Page 327 – Channelchek

Kratos Defense & Security (KTOS) – Reports Second Quarter Results

Posted on August 8, 2023August 8, 2023 by cpereira@noblefcm.com

Tuesday, August 08, 2023

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.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.

2Q23 Results. Results came in above expectations. Revenue totaled $256.9 million, up 14.6% y-o-y. Adjusted EBITDA came in at $21.6 million, up from $17.7 million in 2Q22. GAAP EPS loss was $0.02 and adjusted EPS was $0.09, compared to a EPS loss of $0.04 and adjusted EPS of $0.07, respectively, a year ago. We had forecasted $235 million, $16.5 million, $(0.03), and $0.06, respectively.

Solid Organic Growth In KGS. The Government Solutions Segment saw overall revenue increase 22.1% to $204.8 million. Organic growth for KGS grew 17.1% in the quarter, with organic growth across all businesses within KGS and notable increases in the Space and Satellite, Turbine Technologies, Microwave products, and C5ISR units.

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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 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.

Gray Television (GTN) – Leading The Industry

Posted on August 8, 2023August 8, 2023 by cpereira@noblefcm.com

Tuesday, August 08, 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.

Patrick McCann, CFA, Research Analyst, 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, better than our estimate of $802 million; adj. EBITDA in the quarter was $225 million, beating our estimate of $187 million by 20%. Notably, Local and National core advertising revenues performed strongly, increasing in the low single-digits from the prior year period.

Positive momentum. In our view, the company’s Local and National core 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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This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Energy Fuels (UUUU) – Progress one quarter at a time

Posted on August 8, 2023August 8, 2023 by cpereira@noblefcm.com

Tuesday, August 08, 2023

Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. Energy Fuels also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up commercial-scale production of REE carbonate. Its corporate offices are in Lakewood, Colorado, near Denver, and all its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch in-situ recovery (“ISR”) Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, has the ability to produce vanadium when market conditions warrant, as well as REE carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also on standby and has a licensed capacity of 1.5 million pounds of U3O8 per year. In addition to the above production facilities, Energy Fuels also has one of the largest NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.

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.

Energy Fuels reported 2023-2Q results in line with expectations as rare earth element carbonite sales expand. Uranium sales to a major nuclear utility kicked in and rare earth carbonate sales accelerated. Of note, uranium sales were done at an operating cost of $26.40/lb. below the price in our models. Also notable was an increase in REE sales after several quarters of sales being limited by monzanite supply issues.

With sales still in the early stages, operating line items were fairly predictable. Of course, the Energy Fuel story has never been about near-term results. Instead, the stock moves on corporate developments. And, while there have been some setbacks (REE supply issues, share dilution, foreign uranium supply competition), the company has made steady progress in recent quarters towards its goals.

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

CoreCivic, Inc. (CXW) – 2Q23 In Line With Our Expectations

Posted on August 8, 2023August 8, 2023 by cpereira@noblefcm.com

Tuesday, August 08, 2023

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

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

2Q23 Results. Total revenue of $463.7 million, better than our $463.1 million estimate, and up from $456.7 million last year. Adjusted EBITDA of $72.1 million compared to $78.8 million last year and our $73.2 million projection. Net income of $14.8 million, or EPS of $0.13, compared to $10.6 million, or EPS of $0.09, last year. We had forecast net income of $14.4 million, or $0.13 per share.

ICE, ICE Baby. The expiration of COVID related regulations in May has resulted in a 45% increase in ICE populations at CoreCivic facilities through July 31st. We would anticipate ICE populations to increase further as the border situations remains volatile, although politics make predictions challenging.

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

AI Model Can Help Determine Where a Patient’s Cancer Arose

Posted on August 8, 2023August 8, 2023 by phoffman@channelchek.com

Prediction Model Could Enable Targeted Treatments for Difficult Tumors

Anne Trafton | MIT News

For a small percentage of cancer patients, doctors are unable to determine where their cancer originated. This makes it much more difficult to choose a treatment for those patients, because many cancer drugs are typically developed for specific cancer types.

A new approach developed by researchers at MIT and Dana-Farber Cancer Institute may make it easier to identify the sites of origin for those enigmatic cancers. Using machine learning, the researchers created a computational model that can analyze the sequence of about 400 genes and use that information to predict where a given tumor originated in the body.

Using this model, the researchers showed that they could accurately classify at least 40 percent of tumors of unknown origin with high confidence, in a dataset of about 900 patients. This approach enabled a 2.2-fold increase in the number of patients who could have been eligible for a genomically guided, targeted treatment, based on where their cancer originated.

“That was the most important finding in our paper, that this model could be potentially used to aid treatment decisions, guiding doctors toward personalized treatments for patients with cancers of unknown primary origin,” says Intae Moon, an MIT graduate student in electrical engineering and computer science who is the lead author of the new study.

Mysterious Origins

In 3 to 5 percent of cancer patients, particularly in cases where tumors have metastasized throughout the body, oncologists don’t have an easy way to determine where the cancer originated. These tumors are classified as cancers of unknown primary (CUP).

This lack of knowledge often prevents doctors from being able to give patients “precision” drugs, which are typically approved for specific cancer types where they are known to work. These targeted treatments tend to be more effective and have fewer side effects than treatments that are used for a broad spectrum of cancers, which are commonly prescribed to CUP patients.

“A sizeable number of individuals develop these cancers of unknown primary every year, and because most therapies are approved in a site-specific way, where you have to know the primary site to deploy them, they have very limited treatment options,” Gusev says.

Moon, an affiliate of the Computer Science and Artificial Intelligence Laboratory who is co-advised by Gusev, decided to analyze genetic data that is routinely collected at Dana-Farber to see if it could be used to predict cancer type. The data consist of genetic sequences for about 400 genes that are often mutated in cancer. The researchers trained a machine-learning model on data from nearly 30,000 patients who had been diagnosed with one of 22 known cancer types. That set of data included patients from Memorial Sloan Kettering Cancer Center and Vanderbilt-Ingram Cancer Center, as well as Dana-Farber.

The researchers then tested the resulting model on about 7,000 tumors that it hadn’t seen before, but whose site of origin was known. The model, which the researchers named OncoNPC, was able to predict their origins with about 80 percent accuracy. For tumors with high-confidence predictions, which constituted about 65 percent of the total, its accuracy rose to roughly 95 percent.

After those encouraging results, the researchers used the model to analyze a set of about 900 tumors from patients with CUP, which were all from Dana-Farber. They found that for 40 percent of these tumors, the model was able to make high-confidence predictions.

The researchers then compared the model’s predictions with an analysis of the germline, or inherited, mutations in a subset of tumors with available data, which can reveal whether the patients have a genetic predisposition to develop a particular type of cancer. The researchers found that the model’s predictions were much more likely to match the type of cancer most strongly predicted by the germline mutations than any other type of cancer.

Guiding Drug Decisions

To further validate the model’s predictions, the researchers compared data on the CUP patients’ survival time with the typical prognosis for the type of cancer that the model predicted. They found that CUP patients who were predicted to have cancer with a poor prognosis, such as pancreatic cancer, showed correspondingly shorter survival times. Meanwhile, CUP patients who were predicted to have cancers that typically have better prognoses, such as neuroendocrine tumors, had longer survival times.

Another indication that the model’s predictions could be useful came from looking at the types of treatments that CUP patients analyzed in the study had received. About 10 percent of these patients had received a targeted treatment, based on their oncologists’ best guess about where their cancer had originated. Among those patients, those who received a treatment consistent with the type of cancer that the model predicted for them fared better than patients who received a treatment typically given for a different type of cancer than what the model predicted for them.

Using this model, the researchers also identified an additional 15 percent of patients (2.2-fold increase) who could have received an existing targeted treatment, if their cancer type had been known. Instead, those patients ended up receiving more general chemotherapy drugs.

“That potentially makes these findings more clinically actionable because we’re not requiring a new drug to be approved. What we’re saying is that this population can now be eligible for precision treatments that already exist,” Gusev says.

The researchers now hope to expand their model to include other types of data, such as pathology images and radiology images, to provide a more comprehensive prediction using multiple data modalities. This would also provide the model with a comprehensive perspective of tumors, enabling it to predict not just the type of tumor and patient outcome, but potentially even the optimal treatment.

Alexander Gusev, an associate professor of medicine at Harvard Medical School and Dana-Farber Cancer Institute, is the senior author of the paper, which appeared on August 7, 2023, in Nature Medicine.

Reprinted with permission from MIT News ( http://news.mit.edu/ )

Antitode for a Potential Indexed Fund Bubble?

Posted on August 8, 2023August 8, 2023 by phoffman@channelchek.com

Equity Research Allows Investors to More Confidently Step Away from the Growing Index Valuations

Hedge Fund Managers Michael Burry and Bill Ackman have expressed deep concern over indexed funds for a years and for different reasons. Burry primarily fears a bubble growing, and Ackman agrees but also fears investors are giving away control to parties that may not have their best interests at heart. Both make understandable cases. Below we discuss the overall concerns and how an individual investor who shares their concerns may “hedge” their portfolio against these risks.

Michael Burry

“The bubble in passive investing through ETFs and index funds as well as the trend to very large size among asset managers has orphaned smaller value-type securities globally,” Michael Burry told Bloomberg News in August of 2019. “Orphaned” presumably refers to a lack of attention now paid to this market segment.

Burry’s concerns centered around the idea that the rise of passive investing could lead to distortions in the stock market. He believed that as more and more investors put their money into indexed funds, the valuations of the companies included in those indices might become disconnected from their underlying fundamentals as fund managers were required to own the index at the established weighting. In his view, this could create a bubble-like situation where certain stocks are overvalued due to indiscriminate buying driven by the popularity of index funds.

While many view this hedge fund manager, made most famous by the movie The Big Short, as a pessimist, it is easy to think of him as an optimist finding opportunity, even where there could be trouble.

As he discussed then, the rush into indexed funds has punished small cap value stocks. Burry also highlighted, “There is all this opportunity, but so few active managers.”

Bill Ackman

“We believe that it is axiomatic that while capital flows will drive market values in the short term, valuations will drive market values over the long term. As a result, large and growing inflows to index funds, coupled with their market-cap driven allocation policies, drive index component valuations upwards and reduce their potential long-term rates of return,” according to Bill Ackman in a statement which agrees with Burry’s thoughts. Bull Bill Ackman also sees another risk.

In a letter to shareholders earlier this year, the activist investor, and big boss at Pershing Square Capital, made the point that the passive funds not only follow indexes but encourage active managers to stay close to the index where investors pay for active management, but get index-like results because the fund company fears shareholder reaction if returns deviates sharply from the index benchmark.

More telling is Ackaman’s fear of proxy votes and other governance taken out the hands of the masses and bestowed on so few. Ackman believes that passive managers like Vanguard, BlackRock, and State Street hurt investors by concentrating corporate power in a small group of players “who get larger by the minute.” With 20% or more of fund flows headed to an indexed fund or ETF, Ackman wonders who will “look out for one another’s interests?”

Actively Managed and Self-Directed Investing

The Nasdaq 100 index just reorganized in order to lessen potential risks to being overweighted in a few stocks. Surrounding this event and through the years there has been no shortage of discussion around index bubbles and why some see indexes as an eventual train wreck:

“Is There an Index Fund Bubble?” (Bloomberg, September 4, 2019)

“The Index Fund Bubble Is Coming” (The Motley Fool, January 23, 2020)

“Is the Index Fund Bubble About to Burst?” (Investopedia, March 11, 2021)

“The Index Fund Bubble Is Real, and It’s Going to Burst” (MarketWatch, April 20, 2022)

“The Index Fund Bubble Is Even Bigger Than You Think” (Barron’s, May 23, 2023)

And there is also fear in the consolidation of power into the hands of a few fund companies that could impact all of us more subtly.

While index fund investing is growing in popularity and has been rewarding, investors can prepare by scaling down these investments and making their own selections, weighting their portfolio in a way that makes more sense in light of the risks to them. This could include seeking managed funds with a manager that has a good track record over the years, but it also may mean adding stocks that are not well represented in major indexes. Investors like to use Morningstar for fund selection, for stocks information including excellent research on what Burry termed “small-cap value stocks,” and other small and microcap offerings is likely found on Channelchek.

The Forgotten Benefits of Equity Research

Informed stock market investors read equity research reports for several reasons:

Informed Decision-Making: Equity research reports provide detailed analysis and insights about a company’s financial performance, industry trends, competitive landscape, and growth prospects. Investors may save weeks putting together enough information to believe they understand an opportunity enough to make a decision.

Valuation Insights: Research reports will include valuation models that estimate a company’s intrinsic value. This can help investors understand whether a stock is overvalued, undervalued, or fairly priced, guiding their buy, sell, or hold decisions. Some research will actually provide an analyst’s price target.

Risk Assessment: Equity research reports assess the risks associated with an investment. This could include factors like regulatory changes, industry volatility, management quality, and financial stability. Understanding these risks helps investors manage their portfolios effectively.

Industry and Market Trends: Research reports not only focus on individual companies but also provide insights into broader industry trends and market dynamics. Investors can gain a better understanding of how macroeconomic factors might impact their investments.

Company Performance Analysis: Detailed financial analysis in these reports helps investors understand a company’s revenue streams, profit margins, debt levels, and growth potential. This information is crucial for evaluating a company’s overall financial health.

Competitive Landscape: Equity research reports often compare a company’s performance to its competitors. This analysis helps investors gauge a company’s competitive position within its industry.

Long-Term Investment Strategy: Investors with a long-term perspective can benefit from equity research by identifying companies with strong growth potential, sustainable competitive advantages, and solid management teams.

Industry Diversification: Research reports can make it easier for investors to diversify holdings by defining the category the company is in and even highlighting opportunities in various sectors or industries.

News Interpretation: Equity research reports can provide context and interpretation for press releases and other news including, earnings releases, and developments related to the company. This helps investors understand the potential impact on the stock price.

Investor Growth: For novice investors, equity research reports can provide valuable insights into how professionals analyze stocks and make investment decisions, enhancing their investment knowledge over time.

It’s important to note that equity research reports are typically produced by financial analysts working for brokerage firms, investment banks, or independent research firms. Investors should exercise critical thinking and compare and contrast multiple sources of information.

Take Away

Credible professional investors make the case that the surging assets in index funds are leading to a bubble. There is also concern that control is taken out of the hands of individuals and placed in the hands of a few large companies whose corporate interests may not match individual investor interests.

Taking back control of the management of one’s portfolio may seem daunting, but quality equity research is a tool that can serve to help the selection process while at the same time increasing the self-directed investors’ understanding of what is important to watch. Channelchek is a no-cost platform leading the way in North America, providing company-sponsored research on small and microcap stocks.

Individual stock investors may also wish to consider attending NobleCon19, in December. This investment conference is widely recognized as the place investors go to discover small emerging companies that they may act upon through their traditional brokerage account. Discover more about about NobleCon19 here.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.bloomberg.com/news/articles/2019-08-28/the-big-short-s-michael-burry-sees-a-bubble-in-passive-investing

https://www.harriman-house.com/press/full/2958#:~:text=%E2%80%9CIndex%20funds%20and%20other%20passive,is%20good%20reason%20for%20this.

https://www.marketwatch.com/story/bubble-in-passive-investing-offers-small-cap-opportunity-big-short-investor-says-2019-08-28

Release – Johnny Rockets Announces Twenty New Texas Locations

Posted on August 7, 2023August 7, 2023 by aweinsoff@channelchek.com

Research News and Market Data on FAT

AUGUST 07, 2023

DOWNLOAD PDFPDF FORMAT (OPENS IN NEW WINDOW)

Iconic Burger Chain to Triple State’s Footprint By 2033

LOS ANGELES, Aug. 07, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Johnny Rockets and 16 other restaurant concepts, announces a new development deal set to bring 20 new franchised Johnny Rockets locations to Texas in the next 10 years with the first unit set to open in 2024.

The brand currently operates a number of restaurants in the Lone Star State. The new locations will open in partnership with Brame Holdings LLC, featuring the classic fare that put the brand on the map over 35 years ago, including juicy, made-to-order burgers and hand-spun shakes.

“Brame Holdings LLC continues to be a great growth partner in Texas across the FAT Brands portfolio,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “They are quickly developing many Fatburger and Buffalo’s Express locations in addition to Round Table Pizza locations which is part of an 80-store development deal for the state, the first of these stores are set to open soon in San Antonio. We are thrilled to extend our relationship with an experienced operator like Brame Holdings LLC, driving further domestic growth in Texas for another beloved, iconic brand of ours, Johnny Rockets.”

The first Johnny Rockets restaurant opened June 6, 1986 on Melrose Avenue in Los Angeles. Since that time, the chain’s timeless all-American brand has connected with customers across the U.S. and in 25 other countries around the globe.

For more information on Johnny Rockets, visit www.johnnyrockets.com.

###

About FAT (Fresh. Authentic. Tasty.) Brands

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

About Johnny Rockets
Founded in 1986 on Melrose Avenue in Los Angeles, Johnny Rockets is a world-renowned international franchise that offers high-quality, innovative menu items including Certified Angus Beef^® cooked-to-order hamburgers, veggie burgers, chicken sandwiches, crispy fries, and rich, delicious hand-spun shakes and malts. With over 325 locations in over 25 countries around the globe, this dynamic lifestyle brand offers friendly service and upbeat music contributing to the chain’s signature atmosphere of relaxed, casual fun.
For more information, visit www.johnnyrockets.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing and performance of new store openings. Forward-looking statements reflect expectations of FAT Brands Inc. (“we”, “our” or the “Company”) concerning the future and are subject to significant business, economic and competitive risks, uncertainties and contingencies. These factors are difficult to predict and beyond our control, and could cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other factors. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

MEDIA C ONTACT :
Erin Mandzik, FAT Brands
emandzik@fatbrands.com
860-212-6509

Source: FAT Brands Inc.

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

Posted on August 7, 2023August 7, 2023 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 August 7, 2023August 7, 2023 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 August 7, 2023August 7, 2023 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 COVID^6,7,8, 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

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).
Tonix Pharmaceuticals Press Release. Feb 22, 2023. https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
Harris, H. et al. Tonix data on file 2023
Lederman S, et al. Arthritis Care Res (Hoboken). 2023
Moldofsky H, et al. J Rheumatol. 2011. 38(12):2653-63
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).
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
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/
Clauw DJ, and Calabrese L. Ann Rheum Dis. 2023
Thaweethai T, et al. JAMA. 2023. 329(22):1934-1946
Clauw DJ, et al. Pain. 2020. 161(8):1694-1697
Briggs, A, and Vassall, A. Nature. 2021. 593(7860): 502-505
Nittas V, et al. Public Health Rev. 2022. 43:1604501
Davis, HE., et al. EClinicalMedicine. 2021. 38:101019
Martin C, et al. PLoS One. 2021. 16(12):e0260843
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.
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
Maixner W, et al. J Pain. 2016. 17(9 Suppl):T93-T107
Haider S, et al. Pain. 2023. 164(2):385-401
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 August 7, 2023August 7, 2023 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 August 7, 2023August 7, 2023 by cpereira@noblefcm.com

Monday, August 07, 2023

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

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

Posted on August 7, 2023August 7, 2023 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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This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).