| Annovis Bio (NYSE American: ANVS) Announces Update on Phase II Clinical Trial for Alzheimer’s Disease |
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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, announced that the Data Safety Monitoring Board has reviewed the safety data, enrollment, participant status, demographic data and vital signs of patients enrolled in their Phase II clinical trial for the treatment of Alzheimer’s disease and unanimously supported that the study, which is named DISCOVER, continue without modification.
Why It Matters: This study is breaking new ground in the Alzheimer’s field. It combines state-of-the-art SILK (stable isotope labeling kinetics) to evaluate the effects of ANVS401 on neurotoxic proteins in spinal fluid with safety, pharmacokinetics, pharmacodynamics and efficacy.
Key Quote: “We believe our approach to the treatment of Alzheimer’s is unique. There have been over 500 failed attempts at developing Alzheimer’s drugs. But we have taken a different approach by focusing on improving the information highway of the nerve cell. Our lead compound, ANVS401, is the only drug to improve axonal transport, the information highway of the nerve cell, by attacking multiple neurotoxic proteins simultaneously.” - 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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| Digital Ally (NASDAQ: DGLY) Partners with InSight Mobile Data |
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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 a partnership with InSight Mobile Data, a leading provider of fleet management, driver safety and mobile data solutions, to provide commercial fleet managers with the highest quality video event recorders and software.
Why It Matters: Critical new software features to be integrated into Digital Ally’s solution include electronic logging devices (ELDs), which replaced paper logbooks used to record hours of service for over-the-road trucking, motor coaches and commercial buses. Other features include enhanced video transfers along with the integration of dispatch (CAD) systems used primarily in the EMS community.
Key Quote: “Partnering with InSight Mobile Data gives Digital Ally the ability to incorporate crucial software features into our products that will increase the overall productivity for our customers while expanding into new markets.” – Stan Ross, CEO
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) Submits Liver Cancer Phase 3 Protocol to EMA |
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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 the study’s protocol design and registration plan for its pivotal Phase III liver cancer trial to the European Medicines Agency’s (EMA) Committee for Medicinal Product and Human Use (CHMP).
Why It Matters: The Phase III pivotal trial will evaluate the efficacy of its drug candidate Namodenoson in patients with advanced hepatocellular carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy. The filing with the EMA follows Can-Fite’s successful conclusion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA), in which the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval of Namodenoson in the treatment of HCC.
Key Quote: “Having submitted our study design to both U.S. and European regulators, we look forward to initiating this Phase III study. Should Namodenoson meet the study’s primary endpoint of improved overall survival for liver cancer patients, then we intend to file for concurrent approval of our drug in both the U.S. and Europe, two of the largest healthcare markets in the world.” – 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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| Cyclo Therapeutics (OTCQB: CTDH) Announces Last Visit of Last Patient in NPC Phase 1 Trial |
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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, announced that the last patient has undergone the final assessment in its Phase I trial to evaluate the safety and tolerability of Trappsol® Cyclo™ administered intravenously to NPC patients.
Why It Matters: Data from the current study (ClinicalTrials.gov NCT02939547) combined with those of the companion Phase I/II study (ClinicalTrials.gov NCT02912793) will be used to inform the design of the Phase III global pivotal trial. Cyclo Therapeutics 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 a Phase III pivotal trial.
Key Quote: “We are very grateful to the investigators, the patients, and their families whose coordinated efforts made this study possible. Our team has now started the process to clean the data, with a view toward top-line reports in the March/April timeframe. Our announcement today represents another significant milestone for the company and for 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 (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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| CytoDyn (OTCQB: CYDY) Reports Continued Positive Clinical Data on its Phase 1b/2 mTNBC and Expanded Access Studies for MBC Ahead of Breakthrough Therapy Designation Decision From the FDA |
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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 today continued positive data for its mTNBC and MBC patients.
Why It Matters: Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyn’s mission and purpose is to provide effective therapeutic solutions to these patients.
Key Quote: “These findings are extremely promising in light of the success rate of other treatment options. Therapeutic options for patients suffering from breast cancer are highly limited and we look forward to continuing enrollment and exploring leronlimab’s potential to treat this devastating disease. Since our basket trial for all solid tumor cancers has been initiated, we are currently screening a prostate cancer patient, and if continued positive clinical results are forthcoming from this patient, we are hopeful that this will clear the path for CytoDyn to file for Breakthrough Therapy designation for all solid tumor cancers. Our mechanism of action is not only focused on the inhibition of metastasis of solid tumor cancers, but also targets the tumor itself through macrophages, angiogenesis and T-reg.” – 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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| Medalist Diversified REIT (NASDAQ: MDRR) Prices $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 today the pricing of its underwritten public offering with gross proceeds to the Company expected to be $4,600,000 before deducting underwriting discounts, commissions, and expenses.
Details: The proposed offering equates to 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. The Company has applied to list the Series A Preferred Stock on the Nasdaq Capital Market under the symbol "MDRRP." The offering is expected to close on or about February 19, 2020, subject to customary closing conditions. The Company intends to use the net proceeds from the offering to acquire additional properties, for working capital, for general corporate purposes, and to repay outstanding debt. In addition, a portion of the net proceeds from the offering in an amount equal to the first four quarterly dividends of the Series A Preferred Stock will be placed into an irrevocable escrow account with such funds to be released to the holders of Series A Preferred Stock upon the declaration of such dividends.
The Company has granted the underwriters a 45-day option to purchase up to an additional 15% of the number of shares of Series A Preferred Stock offered in the public offering to cover overallotments, if any.
Aegis Capital Corp. is acting as sole bookrunner for the offering and Maxim Group LLC is serving as the Company’s financial advisor.
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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| SPI Energy (NASDAQ: SPI) Submits Projects to Oregon Community Solar Program |
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SPI Energy (NASDAQ: SPI), a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors announced the submission of the previously closed solar projects (18MW) in the Oregon Portfolio to the newly formed Oregon Community Solar Program.
Why It Matters: Following the acceptance and approval from the Public Utility Commission of Oregon, SPI, through its wholly owned subsidiary Solar Town, will begin offering Community Solar Subscriptions to Businesses, Non-Profits & Homeowners in the Portland General Electric (PGE) utility territory. Electricity users will be able to save up to 10% on their electricity bills from the off-site solar gardens. Customers will be able to subscribe to a Community Solar Project and get a credit on their utility bill for their portion of the energy generated by the project. It is an easy and low-risk way for customers to get the advantages of solar energy – even if they don’t have a roof with applicable sun or rent in an urban area or live in a rural community.
Key Quote: “We are happy with the progress of the Oregon Community Solar Program and look forward to providing PGE customers with more cost-effective options for their electricity with our Community Solar Gardens. We are taking prudent steps to expand our solar platform in the United States as we continue to rebalance our business-mix and refine our strategic investment in projects or businesses that have high growth potential.” - 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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| Quote of the Week |
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"Be wary of bad management teams, don’t bet on dreams. Do your homework and be careful."
- Dave Maley, Manager Ariel Discovery Fund |
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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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