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Release – PDS Biotechnology Appoints Seasoned Business Development Executive Sanjay Zaveri as Senior Vice President, Business Development

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PDS Biotechnology Appoints Seasoned Business Development Executive Sanjay Zaveri as Senior Vice President, Business Development

Research, News, and Market Data on PDS Biotech


Reports An Inducement Grant
Under NASDAQ Listing Rule 5635(c)(4)

FLORHAM PARK, N.J., May 18, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced that Sanjay Zaveri has joined PDS Biotech as Senior Vice President, Business Development. Mr. Zaveri has extensive partnering experience having completed licenses and acquisitions between leading biotechnology and pharmaceutical companies. As PDS Biotech’s Senior Vice President of Business Development, he is responsible for business strategy, and managing the Company’s potential licensing and partnering opportunities in support of PDS Biotech’s pipeline. Prior to joining PDS Biotech he held the position of Head of Business Development and Corporate Strategy at Strongbridge Biopharma, leading their business development, licensing and partnership strategy prior to its acquisition by Xeris Pharmaceuticals. Before Strongbridge, he held biotechnology consulting positions with Guidehouse, formerly Navigant Consulting, and IQVIA. Mr. Zaveri holds a Bachelor of Science in Pharmacy from Massachusetts College of Pharmacy and a Master of Business Administration from the University of Minnesota, Carlson School of Management.

“We are pleased to have Sanjay join the PDS Biotech management team. He brings a great depth of experience successfully conducting business development in the life science industry,” said PDS Biotech Chief Executive Officer, Frank Bedu-Addo. “As we demonstrate proof-of-concept for PDS0101 and our Versamune® and Infectimune™ platforms, Sanjay’s proven ability to execute a sound business development strategy will be an asset to PDS Biotech.”

Additionally, PDS Biotech granted Mr. Zaveri nonstatutory stock options to purchase 150,000 shares of PDS’s common stock as a material inducement to his employment with PDS Biotech in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended. PDS Biotech’s 2019 Inducement Plan, as amended, provides for the granting of equity awards to new employees of PDS Biotech. The stock option award has an exercise price of $5.35, the closing price of PDS Biotech’s common stock on May 17, 2022. The option award vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date (May 17, 2023) and then monthly over the following 36 months, subject to continued employment with the company through the applicable vesting dates.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in
vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™ -based vaccines have 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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


Release – Salem Media to Present at the Singular Research Spring Select Webinar

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Salem Media to Present at the Singular Research Spring Select Webinar

Research, News, and Market Data on Salem Media

IRVING, Texas–(BUSINESS WIRE)– Salem Media
Group, Inc. (NASDAQ: SALM), announced today that it will present virtually at the Singular Research Spring Select Webinar on Wednesday, May 25th at 12:00 PM Central Time. The presentation will be available on the investor relations portion of the company’s website www.salemmedia.com prior to the company’s presentation.

ABOUT SINGULAR RESEARCH

Singular Research aims to be the most trusted supplier of independent, trusted, single-sources research on small-to-micro cap companies to the small-to-medium sized Hedge Fund manager. Singular Research provides quarterly updates for 40 to 70 companies and makes recommendations.

Singular strives to achieve goals by finding under or overvalued securities. Singular’s goal is to provide initiation reports and quarterly updates for approximately 40 micro-to-small cap companies. In most cases, Singular analysts research companies that are not covered by any other firms.

Singular provides honest advice. Independent analysts have no financial interest in the stocks covered. Analysts are compensated based on the accuracy of their research calls not through trading commissions or potential deal flow.

ABOUT SALEM MEDIA GROUP

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220517006118/en/

Evan D. Masyr
Executive Vice President and Chief
Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released May 18, 2022


Release – PsyBio Therapeutics Develops Commercial Purification Process for Second Generation Psycho-Targeted Compound

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PsyBio Therapeutics Develops Commercial Purification Process for Second Generation Psycho-Targeted Compound

Research, News, and Market Data on PsyBio

PsyBio Therapeutics Further
Expands Scalable Manufacturing Process Development

OXFORD, Ohio and COCONUT CREEK, Fla., May 16, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), a fully integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today reported that it has achieved a commercially scalable purification method for one of its second generation compounds. This manufacturing process achievement is expected to enable the commercial scale purification of bioreactor produced products utilizing state of the art manufacturing methodology to further expand PsyBio’s portfolio of compounds that can be more readily and rapidly developed than competitive methods. This purification process methodology is a necessary component for the Chemistry, Manufacturing and Controls section (“CMC”) for this second-generation candidates Investigational New Drug (“IND”) application with the US Food and Drug Administration (“FDA”).

“Developing adequate and scalable methodology for the purification of pipeline compounds will allow PsyBio to enable bench scale technology to be adapted to modern biotechnological production efficiency.  This technology is necessary to produce reliable and predictable purity which allows more rapid development of large scale lots of material,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “This is expected to facilitate effective in vitro and in
vivo testing, moving towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health.”

PsyBio retains the global, exclusive, and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale.    Commercial purification process development furthers the ability to manufacture compounds with predictable and reproducible purity.

“PsyBio continues to make significant progress in the manufacturing arena, developing effective and scalable techniques to enhance the ability to produce an ever-growing number of psycho-targeted therapeutic candidates in a rapid and highly cost-efficient manner,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The development of this type of manufacturing processes improves PsyBio’s capability to develop and rapidly manufacture novel therapeutic agents. PsyBio remains one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds as most of the landscape appears to rely on third party providers.”

About
PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary
Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the impact of this manufacturing process achievement on commercial scale purification; the impact of this manufacturing process achievement on the CMC section of PsyBio’s IND application with the FDA; PsyBio’s ability to develop compounds more readily and rapidly than competitive methods; PsyBio’s plans for filing IND applications with the FDA; the impact of this new manufacturing on potential 
in vitro and in
vivo testing; PsyBio’s plans to move towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health; PsyBio’s ability to develop novel therapeutic agents; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to launch clinical trials; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; PsyBio’s ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio’s ability to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: this manufacturing process will enable commercial scale purification of bioreactor produced products; this manufacturing process will have a positive impact on potential 
in vitro and in
vivo testing; this manufacturing process will have a positive impact on progress toward the filing of IND applications with the FDA; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining IND applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy, and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.


AI Navigating Intersections Through Trial and Error

Posted on by Admin 


Image Credit: MIT News


On the Road to Cleaner, Greener, and Faster Driving

No one likes sitting at a red light. But signalized intersections aren’t just a minor nuisance for drivers; vehicles consume fuel and emit greenhouse gases while waiting for the light to change.

What if motorists could time their trips so they arrive at the intersection when the light is green? While that might be just a lucky break for a human driver, it could be achieved more consistently by an autonomous vehicle that uses artificial intelligence to control its speed.

In a new study, MIT researchers demonstrate a machine-learning approach that can learn to control a fleet of autonomous vehicles as they approach and travel through a signalized intersection in a way that keeps traffic flowing smoothly.

Using simulations, they found that their approach reduces fuel consumption and emissions while improving average vehicle speed. The technique gets the best results if all cars on the road are autonomous, but even if only 25 percent use their control algorithm, it still leads to substantial fuel and emissions benefits.

“This is a really interesting place to intervene. No one’s life is better because they were stuck at an intersection. With a lot of other climate change interventions, there is a quality-of-life difference that is expected, so there is a barrier to entry there. Here, the barrier is much lower,” says senior author Cathy Wu, the Gilbert W. Winslow Career Development Assistant Professor in the Department of Civil and Environmental Engineering and a member of the Institute for Data, Systems, and Society (IDSS) and the Laboratory for Information and Decision Systems (LIDS).

Intersection Intricacies

While humans may drive past a green light without giving it much thought, intersections can present billions of different scenarios depending on the number of lanes, how the signals operate, the number of vehicles and their speeds, the presence of pedestrians and cyclists, etc.

Typical approaches for tackling intersection control problems use mathematical models to solve one simple, ideal intersection. That looks good on paper, but likely won’t hold up in the real world, where traffic patterns are often about as messy as they come.

Wu and Jayawardana shifted gears and approached the problem using a model-free technique known as deep reinforcement learning. Reinforcement learning is a trial-and-error method where the control algorithm learns to make a sequence of decisions. It is rewarded when it finds a good sequence. With deep reinforcement learning, the algorithm leverages assumptions learned by a neural network to find shortcuts to good sequences, even if there are billions of possibilities.

This is useful for solving a long-horizon problem like this; the control algorithm must issue upwards of 500 acceleration instructions to a vehicle over an extended time period, Wu explains.

“And we have to get the sequence right before we know that we have done a good job of mitigating emissions and getting to the intersection at a good speed,” she adds.

But there’s an additional wrinkle. The researchers want the system to learn a strategy that reduces fuel consumption and limits the impact on travel time. These goals can be conflicting.

“To reduce travel time, we want the car to go fast, but to reduce emissions, we want the car to slow down or not move at all. Those competing rewards can be very confusing to the learning agent,” Wu says.

While it is challenging to solve this problem in its full generality, the researchers employed a workaround using a technique known as reward shaping. With reward shaping, they give the system some domain knowledge it is unable to learn on its own. In this case, they penalized the system whenever the vehicle came to a complete stop, so it would learn to avoid that action.

Traffic Tests

Once they developed an effective control algorithm, they evaluated it using a traffic simulation platform with a single intersection. The control algorithm is applied to a fleet of connected autonomous vehicles, which can communicate with upcoming traffic lights to receive signal phase and timing information and observe their immediate surroundings. The control algorithm tells each vehicle how to accelerate and decelerate.

Their system didn’t create any stop-and-go traffic as vehicles approached the intersection. (Stop-and-go traffic occurs when cars are forced to come to a complete stop due to stopped traffic ahead). In simulations, more cars made it through in a single green phase, which outperformed a model that simulates human drivers. When compared to other optimization methods also designed to avoid stop-and-go traffic, their technique resulted in larger fuel consumption and emissions reductions. If every vehicle on the road is autonomous, their control system can reduce fuel consumption by 18 percent and carbon dioxide emissions by 25 percent, while boosting travel speeds by 20 percent.

“A single intervention having 20 to 25 percent reduction in fuel or emissions is really incredible. But what I find interesting, and was really hoping to see, is this non-linear scaling. If we only control 25 percent of vehicles, that gives us 50 percent of the benefits in terms of fuel and emissions reduction. That means we don’t have to wait until we get to 100 percent autonomous vehicles to get benefits from this approach,” she says.

Down the road, the researchers want to study interaction effects between multiple intersections. They also plan to explore how different intersection set-ups (number of lanes, signals, timings, etc.) can influence travel time, emissions, and fuel consumption. In addition, they intend to study how their control system could impact safety when autonomous vehicles and human drivers share the road. For instance, even though autonomous vehicles may drive differently than human drivers, slower roadways and roadways with more consistent speeds could improve safety, Wu says.

While this work is still in its early stages, Wu sees this approach as one that could be more feasibly implemented in the near-term.

“The aim in this work is to move the needle in sustainable mobility. We want to dream, as well, but these systems are big monsters of inertia. Identifying points of intervention that are small changes to the system but have significant impact is something that gets me up in the morning,” she says. 

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


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Is the Bear Market Bull?

Posted on by Admin 


Image Credit: Forextime (Flickr)


The Battle Between Bull and Bear Has Become Intense

A bull facing off with a bear is among the most entrenched icons and lore in stock market trading. Bull vs. bear icons can be found in almost any office that is involved in the stock market. Long ago, people came to use the terms “bullish” and “bearish” to reflect their thoughts on market direction, and the meanings are universally understood. In 2022 the memes of bulls and bears struggling with each other have reached a crescendo. After an incredibly long and strong market from Spring 2020 until year-end 2021, there has been no question we were in a bull market. As we entered 2022, the sentiment which drives markets has been less confident and decidedly more negative.

The terms are based on direction and overall sentiment, but over time, analysts have attempted to define what a bear market is. In recent years, a bear market has been defined as having fallen 20% or more from recent highs.


Source: Koyfin

The chart above shows the volatility index (%) against
the S&P 500 index (%). Since December 2021, the index has hit higher highs
and higher lows as the markets are wrestling with more negativity than prior
periods.

 

Bull and Bear Facing Off

In a bear market, share prices are on average dropping each week. This results in a downward trend that investors believe will continue; the belief, in turn, snowballs into an entrenched downward trend.

To date (May 18), none of the major indices have fallen 20% or more from their high. But for many in the markets, it feels as though they have. Investors had been velocitized by the swift gains over the prior years, so even sideways movement for a period would feel negative. The current 16% decline of the S&P 500 feels much steeper than it is. It has been held up by many strong up days showing there are still plenty of bottom-fishing bulls. This is the essence of the bull and bear facing off.

Bullish Position

The economy may seem to have the ingredients for a reduction in growth that could lead to a reduction in corporate earnings, but the most followed measurement, employment, isn’t showing signs of faltering. Confidence is created by knowing if one wants a job, they can get a job. Job growth and wages have been marching higher through most of 2022. So much so, that wage inflation is becoming a concern.

There is still ample stimulus in the system as a result of quantitative easing and low-interest rates. The Fed has discontinued adding stimulus in the form of bond purchases and has begun raising rates, but real rates are still negative, and the mopping up of money injected into the system is scheduled and will follow a slow timeline.

Consumers are still spending. Retail sales for April rose a seasonally adjusted 0.9% in April. Demand is strong for most goods and services, especially those involving leisure activities. With the consumer still looking to spend, the markets may hold up well.

Bearish Position

Fed Chair Jerome Powell gave a talk yesterday at the Wall
Street Journal’s Future of Everything Festival. During his talk, he discussed his resolve to bring down the 40-year high inflation rate and bring it in line with their 2% target range. He admitted that the landing might be bumpy, but he believes it can be done without causing a recession. A recession is generally defined as two consecutive quarters of negative growth (GDP). We are now halfway through the second quarter of the year. The first quarter, which came off a very strong 4th quarter, showed the economy had negative growth of 1.6%. So we may already be in a recession. If job growth falters, it will become a problem.

The Fed is raising rates and draining stimulus with an eventual target of 2% inflation. This would seem to argue for aggressively applying of the economic brake pedal.

Higher rates increase costs for businesses that borrow money and slow down purchases for households that were planning on making a purchase on credit. For businesses, higher rates could cut into profits, and households may decide to curtail purchases because of the high cost of money (borrowing costs).

Take-Away

By definition, it is premature to call this market a bear market, yet it has ceased to be a bull market. On up days, the bulls come out in force and have driven the markets up by 2% or more in a trading session. This shows that there are many positive participants buying in at these lower prices. The bearish sentiment is in large part based on future expectations, not economic reports. The feeling is based on previous Fed tightenings and the heightened probability of entering a recession.

This market has continued to surprise over the previous decade, and the future won’t be any different. In addition to overall growth or recession, there is the potential for a rolling recession. This could play out where it affects companies that rely on low interest rates such as housing, while at the same time those that still prosper while the job market is good and continues to grow. Examples of this are sectors where people spend disposable income on things such as leisure, entertaining, or clothing. In the meantime, the bulls and bears are thrashing to determine how 2022 will play out in the markets.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.bea.gov/data/gdp/gross-domestic-product

https://www.wsj.com/articles/feds-powell-to-take-wsj-questions-on-inflation-and-economic-outlook-11652779802?mod=Searchresults_pos7&page=1

www.koyfin.com

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FDA Program May Help Investors Uncover Breakthrough Medical Technology

Posted on by cpatches

The FDA Breakthrough Devices Program may be a starting point for investors exploring the medical space. It’s designed to create a quicker path for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversible conditions. There are significant benefits for the companies granted access to the program. Lists of devices after the companies have been granted a marketing authorization are available on the FDA website.

While new pharmaceuticals tend to grab headlines quicker than devices, investors looking for public companies, that may be uncorrelated to the pace of US economic growth or the financial markets, may visit the website and then research the companies on Channelchek.

Image Credit: US Food and Drug Administration (Flickr)

Benefits of the Breakthrough Devices Program

The purpose of the Breakthrough Devices Program is to provide patients and health care providers with timely access to novel medical devices by speeding up their development, assessment, and review. At the same time, it preserves the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Manufacturers have the opportunity to interact with the FDA’s experts through several different program options to efficiently address issues that present themselves during the FDA premarket review phase. This feedback from the FDA helps shorten the agreement phase. The company can also expect a prioritized review of its submission. This can have the effect of speeding the product to market with less cost and fewer problems.

How this Works

Pulling an example from the Channelchek library of videos from NobleCon18, we can use Perimeter Medical Imaging AI (PYNKF) to understand what a candidate looks like and how it may bring value to the patient, medical provider, and possibly investors.

Perimeter is an early-stage medical device company that expects its flagship product to address unmet cancer treatment needs. Initially, the device is expected to change the way breast cancer is treated and evaluated to improve outcomes and minimize the chance of recurrence or having to reoperate. In order to apply for the FDA designation, Perimeter’s device was indicated for breast cancer. However, the applications are expected to extend well beyond and into other major cancers in the $3.7 billion total market.

This FDA designation makes for a much more clear regulatory pathway. Perimeter meets the first guideline in that its product has unique technology (breakthrough) that is solving problems with a different method on a scalable platform. The procedures are expected to reduce the cost to patients, minimize the need for repeat surgery and be self-funding from the hospitals’ standpoint. This is because about 20 to 25% of cancer patients now need to return for a re-operation that costs approximately $16,000. Hospitals that adopt the Perimeter AI technology could serve patients better and stand to recover their costs while reducing overall patient costs on average.

Take-Away

There are many ways to uncover companies that are “on the move.” Reviewing those the FDA is likely to help along toward a full “go-ahead” is just one of them. For a more detailed look at Perimeter, their unique business model,  and technology, watch the 20-minute video below. For more on understanding the FDA Breakthrough Device Program in order to uncover companies that could change medicine, go to FDA.gov .

To evaluate small and growing companies, explore Channelchek beginning here.

Paul Hoffman

Managing Editor, Channelchek

Ayala Pharmaceuticals (AYLA) – Data Milestones Reiterated With 1Q22 Financial Report

Posted on by Admin

Tuesday, May 17, 2022

Ayala Pharmaceuticals (AYLA)
Data Milestones Reiterated With 1Q22 Financial Report

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

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

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

1Q22 Reported With Clinical Updates.   Ayala Pharmaceuticals reported a 1Q22 loss of $10.0 million or $(0.66) per share.  Interim results from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors are expected to be announced in mid-2022, unchanged from previous guidance.  The company also expected to provide updates from the Phase 2 ACCURACY trial testing AL102 in adenoid cystic carcinoma (ACC), and plans to begin a trial in acute lymphoblastic leukemia (ALL) later in 2022.  The company ended the quarter with $27.4 million in cash.

Looking Forward To Phase 2/3 Ringside Data.  The RINGSIDE trial is testing AL102 for treatment of desmoid tumors, a rare tumor of the connective tissue.  In February, Ayala announced that Part A of the trial had completed enrollment of 42 patients to evaluate the safety and tolerability, as well as tumor shrinkage at 16 weeks.  Upon completion of Part A, the double-blind placebo-controlled Part B will begin testing efficacy with a target enrollment of 156 patients….

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

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

CoreCivic, Inc. (CXW) – The New Day Has Begun; Announces $150 Million Share Repurchase Authorization

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Tuesday, May 17, 2022

CoreCivic, Inc. (CXW)
The New Day Has Begun; Announces $150 Million Share Repurchase Authorization

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

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

Repurchase Authorization. According to an 8-K filed yesterday, on May 12, 2022, the Board of Directors of CoreCivic Inc. approved a share repurchase program authorizing the Company to repurchase up to $150 million of the Company’s common stock. The authorization is above our projected $100 million plan and represents approximately 11% of Monday’s closing market capitalization.

Program Details. Repurchases of the Company’s outstanding common stock may be made at management’s discretion from time to time in the open market, through privately negotiated transactions, or otherwise. The share repurchase program has no time limit and does not obligate the Company to purchase any particular amount of its common stock….

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

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

Motorsport Games (MSGM) – Moving Forward At A Slightly Slower Speed

Posted on by Admin

Tuesday, May 17, 2022

Motorsport Games (MSGM)
Moving Forward At A Slightly Slower Speed

Motorsport Games, a Motorsport Network company, combines innovative and engaging video games with exciting esports competitions and content for racing fans and gamers around the globe. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”). Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

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

Favorable Q1 results. The company reported strong Q1 revenue of $3.3 million, 95% higher than our estimate of $1.7 million. Adj. EBITDA loss of $5.55 million was in line with our forecast. The company benefited from diversified revenue in the quarter, with 27% of total revenue coming from rFactor 2 and esports. The revenue diversification demonstrates the company’s ability to derive value from more than just its NASCAR franchise.   

Product roadmap changes. Management noted that the company will focus on console and PC games in the near term given strong demand in those areas. Additionally, the company will not release a new NASCAR Ignition title this year, opting to release an expansion pack to the current title instead. Release of the next iteration of the game is planned for mid-2023….

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

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

Tokens.com Corp. (SMURF) – First Quarter Results

Posted on by Admin

Tuesday, May 17, 2022

Tokens.com Corp. (SMURF)
First Quarter Results

Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

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

1Q22 Results. Tokens.com reported revenue of $326,320 in the first quarter of 2022, flat sequentially. We had estimated revenue of $550,000. The operating loss was $631,856 in the quarter, compared to an operating loss of $3.0 million in the fourth quarter of 2021, which was impacted by higher professional fees and listing expenses. Tokens.com reported net income for the quarter of $7.8 million, or $0.08 per share, driven by a gain on the revaluation of warrant liability.

Moving Forward. Tokens.com continues to make inroads in the Web 3.0 universe. The Metaverse Group had a successful Fashion Week and is now generating revenue from leases. Hulk Labs has been successfully launched in the play-to-earn gaming space. And Tokens.com continues to stake various cryptos.…

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

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

Voyager Digital (VYGVF) – Announces $60 Million Raise; Reports 3Q22 Results

Posted on by Admin

Tuesday, May 17, 2022

Voyager Digital (VYGVF)
Announces $60 Million Raise; Reports 3Q22 Results

Voyager Digital Ltd.’s (TSX: VOYG) (OTCQX: VYGVF) (FRA: UCD2) US subsidiary, Voyager Digital, LLC, is a fast-growing cryptocurrency platform in the United States founded in 2018 to bring choice, transparency, and cost-efficiency to the marketplace. Voyager offers a secure way to trade over 100 different crypto assets using its easy-to-use mobile application. Through its subsidiary Coinify ApS, Voyager provides crypto payment solutions for both consumers and merchants around the globe. To learn more about the company, please visit https://www.investvoyager.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

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

3Q22 Results. Voyager reported $102.7 million of revenue for 3Q22, in-line with the $100-$105 million guidance. Trading revenue was off sharply sequentially as trading volume fell, partially offset by merchant services and staking revenue. We had projected revenue of $98 million. Operating loss was $43.2 million compared to our $32.7 million estimate. Voyager reported a net loss of $61.4 million for the quarter, or $0.36 per share, versus our $0.15 estimate.

Key Metrics for the Third Quarter. Total funded accounts reached 1.190 million, a sequential increase of 115,000 from 1.075 million in the second quarter. Total verified users increased by 255,000 to 3.486 million from 3.231 million in the second quarter, while net new deposits decreased by $642 million to $395 million from the previous quarter’s $1.04 billion….

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

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

Release – PDS Biotech to Participate at Upcoming Investor Conferences

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PDS Biotech to Participate at Upcoming Investor Conferences

Research, News, and Market Data on PDS Biotech

FLORHAM PARK, N.J., May 17, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced that its management will present at the H.C. Wainwright Global Investment Conference and the LD Micro Invitational and will participate at the UBS Healthcare Virtual One-on-One Day. 

H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24, 2022
Time: 7:00 AM EDT
Investors can register for the conference here

UBS Healthcare Virtual One-on-One Day
Date: Wednesday, June 1, 2022

LD Micro Invitational Conference
Date: Wednesday, June 8, 2022
Time: 7:30 AM PDT
Virtual Viewers: Livestream

Following the conferences, a webcast replay of the presentations will be available on the Investor section of the company’s website, PDS Biotechnology. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™ -based vaccines have 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Investor
Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838

pdsb@cg.capital


Price Moves When Warren Buffett Buys and Sells (Based on May 16 SEC Filing)

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Image Credit: Fortune Live Media (Flickr)


The Big Price Impact on Stocks After Warren Buffett’s Most Active Buying Spree

Warren Buffett and Berkshire Hathaway (BRK.A, BRK.B) were actively spending down the company’s large pool of cash last quarter, just as they promised during their recent annual meeting. This makes sense as some stock prices are lower than they have been in years, and a few sectors are showing they could have plenty of upside potential. It makes even more sense when you consider that Berkshire Hathaway was sitting on $144 billion in cash. The inflation rate is now running above 8% and eroding the value of every unearning penny.

Jumping into the market can be costly if wrong, but investor’s ‘dry powder’ is being eroded with increased costs by the day – finding a place for money to grow by at least the inflation rate would seem prudent. The analysts at Berkshire Hathaway are certainly aware of this.

The positive impact of Berkshire showing confidence in a company is often all that is needed to exceed the near non-earnings holding a cash position. Below we look at three Berkshire Hathaway changed positions as reported on May 16, and then compare the stock’s price moves versus the overall market.

Where Did They Gain Exposure

As revealed by the companies 13F filed on May 16, as of March 31 Berkshire Hathaway added Citigroup (C), Paramount Global (PARA), and sold Verizon (VZ). There were older positions added to as well, such as Chevron (CVX), and Activision Blizzard (ATVI). But for the purpose of showing the power of Buffett’s believing a stock is attractive, or in Verizon’s case, no longer attractive, we’ll take a look at the market moves of these companies as of 1pm the day after the 13F was made public.


Source: Koyfin

The above chart of Citibank, Paramount Global, and
Verizon from the beginning trading on Monday compares the stocks to the S&P
500 performance during the same short period.

 

The S&P, as reflected during the short period in this chart, beginning on the date of Berkshire’s 13F filing, shows the S&P 500 up 1.60%. This is substantial in a year when the index has mostly been delivering red to investors. Verizon was the most noteworthy sale of Buffett as they brought their position near zero. The company’s stock rose only 0.11%, well below the S&P benchmark performance.

As for the positions opened during the first quarter by Berkshire Hathaway, Citicorp shot up 8.28%. Paramount Global reacted even more strongly, rising double digits to 13.95%. 

Lessons

While an SEC-registered portfolio new holdings are kept close to the vest before reported in order to avoid insider trading problems, listening to what someone like Warren Buffett is saying at annual meetings and at other times can allow you to get a sense if they have been active, and in what industries. More important, is whether they are active buying or selling. For an investor that is holding a stock which a well-followed investor has decided to sell, can cause significant underperformance for at least the near term.

Other Pertinent Info from the 13F Filing

During the first quarter of 2022, the value of Berkshire’s US stock portfolio rose by 10% to $364 billion. Buffett had indicated the firm he manages has been struggling to find bargains in recent years. He blamed this on stocks swelling to record highs, fierce competition from private equity firms, and SPACs which increased competition and costs of acquisitions. Even Berkshire’s own rising stock price made it unappealing as a company stock buy-back.

A change of appetite took place in the first quarter of 2022. Berkshire bought $51 billion worth of equities and sold less than $10 billion in stocks. Its net cash reduction of $41 billion helped slash its cash pile by 28% to $106 billion. Q1 2022 marked one of the most active buying periods in Berkshire Hathaway’s history.

Take-Away

Well known, successful investors can either make a winner out of your holding or cause it to trade at a pace below the market. While knowing and trading on information before it is made public can get you in trouble, investors like Buffett do provide guidance. These hints as to their thinking and likely direction may help investors somewhat. This is why it always makes sense to know what they’re saying – it isn’t fun holding something they just reported sold, and the tailwind they create when you’re long the same company can be profitable.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.sec.gov/Archives/edgar/data/1067983/000095012322006442/xslForm13F_X01/primary_doc.xml

https://whalewisdom.com/filer/berkshire-hathaway-inc#google_vignette

www.koyfin.com

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