| CytoDyn (OTCQB: CYDY) Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Coronavirus |
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CytoDyn (OTCQB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).
Why It Matters: Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected. CytoDyn scientists believe that the Company’s data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in CytoDyn’s clinical trials, the Company believes leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients.
Key Quote: “If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients.” – Nader Pourhassan, Ph.D., President & CEO
The Backstory: CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.
Disclosure
CytoDyn (CYDY) is a client of RedChip Companies, Inc. CYDY agreed to pay RedChip Companies, Inc., a $20,000 quarterly cash fee, beginning in February 2020, for RedChip investor awareness services.
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| Can-Fite BioPharma (NYSE American: CANF) Seeks to Test its Lead Drug Candidate Against Coronavirus |
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Can-Fite BioPharma (NYSE American: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that it is now exploring a collaboration to look at the effect of its rheumatoid arthritis (RA) drug, Piclidenoson, against Coronavirus.
Why It Matters: Recently, two pharmaceutical companies announced the introduction of RA drugs for the treatment of patients with Coronavirus. Gilead is conducting a clinical study in China which combines its anti-viral drug candidate Remdisivir with the old RA drug chloroquine. In addition, Roche has donated its Actemra anti-RA drug for the treatment of patients in China. Can Fite is now exploring the possibility to collaborate with leading virology labs to explore the anti-viral effect of its drugs against the Coronavirus based on the known anti-viral and anti-rheumatic effects of the company drugs.
The Backstory: Can Fite completed the enrolment of 50% of the 525 patients planned for its Phase III ACRobat™ trial to evaluate its drug candidate Piclidenoson as a first-line treatment for RA. An interim analysis is being implemented, and will be managed and monitored by an independent data monitoring committee (IDMC) that will have un-blinded access to the data which are expected during Q3 2020.
Disclosure
Can-Fite Biopharma (CANF) is a client of RedChip Companies, Inc. CANF agreed to pay RedChip Companies, Inc. a cash fee of $5,000 monthly, beginning in August 2019, and 16,500 shares of CANF Rule 144 stock for 6 months of RedChip investor awareness services and consulting services.
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| Medalist Diversified REIT (NASDAQ: MDRR) Announced Revenue Up 67% in Q4 |
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Medalist Diversified REIT (NASDAQ: MDRR), a Virginia-based real estate investment trust that specializes in acquiring, owning and managing value-add commercial real estate in the Mid-Atlantic and Southeast regions, reported unaudited operating results for its year and quarter ended December 31, 2019.
- Revenue up 66.8% in Q4 to $3.1 million
- Positive Adjusted Funds From Operations (AFFO) in Q4; up $823,363 YoY to $380,436
- Total assets increased to $83.2 million, up from $30.1 million at end of prior year period
The Backstory: Medalist specializes in acquiring, owning and managing value-add commercial real estate in the Mid-Atlantic and Southeast regions. The Company's strategy is to focus on value-add and opportunistic commercial real estate which is expected to provide an attractive balance of risk and returns. Medalist utilizes a rigorous, consistent and replicable process for sourcing and conducting due diligence of acquisitions. The Company seeks to maximize operating performance of current properties by utilizing a hands-on approach to property management while monitoring the middle market real estate markets in the southeast for acquisition opportunities and disposal of properties as considered appropriate.
Disclosure
Medalist Diversified REIT (MDRR) is a client of RedChip Companies, Inc. MDRR agreed to pay RedChip Companies, Inc. a monthly cash fee of $4,250 for four (4) months followed by a monthly cash fee of $8,500 for eight (8) months of RedChip investor awareness services, beginning in August 2019.
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| Nemaura Medical (NASDAQ: NMRD) Launches SugarBEAT® App Ahead of Commercial Launch of New Subscription Service |
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Nemaura Medical (NASDAQ: NMRD) launched its sugarBEAT® App for Android devices on the Play Store in preparation for the planned launch of the Company’s BEAT®diabetes subscription based service expected for next month.
Why It Matters: BEAT®diabetes is a subscription-based service which, we believe, over time will provide both people with prediabetes and Type 2 diabetes with a number of affordable and empowering tools to better manage, prevent and potentially even reverse their condition. The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The UK licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®.
Key Quote: “We believe that the launch of our app is a big step towards our commercial milestones, and we are looking forward to launching the BEAT®diabetes subscription service shortly during Type 2 Diabetes Prevention Week in the UK. This is a very exciting time in our company’s development.” – Dr. Faz Chowdhury, CEO
The Backstory: Nemaura is a medical technology company commercializing BEAT®diabetes, a health subscription service designed to help people with diabetes and prediabetes better manage diabetes and reverse Type 2 diabetes or prevent diabetes through 1-on-1 lifestyle coaching and behavior driven by real time continuous glucose monitoring (CGM) and daily glucose trend data provided by sugarBEAT®, a non-invasive and flexible CGM. The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019.
Disclosure
Nemaura Medical (NMRD) is a client of RedChip Companies. NMRD agreed to pay RedChip a monthly cash fee of $6,000 and 15,000 shares of Rule 144 stock for three months of investor awareness services.
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| 1847 Holdings (OTC: EFSH) Appoints Jay Amond as CEO of Newly Created 1847 Hydroponic Inc. Subsidiary |
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1847 Holdings (OTC: EFSH), a unique publicly traded holding company platform that combines the attractive attributes of private, lower-middle market businesses with the liquidity and transparency of a publicly traded company, appointed Jay E. Amond as chief executive officer of its recently formed subsidiary, 1847 Hydroponic Inc.
Why It Matters: Prior to joining 1847, Amond was President & CEO of Nebraska Book Company Holdings, a 100+ year-old bookseller that has grown into one of North America’s largest wholesale textbook distributor, technology solutions provider and a key consulting partner to more than 2,000 Higher Education retailers nationwide. Before becoming President & CEO, Amond held the role of CFO and Treasurer for the company. Previously, Amond held senior financial leadership roles at Patina Solutions, Follett Higher Education Group, Ross Stores, Ultimo Enterprises, Hot Topic, and Federated Department Stores.
Key Quote: “Jay is the right person to lead our newest company as we move forward with a key acquisition poised for significant growth in the cannabis industry. As a results-oriented strategic leader with a high level of expertise in translating a company’s direction and strategic vision into actionable goals, Jay is an extremely welcome asset to our team.” – Ellery Roberts, CEO
The Backstory: 1847 Holdings announced an LOI to acquire a multi-state hydroponics retailer in January. Once completed, this acquisition will be the Company’s third operating subsidiary. 1847 Holdings combines the most attractive attributes of owning private, lower-middle market businesses with the liquidity and transparency of a publicly traded company. 1847 Holdings seeks to generate returns for shareholders in the future through consistent, annual distributions of operating subsidiary income and capital appreciation resulting from the timely sale of operating subsidiaries.
Disclosure
1847 Holdings (EFSH) is a client of RedChip Companies, Inc. EFSH agreed to pay RedChip Companies, Inc. a $8,500 monthly cash fee, beginning in November 2019, and 100,000 restricted common shares of EFSH stock for 12 months of RedChip investor awareness services.
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| Immuron (NASDAQ: IMRN) Provides Update on First Half of FY20 Results |
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Immuron (NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the treatment of gut mediated diseases, announced an update of its results for the first half of fiscal year 2020 ended on December 31, 2019.
Key Highlights:
- Strong continued growth of Travelan® sales reported in all markets
- Global sales reached USD $1.1 million (AUD $1.68 million) for first half FY 2020 up 55% from first half FY 2019
- North American Travelan® sales up by 98% YoY in the first half of FY20
- IMM-124E/Travelan® US registration strategy - Pre-IND meeting completed with the U.S. FDA
- USD $3.7 (AUD $5.5) million non-dilutive funding approved by US Department of Defense to develop and clinically evaluate a new therapeutic targeting Campylobacter and ETEC
- FDA strategy updated for clinical development of IMM-529
- U.S. Department of Defense Travelan® Shigellosis animal study results reported
- Three new Shigella drug product candidates commence preclinical evaluation by WRAIR
- Research and development tax concession refund paid
The Backstory: Immuron (NASDAQ: IMRN) is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron has a novel and safe technology platform with one commercial asset generating revenue. In Australia, Travelan® is a listed medicine on the Australian Register of Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travellers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licenced natural health product (NPN 80046016) and is indicated to reduce the risk of Travellers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA). Immuron’s lead clinical candidate, IMM-124E, is presently in Phase II trials in Severe Alcoholic Hepatitis (SAH) and Pediatric Nonalcoholic Fatty Liver Disease (NAFLD). The company now has plans to develop a U.S. registration dossier for IMM-124E for Travellers’ Diarrhea. Immuron’s second clinical-stage asset, IMM-529, targets Clostridium difficile Infections (CDI), and is in clinical trial development in CDI patients. These products together with the Company’s other preclinical immunotherapy pipeline products currently under development targeting immune-related and infectious diseases are anticipated to meet pressing needs in the global immunotherapy market.
Disclosure
Immuron Ltd. (IMRN) is a client of RedChip Companies, Inc. IMRN agreed to pay RedChip Companies, Inc. a $7,500 monthly cash fee, beginning in June 2017, for investor awareness services.
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| Quote of the Week |
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"If you want to invest in the microcap space buy companies not stocks,
if you buy stocks, the daily fluctuations and lack of liquidity will drive you crazy."
- Byron Roth CEO of ROTH Capital Partners |
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| About RedChip |
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| RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on small-cap and mid-cap companies. Since 1992, RedChip has delivered concrete, measurable results for its clients through the most comprehensive service platform in the industry for small-cap and mid-cap companies. These services include a worldwide distribution network for its stock research written by analysts holding the CFA designation; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated over 2.3 million unique investor views; quarterly global online institutional and retail investor conferences that reach over 10,000 investors annually; "The RedChip Money Report" television show which airs in 100 million homes across the U.S. on The Family Channel; a weekly newsletter delivered to 60,000 investors; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more. |
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| RedChip Disclosure |
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RedChip Companies, Inc. research reports, company profiles and other investor relations materials, publications or presentations, including web content, are based on data obtained from sources we believe to be reliable but are not guaranteed as to accuracy and are not purported to be complete. As such, the information should not be construed as advice designed to meet the particular investment needs of any investor. Any opinions expressed in RedChip reports, company profiles, or other investor relations materials and presentations are subject to change. RedChip Companies and its affiliates may buy and sell shares of securities or options of the issuers mentioned on this website at any time.
RedChip Visibility is a division of RedChip Companies, Inc. and offers research services to paying clients. In the purview of Section 17(b) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader's attention to the fact that the RedChip Companies Inc. is an investor relations firm hired by certain Companies to increase investor awareness to the small-cap equity community.
Stock market investing is inherently risky. RedChip Companies is not responsible for any gains or losses that result from the opinions expressed on this website, in its research reports, company profiles or in other investor relations materials or presentations that it publishes electronically or in print.
We strongly encourage all investors to conduct their own research before making any investment decision. For more information on stock market investing, visit the Securities and Exchange Commission ("SEC") at www.sec.gov and view RedChip’s Disclosures. |
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