Page 293 – Channelchek

September Sees Record Lows in Home Sales

Posted on October 19, 2023October 19, 2023 by slightbourne@noblecapitalmarkets.com

The US housing market continues to show signs of a significant downturn, with existing home sales in September dropping to the slowest pace since October 2010. This marks a 15.4% decline compared to September 2022, according to new data from the National Association of Realtors (NAR).

The sharp drop in home sales highlights how rising mortgage rates and declining affordability are severely impacting the housing market. The average 30-year fixed mortgage rate now sits around 8%, more than double what it was just a year ago. This rapid surge in borrowing costs has priced many buyers out of the market, especially first-time homebuyers.

Only 27% of September home sales went to first-time buyers, well below the historical norm of 40%. Many simply cannot afford today’s high home prices and mortgage payments. As a result, sales activity has fallen dramatically. The current sales pace of 3.96 million units annualized is down markedly from over 6 million just two years ago, when rates were around 3%.

At the same time, inventory remains extremely tight. There were just 1.13 million existing homes available for sale at the end of September, an over 8% decline from last year. This persistent shortage of homes for sale continues to put upward pressure on prices. The median sales price in September hit $394,300, up 2.8% from a year ago.

While higher prices are squeezing buyers, they are not denting demand enough to significantly expand inventory. Many current homeowners are reluctant to sell and give up their ultra-low mortgage rates. This dynamic is keeping the market undersupplied, even as sales cool.

Not all buyers are impacted equally by higher rates. Sales have held up better on the upper end of the market, while declining sharply for mid-priced and affordable homes. This divergence reflects that high-end buyers often have more financial flexibility, including the ability to purchase in cash.

All-cash sales represented 29% of transactions in September, up notably from 22% a year earlier. Wealthier buyers with financial assets can better absorb higher borrowing costs. In contrast, first-time buyers and middle-income Americans are being squeezed the most by rate hikes.

Looking ahead, the housing slowdown is likely to persist and potentially worsen. Mortgage applications are now at their lowest level since 1995, signaling very weak demand ahead. And while inflation has eased slightly, the Federal Reserve is still expected to continue raising interest rates further to combat it.

Higher rates mean reduced affordability and housing activity, especially if home prices remain elevated due to limited inventory. This perfect storm in the housing market points to significant headwinds for the broader economy going forward.

The housing sector has historically been a key driver of economic growth in the US. But with sales and construction activity slowing substantially, it may act as a drag on GDP growth in coming quarters. Combined with declining affordability, fewer homes being purchased also means less spending on furniture, renovations, and other housing-related items.

Some analysts believe the Fed’s aggressive rate hikes will ultimately tip the economy into a recession. The depth of the housing market downturn so far this year does not bode well from a macroeconomic perspective. It signals households are pulling back materially on major purchases, which could contribute to a broader economic contraction.

While no significant recovery is expected in the near-term, lower demand could eventually help rebalance the market. As sales moderate, competitive bidding may ease, taking some pressure off prices. And if economic conditions worsen substantially, the Fed may again reverse course on interest rates. But for now, the housing sector appears poised for more weakness ahead. Homebuyers and investors should brace for ongoing volatility and uncertainty.

Release – Tonix Pharmaceuticals Presents Data from its Horsepox-Based Vaccine Development Platform at the World Vaccine Congress Europe

Posted on October 19, 2023October 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 19, 2023 7:00am EDTDownload as PDF

Preclinical Data Demonstrate Attenuation of TNX‐801 (horsepox live virus vaccine) Compared to Modern Vaccinia Vaccines

TNX-801 is in Preclinical Development as a Novel Vaccine to Protect Against Smallpox and Mpox

CHATHAM, N.J., Oct. 19, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, presented data on its horsepox-based live virus vaccine platform in an oral presentation at the World Vaccine Congress Europe being held in Barcelona, Spain, October 16-19, 2023. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“Tonix’s horsepox-based live virus vaccine platform is designed to help protect against emerging infectious diseases by engaging T cell responses, which have the potential to provide durable protection and block forward transmission,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In addition, we believe horsepox-based vaccines can be widely deployed without the need for sterile injection or ultra-cold shipping and storage. Our lead vaccine candidate, TNX-801¹, is in development to protect against Mpox (monkeypox) and smallpox. Tonix’s TNX-801 is based on the sequence of a natural field isolate.^2,3 Molecular analysis suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 1798^4-6. Archaic smallpox vaccines based on horsepox were used in the U.S. and Europe to successfully control smallpox in the Nineteenth Century.”^4,7-9

The presentation, titled, “A Novel Mpox Vaccine (Horsepox virus) to Enhance Preparedness and Vaccine Equity,” includes recent preclinical data that indicate that the TNX-801 platform is naturally attenuated and potentially safer than the vaccines utilized to eradicate smallpox.

“TNX-801 was found to be up to 100-fold more attenuated than modern vaccinia vaccine viruses in primary human cell lines derived from dermal and respiratory tract cells, which are the two main poxvirus routes of entry and transmission,” said Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical. “TNX-801 was also found to be more than 1,000-fold attenuated relative to modern vaccinia vaccine viruses (“VACV”) in an immunocompromised murine model with targeted knock-outs of the IFN- and/or IFN- receptors. In these mice, TNX-801 did not cause any observable clinical disease, and in most measured parameters (disease score, body temperature, weight loss, and survival), the TNX-801 infected mice were indistinguishable from the uninfected mice. Together, these data suggest that TNX-801 potentially should be a safer vaccine in immunocompromised populations than many VACV-based vaccines.”

Dr. Rosenberg added, “A new attenuated live-virus smallpox and Mpox vaccine has the potential to enhance vaccine equity and preparedness in the event of a global emergency.”

About TNX-801

TNX-801 is a live virus vaccine based on horsepox^2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against Mpox and smallpox. Tonix’s TNX-801 is based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-76.^2,3 Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 1798^4-6. For example, recent studies^7,8 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.⁹ The small plaque size in the culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate¹⁰. Relative to vaccinia, horsepox has substantially decreased virulence in mice². Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses⁶. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’¹¹. Equination and vaccination were practiced side-by-side in Europe^11,12. Tonix received an official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against Mpox disease and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.

About the Recombinant Pox Virus (RPV) Platform

Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Horsepox-based vaccines are designed to be single-dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass-scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle, and are amendable to microneedle technology. The major cutaneous reaction or “take” to the vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.

About Mpox and Smallpox

Mpox¹³ and smallpox¹⁴ are diseases in humans caused by the Mpox and smallpox (or variola) viruses, respectively. Mpox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against Mpox. After routine smallpox vaccination was stopped in about 1970, Mpox has become a growing problem in Africa. Since May of 2022, approximately 30,000 cases have been identified in the United States^15,16. There are two distinct clades of the Mpox virus: the central African (Congo Basin) clade, and the West African clade which is associated with the recent outbreak. Historically, the Congo Basin clade has caused more severe disease than the West African clade. In recent times, the case fatality ratio for the virus is about 3–6%¹⁷. In November 2022, the WHO began using a new preferred term “Mpox” as a synonym for monkeypox¹⁸. Smallpox is considered eradicated, but there are concerns about malicious reintroduction.

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 portfolio¹⁹ 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 enrollment of a potentially confirmatory Phase 3 study in the third 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. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease, and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment 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. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small-molecule oral antivirals.

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 the property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

¹TNX-801 is an investigational new drug and has not been approved for any indication.
²Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
³Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536
⁴Schrick L et al. (2017) N Engl J Med. 377:1491.
⁵Qin et al. (2015) J. Virol. 89:1809.
⁶Jenner E. “An Inquiry Into the Causes and Effects of the Variolae Vaccinae: A Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire, and Known by the Name of the Cow Pox.” London: Sampson Low, 1798.
⁷Brinkmann A et al, Genome Biology (2020) 21:286.
⁸Duggan A et al. Genome Biology (2020) 21:175.
⁹Tonix press release. Dec 4, 2020 https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity
¹⁰Trindale GS et al. (2016) Viruses (12). Pii: E328. PMID:27973399
¹¹Esparza E, et al (2017) Vaccine. 35(52):7222-7230.
¹²Esparza J et al. (2020) Vaccine.; 38(30):4773-4779.
¹³www.cdc.gov/poxvirus/monkeypox/about.html
¹⁴www.cdc.gov/smallpox/research/
¹⁵Mandavilli, A. The New York Times. May 26, 2020. “Who is protected against monkeypox”
¹⁶www.cdc.gov/poxvirus/monkeypox/response/2022/us-map.html – Accessed October 18, 2023
¹⁷https://www.who.int/news-room/fact-sheets/detail/monkeypox#:~:text=There%20are%20two%20distinct%20genetic,thought%20to%20be%20more%20transmissible – Accessed October 18, 2023
¹⁸https://www.who.int/news/item/28-11-2022-who-recommends-new-name-for-monkeypox-disease – Accessed October 18, 2023
¹⁹Tonix’s product candidates in development are investigational new drugs and have not been approved for any indication

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; delays and uncertainties caused by the global COVID-19 pandemic; 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 October 19, 2023

Release – MustGrow Announces Participation at Biocontrol Industry Conference and Investor Webinar

Posted on October 19, 2023October 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, October 19, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) will be participating in next week’s Annual Biocontrol Industry Meeting (“ABIM”) in Basel, Switzerland from October 23rd to 25th. ABIM is regarded as the premier event in the biocontrol industry. From policy makers, to farmers, to the end product users, global agriculture professionals attend ABIM each year to drive the sustainable agriculture industry forward.

For more information, please visit ABIM’s website here.

“As a meeting place for the biocontrol industry, ABIM is internationally recognized and remains one of the best places to discover new products, to discuss market opportunities with multiple organizations, to present new research and products, and to liaise with fellow professionals. The large number of delegates attending the event demonstrates the continued importance of sustainable agriculture and MustGrow is excited to be a participant,” Corey Giasson, MustGrow’s President & CEO explains. “Biocontrols are essential in the transition of agriculture. These nature-based technologies can potentially improve biodiversity, soil quality, crop health and resilience contributing to sustainable food production.”

MustGrow is also pleased to invite investors and the broader financial community to a fully interactive webinar hosted by President & CEO Corey Giasson and Chief Operating Officer Colin Bletsky. The webinar will take place on Tuesday, October 31st at 2:00 pm EDT and will consist of a 20-minute management presentation followed by an interactive question and answer session.

Please register in advance here.

After registering, you will receive a confirmation email containing information about joining the webinar. Prior to October 31st, please email questions to info@mustgrow.ca to be addressed during the Q&A portion of the webcast.

______________

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg – are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 56.3 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson

Director & CEO

Phone: +1-306-668-2652

info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding its participation at the Annual Biocontrol Industry Meeting and the upcoming interactive webinar hosted by President & CEO Corey Giasson and Chief Operating Officer Colin Bletsky.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

Release – CoreCivic Announces 2023 Third Quarter Earnings Release and Conference Call Dates

Posted on October 19, 2023October 19, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CXW

October 18, 2023

PDF Version

BRENTWOOD, Tenn., Oct. 18, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2023 third quarter financial results after the market closes on Monday, November 6, 2023. A live broadcast of CoreCivic’s conference call will begin at 11:00 a.m. central time (12:00 p.m. eastern time) on Tuesday, November 7, 2023.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BI3e522c1e25f444ec98977db80437da4f. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Contact:	Investors: David Garfinkle – Chief Financial Officer – (615) 263-3008
	Media: Steve Owen – Vice President, Communications – (615) 263-3107

Inflation Battle Goes On: Powell’s Reassuring Message from the Fed

Posted on October 19, 2023October 19, 2023 by slightbourne@noblecapitalmarkets.com

Federal Reserve Chair Jerome Powell reiterated the central bank’s determination to bring down inflation in a speech today, even as he acknowledged potential economic risks from sustained high interest rates. His remarks underline the Fed’s unwavering focus on price stability despite emerging signs of an economic slowdown.

While noting welcome data showing inflation may be starting to cool, Powell stressed it was too early to determine a downward trend. He stated forcefully that inflation remains “too high”, requiring ongoing policy resolve from the Fed to return it to the 2% target.

Powell hinted the path to lower inflation likely entails a period of below-trend economic growth and softening labor market conditions. With jobless claims recently hitting a three-month low, the robust job market could exert persistent upward pressure on prices. Powell indicated weaker growth may be necessary to rebalance supply and demand and quell wage-driven inflation.

His remarks mirror other Fed officials who have suggested a growth sacrifice may be required to decisively curb inflation. The comments reflect Powell’s primary focus on price stability amid the worst outbreak of inflation in over 40 years. He admitted the path to lower inflation will likely prove bumpy and take time.

Powell stated the Fed will base policy moves on incoming data, risks, and the evolving outlook. But he stressed officials are united in their commitment to the inflation mandate. Additional evidence of strong economic growth or persistent labor market tightness could necessitate further rate hikes.

Markets widely expect the Fed to pause rate increases for now, after aggressively raising the federal funds rate this year from near zero to a current target range of 3.75%-4%. But Powell avoided any definitive signal on the future policy path. His remarks leave the door open to additional tightening if high inflation persists.

The speech underscores the Fed’s data-dependent approach while maintaining flexibility in either direction. Powell emphasized officials will proceed carefully in evaluating when to halt rate hikes and eventually ease monetary policy. The Fed faces heightened risks now of overtightening into a potential recession or undertightening if inflation remains stubbornly high.

After being accused of misreading rapidly rising inflation last year, Powell stressed the importance of policy consistency and avoiding premature pivots. A sustainable return to the 2% goal will require ongoing tight monetary policy for some time, even as economic headwinds strengthen.

Still, Powell acknowledged the uncertainties in the outlook given myriad economic crosscurrents. While rate hikes will continue slowing growth, easing supply chain strains and improving global trade could help counter those drags next year. And robust household savings could cushion consumer spending despite higher rates.

But Powell made clear the Fed will not declare victory prematurely given the persistence of inflation. Officials remain firmly committed to policy firming until convincing evidence demonstrates inflation moving down sustainably toward the target. Only then can the Fed safely conclude its aggressive tightening cycle.

For investors, Powell’s speech signals monetary policy will likely remain restrictive for some time, though the ultimate peak in rates remains uncertain. Markets should prepare for extended volatility as the Fed responds to evolving economic data. With risks tilted toward policy tightness, interest-sensitive assets could face ongoing pressure.

Gas Prices Drop As Oil Prices Rise

Posted on October 18, 2023October 18, 2023 by slightbourne@noblecapitalmarkets.com

U.S. drivers have seen welcome relief in recent weeks as gas prices steadily drift lower, even while oil continues to trade near $90 per barrel. The national average gasoline price now sits at $3.58 per gallon, down 30 cents over the last month.

What’s behind this divergence between oil and gas prices? And what does it mean for the average American’s wallet?

Seasonal Shifts Push Gas Prices Lower

The primary drivers pulling gas prices downward are seasonal factors. In the fall, refineries begin switching to cheaper winter-blend gasoline formulations. At the same time, cooler weather means lower fuel demand. Both these trends allow gas prices to detach from oil markets.

Rebecca Babin, an energy trader at CIBC Private Wealth, explained that “gas prices seasonally fall every autumn. 2022 is no exception.” Gas prices often decline 20 to 25 cents per gallon or more between September and December.

Supply Growth Eases Market Tightness

This year’s price declines also come as fuel inventories have rebounded nearly 10% from 2021 levels. Whereas last year saw tight fuel supplies amid recovering demand, expanded refinery runs have improved market balance in 2022.

“Anything that adds product to the market is going to help bring down refinery margins,” said Jeff Barron of the U.S. Energy Information Administration. These inventory and supply differences make today’s environment markedly different from a year ago.

OPEC Cuts, Geopolitics Still Support Oil

On the crude side, OPEC+ production cuts and global disruptions have kept oil prices elevated. Prices spiked last week on Middle East escalation fears before retreating again.

According to Babin, oil markets remain well-supported in the low $80s per barrel due to the supply-demand balance. Further gains into the $90s could threaten demand, however. The key uncertainty is whether OPEC+ extends output curbs into 2023.

Gas Demand Slackens Amid High Prices

Sky-high prices have also dampened U.S. retail fuel demand, which recently slipped below 2020 levels. Brenda Shaffer, an energy specialist at Georgetown University, notes demand may decline “as Americans cut back on unnecessary car trips to save money.”

With households pinched by inflation, discretionary driving becomes a prime target for budget cuts. But lower fuel consumption then puts further downward pressure on prices.

The Consumer Impact

Falling pump prices come as welcome relief, especially heading into the busy holiday travel season. The 40-cent drop from the September peak has saved U.S. households nearly $10 billion, by some estimates.

“It’s like getting a little raise, without having to ask your boss,” says Patrick De Haan, head of petroleum analysis at GasBuddy.

Lower fuel costs help curb inflationary pressures and provide savings that can be redirected to other household needs. But prices remain elevated historically. Americans are still paying nearly $400 more per year to fill up than just two years ago.

While the gas price outlook remains murky, any further declines over the next few months would aid consumers through winter. Yet many will likely remain wary of rising fuel bills cutting into tight budgets.

Take a moment to take a look at other oil and energy companies covered by Noble Capital Markets’ Research Analyst Michael Heim.

Release – Baudax Bio Announces Corporate Update

Posted on October 18, 2023October 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BXRX

October 18, 2023 8:00am EDT

Company Poised to Initiate TI-168 Clinical Development Following Recent Shareholder Approval of Corporate Actions Related to TeraImmune Acquisition

Phase 1/2a Clinical Study of TI-168 In Hemophilia A with FVIII Inhibitors Projected to Begin Q1 2024

MALVERN, Pa., Oct. 18, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that following recent shareholder approval of corporate actions related to its June 29 2023 acquisition of TeraImmune, the Company is now poised to initiate clinical development of TI-168, the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors. The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.

“We are very pleased with the broad support received in last week’s special shareholder meeting, during which shareholders approved all remaining issues related to our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We believe this combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value. With shareholder support now secured, we can finalize our preparations for initiating a Phase 1/2a clinical study of TI-168 in Hemophilia A patients in Q1 of 2024.”

Stewart Mc Callum, MD, Consulting Chief Medical Officer for Baudax, added, “TI-168 is a TCR Treg designed to eliminate autoantibodies to Factor VIII in Hemophilia A patients, which significantly complicates the management of Hemophilia A. This product candidate previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA. Since our trial has an open label design, we anticipate early visibility on tolerability and initial efficacy data.”

“This trial represents the first time that TCR Tregs will be in a human clinical trial, and will seek to establish a dose where TI-168 eliminates T-cell and B cell mediated production of autoantibodies, demonstrating the potential of TI-168 to make Hemophilia A much less complicated for patients with inhibitors to manage. We are very excited for the opportunity to work toward this potential improvement to patient quality of life, and to deliver enhanced value for our shareholders and other stakeholders,” concluded Ms. Henwood.

About Baudax Bio

Baudax Bio is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibitors.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released October 18, 2023

Release – Direct Digital Holdings Appoints Diana Diaz as Chief Financial Officer

Posted on October 18, 2023October 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on DRCT

October 18, 2023 9:00am EDT

HOUSTON, Oct. 18, 2023 /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 Company appointed Diana Diaz, who had been serving as the Company’s interim Chief Financial Officer, as permanent Chief Financial Officer, effective October 16, 2023.

Ms. Diaz served as interim Chief Financial Officer of Direct Digital Holdings beginning June 5, 2023. As permanent Chief Financial Officer, she will continue to lead the Company’s finance, accounting and treasury organization and report directly to the Company’s Chief Executive Officer.

Mark D. Walker, Chairman and Chief Executive Officer, commented, “We are grateful for the hard work and dedication Diana has provided our team over the past several months and greatly excited to appoint her as our permanent Chief Financial Officer. She has been a trusted partner and an excellent leader of our finance division. With the help of her leadership and financial acumen, we are now more confident than ever in our team’s ability to execute our various strategies for growth in the coming months and years.”

Ms. Diaz joined the Company from Sharps Compliance Corp. (previously Nasdaq listed (SMED)) until its acquisition, a leading national healthcare waste management provider to customers in multiple healthcare-related markets, specializing in regulated waste streams including medical, pharmaceutical and hazardous, where she served for a total of 13 years, including as Vice President and Chief Financial Officer from June 2010 to February 2022. Ms. Diaz’s prior positions include Chief Financial Officer of University General Hospital in Houston, Texas from September 2006 to May 2009, Controller at Memorial Hermann Healthcare System, Texas Medical Center from September 2002 to August 2006 and Controller of the wholesale group at Reliant Energy from July 1998 to May 2002. Ms. Diaz received her BBA in Accounting from The University of Texas at Austin and her MBA from Rice University’s Jesse H. Jones Graduate School of Management.

Ms. Diaz said of her appointment, “This is a very exciting time to have joined Direct Digital Holdings. As Chief Financial Officer, I will continue to work closely with my fellow executive team members to capitalize on the Company’s strategic position and current favorable market dynamics to continue our growth. I am grateful for this appointment and look forward to continuing my work with this incredible team.”

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to the Company. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

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 136,000 clients monthly, generating approximately 250 billion impressions per month across display, CTV, in-app and other media channels.

Contacts:
Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com

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SOURCE Direct Digital Holdings

Released October 18, 2023

Research – ZyVersa Therapeutics Announces a Publication in the Peer-Reviewed Journal, Aging, Linking Inflammasome NLRP3 Activation with Age-Related Structural Changes in the Kidney and Reduced Kidney Function

Posted on October 18, 2023October 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 18, 2023

Chronic kidney disease is most common in people 65 years and older.
NLRP3 inflammasomes signaling in the kidneys’ filtration system (“glomerular podocytes”) occurs as early as middle age, leading to scarring, podocyte loss, and impaired function, which may be a critical contributor to a lower threshold for developing kidney disease in older people.
Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.

WESTON, Fla., Oct. 18, 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, Aging, demonstrating that inflammasome NLRP3 activation is associated with an age-related decline in kidney health, which is compounded in the presence of kidney disease resulting in worsening outcomes.

In the paper titled, “Inhibiting NLRP3 signaling in aging podocytes improves their life-and health-span,” the authors conducted studies in various mouse models, human kidney tissues, and human kidney organoids. Data demonstrate a critical role for NLRP3 inflammasomes in age-related kidney deterioration, which is exacerbated in the presence of kidney disease. Following are key findings reported in the paper:

Glomerular NLRP3 levels in human kidney tissue were associated with pathological changes in the kidneys’ filtration system: higher levels of glomerular scarring (glomerulosclerosis) and enlargement (hypertrophy), and reduced podocyte density.
Glomerular NLRP3 inflammasome levels were higher in aged mice with experimental focal segmental glomerulosclerosis (FSGS) compared to age-matched mice without disease, indicating that FSGS injury augments the age-dependent increase of NLRP3 signaling.
NLRP3 inflammasome signaling and its effects on podocytes may be a critical contributor to a lower threshold for developing kidney disease in older people.
Reduction in NLRP3 signaling, either pharmacologically or by gene deletion, in human kidney organoids and in middle-aged mice decreased age-associated podocyte injury.

The authors stated, “By showing that in aged mice with experimental FSGS, injury augments the age-dependent increase of NLRP3 signaling, it makes this pathway an intriguing therapeutic target for podocyte (kidney) diseases in the elderly.” To read the article, Click Here.

“The research published in the Journal, Aging, demonstrates that age-related NLRP3 inflammasome signaling in the kidneys’ filtration system leads to scarring and podocyte loss, which are exacerbated when superimposed by kidney disease, leading to poorer outcomes,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “This research provides support for inflammasome inhibition as a promising treatment option for kidney disease, which is most common in the elderly. ZyVersa is developing Inflammasome ASC inhibitor IC 100. Unlike NLRP3 inhibitors, designed to inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, IC 100 was designed to inhibit formation of multiple types of inflammasomes, and to uniquely inhibit their associated ASC specks to block perpetuation of damaging inflammation.” 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 in 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.

Cautionary Statement Regarding Forward-Looking Statements

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.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Research – Tonix Pharmaceuticals Announces Publication of Data in the Journal Nature Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) for the Prevention of Rejection in Kidney Xenotransplantation in Animal Models

Posted on October 18, 2023October 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 18, 2023 7:00am EDT

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

TNX-1500 is Enrolling in a Phase 1 Clinical Trial

Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication: Multiple Other Indications, including Autoimmune Disorders, are Planned

CHATHAM, N.J., Oct. 18, 2023 (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 that a study published in the Journal Nature¹ by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with biotechnology company, eGenesis, utilized TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal antibody [mAb]) as part of the immune modulating regimen to prevent organ transplant rejection. Tonix’s TNX-1500 is in development for the prevention of human kidney organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154.

TNX-1500 was invented and developed in-house by Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, and colleagues. TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. Preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft and xenograft organ rejection and was well tolerated. The research in the Nature paper was conducted at MGH, led by principal investigator Tatsuo Kawai, M.D., Professor of Surgery, Harvard Medical School and the Center for Transplantation Science. A “News and Views” editorial² and a News³ story appeared in the same issue of Nature.

The Nature article titled, “Design and testing of a humanized porcine donor for xenotransplantation” includes data that provide additional support for TNX-1500’s activity in preventing pig xenograft organ rejection and for its tolerability in non-human primates. Because anti-CD40L treatment is widely recognized as critical to the success of xeno organ transplant, no animals were transplanted without anti-CD40L treatment. Four of the transplanted animals received prophylactic treatment with TNX-1500. The other animals were treated with a primate-adapted version of mAb 5c8, which is an earlier antibody that was also discovered by Dr. Lederman, when he was an assistant professor at Columbia University.⁴ The primate-adapted 5c8 anti-CD40L mAb⁵ has been provided to qualified researchers at a nominal charge for more than 20 years in an National Institute of Health (NIH)-funded program called the “Non-human Primate Reagent Resource Center” (NHPRRC).

“The animal study described in the Nature publication¹ supports the growing evidence that the protein engineering behind the invention of TNX-1500 resulted in a dimeric antibody that retains activity to prevent rejection and preserve graft function. These and other data^6,7 confirm the rationale for us to pursue development of TNX-1500 to prevent rejection in human transplantation,” said Dr. Lederman. “We are currently enrolling in a Phase 1 trial with TNX-1500 in healthy volunteers to support the development of TNX-1500 for the prevention of allograft rejection. There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection.”

Dr. Lederman added, “Our primary focus of early development will be allotransplantation in which the donor organ comes from a human volunteer or cadaver. However, long term we hope to develop TNX-1500 for xenograft transplantation in which the donor organ comes from genetically engineered pigs. Several lines of research indicate that anti-CD40L is required for long term xenograft acceptance. I believe it is unlikely for human xenotransplantation to proceed without CD40L blockade. In addition, anti-CD40L monoclonal antibodies have demonstrated efficacy in autoimmune diseases like systemic lupus erythematosus and Sjögren’s Syndrome.”

About TNX-1500

TNX-1500 (Fc-modified anti-CD40L mAb) is a humanized dimeric monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases including multiple sclerosis and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is currently enrolling. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. The disulfide-linked dimeric structure is similar to natural antibodies and in the case of anti-CD40L is believed to confer to TNX-1500 a higher avidity for cell-associated CD40L, relative to soluble CD40L. Two articles were recently published in the American Journal of Transplantation that demonstrate TNX-1500 prolongs nonhuman primate renal and heart allograft survival^6,7. Other anti-CD40L mAbs are in development for treating systemic lupus erythematosus, Sjögren’s syndrome and multiple sclerosis.^8-10 CD40-L is a member of the TNFα super gene family. Other members have been the targets of successful mAb: TNFα and RANKL for autoimmune diseases and osteoporosis, respectively. Other TNFα super gene family members are targeted by mAbs in development including, TNF-like ligand 1A (TL1A) and CD30L for ulcerative colitis.

Anand R.P., et al. Nature. 2023. 622, 393–401.
Mohiuddin M. Nature. News and Views. 2023. “Pig-to-primate organ transplants require genetic modifications of donor.”
Kozlov M. Nature. New, 2023. “Monkey survives two years after gene-edited pig-kidney transplant.”
Lederman S, et al. J Exp Med. 1992. 175(4):1091-101.
NHPRRC anti-CD154 clone 5C8H1D MassBiologics PR-1547
Lassiter G., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
Miura S., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
UCB Pipeline – https://www.ucb.com/our-science/pipeline
BioSpace. September 12, 2022 – https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-sjoegren-s-syndrome-meets-primary-endpoint/
Business Wire. January 18, 2023 – https://www.businesswire.com/news/home/20230118005359/en/Horizon-Therapeutics-plc-Announces-Phase-2-Trial-Evaluating-Dazodalibep-for-the-Treatment-of-Sj%C3%B6gren%E2%80%99s-Syndrome-Meets-Primary-Endpoint-in-the-Second-Study-Population-Only-Phase-2-Trial-to-Meet-Primary-Endpoint-in-Both-Patient-Populations

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 enrollment of a potentially confirmatory Phase 3 study in the third 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. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. 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. 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.

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 October 18, 2023

Release – The GEO Group Announces Date for Third Quarter 2023 Earnings Release and Conference Call

Posted on October 18, 2023October 18, 2023 by aweinsoff@channelchek.com

Research News and Market Data on GEO

October 17, 2023

PDF Version

Earnings Release Scheduled for Tuesday, November 7, 2023 Before the Market Opens
Conference Call Scheduled for Tuesday, November 7, 2023 at 11:00 AM (Eastern Time)

BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 17, 2023– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its third quarter 2023 financial results on Tuesday, November 7, 2023 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Tuesday, November 7, 2023.

Hosting the call for GEO will be George C. Zoley, Executive Chairman of the Board, Jose Gordo, Chief Executive Officer, Brian R. Evans, Senior Vice President and Chief Financial Officer, Wayne Calabrese, Senior Vice President and Chief Operating Officer, and James Black, President, GEO Secure Services.

To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:

1-877-250-1553 (U.S.)
1-412-542-4145 (International)

In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.

A telephonic replay will also be available through November 14, 2023. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 4528594. If you have any questions, please contact GEO at 1-866-301-4436.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231017118836/en/

Pablo E. Paez
Executive Vice President, Corporate Relations
1-866-301-4436

Source: The GEO Group, Inc.

Comstock Inc. (LODE) – All Pieces Are In Place To Commercialize Full Fuels Product Suite

Posted on October 18, 2023October 18, 2023 by cpereira@noblefcm.com

Wednesday, October 18, 2023

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

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.

Innovative products for producing renewable fuels. Comstock Fuels, a wholly owned subsidiary, converts lignocellulosic biomass into cellulosic ethanol and proprietary Bioleum bio-intermediate blends at yields exceeding 100 gallons per dry tonne of biomass on a gasoline gallon equivalent (GGE) basis with low market-leading carbon intensity scores.

Hydro-deoxygenated Bioleum Oil (HBO). The innovative break throughs are achieved in part by using catalytic esterification and hydro-deoxygenation to process Bioleum into Hydro-deoxygenated Bioleum Oil (HBO). HBO is a proprietary drop-in bio-intermediate that can be sold to advanced biofuel refineries for use in blending with fat-based feedstocks to produce sustainable aviation and renewable diesel fuels.

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

PCTEL to be Acquired by Amphenol in $139.7 Million All-Cash Deal

Posted on October 18, 2023October 18, 2023 by slightbourne@noblecapitalmarkets.com

PCTEL, a leading global provider of wireless technology solutions, announced last week that it has reached a definitive agreement to be acquired by Amphenol Corporation in an all-cash transaction valued at approximately $139.7 million.

Under the terms of the agreement, Amphenol will acquire all outstanding shares of PCTEL common stock for $7.00 per share. This offer price represents a premium of over 50% compared to PCTEL’s closing share price of $4.62 on October 13, 2023, the last full trading day before the deal was announced.

The acquisition will allow PCTEL to leverage Amphenol’s global presence, dedicated customer base, and scale to accelerate the growth of PCTEL’s business. Amphenol is one of the world’s largest providers of high-technology interconnect, sensor and antenna solutions.

PCTEL is seen as a clear innovation leader in wireless technology solutions, making it an excellent strategic fit within Amphenol’s portfolio. PCTEL’s capabilities in antennas and test and measurement will complement Amphenol’s strengths in interconnect and sensor technologies.

The deal has been approved by PCTEL’s Board of Directors and is expected to close either in Q4 2023 or early 2024, subject to shareholder approval and customary closing conditions. Once the acquisition is completed, PCTEL will no longer be a publicly traded company on the Nasdaq.

PCTEL provides purpose-built Industrial IoT devices, antenna systems, and test and measurement products to customers worldwide. The company has built trusted relationships through nearly 30 years of experience solving complex wireless challenges and helping organizations stay connected, transform and grow.

Take a moment to take a look at Comtech Telecommunications Corp., a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies.

Amphenol has a diversified presence across high-growth segments including automotive, broadband communications, commercial aerospace, industrial, information technology, military, mobile devices and mobile networks. Amphenol’s sustained financial strength and entrepreneurial culture will support taking PCTEL’s business to new heights.

The transaction follows a nearly year-long strategic review process overseen by PCTEL’s Board of Directors. In their announcement, PCTEL highlighted that Amphenol’s culture is well-aligned and will provide a valuable home for PCTEL’s global employees after the acquisition.

For investors, the all-cash deal provides certainty of value at an attractive premium to PCTEL’s recent trading prices. The $7.00 per share price is over 50% higher than the 30-day volume weighted average share price prior to the deal announcement.

PCTEL’s CEO David Neumann noted that the company’s team has done an excellent job growing the business and meeting strong customer demand globally, especially for high reliability applications. This established market position made PCTEL an appealing target for Amphenol.

The deal marks an exciting milestone for PCTEL, allowing the company to join forces with an industry leader in Amphenol. Investors can expect an accelerated growth trajectory as the combined companies leverage their technical strengths and customer relationships.

After 29 years as an independent public company, PCTEL is set to start an exciting new chapter as part of Amphenol. This transaction highlights the ongoing demand for antennas, sensors and other wireless connectivity technology solutions.