BOTHELL, Wash., Dec. 06, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344 treatment.
“There is an urgent need for new oral antivirals targeting pandemic and seasonal influenza that address drug resistance. CC-42344 was discovered using our proprietary structure-based drug discovery platform technology to inhibit the viral replication process. The data from this proof-of-concept clinical study will further validate CC-42344’s novel mechanism of action,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We expect to report topline data from this clinical trial in 2024.”
“We are excited about the potential CC-42344 holds to create a paradigm shift in the treatment of one the world’s most common viral infections,” added James Martin, Cocrystal’s CFO and co-CEO. “Currently approved antiviral treatments for influenza are prone to viral resistance, increasing the need for improved influenza treatments for patients that also provide significant cost savings to the global healthcare system.”
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 2a study for CC-42344 as a product candidate for oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A, the potential efficacy and clinical benefits of, and market for, such product candidate, and the expected results and topline data from this clinical trial in 2024. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the Phase 2a study including recruiting volunteers and procuring materials for such study by our clinical research organizations and vendors, and the results of such study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Atherosclerosis, an inflammatory disease characterized by buildup of cholesterol, lipids, and other substances (plaque) in arteries leading to heart attack and stroke, is accelerated in patients with diabetes.
The study published in Diabetes demonstrates that AIM2 and NLRP3 inflammasome activation leads to development of atherosclerotic lesions in diabetic mice.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including NLRP3 and AIM2) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in numerous diseases.
WESTON, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Diabetes, demonstrating that AIM2 and NLRP3 inflammasome activation contributes to development of atherosclerosis in two different animal models of type 1 diabetes.
In the paper titled, “Hematopoietic NLRP3 and AIM2 inflammasomes promote diabetes-accelerated atherosclerosis, but increased necrosis is independent of pyroptosis,” the authors studied mouse models of type 1 diabetes and atherosclerosis. Following are key findings reported in the paper:
Diabetic animals demonstrated activation of inflammasome pathways, based on increased levels of plasma IL-1β and IL-18, and elevated levels of cleaved caspase- 1 in the peritoneal cavity fluid.
Each of the two different type 1 diabetes models exhibited similar levels of plasma IL- 1β and IL-18 and similar aortic lesion sizes and severity.
Diabetic mice deficient in NLRP3 and/or AIM2 had reduced aortic lesion size compared to diabetic controls, indicating that NLRP3 and AIM2 inflammasome activation contributes to atherosclerotic lesion development.
Results are consistent with other animal model studies showing deficiencies in essential inflammasome components, such as NLRP3, AIM2, ASC, and caspase-1, appear to protect against atherosclerosis.
“The research published in Diabetes reinforces that inhibition of multiple types of inflammasomes, not just NLRP3, may be required to effectively control inflammation in diseases, such as atherosclerosis, in which activation of more than one type of inflammasome is pathogenic,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation contributing to numerous diseases.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
The Economic Perspectives Panel’s discussions at the recent NobleCon19 emerging growth conference not only provided valuable insights into various sectors and the broader economic landscape but also served as a comprehensive analysis that captivated the audience’s attention. The panel, featuring a diverse range of experts from industry leaders to economists, offered nuanced perspectives on the challenges that have characterized markets since 2021 and identified potential opportunities, notably emphasizing the potential for undervalued small-cap investments.
The conference kicked off with an Economic Outlook Panel, expertly moderated by Michael Williams, a seasoned News Anchor at WPTV/NBC in West Palm Beach. Williams adeptly steered the discussions through key topics, leveraging the wealth of knowledge from panelists such as Lisa Knutson, COO of E.W. Scripps;Cary Marshall, CFO of Alliance Resource Partners; Jose Torres, Senior Economist at Interactive Brokers; Shanoop Kothari, Co-CEO of LuxUrban Hotels; and Dan Thelen, Managing Director of Small/Mid Caps at Ancora.
A prevailing sentiment among the panelists was the intriguing possibility of 2024 mirroring the economic resurgence experienced in 1990, a year that followed a challenging period. Notably, the consensus was that small-cap investments tend to outperform larger companies during economic recoveries due to their inherent agility and greater potential for growth. The panel expressed cautious optimism, suggesting that the Russell 2000 index might pleasantly surprise investors in the upcoming year.
The discussion also spotlighted sectors of particular interest, with media and advertising taking center stage. The anticipation of heavy political ad spending, estimated at an impressive $10-12 billion leading up to the 2024 election, captured the attention of the panel. Additionally, the oil and gas markets were under scrutiny, with a notable supply response identified as a contributing factor in curbing recent inflation concerns. Projections indicated a forecasted addition of 2.2 million extra barrels per day in the US in 2023, with prices already having experienced a 17% drop from their earlier peak in the year.
Delving into broader economic discussions, the panel highlighted the resilience observed in 2023 to date, supported by a robust labor market and excess pandemic savings fueling consumption. However, the panel cautioned against undue optimism, pointing to expectations of a potential slowdown in 2024, particularly as the Federal Reserve eases interest rates and government spending recedes. The acceptance of a 3-3.5% baseline inflation in the long term was posited as a necessary acknowledgment, notwithstanding the official 2% target.
While acknowledging potential risks in the commercial real estate sector, the panel expressed confidence that forward-thinking companies were actively engaged in cost-cutting measures and prudent inventory management. The overarching expectation was that stock returns would follow a trajectory reminiscent of the positive trends witnessed in 1990, thereby making small-cap investments an attractive prospect for investors keen on capitalizing on emerging opportunities.
Addressing the transformative impact of artificial intelligence (AI) on various facets of business and society, the panel collectively agreed that AI is not just a passing trend but a transformative force that is here to stay. Cary Marshall went as far as declaring, “AI is the electrification of this country.” While recognizing the potential for AI to reduce labor costs, the panelists cautioned that widespread adoption might take longer than initially anticipated. Jose Torres added a nuanced perspective, suggesting that AI could lead to shorter workdays but expressed concerns about the potential erosion of interpersonal skills critical for persuasion and influence.
In conclusion, the panel emphasized the indispensable need for mental toughness, emotion management, and discipline in navigating the inevitable cycles of the markets. Despite the multifaceted challenges, the prevailing sentiment was one of guarded optimism for the road ahead. As markets continue to evolve and present new dynamics, these key takeaways from the Economic Perspectives Panel offer invaluable insights for investors seeking to navigate the intricate landscape of emerging growth and economic recovery, providing a robust foundation for strategic decision-making in the ever-changing financial environment.
TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating
Preclinical data show magnesium-potentiation increases the potency of exogenous oxytocin
Formulations of intranasal oxytocin without magnesium have reported inconsistent results in clinical trials of Prader Willi Syndrome1,2
CHATHAM, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900 (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-enhanced formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022.
The Phase 2 study approved by the IND is a dose-finding study involving approximately 36 PWS patients divided into four groups with approximately nine PWS patients per group. One group will receive placebo and three groups will receive different dosage regimens of TNX-2900. Tonix intends to seek a partner to advance TNX-2900 for PWS in clinical development.
“We are pleased that TNX-2900 is cleared for clinical studies for the treatment of PWS in children and adolescents as there remains a significant need for new therapies, particularly for PWS hyperphagia, which currently has no approved treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “PWS is the most common genetic cause of life-threatening childhood obesity.3,4 We believe adding Mg2+ to the formulation has the potential to improve intranasal oxytocin’s therapeutic action.”
The IND application for TNX-2900 was supported by preclinical data demonstrating that Mg2+ enhances the potency of oxytocin. Oxytocin is a naturally-occurring hormone that reduces appetite and eating and regulates hunger, anxiety and prosocial behavior. PWS is a genetic disorder associated with abnormalities of the oxytocin system5. Several previous clinical studies in PWS of intranasal oxytocin without Mg2+-potentiation have shown trends toward improvement, but the results have been inconsistent.1,2 Tonix believes that Mg2+-potentiation of intranasal oxytocin in PWS may improve consistency in clinical trials because in animal studies Mg2+-potentiation appears to eliminate the high-dose suppression of oxytocin’s inverted “U”-shaped dose response.6
Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “Recent reports show Mg2+ is necessary for oxytocin to fully activate the oxytocin receptor.3,6 Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.4 Oxytocin has many potential therapeutic roles in reducing appetite, eating, weight, migraine pain and autistic spectrum behaviors. Tonix recently completed enrollment in a Phase 2 study of TNX-1900, a related Mg2+-potentiated intranasal oxytocin candidate, for the prevention of migraine headaches, and is also studying TNX-1900 through external collaborations for the treatment of obesity in adolescents, binge eating disorder, bone health in autism, and social anxiety disorder.”
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.7 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.4 In addition, oxytocin has potent effects in correcting behavioral characteristics of the neonatal Magel2 knock-out mouse model for PWS and autism8 and intriguing effects in a clinical trial of neonates with PWS.9
About TNX-2900 and Tonix’s Potentiated Oxytocin Platform TNX-2900 is based on 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. Tonix is also developing a different intranasal formulation, designated TNX-1900, for prophylaxis of chronic migraine as well as for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. 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.10,11 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). *Pitocin® is a trademark of Par Pharmaceutical, Inc.
**Syntocinon® is a trademark of BGP Products Operations GmbH
Citations
Shalma NM, et al. Diabetes Metab Syndr. 2023. 17(2):102711.
Rice LJ, et al. Curr Opin Psychiatry. 2018. 31(2):123-127.
Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
Correa-da-Silva F, et al. J Neuroendocrinol. 2021. 33(7):e12994.
Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
Oxytocin in Wikipedia https://en.wikipedia.org/wiki/Oxytocin (accessed 8-8-23)
Tonix Pharmaceuticals Holding Corp.* Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed the clinical phase of a potentially confirmatory Phase 3 study in the fourth quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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.
Gold prices have been on a dazzling run in recent months, with the precious metal notching consecutive monthly gains to reach new all-time highs. On Monday, spot gold prices topped $2,100 an ounce for the first time ever, hitting $2,110 before pulling back slightly. This adds to the previous record set back on Friday when prices exceeded $2,075, blowing past 2020’s earlier high point.
Analysts say gold still has room to run in 2023 and 2024 as key conditions line up to support further upside for bullion. Low interest rates, a weakening US dollar, rising inflation concerns globally, and an array of simmering geopolitical conflicts should all conspire to keep safe haven demand elevated.
“There is simply less leverage this time around versus 2011 in gold,” said Nicky Shiels of MKS PAMP, noting that the current dynamics put $2,200/oz within reach. Other experts concur, with UOB strategist Heng Koon How targeting $2,200 gold by end-2024, and TD Securities anticipating average prices around $2,100 in Q2 2024.
Fueling this gold fever has been robust central bank buying, especially across emerging markets. Recent data shows 24% of central banks worldwide intend to pad their gold reserves over the next year as economic uncertainty persists. With these institutions showing waning faith in traditional reserve assets like the US dollar, their bullion accumulation provides a sturdy pillar of support.
Geopolitical Flare-Ups Stoke Safe Haven Appeal
Mounting geopolitical tensions represent another propellant behind gold’s rise. The bloody conflict between Israel and Palestine has recently stoked investor fears, driving many towards gold’s relative stability. Looking ahead, strategists believe various other hotspots could flare up and lift bullion demand more.
Besides the Middle East, worsening frictions between China and Taiwan or a resurgence of the crisis in Ukraine could shock markets. And if the US gets dragged into any new foreign entanglements, it may have to ramp up defense spending and borrowing, potentially weakening both growth and the dollar.
With so many risks swirling, portfolio managers and retail buyers appear increasingly eager to hedge with gold. Notably, demand has climbed even as gold prices touched multi-year highs. This underscores bullion’s unique status as a tried-and-true safe haven asset.
Fed Policy Outlook Could Offer Further Boost
Though gold has powered higher despite a spate of Fed rate hikes, any change in this tightening cycle would provide another major catalyst. After lifting interest rates rapidly from near-zero, policymakers must now decide whether to keep tightening or ease off the brakes.
Several officials, including Governor Christopher Waller, have hinted rates may not rise much further if inflation keeps slowing as expected. Markets thus see potential Fed rate cuts arriving sometime in 2024.
If implemented, this dovish shift would likely hamstring the dollar and bond yields, stirring more demand for non-interest-bearing gold. Hence analysts view Fed pivots as a probable linchpin that keeps prices locked above $2,000 over the next couple of years.
With stars aligned for gold both fundamentally and geopolitically, all the ingredients seem in place for its dazzling run to continue. That leaves bulls dreaming ever more ambitiously of how high prices could yet soar. However, given gold’s inherent volatility, traders should steel themselves for pullbacks as well while enjoying the ride upwards.
DAVENPORT, Iowa, Dec. 01, 2023 (GLOBE NEWSWIRE) — Lee Enterprises, Incorporated (NASDAQ: LEE), a major subscription and advertising platform and a leading provider of high quality, trusted, local news and information in 75 markets, has scheduled an audio webcast and conference call for Thursday, December 7, 2023, at 9 a.m. Central Time. Lee plans to issue a news release before market opens that day with preliminary results for its year ended September 24, 2023.
A live webcast of the conference call may be accessed via the Investor Relations portion of Lee’s website or here and will be available for replay 24 hours later.
ABOUT LEE
Lee Enterprises is a major subscription and advertising platform and a leading provider of local news and information with daily newspapers, rapidly growing digital products and, nearly 350 weekly and specialty publications serving 75 markets in 26 states. Lee’s newspapers have average daily circulation of 1.0 million, and reach more than 31 million digital unique visitors. Lee’s markets include St. Louis, MO; Buffalo, NY; Omaha, NE; Richmond, VA; Lincoln, NE; Madison, WI; Davenport, IA; and Tucson, AZ. Lee Common Stock is traded on the NASDAQ under the symbol LEE. For more information about Lee, please visit www.lee.net.
Federal Reserve Chair Jerome Powell threw cold water on mounting speculation that the central bank is nearing the end of its tightening campaign and will soon reverse course to cutting interest rates.
In a speech at Spelman College on Friday, Powell asserted “it would be premature” for investors to conclude the Fed’s policy stance is restrictive enough given lingering inflation pressures. He stated plainly that more rate hikes could still be on the table if appropriate.
His sobering comments follow the latest inflation data showing core PCE, the Fed’s preferred gauge, ticked down slightly to 3.5% annually in October. Though marking a fourth consecutive month of slow improvement, Powell emphasized the number remains well above the Fed’s 2% target.
“While the lower inflation readings of the past few months are welcome, that progress must continue if we are to reach our 2% objective,” he said.
Nonetheless, overeager investors have jumped the gun on declaring victory over inflation and penciling in imminent rate cuts. Billionaire Bill Ackman predicted this week that cuts could come as soon as Q1 2024.
But Powell asserted the full impact of the Fed’s blistering pace of rate hikes this year has likely not yet transmitted through the economy. Plus, he noted core PCE has averaged 2.5% over the past six months – still too high for comfort.
Key Takeaways for Investors The Fed chair’s remarks make clear that policymakers see their inflation-taming mission as incomplete despite markets cheering each new downward tick. Here are the big implications for investors:
Rate cuts are not coming anytime soon. The Fed wants concrete evidence that inflation is reverting steadily to its 2% goal before it contemplates easing policy. Powell admission that more hikes could happen dispels investor hopes for a swift policy pivot.
Stocks may face renewed volatility. Exuberant bets on imminent rate cuts provided major tailwinds for this year’s risk asset rebound. With the Fed dampening that narrative, investors may recalibrate positions. Powell cautioned about the unusual uncertainty still permeating the economic outlook.
Recession risks linger in 2024. The full brunt of the Fed’s Super-Size rate hikes has yet to impact the real economy. Powell made clear policy will stay restrictive for some time to have its intended effect of slowing demand and consumer spending. That keeps recession risks on the radar, especially in the back half of next year.
Navigating the Volatility Ahead With the Fed determined to remain the grinch raining on investor enthusiasms around pivots, next year promises more turbulence for markets. Savvy investors should:
Trim exposure to interest-rate sensitive assets: Risks remain heavily skewed towards more volatility as the Fed asserts its hawkish credibility. ratchet down exposure to bonds, utilities, real estate and other rate-vulnerable sectors.
Emphasize inflation hedges: The Fed’s clear-eyed focus on returning inflation to 2% means investors should still prioritize inflation-fighting assets like commodities, TIPS, floating-rate bank loans, and short-duration bonds. These provide buffers against rising prices.
Stay nimble amid cross-currents: Between lingering inflation and slowing growth, crosswinds for investors abound. Being opportunistic yet disciplined will be critical, as risk appetites could sour quickly depending on upcoming data and guidance from the Fed. Maintaining flexibility and even selective hedges allows investors to adeptly navigate the turbulence ahead under Powell’s resolute hawkish watch.
NEW YORK, Dec. 01, 2023 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, today announced that it is scheduled to present at the following investor conferences:
Noble Capital Markets 19th Annual Emerging Growth Equity Conference Location: Boca Raton, FL Date: December 4 – 5, 2023 Presentation Time: December 5 at 3:00 pm ET Webcast: www.nobleconference.com
Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel Brands, will be leading the formal presentation and answering questions from investors. Xcel Brands will also provide an overview of its growth opportunities and business transformation, including a first look at the Company’s new livestream shopping technology and social commerce platform.
About Xcel Brands
Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, production, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone, and over 20,000 hours of live-stream and social commerce. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “ongoing,” “could,” “estimates,” “expects,” “intends,” “may,” “appears,” “suggests,” “future,” “likely,” “goal,” “plans,” “potential,” “projects,” “predicts,” “seeks,” “should,” “would,” “guidance,” “confident” or “will” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding our anticipated revenue, expenses, profitability, strategic plans, and capital needs. These statements are based on information available to us on the date hereof and our current expectations, estimates and projections and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors, including, without limitation, the risks discussed in the “Risk Factors” section and elsewhere in the Company’s Annual Report on form 10-K for the year ended December 31, 2022 and its other filings with the SEC, which may cause our or our industry’s actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances, or any other reason.
For further information please contact: Andrew Berger SM Berger & Company, Inc. 216-464-6400 andrew@smberger.com
HOUSTON, Nov. 30, 2023 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, announced today that CEO Travis Boone and CFO Scott Thanisch will be participating in NobleCon 19 Emerging Growth Equity Conference being held at Florida Atlantic University in Boca Raton. Orion Management will be presenting on December 4, 2023, at 2:30 p.m. Eastern Time. Following the presentation there will be a breakout session with investors as well as scheduled one-on-one meetings.
A high-definition video webcast of the presentation will be available the following day on the Company’s website at https://www.oriongroupholdingsinc.com. The presentation will also be available on Noble Capital Markets’ Conference website www.nobleconference.com and on Channelchek www.channelchek.com, Noble Capital’s investor portal. The webcast will be archived for 90 days following the event.
About Orion Group Holdings Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design, and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. https://www.oriongroupholdingsinc.com.
About Noble Capital Markets, Inc. Noble Capital Markets (“Noble”) is a research-driven investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last decade. Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 public emerging growth companies are listed on the site, with growing content including research, webcasts, podcasts, and balanced news.
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
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.
New CEO. Yesterday, GEO announced Brian Evans, who has been with the Company for 23 years and has served as the Company’s Chief Financial Officer for 14 years, has been appointed Chief Executive Officer, effective January 1, 2024. Current CEO Jose Gordo is transitioning to an advisor role, by mutual agreement. Given Mr. Evans’ familiarity with GEO and his strong performance as CFO, we believe this is a strong choice for the Company.
Zoley Term. Company founder and Executive Chairman George Zoley will step down as Executive Chairman as of June 30, 2026, the end of his current employment term. Mr. Zoley then will transition into the role as an advisor to the Company, while continuing to serve as the Company’s non-Executive Chairman of the Board of Directors.
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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.
Pharmaceutical giant Pfizer suffered a setback this week in the high-stakes race to tap into the burgeoning multi-billion dollar weight loss drug market. The company announced it is halting development of the twice-daily formulation of its experimental obesity pill danuglipron after underwhelming mid-stage trial results.
While the drug induced significant weight loss in obese patients, it came at the cost of poor tolerability. Over half of participants dropped out of the phase 2 study due to adverse gastrointestinal side effects like nausea and diarrhea.
Nonetheless, Pfizer still intends to stay in the game with a once-daily version of danuglipron. The company aims to release fresh phase 2 data on the more competitive formulation in early 2024 before determining next steps.
For a drugmaker grappling with fading Covid-19 revenues, the news deals a tough blow to its strategy to offset declines through potential new blockbusters for obesity. Just last year, CEO Albert Bourla tagged the total addressable weight loss market at a whopping $90 billion.
But competition is cutthroat, with Novo Nordisk and Eli Lilly vying to convert millions from their injectable diabetes meds to an oral option. Their rival pills have already posted mid-teens percentage weight loss results that position them to potentially leapfrog Pfizer’s attempt.
Danuglipron Quick Facts
Twice-daily formulation now discontinued after 6.9% to 11.7% weight loss at 32 weeks
Well below 14-15% loss seen as competitive threshold
High rates of nausea, vomiting, diarrhea
Over 50% dropout rate
Key Takeaways for Investors The disappointing data for danuglipron’s twice-daily pill underscores several investor concerns around Pfizer’s efforts to expand into weight loss medicines.
Uphill Battle Against Rivals Novo Nordisk and Eli Lilly already dominate the obesity drug landscape with their injectable products Saxenda and Ozempic. Lilly’s oral candidate tirzepatide is showing roughly 15% weight loss over 72 weeks, clearing the competitive bar Pfizer failed to hit.
While the field is large enough for multiple winners, Pfizer faces substantial share challenges from these deeply entrenched rivals. Its best-case outcome may be carving off a small slice rather than market leadership.
Tolerability Issues Limiting Danuglipron has now faltered twice in mid-stage studies due to side effects leading over half of volunteers to quit treatment. The once-daily route shows some promise, but gastrointestinal problems may hamper uptake if they persist. By comparison, tirzepatide posted a 21% dropout rate.
Uncertainty Remains High With phase 3 trials still a distant prospect, the program faces a long road ahead fraught with risk. While danuglipron evinced significant weight-loss efficacy, real-world commercial success depends greatly on improving its poor tolerability profile.
Until then, uncertainty around Pfizer’s weight loss aspirations stays high. Expect sales projections to remain muted absent positive late-stage outcomes down the line. But rivals like Lilly and Novo aren’t standing still either, making danuglipron’s path ahead even trickier.
