Page 398 – Channelchek

Release – ZyVersa Therapeutics Reports First Quarter 2023 Corporate and Financial Results

Posted on May 12, 2023May 12, 2023 by aweinsoff@channelchek.com

May 12, 2023

Key Highlights:

Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal disease
Announced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target – data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer’s disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as Parkinson’s disease and alcoholic hepatitis
Added three internationally recognized experts in the field of glomerular disease to Renal Scientific Advisory Board, and an internationally recognized authority in the field of innate immunity to our Inflammatory Disease Scientific Advisory Board
Enhanced our Board of Directors with addition of three biopharmaceutical leaders with impeccable credentials and a proven track record of success

WESTON, Fla., May 12, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, provides a corporate update and reports financial results for the first quarter of 2023 ending March 31, 2023.

“This is a very exciting time in the growth and evolution of ZyVersa as we seek to build shareholder value through development of first-in-class drugs at the forefront of innovation for renal and inflammatory diseases,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are currently advancing a dynamic pipeline of drug candidates with multiple programs built around our two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases and Inflammasome ASC Inhibitor IC 100 for treatment of multiple CNS and other inflammatory diseases. We believe that both technologies have transformative potential, enabling development of drugs for patients who have limited or no therapeutic options.”

Mr. Glover continued: “Highlighting our Inflammasome ASC Inhibitor IC 100, ZyVersa expects to complete IC 100’s preclinical program this year, with an Investigational New Drug (“IND”) submission anticipated in second quarter of 2024. We were pleased to report publication of data in several peer-reviewed journal articles demonstrating the role of ASC specks in heightening and perpetuating damaging inflammation in neurological conditions (Alzheimer’s disease, Parkinson’s disease, and traumatic brain injury), and in alcoholic hepatitis. These data support the therapeutic potential of inhibiting ASC and ASC specks with IC 100 to control inflammation associated with various inflammatory diseases.”

“Regarding Cholesterol Efflux Mediator™ VAR 200, ZyVersa continues to leverage relationships with experts in the field of renal disease,” stated Mr. Glover. “To that end, we welcomed three new members to our Renal Disease Scientific Advisory Board. We look forward to benefitting from their decades of experience as we advance our investigator-initiated trial to evaluate VAR 200 in patients with renal disease, expected to begin in the fourth quarter of 2023.”

FIRST QUARTER AND RECENT PROGRAM UPDATES

Targeting Renal Disease with Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200

Continued progress is being made to launch an investigator-initiated clinical trial in patients with renal disease to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200, with trial initiation expected in the fourth quarter of 2023
Added to ZyVersa’s Renal Scientific Advisory Board (1) Dr. Daniel C. Cattran, Professor of Medicine, University of Toronto; (2) Dr. Fernando C. Fervenza, Professor of Medicine, Mayo Graduate School of Medicine and Director of the Nephrology Collaborative Group; and (3) Dr. Richard J. Glassock, Professor Emeritus, David Geffen School of Medicine, UCLA

Inflammasome ASC Inhibitor IC 100: Targeting Inflammation Associated with Multiple CNS and Other Inflammatory Diseases

On track to complete IND-enabling preclinical studies by end of year, with the goal of filing an IND application with the U.S. Food and Drug Administration in the second quarter of 2024
Highlighted peer-reviewed journal articles supporting the potential of ASC inhibition to control damaging inflammation associated with numerous diseases, including Alzheimer’s disease, Parkinson’s disease, traumatic brain injury, and alcohol induced hepatitis
Added to ZyVersa’s Inflammatory Disease Scientific Advisory Board Dr. Douglas Golenbock, The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology, and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School

FIRST QUARTER FINANCIAL RESULTS
Since its inception in 2014 through March 31, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $1.3 million as of March 31, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.

Research and development expenses were consistent at approximately $1.1 million for the three months ended March 31, 2023 (“Successor Period”), with an immaterial decrease of $11 thousand or 1.0% from the three months ended March 31, 2022 (“Predecessor Period”).

General and administrative expenses were $3.5 million for the three months ended March 31, 2023, an increase of $1.2 million or 53.7% from $2.3 million for the three months ended March 31, 2022. The increase is primarily attributable to an increase of $0.4 million in director and officer insurance, a $0.4 million increase in marketing costs for investor and public relations, and $0.4 million in payments for the Effectiveness Failure related to the PIPE shares.

Net losses were approximately $3.5 million for the three months ended March 31, 2023, with an improvement of $0.2 million or 5.5% compared to a net loss of approximately $3.7M, for the three months ended March 31, 2022. Net losses for the three months ended March 31, 2023 benefited from a $1.0 Million deferred tax benefit compared to none for the year earlier period.

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 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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

Release – Onconova Therapeutics To Participate In Ladenburg Thalmann Virtual R&D Showcase On Narazaciclib In Endometrial Cancer

Posted on May 12, 2023May 12, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

Showcase to feature presentations by key opinion leaders Drs. Gaël Roué and Bhavana Pothuri

Showcase to take place on May 18, 2023 at 11:00 a.m. ET

NEWTOWN, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven M. Fruchtman, M.D., President & CEO of Onconova Therapeutics, will participate in a Ladenburg Thalmann virtual R&D showcase on Thursday, May 18, 2023, at 11:00 a.m. ET.

The R&D showcase will feature presentations by key opinion leaders Gaël Roué, Ph.D. (Josep Carreras Leukaemia Research Institute), and Bhavana Pothuri, M.D. (New York University Langone Health), who will discuss narazaciclib’s differentiated kinase inhibitory profile, the current treatment landscape in endometrial cancer, as well as Onconova’s planned Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). Presentations by the KOLs will be followed by remarks from Dr. Fruchtman as well as a question and answer session moderated by Ahu Demir, Ph.D., Managing Director, Senior Research Analyst, Ladenburg Thalmann & Co.

To register for the showcase, click here.

KOL Bios

Dr. Gaël Roué leads the Lymphoma Translational Group at the Josep Carreras Leukaemia Research Institute, with a special focus on oncogenic signaling, B-cell receptor pathways and the role of intrinsic protein homeostasis in the control of lymphoma-stroma crosstalk. Dr. Roué obtained his Ph.D. in Molecular and Cellular Biology from the University of Caen. Dr Roué is co-author and lead author of a patent, two book chapters, and nearly 90 articles published in international peer-reviewed journals. He has led almost 20 national and international research projects. Dr Roué also serves as an ad-hoc reviewer for several journals in the fields of hematology and oncology, being an editorial board member for three of them, and is an external evaluator for different national and European funding agencies.

Dr. Bhavana Pothuri earned her medical degree from Jefferson Medical College at Thomas Jefferson University. She completed her residency in Obstetrics and Gynecology at the Jefferson Health System and a fellowship in Gynecologic Oncology at Memorial Sloan Kettering Cancer Center. She is a Professor in the Departments of Obstetrics and Gynecology and Medicine at the New York University (NYU) School of Medicine, Medical Director of Clinical Trials Office, Director of Gynecologic Oncology Clinical Trials, Director of Gynecologic Oncology Research, and Site Principal Investigator for the Perlmutter Cancer Center, NYU Langone Health. Dr. Pothuri is also the Principal Investigator for Onconova’s planned Phase 1/2a trial in endometrial cancer. In addition, her research focuses on using the PARP inhibitor, niraparib, as frontline maintenance treatment for ovarian cancer, as well as dostarlimab, a PD-1 inhibitor, in endometrial cancer.

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, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).

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 – Multi-State Cannabis Operator, Schwazze, Acquires Two Retail Dispensaries From Smokey’s Cannabis Company

Posted on May 12, 2023May 12, 2023 by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

May 12, 2023

OTCQX: SHWZ
NEO: SHWZ

Star Buds Retailer Now Enters the Fort Collins and Garden City Markets in Colorado

DENVER, May 12, 2023 /CNW/ – Schwazze, (NEO: SHWZ) (OTCQX: SHWZ) (“Schwazze” or the “Company”), announced today that it closed the transaction to acquire certain assets of Cannabis Care Wellness Centers, LLC and Green Medicals Wellness Center #5, LLC (d/b/a “Smokey’s”). The transaction includes the recreational and medical use Smokey’s dispensaries located at 2515 7^th Avenue in Garden City as well as 5740 S. College Avenue in Fort Collins. These two vibrant cannabis markets have limited licenses and present Schwazze with more opportunities to serve customers in northern Colorado. This acquisition continues Schwazze’s deliberate expansion in Colorado, bringing the Company’s total number of Colorado dispensaries to 27. The acquired assets included state and local retail marijuana licenses supporting the adult use dispensaries acquired in the transaction.

The consideration for the acquisition was US$7.5 million paid as a combination of cash and stock.

“As we continue to go deep in the state of Colorado, we’re excited to bring our Star Buds operations to both Garden City and Fort Collins. We will operate a store within a store concept to serve both recreational consumers as well as medical patients. By bringing our operating playbook to two key cities in northern Colorado, it allows us to deliver our brands, product assortment and dedicated service to customers in expanded areas throughout the state,” said Collin Lodge, Colorado Division President of Schwazze.

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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-state-cannabis-operator-schwazze-acquires-two-retail-dispensaries-from-smokeys-cannabis-company-301823025.html

SOURCE Medicine Man Technologies, Inc.

Alvopetro Energy (ALVOF) – Conference Call Provides Addition Details On Results and Gas Sales Decline

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

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.

2023-1Q results continued a steady upward production trend and biannual gas price resetting that has lead to higher revenues, fund flow from operations, and earnings. Results were generally in line with expectations. Although gas sales and prices were previously disclosed, total revenues were slightly below expectations due to lower natural gas liquid pricing. Royalty rates fell sharply due to a restructuring and lower natural gas prices.

Sale decline further explained. April volumes averaged 1,972 boepd vs. 2023-1Q production of 2,767 boepd. Management cited reduced demand and higher nominated volumes from its partner in the Cabure unit. Sales in the Cabure field are subject to a partnership agreement based on reserves in the ground. Alvopetro’s partner can then nominate the amount of reserves that are sold from its “piggy bank.” Bahia Gas, the consumer of Alvopetro’s gas supply, can take gas on a firm or interruptible basis. For a 7-10 day period, it took gas primarily from firm customers decreasing the demand for other customers.

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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.

Tokens.com Corp. (SMURF) – A First Look into the Second Quarter

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

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, 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.

Results. Tokens.com reported revenue of $303,217 compared to $326,320 in the prior year. Driven by a $2.6 million digital asset revaluation gain, operating income was $1.9 million compared to a loss of $3.2 million last year. Net income for the quarter was $1.7 million, or diluted EPS of $0.02, compared to $7.8 million, or $0.07. We estimated revenue of $115,000, operating loss of $482,000, and breakeven EPS.

Macro Environment. Tokens.com noted that the ETH Shapella upgrade showed an increase in staking activity, which results in lower yields but is countered with the increase in crypto prices over the last few months. We expect that staking revenue will remain volatile for Tokens.com’s ETH and DOT but will have increases quarter-over-quarter, assuming prices stay level or increase.

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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).

RCI Hospitality Holdings (RICK) – Continuing the Momentum

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

With more than 60 units, RCI Hospitality Holdings, Inc., through its subsidiaries, is the country’s leading company in adult nightclubs and sports bars/restaurants. Clubs in New York City, Chicago, Dallas-Fort Worth, Houston, Miami, Minneapolis, Denver, St. Louis, Charlotte, Pittsburgh, Raleigh, Louisville, and other markets operate under brand names such as Rick’s Cabaret, XTC, Club Onyx, Vivid Cabaret, Jaguars Club, Tootsie’s Cabaret, Scarlett’s Cabaret, Diamond Cabaret, and PT’s Showclub. Sports bars/restaurants operate under the brand name Bombshells Restaurant & Bar.

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.

Second Quarter Results. RCI reported revenue of $71.5 million, up 12.3% from last year. Net income was $7.7 million, or EPS of $0.83 compared to $11 million, or $1.15, last year due to a legal settlement expense, goodwill impairment, and SG&A expenses. Adjusted EPS was $1.30 versus $1.19. Adjusted EBITDA was at $21.7 million versus $19.9 million last year. We estimated revenue of $71 million, net income of $10.6 million, EPS of $1.15, and adjusted EBITDA of $21.3 million.

A Busy Quarter. The Baby Dolls-Chicas Locas acquisition was completed. The steakhouse and casino project continued to move forward. The Company purchased another Central City property for development of another potential future casino. The San Antonio Bombshells location was purchased and development moved forward on locations in Colorado and Texas. These investments will help drive results going forward.

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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).

Largo Inc. (LGO) – Post conference call thoughts

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURE™ and VPURE+™ products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business support a low carbon future.

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.

Quarterly results reviewed. As indicated in an earlier report, first-quarter results were generally in line with expectations. Revenues ran a bit above expectations on favorable pricing, but costs were higher than expected as well.

Production and sales guidance reductions. Management reduced production and sales guidance by roughly 20% due to drilling delays caused by wet weather. Management explained that vanadium production requires blending, and we believe regular drilling is needed to identify blending supplies. Drilling has resumed, and management should have a better idea what production and sales could look like for the rest of 2024 soon.

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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).

Motorsport Games (MSGM) – Is There Enough Gas To Get To The Finish Line?

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

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, 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.

Q1 results disappoint. The company reported its first quarter results, which were disappointing, but not unexpected. With the lack of current franchise game releases, total company revenues declined 48% to $1.7 million. Given the continued investment in game development, EBITDA loss increased to $4.6 million, well above our $2.2 million loss estimate.

A tough situation. Management is trying to get to the finish line of launching new franchise motorsport games, which should provide a significant revenue lift and generate positive cash flow. The largest opportunity for that prospect would be in the second quarter 2024 when it launches its new IndyCar game.

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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).

Direct Digital Holdings (DRCT) – Posted Some Great Digits To Start The Year

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

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.

Strong Q1 results. The company reported strong quarterly results. Revenue grew 87% from Q1 22 to $21.2 million, beating our estimate of $17.1 million by 24%. Additionally, Adj. EBITDA of $0.5 million surpassed our estimate of negative $0.2 million. The better than expected results were a product of strength in both Buy-side and Sell-side segments.

Buy-side excels. The company’s higher margin Buy-side segment reported revenue of $7.4 million, beating our estimate of $6.1 million by 22%. While Buy-side only comprises 35% of revenues, its margins are much higher than Sell-side and contributes to cash flow in a more meaningful way. Management attributed the success of its Buy-side segment to existing clients spending 20% to 30% more, and increasing is client base by 3%.

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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).

Codere Online (CDRO) – Another Quarter Of Favorable Execution

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.

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.

Beats Q1 expectations. The company reported strong Q1 results with net gaming revenue (NGR) of €39.5 million and an adj. EBITDA loss of €2.3 million, compared with our forecast of €33.5 million and a loss of €9.2 million, respectively. The company achieved the favorable results after lowering its marketing spend to streamline its path to profitability.

Performing well in Mexico. Despite lower marketing spend, net gaming revenue (NGR) in Mexico continued to grow in Q1. NGR of €17.6 million was up 75% while the adj. EBITDA loss of €2.0 million, compared with a €7.7 million loss in the prior year period. The strong results in Mexico were driven by a 42% increase in active users and higher spend per active user.

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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).

1·800·Flowers.com, Inc. (FLWS) – Margin Improvement Could Even Accelerate

Posted on May 12, 2023May 12, 2023 by cpereira@noblefcm.com

Friday, May 12, 2023

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

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.

Margins improve. The company reported $417.6 million in revenue, 1.9% below our estimate of $425.8 million. But, importantly, adj EBITDA in the quarter was negative $5.5 million, beating our estimate of a loss of $13.1 million by 57.5%. Improved margins in the quarter were attributed to reduced ocean freight costs and some commodity price decreases.

Raises fiscal 2023 adj. EBITDA guidance. Management provided full year fiscal 2023 guidance of revenue down 8% and adj. EBITDA to be in the range of $85 million to $90 million, an increase from its previous guidance of $75 million to $80 million. In addition, the company reiterated that it will exceed $75 million in free cash flow.

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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).

Investing in Futures Contracts: What Beginners Should Know

Posted on May 12, 2023May 12, 2023 by phoffman@channelchek.com

Basics for Individuals Looking to Use Futures in Investing

Should you use futures in investing your portfolio? Futures trading can be an exciting and potentially lucrative investment opportunity for those who are willing to assume the risks involved. The contracts allow investors to trade a wide range of assets, from commodities like oil and gold to financial instruments like stock indices and currencies. Below we’ll explore what futures trading is, what types of assets are traded in the futures market, the advantages and disadvantages of futures trading, and what beginners should know about trading platforms and the Chicago Mercantile Exchange (CME).

Background

Futures were originally designed to allow buyers and sellers of raw materials to lock in a price and know their future costs to avoid being impacted by factors affecting the commodity’s price, like weather. The market later grew to help other businesses, such as utilities and airlines, hedge against unknown fuel costs – and the products continue to expand today. Currently, futures are being used by all manners of investors, speculators, and those that want to hedge against the risk of future cost spikes.

This has made for deep markets, the trading volume in futures contracts, is now often a multiple of the trading of the underlying physical assets. This is the case with oil futures contracts. The addition of professional and individual investors and speculators has dramatically increased trading volume. This helped make the financial products extremely liquid compared to when they just functioned as insurance against manufacturing price risk.

It is no surprise, then, that many speculators are drawn to futures trading, both for the potential of outsized profits and the ability to have exposure to assets that may otherwise not be accessible to the investor.

What is Futures Trading?

A futures contract is an agreement to buy or sell an asset at a specified price and time in the future. Futures contracts are traded on organized exchanges, such as the CME, which provide a platform for buyers and sellers to trade contracts. Unlike stocks or bonds, futures contracts are derivative products, meaning that their value is derived from the underlying asset. The underlying asset can be a physical commodity, such as gold or oil, or a financial instrument, such as a stock index or a currency.

Terms Used in Futures Trading

Before making any transaction, especially investing in futures contracts, it is critical to understand some of the most used key terms in futures trading:

Contract Size: The amount of the underlying asset covered by one futures contract.

Contract Expiration: The date when the futures contract expires.

Margin: The amount of money an investor must deposit to buy or sell a futures contract.

Settlement: The process of fulfilling the terms of a futures contract by exchanging the underlying asset or its cash value.

Types of Assets Traded in the Futures Market

As mentioned earlier, there continue to be new types of futures contracts being brought to market. The futures market offers a wide range of assets that can be traded through futures contracts. Some of the more commonly traded assets among self-directed traders include:

Commodities: Futures contracts are frequently used to trade commodities like crude oil, gold, silver, and agricultural products like wheat and corn.

Financial Instruments: Futures contracts are also used to trade financial instruments like stock indices, bonds, and currencies.

Advantages and Disadvantages of Futures Trading

Like any investment opportunity, futures trading has its advantages and disadvantages. Here are a few of the key advantages and disadvantages of investing in futures contracts:

Advantages:

Leverage: Futures contracts offer investors the ability to leverage their investment, meaning that they can control a larger amount of the underlying asset with a smaller amount of capital.

Diversification: Futures contracts provide investors with a way to diversify their portfolio by investing in a wide range of assets.

Liquidity: The futures market is highly liquid, meaning that investors can easily buy and sell contracts without impacting the market.

Disadvantages:

Risk: Futures trading is a highly speculative investment opportunity and involves significant risk. A futures position can also quickly turn against you – the high leverage could make matters worse this is because margin magnifies both profits and losses.

Complexity: Futures trading can be complex and requires a good understanding of the underlying asset and market conditions. Often there are factors that impact price movements that are well beyond the ability of an individual to account for.

Costs: Futures trading can be expensive, while commissions on future trades are very low and are charged when the position is closed, usually as low as 0.5% of the contract value, the spread between the bid and offer may be wide which could impact costs when it’s time to close out the position.

What is the CME?

The Chicago Mercantile Exchange, or The Merc is one of the largest and most well-known futures exchanges in the world. It offers a platform for trading futures contracts on a wide range of assets, including commodities, financial instruments, and currencies. The CME also provides a range of resources for investors, including market data, trading tools, and educational materials.

What Should Self-Directed Investors Look for in a Trading Platform?

Self-directed investors who are interested in trading futures contracts should look for a trading platform that doesn’t limit their growth as a trader. As such it should offer a range of broad range features and resources. Here are a few key features beginner futures traders look for:

Easy-to-use interface: Auser-friendly interface can make it easier for investors to navigate the trading platform and place trades. A complex and confusing interface can make it difficult for investors to execute trades quickly and efficiently, which could result in missed opportunities or costly mistakes. If you are currently using a platform for stock trading, see if they have ample futures capabilities. At times, comfort and familiarity navigating a platform can make all the difference.

Mobile compatibility: Many investors prefer to trade on-the-go using their mobile devices. A good trading platform should be compatible with mobile devices, allowing investors to monitor their trades and make trades from anywhere with an internet connection.

Access to market data: This would seem basic, but access to real-time market data, including price quotes, charts, and news feeds, is essential. This information can keep you looking at what is occurring now, not 20 minutes ago before a market-moving economic report was released.

Advanced order types: The ability to place advanced order types, such as stop-loss and limit orders, can help investors manage their risk and control their trades more effectively.

Educational resources: Futures trading can be complex and requires a good understanding of the underlying asset and market conditions. A good trading platform should provide investors with access to educational resources, such as articles, tutorials, and webinars, to help them learn about futures trading and stay up-to-date on market trends.

Commission and fees: Trading fees can add up quickly and eat into profits. It is important to choose a trading platform that offers competitive commission and fees, without sacrificing the quality of service or features offered.

Take Away

Investing in futures contracts has developed to include many different underlying asset types. It has also become much easier for the individual and average investor to be involved. The leverage magnifies moves, this can be a high-risk, high-reward trading experience.

Before investing, it is important to understand the risks and benefits of futures trading, as well as the key terms and concepts used in the futures market. Choosing the right trading platform can also be crucial to success, as it can provide investors with the tools, resources, and support needed to make informed trading decisions and stay ahead of the market.

Paul Hoffman

Managing Editor Channelchek

Sources

https://www.cmegroup.com/trading/why-futures/get-started-trading-futures.html

How to Determine When a Biotech Stock Could Expect Market-Moving News

Posted on May 12, 2023May 12, 2023 by phoffman@channelchek.com

Does the FDA Provide Information that Helps Pharmaceutical Stock Investors?

Investors with a “Stocks on the Move” or “Market Movers” window open sometimes witness a stock climb double or triple digits during a single trading day. It often turns out that it’s a drug company that just passed an FDA milestone. When this happens, these companies have the potential for large movements. The natural question investors ask is, how does one become more aware that there may be an extreme movement in a biotech, or pharmaceutical stock? For wisdom on this subject, I turned to Robert LeBoyer, the Senior Life Sciences Analyst at Noble Capital Markets. Below, cutting through many complex details and variables, is what I discovered from the veteran equity analyst.

The key is to first understand the framework of the FDA approval process. This will help an investor understand the significance of activity and even where to find key dates and imminent decision periods. Especially toward the end of the process, it is especially then when there are events that could rocket the company stock or cause it to retreat. These are PDUFA calendar deadlines and advisory panel meeting dates. Below is an outline of the process and key dates that may allow investors to position themselves to take advantage of any big jump (or even sudden decline) in a biotech’s stock price.

Understanding The FDA Approval Process

The FDA is responsible for regulating the safety and efficacy of drugs and medical devices in the United States. The review process for new drug applications falls under the legally required format called the Prescription Drug User Fee Act (PDUFA).

PDUFA requires the FDA to collect fees from drug developers to fund the review process, in exchange, the FDA has an obligation to answer the application within ten months. The PDUFA legislation has improved the process for companies seeking FDA approval helping to speed the review process. The fees collected are used to hire additional staff and overall improve the FDA’s review process. This avenue has many benefits. It accelerates the process for the companies that are seeking approval as the FDA can afford greater resources, it benefits the taxpayers as the FDA is then subsidized by those that use its service to review potential products, and it helps those with medical conditions that may benefit from a new drug or class of therapy coming to market sooner as a result of the FDA having greater resources.

The first step is pre-clinical testing in animals for indications of effectiveness and toxicity in a laboratory. If satisfactory, it clears the way for the company to submit an investigational new drug application (IND) to the FDA. The overriding goal of pre-clinical testing is to demonstrate that the product safe to then be tested in humans. The IND application outlines what the sponsor of the new drug proposes for human testing in clinical trials. Once reviewed and granted the company can move to clinical trials.

Clinical Trials

Clinical Trials are done in three phases designed to determine the drug candidate’s safety, characterization, and proof of efficacy.

Phase 1 studies (typically involves 20 to 80 people).

This phase involves testing the drug candidate on a small group of healthy volunteers to assess the drug’s safety and determine the appropriate dosage range. The primary goal is to verify safety and to identify any potential side effects.

Phase 2 studies (typically involve a few dozen to about 300 people).

This phase involves testing the drug on a larger trial group of patients that have the condition the drug is intended to treat. In this phase, the developer determines the drug’s efficacy, optimal dosage, and potential side effects. The primary goal is to assess and characterize the drug’s effectiveness in treating the targeted condition. Stocks will sometimes move on Phase 2 effiacy results.

Phase 3 studies (typically involve several hundred to about 3,000 people).

This final clinical study phase involves testing the drug on an even larger and intentionally diversified group of patients with the very condition the drug is intended to treat. These clinical trials are randomized and controlled to confirm the drug’s safety and efficacy in comparasin to existing treatments, a placebo, or both. The primary goal is to demonstrate statistically significant benefit, as defined by the trial parameters.

The announcement of Phase 3 results is a huge milestone, and by itself ordinarily impacts a stock’s price.

According to the Congressional Budget Office (CBO) only about 12 percent of drugs entering clinical trials are ultimately approved for introduction by the FDA. But it is costly; estimates of the average R&D cost per new drug range from less than $1 billion to more than $2 billion per drug. So in addition to being expensive, it’s an uncertain process – many potential drugs never make it to market. This is why full FDA approval, which isn’t automatic after a successful Phase 3 clinical trial, can create an huge upswing, even when expected.

Several things can go wrong during the three phases; these include unexpected side effects or toxicity, lack of efficacy, or failure to meet the primary endpoints of the clinical trial. The developer may even find that it is less effective than current medications. These issues can lead to delays in the approval process, additional studies, or even the termination of the drug’s development.

However, if the clinical trials are successful, the company is ready to file a New Drug Application with the FDA.

FDA Panels are experts with knowledge specific to what is being reviewed (Source: FDA)

New Drug Application (NDA)

There is a pre-NDA period, just before a new drug application is submitted to the FDA. At this time the company may seek guidance from the FDA on the new drug process.

The Submission of an NDA is the formal step that asks the FDA to consider the drug for approval to market. The FDA then has 60 days to decide whether the application gets filed for review. If the FDA files to review the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.

The FDA review includes a product label approval which includes how the drug can be used. This is very important because the drug can only be marketed within the label indications. The FDA also will inspect the facilities where the drug will be manufactured as part of the approval process.

FDA reviewers will either approve the application or instead issue a complete response letter.

PDUFA Calendar

The FDA PDUFA calendar is a schedule of dates for upcoming PDUFA decisions. These dates are important to investors in biotech and pharmaceutical companies because they represent the time period when the FDA will make a decision about a new drug application. If a drug is approved, it can eventually generate significant revenue for the company, while rejection can lead to a decline in the stock price as investors are disappointed.

Updates direct from the FDA on their calendar and meeting schedule can be subscribed to here.

Advisory Panel

In addition to PDUFA dates, there are other FDA events that can trigger movement in biotech and pharmaceutical stocks. These events include advisory committee meetings, which are meetings where a panel of experts provides recommendations to the FDA on whether to approve a drug or not. These meetings can provide insight into the FDA’s thinking and can influence the stock price.

A schedule of FDA Advisory Panel meetings can be found here.

Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.

Other events that can impact the stock price include Complete Response Letters (CRLs), which are letters from the FDA that outline deficiencies in a drug application and can delay approval. Additionally, FDA inspections of manufacturing facilities can impact the stock price if there are concerns about quality control or manufacturing processes.

Take Away

Investors looking to grow their watch list to include biotech stocks that are in line to receive positive news that could drive the stock value way up or even disappointing news that would weigh on the price, could pay attention to the FDA approval process.

The process is an important tool for biotech and pharmaceutical companies, investors, and analysts. PDUFA dates represent the time when the FDA will make a decision about a new drug application, and can have a significant impact on the stock price. However, there are other FDA events that can also impact the stock price, such as advisory committee meetings, CRLs, and manufacturing facility inspections. It is helpful to stay informed about these events to make knowledgeable investment decisions in the biotech and pharmaceutical industry.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-28-2023-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04282023

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued#:~:text=Phase%201%20studies%20(typically%20involve,application%20(NDA)%20is%20submitted.

https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-pdufa-meeting-management#subscribe