| CytoDyn (OTCQB: CYDY) Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial |
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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 continued positive data for its metastatic triple-negative breast cancer (mTNBC) and (metastatic breast cancer) MBC patients.
Why It Matters: Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far.
Key Quote: “These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval.” – 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) Awarded $1.7 Million NIH Grant for ANVS401 Chronic Toxicology Studies |
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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 awarded a $1.7 million grant from the National Institutes of Health (NIH) for the Company’s long-term toxicology studies in rats and in dogs of its lead therapeutic compound ANVS401. Annovis began the animal toxicology studies in the fourth quarter of 2019 and expects to complete the studies in the third quarter of 2020.
Why It Matters: Annovis previously conducted one-month safety studies in mice, rats and dogs, and conducted two human safety studies in 120 healthy volunteers. In an interim analysis of an ongoing Phase 2a clinical trial in AD patients, the Data Safety Monitoring Board recommended the trial continue without modification. In these one-month studies, ANVS401 was shown to be well tolerated. Chronic toxicology studies are required to allow Annovis to test ANVS401 in humans for extended periods of time. This safety data is applicable to the clinical development of ANVS401 for AD, PD and other chronic neurodegenerative disorders.
Key Quote: “The NIH has supported us with funds and expertise over the years, most recently through the National Institute on Aging ADCS grant which is funding the ongoing Phase 2a clinical trial in AD patients and presently with the grant for the chronic toxicology. The successful completion of the animal toxicology studies, our ongoing Phase 2a study in AD patients and our planned Phase 2a study in PD patients, will position us to enter ANVS401 into pivotal Phase 2/3 studies in both indications to show efficacy.” - 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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| Cyclo Therapeutics (OTCQB: CTDH) Completes Enrollment in 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, received positive feedback on our Type C Meeting from the U.S. Food and Drug Administration ("FDA") on its global pivotal trial design for intravenous administration of Trappsol® Cyclo™ in NPC1.
Why It Matters: Niemann-Pick Disease Type C is a rare genetic disease affecting 1 in 100,000 live births globally. NPC affects every cell in the body due to a defect in the NPC1 protein which is responsible for cholesterol processing in the cell. NPC causes symptoms in the brain, liver, spleen, lung and other organs and often leads to premature death. There are no approved drug therapies for NPC in the United States and only one approved therapy in Europe.
Key Quote: “We were very pleased with the productive and supportive discussions with FDA and our ability to obtain information to inform our next steps in the finalization of our pivotal trial. The design of our pivotal trial is based on data and experience from our completed Phase I trial in the US, and on our Phase I/II trial in Europe and Israel, for which we look forward to sharing data as part of our protocol submission to the agency. Based on the encouraging feedback received at our face-to-face meeting, Cyclo Therapeutics is looking forward to executing the regulatory processes required to start our global pivotal trial as quickly as possible.” 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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| Can-Fite BioPharma (NYSE American: CANF) and Univo Pharmaceuticals Expand Collaboration Agreement Based on Positive Pre-Clinical Data |
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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 new pre-clinical findings in connection with its on-going collaboration with Univo Pharmaceuticals (TASE:UNVO), demonstrating CBD’s robust anti-neoplastic effect against liver cancer.
Why It Matters: Can-Fite is greatly encouraged and sees clinical potential in treating patients with minute CBD dosages which are effective and at the same time may minimize potential adverse effects. Based on this approach, an expansion of the agreement with Univo Pharmaceuticals has been entered into to allow the testing of minute CBD concentrations/dosages in combination with Namodenoson on liver cancer and additional oncological indications. As part of the expansion, Can-Fite will fund the research and development activities for the two new indications, to be jointly performed, for an amount of US$200,000 per indication.
Key Quote: “Many of the liver cancer patients are already treated with cannabinoids for management of constitutional symptoms such as anorexia, nausea, and fatigue. These novel findings of anti-cancer cell effects found with minute dosages of CBD may open up new avenues of utilizing cannabinoids to treat cancer patients while minimizing adverse effects.” – Dr. Michael Silverman, M.D., Can-Fite Medical Director
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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| Nemaura (NASDAQ: NMRD) Plans Head to Head Study with Major Glucose Monitoring System |
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Nemaura Medical (NASDAQ: NMRD) plans to initiate a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive invasive CGM.
Why It Matters: Several studies are planned over the course of this year designed to demonstrate the effectiveness of sugarBEAT® to increase Time-In-Range, thus reducing HbA1C with intermittent (non-consecutive days) use over a few days per week or even month. Initial results from studies comparing the various market leading CGM devices indicates sugarBEAT’s® accuracy (MARD mean absolute relative difference), to be on par with the major incumbent invasive CGM sensors, using single finger-stick blood glucose meter calibration in real-life settings.
Key Quote: “We believe that most people with diabetes do not currently use any continuous glucose monitoring system due to the high costs and the invasiveness of current products. We believe that sugarBEAT® changes this paradigm and is the first non-invasive CGM to provide the masses an option for daily monitoring whenever they choose at an affordable price point.” – 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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| Digital Ally (NASDAQ: DGLY) Prices $2.9M Underwritten Public Offering of Common Stock |
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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 the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $2.9 million before deducting underwriting discounts and other estimated offering expenses.
Details: The proposed offering equates to 2,521,740 shares of the Company’s common stock at a price of $1.15 per share. The Company intends to use the net proceeds from this offering to fund the repayment of debt and for general corporate purposes. In addition, the Company expects to grant the underwriter a 45-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering to cover over-allotments, if any.
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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| eMARINE Global (OTCQB: EMRN) Upgrades to OTCQB |
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eMARINE Global (OTCQB: EMRN), a leading provider of information and communications technology for the maritime industry, upgraded to the OTCQB on February 25.
Key Quote: “As a leading innovator of maritime ICT and autonomous ship technology, we believe that this upgrade to the OTCQB is a significant milestone for our company. With recent double-digit revenue growth, large contracts with notable partners, and now our OTCQB upgrade, eMARINE is ready to prove that 2020 will be our year.” - Ung Gyu Kim, Chairman and CEO
The Backstory: Founded in 2001 and based in South Korea, eMARINE Global is working with a growing base of marquee customers to achieve maritime ICT convergence through fully integrated products and services, offering state-of-the-art e-navigation, marine Internet of Things (IoT), and marine big data solutions, primarily in Korea with near-term expansion into U.S. and Chinese markets. Specifically, eMARINE provides solutions for collection, integration and display of maritime information abroad and ashore by electronic means to enhance berth to berth navigation and related services. These solutions provide the most efficient means to secure the safety of life at sea and to protect the marine environment. All products and services are offered through subscription, installation, updates and/or maintenance contracts.
Disclosure
eMARINE Global (EMRN) is a client of RedChip Companies. EMRN agreed to pay RedChip Companies a monthly cash fee of $3,500, beginning in July 2017, for RedChip investor awareness services. RedChip Companies, Inc. was paid 613,000 shares of EMRN Rule 144 stock for consulting services.
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| SinglePoint (OTCQB: SING) Subsidiary Direct Solar of America Continues National Footprint Expansion |
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SinglePoint (OTCQB: SING) subsidiary Direct Solar of America is continuing to expand its national solar brokerage footprint meeting increased consumer and customer demand for solar solutions for their homes and businesses, adding two additional markets, Minnesota and Wisconsin.
Why It Matters: As reported in the Star Tribune, Legislators in Minnesota recently outlined their 2020 agenda including a requirement that all the electrical energy generated for the state come from carbon-free sources such as wind and solar power. Solar power is getting its time in the sunlight.
“It’s growing at about 30 percent per year,” explained Greg Nemet, professor of public affairs at the University of Wisconsin-Madison. “There are studies that say solar could be 50 percent of our electricity within 10, 15 or 20 years.” “Solar is for real now and … people are installing solar because it’s the cheapest way to make electricity, even in a place like Wisconsin. I would expect to see more of that.”
Key Quote: “The solar and clean energy solutions (both in the Americas and globally) have undergone enormous change over the last decade and we feel the acquisition of Direct Solar of America has firmly positioned SinglePoint and its stakeholders to take advantage of the opportunities created by these changes as we move into the next 10 years that is being described as the Solar+ Decade.” – Greg Lambrecht, Chairman & CEO
The Backstory: Founded in 2011 SinglePoint, Inc (SING) invests in and acquires brands and companies that will benefit from injection of growth capital and the sales and marketing expertise of SinglePoint. The company portfolio currently includes solar, hemp and technology applications. SinglePoint is working to grow the company to a multinational brand.
Disclosure
SinglePoint, Inc. (SING) is a client of RedChip Companies, Inc. SING agreed to pay RedChip Companies, Inc. a $10,000 monthly cash fee, beginning in June 2019, for RedChip investor awareness services and consulting 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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