Page 305 – Channelchek

FAT Brands Inc. (FAT) – Management Discussions on Smokey Bones Acquisition

Posted on September 28, 2023September 28, 2023 by cpereira@noblefcm.com

Thursday, September 28, 2023

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

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.

Management Conversation. We had an opportunity to speak with FAT Brands Chairman of the Board Andy Wiederhorn regarding the Smokey Bones acquisition. As we highlighted in our Tuesday report, the acquisition adds 61 corporate owned locations and adds the barbeque vertical to Fat Brands portfolio. But, we believe the acquisition will add even more.

A Better Price. FAT Brands had been eyeing Smokey Bones for a while and, in fact, had almost closed the deal over a year ago, but at a much higher price than the $30 million deal. Based on a $10 million annual adjusted EBITDA run rate, the chain was acquired at 3x, which will help lower FAT Brands’ overall leverage ratio by nearly a turn. According to Mr. Wiederhorn, annual revenue is in the $170-$180 million range.

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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.

DoorDash Ditches NYSE for Nasdaq in Major Stock Exchange Switch

Posted on September 28, 2023September 28, 2023 by slightbourne@noblecapitalmarkets.com

Food delivery app DoorDash announced it will transfer its stock exchange listing from the New York Stock Exchange to the Nasdaq. The company will begin trading on the Nasdaq Global Select Market under the ticker ‘DASH’ starting September 27, 2023.

This represents a high-profile switch that exemplifies the fierce competition between the NYSE and Nasdaq to attract Silicon Valley tech listings. It also reflects shifting sentiments around brand associations and target investor bases.

DoorDash first went public on the NYSE in December 2020 at a valuation of nearly $60 billion. At the time, the NYSE provided the prestige and validation desired by the promising young startup.

However, DoorDash has since grown into an industry titan boasting a market cap of over $30 billion. As a maturing technology company, Nasdaq’s brand image and investor mix provide better positioning.

Tony Xu, co-founder and CEO of DoorDash, emphasized the benefits of the Nasdaq in the company’s announcement. “We believe DoorDash will benefit from Nasdaq’s track record of being at the forefront of technology and progress,” he said.

Nasdaq has built a reputation as the go-to exchange for Silicon Valley tech firms and growth stocks. Big name residents include Apple, Microsoft, Amazon, Tesla, Alphabet, and Facebook parent company Meta.

The exchange is also home to leading next-gen companies like Zoom, DocuSign, Crowdstrike, Datadog, and Snowflake. This creates an environment tailor-made for high-growth tech outfits.

Meanwhile, the NYSE leans toward stalwart blue chip companies including Coca Cola, Walmart, Visa, Walt Disney, McDonald’s, and JPMorgan Chase. The historic exchange tends to attract mature businesses and financial institutions.

Another factor likely influencing DoorDash is the investor makeup across the competing exchanges. Nasdaq generally appeals more to growth-oriented funds and active traders. The NYSE caters slightly more to institutional investors like pension funds, endowments, and passive index funds.

DoorDash’s switch follows ride sharing pioneer Lyft’s jump from Nasdaq to the NYSE exactly one year ago. Like DoorDash, Lyft desired a brand halo as it evolved past its early startup days.

“It’s a signal of us being mature, of us continuing to build a lasting company,” said Lyft co-founder John Zimmer at the time of the company’s NYSE listing.

Jared Carmel, managing partner at Manhattan Venture Partners, believes these exchange transfers reflect the “changing identities of the companies.”

As startups develop into multi-billion dollar giants, they evaluate whether their founding exchange still aligns with their needs and desired perceptions. Brand association and shareholder registration are becoming as important as operational capabilities for listings.

High-flying growth stocks like DoorDash also consider indexes, as the Nasdaq 100 often provides greater visibility and buying power from passive funds tracking the benchmark. Prominent inclusion in those indexes requires trading on Nasdaq.

Whether mature blue chips or emerging Silicon Valley darlings, the rivalry between Nasdaq and NYSE will continue heating up as each exchange vies to attract and retain brand name public companies. With lucrative listing fees on the line, exchanges will evolve branding, services, and capabilities to better cater to their target customers.

The DoorDash switcheroo exemplifies the changing perspectives and motivations influencing exchange selection. As companies lifecycles and personas transform, they reevaluate decisions made during those frenetic early IPO days.

Chesapeake Utilities to Acquire Florida City Gas in $923 Million Deal

Posted on September 28, 2023September 28, 2023 by slightbourne@noblecapitalmarkets.com

Chesapeake Utilities Corporation announced Monday that it has entered into an agreement to acquire Florida City Gas (FCG) from NextEra Energy for $923 million in cash. The acquisition will significantly expand Chesapeake’s presence in the growing Florida energy market.

FCG is the eighth largest natural gas local distribution company in Florida, serving around 120,000 residential and commercial customers across eight counties. Its infrastructure includes approximately 3,800 miles of distribution pipelines and 80 miles of transmission pipelines.

According to Jeff Householder, President and CEO of Chesapeake Utilities, natural gas demand in Florida continues to rise as consumers and businesses seek reliable, domestic, and affordable energy. With this acquisition, Chesapeake aims to capitalize on the robust growth opportunities across the state.

“This acquisition will more than double our natural gas business in Florida, one of the fastest growing states in the nation,” said Householder. “We see significant potential to continue pursuing long-term earnings growth.”

The deal is expected to close by the end of the fourth quarter of 2023, subject to regulatory approvals. Once completed, FCG will become a wholly owned subsidiary of Chesapeake Utilities.

Chesapeake has a strong track record of successfully integrating acquisitions to drive growth, as seen in its purchase of Florida Public Utilities in 2009. The company believes it can optimize FCG’s operations and execute on additional investments in gas distribution, transmission, and other energy platforms.

To finance the deal, Chesapeake plans to utilize a mix of equity and long-term debt to maintain balance sheet strength. The company has also obtained committed financing from Barclays.

Chesapeake has extended its earnings guidance through 2028 based on the increased scale and opportunities from FCG. It expects earnings per share growth of approximately 8% through 2028. The company also increased its 5-year capital expenditure guidance to $1.5-$1.8 billion.

The FCG acquisition demonstrates Chesapeake’s strategy of consolidating natural gas assets and positioning itself for growth in key geographies. As energy markets evolve, strategic deals allow companies like Chesapeake to enhance their competitive position.

Mortgage Rates Hit 23-Year High

Posted on September 28, 2023September 28, 2023 by slightbourne@noblecapitalmarkets.com

Mortgage rates crossed the 7% threshold this past week, as the 30-year fixed rate hit 7.31% according to Freddie Mac data. This marks the highest level for mortgage rates since late 2000.

The implications extend far beyond the housing market alone. The sharp rise in rates stands to impact the stock market, economic growth, and investor sentiment through various channels.

For stock investors, higher mortgage rates pose risks of slower economic growth and falling profits for rate-sensitive sectors. Housing is a major component of GDP, so a pullback in home sales and construction activity would diminish economic output.

Slower home sales also mean less revenue for homebuilders, real estate brokers, mortgage lenders, and home furnishing retailers. With housing accounting for 15-18% of economic activity, associated industries make up a sizable chunk of the stock market.

A housing slowdown would likely hit sectors such as homebuilders, building materials, home improvement retailers, and home furnishing companies the hardest. Financial stocks could also face challenges as mortgage origination and refinancing drop off.

Broader economic weakness resulting from reduced consumer spending power would likely spillover to impact earnings across a wide swath of companies and market sectors. Investors may rotate to more defensive stocks if growth concerns escalate.

Higher rates also signal tightening financial conditions, which historically leads to increased stock market volatility and investor unease. Between inflation cutting into incomes and higher debt servicing costs, consumers have less discretionary income to sustain spending.

Reduced consumer spending has a knock-on effect of slowing economic growth. If rate hikes intended to fight inflation go too far, it raises the specter of an economic contraction or recession down the line.

For bond investors, rising rates eat into prices of existing fixed income securities. Bonds become less attractive compared to newly issued debt paying higher yields. Investors may need to explore options like floating rate bonds and shorter duration to mitigate rate impacts.

Rate-sensitive assets that did well in recent years as rates fell may come under pressure. Real estate, utilities, long-duration bonds, and growth stocks with high valuations are more negatively affected by rising rate environments.

Meanwhile, cash becomes comparatively more attractive as yields on savings accounts and money market funds tick higher. Investors may turn to cash while awaiting clarity on inflation and rates.

The Fed has emphasized its commitment to bringing inflation down even as growth takes a hit. That points to further rate hikes ahead, meaning mortgage rates likely have room to climb higher still.

Whether the Fed can orchestrate a soft landing remains to be seen. But until rate hikes moderate, investors should brace for market volatility and economic uncertainty.

Rising mortgage rates provide yet another reason for investors to ensure their portfolios are properly diversified. Maintaining some allocation to defensive stocks and income plays can help smooth out risk during periods of higher volatility.

While outlooks call for slower growth, staying invested with a long-term perspective is typically better than market timing. Patience and prudent risk management will be virtues for investors in navigating markets in the year ahead.

Release – Tonix Pharmaceuticals Announces Department of Defense Grant to Support the University of North Carolina’s Proposed Investigator Sponsored OASIS Trial of TNX-102 SL for Treatment of Acute Stress Reaction, Acute Stress Disorder, and Posttraumatic Stress Disorder

Posted on September 27, 2023September 27, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 27, 2023 8:30am EDT

$3 million awarded by DoD to University of North Carolina Institute of Trauma Recovery to support a proposed 180-patient, randomized, placebo-controlled trial in acute trauma patients

Investigator sponsored trial to evaluate the potential for TNX-102 SL¹ to reduce the frequency and severity of acute stress reaction, acute stress disorder, and post-traumatic stress disorder (PTSD)

Acute stress disorder is identified in 13-21% of motor vehicle accidents;^2,3 Individuals with acute stress disorder have an increased risk of developing PTSD; U.S. lifetime PTSD prevalence is approximately 6%^4-7

CHATHAM, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that the University of North Carolina (UNC) Institute for Trauma Recovery has been awarded a $3 million grant from the Department of Defense (DoD) to investigate the potential of Tonix’s TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to reduce the frequency and severity of adverse effects of acute trauma. Such adverse effects include acute stress reaction (ASR), acute stress disorder (ASD), and posttraumatic stress disorder (PTSD). ASR refers to the body’s immediate response to trauma, whereas ASD represents the short-term effects of trauma, and PTSD represents the long-term effects of trauma.

“In addition to emergency care to treat and help patients recover from physical wounds, whether in the emergency room or on the battlefield, we must also address the unmet need for treatment options to address ‘invisible wounds’ that survivors may experience following a traumatic event,” said Samuel McLean, M.D., Professor of Psychiatry and Emergency Medicine at the UNC School of Medicine at UNC, School of Medicine, and lead principal investigator of the proposed study. “To address these needs, we are investigating TNX-102 SL as a potential treatment for patients who experience trauma and traumatic stress.”

The proposed Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department after a motor vehicle collision. The trial will enroll approximately 180 trauma survivors at study sites around the U.S. Participants will be randomized in the emergency department to receive a two-week course of either TNX-102 SL or placebo.

Initiation of patient enrollment in the proposed investigator sponsored OASIS trial is anticipated in the beginning of 2024, subject to Investigational New Drug (IND) application submission and U.S. Food and Drug Administration (FDA) clearance.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. The AURORA study is a major national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the health care arm of Google’s parent company Alphabet.

“No medications are currently available at or near the point of care to treat patients suffering from traumatic events and support long-term health, whether U.S. military exposed to life-threatening events or civilians experiencing traumatic events such as motor vehicle collisions,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Acute stress reaction and posttraumatic stress symptoms are common among civilian motor vehicle collision survivors. The AURORA study, which has collected thousands of data points from motor vehicle collisions, will allow us to better investigate the correlation between motor vehicle collisions and the emergence of acute stress disorder or PTSD symptoms. And leveraging support from the AURORA study and utilizing the DoD’s non-dilutive capital to primarily fund OASIS allows Tonix and UNC to streamline trial efficiency, reduce costs and increase trial power through enriching the target patient population.”

Added Brandon Staglin, President of One Mind, “For individuals who experience trauma and traumatic stress, the need for effective treatments is an urgent one. The OASIS trial’s focus on evaluating a promising potential treatment option exemplifies the kind of evidence-based outcomes One Mind and our partners hoped to achieve as part of the AURORA initiative’s broader efforts to improve the lives of trauma survivors.”

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives.⁵ In the U.S. alone, one-third of emergency department visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.⁸ Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.⁹

About TNX-102 SL in Post-Traumatic Stress Disorder

Sleep disturbances in PTSD are a potential target for pharmacotherapy. TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for once-daily bedtime dosing and rapid transmucosal absorption such that cyclobenzaprine plasma levels rapidly rise during the onset of sleep and first four hours of sleep, then rapidly fall through the second half of sleep through awakening. Cyclobenzaprine has potent binding and antagonist activity at 5-HT_2A, α₁-adrenergic, H₁-histaminergic, and M₁ muscarinic receptors, each of which play roles in the pharmacological management of insomnia. The sublingual transmucosal formulation of cyclobenzaprine is designed to bypass first-pass hepatic metabolism, increasing the ratio in plasma of the parent cyclobenzaprine to the long-lived active metabolite, norcyclobenzaprine, which has a longer half-life and consequently less circadian variation with once-daily dosing. The use of TNX-102 SL 5.6 mg administered daily at bedtime to reduce PTSD symptoms and improve sleep quality in patients with PTSD is supported by the results of a Phase 2 trial (AtEase NCT02277704 in military-related PTSD) and two Phase 3 trials (HONOR or NCT03062540 in military-related PTSD and RECOVERY or NCT03841773 in PTSD). ^10-12 In each of these studies, early improvements in sleep were associated with TNX-102 SL treatment as measured by the PROMIS sleep disturbance (SD) scale. Moreover, in AtEase and HONOR, early and sustained improvement in sleep were associated with TNX-102 SL treatment by the Clinician Administered PTSD Scale (CAPS-5)¹³ “sleep disturbance” item. Primary analyses comparing change from baseline CAPS-5 total severity between TNX-102 SL 5.6 mg and placebo at week 12 were not significant in AtEase, HONOR or RECOVERY. However, in HONOR and RECOVERY at week 4, TNX-102 SL treatment was associated with an improvement in CAPS-5 total severity as compared to placebo. Moreover, secondary analyses in all three studies showed TNX-102 SL treatment was associated with benefits on the patient global impression of change (PGIC), indicating that across studies TNX-102 SL treated patients self-reported greater symptom improvement than those treated with placebo. The most common side-effects were administration site reactions described as tongue numbness or abnormal taste and reported by approximately 30% of participants. There were no unexpected safety findings. Together these studies, with approximately 650 trauma-exposed patients (included 254 patients treated with TNX-102 SL 5.6 mg), provide preliminary evidence that TNX-102 SL is well-tolerated and may promote recovery from PTSD via a pharmacodynamic mechanism of sleep-dependent emotional memory processing.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

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 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 the fourth quarter of 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 the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, 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 the fourth quarter of 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.

TNX-102 SL has not been approved for any indication
Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Association. Pg 284
Dai W, et al. BMC Psychiatry. 2018. 18, 188
U.S. Department of Veterans Affairs. Epidemiology and Impact of PTSD. www.ptsd.va.gov/professional/treat/essentials/epidemiology.asp#one
Goldstein RB, et al. Soc Psychiatry Psychiatr Epidemiol. 2016. 51(8):1137-48
Kessler RC, et al. Arch Gen Psychiatry. 2005. 62(6):593-602
U.S. Department of Veteran Affairs. How Common is PTSD in Adults? www.ptsd.va.gov/understand/common/common_adults.asp
Wisco BE, et al. J Clin Psychiatry. 2014. 75(12):1338-46
Thompson M. Time. 2015;185(12):40-3
Sullivan GM, et al. Psychiatry Res. 2021. 301:113974
Rauch SAM, et al. J Clin Psychiatry. 2021. 82(4)
Ivanova A, et al. J Biopharm Stat. 2022. 32(3):441-449
U.S. Department of Veterans Affairs. PTSD Checklist for DSM-5 (PCL-5). https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp#obtain

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
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released September 27, 2023

Uranium Prices Hit 12-Year High on Rising Demand

Posted on September 27, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

Uranium prices have hit their highest level in 12 years, reaching around $70 per pound in recent trading. This marks a major rally for the nuclear fuel, as prices were languishing below $30 per pound just a couple years ago. The uranium market has seen renewed interest from investors and utilities lately, driving the huge spike in prices.

Uranium is a key material used in nuclear power generation. It is the fuel inside nuclear reactors that undergoes fission to release massive amounts of energy. Uranium is mined from the ground, then processed and enriched before being fabricated into fuel rods for insertion into reactors. Nuclear power plants require a steady supply of uranium fuel to continue operating.

There are several factors behind the big jump in uranium prices recently. A major one is increased demand, as more nuclear reactors are being built around the world. China in particular has been rapidly expanding its nuclear energy capabilities. More reactors coming online globally means more demand for uranium fuel. Supply has also been constrained lately, with pandemic-related disruptions slowing some uranium mining operations. This demand/supply imbalance has helped drive uranium prices markedly higher.

The surge in uranium prices is great news for uranium mining companies and producers. Major players in the global uranium market like Cameco, Kazatomprom, and Energy Fuels stand to benefit greatly from elevated prices. Their profitability increases significantly when uranium prices rise. These companies have seen their stock prices jump this year in tandem with the uranium price rally. Many uranium stocks are up 50% or more year-to-date.

According to Noble Capital Markets Senior Research Analyst Michael Heim, “There has been an imbalance between domestic uranium supply and demand over the last 15 years as consumers (electric utilities) purchased cheap uranium from foreign nations such as Kazakhstan under short-term contracts. Domestic producers curtailed production with spot prices below production costs. With prices now near $70 per pound and electric utilities increasingly willing to sign longer-term contracts, domestic uranium companies like Energy Fuels are able to restart operations.”

Take a moment to take a look at Energy Fuels Inc., a leading U.S.-based uranium mining company, supplying major nuclear utilites.

The hot uranium market also has implications for the broader stock market. The S&P 500 energy sector has been one of the top performing segments this year. Rising uranium prices provide an added catalyst, as nuclear energy becomes relatively more cost competitive. Utility companies running nuclear power plants also benefit from lower relative fuel costs. This can enhance their profitability and lead to upside in the utilities sector.

Overall, the big rebound in uranium prices reflects growing global demand for nuclear power. New reactor projects and increased focus on energy security are driving uranium back to multi-year highs. This should provide a boost to uranium producers and related stocks going forward. Nuclear power appears poised for increased utilization in the years ahead, which points to a strong fundamental outlook for uranium prices. As long as demand keeps rising faster than supply, uranium seems likely to maintain its bull run.

One Stop Systems (OSS) – A New Market

Posted on September 27, 2023September 27, 2023 by cpereira@noblefcm.com

Wednesday, September 27, 2023

One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays, and Ion Accelerator™ SAN, NAS, and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles, and rugged entertainment applications. OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge,’ especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training, and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.

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.

Submarine Award. One Stop Systems has received an order to design and develop prototypes for a sonar data processing system to be used in a foreign navy submarine application. The order expands OSS’s AI Transportable solutions into a new vertical, new prime relationship, and new application.

Details. The award was procured through a new global defense prime contractor. The win represents the first AI transportable program win for a foreign navy as well as for a subsurface application. OSS expects to deliver the first prototypes by the end of 2023, followed by potential production orders in 2024. If production orders begin, we anticipate the award could add over $2 million to 2024 revenue.

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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).

Eledon Pharmaceuticals (ELDN) – Initiating Coverage With An Outperform Rating and $10 Price Target

Posted on September 27, 2023September 27, 2023 by cpereira@noblefcm.com

Wednesday, September 27, 2023

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

We Are Initiating Coverage Of EledonPharmaceuticals. Eledon is developing tegoprubart, an anti-CD40L antibody to modulate the immune response. Phase 1b and Phase 2 clinical trials in progress for prevention of kidney transplant rejection. The clinical trial program is designed to show superiority to the immunosuppressive drugs that are currently the standard of care after organ transplants.

Tegoprubart Blocks CD40/CD40L. Tegoprubart blocks the step in the immune response where the CD40 ligand (CD40L, also known as CD154) on T cells interacts with the CD40 receptor on either B cells or antigen-presenting cells. This binding connects the innate and adaptive immune systems and leads to a full immune response. Tegoprubart binds to the CD40L to block this step, inhibiting both B cell maturation and T-cell proliferation that leads to cellular immune responses.

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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).

CoreCivic, Inc. (CXW) – New Contracts; Rising Populations

Posted on September 27, 2023September 27, 2023 by cpereira@noblefcm.com

Wednesday, September 27, 2023

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 nearly 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.

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 Contract. CoreCivic signed a new management contract with Hinds County, Mississippi for up to 250 adult male pre-trial detainees at the Company’s 2,672-bed Tallahatchie County Correctional Facility. The initial contract term is for two years. CoreCivic remains in discussions with additional federal, state, and local government agencies to utilize capacity in numerous CoreCivic facilities.

Other Business. CoreCivic recently accepted approximately 160 additional residents from the state of Idaho under an existing contract at the Saguaro Correctional Facility in Arizona. The Company also recently signed contract extensions with the state of Vermont at the Tallahatchie facility, with ICE at the Elizabeth Detention Center in New Jersey, with the Texas Department of Criminal Justice for five residential reentry centers in Texas, and with the state of Montana at the Crossroads Correctional Center in Montana.

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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).

Alfasigma Makes Big Bet on Liver Disease With $1.25 Billion Intercept Buyout

Posted on September 27, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

Italian pharma Alfasigma is expanding its gastroenterology portfolio in a major way with the proposed $1.25 billion acquisition of Intercept Pharmaceuticals. The all-cash deal provides Alfasigma with Intercept’s leading drug Ocaliva and a strengthened pipeline in progressive liver diseases.

Alfasigma will pay $19 per share to acquire Intercept, representing an 82% premium over Intercept’s share price before the deal announcement. The purchase price reflects a big bet on Ocaliva’s growth prospects and Intercept’s broader capabilities in rare liver conditions.

Ocaliva is the key asset Alfasigma gains from the deal. It’s the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disorder that damages the bile ducts in the liver. Ocaliva hit $152 million in sales over the first half of 2023 alone, underscoring its rapid growth trajectory.

Beyond Ocaliva, Alfasigma also adds Intercept’s emerging pipeline of novel therapies for PBC and other liver diseases. The crown jewel is a promising fixed-dose combination regimen that could transform the PBC treatment paradigm.

Take a look at Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer’s coverage universe.

The deal dramatically expands Alfasigma’s presence in the high-value U.S. pharma market. Previously focused primarily on the Italian market, the Intercept acquisition gives Alfasigma an anchor asset and commercial team in the U.S.

Strategically, the move aligns with Alfasigma’s vision to build up its gastroenterology and hepatology business. CEO Francesco Balestrieri highlighted Intercept’s compelling strategic fit with Alfasigma’s focus in these therapeutic areas.

Expect Alfasigma to invest heavily to maximize Ocaliva’s potential. The company sees major commercial expansion opportunities to extend Ocaliva’s reach across PBC patient populations. Alfasigma also gains Intercept’s seasoned specialty sales force to drive prescription growth.

With Intercept operating as a wholly-owned subsidiary once the buyout closes, Alfasigma is well-positioned to become a global force in progressive liver diseases. The deal enhances Alfasigma’s standing as an emerging player in the U.S. pharma market.

Look for Alfasigma to continue seeking acquisition targets to accelerate its growth. The company has the financial firepower to pursue additional deals that build up its portfolio. If the Intercept acquisition is any indication, Alfasigma has appetite for bold, transformative M&A.

The proposed buyout still requires regulatory and shareholder approval. But with a massive 82% premium offered, Intercept shareholders are likely to approve the $19 per share deal price. Expect Alfasigma to move rapidly to complete the acquisition by the end of 2023.

Soleno Therapeutics Stock Skyrockets 505% on Hunger Pill Promise

Posted on September 27, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

Shares of Soleno Therapeutics (SLNO) catapulted an astonishing 505% higher last week after positive late-stage clinical results for the company’s experimental obesity and hunger control pill. The massive stock surge demonstrates investor enthusiasm around Soleno’s DCCR pill as a potential new medicine for Prader-Willi syndrome (PWS).

DCCR aims to treat hyperphagia, or abnormally increased hunger and food drive, in patients with PWS. The rare genetic disorder can lead to excessive eating, obesity, and other complications. Soleno’s pill showed promising ability to control hunger signals in PWS patients during a 4-month placebo-controlled withdrawal study.

The trial enrolled 77 PWS patients who had been taking DCCR for 2-4 years. Half the participants continued their DCCR regimen, while the other half were switched to placebo. After just one month, the placebo group showed a rapid return of hyperphagia symptoms. On a 9-point clinical scale, their hunger scores increased by a significant 5 points on average.

In contrast, PWS patients who remained on DCCR maintained stable, controlled hunger levels throughout the 4-month trial. The results provide strong evidence that DCCR specifically curbs abnormal hunger drive in PWS, rather than just having a placebo effect.

Beyond hunger control, PWS patients taking placebo also showed worsening in overall PWS symptoms and severity. No new safety issues emerged during the 4 months on placebo, indicating the hunger control benefits of DCCR remained after stopping treatment.

Armed with the successful phase 3 results, Soleno now plans to submit a New Drug Application for DCCR to the FDA in mid-2024. The company is seeking an initial approval in PWS, which would make DCCR the first ever pharmacotherapy for hyperphagia associated with the condition.

The FDA previously designated DCCR an Orphan Drug for treating PWS. This status provides incentives to develop medicines for rare diseases, since PWS affects only about 15,000-16,000 individuals in the U.S. The new trial results could support approval based on the FDA’s prior guidance.

If greenlighted, analysts project DCCR peak sales could reach $500 million – $1 billion annually. The pill would provide a novel, non-surgical therapeutic option to manage hyperphagia and obesity in PWS. DCCR’s unique clinical benefits could command premium pricing above $100,000 per patient annually.

Soleno still has work ahead to realize commercialization, including securing FDA approval and payer coverage. But the company now has a de-risked late stage asset and clear regulatory path forward. The 505% share price spike last week reflects renewed investor confidence in DCCR’s commercial potential.

Despite the rally, Soleno still trades 70% below its 2018 highs. The stock has suffered from past clinical setbacks that stoked skepticism around DCCR. But with a successful phase 3 trial now completed, the tide may be turning.

Soleno could seek to expand DCCR’s use into additional patient populations with uncontrolled hunger and obesity issues beyond PWS. The pill works by modulating metabolic pathways that drive hyperphagia symptoms.

While gains may moderate going forward, last week’s huge rally kicks off a new chapter for Soleno stock. Look for the company to shift focus from pivotal trial execution to commercial planning. Investors cheered the pivotal data, signaling confidence in DCCR’s prospects. Soleno still has work left to turn its hunger-controlling pill into an FDA-approved medicine, but the 505% surge shows just how much upside investors anticipate.

Release – Tonix Pharmaceuticals Announces Initiation of Enrollment in the MGH Phase 2 ‘POWER’ Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Pediatric Obesity

Senate Poised to Advance Landmark Marijuana Banking Reform

Posted on September 27, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

A long-awaited bill that could unlock banking access for the marijuana industry is slated for a historic Senate vote this week. The Secure and Fair Enforcement (SAFE) Banking Act aims to allow financial institutions to work with state-legal cannabis businesses without facing federal punishment.

The Senate Banking Committee will vote Wednesday on whether to advance the bill to the full chamber floor. If approved as expected, it would mark the first time the SAFE Banking Act has ever cleared the Senate.

The bill takes aim at a major hurdle facing the growing marijuana industry – lack of access to basic banking and financial services. Currently, most banks and credit unions refuse to handle cannabis company accounts due to marijuana’s federal prohibition as an illegal Schedule 1 drug.

That forces many marijuana firms to operate entirely in cash, creating public safety issues and barriers to business expansion. The SAFE Banking Act provides legal cover for financial institutions to work with state-approved cannabis companies.

The bipartisan bill is sponsored by Senators from both parties representing states with legal marijuana markets. It previously passed the Democrat-led House seven times, but stalled each time in the Senate. Wednesday’s vote would break the logjam.

If enacted into law, industry analysts project the SAFE Banking Act could catalyze billions in new capital investment into the marijuana sector. Cannabis companies would gain access to basic banking and credit services to help fuel their growth.

Take a moment to look at Schwazze, a leading vertically integrated cannabis holding company with a portfolio spanning cultivation, extraction, infused-product manufacturing, dispensary operations, consulting, and a nutrient line.

However, the bill still faces an uphill path to final passage. It must clear both the full Senate and the Republican-controlled House, where some members remain opposed to marijuana reform. But the historic committee vote marks a major milestone after years of lobbying from cannabis businesses.

The SAFE Banking Act underscores marijuana’s transition from the black market to a legitimate, multibillion-dollar American industry. Medical and recreational cannabis is now legal in 39 states, but lack of banking access continues to hinder the sector’s expansion and safety.

Wednesday’s vote is a significant step toward providing financial access and security for state-compliant marijuana companies. Passage would enable the cannabis industry to further emerge from the shadows.

President Biden Makes History by Joining UAW Picket Line

Posted on September 26, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

On Tuesday, September 26, 2023, President Joe Biden made history by joining striking United Auto Workers (UAW) members on the picket line in Wayne County, Michigan. It was the first time a sitting president had ever joined an ongoing strike.

Biden’s visit came as the UAW was in its 12th day of a strike against General Motors, Ford, and Stellantis, demanding better wages, benefits, and job security. The strike had caused significant disruptions to the auto industry and had put thousands of workers out of work.

Despite the risks, Biden was determined to show his support for the UAW and for working families. He arrived at the picket line early in the morning and was greeted by cheers and applause from the strikers.

“It’s an honor to be here with you today,” Biden said to the strikers. “You are fighting for the middle class. You are fighting for the soul of this nation.”

Biden went on to praise the UAW for its long history of fighting for the rights of workers and their families. He also pledged his support for the union and said that he would continue to work to create an economy that works for everyone.

“I want to be clear: I stand with the UAW,” Biden said. “I will always stand with workers who are fighting for a fair deal.”

Biden’s visit to the picket line was a significant show of support for the UAW and for labor unions in general. It came at a time when unions are facing increasing attacks from corporations and anti-union politicians.

Biden’s visit was also a reminder of his commitment to working families. He has repeatedly said that he will fight to create an economy that works for everyone, not just the wealthy few.

Biden’s visit to the picket line could have a number of positive consequences for the UAW and for labor unions in general.

First, it could help to raise public awareness of the strike and the union’s demands. This could put pressure on the auto companies to settle the strike on the union’s terms.

Second, Biden’s visit could help to boost morale among the strikers. It could show them that they have the support of the president and that they are not alone in their fight.

Third, Biden’s visit could help to strengthen the labor movement as a whole. It could show that unions are still a powerful force and that they can win when they stand together.

Biden’s visit to the picket line was also significant for its historical implications. It was the first time a sitting president had ever joined an ongoing strike. This sent a powerful message that the president stands with working families and that he supports the right of workers to organize and bargain collectively.

Biden’s visit to the picket line was a courageous and important act. It showed that he is a president who is not afraid to stand up for working families, even when it is politically difficult.

The UAW strike is a critical test for Biden’s presidency. If the union is able to win a fair contract, it will be a victory for working families and for the labor movement as a whole. It will also be a sign that Biden is delivering on his promise to create an economy that works for everyone.

The strike is also a test for the Biden administration’s commitment to industrial policy. Biden has repeatedly said that he wants to revitalize the American manufacturing sector. The UAW strike is an opportunity for Biden to show that he is serious about this commitment.

The Biden administration can support the UAW strike in a number of ways. First, it can put pressure on the auto companies to settle the strike on the union’s terms. Second, it can provide financial assistance to the strikers and their families. Third, it can use its regulatory authority to make it easier for workers to organize and bargain collectively.

The UAW strike is a critical moment for working families and for the labor movement. The outcome of the strike will have a major impact on the future of the American economy. Biden’s visit to the picket line was a significant show of support for the UAW and for working families. It is now up to the Biden administration to follow through on its promises and to ensure that the UAW strike is a victory for working families.