Month: March 2024

Release – Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 21, 2024 8:00am EDT

Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder

TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating

TNX-1900 and TNX-2900 may serve as novel neuroendocrine treatments for certain pain, eating and endocrine disorders 

CHATHAM, N.J., March 21, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the American Chemistry Society (ACS) Spring 2024 Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy of the poster is available under the scientific presentations page of the Tonix website at www.tonixpharma.com.

The poster presentation titled, Oxytocin Analogs with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium Formulations, describes the discovery and characterization of novel oxytocin analogues that are candidate treatments for craniofacial pain, excessive eating (including Prader Willi Syndrome), and endocrinological conditions including bone health in autism and insulin resistance.

“Intranasal oxytocin has several potential therapeutic applications,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Preclinical studies have shown that oxytocin, a hypothalamic peptide hormone, simultaneously reduces food intake and increases energy expenditure, leading to weight loss.1-3 Intranasal oxytocin is well-tolerated and in published studies of adults, results in reduced caloric intake, increased fat burning and improved insulin sensitivity.1-3”

Dr. Lederman continued, “There is preclinical evidence that the activity of intranasal oxytocin is dependent on magnesium (Mg++) concentration.4-6 Our current intranasal oxytocin formulations of TNX-1900 and TNX-2900 contain Mg++ to augment the activity. We believe the new oxytocin analogues described in the poster have enhanced binding to Mg++ and consequently their activity does not require Mg++ augmentation.”

Four Phase 2 investigator-initiated studies of TNX-1900 are currently ongoing; three at the Massachusetts General Hospital (MGH) and one at the University of Washington. The Phase 2 ‘POWER’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to induce weight loss and improve indicators of cardiometabolic risk in adolescent patients with obesity. The Phase 2 ‘STROBE’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. The Department of Defense (DoD)-funded Phase 2 ‘BOX’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to improve bone health in children with autism spectrum disorder. In addition, a Phase 2 study at the University of Washington is investigating the potential role of TNX-1900 in enhancing vicarious extinction learning in social anxiety disorder, compared to healthy controls.

About TNX-1900 and TNX-2900

TNX-1900 and TNX-2900 (intranasal potentiated oxytocin) are proprietary formulations of oxytocin. TNX-1900 is in Phase 2 development under investigator-initiated INDs as a candidate for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. TNX-1900 is also planned for development in treating insulin resistance. TNX-2900 is in development as a treatment for Prader Willi Syndrome. TNX-2900 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and its IND has been cleared. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Tonix’s patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. Tonix’s patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians and fish.7 It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal formulation of oxytocin is marketed in some European countries to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml). Oxytocin has no recognized addiction potential. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system. With TNX-1900 and TNX-2900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding8 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models9. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children10. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

About Prader-Willi Syndrome (PWS)

PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.11 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given these serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.12 In addition, oxytocin has potent effects in correcting behavioral characteristics of the neonatal Magel2 knock-out mouse model for PWS and autism13 and intriguing effects in a clinical trial of neonates with PWS.14

*Pitocin® is a trademark of Par Pharmaceutical, Inc.

**Syntocinon® is a trademark of BGP Products Operations GmbH

References

1Lawson EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi: 10.1111/jne.12805.
2Niu J, et al. Front Neurosci 2021;15:743546. doi: 10.3389/fnins.2021.743546.
3Maejima Y, et al. Neuroendocrinology 2018;107(1):91-104.
4Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
5Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
6Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
7Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561.
8Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
9Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
10Yeomans, DC et al. 2017. US patent US2017368095.
11Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
12Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
13Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
14Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with 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 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. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.

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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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
Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released March 21, 2024

Lifeway Foods (LWAY) – Capping a Year of Growth in Sales and Margins

Posted on by cpereira@noblefcm.com


Thursday, March 21, 2024

Joe Gomes, 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.

Fourth Quarter Results. The fourth quarter was another quarter of y-o-y revenue growth, making it the 17th consecutive quarter. The quarter also represented the highest ever quarterly net sales. Net sales were $42.1 million compared to $35.8 million last year and above our $40 million estimate. Gross margin was 28.0% versus 22.1% last year. Net income totaled $4.0 million, or $0.26 per diluted share, compared to $0.7 million or $0.05 last year. We estimated net income of $3.2 million or EPS of $0.21.

Fiscal Year Results. Net sales for the year were $160.1 million, a record-high annual top line result, an increase from $141.6 million in the prior year due to higher volumes of Lifeway’s drinkable kefir. Net income for the year was $11.4 million, or $0.75 per diluted share, compared to $0.9 million or $0.06.


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Aemetis Secures $200 Million for Renewable Fuels Expansion Through Immigrant Investor Program

Posted on by slightbourne@noblecapitalmarkets.com

In a major boost to its ambitious renewable energy growth plans, Aemetis, Inc. has received approval from U.S. immigration authorities for $200 million in low-cost funding from foreign investors through the EB-5 Immigrant Investor Visa Program. This influx of capital will support construction of several key initiatives at the forefront of Aemetis’ drive to replace petroleum-based products with renewable alternatives.

The $200 million EB-5 investment will primarily fund three transformative projects – the development of a cutting-edge sustainable aviation fuel (SAF) production plant in Riverbank, California, a vast network of dairy farms generating renewable natural gas, and systems to capture and sequester carbon emissions.

At the centerpiece is Aemetis’ newly permitted Riverbank SAF refinery, designed to produce a staggering 78 million gallons of the low-carbon fuel annually to meet skyrocketing demand from airlines. The company has already secured over $3 billion worth of SAF supply contracts with major carriers desperate to reduce their environmental footprint and comply with tightening regulations.

“This $200 million of EB-5 funding provides us with attractive low-interest capital to construct our sustainable aviation fuel plant and build out other negative carbon intensity projects like dairy biogas and CO2 sequestration,” said Eric McAfee, CEO of Aemetis. “These investments will be transformative for our company’s growth.”

The EB-5 program, created in 1990, allows foreign investors to obtain U.S. permanent residency through investing substantial funds into domestic projects that create full-time jobs in high unemployment areas or rural regions. Aemetis’ projects qualified by being located at the company’s existing ethanol production facility in Keyes and the new Riverbank plant site, both classified as high unemployment zones by authorities.

In total, 245 foreign investors were approved to participate by providing $800,000 each, joining 8 others who had previously invested $4 million. The $200 million sum represents a considerable capital raise for Aemetis on highly attractive terms, enabling the company to expand its suite of renewable offerings.

In addition to the SAF refinery, funds will go towards building out the company’s dairy renewable natural gas operations across California’s Central Valley. Aemetis plans to construct biodigesters to capture methane from cattle waste at numerous dairy farms, which will then be processed into pipeline-quality renewable natural gas (RNG) as an ultra-low carbon substitute for fossil gas. The funding will cover new gas pipelines, biofuel conversion facilities, and RNG fueling stations to service this rapidly growing market.

A portion of the EB-5 investment is also earmarked for carbon capture and sequestration systems at Aemetis’ biorefineries, furthering efforts to shrink the company’s carbon footprint to negative levels. By safely storing emissions underground, Aemetis aims to produce some of the most environmentally friendly and low carbon-intensity biofuels, bioenergy, and biomaterials in the world.

“The EB-5 funding, combined with our other financing sources like 20-year USDA loans, provide the growth capital for Aemetis to construct large-scale projects in line with our bold Five Year Plan,” McAfee stated. “We deeply appreciate the confidence shown by these investors in our vision for revolutionizing the renewable fuels landscape.”

As global demand for sustainable energy solutions continues rising, the $200 million EB-5 infusion positions Aemetis at the forefront of this transition, paving the way for its pioneering dairy biogas, carbon-negative biofuels, and other low-carbon innovations to scale up rapidly in the coming years.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Michael Heim’s coverage list.

Fed Keeps Rates Steady, But Signals More Cuts Coming in 2024

Posted on by slightbourne@noblecapitalmarkets.com

The Federal Reserve held its benchmark interest rate unchanged on Wednesday following its latest two-day policy meeting. However, the central bank signaled that multiple rate cuts are likely before the end of 2024 as it continues efforts to bring down stubbornly high inflation.

In its post-meeting statement, the Fed kept the target range for its federal funds rate at 5.25%-5.5%, where it has been since last July. This matched widespread expectations among investors and economists.

The more notable part of today’s announcements came from the Fed’s updated Summary of Economic Projections. The anonymous “dot plot” of individual policymaker expectations showed a median projection for three quarter-point rate cuts by year-end 2024.

This would mark a pivotal shift for the Fed, which has been steadily raising rates over the past year at the fastest pace since the 1980s to combat surging inflation. The last time the central bank cut rates was in the early days of the COVID-19 pandemic in March 2020.

Fed Chair Jerome Powell and other officials have signaled in recent months that softer policies could be appropriate once inflation shows further clear signs of moderating. Consumer prices remain elevated at 6% year-over-year as of February.

“While inflation has moderated somewhat since the middle of last year, it remains too high and further progress is needed,” said Powell in his post-meeting press conference. “We will remain data-dependent as we assess the appropriate stance of policy.”

The Fed’s updated economic projections now forecast GDP growth of 2.1% in 2024, up sharply from the 1.4% estimate in December. Core inflation is seen decelerating to 2.6% by year-end before returning to the Fed’s 2% target by 2026. The unemployment rate projection was nudged down to 4%.

With economic conditions still relatively strong, Powell stressed the central bank’s ability to move gradually and in a “risk management” mindset on raising or lowering interest rates. Markets expect the first rate cut to come as soon as June.

“The process of getting inflation down to 2% has a long way to go and is likely to be bumpy,” said Powell. “We have more work to do.”

The potential for rate cuts this year hinges on how quickly the lagging effects of the Fed’s aggressive tightening campaign over the past year feed through into lower price pressures. Policymakers will be closely watching metrics like consumer spending, wage growth, supply chains and inflation expectations for any signs that demand is cooling sustainably.

So far, the labor market has remained resilient, with job gains still robust and the unemployment rate hovering near 50-year lows around 3.5%. This tightness has allowed for solid wage gains, which risks perpetuating an inflationary price-wage spiral if not brought to heel.

While the road ahead remains highly uncertain, Powell stated that he feels the Fed has made enough policy adjustments already to at least pause the rate hiking cycle for now and switch into a data-driven risk management mode. This allows officials to be “patient” and avoid over-tightening while monitoring incoming information.

The Fed Chair also noted that discussions on reducing the central bank’s $8.4 trillion balance sheet began at this meeting, but no decisions have been made yet on adjusting the current runoff caps or pace.

In all, today’s Fed meeting reiterated the central bank’s intention to keep rates elevated for now while laying the groundwork for an eventual pivot to easier policy sometime later this year as disinflationary forces take deeper hold. Striking that balance between under and overtightening will be key for engineering a long-awaited soft landing for the economy.

Release – Direct Digital Holdings Announces Rescheduling of Fourth Quarter and FY 2023 Financial Results Release and Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

March 20, 2024 4:01 pm EDT

HOUSTON, March 20, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the earnings call originally scheduled for March 21, 2024 at 5:00 PM ET will be postponed to March 26, 2024 at 5:00 PM ET to provide additional time to complete the audit of its financial statements.

For further information, please contact investors@directdigitalholdings.com.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.

Contacts: 

Investors:
Brett Milotte, ICR
investors@directdigitalholdings.com

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SOURCE Direct Digital Holdings

Released March 20, 2024

Release – AdTheorent Wins 2024 Artificial Intelligence Excellence Award

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ADTH

Mar 20, 2024

Company honored for AdTheorent Predictive Audiences, Built by ABi™

NEW YORK, March 20, 2024 /PRNewswire/ — AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a machine learning pioneer using privacy-forward solutions to deliver measurable value for programmatic advertisers, today announced that it has been selected by Business Intelligence Group (B.I.G.) as a winner of the 2024 AI Excellence Awards for its AI-based technology innovation. This annual business awards program recognizes organizations, products, and people that are leveraging AI technology to solve real world problems. AdTheorent was recognized for its groundbreaking ID-independent audience targeting solutions: AdTheorent Predictive Audiences, built by ABi™.

   

AdTheorent Predictive Audiences are an ID-independent and algorithm-based method for audience creation and targeting. AdTheorent’s Predictive Audience Builder, or ABi™ is a transformational suite of platform tools designed to enable users to create and activate predictive models which score audience quality. ABi™ leverages customizable and primary-sourced seed data sets to mimic the audience profile of an advertiser’s desired target. In a major departure from industry-standard audience segments, that seed data set is not used for direct targeting. Instead AdTheorent’s machine-learning platform reads signals from those data sets to build a predictive model which scores programmatic inventory based on its likelihood to reach an individual who meets the desired audience profile. This privacy-forward predictive scoring delivers superior audience quality and KPI performance, without the use of cookies or IDs of any kind. When AdTheorent Predictive Audiences are deployed in platform to enhance AdTheorent’s KPI-based impression scoring, the result is a superior level of privacy-forward data-driven accuracy and accountability.

AdTheorent also offers a Health Audience solution, powered by HABi™, which is also ID-independent and not built on or sourced from individualized information, including user browsing activity or observed user location. Rather, HABi™-built Health Audiences are based on anonymized and deidentified datasets constituting over 30 billion records across more than 300 million unique U.S. patients.

“AdTheorent is not new to the AI and machine learning opportunity – we have been refining advanced ML-based solutions since 2012. We remain committed to building and enhancing the most advanced and differentiated machine learning-powered advertising technology and solutions ever deployed in market,” said Jim Lawson, CEO of AdTheorent. “AdTheorent is driving superior performance for our advertisers without the need for cookies – and we sincerely thank the B.I.G. Artificial Intelligence Award judges for this valuable recognition.”

“We are truly honored to recognize AdTheorent with this prestigious award,” stated Maria Jimenez, Chief Nominations Officer for the Business Intelligence Group. “The unwavering commitment of the AdTheorent team to excellence, and their innovative AI-based products and solutions have catapulted them to this remarkable achievement. Congratulations to the entire organization!”

For more information about AdTheorent Predictive Audiences, click here. For more information about the B.I.G. AI Excellence awards, click here.

About AdTheorent 
AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals.

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.

About Business Intelligence Group www.bintelligence.com 
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, these programs are judged by business executives having experience and knowledge. The organization’s proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.

Contact:
Melanie Berger, AdTheorent
850-567-0082
melanie@adtheorent.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/adtheorent-wins-2024-artificial-intelligence-excellence-award-302094852.html

SOURCE AdTheorent

Release – Lifeway Foods® Announces Record-Breaking Fourth Quarter and Monumental Full Year 2023 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LWAY

20 Mar, 2024, 09:00 ET

Record annual net sales of $160.1 million; up 13.1% year-over-year

17th consecutive quarter of year-over-year growth

Delivers 760 basis points of annual gross profit margin expansion

MORTON GROVE, Ill., March 20, 2024 /PRNewswire/ — Lifeway Foods, Inc. (Nasdaq: LWAY) (“Lifeway” or “the Company”), a leading U.S. supplier of kefir and fermented probiotic products to support the microbiome, today reported financial results for the fourth quarter and full year ended December 31, 2023.

“I am pleased to report another outstanding year for Lifeway Foods, highlighted by our record-breaking annual net sales, and driven by volume growth in our flagship Lifeway drinkable kefir,” commented Julie Smolyansky, President and Chief Executive Officer of Lifeway Foods. “Our exceptional results in 2023 culminated with our highest ever quarterly net sales of $42.1 million in the fourth quarter, our 17th consecutive quarter of year-over-year growth. Our volume growth throughout the year is a testament to the steadfast loyalty of our expanding customer base. It is also a product of the effectiveness of our strategic sales and marketing investments at driving velocities in our core products and capturing additional consumers seeking premium, healthy offerings. Our profitability improvements for the year were significant across all of our key metrics, including gross profit margin and net income, guided by our strong operational execution and aided by favorable milk pricing. We are well positioned to build on this momentum in 2024, and plan to continue reinvesting in our core products to drive brand exposure and further growth. I would like to thank the entire Lifeway team, including our customers and retail partners, for helping us deliver these excellent results for 2023.”

Full Year 2023 Results

Net sales were $160.1 million for the year ended December 31, 2023, an increase of $18.6 million or 13.1% versus prior year. The net sales increase was primarily driven by higher volumes of our branded drinkable kefir, and to a lesser extent the impact of price increases implemented during the fourth quarter of 2022.

Gross profit as a percentage of net sales increased to 26.5% for the year ended December 31, 2023 from 18.9% during the same period in 2022. The 760-basis point increase versus the prior year was primarily due to the higher volumes of Lifeway branded products and the favorable impact of milk pricing, and to a lesser extent the price increases implemented during the fourth quarter of 2022 and decreased transportation costs.

Selling, general and administrative expenses as a percentage of net sales were 15.6% for the year ended December 31, 2023, compared to 16.9% in the prior year.

The Company reported net income of $11.4 million or $0.77 per basic and $0.75 per diluted common share for the year ended December 31, 2023 compared to net income of $0.9 million or $0.06 per basic and diluted common share during the same period in 2022.

Conference Call and Webcast
A pre-recorded conference call and webcast with Julie Smolyansky discussing these results with additional comments and details is available through the “Investor Relations” section of the Company’s website at https://lifewaykefir.com/webinars-reports/  and will also be available for replay.

About Lifeway Foods, Inc.
Lifeway Foods, Inc., which has been recognized as one of Forbes’ Best Small Companies, is America’s leading supplier of the probiotic, fermented beverage known as kefir. In addition to its line of drinkable kefir, the company also produces a variety of cheeses and a ProBugs line for kids. Lifeway’s tart and tangy fermented dairy products are now sold across the United States, Mexico, Ireland and France. Learn how Lifeway is good for more than just you at lifewayfoods.com.

Forward-Looking Statements

This release (and oral statements made regarding the subjects of this release) contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product development, market position, business strategy and objectives. These statements use words, and variations of words, such as “continue,” “build,” “future,” “increase,” “drive,” “believe,” “look,” “ahead,” “confident,” “deliver,” “outlook,” “expect,” and “predict.” Other examples of forward-looking statements may include, but are not limited to, (i) statements of Company plans and objectives, including the introduction of new products, or estimates or predictions of actions by customers or suppliers, (ii) statements of future economic performance, and (III) statements of assumptions underlying other statements and statements about Lifeway or its business. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events and thus are inherently subject to uncertainty. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from Lifeway’s expectations and projections. These risks, uncertainties, and other factors include: price competition; the decisions of customers or consumers; the actions of competitors; changes in the pricing of commodities; the effects of government regulation; possible delays in the introduction of new products; and customer acceptance of products and services. A further list and description of these risks, uncertainties, and other factors can be found in Lifeway’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s subsequent filings with the SEC. Copies of these filings are available online at https://www.sec.gov, http://lifewaykefir.com/investor-relations/, or on request from Lifeway. Information in this release is as of the dates and time periods indicated herein, and Lifeway does not undertake to update any of the information contained in these materials, except as required by law. Accordingly, YOU SHOULD NOT RELY ON THE ACCURACY OF ANY OF THE STATEMENTS OR OTHER INFORMATION CONTAINED IN ANY ARCHIVED PRESS RELEASE.

Media:
Derek Miller 
Vice President of Communications, Lifeway Foods
Email: derekm@lifeway.net 

General inquiries:
Lifeway Foods, Inc.
Phone: 847-967-1010
Email: info@lifeway.net

View full release here.

Release – PDS Biotechnology Announces Conference Call and Webcast for Business Update and Full Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., March 20, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell-activating platforms, today announced that the Company will provide a business update and release financial results for the year ended December 31, 2023, on Wednesday, March 27, 2024. Following the release, management will host a conference call to review the financial results and provide a business update.

Wednesday, March 27, 2024, 8:00 AM ET
Domestic: 877-704-4390
International: 201-389-0920
Conference ID: 13745320
Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS01ADC and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches. Our Versamune® platform activates the right type, quantity and potency of tumor attacking T cells. Our IL-12 fused antibody drug conjugate (PDS01ADC) is designed to target the tumor to promote suppression of the tumor’s defenses while promoting T-cell activity in the tumor. To date, Versamune® HPV (PDS0101), PDS01ADC and PDS0101 co-administered with PDS01ADC, our lead clinical candidates, have demonstrated the ability to shrink tumors and/or stabilize disease when used as single agents or in combination with approved therapies in patients with a broad range of solid tumors in multiple Phase 2 clinical trials. We plan to advance our lead program into a pivotal trial for the treatment of recurrent/metastatic HPV16-positive head and neck cancer. Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on X at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 20, 2024 8:00am EDTDownload as PDF

Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies

New Drug Application (NDA) submission to the FDA planned for second half of 2024

CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services, a member of the privately owned Almac Group, as dual supply sources for the potential launch and commercialization of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S.

“Dual sourcing is a critical element for the successful commercial launch and supply chain management of a product,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to advance our first internally developed program toward NDA submission and to work with two well-established CMOs for commercial supply and potential launch of Tonmya.”

“Having supported the development and clinical trial supply of this drug, we’re thrilled to be continuing our partnership with Tonix to support the commercial launch and ongoing supply of this important new non-opioid analgesic to patients with fibromyalgia, a chronic debilitating disease,” said Mark English, VP Operations, Almac Pharma Services.

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, 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 (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed.

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia.

About Tonmya* (also known as TNX-102 SL)

TNX-102 SL is a tablet containing 2.8 mg cyclobenzaprine HCl that will be administered sublingually once daily at bedtime for the first 2 weeks, titrating subsequently to 2 tablets (5.6 mg total per day) at bedtime, as tolerated, for chronic, long-term use. The sublingual tablet is formulated using a patented Protectic™ eutectic formulation including a basifying agent for transmucosal absorption with rapid systemic exposure pharmacokinetic properties suitable for bedtime administration. The eutectic properties enhance the stability with a predicted shelf life of greater than 48 months, at room temperature conditions. The planned commercial distribution will be a 14, 60 and 90 count tablet bottles allowing for titration, flexible and three-month chronic supply. Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. RELIEF, the first positive Phase 3 trial of Tonmya 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.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

Employing over 1,600 highly skilled individuals across 4 locations in Europe and the US, the company provides tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.

On March 6, 2024, the company announced the completion of a custom-built, high-volume facility that significantly increases commercial manufacturing and packaging of sachet drug product presentations forming part of the Group’s ongoing global expansion investment now totaling over £400 million.

To keep up to date with latest news, follow us on LinkedIn or visit our website.

About Almac Group

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically, now employing 7,200 highly skilled personnel across 18 facilities including Europe, the USA and Asia.

To keep up to date with latest news, follow us on X and LinkedIn or visit almacgroup.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with 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 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released March 20, 2024

Defense Metals Corp. (DFMTF) – On a Roll

Posted on by cpereira@noblefcm.com


Wednesday, March 20, 2024

Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

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.

Appointment of corporate financial adviser. Defense Metals appointed HCF International Advisers Ltd., a London-based corporate financial advisory firm, to conduct a strategic funding review for the company’s Wicheeda Rare Earth Elements Project. The review will help Defense Metals analyze and evaluate potential funding and strategic partnership options associated with the development of the Wicheeda Project post completion of its preliminary feasibility study (PFS). HCF’s experience in financing globally recognized mining projects include its role as financial adviser to Arafura Rare Earths Limited (ASX: ARU) in the financing of the Nolan Project in Australia.

Upcoming preliminary feasibility study. Defense Metals expects to complete a PFS in the second calendar quarter of 2024 for which metallurgical test work has been completed. Bench-scale and hydrometallurgical pilot plant test work indicates the planned acid bake process will deliver approximately 90% total rare earth oxide (TREO) extraction from the mineral concentrate to a mixed rare earth carbonate product.


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. 

Bit Digital (BTBT) – Being More Diversified

Posted on by cpereira@noblefcm.com


Wednesday, March 20, 2024

Joe Gomes, 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.

Diversification Heading into 2024. The Company’s fiscal year 2023 saw the company expand its bitcoin miners and change from ETH mining to native and liquid staking. Most importantly, during the fall of 2023, management announced a new segment, Bit Digital AI, to provide digital infrastructure services, including GPU rental services. With the AI business line, Bit Digital has recurring revenue that gives the Company stability in times of volatility with BTC and ETH prices, in our view.

BTC Mining and ETH Staking. For the year, the Company earned 1,507.3 bitcoins, a 21% increase from last year driven by a higher active hash rate partially offset by an increase in network difficulty. The average fleet efficiency for the active fleet was approximately 28.8 J/TH as of December 31, 2023. The Company earned 287.0 ETH in native staking and 81.9 ETH in liquid staking for the year.


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. 

Curaleaf Goes Global with Acquisition of Northern Green Canada

Posted on by slightbourne@noblecapitalmarkets.com

In a major move to solidify its position as a global cannabis leader, Curaleaf Holdings has announced the acquisition of Northern Green Canada (NGC), a Canadian licensed producer with EU-GMP certification. This strategic deal provides Curaleaf with a crucial supply chain advantage as it expands into key international markets like Germany, Poland, the United Kingdom, Australia and New Zealand.

The cannabis industry is entering an exciting new phase of globalization and maturation. As more countries legalize and regulate medical and adult-use cannabis, massive investment opportunities are emerging for companies that can scale operations and establish early mover advantages in these blossoming markets.

Germany’s recent groundbreaking decision to legalize recreational cannabis has put the European Union’s biggest economy squarely in the spotlight. With over 80 million people, Germany represents a behemoth market opportunity that could push the broader European cannabis industry into an economic windfall. Securing NGC’s supply of high-quality EU-GMP certified flower puts Curaleaf in pole position as this enormously lucrative German market takes shape.

But Curaleaf’s ambitions extend far beyond Europe with this acquisition. NGC also has an established presence supplying the booming Australian and New Zealand markets, which are experiencing some of the highest rates of cannabis usage and sales growth worldwide. Cannabis spending in Australasia is projected to swell to over $6 billion by 2025 as new legal regimes open up access.

By vertically integrating NGC’s operations, Curaleaf can significantly increase margins on its international distribution while ensuring consistent supply of premium indoor flower to meet surging global demand. NGC’s facility also has abundant space certified for additional grow operations, giving Curaleaf tremendous ability to scale up production capacity as these markets expand.

For investors, this deal heralds an acceleration of Curaleaf’s transition into a true multinational cannabis titan with the reach, resources and efficiencies of scale to capitalize on emerging legal markets worldwide. The cannabis sector has already witnessed multiple cross-border merger & acquisition deals in recent years as companies jockey for position. Curaleaf’s acquisition of NGC represents one of the most ambitious international cannabis plays yet attempted.

While recent years have seen valuations in the cannabis space take a hit amidst an extended cash crunch, this period of consolidation sets the stage for the industry’s impending global expansion. The total addressable market size for legal cannabis could eventually reach into the hundreds of billions as more national markets open up. Companies that can successfully execute on international growth strategies and stake out early footholds globally stand to reap immense rewards in the years ahead.

Investors attuned to this next wave of cannabis market maturation would be wise to seek out multi-national operators building vertically integrated cultivation, processing and distribution channels to capture value across the supply chain. Curaleaf’s acquisition of NGC shows it is positioning to ride this rising tide as the cannabis industry transitions to a new era of globalization.

What Exactly is the Russell Reconstitution?

Posted on by slightbourne@noblecapitalmarkets.com

If you’re an investor, there’s an annual event on Wall Street that you should be aware of – the Russell Reconstitution. While it may not get much mainstream attention, this yearly process can have a major impact on certain stocks and drive significant trading activity.

So what exactly is the Russell Reconstitution? Let’s break it down in simple terms.

The Russell family of indexes is one of the most widely-followed equity benchmarks. The headline Russell 3000 represents the broad U.S. stock market, while the Russell 1000 tracks large-cap stocks and the Russell 2000 focuses on small-caps.

These indexes aim to be an accurate representation of the overall U.S. public market at any given time. However, company valuations and rankings are constantly evolving as businesses grow, stagnate, or decline.

To ensure the indexes stay up-to-date and reflective of the current market, they go through an annual “reconstitution” process of completely rebuilding membership from the ground up.

Each year, the Russell indexes perform this rebuilding exercise based on the latest market capitalization rankings for U.S. public companies after the market closes on a predetermined “ranking day.”

Companies are re-ranked from largest to smallest based on their new market caps. The top x% make up the Russell 1000 large-cap index, the bottom y% are assigned to the small-cap Russell 2000 index, and so on across Russell’s various capitalization-based indexes.

This rebalancing and membership shuffle occurs annually to keep the indexes properly aligned with the ever-changing market landscape. Companies experiencing strong growth may graduate into a higher cap-weighted index, while those losing ground get demoted to lower indexes.

Being added to the Russell 1000 or Russell 2000 indexes can provide a meaningful boost to a stock. These indexes are tracked by hundreds of billions in assets, so inclusion often comes with heightened liquidity, passive fund exposure, and institutional investor interest.

Conversely, stocks being removed from the headline indexes can suffer the opposite effects of reduced volume, investor exits, and volatility as funds rebalance their holdings.

Historically, stocks slated for inclusion in the Russell 2000 small-cap index have enjoyed a “reconstitution rally” in the run-up period as index funds buy in ahead of the official rebalance. Those migrating out often see selling pressure over this pre-rebalance window.

Why the Russell Rebalance Matters

While seemingly an administrative exercise, the annual Russell Reconstitution has taken on outsized significance in recent decades due to the explosion of passive index-tracking investment vehicles and strategies.

As major funds reposition their portfolios to replicate the updated index compositions each year, it creates a temporary imbalance of concentrated buying and selling in the impacted stocks joining or leaving the main benchmarks.

This trading frenzy can unlock rapid changes in volume, volatility, and institutional ownership levels for stocks experiencing an index status change – especially those smaller names making the cut for inclusion in the Russell 2000.

As index funds have grown to control trillions in assets tracking these benchmarks, the annual Russell rebalancing period has become an increasingly important event to monitor, particularly for stocks straddling the cap thresholds between indexes.

What to Watch For

While the Russell Reconstitution operates seamlessly in the background for most investors, those holding impacted stocks may want to anticipate potential volatility and position accordingly in the typical multi-week period ahead of each year’s official rebalance implementation.

The annual event reinforces the profound impact that passive investment strategies can wield on individual stocks simply due to their membership status in closely-tracked equity benchmarks. For better or worse, joining or leaving a major index can drastically alter a stock’s profile and trading dynamics – at least in the short-term rebalancing period.

As indexing grows even more ubiquitous, watching for potential reconstitution impacts could remain a wise practice for active traders and investors holding smaller stocks near the index composition cutoff levels.

2024 Russell US Indexes Reconstitution Schedule

  • Tuesday, April 30th – “Rank Day” – Index membership eligibility for 2024 Russell Reconstitution determined from constituent market capitalization at market close.
  • Friday, May 24th – Preliminary index additions & deletions membership lists posted to the website after 6 PM US eastern time.
  • Friday, May 31st, June 7th, 14th and 21st – Preliminary membership lists (reflecting any updates) posted to the website after 6 PM US eastern time.
  • Monday, June 10th – “Lock-down” period begins with the updates to reconstitution membership considered to be final.
  • Friday, June 28th – Russell Reconstitution is final after the close of the US equity markets.
  • Monday, July 1st – Equity markets open with the newly reconstituted Russell US Indexes.