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Release – Tonix Pharmaceuticals Initiates Enrollment in Phase 2 ‘UPLIFT’ Study of TNX-601 ER (Tianeptine Hemioxalate Extended-Release Tablets) for the Treatment of Major Depressive Disorder (MDD)

Posted on March 16, 2023March 16, 2023 by aweinsoff@channelchek.com

March 16, 2023 7:00am EDTDownload as PDF

Results from Planned Interim Analysis Expected Fourth Quarter 2023

Approximately 21 Million Adults in U.S. Suffer From a Major Depressive Episode Each Year

TNX-601 ER is a Once-Daily Tablet that is Bioequivalent to Three-Times-Daily Tianeptine Sodium Immediate Release (IR) that has been available in Europe, Asia and Latin America for More than Three Decades

Tianeptine IR is Associated with Low Incidences of Sexual Dysfunction, Sleep Disruption, Sedation, Weight Gain, and Cognitive Impairment Compared with Traditional Monoaminergic Antidepressants

TNX-601 ER is a New Chemical Entity in the U.S. and Represents a Potential Innovative Approach to Addressing Depression: Restoration of Neuroplasticity and Neurogenesis Rather than Modulation of Neurotransmitter Levels and Activity

CHATHAM, N.J., March 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 ‘UPLIFT’ study of TNX-601 ER¹ (tianeptine hemioxalate extended-release tablets) for the treatment of major depressive disorder (MDD). The double-blind, placebo-controlled registrational-quality study has a target enrollment of 300 participants at approximately 30 sites across the U.S. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023.

The proprietary once-daily formulation of TNX-601 ER was designed to be bioequivalent to the three-times-a-day formulation of tianeptine sodium (amorphous) immediate release (IR) tablets. IR tianeptine sodium has been available in Europe and many countries in Asia and Latin America for the treatment of MDD for more than three decades since being first marketed in France in 1989. No tianeptine-containing product has been approved by the U.S. Food and Drug Administration (FDA).

“Despite the availability of several classes of MDD treatments in the U.S. that directly modulate neurotransmitters and their synaptic receptors, there remains an unmet need for novel approaches,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In animal studies, TNX-601 ER has a unique mechanism of action that restores brain neuroplasticity by exerting biological effects on neurons and glial cells that increase arborization of dendrites in critical hippocampal circuits.² In animal models, tianeptine also reverses stress-induced impairments in synaptic glutamate neurotransmission, and it restores hippocampal neurogenesis.²”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “After a decade of development of our proprietary once-daily tianeptine formulation, it is very gratifying to enter the next stage of clinical testing required to make TNX-601 ER available to those suffering from MDD in the U.S. TNX-601 ER not only has the potential to relieve depressive symptoms, but also to improve the quality of life and resiliency for the millions of MDD sufferers. The short and long-term safety of tianeptine sodium IR has been well-established based on its clinical use outside the US.”

Dr. Sullivan added, “The efficacy of tianeptine sodium IR has repeatedly been shown to be comparable with that of either selective serotonin reuptake inhibitor (SSRI) or tricyclic antidepressants^3,4 while being associated with a lower incidence of sexual dysfunction, derangement of sleep architecture, sedation, weight gain, or cognitive impairment.^5-7 Given tianeptine’s metabolic pathway, which is independent of the hepatic cytochrome P450 system, we believe that TNX-601 ER has a reduced risk of drug-drug interactions compared to antidepressants marketed in the U.S.⁷

“MDD is a seriously disabling condition that is also often associated with suicidal behavior. Extensive animal studies have taught us that tianeptine restores the stress-induced deficits in neuroplasticity and neurogenesis. The dramatic impact of tianeptine on a brain experiencing many types of stress is best illustrated by the effects it has in restoring dendritic arborization and spine synapse remodeling of pyramidal neurons in the CA3 region of hippocampus, as well as new neuron formation and their microglia-mediated integration into neuronal networks of the hippocampal formation. With an estimated 21 million individuals suffering from a major depressive episode each year in the U.S., it’s exciting to move beyond neurotransmitter modulation and begin an era where MDD may be treated by enhancing a resilient biological phenotype of neurons and glial cells under stress.”

¹TNX-601 ER is in the Phase 2 stage of development and is not approved for any indication
²McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
³Jeon, H. J., et al. .J. Clin. Psychopharmacol. 2014, 34 (2), 218–225.
⁴Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
⁵Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
⁶Costa e Silva, J. A., et al. Neuropsychobiology 1997, 35 (1), 24–29.
⁷Wagstaff, A. J. et al. CNS Drugs 2001, 15 (3), 231–259.

About the Phase 2 UPLIFT Study

The Phase 2 UPLIFT study, TNX-TI-M201, is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken by mouth once-daily for 6 weeks for the treatment of MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 300 participants will be randomized in a 1:1 ratio into the two arms across approximately 30 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode (MDE) of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS). An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of potential sample size re-estimation, currently anticipated in the fourth quarter of 2023. A 24-week open-label extension study, TNX-TI-M202, is planned to receive patients completing the UPLIFT study.

For more information, see ClinicalTrials.gov Identifier: NCT05686408

About Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode¹, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behavior. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.² The current FDA approved drugs for long term monotherapy treatment of MDD include selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and Auvelity® (dextromethorphan HBr-bupropion HCl). Dextromethorphan is a direct antagonist of the NMDA-type glutamate receptor.

¹Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml
²Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine hemioxalate designed for once-daily daytime dosing in development as a candidate for the treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restores hippocampal long-term potentiation and neurogenesis, and reverses the negative neuroplastic changes from stress and corticosteroid exposure. In contrast with the modulation of neurotransmitter levels and activity at synaptic receptors like traditional antidepressants, in animal models tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.¹ Tianeptine’s enhancement of neuroplasticity in animal models of stress implies a mechanism of action involving indirect glutamatergic modulation, which makes TNX-601 ER’s properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis²). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated³ suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks^4-8, 3-months⁹, or 12-months¹⁰ of treatment. The ER formulation of TNX-601 includes several potentially abuse deterrent ingredients include gel forming polymers which impede extraction. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which potentially hinders efforts to misuse by insufflation or intravenous routes. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use. TNX-601 ER is expected to have patent protection through 2037.

¹McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
²Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
³Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
⁴Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
⁵Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
⁶Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
⁷Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
⁸Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
⁹Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
¹⁰Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

About Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition, for which a Phase 2 study was initiated in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. 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 second quarter of 2023. Tonix’s rare disease 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 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900, a class of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

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; 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.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released March 16, 2023

InPlay Oil (IPOOF) – Results meet expectations, new drilling may be accelerating growth

Posted on March 16, 2023March 16, 2023 by cpereira@noblefcm.com

Thursday, March 16, 2023

InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

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

Results demonstrate strong growth, generally meeting expectations. Annual production volumes came in at the lower end of guidance but 58% above last year. Higher production levels in the area may be beginning to show signs of affecting takeaway capacity (see third party curtailment and widening basis discount differentials). Weak summer natural gas prices bounced back nicely in the fourth quarter.

Drilling is accelerating and creating higher producing wells. The company drilled 17.5 net wells in 2022 surpassing our 15 well estimate. Management reports that initial production rates for recent wells were “significantly above internal expectations”. InPlay has been shifting towards longer horizontal laterals and spending more on infrastructure. Production increases seem to justify the higher costs. Management believes the steps it is taking will offset recent curtailments and reiterated 2023 production guidance.

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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.

Onconova Therapeutics (ONTX) – Two Narazaciclib Studies To Be Presented At AACR Meeting

Posted on March 16, 2023March 16, 2023 by cpereira@noblefcm.com

Thursday, March 16, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Narazaciclib Data To Be Presented. Onconova announced two narazaciclib studies have been accepted for poster presentations at the American Association for Cancer Research (AACR) meeting to be held April 14-19, 2023. The abstracts for the presentations include preclinical data on narazaciclib targets and activity that show it to have greater potency and/or broader activity than approved drugs in the CDK4/6 inhibitor category.

Models In Mantle Cell Lymphoma. The first study tested narazaciclib alone and in combination with ibrutinib (Imbruvica, AbbVie) in preclinical models of mantle cell lymphoma. Narazaciclib was tested as a single-agent in both ibrutinib-resistant and ibrutinib-sensitive cell lines and showed significant anti-tumor activity. Next, the combination of narazaciclib with ibrutinib was found to synergistic compared with either drug alone in both resistant and sensitive cell lines. The study also tested narazaciclib against approved CDK4/6 inhibitors in mantle cell lymphoma cell lines and found it to be superior to palbociclib (Ibrance, Pfizer) and ribociclib (Kisqali, Novartis) and similar to abemaciclib (Verzenio, Lilly).

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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).

What AI Will do to Job Availability

Posted on March 16, 2023March 16, 2023 by phoffman@channelchek.com

The Fear of Mass Unemployment Due to Artificial Intelligence and Robotics Is Unfounded

People are arguing over whether artificial intelligence (AI) and robotics will eliminate human employment. People seem to have an all-or-nothing belief that either the use of technology in the workplace will destroy human employment and purpose or it won’t affect it at all. The replacement of human jobs with robotics and AI is known as “technological unemployment.”

Although robotics can turn materials into economic goods in a fraction of the time it would take a human, in some cases using minimal human energy, some claim that AI and robotics will actually bring about increasing human employment. According to a 2020 Forbes projection, AI and robotics will be a strong creator of jobs and work for people across the globe in the near future. However, also in 2020, Daron Acemoglu and Pascual Restrepo published a study that projected negative job growth when AI and robotics replace human jobs, predicting significant job loss each time a robot replaces a human in the workplace. But two years later, an article in The Economist showed that many economists have backtracked on their projection of a high unemployment rate due to AI and robotics in the workplace. According to the 2022 Economist article, “Fears of a prolonged period of high unemployment did not come to pass. . . . The gloomy narrative, which says that an invasion of job-killing robots is just around the corner, has for decades had an extraordinary hold on the popular imagination.” So which scenario is correct?

Contrary to popular belief, no industrialized nation has ever completely replaced human energy with technology in the workplace. For instance, the steam shovel never put construction workers out of work; whether people want to work in construction is a different question. And bicycles did not become obsolete because of vehicle manufacturing: “Consumer spending on bicycles and accessories peaked at $8.3 billion in 2021,” according to an article from the World Economic Forum.

Do people generally think AI and robotics can run an economy without human involvement, energy, ingenuity, and cooperation? While AI and robotics have boosted economies, they cannot plan or run an economy or create technological unemployment worldwide. “Some countries are in better shape to join the AI competition than others,” according to the Carnegie Endowment for International Peace. Although an accurate statement, it misses the fact that productive economies adapt to technological changes better than nonproductive economies. Put another way, productive people are even more effective when they use technology. Firms using AI and robotics can lower production costs, lower prices, and stimulate demand; hence, employment grows if demand and therefore production increase. In the unlikely event that AI or robotic productive technology does not lower a firm’s prices and production costs, employment opportunities will decline in that industry, but employment will shift elsewhere, potentially expanding another industry’s capacity. This industry may then increase its use of AI and robotics, creating more employment opportunities there.

In the not-so-distant past, office administrators did not know how to use computers, but when the computer entered the workplace, it did not eliminate administrative employment as was initially predicted. Now here we are, walking around with minicomputers in our pants pockets. The introduction of the desktop computer did not eliminate human administrative workers—on the contrary, the computer has provided more employment since its introduction in the workplace. Employees and business owners, sometimes separated by time and space, use all sorts of technological devices, communicate with one another across vast networks, and can be increasingly productive.

I remember attending a retirement party held by a company where I worked decades ago. The retiring employee told us all a story about when the company brought in its first computer back in the late ’60s. The retiree recalled, “The boss said we were going to use computers instead of typewriters and paper to handle administrative tasks. The next day, her department went from a staff of thirty to a staff of five.” The day after the department installed computers, twenty-five people left the company to seek jobs elsewhere so they would not “have to learn and deal with them darn computers.”

People often become afraid of losing their jobs when firms introduce new technology, particularly technology that is able to replicate human tasks. However, mass unemployment due to technological innovation has never happened in any industrialized nation. The notion that AI will disemploy humans in the marketplace is unfounded. Mike Thomas noted in his article “Robots and AI Taking Over Jobs: What to Know about the Future of Jobs” that “artificial intelligence is poised to eliminate millions of current jobs—and create millions of new ones.” The social angst about the future of AI and robotics is reminiscent of the early nineteenth-century Luddites of England and their fear of replacement technology. Luddites, heavily employed in the textile industry, feared the weaving machine would take their jobs. They traveled throughout England breaking and vandalizing machines and new manufacturing technology because of their fear of technological unemployment. However, as the textile industry there became capitalized, employment in that industry actually grew. History tells us that technology drives the increase of work and jobs for humans, not the opposite.

We should look forward to unskilled and semiskilled workers’ upgrading from monotonous work because of AI and robotics. Of course, AI and robotics will have varying effects on different sectors; but as a whole, they are enablers and amplifiers of human work. As noted, the steam shovel did not disemploy construction workers. The taxi industry was not eliminated because of Uber’s technology; if anything, Uber’s new AI technology lowered the barriers of entry to the taxi industry. Musicians were not eliminated when music was digitized; instead, this innovation gave musicians larger platforms and audiences, allowing them to reach millions of people with the swipe of a screen. And dating apps running on AI have helped millions of people fall in love and live happily ever after.

About the Author

Raushan Gross is an Associate Professor of Business Management at Pfeiffer University. His works include Basic Entrepreneurship, Management and Strategy, and the e-book The Inspiring Life and Beneficial Impact of Entrepreneurs.

The FOMC’s March Meeting Considerations

Posted on March 16, 2023March 16, 2023 by phoffman@channelchek.com

Will Systemic Risks to the Banking System Override Inflation Concerns When the Fed Meets?

Yes, the Federal Reserve’s central objective is to help maintain a sound banking system in the United States. The Fed’s regional presidents are currently in a blackout period (no public appearances) until after the FOMC meeting ends on March 22. So there is little for markets to go on to determine if the difficulties being experienced by banks will hinder the Fed’s resolve to bring inflation down to 2%. Or if the systemic risks to banks will override concerns surrounding inflation. Below we discuss some of the considerations the Fed may consider at the next meeting.

The Federal Reserve’s sound banking system responsibility is part of its broader responsibility to promote financial stability in the U.S. economy. The Fed does its best to balance competing challenges through monetary policy to promote price stability (low-inflation), maintaining the safety and soundness of individual banks, and supervising and regulating the overall banking industry to ensure that it operates in a prudent and sound manner.

While the headline news after the Fed adjusts monetary policy is usually about the Fed Funds target, the Fed can also adjust Reserve Requirements for banks. Along with that, the rate paid on these reserves, Interest on Excess Reserves (IOER). Another key bank rate that is mostly invisible to consumers is the Discount Rate. This is the interest rate at which banks can borrow money directly from the Federal Reserve. The discount rate is set by the Fed’s Board of Governors and is typically higher than the Federal Funds rate.

Banks try to avoid going to the Discount Window at the Fed because using this more expensive money is a sign to investors or depositors that something may be unhealthy at the institution. Figures for banks using this facility are reported each Thursday afternoon. There doesn’t seem to be bright flashing warning signs in the March 9 report. The amount lent on average for the seven-day period ending Thursday March 9, had decreased substantially, following a decrease the prior week. While use of the Discount Window facility is just one indicator of the overall banking systems health, it is not sending up red flags for the Fed or other stakeholders.

The European Central Bank Raised Rates

There is an expression, “when America sneezes, the world catches a cold.” The actions of the central bank in Europe, (the equivalent of the Federal Reserve in the U.S.) demonstrates that the bank failures in the U.S. are viewed as less than a sneeze. The ECB raised interest rates by half of a percentage point on Thursday (March 16). This is in line with its previously stated plan, even as the U.S. worries surrounding the banking system have shaken confidence in banks and the financial markets in recent days.

The ECB didn’t completely ignore the noise across the Atlantic; it said in a statement that its policymakers were “monitoring current market tensions closely” and the bank “stands ready to respond as necessary to preserve price stability and financial stability in the euro area.”

While Fed Chair Powell is restricted from making public addresses during the pre-FOMC blackout period, it is highly likely that there have been conversations with his cohorts in Frankfurt.

The Fed’s Upcoming Decision

On March 14, the Bureau of Labor Statistics (BLS) reported core inflation (without volatile food and energy) rose in February. Another indicator, the most recent PCE index released on February 24 also demonstrated that core prices are rising at a pace faster than the Fed deems healthy for consumers, banking, or the economy at large. The inflation numbers suggest it would be perilous for the Fed to pause its tightening efforts now.

What has so far been limited to a few U.S. banks is not likely to have been a complete surprise to those that have been setting monetary policy for the last 12 months. It may have surprised most market participants, but warning signs are usually picked up by the FRS, FDIC, and even OCC well in advance. And before news of a bank closure becomes public. Yet, the FOMC continued raising rates and implementing quantitative tightening. The big difference today is, the world is now aware of the problems and the markets are spooked.

The post-meeting FOMC statement will likely differ vastly from the past few meetings. While what the Fed decides to do remains far from certain, what is certain is that inflation is still a problem, and rising interest rates mathematically erode the value of bank assets. At the same time, money supply (M2) is declining at its fastest rate in history. At its most basic definition, M2 is consumer’s cash position, including held at banks. As less cash is held at banks, some institutions may find themselves in the position SVB was in; they have to sell assets to meet withdrawals. The asset values, which were “purchased” at lower rates, now sell for far less than were paid for them.

This would seem to put the Fed in a box. However, if it uses the Discount Window tool, and makes borrowing easier by banks, it may be able to satisfy both demands. Tighter monetary policy, while providing liquidity to banks that are being squeezed.

Take Away

What the Fed will ultimately do remains far from certain. And a lot can happen in a week. Bank closings occur on Friday’s so the FDIC has the weekend to seize control. So if you’re concerned, don’t take Friday afternoons off.

If the Fed Declines to raise rates in March it could send a signal that the Fed is weakening its fight against inflation. This could cause rates to spike higher in anticipation of rising inflation. Everyone loses if that is the case, consumers, banks, and those holding U.S. dollars.

The weakness appears to be isolated in the regional-bank sector and was likely known to the Fed prior to the closing of the banks.

Consider this, only two things have changed for Powell since the last meeting, one is rising core CPI. The other is that he will have to do an even better job at building confidence post-FOMC meeting. Business people and investors want to know that the Fed can handle the hiccups along the path to stamping out high inflation.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/releases/h41/20230309/

https://www.bls.gov/news.release/cpi.nr0.htm

Release – Comtech Successfully Tests and Validates 5G Connection Over Satellite

Posted on March 15, 2023March 15, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CMTL

Mar 15, 2023 9:06 AM

Comtech Collaborates with Leading MNO in Greece and Other Technology Leaders to Demonstrate the Benefits of Blended 5G and Satellite Services

MELVILLE, N.Y. –
March 15, 2023–Comtech announced today, in collaboration with three global technology leaders: Cloud Signals, Hellas Sat, and a leading Mobile Network Operator (MNO), that the companies successfully tested and validated 5G connectivity over a satellite network in Greece.

During the demonstration, a commercial 5G node was connected to the leading MNO’s 5G testbed network and relayed over a satellite link provided by the Hellas Sat.

“This demonstration showcased our ability to easily blend satellite and terrestrial technologies to deliver 5G capabilities to remote areas that are unconnected or underserved by traditional terrestrial and wireless infrastructures,” said Ken Peterman, President and CEO, Comtech. “By working with Cloud Signals, Hellas Sat and the leading MNO, we were able to deliver a wide range of 5G satellite-enabled services, which can create incredible value for customers across Greece and bridge the digital divide in disconnected parts of the world.”

Comtech’s technology leadership was a significant enabler for this breakthrough demonstration, which included its ELEVATE Very Small Aperture Terminal solution that delivered high speed backhaul services for the 5G satellite-based connection.

“After observing a real need for providing 5G network onboard commercial and government maritime vessels, we are delighted to showcase that it can work by successfully transporting, via satellite, an end-to-end live 5G stream with the help of our partners,” said Dr. Christos Papachristos, CEO, Cloud Signals. “What remains to be done is a commercial cooperation and a market launch for our service.”

Cloud Signals specializes in the development of space technologies and is based in Athens, Greece.

“Satellites play an essential role in helping MNOs serve customers in remote and underserved areas, being a flexible, cost-efficient, scalable, and reliable solution for delivering communication services. In collaboration with our partners, using our Hellas Sat 3 satellite at 39^o East, we demonstrated the substantial impact of satellite communications in the advancement of the 5G infrastructure,” said Christodoulos Protopapas, CEO, Hellas Sat.

Hellas Sat is a premium satellite services provider that owns and operates satellites delivering services in Europe, the Middle East, and Southern Africa.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing space and satellite communications technologies, terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

About Cloud Signals

Cloud Signals is a startup specialized in the development of space technologies based in Athens, Greece. In 2021, the company was selected among the first incubatees of ESA BIC (Business Incubation Centre) Greece. The startup is developing a 5G cellular backhaul interface to provide, among others, maritime connectivity to passenger boats in the sea. GEO and LEO satellites are part of the trials that are currently being deployed with the largest mobile service operators in the country.

About Hellas Sat

Hellas Sat is a premium satellite services provider that owns and operates three satellites delivering high-quality, cost-effective video, broadband and data services in Europe, Middle East and Southern Africa. The Company also provides managed services such as digital broadcasting and connectivity to its customers from its own premises in Greece and Cyprus as well as through its network of partners around the world. Hellas Sat is a subsidiary of Arabsat and is based in Greece and Cyprus.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005545/en/

Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Onconova Therapeutics Announces Upcoming Poster Presentations at The Aacr Annual Meeting

Posted on March 15, 2023March 15, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ONXT

Mar 15, 2023

PDF Version

NEWTOWN, Pa., March 15, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the publication of two abstracts that have been accepted for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting, which is taking place at the Orange County Convention Center in Orlando, Florida from April 14 – 19, 2023.

The full texts of the published abstracts can be found on the AACR Annual Meeting website. The corresponding posters will be presented during the “Cyclin-dependent Kinases and Cyclin-dependent Kinase Inhibitors” poster session, which is taking place from 9:00 a.m. – 12:30 p.m. ET on April 19, 2023. Additional information on the posters is shown below.

Poster Title: Synergistic activity of the CDK4/6 antagonist narazaciclib (ON123300) with irreversible BTK inhibition in ibrutinib-resistant mantle cell lymphoma

Abstract Number: 5974

This poster will describe studies evaluating narazaciclib in preclinical models of mantle cell lymphoma (MCL). Results from these studies demonstrated narazaciclib’s single-agent antitumor activity in MCL cell lines independent of their sensitivity to ibrutinib, which is a Bruton’s tyrosine kinase inhibitor (BTKi) approved by the U.S. Food and Drug Administration (FDA) for the treatment of MCL. When combining narazaciclib with ibrutinib, synergistic increases in antitumor activity against both BTKi-resistant and BTKi-sensitive MCL cell lines were observed.

Additional analyses showed that narazaciclib’s antitumor activity against the evaluated MCL cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Treatment with narazaciclib also led to tumor growth inhibition without detectable toxicity in a chicken embryo chorioallantoic membrane (CAM) xenograft model of MCL.

Poster Title: Differential targets engaged by narazaciclib in comparison to the approved CDK4/6 inhibitors contribute to enhanced inhibition of tumor cell growth

Abstract Number: 5987

This poster will describe cell-based, in vitro, and bioinformatic analyses comparing narazaciclib and palbociclib. Results from a cell-based murine mammary carcinoma model showed a stronger induction of programmed cell death with narazaciclib compared to palbociclib. In vitro and cell-based analyses revealed multiple targets that are engaged by narazaciclib but not by palbociclib. These targets included BUB1, the overexpression of which is correlated with poor survival in triple negative breast cancer. The results of additional cell-based assays that will be described in the poster suggest that narazaciclib may promote antitumor immunity and show that combining narazaciclib with autophagy inhibitors sensitizes breast cancer cells to cell death.

About Onconova Therapeutics, Inc.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Seanergy Maritime (SHIP) – Results fall on lower shipping rates but Seanergy is finding ways to offset the decline

Posted on March 15, 2023March 15, 2023 by cpereira@noblefcm.com

Wednesday, March 15, 2023

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of approximately 12 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

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

Fourth-quarter revenues fell sharply once again. Shipping rates continued to decline. The average TCE rate fell 53% year over year and 15% quarter over quarter. Seanergy was able to partially offset the impact of lower rates because of the net addition of ships in 2022 and thus a higher number of operating days. The company was also able to generate new revenues by providing management services to United Maritimes Corporation, which was spun off in July.

Lower revenues partially offset by cost reductions and share repurchases. Daily vessel operating costs were $6,651 during the quarter, down from $7,184 last year and $7,593 in the third quarter. Financing costs were below expectations despite the investment in new ships. Management has been active refinancing debt when possible. Of particular note was the decrease in diluted share count due to the repurchase of convertible notes.

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Orion Group Holdings (ORN) – Fourth Quarter First Look

Posted on March 15, 2023March 15, 2023 by cpereira@noblefcm.com

Wednesday, March 15, 2023

Joe Gomes, Managing Director – Generalist Analyst, 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.

4Q22 Results. Contract revenues were at $196.2 million from $162.3 million last year. We estimated revenue of $165 million. Operating loss was reported at $3.5 million versus a loss of $8.2 million last year, with a net loss of $4.9 million, or $0.15 per share, compared to a loss of $8.8 million, or $0.29 per share, in the prior year. Adjusted EPS loss was $0.12 versus $0.17. Adjusted EBITDA was at $3.2 million from a negative $0.8 million last year.

A Strategic Plan. Orion showed a three point strategic plan in regards to the overall business that the Company will follow in 2023. The plan consists of improving the profitability in the Company’s concrete segment, strengthening the business to drive growth, and investing resources into the Company to realize its full potential. Among the actions in these plans are refocusing on core Texas markets in the concrete business, building on successful sales efforts and capitalizing on favorable industry dynamics, and strengthen the balance sheet. We believe the plan provides a pathway towards efficiency and growth for Orion.

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Largo Inc. (LGO) – Results disappointing but future remains bright.

Posted on March 15, 2023March 15, 2023 by cpereira@noblefcm.com

Wednesday, March 15, 2023

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURE™ and VPURE+™ products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business support a low carbon future.

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

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

Sales and realized prices were down. Production volumes (preannounced) fell 31% q-t-q due to maintenance and rain. Realized vanadium prices fell 12% with Largo prices falling below benchmark prices due to a drop in ferrovanadium prices and timing factors associated with contract deliveries.

Costs were up. Operating costs continued to rise in the fourth quarter. The change in cost per unit produced was especially noteworthy as production levels dropped. Management has put a priority on controlling operating costs and expects costs in future quarters to decline. Non-operating cost remain high, although they have eased since the third quarter.

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Oil Prices Could Have a Huge Impact on These Sectors

Posted on March 15, 2023March 15, 2023 by phoffman@channelchek.com

Which Way is Oil Going, and What it Could Mean for Investors in Related Sectors

Whether the sudden and severe decline in oil prices is an opportunity to invest in sectors that will benefit from cheaper fuel, a sign of further problems in the economy, or transitory, remains to be seen. It may depend on two overriding factors – and there are strong arguments supporting each. Below we look at the different scenarios and the sectors that are impacted.

Background

Energy futures and oil-related stocks like Chevron (CVX) and Exxon (XOM) gapped down at the open two days this week as concern about the overall health of the financial sector as two banks were closed and a major rating agency downgraded the banking sector Since Friday. U.S. oil futures remained below $70 per barrel midweek, as prices of WTI have now dipped 13% to levels not seen since December 2021.

These downward price moves are a reaction to thinking that demand will wane in a slowing U.S. economy. Also that it may take longer for the Chinese economy to rise to expected levels. Although far less impactful, approval of the Willow oil drilling project by the White House demonstrates a reversal of the ‘no more drilling’ policy by this administration.

A report by the International Energy Agency (IEA) this morning suggests the price decline may be temporary. The IEA anticipates that the oil markets will switch from a supply overhang in the first half of 2023 to a deficit later in the year. This is expected as OPEC continues its plan to cut production, and that the increased air traffic, along with an economic rebound in China will push global oil demand to a record high, according to the IEA.

*Image: President Joe Biden meets with staff in the Oval Office, Monday, January 23, 2023, to discuss the Willow oil project. (Official White House Photo by Cameron Smith)*

Oil remains one of the most crucial commodities to the modern world. Its price has a significant impact on various industries and investment sectors. Below are the sectors that stand to benefit if the recent decline in prices remains intact or declines further:

Transportation Industry is a significant beneficiary of lower oil prices. The reason of course is because fuel costs are a significant expense for airlines, trucking, and shipping companies. When the cost of fuel follows the decline, the transportation industry enjoys a reduction in operating costs. This can result in wider margins on tickets sold for air travel, lower shipping costs for businesses including retailers, and lower prices for cruise lines.

The Chemical Industry is another sector that benefits from declining oil prices. Many chemicals are derived from crude oil, and a decrease in oil prices means a decrease in the cost of raw materials. This, in turn, can lead to lower prices for chemical products such as fertilizers, plastics, and other materials.

The Consumer Goods Industry is also a significant beneficiary of declining oil prices. This is because many consumer goods are made from oil-based materials such as plastics, rubber, and synthetic fabrics. When oil prices decline, the cost of these materials decreases, resulting in lower production costs and, ultimately, lower prices for consumers.

The Renewable Energy Industry is not directly related to oil prices, a decline in oil prices can benefit this sector indirectly. Renewable energy sources such as wind and solar power are becoming increasingly competitive with traditional fossil fuels, and a decrease in the price of oil can make it more challenging for the fossil fuel industry to compete. This can result in increased investment in renewable energy and a shift toward cleaner, more sustainable sources of energy.

Emerging Markets, particularly those that are oil-importing countries, can benefit significantly from declining oil prices. These countries rely heavily on imported oil, and a decrease in oil prices can result in significant cost savings for these countries. This can lead to increased economic growth, as businesses have more money to invest in other areas and consumers have more disposable income to spend.

Take Away

Oil has dropped considerably this year. This is in part because economic activity is expected to become lower, and problems in the banking sector. This may not last through the year as indicated by the IEA. Others believe this is the start of further declines. Should oil prices not track higher, stock market investors could look at the transportation, chemical, and consumer goods industries, as well as the renewable energy sector and emerging markets. As with any economic change, it is essential to carefully analyze the potential effects on different industries and sectors to make informed investment decisions.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.iea.org/topics/oil-market-report

https://www.investing.com/news/commodities-news/oil-sinks-as-moodys-banking-downgrade-drops-another-shoe-on-crisis-3030407

Guess the Odds that the NCAA Games Will Attract More Gambling in 2023

Posted on March 15, 2023March 15, 2023 by phoffman@channelchek.com

As March Madness Looms, Growth in Legalized Sports Betting May Pose a Threat to College Athletes

March Madness began on March 14, 2023, it’s a sure bet that millions of Americans will be making wagers on the annual college basketball tournament.

The American Gaming Association estimates that in 2022, 45 million people – or more than 17% of American adults – planned to wager US$3.1 billion on the NCAA tournament. That makes it one of the nation’s most popular sports betting events, alongside contests such as the Kentucky Derby and the Super Bowl. By at least one estimate, March Madness is the most popular betting target of all.

While people have been betting on March Madness for years, one difference now is that betting on college sports is legal in many states. This is largely due to a 2018 Supreme Court ruling that cleared the way for each state to decide whether to permit people to gamble on sporting events. Prior to the ruling, legal sports betting was only allowed in Nevada.

Since the ruling, sports betting has grown dramatically. Currently, 36 states allow some form of legalized sports betting. And now, Georgia, Maine and Kentucky are proposing legislation to make sports betting legal.

About two weeks after sports betting became legal in Ohio on Jan. 1, 2023, someone, disappointed by an unexpected loss of the University of Dayton men’s basketball team to Virginia Commonwealth University, made threats and left disparaging messages against Dayton athletes and the coaching staff.

The Ohio case is by no means isolated. In 2019, a Babson College student who was a “prolific sports gambler” was sentenced to 18 months in prison for sending death threats to at least 45 professional and collegiate athletes in 2017.

Faculty members of Miami University’s Institute for Responsible Gaming, Lottery, and Sports are concerned that the increasing prevalence of sports betting could potentially lead to more such incidents, putting more athletes in danger of threats from disgruntled gamblers who blame them for their gambling losses.

The anticipated growth in sports gambling is quite sizable. Analysts estimate the market in the U.S. may reach over US$167 billion by 2029.

Gambling Makes Inroads into Colleges

Concerns over college athletes being targeted by upset gamblers are not new. Players and sports organizations have expressed worry that expanded gambling could lead to harassment and compromise their safety. Such concerns led the nation’s major sports organizations – MLB, NBA, NFL, NHL and NCAA – to sue New Jersey in 2012 over a plan to initiate legal sports betting in that state. They argued that sports betting would make the public think that games were being thrown. Ultimately, the Supreme Court ruled that it was up to states to decide if they wanted to permit legal gambling.

Sports betting has also made inroads into America’s college campuses. Some universities, such as Louisiana State University and Michigan State University, have signed multimillion-dollar deals with casinos or gaming companies to promote gambling on campus.

Athletic conferences are also cashing in on the data related to these games and events. For instance, the Mid-Atlantic Conference signed a lucrative five-year deal in 2022 to provide real-time statistical event data to gambling companies, which then leverage the data to create real-time wager opportunities during sporting events.

As sports betting comes to colleges and universities, it means the schools will inevitably have to deal with some of the negative aspects of gambling. This potentially includes more than just gambling addiction. It could also involve the potential for student-athletes and coaches to become targets of threats, intimidation or bribes to influence the outcome of events.

The risk for addiction on campus is real. According to the National Council on Problem Gambling, over 2 million adults in the U.S. have a “serious” gambling problem, and another 4 million to 6 million may have mild to moderate problems. One report estimates that 6% of college students have a serious gambling problem.

What Can be Done?

Two faculty fellows at Miami University’s Institute for Responsible Gaming, Lottery, and Sport – former Ohio State Senator William Coley and Sharon Custer – recommend that regulators and policymakers work with colleges and universities to reduce the potential harm from the growth in legal gaming. Specifically, they recommend that each state regulatory authority:

Develop plans to coordinate between different governmental agencies to ensure that individuals found guilty of violations are sanctioned in other jurisdictions.
Dedicate some of the revenue from gaming to develop educational materials and support services for athletes and those around them.
Create anonymous tip lines to report threats, intimidation or influence, and fund an independent entity to respond to these reports.
Assess and protect athlete privacy. For instance, schools might decline to publish contact information for student-athletes and coaches in public directories.
Train athletes and those around them on basic privacy management. For instance, schools might advise athletes to not post on public social media outlets, especially if the post gives away their physical location.

The NCAA or athletic conferences could lead the development of resources, policies and sanctions that serve to educate, protect and support student-athletes and others around them who work at the schools for which they play. This will require significant investment to be comprehensive and effective.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Jason W. Osborne, Professor of Statistics, Institute for Responsible Gaming, Lottery, and Sport, Miami University.

Tonix Pharmaceuticals (TNXP) – FY2023 Reported – Clinical Milestones Expected In 2Q23

Posted on March 14, 2023March 14, 2023 by cpereira@noblefcm.com

Tuesday, March 14, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Tonix Reported FY2022 and Gave Clinical Milestone Updates. Tonix reported a loss of $34.1 million or ($0.56) per share for 4Q22 and $116.9 million or $(3.27) per share for FY2022. The company reaffirmed its guidance for a 2Q23 announcement of interim analysis for TNX102 SL in the Phase 3 RESILIANT trial testing in fibromyalgia. The full analysis is expected in 4Q23, one of several clinical milestones expected in 2023. Tonix had $120.2 million in cash on December 31.

Interim Analysis Expected For Phase 3 in Fibromyalgia. The RESILIANT Phase 3 trial is a double-blind, placebo-controlled study for fibromyalgia. It reached the 50% patient milestone in December 2022, with the interim analysis results expected in 2Q23. If successful, the RESILIANT trial could lead to an NDA filing for product approval.

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