| Can-Fite BioPharma (NYSE American: CANF) Submits Piclidenoson for Compassionate Use Treatment for 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, submitted Piclidenoson for a compassionate use program to treat coronavirus patients to the Institutional Review Board at Rabin Medical Center in Israel.
Why It Matters: If approved, the compassionate use program will be led by Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center. Patients would be treated at Rabin’s Golda Hasharon Campus which is currently positioned to treat coronavirus patients in a specialized setting. The rationale to treat coronavirus with Piclidenoson is based on the drug’s anti-rheumatic effect, proven in earlier Phase II clinical studies conducted under an open IND with the U.S. Food and Drug Administration (FDA). A Phase III trial in agreement with the European Medicines Agency (EMA) and FDA for the treatment of rheumatoid arthritis is ongoing. Rheumatoid arthritis drugs are currently being evaluated as a treatment for the uncontrolled immune response and cytokine release syndrome (CSR) created by coronavirus.
The Backstory: Can Fite’s drug Piclidenoson is currently in Phase III study for the treatment of patients with rheumatoid arthritis and on top of it has been shown to possess anti-viral effects against 2 single stranded RNA viruses HIV and HCC. The Coronaviruses are also single stranded RNA viruses. Can-Fites’s Piclidenoson’s anti-viral effect is protected by U.S. patent US7589075.
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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| CytoDyn (OTCQB: CYDY) Treating Four Coronarivus Patients Under Emergency IND |
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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 that the third and fourth coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.
Why It Matters: The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).
Key Quote: “We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can.” – 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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| Nemaura (NASDAQ: NMRD) Prepares for Launch of sugarBEAT® CGM In the U.S. Following FDA Feedback |
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Nemaura Medical (NASDAQ: NMRD) is preparing for the launch of sugarBEAT® in the U.S. under the wellness category following recent feedback from the U.S. Food and Drug Administration (the "FDA"). The Company is prioritizing launch plans in the U.S. and is considering various options to expedite the launch, including potential partnering in continuation of its on-going discussions with multi-national companies.
Why It Matters: The total global addressable market for CGM is estimated at $82.0 billion per annum, consisting of $12.7 billion for Type 1 insulin users (5% of diabetics), $38.0 billion for Type 2 insulin users (15% of diabetics) and $31.4 billion for Type 2 non-insulin users (80% of diabetics) . These numbers exclude the pre-diabetes population, which is estimated at nearly three times as large as the diabetes population.
Key Quote: “Under the FDA’s wellness category, the Company intends to make sugarBEAT® available to any adult wishing to be empowered with knowledge of how different lifestyle, dietary and health and wellbeing factors impact their sugar levels and is potentially appropriate to the pre-diabetic and diabetic market.” – Dr. Faz Chowdhury, CEO
The Backstory: 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®. The Company is currently planning 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 and invasive CGM.
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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| Piedmont Lithium (NASDAQ: PLL) Issues Shareholder Letter from CEO |
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Piedmont Lithium (NASDAQ: PLL) President and CEO Keith Phillips issued a letter to shareholders.
- Lithium hydroxide testwork. Hydroxide testwork is nearing completion at SGS in Lakefield, Ontario. As reported on February 25, 2020, we have completed 9 of the 10 steps with positive results. The final crystallization steps are under way but will take longer than planned due to some remote working practices being implemented at the SGS laboratory. We do not expect this extended completion of testwork to have an impact on our other activities.
- Chemical plant prefeasibility study. Hatch is progressing its work on the chemical plant pre-feasibility study ("PFS") and remains on track for delivery in Q2 2020. The chemical plant PFS will provide refined estimates of our capital and operating costs and should reinforce our position as a low-cost US-based producer of lithium hydroxide.
- Chemical plant permitting activities. Background studies to be used in the chemical plant permit applications are ongoing and proceeding on schedule. We still plan to submit these permit applications shortly after completion of the chemical plant PFS and expect to receive these permits during 2020.
The Backstory: Piedmont holds a 100% interest in the Piedmont Lithium Project ("Project") located within the world-class Carolina Tin-Spodumene Belt ("TSB") and along trend to the Hallman Beam and Kings Mountain mines, historically providing most of the western world’s lithium between the 1950s and the 1980s. The TSB has been described as one of the largest lithium provinces in the world and is located approximately 25 miles west of Charlotte, North Carolina. It is a premier location for development of an integrated lithium business based on its favorable geology, spodumene-only mineralogy, proven metallurgy and easy access to infrastructure, power, R&D centers for lithium and battery storage, major high-tech population centers and downstream lithium processing facilities.
Disclosure
Piedmont Lithium (PLL) is a client of RedChip Companies, Inc. PLL agreed to pay RedChip Companies, Inc. a quarterly cash fee of $20,000, beginning in April 2019, for 12 months of RedChip investor awareness services.
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| eMARINE Global (OTCQB: EMRN) Awarded $1.9 Million ECDIS Maintenance Contract from Korean Navy |
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eMARINE Global (OTCQB: EMRN), a leading provider of information and communications technology for the maritime industry, is pleased to announce that the Republic of Korea (ROK) Navy renewed its annual contract with eMARINE to maintain the electronic charts display and information systems (ECDIS) onboard 225 naval ships. The contract is valued at $1.9 million (2.4 billion Won).
Why It Matters: eMarine has been providing maintenance work on an annual contract basis for the ROK Navy since 2007, when the Company’s navigation technology was first installed. Since then, the volume or work and budget have increased each year. Today, eMarine's ECDIS technology is the primary navigation solution used by the ROK Navy fleet. The ROK Navy increased the budget and number of ships serviced under the maintenance contract over the prior year’s contract.
Key Quote: “We have a remarkable record of providing excellent and professional service to our customers, and this latest renewal from the ROK Navy further strengthens that record.” - 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.
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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| Digital Ally (NASDAQ: DGLY) Sets Date for Q4 Earnings Call |
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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, today announced that it will host an investor conference call on Monday, April 6, 2020 at 11:15 a.m. eastern time to discuss its operating results for fourth quarter and the year ended December 31, 2019, the status of its patent infringement litigation against Axon Enterprise, Inc. (“Axon,” formerly known as TASER International, Inc.) and other topics of interest. The Company will release its operating results for fiscal 2019 in a press release prior to the investor conference call on April 6, 2020.
Call Details:
Shareholders and other interested parties may participate in the conference call by dialing (844) 761-0863 and entering conference ID #3474957 a few minutes before 11:15 a.m. Eastern on Monday, April 6, 2020.
A replay of the conference call will be available two hours after its completion, from Monday, April 6, 2020 until 11:59 p.m. on June 6, 2020 by dialing 855-859-2056 and entering the conference ID #3474957.
The Backstory: Digital Ally, headquartered in Lenexa, KS, 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 vehicle and body cameras, flexible software storage, 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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| SPI Energy (NASDAQ: SPI) Enters into Amendment to Convertible Promissory Note |
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SPI Energy (NASDAQ: SPI), a global provider of green energy solutions for business, residential, government, utility customers, and investors, repaid $150,000 to Iliad Research & Trading, L.P. (“Investor”) on March 19, 2020 related to a Security Purchase Agreement (“SPA”) from May 2019.
Why It Matters: Under the terms of the original SPA, SPI Energy issued the Investor a Convertible Promissory Note dated May 28, 2019 in the principal amount of $1,331,500 (“Note”). With this latest payment, the Company has repaid $450,000 of the Note. The Investor may redeem up to $200,000.00 per calendar month of the remaining balance of the Note.
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 headquarter 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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| 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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