| CytoDyn (OTCQB: CYDY) Provides Update on COVID-19 Treatments |
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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, provided a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Company’s trials.
Key Highlights:
Patient enrollment in the Company’s two clinical trials and Emergency Investigational New Drug (EIND) for the coronavirus is as follows:
- More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA)
- Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen
- As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available
- First site cleared to enroll patients in Phase 2b/3 beginning April 13
Key Quote: “We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.” – Nader Pourhassan, Ph.D., President & CEO
The Backstory: CytoDyn is a late-stage 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 critical 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 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 April 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. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it 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, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained 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) to Hold Investor Webinar and Q&A Session with CEO on April 14 |
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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, is hosting an investor webinar with its CEO Maria Maccecchini, Ph.D. who will share insight into the company’s recent developments on Tuesday April 14, 2020 at 4:05 p.m. ET. A live Q&A session with Dr. Maccecchini will follow the presentation.
To participate in the webinar, please register at: www.redchip.com/corporate/webinar_register/56
Questions can be pre-submitted to [email protected] or online during the event.
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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| Can-Fite Biopharma (NYSE American: CANF) Receives Approval for COVID-19 Clinical Trial in Israel, Patient Enrollment and Dosing to Commence Immediately |
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Can-Fite Biopharma (NYSE American: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has received approval from the Institutional Review Board (IRB) at Rabin Medical Center to initiate a pilot clinical study of its drug candidate Piclidenoson for the treatment of moderate-to-severe symptoms in coronavirus (COVID-19) infected patients.
Why It Matters: The pilot trial is a randomized, open-label, 2-arm study of Piclidenoson plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19 infected patients with moderate-to-severe symptomatic disease. Patients will be randomized in a 1:1 ratio to one of the trial arms and treated for up to 4 weeks. Key efficacy measures include time to resolution of viral shedding, time to resolution of clinical symptoms, measures of respiratory function, need for ventilatory support, and overall mortality. Standard safety parameters will also be measured. Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center, is the Principal Investigator of the study.
Key Quote: “Piclidenoson’s anti-viral, anti-inflammatory, and anti-rheumatic properties combined with its excellent safety profile make it a strong candidate for the potential treatment of coronavirus. We are very pleased to work with Dr. Diker and are grateful for the rapid response of Rabin Medical Center’s IRB, enabling us to treat patients without delay.” – Stan Ross, CEO
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 COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint 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 U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 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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| Catasys (NASDAQ: CATS) Expands OnTrak-A Solution with Leading National Health Plan into Indiana, Wisconsin, Kentucky and Arkansas |
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Catasys (NASDAQ: CATS), a leading AI-powered and telehealth-enabled, virtualized outpatient healthcare treatment company, today announced the expansion of its OnTrak-A solution with a leading national health plan into Indiana, Wisconsin, Kentucky and Arkansas.
Why It Matters: This expansion ensures that eligible commercial and Medicare Advantage members of the health plan in these four states will have access to critical behavioral healthcare to help them better manage chronic disease. With the expansions into Indiana and Arkansas, OnTrakTM is now available in 30 states, as well as the nation’s capital. Additional OnTrak-A expansions are expected in the remainder of 2020.
Key Quote: “We look forward to serving the members of this national plan in these additional four states, and treating those who struggle with the burden of managing heightened anxiety in addition to their behavioral conditions and chronic disease. Only a few months into 2020, this particular health plan partner has expanded OnTrakTM into seven additional states and Washington, D.C., validating the ROI of our programs and the positive outcomes we deliver for members.” – Terren Peizer, Chairman & CEO
The Backstory: Catysys’ OnTrak platform integrates evidence-based psychosocial and medical interventions delivered either in-person or via telehealth, along with care coaching and in-market Community Care Coordinators who address the social and environmental determinants of health, including loneliness. The program improves member health and delivers validated cost savings to healthcare payers of more than 50 percent for enrolled members. OnTrak is available to members of leading national and regional health plans in 30 states and in Washington, D.C.
Disclosure
Catasys (CATS) is a client of RedChip Companies, Inc. CATS agreed to pay RedChip Companies, Inc. a $5,000 monthly cash fee, beginning in February 2017, for RedChip investor awareness services and consulting services.
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| Esports Entertainment Group (NASDAQ: GMBL) Announces Pricing of Above Market $8.4 Million Public Offering and Uplisting to Nasdaq |
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Esports Entertainment Group (NASDAQ: GMBL), a licensed online gambling company with a focus on esports wagering and 18+ gaming, today announced the pricing of its public offering of 1,980,000 units at a price to the public of $4.25 per unit.
Why It Matters: Esports Entertainment Group is the first US-based iGaming (online gambling) company to list on the NASDAQ, and the company intends to leverage this status to execute an aggressive rollup M&A strategy in the highly fragmented esports and online gambling markets. An LOI was already signed to acquire the first target, which generates approximately $12 million in revenue. Organic sales growth is expected to scale rapidly, driven by a vast network of affiliate marketing partners (190+ esports teams and 600+ industry influencers). Globally, esports betting is already significantly larger than the esports economy itself and is projected to exceed $23 billion in 2020. GMBL is well positioned to capitalize on this opportunity and emerge as a leader in esports betting.
The Backstory: Esports Entertainment Group is a licensed online gambling company with a specific focus on esports wagering and 18+ gaming. Esports Entertainment offers fantasy, pools, fixed odds and exchange style wagering on esports events in a licensed, regulated and secure platform to the global esports audience at vie.gg. In addition, Esports Entertainment intends to offer users from around the world the ability to participate in multi-player mobile and PC video game tournaments for cash prizes. Esports Entertainment is led by a team of industry professionals and technical experts from the online gambling and the video game industries, and esports. The Company holds a license to conduct online gambling and 18+ gaming on a global basis in Curacao, Kingdom of the Netherlands. The Company maintains offices in Malta.
Disclosure
Esports Entertainment Group, Inc. (GMBL) is a client of RedChip Companies, Inc. GMBL agreed to pay RedChip Companies, Inc. a $4,000 monthly cash fee, beginning in June 2018, and 225,000 shares of Rule 144 stock for RedChip investor awareness 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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