing infrastructure will enable businesses to create more personalized and rewarding experiences for their customers. This focus on customer retention and engagement is crucial in today’s market, where consumer loyalty is harder than ever to maintain.

In conclusion, Shift4’s acquisition of Givex Corp. marks a significant milestone in the company’s growth strategy. By expanding its global reach, enhancing its product offerings, and strengthening its market position, Shift4 is well-positioned to capitalize on the growing demand for integrated payment and loyalty solutions. As the transaction moves towards completion, industry observers and stakeholders will be watching closely to see how this strategic move unfolds and shapes the future of payment processing and customer engagement technologies.

Great Lakes Dredge & Dock (GLDD) – Additional Information on New Awards

Posted on by cpereira@noblefcm.com


Tuesday, August 27, 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.

New Awards. Yesterday, Great Lakes issued a press release revealing receipt of $256.2 million of dredging awards, including the $120 million of awards we highlighted last week. The six awards the Company noted included two capital projects, three coastal protection, and one maintenance award.

Pipeline Over $1 Billion. In addition to the noted awarded projects, Great Lakes has approximately $318 million in low bids and options pending award, according to the release, which includes two jobs on which the Company was low bidder on this month. This brings Great Lakes’ potential total pipeline of work to over $1.2 billion.


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

*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. 

FreightCar America (RAIL) – Positive Momentum Driven by Potential for Market Share Gains and Margin Expansion

Posted on by cpereira@noblefcm.com


Tuesday, August 27, 2024

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

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

Pure play manufacturer. FreightCar America, Inc. is a diversified manufacturer of railroad cars and rail car components. The company designs and manufactures a broad variety of railroad car types for the transportation of bulk commodities and containerized freight products primarily in North America. The company recently reported strong second-quarter financial results and appears poised for greater scale and margin expansion as it increases its market share and expands its product suite.

Updating estimates. While our 2024 and 2025 earnings per share estimates are unchanged at $0.25 and $0.47, respectively, we have increased our EBITDA estimates to $38.8 million and $46.7 million from $38.6 million and $46.0 million. We have assumed modestly higher sales. Importantly, we have increased our forward estimates beginning in 2026 to better reflect the company’s recent order for 1,000 tank car conversions and entry into the new tank car market beginning in 2028 which is expected to have a positive impact on gross margin.


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. 

Oil Prices Spike on Middle East Tensions and Supply Disruptions

Posted on by slightbourne@noblecapitalmarkets.com

Crude oil prices have spiked nearly 3% as geopolitical tensions in the Middle East escalate and Libya halts its oil production. This sudden surge has caught the attention of investors worldwide, potentially signaling a shift in the energy market landscape.

West Texas Intermediate (WTI) crude jumped to over $77 per barrel, while Brent crude, the international benchmark, surpassed $80 per barrel. This sharp increase comes after a weekend of heightened tensions in the Middle East and a significant disruption in Libyan oil production.

The catalyst for this price surge appears to be twofold. First, Israel’s recent airstrike against Hezbollah’s rocket launching stations in Lebanon has exacerbated fears of a broader conflict involving Iran. The potential for Iranian military response has raised concerns about possible disruptions to global oil movements, a factor that could significantly impact supply chains and pricing.

Adding fuel to the fire, Iran-backed Houthi rebels continue their attacks on vessels in the Red Sea, with a Greek oil tanker being the latest casualty. These ongoing hostilities pose a substantial threat to one of the world’s most crucial shipping routes, potentially disrupting oil transportation and further tightening supply.

The second major factor driving oil prices higher is Libya’s decision to temporarily halt its oil production and exports. This move, prompted by a dispute over the leadership of Libya’s central bank, removes over 1 million barrels of daily crude production from the global market. The sudden supply shock has left traders scrambling to adjust their positions, contributing to the price surge.

For investors, these developments present both opportunities and risks. The energy sector, which has been under pressure due to concerns about global demand, may see a resurgence if oil prices continue their upward trajectory. Oil majors and exploration companies could benefit from higher crude prices, potentially boosting their profit margins and stock valuations.

However, the situation remains fluid. While oil prices have jumped over 5% in the past three sessions, long-term demand concerns still linger in the market. The global economic outlook, particularly in China, continues to cast a shadow over future oil demand projections.

Interestingly, despite the surge in crude prices, U.S. gasoline prices have continued their downward trend. The national average gasoline price currently hovers around $3.35 per gallon, significantly lower than both last month and last year. Industry experts attribute this to seasonal factors and expectations of reduced demand post-Labor Day.

Looking ahead, investors should keep a close eye on several key factors:

  1. Developments in the Middle East, particularly any escalation involving Iran.
  2. Libya’s oil production status and any potential resolution to the current dispute.
  3. OPEC+ decisions on future production levels.
  4. Global economic indicators, especially from major oil consumers like China and the U.S.
  5. Hurricane season’s impact on U.S. Gulf oil production.

While the current price surge may offer short-term opportunities, prudent investors will need to weigh these against longer-term trends in oil demand and the ongoing global transition towards renewable energy sources.

As always, diversification and careful risk management remain key in navigating the volatile energy markets. With geopolitical tensions high and supply disruptions ongoing, the oil market promises to be an area of keen interest for investors in the coming weeks and months.

Federal Reserve Pivots: Job Market Protection Takes Center Stage

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Fed shifts focus from inflation to job market protection
– Powell signals upcoming interest rate cuts
– Uncertainty surrounds job market strength and future policy decisions

In a significant shift of monetary policy, the Federal Reserve has turned its attention from battling inflation to safeguarding the U.S. job market. This change in focus, articulated by Fed Chair Jerome Powell at the annual Jackson Hole conference, marks a new chapter in the central bank’s strategy and sets the stage for potential interest rate cuts in the near future.

Powell’s speech at Jackson Hole served as a clear indicator of the Fed’s evolving priorities. After two years of aggressive rate hikes aimed at curbing inflation, the Fed now sees emerging risks to employment as its primary concern. “We do not seek or welcome further cooling in labor market conditions,” Powell stated, effectively drawing a line in the sand at the current 4.3% unemployment rate.

This pivot comes at a critical juncture for the U.S. economy. The Fed’s current interest rate, standing at 5.25%-5.50%, is widely considered to be restricting economic growth and potentially jeopardizing jobs. This rate significantly exceeds the estimated 2.8% “neutral” rate – the theoretical point at which monetary policy neither stimulates nor constrains the economy.

The job market, while still robust by historical standards, has shown signs of cooling. July’s job gains of 114,000 were noticeably lower than the pandemic-era average, though they align with pre-pandemic norms. Another key indicator, the ratio of job openings to unemployed persons, has decreased from a pandemic high of 2-to-1 to a more balanced 1.2-to-1.

These trends have sparked debate among economists and policymakers. Some argue that the economy is simply normalizing after the extremes of the pandemic era. Others, however, worry that the Fed may have delayed its policy shift, potentially risking a more severe economic downturn.

Adding to the complexity is the possibility of data mismeasurement. Fed Governor Adriana Kugler, a labor economist, suggested that both job openings and unemployment might be underreported in current surveys. If true, this could paint a bleaker picture of the job market than official figures indicate.

Looking ahead, the Fed faces a delicate balancing act. Powell expressed hope that the economy can achieve the 2% inflation target while maintaining a strong labor market – a scenario reminiscent of the pre-pandemic economy he oversaw. However, the path to this ideal outcome remains uncertain.

The Fed’s next moves will be closely watched by markets and policymakers alike. In September, officials will update their interest rate projections, providing insight into the expected pace and extent of future rate cuts. These decisions will hinge heavily on upcoming employment reports and other economic indicators.

The central bank’s shift in focus represents more than just a change in policy direction; it reflects a broader reassessment of economic priorities in the post-pandemic era. As the Fed navigates this transition, it must weigh the risks of premature policy easing against the potential consequences of a weakening job market.

For American workers and businesses, the implications of this policy pivot are significant. Lower interest rates could stimulate economic activity and hiring, but they also risk reigniting inflationary pressures. The coming months will be crucial in determining whether the Fed can successfully steer the economy towards a “soft landing” – achieving its inflation target without triggering a recession.

As the economic landscape continues to evolve, one thing is clear: the Federal Reserve’s role in shaping the future of the U.S. job market has never been more critical. With its new focus on employment protection, the Fed is embarking on a challenging journey to maintain economic stability in an increasingly uncertain world.