Month: August 2023

Release – PDS Biotechnology Announces Conference Call and Webcast for Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that the Company will release financial results for the second quarter of 2023 on Monday, August 14, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

Monday, August 14, 2023, 8:00 AM ET 
Domestic: 877-407-3088
International: 201-389-0927
Conference ID: 13739270 
Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology 
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com 

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com   

Eric Reiss
Phone: +1 (802) 249-1136
ereiss@tiberend.com

Different Impacts of Gasoline Price Volatility on Industries

Posted on by phoffman@channelchek.com

Industries are Impacted in Multiple Ways by Rising Gas Prices

High gas prices have again become a consideration when planning a roadtrip. The rollercoaster ride of very highs, then lows, and back again to highs, since the beginning of the decade has been numbing.  The uncertainty of changing costs from one season to another has made it difficult for both businesses to plan, and for any individual driver, it all impacts decisions well beyond your weekend getaway.

Over the years, the price at the pump was driven up from factors such as geopolitical tensions, storms including hurricanes, a flood in Mississippi, and normal heightened demand during the summer driving season. On an individual level, increased gasoline costs translate to less disposable income for other necessities and luxuries. But, from an investor standpoint, the ramifications of soaring gas prices reach far beyond the service station, it deeply affect the broader economy and industry segments.

Conversely, plummeting gas prices mean lighter expenditures for households and businesses alike, relieving financial strains on transport-centric sectors such as airlines and trucking. However, these price drops also cast a shadow on some industries, especially the oil sector.

Below we highlight the direct and indirect adverse repercussions of high gas prices.

The Economic Ripples of Gas Prices

Employment

Job growth serves as a pivotal indicator of an economy’s recovery, and economists warn that surging gas prices could undermine hiring practices. Gas prices might prompt businesses to rethink their hiring plans, leading to a temporary hold as uncertainty about the economy’s well-being unfolds. Decreased discretionary spending and sales can influence a company’s hiring capacity.

Retailers

An indirect effect of soaring gas prices is a reduction in consumer discretionary spending due to a larger share of income being budgeted toward gasoline. Higher prices also induce consumers to drive less, even to places like malls and shopping centers. This is substantiated by both academic and industry studies, showing a direct correlation between driving miles and gas prices.

While shoppers might cut back on driving, they tend to increase online shopping when gas prices climb. Searches for online shopping surge in tandem with escalating gas prices.

Nonetheless, all retailers face added pressure to pass on the increased expenses they incur, particularly in shipping costs to consumers. Anything requiring transportation, from lumber to electronics, could incur higher costs due to surging gas prices. This holds true for products manufactured overseas or components sourced internationally. Moreover, products containing petroleum-derived materials or plastics also experience price hikes.

Auto Industry

Historically, the automobile industry responds to surging gas prices by producing smaller, more fuel-efficient vehicles, such as hybrids and all-electric cars capable of traveling long distances on a single charge. Consumers have shown robust support for this shift, evident from the upward trajectory of hybrid and all-electric vehicle sales in the United States since 2010, while sales of gas-guzzling trucks and SUVs lag.

Airlines

Fuel expenses are the single largest operational costs for airlines, constituting a substantial proportion of their overhead. Hence, fluctuations in oil prices significantly impact their bottom line. With rising gas prices, airlines are compelled to hike ticket prices, potentially discouraging non-essential air travel and burdening consumers financially.

To hedge against volatile oil costs, airlines often engage in fuel hedging, buying or selling expected future oil prices through various investment products. This strategy safeguards airlines from surging prices and sometimes even capitalizes on them.

New Jobs and Freelancers

Prospective job candidates must factor in commuting costs when evaluating potential positions. Some workers have had to decline job offers due to the exorbitant costs of commuting, consuming a significant chunk of their salary. Freelancers, most directly Uber and Lyft drivers,  also feel the impact of higher gas prices, limiting their geographical scope of business as commuting expenses render some gigs unprofitable.

Take Away

Rising gas prices usually parallel a growing pessimism about the economy. While economists and analysts may debate the precise degree to which gas prices affect the economy, there undeniably exists a connection between consumer confidence, spending behaviors, and gas prices. This mood and actual level of sales have an impact on stock market activity, depending on how long fuel prices are expected to stay high (or low).

Paul Hoffman

Managing Editor, Channelchek

Release – Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 07, 2023 7:00am EDT

Topline Results Expected Third Quarter 2023

Long COVID Afflicts Approximately 19% of Patients Following COVID-191, and is Expected to be a Global Health Burden

Fibromyalgia-Type Long COVID with Multi-Site Pain Affects Approximately 40% of Long COVID Patients

CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID. Topline results for the PREVAIL study are expected in the third quarter of 2023.

“Approximately 40% of U.S. Long COVID patients have fibromyalgia-like multi-site pain symptoms based on our observational studies of Long COVID patients from the TriNetX claims database,”2,3 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In addition to multi-site pain, these individuals often suffer from one or more other symptoms typically associated with fibromyalgia such as fatigue, sleep disturbance, and brain fog. We have termed this subgroup, ‘Fibromyalgia-type Long COVID.’ Given our encouraging results with TNX-102 SL as a potential treatment for fibromyalgia4, we are testing TNX-102 SL as a bedtime medicine for the management of Fibromyalgia-type Long COVID. In completing this clinical milestone, marked by the last enrolled patient finishing their final visit, we can now begin to look forward to topline results from the 63-patient PREVAIL study later this quarter.”

Dr. Lederman continued, “TNX-102 SL improves sleep quality in fibromyalgia, and we believe this is the mechanism by which TNX-102 SL improves other symptoms, like multi-site pain.5 Recently, the U.S. National Institutes of Health (NIH) has identified improving sleep quality as a target for potential therapeutics for Long COVID6,7,8, consistent with the proposed mechanism of TNX-102 SL.

“Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are also hallmarks of conditions like fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME),”9 said Herbert Harris, M.D., Ph.D., Executive Vice President and Head of Translational Medicine of Tonix Pharmaceuticals. “Defining subgroups of Long COVID patients that overlap with fibromyalgia and CFS/ME is expected to facilitate the development of new treatments.4 It can be challenging to distinguish fibromyalgia and CFS/ME clinically, given the high level of symptom overlap between them.  Each of these conditions is defined by a constellation of symptoms, and there is no widely recognized diagnostic laboratory test that distinguishes them.”

Dr. Harris continued, “The recent identification of Long COVID subgroups in the National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored RECOVER study10 was an important step. In their recent publication, cluster analysis of the symptom frequencies in the RECOVER study identified four subgroups of Long COVID patients. Cluster #4 represented approximately one-quarter of the population (28%) and reported the highest frequencies of pain (back pain (58%), joint pain (64%) or muscle pain (60%)), high frequencies of fatigue (94%) and ’Brain Fog,’ (94%) and a high level of impairment of Quality of Life. We believe Cluster #4 is a subgroup of Long COVID that shares many clinical features with fibromyalgia and may involve common disease mechanisms. We also believe that Cluster #3, representing another approximately 29% of the RECOVER cohort, includes many patients with fibromyalgia-type Long COVID because 100% of that group suffer from ‘Brain Fog’, 94% experience fatigue and approximately one-third experience pain (back pain (32%), joint pain (36%) or muscle pain (34%)).”

Dr. Harris concluded, “With no FDA approved treatment for Long COVID, we understand the need to better understand long COVID and to develop treatments for subgroups of this unserved population of patients. Fibromyalgia has been recognized by the U.S. Food and Drug Administration (FDA) with three approved medicines. Consequently, measuring daily pain is a validated endpoint for FDA registrational studies in fibromyalgia. We believe that daily pain has the potential to be an endpoint for registrational studies in fibromyalgia-like long COVID.”

About the Phase 2 PREVAIL Study

The Phase 2 PREVAIL study is a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-CoV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. The primary efficacy endpoint will be the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue, and cognitive function. Topline results are expected in the third quarter of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or Post-Acute Sequelae of COVID-19 (PASC)

Post-acute sequelae of COVID-19, or PASC is the formal name for a condition now widely known as Long COVID. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops a chronic syndrome called Long COVID.11 These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. According to the Centers for Disease Control and Prevention (CDC), 1 in 13 adults in the U.S. (7.5%) have Long COVID symptoms.1 Long COVID is typically associated with moderate or severe COVID-19, but can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. More than 40% of adults in the United States reported having COVID-19 in the past, and nearly one in five of those (19%) are currently still having symptoms of Long COVID.1 Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.12-15 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 202016 The U.S. Department of Health and Human Services National Research Action Plan on Long COVID17, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central and peripheral sensitization.18 A published survey19 found comparable pain, fatigue, and functional impairment between Long COVID, fibromyalgia, and CFS/ME. This symptom overlap between these conditions has suggested that altered neurologic function is one of the leading hypotheses to explain them.20 While the vaccines available in the U.S., through either FDA approval or under Emergency Use Authorization, have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID. Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be one of several chronic overlapping pain conditions that have in common the neurological process called central and peripheral sensitization, which is increasingly known by the term nociplastic pain.

About TNX-102 SL

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

*TNX-102 SL is an investigational new drug and is not approved for any indication

  1. NIH News Release. June 22, 2022. “Nearly One in Five American Adults Who Have Had COVID-19 Still Have ‘Long COVID’” https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm (accessed August 4, 2023).
  2. Tonix Pharmaceuticals Press Release. Feb 22, 2023. https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
  3. Harris, H. et al. Tonix data on file 2023
  4. Lederman S, et al. Arthritis Care Res (Hoboken). 2023
  5. Moldofsky H, et al. J Rheumatol. 2011. 38(12):2653-63
  6. NIH News Release. July 31, 2023. “NIH launches long COVID clinical trials through the RECOVER Initiative, opening enrollment.” https://www.nih.gov/news-events/news-releases/nih-launches-long-covid-clinical-trials-through-recover-initiative-opening-enrollment (accessed August 4, 2023).
  7. Howard, J. CNN. July 31, 2023. “Biden administration announces launch of HHS office focused on long Covid research” https://edition.cnn.com/2023/07/31/health/long-covid-research-office/index.html
  8. Johnson, M and Goldstein A. Washington Post. July 31, 2023. “NIH announces long covid treatment studies with hundreds of patients” www.washingtonpost.com/health/2023/07/31/long-covid-treatment-studies-nih/
  9. Clauw DJ, and Calabrese L. Ann Rheum Dis. 2023
  10. Thaweethai T, et al. JAMA. 2023. 329(22):1934-1946
  11. Clauw DJ, et al. Pain. 2020. 161(8):1694-1697
  12. Briggs, A, and Vassall, A. Nature. 2021. 593(7860): 502-505
  13. Nittas V, et al. Public Health Rev. 2022. 43:1604501
  14. Davis, HE., et al. EClinicalMedicine. 2021. 38:101019
  15. Martin C, et al. PLoS One. 2021. 16(12):e0260843
  16. The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.
  17. Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201. www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf
  18. Maixner W, et al. J Pain. 2016. 17(9 Suppl):T93-T107
  19. Haider S, et al. Pain. 2023. 164(2):385-401
  20. Sutherland, S. Scientific American. 2023

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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

Forward Looking Statements

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

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released August 7, 2023

Three Biotech Industry Challenges Investors Should Monitor

Posted on by phoffman@channelchek.com

Regulatory, Competitive, and Pricing Challenges That Analysts Believe Biopharma Will Face

Trends in biotech are changing, and if certain events play out, the field could become more challenging on three fronts, according to a new report from analysts from the biotech team at RBC Capital Markets. The report discusses advancements in science that could trump others currently in use or some nearing the end of pipelines, along with regulations that could alter scarcity and prices that stem from recent actions.

In its industry report released on August 4, RBC’s biotech team discussed how deep discounts may be dictated by government programs. It also details how new competition could arise for drugs now offered by Biogen (BIIB) and Incyte (INCY) companies. And also how improvements in public-health from new weight-loss drugs and from gene-editing treatments may reduce demand for other products.

Pricing Challenges

The Inflation Reduction Act in its current form will reduce the prices paid for drugs by federal programs like Medicare, the analysts warn. Mandatory discounts, which will rise from 25% to 60%, will phase in for covered medicines beginning at the ninth to 16th years on the market. Any increases in the prices charged to the government program Medicare would be capped at the inflation rate.

The mechanisms by which these pricing measures will be rolled out by the Centers for Medicare Services will become more clear later this year. On the positive side for the industry, RBC noted a number of biotech companies have asked federal courts to block the law enacted in 2022. And if Republicans win controlling seats in the House in the fall, or even the Executive Branch next year, this would increase the chances of a rollback of the federal pricing provisions.

Exclusivity Challenges

A separate issue is that a lapse of exclusivity protection could affect companies such as Biogen, says RBC. That company’s big-selling product Tysabri, a multiple sclerosis treatment brings in about $2 billion a year. But lower protections may cause it to face competition from a generic “biosimilar” version from the Sandoz unit of Novartis (NVS). Earlier this summer, a court denied Biogen’s request for a preliminary injunction that would have kept the Sandoz biosimilar off the market while Biogen would press a patent infringement claim. The RBC analysts see signs that the Food and Drug Administration (FDA) is gearing up to approve the Sandoz biosimilar. The analysts mentioned that any sales losses at Biogen could be offset by the successful growth of its new anti-Alzheimer’s treatments.

You’re Invited to Learn More About NobleCon19

Another exclusivity threat concerns the product Jakafi, which is a successful Incyte cancer and immune disorder drug, its annual sales could exceed $3.5 billion in the next few years. But the expiration of Jakafi’s patent protection in 2029 could bring a stream of generics it would compete with. This places the maker Incyte under pressure to develop products to extend its Jakafi franchise, says RBC.

Medical Success Challenges

The team at RBC writes that some welcome medical advances might prove so successful that they would reduce the need for other products. They gave examples that include the class of diabetes and obesity treatments known as GLP-1 drugs, which they expect are on their way to becoming enormous sellers for Novo Nordisk (NOVO) and Eli Lilly (ELI).

In addition to the dramatic weight loss achieved by the drugs, the GLP-1s may also become useful to reduce cardiovascular and liver disease. While the public health aspect would be cause to celebrate, investors should be cognizant that the prospects for other drugs sold to treat illnesses such as the liver disease called nonalcoholic steatohepatitis, or NASH, may get new competition.

Another promising breakthrough are gene-editing therapies, the one-time treatments that use the Nobel Prize-winning technology known as CRISPR to permanently blunt genetic illnesses.

Intellia Therapeutics (NTLA) and Verve Therapeutics (VERV) are testing such approaches as treatments for nerve and heart disorders that otherwise require continuing doses of medicines sold by other biotech companies. The RBC team says that the success of the one-shot editing therapies could trim the need for drugs that at present must be continually taken.

Take Away

Analysts don’t have a crystal ball, but investors do rely on their expertise to gain insight as to industry trends and individual company insights. There are many changes occurring in the biotech and biopharma space that could change the competitive landscape, some better for investors, some better for patients, and some even better for taxpayers and social security and Medicaid recipients.

Investors that wish to increase their knowledge of the industry and smaller innovative companies within the segment should explore the data and information in this section of Channelchek and dig even deeper into companies specifically covered by the industry analyst at Noble Capital Markets by using this link.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.rbccm.com/en/insights/industries-in-motion/podcast.page?dcr=templatedata/article/podcast/data/2021/09/how_biotech_breakthroughs_are_changing_healthcare

https://www.barrons.com/articles/biotech-stocks-changing-regulation-disruption-1b4b3ee

https://www.fiercebiotech.com/biotech/peter-marks-says-base-editing-could-be-incredible-game-changer

Gray Television (GTN) – Core Advertising Outshines The Industry

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

Gray Television is a multimedia company headquartered in Atlanta, Georgia. We are the nation’s largest owner of top-rated local television stations and digital assets in the United States. Our 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 100 markets with the first and/or second highest rated television station. We also own video program companies Raycom Sports, Tupelo Honey, PowerNation Studios and Third Rail Studios.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Solid Q2 results. The company reported Q2 revenue of $813 million, a tad better than our estimate of $802 million; adj. EBITDA in the quarter was $225 million, beating our estimate of $187 million by 20%. Q2 results are Illustrated in Figure #1 Results. Notably, Local and National core advertising revenues performed strongly, increasing in the low single-digits from the prior year period. Additionally, Political revenue in the quarter was a strong $12 million, beating our estimate of $6 million by 100%.

Positive momentum.  In our view, the company’s Local and National advertising growth was impressive, with many industry peers reporting declines. Notably, management highlighted that National and Local advertising are pacing up in Q3 as well. We believe the company has favorable operating momentum, given its resilient advertising revenues and expected influx of political revenue later this year and in 2024.


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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. 

E.W. Scripps (SSP) – A Temporary Hurdle

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Beats expectations. The company reported a solid second quarter, beating both our revenue and adj. EBITDA estimates. Total company revenues decreased a modest 2.0% to $582.8 million, versus our $572.5 million estimate. Combined with the revenue improvement and the lower expenses, adj. EBITDA of $120.9 million was well above our $90 million estimate. 

Is the worst behind us? The upside revenue variance was due to stronger than expected National Media revenues, $231.2 million versus our $217.0 million estimate. The latest results marked a sequential quarterly improvement from a Q1 decline of 9.5% to a more modest 3.2% decline in Q2. While Q3 guidance is not as hopeful, management indicated that scatter prices are improving for its Network business. 


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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. 

Information Services Group (III) – No Signs of Slowing Down

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.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.

Still Seeing Demand. ISG is continuing to experience increasing demand for its services, evidenced by the record second quarter revenue of $74.6 million. As noted in our previous report, recurring revenues now represents more than 40% of Company revenue and we anticipate the number to climb due to further demand from verticals such as consumer services, life sciences, and the public sector for the Company’s cost optimization services.

Balance Sheet. ISG reported a cash balance of $19.6 million as of June 30, 2023 compared to $23.7 million at March 31, 2023. The Company’s debt outstanding was at $79.2 million, unchanged from the first quarter, with the Company’s debt-to-EBITDA ratio remaining at 1.8x. 


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Haynes International (HAYN) – Third Quarter Earnings Were Modestly Above Our Expectations; Outlook Remains Favorable

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Third quarter financial results.  Haynes International reported third quarter fiscal 2023 net income of $8.8 million, or $0.68 per share compared to $15.6 million, or $1.24 per share, during the prior year period and $12.3 million, or $0.96 per share, during the prior quarter. We had forecast net income of $8.5 million or $0.67 per share. Revenues of $143.9 million increased 10.6% on a year-over-year basis but declined 5.8% compared to the prior quarter. A cybersecurity incident negatively impacted net revenues by an estimated $18 to $20 million. Lower production compressed gross margin and earnings were also impacted by costs associated with the investigation and restoration efforts. In total, the company estimates the impact of the event to be $0.40 to $0.45 per diluted share. Earnings were also negatively impacted by raw material fluctuations, primarily for cobalt, which resulted in a $0.09 per share impact.

Updating estimates. Management expects shipments, net revenues, and earnings during the fourth quarter to be the highest of the fiscal year. Anticipating a negative fourth quarter impact from fluctuations in raw materials prices, we have adjusted our 2023 EBITDA, net income, and EPS estimates to $82.0 million, $42.1 million, and $3.30 from $82.6, $43.2 million, and $3.40, respectively. We forecast 2024 EBITDA, net income, and EPS of $106.8 million, $59.1 million, and $4.65.


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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. 

Eagle Bulk Shipping (EGLE) – Eagle reports results slightly below expectations, goes all in on shipping improvement

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

Eagle Bulk Shipping Inc. (“Eagle”) is a US-based drybulk owner-operator focused on the Supramax/Ultramax mid-size asset class, which ranges from 50,000 and 65,000 deadweight tons in size; these vessels are equipped with onboard cranes allowing for the self-loading and unloading of cargoes, a feature which distinguishes them from the larger classes of drybulk vessels and provides for greatly enhanced flexibility and versatility- both with respect to cargo diversity and port accessibility. The Company transports a broad range of major and minor bulk cargoes around the world, including coal, grain, ore, pet coke, cement, and fertilizer. Eagle operates out of three offices, Stamford (headquarters), Singapore, and Hamburg, and performs all aspects of vessel management in-house including: commercial, operational, technical, and strategic.

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.

Eagle reported 2023-2Q results that were slightly below expectations. Top-line results were slightly above expectations on higher-than-expected TCE rates (increased premium to index prices), but higher TCE reveues were offset by higher than expected operating costs. Adjusted net income/EPS ($16.7m/$1.13) was above our estimate of $7.7m/$0.47, but that was due to an $11.6m gain on the sale of ships. Absent that gain, earnings would have been $5.2m or $0.32 per share.

Management is betting on the shipping market. During the quarter, the company upgraded its fleet by acquiring two scrubber-fitted ships and selling two non-scrubber ships. It also repurchased 3.8m shares (28% of outstanding) at a cost of $221 million and increased its borrowing capacity by $175m.


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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.

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Bit Digital, Inc. (BTBT) – July Production Up Sequentially

Posted on by cpereira@noblefcm.com


Monday, August 07, 2023

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.

July Production. In July, Bit Digital produced 133.0 BTC, up 12% from 119.1 BTC in June. The increase in production was primarily driven by a higher average active hash rate and was partially offset by an increase in network difficulty. The active hash rate was approximately 1.78 EH/s as of the end of the month, flat with the end of June.

Ethereum. The Company had approximately 12,708 ETH actively staked in native and liquid staking protocols as of July 31, 2023, up from 11,716 at the end of the prior month. Approximately 10,304 were natively staked and 2,404 ETH were deployed in liquid staking protocols. Additionally, Bit Digital had 576 ETH deposited but in queue to be activated on the Ethereum staking network. Bit Digital earned a blended APY of approximately 4.5% on its staked ETH position for the month.


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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. 

The Week Ahead –  Oil Prices, Consumer Prices, and Consumer Sentiment

Posted on by phoffman@channelchek.com

This Trading Week Markets Will See if CPI Confirms Decelerating Inflation

After last week’s employment figures came in lower than expectations, this week the potential catalyst for a shift in monetary policy is inflation measures. July Consumer Price Index (CPI) is scheduled for release on Thursday. The June report allowed for optimism that inflation was not only moving in a favorable direction but that a sustainable downward trajectory was emerging. However, the upcoming July figures might not live up to the market celebration that followed the previous CPI report. This is because rising energy costs are likely to contribute to an increase in the year-over-year all-items CPI rate. If the core CPI annual rate does not exhibit substantial progress in its declining trend, this could set the stage for another interest rate hike as early as the September 19-20 Federal Open Market Committee (FOMC) meeting.

Monday 8/7

•             3:00 AM ET, Consumer credit is expected to increase $14.1 billion in June versus a smaller-than-expected increase of $7.3 billion in May.

Tuesday 8/8

•             6:00 AM ET, The Small Business Optimism Index has been well below the historical average of 98 for 18 months in a row. July’s consensus is 91.5 versus 91.0 in June.

•             8:30 AM ET, An International Trade in Goods and Services deficit of $65.4 billion is expected in June for total goods and services trade. This would compare with a $69.0 billion deficit in May. Advance data on the goods side of June’s report showed a $4.0 billion narrowing in the deficit.

•             10:00 AM ET, Wholesale Inventories preliminary number (second estimate) is expected down 0.3 percent, unchanged from the first estimate.

Wednesday 8/9

•             10:30 AM ET,  The Energy Information Administration (EIA) provides weekly information on petroleum inventories in the US, whether produced here or abroad. The inventory level impacts prices for petroleum products.

Thursday 8/10

•             8:30 AM ET, The Consumer Price Index (CPI) is expected to rise 0.2 percent, which would match June. Annual rates, which in June were 3.0 percent overall and 4.8 percent for the core, are expected at 3.3 and 4.8 percent, respectively. Core prices in July are expected to hold steady at a modest monthly increase of 0.2 percent which would match June’s showing.

•             8:30 AM ET, Jobless Claims for the August 5 week are expected to come in at 230,000 versus 227,000 in the prior week, which was 6,000 higher than expected.

•             4:30 AM ET, The Fed’s Balance Sheet is expected to have decreased by $36.580 to $8.207 trillion. Market participants and Fed watchers look to this weekly set of numbers to determine, among other things if the Fed is on track with its stated quantitative tightening (QT) plan.

Friday 8/11

•             8:30 AM ET, Producer Prices in July are expected to have risen 0.2 percent on the month versus a 0.1 percent increase in June. The annual rate in July is seen as rising 0.7 percent versus June’s gain. July’s ex-food and ex-energy rate is seen at 0.2 percent on the month and 2.3 percent on the year versus June’s 0.1 percent on the month and 2.4 percent yearly rate.

•             10:00 AM ET, Consumer Sentiment in August, which in July jumped more than 7 points to 71.6, is expected to edge back .3 to 71.3.

What Else

Crude Oil futures rose to around $83 per barrel, hovering at the highest levels in four months. The main reason is the Saudi Arabia and Russia’s announcement that they would extend voluntary supply cuts through next month to bolster oil prices. Saudi Arabia said on Thursday it would extend its 1 million barrels per day production cut for another month, while Russia said it will also reduce its oil exports by 300,000 bpd in September. Saudi Arabia also said its production cuts could be extended beyond September or deepened, catching markets off guard.

Most industries are impacted by energy prices, we whether it is all conasumer prices, or core, crude oil trading impacts consumer prices.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/newsevents/calendar.htm

https://us.econoday.com/byweek.asp?cust=us

Orion Group Holdings (ORN) – Some Good Contract News

Posted on by cpereira@noblefcm.com


Friday, August 04, 2023

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 Awards. Orion has been the recipient of two significant awards from the Army Corps of Engineers in the last two days, according to the DoD. Together, the new awards represent some $58 million of new dredging business, which typically has had an outsized impact on profit. We are encouraged by the recent awards and are hopeful proposal and award activity from the Corps ramps up to more historic levels.

Contract One. Last night, the DoD, in its daily contract awards press release, noted that Orion Marine Construction Inc., Tampa, Florida, was awarded a $40 million firm-fixed-price contract for Atchafalaya Basin, Gulf Intracoastal Waterway dredging. Work locations and funding will be determined with each order, with an estimated completion date of July 27, 2025. 


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Maple Gold Mines (MGMLF) – A Significant Discovery in the Making?

Posted on by cpereira@noblefcm.com


Friday, August 04, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Douay first phase deep drilling program. Maple Gold Mines released complete gold assay results from the first phase of deep drilling at the Douay Gold Project which is held in a 50/50 joint venture between the company and Agnico Eagle Mines Limited (NYSE: AEM). During the first half of 2023, the joint venture completed a total of 5,793 meters of drilling in three new holes and two extension holes. The deep drilling program is intended to test the potential for a much larger gold system at Douay while demonstrating continuity of mineralization beneath the currently defined mineral resource.

All five drill holes intersected gold mineralization. All five drill holes intersected gold mineralization greater than 1 gram of gold per tonne, with 10 intercepts greater than 2.5 grams of gold per tonne and several broad low-grade intervals averaging 0.1 to 0.3 grams of gold per tonne. The drilling affirmed the continuity of the gold system down to at least approximately 1,600 meters vertical depth or up to four times deeper than Douay’s currently defined mineral resources.


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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.