Month: January 2024

Fed Holds Rates Steady, Cools Expectations for Imminent Cuts

Posted on by slightbourne@noblecapitalmarkets.com

The Federal Reserve left interest rates unchanged on Wednesday following its January policy meeting, keeping the federal funds rate target range at 5.25-5.50%, the highest level since 2007. The decision came as expected, but Fed Chair Jerome Powell pushed back on market bets of rate cuts potentially starting as soon as March.

In the post-meeting statement, the Fed removed language about needing additional policy tightening, signaling a likely prolonged pause in rate hikes as it assesses the impact of its aggressive actions over the past year. However, officials emphasized they do not foresee cuts on the horizon until inflation shows “greater progress” moving back to the 2% goal sustainably.

Powell Caution on Rate Cuts

During his press conference, Powell aimed to temper expectations that rate cuts could begin in just a couple months. He stated March is “probably not the most likely case” for the start of easing, rather the “base case” is the Fed holds rates steady for an extended period to confirm inflation is solidly on a downward trajectory.

Markets have been pricing in rate cuts in 2024 based on recent data showing inflation cooling from 40-year highs last year. But the Fed wants to avoid undoing its progress prematurely. Powell said the central bank would need more consistent evidence on inflation, not just a few months of decent data.

Still Room for Soft Landing

The tone indicates the Fed believes there is room for a soft landing where inflation declines closer to target without triggering a recession. Powell cited solid economic growth, a strong job market near 50-year low unemployment, and six straight months of easing price pressures.

While risks remain, the Fed views risks to its dual mandate as balancing out rather than tilted to the downside. As long as the labor market and consumer spending hold up, a hard landing with severe growth contraction may be avoided.

Markets Catching Up to Fed’s Thinking

Markets initially expected interest rate cuts to start in early 2024 after the Fed’s blistering pace of hikes over the past year. But officials have been consistent that they need to keep policy restrictive for some time to ensure inflation’s retreat is lasting.

After the latest guidance reiterating this view, traders adjusted expectations for the timing of cuts. Futures now show around a coin flip chance of a small 25 basis point rate cut at the March FOMC meeting, compared to up to a 70% chance priced in earlier.

Overall the Fed is making clear that investors are too optimistic on the imminence of policy easing. The bar to cutting rates remains high while the economy expands moderately and inflation readings continue improving.

Normalizing Policy Ahead

Looking beyond immediate rate moves, the Fed is focused on plotting a course back to more normal policy over time. This likely entails holding rates around the current elevated range for much of 2024 to solidify inflation’s descent.

Then later this year or early 2025, the beginnings of rate cuts could materialize if justified by the data. The dot plot forecast shows Fed officials pencil in taking rates down to 4.5-4.75% by year’s end.

But Powell was adamant that lowering rates is not yet on the table. The Fed will need a lengthy period of inflation at or very close to its 2% goal before definitively shifting to an easing cycle.

In the meantime, officials are content to pause after their historic tightening campaign while still keeping rates restrictive enough to maintain control over prices. As Powell made clear, investors anxiously awaiting rate cuts will likely need to keep waiting a bit longer.

Neuralink’s First Human Implant Could Spark Tech Stock Volatility

Posted on by slightbourne@noblecapitalmarkets.com

Elon Musk’s brain-computer interface company Neuralink announced this week it has conducted the first-ever implant of its device in a human subject. While details remain scant, the news serves as a milestone for a technology some believe could transform human capability. For tech investors, Neuralink’s progress stokes excitement but also uncertainty around the winners and losers in an era of enhanced humans.

Neuralink aims to develop a brain implant allowing paralyzed patients to control devices with their thoughts and able-bodied people to digitally communicate at speeds faster than speech. The first implant surgery comes after years of animal testing and brings the possibilities closer to reality.

According to Musk, the anonymous volunteer patient is “recovering well” and initial results show “promising neuron spike detection” from the 1024 electrode threads inserted by a surgical robot. The goal is for the implants to interpret brain signals, replacing the need for physical movement to operate computers or smartphones.

While the current trial is focused on quadriplegic patients, the ultimate vision is a technology so seamless it augments natural brain function. With the ability to download information directly into the brain, Neuralink promises a future where humans can achieve computer-like efficiency.

Leaps Forward, Ethical Debates

To technologists, successfully reading and transmitting neural signals brings humanity to the brink of a productivity revolution. Brain enhancement could elevate human potential and economic output, feeding into further innovation and growth.

However, developers must tread carefully given sobering lessons from the smartphone era’s negative effects on mental health. Addictive potential and unintended consequences abound when tampering with humanity’s most complex organ.

Investing Implications

For stocks, Neuralink’s progress exemplifies the promise and peril of emerging technologies. Huge opportunity exists as brain-computer interfaces enable new industries and services. But ethical debates or setbacks could also derail optimism.

The saga of Meta’s metaverse ambitions is instructive. Despite billions invested, underwhelming VR technology and idealistic vision have sunk the stock. Neuralink requires immense scientific progress to become reality. Any stumbles or loss of faith in the vision could rapidly deflate hype.

Yet some secular growth trends appear inevitable. Neuralink-inspired advances will boost artificial intelligence capabilities, a priority for giants like Alphabet and Amazon. Cloud infrastructure and high-performance computing demands will accelerate. Medical device makers and chip developers enabling products like Neuralink will see new markets open.

Mark your calendars for the upcoming Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference from April 17-18, 2024. The premier small-cap event will feature presentations from over 50 public emerging growth companies in the space.

But more speculative ideas or overvalued stocks could crumble on the slightest speedbump. Investors must differentiate between progress and promotional hype. In biotech, this means focusing on companies with robust, diversified drug pipelines rather than single-product moonshot bets.

Betting on Musk himself is dubious given the seesawing markets have experienced around Tesla and Twitter. While his cult of personality propels cash into his ventures, realistic timeframes and execution risks are higher than perceived.

Ultimately, Neuralink is emblematic of both the transformative potential and inherent volatility of disruptive technology. Its first human application sparks excitement, but a measured approach accounts for hurdles ahead. Investors can embrace futuristic optimism while grounding in reality.

Release – Cadrenal Therapeutics Highlights Publication of Peer-Reviewed Article Supporting Need for New Anticoagulation Therapy for Patients with Certain Medical Conditions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

31 Jan, 2024, 09:00 ET

PONTE VEDRA, Fla., Jan. 31, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, cited today a recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, “When Direct Oral Anticoagulants Should Not Be Standard Treatment” by Antoine Bejjani, MD, et.al. The article examines the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed.

Consistent with the evolving evidence documenting the need for VKA-based anticoagulant therapy, while simultaneously recognizing the deficiencies of the available VKA anticoagulants (such as warfarin), this latest peer-reviewed journal publication highlights:

  • For most patients, DOACs are preferred over existing Vitamin K Antagonists [warfarin] for stroke prevention in atrial fibrillation (AFib) and venous thromboembolism treatment.
  • However, randomized controlled trials indicate that DOACs may not be as efficacious or as safe in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome (APS), and AFib associated with end-stage kidney disease (ESKD).
  • Their [DOACs] efficacy is uncertain for conditions such as left ventricular thrombus, and for patients with AFib or venous thrombosis who have ESKD.

“This expert review provides an assessment of the available evidence regarding DOACs, detailing not only when they have demonstrated efficacy and safety, but also when the DOACs have failed and therefore should not be the standard of care,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “These critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlight and support the need for the advancement of our tecarfarin development program to serve these patients.”

Further information on the article is available at https://www.jacc.org/doi/epdf/10.1016/j.jacc.2023.10.038.

ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.  

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlighting and supporting the need for the advancement of our tecarfarin development program to serve these patients.The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com 

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com 

SOURCE

Release – ZyVersa Therapeutics Highlights Publication Indicating That Inflammasome NLRP3-Mediated Inflammation in Obese Children Leads to Insulin Resistance and Risk of Complications Such as Type 2 Diabetes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 31, 2024

Insulin resistance (IR), a common feature of childhood obesity which affects 15 million children and adolescents, is the main driver of obesity-related metabolic complications such as Type 2 diabetes, hypertension, and premature heart disease.

  • This study demonstrated that NLRP3 inflammasome activation was highest in obese children with the worst metabolic profile (higher serum glucose levels, a late insulin response to glucose tolerance tests, adverse serum lipid profiles, and higher oxidative stress (based on ROS levels).
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which inhibits NLRP3 and other types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.

WESTON, Fla., Jan. 31, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, highlights an article published in the peer-reviewed Journal of Translational Medicine supporting that NLRP3 activation is associated with a pathologic inflammatory response in obese children with insulin resistance and increased risk of developing metabolic complications. Inflammation and oxidative stress, which are closely related pathophysiological processes, one of which can be easily induced by the other, are key drivers for developing metabolic complications, such as type 2 diabetes and cardiovascular disease, in this population.

In the paper titled, “Altered insulin secretion dynamics relate to oxidative stress and inflammasome activation in children with obesity and insulin resistance,” the authors conducted a case-controlled study of 132 children who were either lean or obese. The obese group was segmented into those with or without insulin resistance, and those with insulin resistance were segmented into those with an early and late insulin response to glucose as determined by an oral glucose tolerance test (OGTT).

The researchers reported the following key findings in Children with obesity, insulin resistance, and increased risk of metabolic complications:

  • Higher levels of NLRP3 and its effector proteins (active IL-1β, caspase-1, and gasdermin D) in peripheral blood mononuclear cells (PBMCs) and serum compared to the other groups studied, indicative of NLRP3 activation and an inflammatory response.
  • Higher levels of uric acid versus the other groups, a well-known trigger of NLRP3 activation.
  • Increased levels of oxidative stress and oxidative damage versus the other groups.

The authors concluded, “It is insulin response to an OGTT that identifies children with obesity suffering oxidative stress, and inflammasome activation more specifically. Uric acid could be mediating this pathological inflammatory response by activating NLRP3 in peripheral blood mononuclear cells.”

To read the article, Click Here.

“Childhood obesity, which has increased more than 8-fold over the last 40 years, is an alarming health problem today due to the increased risk for developing type 2 diabetes, early heart disease, and other co-morbidities,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The research published in the Journal of Translational Medicine points to a significant role for inflammasome-mediated inflammation and oxidative stress in development of metabolic complications in obese children. ZyVersa is developing Inflammasome ASC Inhibitor IC 100 designed to inhibit NLRP3 and other types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of inflammation, which may have therapeutic potential to alleviate metabolic complications of childhood obesity with early intervention.”

To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

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

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

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

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

Release – Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibromyalgia-Type Symptoms May Increase the Risk of Developing Long COVID

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

January 31, 2024 7:00am EST

Retrospective observational study of electronic medical records of more than 90 million people living in the U.S.

Long COVID shares symptoms with chronic overlapping pain disorders like fibromyalgia and appears mechanistically related

Tonix is studying TNX-102 SL for both the management of fibromyalgia and management of fibromyalgia-type Long COVID.

CHATHAM, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates and currently focused on preparing a New Drug Application (NDA) for Tonmya (formerly TNX-102 SL, sublingual cyclobenzaprine HCl) for the management of fibromyalgia, today announced the online publication of a research paper in the Journal Pain. The article titled, “Chronic Overlapping Pain Conditions Increase the Risk of Long COVID Features, Regardless of Acute COVID Status,” by Bergmans, et al. 1, found that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID1. Faculty at the University of Michigan directed the research. Commentary on the article titled, “A step towards better understanding chronic overlapping pain conditions” by Fitzcharles, et al,2 is in the same issue of the journal.

COPCs include fibromyalgia, chronic fatigue syndrome, migraine headache, irritable bowel syndrome, endometriosis and low back pain. The TriNetX Analytics platform was used to extract anonymized electronic health record data from more than 91 million people in the U.S. These findings showed that: (1) in addition to COVID, prolonged pain may occur after recovery from viral infections like influenza, (2) people with pre-existing pain are at risk for exacerbation of their pain after viral illness, (3) pre-existing COPCs increase the risk of Long COVID, and (4) COPCs and Long COVID likely result from the same or similar brain processes, and Long COVID can be conceptualized as a new onset COPC or an exacerbation of a pre-existing COPC.

“These results contribute to a growing body of evidence that most symptoms of Long COVID are at least partly driven by central nervous system mechanisms rather than persistent exposure to the SARS-CoV-2 virus,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tonix is studying TNX-102 SL for the management of fibromyalgia (conditionally approved by U.S. Food and Drug Administration as “Tonmya”) and for fibromyalgia-type Long COVID. Fibromyalgia is already recognized as a COPC. The new paper adds to the growing body of evidence that many cases of Long COVID should be viewed in the COPC framework, rather than in a purely post-infectious disease perspective.”

Dr. Lederman continued, “In the post-pandemic era, in which COVID is endemic and repeated bouts are common, it will be important to learn if appropriate management of fibromyalgia may reduce the risk of developing Long COVID. Moreover, since fibromyalgia symptoms like widespread pain were risk factors for COVID even without a diagnosis of fibromyalgia, these findings suggest that earlier diagnosis and management of fibromyalgia may be advised.”

“The magnitude of Long COVID risk conferred by a pre-existing COPC was comparable with, if not larger than, that for sex and acute COVID hospitalization status, which are known risk factors for Long COVID,” 2,3 said Rachael Bergmans, M.P.H, Ph.D., Research Assistant Professor at the University of Michigan Medical School Department of Anesthesiology, Chronic Pain and Fatigue Research Center (CPFRC) and lead author of the paper. “These findings are consistent with previous research where pre-existing chronic pain conditions including fibromyalgia, back pain, and migraine increase the risk of Long COVID.”2-4

Tonmya* has shown positive results in two Phase 3 clinical trials for the management of fibromyalgia. Tonix plans to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for the management of fibromyalgia.

About Tonmya™ (formerly known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya 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 cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development fibromyalgia-type 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 Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

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

1Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110
2Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129
3Subramanian A, et al. Nat Med. 2022. 28(8):1706-1714.
4 Galal I, et al. Egypt J Bronchol. 2021. 15(1):10.

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’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third 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 first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

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

Source: Tonix Pharmaceuticals Holding Corp.

Released January 31, 2024

Seanergy Maritime (SHIP) – Seanergy enters into a partnership to develop an alternative fuel ship

Posted on by cpereira@noblefcm.com


Wednesday, January 31, 2024

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, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

A Seanergy division will join the Safecraft Project Consortium to retrofit a ship to use hydrogen as the main energy source. In December of last year, the European Commission founded the project and committed $10 million to the $13.5 million cost. The Safecraft consortium includes a dozen shipping, engineering, and research organizations committed to demonstrate the safety and viability of Sustainable Alternative Fuels (SAFs). Hydrogen will be the main source of electric power generation and will also help with propulsion.


Hydrogen ships are coming. Hydrogen ships (including submarines) have been around for decades, but are becoming more common place in recent years. The MF Hydra, for example, became the first hydrogen-powered ferry in 2021. China has launched a hydrogen ship in 2022 and is developing more. Kawasaki has been approved to develop an engine that will run on hydrogen for use on carriers. Other vessels such as yachts and speedboats use hydrogen fuel cells to provide electricity. Seanergy is the first Greek-based shipping company to form a partnership with Safecraft. 


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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. 

InPlay Oil (IPOOF) – Updated guidance reflects reduced production expectations

Posted on by cpereira@noblefcm.com


Wednesday, January 31, 2024

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, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Management updated its 2023 guidance. The adjustment reflects a drop in production expectations. New guidance is significantly below the 9,700 boe/d production flow reported from the field on November 9, 2023. The decline may represent a sharper decline rate from initial production rates than had previously been expected by management. The drop in production lead to a sharp reduction in projected Adjusted Funds Flow and Free Funds Flow.

Management also sharply reduced its 2024 production estimates. New guidance calls for 2024 production that is only slightly higher than newly revised 2023 guidance despite the drilling of 14-15 new wells and an expected reduction in curtailment. While it is possible that management is simply being conservative, it may also reflect well decline rates as discussed above. 


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

ACCO Brands (ACCO) – New Cost Reduction Plan

Posted on by cpereira@noblefcm.com


Wednesday, January 31, 2024

ACCO Brands Corporation is one of the world’s largest designers, marketers and manufacturers of branded academic, consumer and business products. Our widely recognized brands include AT-A-GLANCE®, Esselte®, Five Star®, GBC®, Kensington®, Leitz®, Mead®, PowerA®, Quartet®, Rapid®, Rexel®, Swingline®, Tilibra®, and many others. Our products are sold in more than 100 countries around the world. More information about ACCO Brands, the Home of Great Brands Built by Great People, can be found at www.accobrands.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 Plan. ACCO announced a multi-year restructuring and cost savings program, with anticipated annualized pre-tax cost savings of at least $60 million. The Company expects to record a pre-tax restructuring charge for the period ended December 31, 2023 of approximately $13 million. This is in addition to a $9 million charge relating to the closure of the Sidney, NY facility. Total cash expenditures are expected to be $26 million with cash outflows of $18 million in 2024 and $8 million in 2025. The restructuring will better position the Company for long-term sustainable profitable growth, in our view, adding to the Company’s 2023 improvement in margins.

Details. The program incorporates initiatives to simplify and delayer the Company’s operating structure and reduce costs through headcount reductions, supply chain optimization, global footprint rationalization, and better leveraging of sourcing capabilities.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

Gilead Deepens Arcus Ties With $320M Investment to Accelerate Cancer Immunotherapy Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences and biotech partner Arcus Biosciences announced Tuesday an amended collaboration to accelerate development of their cancer immunotherapy programs, along with a $320 million equity investment by Gilead.

The deal builds on the companies’ 2020 partnership and boosts Gilead’s ownership in Arcus to 33% through an additional stake purchase at $21 per share. Gilead also gains a third seat on Arcus’ board, having their Chief Commercial Officer Johanna Mercier join as a director.

Strategic Focus on TIGIT

A key change is prioritizing late-stage studies for the anti-TIGIT antibody domvanalimab, the lead candidate from the collaboration. Arcus CEO Terry Rosen stated the partners want to “leverage their strengths and focus on efficiently advancing novel combinations.”

Domvanalimab is progressing in Phase 3 for non-small cell lung cancer and gastric/GEJ cancer. By accelerating these pivotal studies, expected to fully enroll by year-end, the drug could reach approval sooner if successful.

However, they are discontinuing the ARC-10 Phase 3 lung cancer trial to devote resources to the other domvanalimab studies targeting greater unmet need.

This streamlining highlights the companies’ faith in TIGIT’s potential but the necessity to optimize their most promising assets. TIGIT is an emerging immunotherapy target and domvanalimab a next-gen asset, so focusing late-stage research is prudent.

Quemliclustat Now Solo Arcus Program

Meanwhile, the planned Phase 3 study of Arcus’ CD73 inhibitor quemliclustat in pancreatic cancer will become an Arcus-only program, no longer jointly developed.

Again the theme is concentrating human capital and financial resources where they can make the biggest difference. For smaller Arcus, independence for some programs provides flexibility.

Arcus can also now fully control projects beyond domvanalimab and their PD-1 drug zimberelimab, which Gilead has options to license. This benefits Arcus’ broader pipeline and product vision.

Extends Arcus Cash Runway

Importantly, the $320 million cash infusion lengthens Arcus’ funding horizon until 2027 by their estimates. This enables advancing Phase 3 quemliclustat and AB154 studies plus potential commercial launch activities without financing concerns.

Any biotech developing novel drugs without revenue benefits immensely from having ample cash reserves. This partly protects Arcus from market volatility and general biotech funding challenges.

Gilead Building a Powerhouse

For Gilead, the enhanced Arcus alliance adds another pillar to their ambitions cancer franchise. The pharma giant has been aggressively wheeling and dealing to expand in oncology, now a key growth area.

Recent moves include the $21 billion Immunomedics acquisition and purchases of companies like Tango Therapeutics, Dragonfly Therapeutics, and Epizyme. The Arcus pact leverages access to next-generation immunotherapy science and pipeline.

Gilead is constructing a vertically integrated oncology player combining in-house and external innovation. Scale and synergies across R&D, manufacturing, and commercialization can accelerate targeted therapies to patients.

With collaborators like Arcus doing the early lifting, Gilead can then optimize late-stage studies and apply their regulatory expertise to reach approvals more quickly.

Overall the amended Arcus agreement highlights Gilead’s commitment to cancer and immunology while bolstering their presence in cutting-edge research like TIGIT inhibition. With the investment and restructuring, Gilead strengthens ties to Arcus’ science while keeping the biotech funded and focused. For both, it’s a win-win accelerating cancer drugs to market.

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Release – GeoVax Announces 1-for-15 Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, January 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the Company’s Board of Directors has approved a reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-15. The Company is effecting the reverse split to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The reverse stock split was approved by the Company’s stockholders at a meeting held January 16, 2024.

The reverse stock split will become effective on January 30, 2024 (the “Effective Date”), and the Common Stock is expected to begin trading on the split-adjusted basis on the Nasdaq Stock Exchange (“Nasdaq”) at the market open on January 31, 2024. Following the reverse split, the Common Stock will continue to trade under the symbol “GOVX”, and the Company’s publicly traded warrants will continue to trade under the symbol “GOVXW”.

On the Effective Date, every 15 issued and outstanding shares of the Company’s Common Stock will be converted automatically into one share of the Company’s Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock will therefore be reduced proportionately from 29,757,823 shares to approximately 1,983,855 shares. On the Effective Date, the publicly traded warrants will be adjusted to require fifteen (15) warrants to be exercised to receive one (1) share of common stock at a price of $75 per share.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the rounding up of any fractional shares to the next whole number of shares. The rights and privileges of the holders of shares of Common Stock will be substantially unaffected by the reverse stock split.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com                paige.kelly@sternir.com                sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – ACCO Brands Corporation Announces Cost Reduction Program Targeting Annualized Pre-Tax Savings of at least $60 Million

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ACCO

01/30/2024

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) announces a multi-year restructuring and cost savings program, with anticipated annualized pre-tax cost savings of at least $60 million. The program incorporates initiatives to simplify and delayer the Company’s operating structure and reduce costs through headcount reductions, supply chain optimization, global footprint rationalization, and better leveraging of our sourcing capabilities. As a result of these actions, the Company will improve its speed of execution and bring key leaders closer to the customers. In connection with this program, the Company will file a Form 8-K with the SEC disclosing its restructuring charges.

“The actions we are announcing today will better position the Company for long-term sustainable profitable growth. The cost reduction actions, as well as a renewed focus on innovation and new product development, will provide fuel for reinvestment and an improved growth trajectory for the long-term. During 2023, we were able to restore the Company’s margin profile and strengthen the balance sheet despite a slow demand environment. Our preliminary results indicate that we ended the year with reported sales and cash flows above our previously communicated outlook. I remain confident in the long-term growth prospects of the Company given our geographically diverse operating platform and our collection of leading brands” said ACCO Brands’ President and Chief Executive Officer, Tom Tedford.

The Company will operate and report under two segments. The Americas reportable segment will include the U.S., Canada, Brazil, Mexico and Chile and the International reportable segment will include EMEA, Australia, New Zealand and Asia. The Company will report on this basis for the fiscal year commencing January 1, 2024.

As a result of the segment realignment, effective January 1, 2024, Cezary Monko has been appointed Executive Vice President and President of the International segment and Patrick Buchenroth, has been appointed Executive Vice President and President of the Americas segment. These leaders have a long-established, successful history with the Company.

The Company will provide additional details about the restructuring program during its upcoming fourth quarter and full year 2023 earnings call.

About ACCO Brands Corporation

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

Forward-Looking Statements

Statements contained in this press release, other than statements of historical fact, particularly statements relating to cost reductions and the anticipated pre-tax savings from the cost reduction program, restructuring costs, footprint rationalization, simplifying and streamlining our operations, reducing complexity, enhancing the speed of decision-making, leveraging our sourcing capabilities and the timing of implementation and completion of the cost reduction program, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the beliefs and assumptions of management based on information available to us at the time such statements are made. These statements, which are generally identifiable by the use of the words “will,” “believe,” “expect,” “intend,” “anticipate,” “estimate,” “forecast,” “project,” “plan,” and similar expressions, are subject to certain risks and uncertainties, are made as of the date hereof, and we undertake no duty or obligation to update them. Forward-looking statements are subject to the occurrence of many events outside the company’s control and actual results and the timing of events may differ materially from those suggested or implied by such forward-looking statements due to numerous factors that involve substantial known and unknown risks and uncertainties.

Factors that could affect our results or cause our plans, actions and results to differ materially from current expectations described in this press release include, among others, our ability to successfully execute the actions identified as part of the cost reduction program and realize the anticipated cost savings and operational synergies as well as other risks and uncertainties described in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and in other reports we file with the SEC. Forward-looking statements should be considered in light of these risks and uncertainties. Investors and others are cautioned not to place undue reliance on forward-looking statements when deciding whether to buy, sell or hold the company’s securities.

Christopher McGinnis
Investor Relations
(847) 796-4320

Kori Reed
Media Relations
(224) 501-0406

Source: ACCO Brands Corporation

Release – Gray Announces Proposed Refinancing of Senior Credit Facilities, Updates Guidance for Fourth Quarter 2023, and Announces Anticipated Proceeds from Sale of BMI

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GTN

January 30, 2024 06:45 ET

ATLANTA, Jan. 30, 2024 (GLOBE NEWSWIRE) — Gray Television, Inc. (“Gray,” “we,” “us” or “our”) (NYSE: GTN) announced today that it is proposing, subject to market and other conditions, to refinance certain of its existing senior credit facilities (the “Senior Credit Facilities”). Gray also announced updates to certain of its previously announced guidance for the fourth quarter of 2023, based on preliminary information available to date.

Refinancing. Today, Gray commenced a process through which it expects to amend certain terms of its $1.19 billion term loan and $500 million revolving credit facility due 2026, including extending the maturity of its $1.19 billion term loan from January 2026 to July 2029 and its $500 million revolving credit facility from January 2026 to December 2027. We cannot provide any assurance about the timing, terms, or interest rate associated with the planned financing, or that the financing transactions will be completed.

Updated Guidance. Gray initially issued guidance for fourth quarter 2023 on November 8, 2023. While Gray is continuing the process of finalizing its financial results for the fourth quarter of 2023, Gray provides the following updates to its guidance on its estimated results of operations representing the most current information and estimates available to Gray as of the date of this release.

As of December 31, 2023, we currently expect to report approximately:

  • $21 million of cash on hand
  • $2,660 million principal amount of secured debt; and
  • $6,210 million principal amount of total debt (excluding unamortized deferred financing costs and premium). 

We currently anticipate that we will record a pre-tax, non-cash impairment of $21 million for certain investments made prior to calendar year 2023. In addition, we anticipate that our total leverage ratio, as defined under our Senior Credit Facility, measured on a trailing eight quarter basis, netting all cash on hand, and giving pro forma effect for all acquisitions completed through the date of this release, will be between 5.60 times and 5.65 times as of December 31, 2023.

We have not yet completed our normal financial closing and review process; therefore, these estimates are subject to change upon finalization. As a result, our actual results may be different and such differences could be material. Investors should exercise caution in relying on the information contained herein and should not draw any inferences from this information regarding financial or operating data that is not presented below.

Anticipated BMI Proceeds. We expect to receive approximately $110 million in pre-tax cash proceeds upon the closing of the previously announced sale of Broadcast Music, Inc. (“BMI”) to a shareholder group led by New Mountain Capital, LLC. Gray’s equity ownership in BMI began decades ago and has increased through various acquisitions of other broadcast stations and companies over the years. We understand that BMI’s sale remains subject to customary regulatory and other approvals and is currently expected to close by the end of the first quarter 2024. We intend to use the proceeds for general corporate purposes, which may include the repayment of debt. 

About Gray:

Gray Television, Inc. is a multimedia company headquartered in Atlanta, Georgia. Gray is the nation’s largest owner of top-rated local television stations and digital assets in the United States. Its television stations serve 113 television markets that collectively reach approximately 36 percent of US television households. This portfolio includes 80 markets with the top-rated television station and 102 markets with the first and/or second highest rated television station. Gray also owns video program companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, as well as the studio production facilities Assembly Atlanta and Third Rail Studios. Gray owns a majority interest in Swirl Films. For more information, please visit www.gray.tv.

Cautionary Statements for Purposes of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act

This press release contains certain forward-looking statements that are based largely on Gray’s current expectations and reflect various estimates and assumptions by Gray. These statements are statements other than those of historical fact, and may be identified by words such as “estimates,” “expect,” “anticipate,” “will,” “implied,” “assume” and similar expressions. Forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such forward-looking statements. Such risks, trends and uncertainties, which in some instances are beyond Gray’s control, include Gray’s current expectations and beliefs of operating results for the fourth quarter of 2023 or other periods, Gray’s ability to complete its proposed refinancing of its Credit Facilities and receive the anticipated proceeds from the sale of BMI, on the terms and within the timeframe currently contemplated, and other future events. Gray is subject to additional risks and uncertainties described in Gray’s quarterly and annual reports filed with the Securities and Exchange Commission from time to time, including in the “Risk Factors,” and management’s discussion and analysis of financial condition and results of operations sections contained therein, which reports are made publicly available via its website, www.gray.tv. Any forward-looking statements in this communication should be evaluated in light of these important risk factors. This press release reflects management’s views as of the date hereof. Except to the extent required by applicable law, Gray undertakes no obligation to update or revise any information contained in this communication beyond the date hereof, whether as a result of new information, future events or otherwise.

Gray Contacts:

Jim Ryan, Executive Vice President and Chief Financial Officer, 404-504-9828
Kevin P. Latek, Executive Vice President, Chief Legal and Development Officer, 404-266-8333

Release – The ODP Corporation Provides Leadership Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ODP

The ODP Corporation Provides Leadership Update

Gerry Smith to Return from Temporary Medical Leave and Resume CEO Role on February 1

David Szymanski, Long-Time Member of ODP’s Board of Directors, to Retire from the Board on February 13

BOCA RATON, Fla.–(BUSINESS WIRE)–Jan. 29, 2024– The ODP Corporation (“ODP” or the “Company”) (NASDAQ:ODP), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, today announced that, following his temporary medical leave, Mr. Gerry Smith will resume his position as Chief Executive Officer (“CEO”), effective February 1, 2024. Upon Mr. Smith’s return, Mr. Joseph S. Vassalluzzo, who had been appointed by the Company’s Board of Directors to assume Mr. Smith’s authority and responsibilities during his medical leave, will return to his sole role as independent non-executive Chairman of the Board.

Mr. Smith said, “I would like to thank everyone for the support they showed during my leave, and especially to Joe for stepping in and leading the Company during my absence. I am very excited about returning to the helm, and eager to continue driving our corporate transformation and maximizing value for our stakeholders.”

In addition, Dr. David Szymanski, a member of ODP’s Board of Directors, notified the Company of his intention to retire from the Board, with his resignation effective February 13, 2024. Dr. Szymanski has served as a director of the Company and its predecessor, OfficeMax Incorporated, since 2004.

Mr. Vassalluzzo said, “On behalf of the Board and the Company, I would like to thank David for his long, dedicated service to ODP. He has been a valued member of the Board with his extensive retail experience, and as he retires from the Board, we wish him well in his future pursuits.”

Dr. Szymanski said, “It has been a pleasure for me to serve on ODP’s Board over the last decade. With the Company well positioned for future growth, and supported by an exceptional leadership team, I feel that now is the right time for me to step aside and provide others with the opportunity to participate and contribute to this great company as it moves forward.”

About The ODP Corporation

The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omni-channel presence, which includes supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence, and a network of Office Depot and OfficeMax retail stores. Through its operating companies ODP Business Solutions, LLC; Office Depot, LLC; Veyer, LLC; and Varis, Inc, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.

ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. ©2023 Office Depot, LLC. All rights reserved. Any other product or company names mentioned herein are the trademarks of their respective owners.

Forward Looking Statements

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements or disclosures may discuss goals, intentions and expectations as to future trends, plans, events, results of operations, cash flow or financial condition, the potential impacts on our business due to the unknown severity and duration of the COVID-19 pandemic, or state other information relating to, among other things, the Company, based on current beliefs and assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “expectations”, “outlook,” “intend,” “may,” “possible,” “potential,” “predict,” “project,” “propose” or other similar words, phrases or expressions, or other variations of such words. These forward-looking statements are subject to various risks and uncertainties, many of which are outside of the Company’s control. There can be no assurances that the Company will realize these expectations or that these beliefs will prove correct, and therefore investors and stakeholders should not place undue reliance on such statements.

Factors that could cause actual results to differ materially from those in the forward-looking statements include, among other things, highly competitive office products market and failure to differentiate the Company from other office supply resellers or respond to decline in general office supplies sales or to shifting consumer demands; competitive pressures on the Company’s sales and pricing; the risk that the Company is unable to transform the business into a service-driven, B2B platform that such a strategy will not result in the benefits anticipated; the risk that the Company will not be able to achieve the expected benefits of its strategic plans, including its strategic shift to maintain all of its businesses under common ownership; the risk that the Company may not be able to realize the anticipated benefits of acquisitions due to unforeseen liabilities, future capital expenditures, expenses, indebtedness and the unanticipated loss of key customers or the inability to achieve expected revenues, synergies, cost savings or financial performance; the risk that the Company is unable to successfully maintain a relevant omni-channel experience for its customers; the risk that the Company is unable to execute the Maximize B2B Restructuring Plan successfully or that such plan will not result in the benefits anticipated; failure to effectively manage the Company’s real estate portfolio; loss of business with government entities, purchasing consortiums, and sole-or limited-source distribution arrangements; failure to attract and retain qualified personnel, including employees in stores, service centers, distribution centers, field and corporate offices and executive management, and the inability to keep supply of skills and resources in balance with customer demand; failure to execute effective advertising efforts and maintain the Company’s reputation and brand at a high level; disruptions in computer systems, including delivery of technology services; breach of information technology systems affecting reputation, business partner and customer relationships and operations and resulting in high costs and lost revenue; unanticipated downturns in business relationships with customers or terms with the suppliers, third-party vendors and business partners; disruption of global sourcing activities, evolving foreign trade policy (including tariffs imposed on certain foreign made goods); exclusive Office Depot branded products are subject to additional product, supply chain and legal risks; product safety and quality concerns of manufacturers’ branded products and services and Office Depot private branded products; covenants in the credit facility; general disruption in the credit markets; incurrence of significant impairment charges; retained responsibility for liabilities of acquired companies; fluctuation in quarterly operating results due to seasonality of the Company’s business; changes in tax laws in jurisdictions where the Company operates; increases in wage and benefit costs and changes in labor regulations; changes in the regulatory environment, legal compliance risks and violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws; volatility in the Company’s common stock price; changes in or the elimination of the payment of cash dividends on Company common stock; macroeconomic conditions such as higher interest rates and future declines in business or consumer spending; increases in fuel and other commodity prices and the cost of material, energy and other production costs, or unexpected costs that cannot be recouped in product pricing; unexpected claims, charges, litigation, dispute resolutions or settlement expenses; catastrophic events, including the impact of weather events on the Company’s business; the discouragement of lawsuits by shareholders against the Company and its directors and officers as a result of the exclusive forum selection of the Court of Chancery, the federal district court for the District of Delaware or other Delaware state courts by the Company as the sole and exclusive forum for such lawsuits; and the impact of the COVID-19 pandemic on the Company’s business. The foregoing list of factors is not exhaustive. Investors and shareholders should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to update or revise any forward-looking statements.

Tim Perrott
Investor Relations
561-438-4629
Tim.Perrott@theodpcorp.com

Source: The ODP Corporation