| CytoDyn (OTCQB: CYDY) Receives Institutional Review Board Approval to Initiate Phase 2 Basket Trial for 22 Solid Tumor Cancers |
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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, received Institutional Review Board (IRB) approval to begin its Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications.
Why It Matters: The basket trial is a 30 patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician. The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.
Key Quote: “We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately ten days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial.” – 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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| Annovis Bio (NYSE American: ANVS) Issued Patent for Method of Treating Parkinson’s Disease and Other Lewy Body Diseases |
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Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s, Parkinson’s and other neurodegenerative diseases, was issued a patent (US 10,383,851) in August 2019 for a method of treating Parkinson’s disease, Lewy body dementia and other Lewy body diseases in humans by administering its lead compound, ANVS401. The Company expects multiple patents to be generated from this patent family, each targeting specific neurodegenerative diseases independently.
Why It Matters: ANVS401 improves axonal transport, the information highway of the nerve cell, by attacking multiple neurotoxic proteins simultaneously. ANVS401 is the lead compound in the Company’s ongoing Phase 2a clinical trial for Alzheimer’s disease and in a planned Phase 2a trial for Parkinson’s disease. The Company is planning a 50-patient Phase 2a study in Parkinson’s disease with primary endpoints targeting a decrease in neurotoxic protein levels, increase in neurotransmitters and neurotrophic factors, lowering of inflammatory proteins, lowering of neurodegeneration markers, and positive cognitive and functional outcomes.
Key Quote: “We believe we have a novel solution to stop the course of Parkinson’s disease and Alzheimer’s disease, areas of unmet need valued in the multibillions of dollars and growing. The successful completion of our two Phase 2a studies will provide optimal information on target and pathway engagement in both diseases and allow us to move into pivotal studies.” - Maria Maccecchini, Ph.D., CEO
The Backstory: Headquartered in Berwyn, Pennsylvania, Annovis is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (ADDS). The Company believes that it is the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. Annovis expects its treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. The Company has an ongoing Phase 2a proof-of-concept study in AD patients and plans to commence a second Phase 2a study in PD patients.
Disclosure
Annovis (ANVS) is a client of RedChip Companies, Inc. ANVS agreed to pay RedChip Companies, Inc. a $8,500 monthly cash fee, beginning in February 2020, for RedChip investor awareness services and consulting services.
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| Oral Argument Set in Digital Ally (NASDAQ: DGLY) Appeal in the Axon Litigation |
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Digital Ally (NASDAQ: DGLY), which develops, manufactures and markets advanced video recording products for law enforcement, emergency management, fleet safety and security, announced that a date for oral argument has been scheduled by the United States Court of Appeals for the Federal Circuit in its appeal of the district court’s summary judgment order. Oral argument will take place on April 6, 2020, at 10:00 a.m.
Why It Matters: The oral argument will address the incorrect and mistaken dismissal of Digital Ally’s claims against Axon Enterprises, Inc. (“Axon” formerly Taser International, Inc.) by Judge Carlos Murguia in the United States District of Kansas litigation. Should the Federal Circuit overturn the summary judgment ruling, a new judge will be assigned to handle the litigation with Axon due to the recent resignation of Judge Murguia.
The Backstory: Headquartered in Lenexa, KS, Digital Ally specializes in the design and manufacturing of the highest quality video recording equipment and video analytic software. Digital Ally pushes the boundaries of technology in industries such as law enforcement, emergency management, fleet safety and security. Digital Ally’s complete product solutions include in-car and body cameras, cloud and local management software, and automatic recording technology. These products work seamlessly together and are simple to install and operate. Digital Ally products are sold by domestic direct sales representatives and international distributors worldwide.
Disclosure
Digital Ally, Inc. (DGLY) is a client of RedChip Companies, Inc. DGLY agreed to pay RedChip Companies, Inc., a $7,500 monthly cash fee, beginning in September 2017, for RedChip investor awareness services.
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| Can-Fite BioPharma (NYSE American: CANF) Expects to Report Results of its NASH Phase 2 Study this Quarter |
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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, plans to release data from its Phase II study of Namodenoson in NASH patients during this quarter.
Why It Matters: The multicenter, randomized, double-blinded, placebo-controlled, dose-finding efficacy and safety study has enrolled 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 mg or 25 mg of oral Namodenoson, or placebo for 12 weeks. The primary endpoint of the Phase II study is the anti-inflammatory effect of the drug, as determined by mean percent change from baseline in ALT blood levels and safety. Secondary endpoints include percentage change from baseline of liver fat, as measured by MRI-PDFF (proton density fat fraction).
Key Quote: “We look forward to reporting our topline results during this quarter.” – Dr. Pnina Fishman, CEO
The Backstory: Can-Fite is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the FDA. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date.
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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| SPI Energy (NASDAQ: SPI) Completes Sale of 5 Solar Plants in Oahu, Hawaii |
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SPI Energy (NASDAQ: SPI), a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors, completed the sale of five solar projects (Oahu 101-2, Oahu 101-4, Oahu 101-9, Oahu 101-14 and Oahu 101-19) totaling 3.3MWs. The projects are located on the island of Oahu in Hawaii.
Key Quote: “The successful development and sale of these 3.3MWs of solar projects is another strong testament to our development expertise. We are delighted to contribute to the State of Hawaii’s goals of reaching 100% renewable energy by 2045.” - Xiaofeng Peng, Chairman and CEO
The Backstory: SPI is a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors. The Company develops solar PV projects that are either sold to third party operators or owned and operated by the Company for selling of electricity to the grid in multiple countries in Asia, North America and Europe. The Company’s subsidiary in Australia primarily sells solar PV components to retail customers and solar project developers. The Company has its operating headquarters in Hong Kong and its U.S. office in Santa Clara, California. The Company maintains global operations in Asia, Europe, North America and Australia.
Disclosure
SPI Energy (SPI) is a client of RedChip Companies, Inc. SPI agreed to pay RedChip Companies, Inc. 25,000 shares of Rule 144 stock and a monthly cash fee of $6,500, beginning in August 2019, for 12 months of RedChip investor awareness services and consulting services.
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| Cyclo Therapeutics (OTCQB: CTDH) Completes Enrollment in its Phase I/II Trial in NPC |
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Cyclo Therapeutics (OTCQB: CTDH), a biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C (NPC) and Alzheimer’s Disease, completed patient enrollment in its Phase I/II trial to evaluate the safety, tolerability, and efficacy of Trappsol® Cyclo™ administered intravenously to Niemann-Pick Disease Type C1 (NPC1) patients.
Why It Matters: Data from the current study combined with those of the companion Phase I study (ClinicalTrials.gov NCT02939547) will be used to inform the design of the Phase III global pivotal trial. Cyclo Therapeutics, Inc. will meet with FDA in the first quarter of 2020 and expects to meet with EMA in the second quarter of 2020 to discuss the global pivotal development plan and timelines to initiate the Phase III pivotal trial.
Key Quote: “Today’s ‘Last-Patient-In’ announcement is a major milestone for our company and the NPC community. It completes another important step in our development and registration strategies for Trappsol® Cyclo™ to treat NPC, a disease which causes so much suffering for the patients and their families. We are delighted to share this news with our many supporters and all of our stakeholders.” N. Scott Fine, CEO
The Backstory: Cyclo Therapeutics is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT03893071) and is planning an early phase trial in Alzheimer’s Disease based in part on an expanded access program in late-onset Alzheimer’s Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development.
Disclosure
Cyclo Therapeutics (OTCQB: CTDH) is a client of RedChip Companies, Inc. CTDH paid RedChip Companies, Inc. a fee of $30,000 per month for four months, beginning in August 2019, and a monthly fee of $7,500, beginning December 2019, for RedChip investor awareness services and consulting services. RedChip's CEO owns 146,128 shares of CTDH stock.
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| Medalist Diversified REIT (NASDAQ: MDRR) Closes $4.6 Million Underwritten Public Offering of Series A Preferred Stock |
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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, announced the closing of its underwritten public offering of 200,000 shares of the Company’s 8.0% Series A Cumulative Redeemable Preferred Stock, liquidation preference of $25.00 per share, at a public offering price of $23.00 per share with gross proceeds to the Company of $4,600,000 before deducting underwriting discounts, commissions, and expenses. Shares of the Series A Preferred Stock trade on the Nasdaq Capital Market under the symbol "MDRRP."
The Backstory: Medalist Diversified REIT Inc. is 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. 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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| 1847 Holdings (OTC: EFSH) Subsidiary Posts Third Highest Sales Day During Presidents Day Promotion |
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1847 Holdings (OTC: EFSH), a 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, announced that its Goedeker's subsidiary generated its third highest sales volume day within the last 12 months on Presidents Day, with unaudited written sales volume of approximately $478,000, up 42% from the prior year's Presidents Day sales volume of approximately $336,000, and only exceeded by written sales volume for 2019's Black Friday and Cyber Monday.
Why It Matters: Headquartered in St. Louis, Missouri, Goedeker's has evolved from a local brick and mortar operation to one of the 30 largest appliance retailers in the country with over 90% of its sales placed through the company's e-commerce platform. The innovative "etailer" utilizes a hybrid approach to marketing and selling to customers on the web, combining live chat and phone center operations that drive leads to its website, providing competitive pricing while delivering and installing appliances and home furnishings across the country.
Key Quote: “Doug Moore, the CEO that we hired to run Goedeker's following its acquisition, has led investments in improving Goedeker's competitive advantages which have been key drivers behind the company's strong financial performance, and we remain optimistic that continued progress will be made in sales and profit as we move through 2020.” – Ellery Roberts, Founder & CEO
The Backstory: 1847 Holdings is a publicly traded partnership that 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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| Quote of the Week |
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"Get to know management, look for intelligence, a high level of integrity, strong communication skills and make sure they understand their products and business well."
- 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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