Month: May 2023

Release – Multi-State Cannabis Operator, Schwazze, Announces Grand Reopening of Emerald Fields Store In Denver, Colorado

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

May 16, 2023

PDF Version

OTCQX: SHWZ
NEO: SHWZ

Grand Reopening Event Scheduled for Saturday, May 20th

DENVER, May 16, 2023 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand reopening of its newly remodeled adult-use Emerald Fields retail dispensary located in the Highlands area of Denver, Colorado. Emerald Fields Highlands is located at 2675 W. 38th Avenue, Denver, Colorado. Store operating hours are 8a to 9:50p Monday through Sunday.

   

The enhanced retail store features new, illuminated exterior signage, updated landscaping and a refreshed exterior of the 100-year-old, formerly residential building. Inside, new casework runs along the perimeter walls to showcase a variety of products while four display monitors feature daily deals, promotional details, and specials. Highlights of the expanded salesfloor include environmental graphics as well as new lighting, flooring, and additional storage.   

“We are excited to debut our newly refreshed Emerald Fields retail dispensary in the Highlands neighborhood of Denver. With our store new remodel, we’re showcasing a wide selection of cannabis products and fresh flower to serve a greater number of shoppers in this community,” said Collin Lodge, Schwazze Colorado Division President.

During its grand reopening period, Emerald Fields Highlands will offer special pricing on flower, edibles, and vapes. Enrollment in the Gratify Rewards customer loyalty program, which can be used at any Schwazze-owned retail dispensary in either New Mexico or Colorado, is now open. On May 20th, customers who are enrolled in Gratify Rewards will earn double points on all purchases.

The grand opening event is scheduled for Saturday, May 20th, beginning at 11:30am. All Gratify Rewards members who make a dispensary purchase of above $100 pre-tax on the 20th of May will automatically be entered to win a PuffCo Proxy valued at $500.

Emerald Fields Highlands will offer the first 50 customers gift bags containing swag, stickers, and branded merchandise. The first 50 customers will also get free breakfast sandwiches from Bodega, an eatery located next door to Emerald Fields Highlands. Diners from Bodega can also bring their receipts into Emerald Fields for an extra 10% off their purchases.

Sano Gardens, a premier vape brand, will be on-site for an educational pop-up from 12 -2 pm, as well as a new brand to the Colorado market, Every Day Weed (EDW), a portable pouch of pre-ground flower complete with rolling papers, perfect for summer socials. For dog owners everywhere, a specialty photographer will be on site to capture fun photos of shoppers with their pets. Take a picture with your dog and, while you wait for it to develop, take advantage of deals on flower, pre-rolls, edibles, and more!

Highlands Store Location
Emerald Fields Highlands
2675 W. 38th Avenue
Denver, Colorado 80211
(720) 389-9179

Grand Opening Celebration
Saturday, May 20, 2023
11:30a to 3p

Store Hours
Monday thru Sunday, 8a to 9:50p

Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as six operating cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division, and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

   

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SOURCE Schwazze

Townsquare Media (TSQ) – Post Quarterly Call Estimate Refining

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

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.

Revising revenue forecast. We are refining our 2023 and 2024 revenue forecasts. The bulk of the changes relate to our Digital subscription and Digital advertising revenue outlooks. Note: our full year total revenue and adj. EBITDA forecasts are largely unchanged. Figure #1 Forecast Revisions illustrates our updated forecast.

Lowering TSI forecast. Economic weakness has put pressure on many of the SMBs that make up TSI’s client base. Typically, the company offers temporary discounts to assist SMBs. We believe this is will have an impact on revenue in 2023, particularly the first half. Our 2023 TSI revenue forecast is lowered from $91.7 million to $85.9 million, which equates to a 6% YoY decline. We are forecasting flat revenue growth in 2024, which offers potential upside should economic conditions improve.


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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).

*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. 

QuoteMedia Inc. (QMCI) – A Solid Start To The Year

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

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 Q1 results. The company reported quarterly revenue of $4.75 million, in line with our forecast of $4.8 million. Revenue increased 14% from the prior year period on a constant currency basis. Adj. EBITDA in the quarter was $830,000, in line with our estimate of $850,000. Notably, interactive revenue grew 22% from the prior year period. Figure #1 Q1 Results highlights results versus our estimates.

Interactive growth. The company’s interactive business had a strong quarter as revenue increased 22% from the prior year period. Management attributed the substantial increase in revenue to an increase in the average size of clients. The company remains focused on signing larger clients, and has increased its headcount in its sales and marketing departments to support that goal.


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

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

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

PDS Biotechnology Corp. (PDSB) – 1Q23 Reported With Clinical Data Update Coming Soon

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

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.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Summary.  PDS Biotech reported 1Q23 loss of $9.7 million or $(0.32) per share. The company ended the quarter with $65.2 million in cash, which it expects to be sufficient to fund operations through 3Q24. The Phase 3 trial testing PDS0101 is expected to begin in 4Q23, and additional data from the Phase 2 VERSATILE-002 trial has been accepted for presentation at the ASCO meeting June 2 through June 6. The data will be also included in an expert panel discussion on head and neck cancer. 

Phase 3 Trial Expected To Begin In 4Q23. An amended IND is expected to be filed in 3Q23 to begin the Phase 3 trial for PDS0101 in 4Q23 in patients with recurrent or metastatic head and neck cancer. The trial is designed to test the combination of PDS0101 and Keytruda against Keytruda monotherapy with primary endpoints of Overall Survival and PFS. Two interim analysis points are planned, which we anticipate may be designed to permit discussion of early application for approval with the FDA.


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

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

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

Onconova Therapeutics (ONTX) – 1Q23 Reported With Clinical Progress Review

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

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

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Onconova Updates Clinical Progress With 1Q23 Financial Report.  Onconova reported a loss of $5.8 million or $(0.28) per share, and gave updates on its clinical programs including Phase 1 testing narazaciclib and several Phase 2 studies testing rigosertib. The company ended 1Q23 with $34.2 million in cash, which it projects to last into 1Q24.

Rigosertib Could Become An Orphan Drug. Results from two patients in an Investigator Initiated Trial testing rigosertib in a rare disease (RDEB-associated SCC, or recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma) were reported at a meeting of the Society of Investigative Dermatology in Osaka, Japan. Both patients had complete clinical responses of all cancerous lesions following treatment. Since this is a fatal disease with no effective therapy, the company has requested an FDA Type B meeting to review the data and discuss a pivotal study. An announcement is expected in 3Q23.


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

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

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

Lifeway Foods (LWAY) – A Strong Start to 2023

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

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

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

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

Overview. The momentum exhibited in 2022 carried over into 2023 as Lifeway reported its 14th consecutive quarter of topline expansion. Higher pricing, accelerating kefir unit volume, and additional distribution drove the top line. Gross margin increased by 530 basis points y-o-y, reflecting higher pricing and volumes as well as favorable milk pricing.

1Q23 Results. Revenue totaled $37.9 million, up 11.2% year-over-year. Gross profit margin was 21.7%, compared to 16.4% in 1Q22. Lifeway reported net income of $830,000, or EPS of $0.06 per share, versus a net loss of $895,000, or a loss of $0.06/sh last year. We had forecast revenue of $36 million, gross margin of 22.2%, and net income of $1.26 million, or EPS of $0.08/sh.


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

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

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

EuroDry (EDRY) – Shipping rates bottoming out and that’s good news for EuroDry

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd. into a separate listed public company. EuroDry was spun-off from Euroseas Ltd. on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY. EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day- to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters and under pool agreements.

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.

EuroDry reported weak 2023-1Q results due to lower shipping rates, largely as expected. The EuroDry fleet ran near full capacity but did so at much lower rates. The average TCE rate for the quarter was $10,674 down 57% versus last year and below our expectations. EuroDry typically only books out less than half of the days beyond the upcoming quarter making it more sensitive to spot shipping rates than most shipping companies. 

Operating costs were generally in line except for voyage expenses. Operating costs for the quarter rose relative to the same period last year and the previous quarter. The increase can largely be attributed to a rise in voyage expenses. Management indicated the increase was due to “expenses incurred by one of our vessels while employed under a voyage charter.” This is in contrast to the previous year when the company recognized “a gain on bunkers” of $1.0 million. The company has traditionally booked a gain in the voyage expense line.


Get the Full Report

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

This 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. 

The Limits to the Artificial Intelligence Revolution

Posted on by phoffman@channelchek.com

What Will AI Never Be Good At?

Artificial intelligence (AI) is a true disruptive technology. As any informed content writer can tell you, the technology creates efficiencies by speeding up data gathering, research, and even graphics that specifically reflect the content. As an example, it is arguably quicker to use ChatGPT to provide a list of ticker symbols from company names, than it is to look them up one by one. With these small time savers, over the course of a week, far more can be produced as a result of AI tools saving a few minutes here and there.

This presents the question, what are the limits of AI – what can’t it do?

Worker Displacement

Technological revolutions have always benefitted humankind in the long run; in the short run, they have been disruptive, often displacing people who then have to retrain.

A new Goldman Sachs report says “significant disruption” could be on the horizon for the labor market. Goldman’s analysis of jobs in the U.S. and Europe shows that two-thirds of jobs could be automated at least to some degree. In the U.S., “of those occupations which are exposed, most have a significant — but partial — share of their workload (25-50%) that can be replaced,” Goldman Sachs’ analysts said in the paper.

Around the world, as many as 300 million jobs could be affected, the report says. Changes to labor markets are therefore likely – although historically, technological progress doesn’t just make jobs redundant, it also creates new ones. And the added productivity allows the masses to live wealthier lives. This clearly was the end result of the  industrial revolution, and years after the computer revolution, we are at a high rate of employment and have at our fingertips much which we never even dreamed.

The Goldman report says the use of AI technology could boost labor productivity growth and boost global GDP by as much as 7% over time.

There are few reasons to expect that the AI revolution won’t also provide more goods and services per person for a richer existence. But, what about the disruption in the interim? I was curious to know what artificial intelligence is not expected to be able to do. There isn’t much information out there, so I went to an AI source and fed it a bunch of pointed questions about its nature. Part of that nature is to not intentionally lie, I found the responses worth sharing as we will all soon be impacted by what the technology can and cannot do.

Limitations of AI that Will Persist

Artificial intelligence has come a long way in recent years and the speed of progression and adoption is accelerating. As a result, applications have become increasingly sophisticated. But, there are still many things that AI cannot do now and may never be able to do.

One thing that AI cannot do now and may never be able to do is to truly understand human emotions and intentions. While AI algorithms can detect patterns in data and recognize certain emotional expressions, they do not have the ability to experience emotions themselves. This means that AI cannot truly understand the nuances of human communication, which can lead to misinterpretation and miscommunication.

Another limitation of AI is that it cannot replicate the creativity and intuition of humans. While AI can generate new ideas based on existing data, it lacks the ability to come up with truly original and innovative ideas. This is because creativity and intuition are often based on a combination of experience, emotion, and imagination, which are difficult to replicate in a machine.

AI also struggles with tasks that require common sense reasoning or context awareness. For example, AI may be able to identify a picture of a cat, but it may struggle to understand that a cat is an animal that can be petted or that it can climb trees. This is because AI lacks the contextual understanding that humans have built up through years of experience and interaction with the world around us.

In the realm of stocks and economics, AI has shown promise in analyzing data and making predictions, but there are still limitations to its abilities. For example, AI can analyze large datasets and identify patterns in market trends, but it cannot account for unexpected events or human behavior that may affect the market. This means that while AI can provide valuable insights, it cannot guarantee accurate predictions or prevent market volatility.

Another limitation of AI in economics is its inability to understand the complexities of social and political systems. Economic decisions are often influenced by social and political factors, such as government policies and public opinion. While AI can analyze economic data and identify correlations, it lacks the ability to understand the underlying social and political context that drives economic decisions.

A concern some have about artificial intelligence is that it may perpetuate biases that exist in the data it analyzes. This is the “garbage in, garbage out” data problem on steroids. For example, if historical data on stock prices is biased towards a certain demographic or industry, AI algorithms may replicate these biases in their predictions. This can lead to an amplified bias that proves faulty and not useful for economic decision making.

Take Away

AI has shown remarkable progress in recent years, but, as with everything that came before, there are still things that it cannot do now and may never be able to do. AI lacks the emotional intelligence, creativity, and intuition of humans, as well as common sense reasoning and social and political systems. In economics and stock market analysis, AI can provide valuable insights, but it cannot assure accurate predictions or prevent market volatility. So while companies are investing in ways to make our lives more productive with artificial intelligence and machine learning, it remains important to invest in our own human intelligence, growth and expertise.

Paul Hoffman

Managing Editor, Channelchek

Sources

OpenAI. (2021). ChatGPT [Computer software]. Retrieved from https://openai.com

https://www.cnbc.com/2023/05/16/how-generative-ai-chatgpt-will-change-jobs-at-all-work-levels.html

The Big Position – Michael Burry’s Holdings

Posted on by phoffman@channelchek.com

Michael Burry, What He Bought, What He Sold, and What He Held

I mark my calendar for the four times a year that Michael Burry is required to make his quarterly holdings public. The founder of Scion Asset Management, who gained additional fame by the portrayal of him in the movie The Big Short, is not a follower of other investors. He does his own unique number crunching and analyzing and is often at odds with mainstream investor thinking. This week he filed his 13F with the SEC, which shows his holdings of publicly traded securities as of the close of business on March 31. It is important to note that his holdings at the close of the following trading day may not be the same.

The Dramatic Holdings Shift

There has been a conspicuous shift in the holdings in Burry’s hedge fund. For the first time that I can recall, he has taken large long positions in companies domiciled in China. This includes an increase in holdings in e-commerce company JD.com Inc. (JD) and retailer Alibaba (BABA).

These positions stood at quarter-end as the largest holdings of Scion, representing 20% of securities held. Many hedge funds have gone sour on investing in Chinese tech companies, Burry isn’t necessarily a contrarian, but it is not unusual for him to be at odds with his peers. Hedge funds’ net exposure to China has dropped to 10.5% from 13.3% in January, according to data from Goldman Sachs Group Inc.’s Prime Services unit. If other large investors are early to the party, or late, that allows him to buy into weakness, or sell into strength – if he’s right.

The Big Position

How big are his positions? After purchasing Alibaba and JD.com in the final months of 2022 as China ended its zero covid 19 policy, Burry, who had held JD.com as of the previous two 13F filings, added to the holdings. His bigger stake more than tripled to 250,000 shares, worth $11 million, or 11% of his portfolio. The report shows his holdings of Alibaba had doubled.

It is not just notable that Burry is long, but that he held larger long positions than he has in many quarters.

The report, which is a snapshot taken just a couple of weeks after Silicon Valley Bank (SVB) shook investors in financial stocks, shows that Michael Burry jumped in and bought shares of smaller banks in the first quarter – where there is fear, there are knee-jerk reactions to take advantage of. In fact, he appears to have jumped into the middle of the firestorm adding long positions of First Republic, Pacific Western (PACW), Western Alliance, New York Community Bank, and Huntington Bank (HBAN) last quarter. Burry also bought other financial stocks, specifically Wells Fargo (WFC) and Capital One (COF). There is no indication if these worked out for the investors in his fund.

Energy, Commodities, and Other Long Positions

Burry also ended last quarter with new positions in energy and commodity stocks. These may be an inflation hedge trade. Holding cash during periods of higher inflation is akin to sitting still while watching money blow away. While there is no guarantee that the investment alternative to cash will do better, the sectors have a long history that supports the trade. Scion was invested in Coterra Energy (CTR), Devon Energy (DVN), and Sibanye Stillwater (SBSW).

Burry closed out the quarter with shares in various other companies including Zoom Video (ZM), The RealReal (REAL), and Signet Jewelers (SIG).

He still maintains his long-term position in Geo Group (GEO). Geo is the world’s second largest private “prison company.” Geo Group has the honor of being  Scion’s longest held position, put on sometime after the incoming administration sought to do away with privately owned prisons. Investors interested in how Geo Group navigated this challenge and is now finding other growth opportunities to utilize its assets, may wish to attend one of three no-cost roadshows in May that are part of the Noble Capital Markets and Channelchek Meet the Management Series. (Get more information here).

Closed Out and Longest Held Positions

Scion exited its positions in Wolverine Worldwide (WWW), MGM Resorts (MGM), Black Knight (BKI), Qurate Retail (QRTEA), and SkyWest (SKYW).

Source: Capedge.com

Take Away

The next Scion Asset Management 13F is expected to be filed on August 15th. While current holdings are unknown, much can be discerned from what top investment managers traded at the time. This information can help guide current thinking. When he has conviction, Michael Burry is not afraid to pull the trigger, long or short. As we have seen, when he lacks conviction, he is equally unafraid to keep his powder dry and sit on the sidelines. Inflation adds a cost to sitting on the sidelines. In late March he was very long and seemed to be gravitating toward segments that were being shunned.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.goldmansachs.com/what-we-do/FICC-and-equities/prime-services/

https://www.sec.gov/Archives/edgar/data/1649339/000090514823000408/xslForm13F_X02/primary_doc.xml

https://capedge.com/filing/1649339/0000905148-23-000408/13FHR/file/2

Release – CVG Announces Participation in The Barrington Virtual Spring Investment Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVG

MAY, 15, 2023

NEW ALBANY, Ohio, May 15, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI) announced today that Andy Cheung, Executive Vice President and Chief Financial Officer, will meet with investors at the Barrington Research Virtual Spring Investment Conference on May 18, 2023.

For further information, please contact CVGI@alpha-ir.com

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Source: Commercial Vehicle Group, Inc.

Release – Onconova Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

May 15, 2023

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., May 15, 2023 (GLOBE NEWSWIRE) —  Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2023, and provided a business update.

Highlights for the first quarter of 2023 and recent weeks include:

  • The first participant was dosed in the Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). The trial remains on track for a preliminary data readout from its Phase 1 portion in the fourth quarter of this year.

  • Safety data from the Phase 1 solid tumor trial evaluating a continuous daily dosing schedule of narazaciclib continue to be encouraging with the maximum tolerated dose awaiting confirmation. The trial has enrolled patients in its sixth dose escalation cohort, which evaluates a 240 mg oral dose of narazaciclib.

  • Two posters presented at the American Association for Cancer Research (AACR) Annual Meeting featured the results of preclinical studies of narazaciclib. Data showed that, in addition to inhibiting kinases such as CDK 4 and CDK 6, narazaciclib treatment led to the degradation of other kinases not targeted by the FDA-approved CDK 4/6 inhibitor palbociclib. These kinases included BUB1, the overexpression of which was shown to be associated with poor prognosis in breast cancer and uterine corpus endometrial carcinomas. In addition, data presented showed that narazaciclib’s activity in several preclinical cancer models compared favorably to that of FDA-approved CDK 4/6 inhibitors.

  • The second of two evaluable participants in the investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) achieved a complete clinical response of all cancerous skin lesions following four treatment cycles of oral rigosertib. Thus, both patients evaluable for response achieved complete cutaneous remissions (CCR). This data and the rational for the study of rigosertib in RDEB-SCC was presented at the recent meeting of the Society of Investigative Dermatology Meeting in Osaka, Japan. Onconova has requested a Type B Meeting to review these initial data with the U.S. Food and Drug Administration (FDA), with the goal of identifying the optimal regulatory path for rigosertib in RDEB-associated SCC. Onconova expects to provide an update on the Type B meeting after it has received written feedback from the agency.

  • Rigosertib’s additional investigator-sponsored trials continue to progress. A Phase 2 trial of rigosertib combined with Merck’s anti-PD-1 therapy KEYTRYDA® (pembrolizumab) in checkpoint inhibitor refractory melanoma recently opened for enrollment. The Phase 1/2a trial of rigosertib in combination with Bristol Meyer Squibb’s OPDIVO® (nivolumab) in KRAS-mutated non-small cell lung cancer (NSCLC) is ongoing. Based on previously reported data that showed an encouraging signal of efficacy and that the studied doublet was well tolerated. The NSCLC trial protocol has been amended to add cohorts evaluating increasing doses of rigosertib in combination with the standard dose of nivolumab. Data from these additional cohorts are expected alongside updated data from the trial’s earlier cohorts in 2023.

  • Onconova recently entered into a collaboration agreement with Pangea Biomed. The collaboration will leverage Pangea Biomed’s proprietary algorithmic platform, ENLIGHT, with the goal of identifying biomarkers of response to rigosertib. Onconova retains all rights to rigosertib and will own intellectual property that may result from the research collaboration.

  • Preclinical data characterizing rigosertib’s multi-faceted mechanism of action were recently featured in a poster presentation at the AACR Targeting RAS Conference.

Management Commentary
“Recent progress has us approaching important clinical and regulatory milestones expected later this year,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We recently dosed the first participant in our Phase 1/2a trial of narazaciclib plus letrozole in recurrent metastatic LGEEC. This trial is supported by prior clinical data providing proof-of-concept for the studied doublet’s mechanism of action, as well as preclinical and Phase 1 results that suggest narazaciclib can overcome the shortcomings of the off-label agents current combined with letrozole to treat this indication. Collectively, these data fuel our enthusiasm for the program as we advance towards a preliminary data readout expected in the fourth quarter.”

Dr. Fruchtman continued, “In rigosertib’s RDEB-associated SCC program, we have requested a Type B meeting to discuss our encouraging clinical data with the FDA and expect to provide an important regulatory update following the meeting. Though from a small number of patients, these data have far exceeded our expectations, with both of the program’s participants achieving durable, complete clinical responses of all cancerous skin lesions on rigosertib monotherapy. Given the strength of these data, the ultra-rare nature of RDEB-associated SCC, and the stark limitations of currently available therapies, we are committed to working with the agency to determine the best, most expeditious path towards a potential approval.”

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2023 were $34.2 million compared with $38.8 million as of December 31, 2022. The company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2024.

Research and development expenses were $4.1 million for the first quarter of 2023, compared with $2.0 million for the first quarter of 2022.

General and administrative expenses were $2.1 million for the first quarter of 2023, compared with $2.2 million for the first quarter of 2022.

Net loss for the first quarter of 2023 was $5.8 million, or $0.28 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.1 million, or $0.20 per share for the first quarter of 2022 on 20.9 million weighted shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the first quarter of 2023, provide a business update, and answer questions. Interested parties can participate by dialing (800) 715-9871 (domestic callers) or (646) 307-1963 (international callers) and using conference ID 9090989.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

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

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

Forward Looking Statements

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

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

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

Release – GeoVax Next-Generation COVID-19 Vaccine Data to be Presented at Two Upcoming Scientific Meetings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Presentations to Include New and Unpublished Data from Phase 2 Open-Label Safety Study of GEO-CM04S1

Atlanta, GA, May 15, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it will be represented during two upcoming scientific meetings, including Vaccines Summit Boston 2023 in Boston, MA, May 22-24, 2023 and CYTO 2023 in Montréal, Québec, Canada, May 20-24, 2023.

Vaccines Summit Presentation: Monday, May 22, 2023, 3:00 pm -3:30 pm ET, Session Talks – II

On Monday, May 22, Don Diamond, Ph.D., Professor, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, will deliver a presentation titled, “Assessment of GEO-CM04S1 for Prevention of COVID-19 in Immunocompromised Cell Therapy Patients; An Open-Label Safety Study.”

Dr. Diamond’s presentation will include a description of the development and clinical testing of GeoVax’s vaccine candidate, GEO-CM04S1. CM04S1 is a next-generation COVID-19 vaccine based on the use of the MVA viral vector platform, which presents multiple antigens to the immune system to induce both antibody and T cell responses. The vaccine is designed to provide durable protection against new and continually emerging variants of COVID-19, limiting the need for frequent modification and updating.

GeoVax is focusing on the clinical development of this vaccine for use in patients with impaired ability to mount adequate protective immune responses to currently available COVID-19 vaccines, to include those with certain malignancies and autoimmune disorders, cell and organ transplant patients, individuals with end-stage kidney disease receiving hemodialysis, and potentially elderly individuals who respond poorly to other vaccines. These individuals may not be able to raise or maintain protective antibody responses following receipt of first-generation mRNA vaccines, contributing to reduced vaccine efficacy.

Dr. Diamond’s presentation will include new and unpublished data from the open-label portion of the Phase 2 trial in patients undergoing hematological cancer treatment.

CYTO Poster Presentation: Tuesday, May 23, 2023, 5:30 pm – 6:00 pm ET, Exhibit Hall 210

On Tuesday, May 23, Sandra Ortega-Francisco, Ph.D., Department of Hematology and Hematopoietic Cell Transplantation and Hematologic Malignancies Research Institute, City of Hope, will participate in a poster presentation titled, “Induction of multi-antigen specific T cell responses by a synthetic MVA-SARS-CoV-2 vaccine in patients with hematological malignancies.”

Similar to the Vaccines Summit presentation by Dr. Diamond, Dr. Ortega-Francisco’s poster presentation will also address preliminary data from the ongoing Phase 2 study of CM04S1 in patients with hematologic malignancies who are at a heightened risk of severe COVID-19.

About GEO-CM04S1

CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to provide protection against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

CM04S1 continues to advance in two Phase 2 clinical studies, one as a primary vaccine for immunocompromised cancer patients, in direct comparison to either the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04977024), and the second as a booster for healthy patients who have previously received either the Pfizer or Moderna vaccine as their initial inoculation (ClinicalTrials.gov Identifier: NCT04639466).

About GeoVax

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

Forward-Looking Statements

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

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

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Release – ZyVersa Therapeutics Announces Article Published in Metabolism Pointing to Glomerular Cholesterol Accumulation as Key Factor Exacerbating Renal Injury and Dysfunction in Diabetic Kidney Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 15, 2023

Published data demonstrate that a deficiency in cholesterol transporter ABCA1 increases deposition of cellular cholesterol, contributing to inflammation, cell death (apoptosis), and damage to the kidney’s filtration barrier in type 2 diabetic mice and in human renal glomerular endothelial cells cultured to simulate type 2 diabetes

  • ZyVersa’s Cholesterol Transport Mediator™ VAR 200 is in development to reduce renal cholesterol and lipid accumulation that damages the kidneys’ filtration system in patients with glomerular diseases (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport Syndrome)
  • VAR 200 mediates transport of excess cholesterol out of kidney cells passively and by upregulating cholesterol transporter ABCA1

WESTON, Fla., May 15, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Metabolism, which supports the mechanism of action of Cholesterol Efflux Mediator™ VAR 200 in development to treat kidney diseases.

In the paper titled, “ABCA1 deficiency-mediated glomerular cholesterol accumulation exacerbates glomerular endothelial injury and dysfunction in diabetic kidney disease,” the authors reported that ABCA1 deficiency contributes to injury and dysfunction of the kidney’s filtration system (glomerular endothelium) in early diabetic kidney disease (“DKD”). They proposed that ABCA1 transporter deficiency results in glomerular cholesterol/lipid accumulation leading to inflammation and cell death. This causes structural and functional damage to the kidney’s filtration system and in turn, protein spillage into the urine (proteinuria) and DKD progression.

The authors concluded that therapies which effectively reduce elevated glomerular cholesterol levels have potential to combat early DKD. To read the article, Click Here.

“The research published in Metabolism demonstrating that deposition of glomerular cholesterol contributes to structural damage and dysfunction of the kidney’s filtration system in models of type 2 diabetes is consistent with data from VAR 200’s preclinical program. Our preclinical program showed similar results not only in models of DKD, but also in models of two orphan kidney diseases, focal segmental glomerular sclerosis (FSGS) and Alport Syndrome. More importantly, by mediating cholesterol transport out of the glomeruli through passive transport and upregulation of ABCA1 transporters, VAR 200 protected against glomerular injury and fibrosis, and significantly reduced protein spillage into the urine in all three kidney diseases,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Given the unmet needs for effective treatments for kidney disease, we are hopeful that VAR 200 will demonstrate similar results in patients with kidney disease in studies planned to initiate late this year,” continued Mr. Glover.

About Cholesterol Efflux Mediator™ VAR 200

Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease progression. VAR 200 passively and actively removes excess lipids from the kidney.

Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate that removal of excess cholesterol and lipids from kidney podocytes protects against structural damage and reduces excretion of protein in the urine (proteinuria).

The lead indication for VAR 200 is orphan kidney disease focal segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat other glomerular diseases, including orphan Alport syndrome and diabetic kidney disease.

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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