| CytoDyn (OTCQB: CYDY) Targets Enrollment Completion for Phase 2 COVID-19 Trial by End of May |
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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 Company is expecting enrollment completion for its 75 patient, Phase 2 double blinded, placebo controlled, randomized study by the end of this month.
Why It Matters: CytoDyn has submitted a request to the FDA to grant expanded access, also known as “compassionate use,” to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections. Many severe and critically ill patients, who have received off-label immunomodulatory treatments for COVID-19, are excluded from participation in the Company’s Phase 2b/3 clinical trial and could potentially benefit from access to leronlimab under a compassionate use program. There are 49 COVID-19 patients who have enrolled for treatment with leronlimab through eIND. Four out of 11 critically ill patients with a multitude of pre-existing conditions survived after treatment, and of the next 38 patients, many were extubated, improved, or were discharged.
Key Quote: “We are very excited about the continuing positive responses from eIND patients following their treatment with leronlimab. We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program.” – 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) Announces Plans for New Phase II Clinical Trial to Treat 68 Parkinson’s and Alzheimer’s Patients |
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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, announced that the protocol for its Phase 2 clinical study in PD and AD patients was submitted to the U.S. Food and Drug Administration (FDA). The Company has received no comments from the FDA and is therefore able to proceed with the launch of the clinical trial.
Why it Matters:The clinical trial is expected to take place at 10 sites across the US. The Company expects to begin recruitment and enrollment in May, with treatment starting in June. The Company believes the study will be completed before the end of 2020, but due to the COVID-19 pandemic, the study’s commencement may be delayed until later this summer and completion may be delayed until the first quarter of 2021.
Key Quote:“We decided to add an Alzheimer’s arm to our Parkinson’s study because we want to treat patients the exact same way, monitor them the exact same way, and measure the exact same biomarkers, transport proteins, inflammatory markers, synaptic and degenerative markers. Although this is a short study, for safety purposes we will also measure cognition and function.” - Maria Maccecchini, Ph.D., CEO
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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| Piedmont Lithium (NASDAQ: PLL) Files March 2020 Quarterly Report |
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Piedmont Lithium (NASDAQ: PLL) filed its March 2020 quarterly report highlighting recent accomplishments.
Key Highlights:
- Chemical plant pre-feasibility study remains on track for delivery in Q2 2020
- Plant permitting activities ongoing
- Continued preliminary off-take, financing and strategic conversations, including companies from the lithium, mining, chemicals, battery, automotive and private equity sectors
- Soil and rock chip sampling at the Project in North Carolina, United States, led to the discovery of five new spodumene-bearing pegmatites in areas that have not previously been explored
Upcoming Milestones:
- Complete the chemical plant PFS and a fully integrated Scoping Study Update in Q2 2020
- Finalize the bench scale lithium hydroxide testwork program and produce initial product samples in Q2 2020
- Submit key chemical plant permit applications including a synthetic minor source air permit application
- Build out project construction and sales & marketing teams
- Continue offtake discussions for lithium hydroxide and by-product quartz, feldspar and mica
- Continue to evaluate strategic partnering options
The Backstory: Piedmont Lithium holds a 100% interest in the Piedmont Lithium Project (“Project”) located within the world-class Carolina TinSpodumene 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, 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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| SinglePoint (OTCQB: SING) Enters JV Agreement to Further Expand and Accelerate Opportunities in Response to Increased Demand in Hand Sanitizer Market |
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SinglePoint (OTCQB: SING) is ramping up efforts to meet inbound demand for hand sanitizer and other sanitizing products and recently entered a JV Agreement with Box-Bioscience as part of those efforts.
Why It Matters: The agreement will provide both parties with the capability to enhance supply and expand sales opportunities of hand sanitizer. The product is current sold in a variety of sizes ranging from 2oz to truckloads for bulk supply. With the successful rollout of Klen, SinglePoint has been approached by larger retailers to supply bulk products. This shift has set the stage for a Joint Venture between the two companies to supply hand sanitizer manufactured to the current FDA guidelines. Box has already completed orders with multiple accounts, including segments of Fortune 500 companies around the nation with new sales and inquiries happening daily.
Key Quote: “We are excited to work with SinglePoint to expand and grow our collective business. We have seen multiple Purchase Orders and we expect an increase over the coming months as many retailers and businesses change protocols around sanitizing. This is a true B2B play with nearly all businesses needing hand sanitizer for customers and employee's protection.” – Ryan Cowell, Founder Box Bioscience
The Backstory: The two companies, through the JV, will collaborate to manufacture and distribute sanitizing products. The initial priority has been focused on increasing production and sales of bulk hand sanitizer to meet the current demand. An increasing demand has come from non-traditional retail and well as manufacturing and other service businesses concerned with providing solutions to meet the new safety protocols, these businesses have been or are currently being undeserved to the increased demand. The JV has plans to quickly introduce additional products leveraging the Simplex + Virus Killer brand to potentially include wipes, spray, and nasal spray
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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"There is no passion to be found playing small - in settling for a life that is less than the one you are capable of living."
- Nelson Mandela |
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