| CytoDyn (OTCQB: CYDY) Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients |
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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, submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication.
Why It Matters: In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
Key Quote: “With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer and immunology.” – Nader Pourhassan, Ph.D., President & CEO
The Backstory: CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension.
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) Publishes Results of Alzheimer’s and Parkinson’s Animal Studies |
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Annovis Bio (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease, Parkinson’s disease and other neurodegenerative diseases, published data from its two double-blind, placebo controlled animal studies in Alzheimer’s disease (AD) and Parkinson’s disease (PD) demonstrating in both diseases preclinical efficacy of ANVS401, the company’s lead compound.
Why it Matters:The Alzheimer’s study, conducted by Professor Ottavio Arancio at Columbia University and published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, is the first study demonstrating the therapeutic efficacy in animals of inhibiting the translation of APP and its fragments in an AD model. Translational inhibition of APP by ANVS401 has been shown to reduce APP and its fragments in cell culture, animal models, and mildly cognitively impaired patients, making it a promising drug candidate for the treatment of AD.
The Parkinson’s study, conducted by Professor Robert Nussbaum at University of California San Francisco and published in the American Journal of Neurodegenerative Disease, is the first study showing the preclinical efficacy of ANVS401 in improving the colonic motility in mouse models of gastrointestinal dysfunction in early PD. This result demonstrates the ability of ANVS401 to reach the nervous system, and its mechanism of action, the translational inhibition of α-synuclein expression, supporting further development of ANVS401 as a drug for the treatment of PD.
The Backstory:Headquartered in Berwyn, Pennsylvania, Annovis Bio 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 (AD-DS). We believe that we are 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. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have an ongoing Phase 2a study in AD patients and plan 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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| Nemaura Medical (NASDAQ: NMRD) Secures $5 Million Loan to Accelerate Commercial Strategy |
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Nemaura Medical (NASDAQ: NMRD), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor ("CGM"), announced it has secured a 24-month, $5 million non-convertible loan. The loan does not include warrants or other equity securities.
Key Quote: “This loan strengthens our financial position without diluting shareholders, and provides additional resources to accelerate our commercial strategy for sugarBEAT® in Europe, as well as support our planned launch of proBEAT™ in the USA.” – Dr. Faz Chowdhurry, CEO
The Backstory: Nemaura is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, and proBEAT™. sugarBEAT® is a Class IIb CE marked non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading. proBEAT™ comprises a prescription free non-invasive glucose monitor and a digital healthcare subscription service planned to be launched in the US as a general wellness product.
Disclosure
Nemaura Medical (NMRD) is a client of RedChip Companies. NMRD agreed to pay RedChip a monthly cash fee of $5,000 for six months of investor awareness services. RedChip also received 20,000 shares of Rule 144 stock for services performed between December 2018 and May 2019.
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| Cuentas (OTCQB: CUEN) Completes $2.5 Million Financing and Receives Final $700K Tranche |
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Cuentas (OTCQB: CUEN), a leading FinTech provider of mobile banking and payment solutions serving Latino and Hispanic consumers, closed on the final $700k tranche of the $2.5 million Dinar Zuz LLC (Dinar Zuz) finance package during the first quarter of 2020. Additionally, Dinar Zuz signed a new promissory note for $250,000 for receipt of funds during the second quarter of 2020.
Why It Matters: During the first Quarter of 2020, Dinar Zuz provided an additional amount of $700,000 to the Company in the form of a convertible note (Dinar Convertible Note) pursuant to a securities purchase agreement between the Company and Dinar Zuz, dated July 30, 2019. Additionally, on March 3, 2020, the Company issued 1,157,478 shares of its Common Stock to Dinar Zuz as a result of the conversion of the Dinar Convertible Note in the amount of $700,000. Cuentas issued such shares in reliance on the exemptions from registration pursuant to Section 4(a)(2) of the Securities Act.
Key Quote: “Dinar Zuz's confidence and financial support of the Cuentas project over the past 14 months has been instrumental in bringing our Mobile App and Prepaid GPR Card online. Dinar Zuz's multi-faceted approach to providing key financing has been extremely supportive and helpful.” - Michael De Prado, Co-Founder, President and COO
The Backstory: Cuentas is a FinTech service provider with proprietary technology to provide solutions for the underbanked and un-bankable Hispanic and Latino population. Its disruptive services include, but are not limited to, mobile banking, online banking, prepaid debit, ACH and mobile deposits, cash remittance, peer to peer money transfer, and bank accounts to customers who previously could not obtain bank accounts. The proprietary Cuentas General Purpose Reloadable (GPR) Card provides holders with a digital wallet, discounts for purchases at major physical and online retailers, rewards, and the ability to purchase digital content.
Disclosure
Cuentas (CUEN) is a client of RedChip Companies, Inc. CUEN agreed to pay RedChip Companies, Inc., a $4,000 monthly cash fee, beginning in April 2020, for the first three months, $8,000 per month for month four through six for RedChip investor awareness services. CUEN will pay RC 5,000 shares of Rule 144 Stock when the stock price reaches $5.00, and another 5,000 shares of Rule 144 Stock when the stock price reaches $8.00.
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| SinglePoint (OTCQB: SING) Files S-1 to Raise up to $7M to Fuel Growth |
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SinglePoint (OTCQB: SING) filed an S-1 registration agreement to raise up to $7,000,000. The Equity Agreement is on a look-back basis and there are no make-up provisions, a true non-toxic equity investment.
Why It Matters: The Company intends to use the net proceeds for product development, repayment of debt, including less favorable convertible notes, sales and marketing, working capital, capital expenditures and other general corporate purposes. The Company is committed to having the ability to access capital in order to maintain and grow its existing core business units. As well as position itself to take advantage of incremental and accretive opportunities to increase revenue, footprint and market share while improving the balance sheet.
Key Quote: “This is a major step for SinglePoint and our shareholders as we now have access to lower cost financing which ultimately lessens dilution to the market. We see this financing as a potential catalyst for SinglePoint to bolster and accelerate expansion into new markets.” – Greg Lambrecht, CEO
The Backstory: Founded in 2011, SinglePoint 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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| Learn About Red Cat’s (OTC: RCAT) Drone Technology in Exclusive Investor Webinar |
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Red Cat Holdings (OTC: RCAT) Founder and CEO Jeff Thompson and CMO Chad Kapper hosted an exclusive investor webinar this week and shared details about the company’s leading position for secure blockchain-based distributed storage, analytics and SaaS solutions commercial and consumer customers in the drone industry.
According to Drone Industry Insights, an industry trade publication, the total global drone market is expected to surpass $43 billion by 2024. Red Cat solves a significant unmet need for secure data and analytics in this rapidly evolving market through an integrated, easy-to-use platform offering secure blockchain-based “black box” storage, analytics, and services for commercial and consumer customers. Red Cat's success is driven by a commitment to deliver unrivaled innovation that makes drones trackable, accountable and the sky a safer place.
Watch the full webinar and Q&A session now
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| Quote of the Week |
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"The single most important way we attempt to manage risk, in any environment, is by seeking to buy stocks very cheaply—we never want to pay too much."
- Bill Hench, Portfolio Manager, Royce Opportunity Funds |
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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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