Archive for Healthcare – Page 2

Heathcare and Biotech Updates

Eli Lilly Trades Up 15% on Positive Phase 3 Breast Cancer Trial Results

By The Life Science Report

Source: Streetwise Reports   06/16/2020

Eli Lilly shares set a new 52-week high price after the company reported that its Verzenio® (abemaciclib) significantly reduced the risk of cancer returning in people with high risk HR+, HER2- early breast cancer.

Eli Lilly and Co. (LLY:NYSE) today announced “Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone.”

The firm advised that “the results are from a pre-planned interim analysis of the Phase 3 monarchE study – making Verzenio the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.”

Maura Dickler, M.D., VP of oncology, late-phase development, Lilly Oncology, stated, “When a person is diagnosed with high risk early stage breast cancer, they strive to do everything in their power to prevent a recurrence. And as clinicians, we have the same goal…monarchE was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high risk HR+, HER2- early breast cancer. This would not have been possible without the tremendous commitment from the people who participated in this trial.”

The company noted that breast cancer is the most common cancer among women worldwide and explained that even though there has been a lot of progress in treating breast cancer, about 30% of those diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning.

Lilly Oncology’s President Anne White commented, “We’re proud that Verzenio has already treated tens of thousands of people around the world who are living with HR+, HER2- advanced breast cancer…And now Verzenio in combination with endocrine therapy has demonstrated positive results in people with high risk HR+, HER2- early breast cancer – a major milestone with the potential to change the paradigm of how early breast cancer is treated and a first for the CDK4 & 6 inhibitor class. The fact that these results were achieved early, at the interim analysis, is also exciting because it will help us speed this innovation to people who need it. We look forward to submitting these data to regulatory authorities before the end of 2020.”

The company indicated that the monarchE trial has a completion date estimated for June 2027. The firm advised that it is a Phase 3, multicenter, randomized trial that enrolled 5,637 patients with high risk, node positive, HR+, HER2- early breast cancer. The primary objective of the trial was listed as “invasive disease-free survival, which in monarchE is defined as the length of time before any cancer comes back or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.”

The firm stated that “Verzenio® (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.”

Eli Lilly began the day with a market capitalization of around $135.4 billion with approximately 956.4 million shares outstanding. LLY shares opened more than 10.00% higher today at $156.32 (+$14.80, +10.46%) over yesterday’s $141.52 closing price and reached a new 52-week high price this morning of $167.43. The stock has traded today between $155.00 and $167.43 per share and is currently trading at $163.56 (+$22.07, +15.60%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: LLY:NYSE,
)

Reata Pharma Announces $350 Million Strategic Investment from Blackstone Life Sciences

By The Life Science Report – Source: Streetwise Reports   06/11/2020

Shares of Reata Pharmaceuticals traded 30% higher after reporting that Blackstone Life Sciences will invest $350 million in the company to advance bardoxolone methyl as a potential therapy for Alport syndrome and other rare and serious chronic kidney diseases.

Clinical-stage biopharmaceutical company Reata Pharmaceuticals Inc. (RETA:NASDAQ) and Blackstone Group Inc. (BX:NYSE) today announced that “funds managed by Blackstone Life Sciences will lead a $350 million royalty and equity investment in Reata to fund the development and potential commercialization of bardoxolone methyl, an investigational once-daily oral therapy being studied for chronic kidney disease (CKD) in Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD).” The firms advised that these are life-threatening diseases with few or no effective U.S. Food and Drug Administration (FDA) approved therapies.

Global Head of Blackstone Life Sciences Nicholas Galakatos, Ph.D., stated, “This investment aligns with Blackstone Life Sciences’ mission to help advance promising new medicines to patients with high unmet needs. If approved, bardoxolone has the potential to provide for the first time a therapy that improves the quality of life for tens of thousands of patients around the world suffering from Alport syndrome.”

Reata’s CEO and President Warren Huff commented, “Bardoxolone has been a primary focus of our company’s research and development efforts to date…We are extremely pleased that Blackstone Life Sciences has recognized the potential of bardoxolone, and the potential of Reata more generally. We are proud to enter into this strategic investment agreement with Blackstone Life Sciences.”

Paris Panayiotopoulos, senior managing director of Blackstone Life Sciences, added, “Bringing the first potential therapy to Alport syndrome patients, a devastating genetic condition with no approved treatments, is very motivating…With this investment, we will support Reata in further developing bardoxolone for CKD in Alport syndrome, autosomal dominant polycystic kidney disease and multiple other chronic kidney diseases.”

Under the terms of the investment agreement, Blackstone Life Sciences will invest $300 million in Reata in return for certain royalty payments on worldwide bardoxolone net sales made by Reata and its licensees with the exception of sales by Kyowa Kirin Co. Ltd. As part of the deal, Blackstone Life Sciences will invest $50 million to buy 340,793 shares of Reata’s Class A common stock at a price of $146.72 per share. The transaction is expected to close on or before June 24, 2020, with Reata receiving the $350 million investment upon closing.

Reata’s COO and CFO Manmeet S. Soni remarked, “This $350 million financing further strengthens Reata’s balance sheet, and extends Reata’s cash runway through the end of 2023. It positions us to make strategic investments to further expand our development and commercial capabilities in preparation for the potential approval and launch of our drugs.”

The company explained that “bardoxolone methyl is an investigational, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling, and that the FDA has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and ADPKD.”

Reata Pharmaceuticals is a clinical-stage biopharmaceutical company based in Plano, Tex., that focuses on developing medicines for patients with serious or life-threatening diseases. The firm’s therapeutics target molecular pathways that are involved regulation of cellular metabolism and inflammation.

Blackstone Life Sciences is a private, global investment firm that invests in numerous companies and products in the life science sectors.

Reata Pharmaceuticals has a market capitalization of around $4.4 billion with approximately 33.24 million shares outstanding and a short interest of about 11%. RETA shares opened 26% higher today at $165.00 (+$34.08, +26.03%) over yesterday’s $130.92 closing price. The stock has traded today between $156.99 and $177.48 per share and is currently trading at $171.24 (+$40.32, +30.80%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: RETA:NASDAQ,
)

Curis’ Shares Take Off as FDA Clears IND Application for Monoclonal Anti-VISTA Antibody

Curis Inc. shares are up more than 130% and established a new 52-week high price after reporting that the FDA cleared the company’s IND Application for CI-8993, its monoclonal anti-VISTA antibody.

By The Life Science Report – Source: Streetwise Reports   06/10/2020

Biotechnology company Curis Inc. (CRIS:NASDAQ), which concentrates its efforts on developing innovative therapeutics for treating cancer, today announced that “the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody. Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020.”

The company’s President and CEO James Dentzer commented, “The clearance of our IND is an important step for the advancement of VISTA therapies, as CI-8993 becomes the first anti-VISTA antibody in development to enter clinical testing…When activated, VISTA plays a critical role in suppressing T cell activity. Conversely, it has been shown in preclinical studies that blocking VISTA reduces the suppression of T cells and reactivates anti-tumor immune function. We are eager to leverage our extensive experience with VISTA and pioneer this first-in-class anti-VISTA antibody program.”

The firm mentioned that certain cancers may be amenable to monotherapy treatment with anti-VISTA therapy. Curis stated that several of these cancers are known to be highly driven by VISTA including mesothelioma, triple negative breast cancer, non-small cell lung cancer and gynecologic malignancies. The company noted that with some other types of cancers, anti-VISTA therapy may be more effective as part of a combination therapy approach.

The company advised that it expects to commence a multi-center Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed/refractory solid tumors in H2/20. The trial will enroll about 50 patients with the objective of determining recommended dosage levels.

The firm explained that “VISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation and that it relieves negative regulation by hematopoietic cells and enhances protective anti-tumor immunity, and is highly expressed on myeloid cells and T cells.”

Curis Inc. is a biotechnology company based in Lexington, Mass., that is engaged in developing therapeutics to treat cancer. The company is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis indicated that it is also collaborating with Genentech, a member of the Roche Group, for commercializing Erivedge® for use in treatment of advanced basal cell carcinoma.

Curis began the day with a market capitalization of around $44.6 million with approximately 36.6 million shares outstanding. CRIS shares opened nearly 80% higher today at $2.19 (+$0.97, +79.51%) over yesterday’s $1.22 closing price and reached a new 52-week high price this morning of $3.59. The stock has traded today between $1.88 to $3.59 per share and is currently trading at $2.87 (+$1.65, +135.24%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: CRIS:NASDAQ,
)

Enochian Shares Trade Up 50% upon Concluding FDA Meeting for Potential HIV Cure

By The Life Science Report – Source: Streetwise Reports   06/08/2020

Shares of Enochian Biosciences reached a new 52-week high after the company reported that it successfully completed its FDA INTERACT meeting for ENOB-HV-01, a potential cure for HIV.

Gene-modified cellular and immune therapies company Enochian Biosciences Inc. (ENOB:NASDAQ) today announced “the completion of an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).”

The company advised that the meeting included management and scientists from Enochian BioSciences together with CBER OTAT staff. The INTERACT meeting’s purpose was said to discuss the direction forward for ENOB-HV-01; “ENOB-HV-01 is a novel approach to autologous stem cell transplantation, with the potential to cure HIV by increasing engraftment of gene-modified cells that are resistant to HIV infection.”.

Dr. Mark Dybul, executive vice-chair of Enochian BioSciences, remarked, “We considered the meeting to be very successful, with strong alignment between Enochian’s approach to developing ENOB-HV-01 and the comments of the FDA reviewers…I want to thank the reviewers from FDA CBER OTAT for their time and helpful insight during our meeting. We look forward to advancing our thoughtful and deliberate pre-clinical work during the remainder of this year and into early next, leading to a pre-IND submission in 2021.”

The company’s Scientific Advisory Board Chair and former Chief Medical Officer of Calimmune Dr. W. David Hardy commented, “The novel approach we are pursuing has the potential to overcome the challenges of engraftment commonly encountered by others in the field. While still early, thus far the data have exceeded my expectations, and I believe the FDA reviewer feedback was very much aligned with our development plan. After more than 30 years as an HIV clinician and researcher, it is a great privilege to be involved with an enterprise with the potential to cure HIV, offering hope to millions of people.”

Enochian BioSciences is a biopharmaceutical company based in Los Angeles, Calif. The firm in engaged in developing and commercializing gene-modified cell therapies. The company noted that it gene-modified cell therapy platform can be utilized in many indications, including HBV, HIV/AIDS and oncology. The company states on its website that in 2017, 36,900,000 people throughout the world were living with HIV and 1,000,000 AIDS related deaths were reported in that same year worldwide.

Enochian started off the day with a market capitalization of around $191.6 million with approximately 46.5 million shares outstanding and a short interest of about 2.8%. ENOB shares opened greater than 220% higher today at $13.25 (+$9.13, +221.60%) over Friday’s $4.12 closing price and reached a new 52-week high price this morning of $13.43. The stock has traded today between $6.39 and $13.43 per share and is currently trading at $6.20 (+$2.08, +50.49%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: ENOB:NASDAQ,
)

Coverage Initiated on Company at ‘Forefront of the Telehealth Revolution’

By The Life Science Report

Source: Streetwise Reports   06/08/2020

A review of CloudMD Software & Services and the reasons why it makes a compelling investment are provided in a Beacon Securities report.

In a June 4 research note, analyst Gabriel Leung reported that Beacon Securities initiated coverage on CloudMD Software & Services Inc. (DOC:TSX.V; DOCRF:OTCQB; 6PH:FSE) with a Speculative Buy rating and a CA$1.50 per share target price. The stock is trading now at about CA$0.71 per share.

Leung reviewed the company’s objective and revenue sources. CloudMD, based in Vancouver, British Columbia, aims to digitize healthcare delivery by providing patients access to all points of their care remotely, from a cellphone, tablet and/or laptop or desktop computer. “CloudMD has generated good early traction on this front,” Leung noted.

CloudMD generates revenues in two ways, Leung stated. One is from software as a service-based subscriptions to its technology services. They include CloudMD, a telemedicine platform that connects patients in British Columbia and Ontario to a licensed physician for real-time virtual appointments. MyHealthAccess is an online portal for patient appointments and a telemedicine platform. JunoEMR is a cloud-based electronic medical records software, and ClinicAid is a medical billing software. Livecare Connect is a standalone telemedicine platform used by health professionals across Canada. KindredPHR is a software for storing, managing and sharing personalized health records. As for future revenue, Beacon estimated CloudMD will generate $15 million in 2020 and $27 million in 2021.

This array of telehealth solutions serves 375-plus clinics and more than 3,000 licensed practitioners, including emergency medicine physicians, which cumulatively have about 3 million registered patients. CloudMD has about 100,000 patients registered on its CloudMD platform alone.

Also, the company has partnerships with Save-On-Foods and Pure Integrative Pharmacies, which are pilot testing the presence of telehealth kiosks inside their facilities for on-demand, on-site virtual care.

Revenue also comes from the healthcare facilities that CloudMD runs, which are five medical clinics in the Lower Mainland and two pharmacies in Metro Vancouver.

“While it does have a brick and mortar presence, we believe the main growth and value driver for CloudMD will come via market share gains in the large and relatively untapped virtual care, telehealth market in Canada,” commented Leung.

Leung highlighted that three existing factors are setting the company up for further success. One is its healthcare background, another is its suite of telehealth offerings. The third is the impact of COVID-19 and new related governmental regulations around remote healthcare. “CloudMD is well positioned to capitalize on the telehealth opportunity in Canada,” he added.

Several potential catalysts are on the near-term horizon for CloudMD, Leung pointed out. They include possible acquisitions of further technology or clinics, for which the company has about $15 million in funds. Other possible stock moving events are an extension beyond the pilot phase of either of its two existing kiosk partnerships and an expansion of its pharmacy kiosk business into Ontario.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with CloudMD Software & Services Inc. Please click here for more information.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of CloudMD Software & Services Inc., a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from Beacon Securities, CloudMD Software & Services Inc., Initiating Coverage, June 4, 2020

Does Beacon, or its affiliates or analysts collectively, beneficially own 1% or more of any class of the issuer’s equity securities? No

Does the analyst who prepared this research report have a position, either long or short, in any of the issuer’s securities? No

Has any director, partner, or officer of Beacon Securities, or the analyst involved in the preparation of the research report, received remuneration for any services provided to the securities issuer during the preceding 12 months? No

Has Beacon Securities performed investment banking services in the past 12 months and received compensation for investment banking services for this issuer in the past 12 months? Yes

Was the analyst who prepared this research report compensated from revenues generated solely by the Beacon Securities Investment Banking Department? No

Does any director, officer, or employee of Beacon Securities serve as a director, officer, or in any advisory capacity to the issuer? No

Are there any material conflicts of interest with Beacon Securities or the analyst who prepared the report and the issuer? No

Is Beacon Securities a market maker in the equity of the issuer? No

This report makes reference to a recent analyst visit to the head office of the issuer or a site visit to an issuer’s operation(s)? No

Did the issuer pay for or reimburse the analyst for the travel expenses? No

Beacon analysts are not permitted to own the securities they cover, but are permitted to have a position, either long or short, in securities covered by other members of the research team, subject to blackout conditions.

Analyst Certification: The Beacon Securities Analyst named on the report hereby certifies that the recommendations and/or opinions expressed herein accurately reflect such research analyst’s personal views about the company and securities that are the subject of the report; or any other companies mentioned in the report that are also covered by the named analyst. In addition, no part of the research analyst’s compensation is, or will be, directly or indirectly, related to the specific recommendations or views expressed by such research analyst in this report.

( Companies Mentioned: DOC:TSX.V; DOCRF:OTCQB; 6PH:FSE,
)

Aurora Cannabis ‘Upside Breakout Looks Imminent’

By The Life Science Report – Source: Clive Maund for Streetwise Reports   06/08/2020

Technical analyst Clive Maund charts the cannabis company and explains why he calls it an “immediate strong buy.”

Further to its being recommended a few days back for an upside breakout from the current bull Pennant pattern leading to another sharp upleg, this brief update is to point out that the pattern in Aurora Cannabis Inc. (ACB:NYSE; ACB:TSX) looks even more bullish now with a continued steady volume dieback, so that at the time of writing only about 3 million shares have been traded so far today compared with over 100 million in one day when it blasted higher in the middle of May. The volume pattern looks very bullish indeed and is consistent with a bull Pennant completing, and volume is now so light relatively speaking that an upside breakout looks imminent.

 

Aurora Cannabis is therefore rated AN IMMEDIATE STRONG BUY for another sharp upleg that is expected to commence very soon.

Another upleg in this large cannabis stock should have a positive effect on many stocks across the sector, including Icanic Brands that we went for a day later than Aurora.

Aurora Cannabis website.

Aurora Cannabis Inc., ACB, ACB.TSX, trading at $14.27, C$19.20 on 4th June 2020.

Originally posted on CliveMaund.com at 2.05 pm EDT on 4th June 2020.

Clive Maund has been president of www.clivemaund.com, a successful resource sector website, since its inception in 2003. He has 30 years’ experience in technical analysis and has worked for banks, commodity brokers and stockbrokers in the City of London. He holds a Diploma in Technical Analysis from the UK Society of Technical Analysts.

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Disclosure:
1) Clive Maund: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. My company has a financial relationship with the following companies mentioned in this article: None. CliveMaund.com disclosures below. I determined which companies would be included in this article based on my research and understanding of the sector.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Charts provided by the author.

CliveMaund.com Disclosure:
The above represents the opinion and analysis of Mr Maund, based on data available to him, at the time of writing. Mr. Maund’s opinions are his own, and are not a recommendation or an offer to buy or sell securities. Mr. Maund is an independent analyst who receives no compensation of any kind from any groups, individuals or corporations mentioned in his reports. As trading and investing in any financial markets may involve serious risk of loss, Mr. Maund recommends that you consult with a qualified investment advisor, one licensed by appropriate regulatory agencies in your legal jurisdiction and do your own due diligence and research when making any kind of a transaction with financial ramifications. Although a qualified and experienced stock market analyst, Clive Maund is not a Registered Securities Advisor. Therefore Mr. Maund’s opinions on the market and stocks can only be construed as a solicitation to buy and sell securities when they are subject to the prior approval and endorsement of a Registered Securities Advisor operating in accordance with the appropriate regulations in your area of jurisdiction.

( Companies Mentioned: ACB:NYSE; ACB:TSX,
)

Mackie Research: Small Cap a World Leader in Health and Safety Wearables

By The Life Science Report – Source: Bill Newman of Mackie Research for Streetwise Reports   06/05/2020

Mackie Research believes Blockchain Holdings’ TraceSafe tracking platform could tap into the “exceptionally large market” for contact tracing during the Covid-19 pandemic.

Note: This article is not research and any companies mentioned are not rated.

TraceSafe Technologies Inc. is a wholly owned subsidiary of Blockchain Holdings Ltd. (BCX:CSE), and owns 100% of the rights and interests in the real-time location tracking technology known as TraceSafe. TraceSafe includes original hardware such as wearable products, like a bracelet band or an access card, which has an embedded chip that can track the wearer’s location.

Also, over a 10-year period, TraceSafe has developed a robust and secure cloud-to-device platform that is designed to be highly flexible. This allows the technology to be tailored to many different applications, including contact tracing, quarantine management and real-time location services for company employees.

chartStock Chart

The TraceSafe technology has been proven effective for tracking purposes in maternity wards and monitoring senior citizens in care facilities. With the outbreak of the Covid-19 (C-19) pandemic, the TraceSafe technology is now being used to assist governments and health agencies to temporarily track international travelers who are required to self-quarantine. TraceSafe bracelets have already been deployed in Hong Kong, and the company recently announced an expansion into Kuwait.

The potential revenue growth from the government sector is large, but the potential of the corporate/enterprise sector could be even larger. TraceSafe is in discussions with multiple companies who need real-time contact-tracing technology to aid in social distancing in the workplace. This provides workers with a level of safety while allowing companies to reopen.

Given the urgent need for companies to resume operations, we believe the emerging category of health and safety wearable technology could be an exceptionally large market, providing TraceSafe the opportunity to continue its rapid expansion.

Key Catalysts/Opportunities

  • TraceSafe Self-Quarantine Monitoring System: TraceSafe technology is ideal for monitoring international travelers who are required to quarantine after travel. The self- monitoring management system registers a user through an identification bracelet. The bracelet tracks the time and location of the user and the logs are sent to a central monitoring system. TraceSafe allows a user to declare once they have entered quarantine, and subsequently prompts periodic check-ins. The tag is inexpensive to produce and is disposable, which provides a level of privacy to the user after the quarantine period has ended.
  • Government Market: Already Deployed in Hong Kong; Rapidly Expanding into Other Countries: The Hong Kong government is already using TraceSafe disposable bracelets to manage and enforce its quarantine program for foreign visitors. Over 100,000 bracelets have already been sold in Hong Kong. Based on the success of this program, TraceSafe expects to expand into multiple countries in the coming weeks and months.On May 21, 2020, the company announced a pilot program with the government of Kuwait to utilize TraceSafe for a safety and contact-tracing program across the country’s food delivery workforce. The company also announced a pilot project with a Southeast Asian country (confidential at this time) to use TraceSafe for self-quarantine management.

    TraceSafe is in talks with over 20 other governments located around the world that are considering the deployment of a tracking pilot project.

  • Corporate Market: Real-Time Tracing Allows Businesses to Reopen: Corporations are proactively seeking real-time contact tracing technology to allow for the continuation of business during the C-19 pandemic. The system will alert those who may have been near a coworker who tested positive for C-19, allowing unexposed workers, and the corporation, to continue operating. Potential clients include manufacturers, schools and shopping centers.
  • TraceSafe Announces Contract with the Toronto Wolfpack: On June 1, 2020, TraceSafe announced it has executed a contract with the Toronto Wolfpack Rugby League Football Club to supply wearable tracking products and services to staff and fans for the 2020–2021 season. This should allow Lamport Stadium to safety reopen for training and future games. TraceSafe does not require the use of the fans’ mobile phones, thereby eliminating privacy concerns.
  • New Chief Revenue Officer: Gordon Zeilstra has been appointed CRO. Gordon has over 20 year of experience and was previously with SAP, Taleo and Monster.com.

Details

  • TraceSafe Bracelet/Tag Are Low Cost and Disposable: TraceSafe offers a complete cloud-to-device solution with real-time location tracking that gives instant alerts and notifications to administrators and users. The bracelet is tamper-proof and paired to a user’s mobile app, which regularly sends location data to the cloud. The tags are inexpensive to manufacture and are designed to be disposed of after use, ensuring privacy for the user. The bracelets are hospital-grade, hypoallergenic, waterproof and utilize the Bluetooth low-energy platform, with a battery life that typically lasts about 20 days.
  • Hardware and Software Revenue Streams: TraceSafe manufactures and sells its propriety hardware, including the disposable bracelet bands. The company will also receive revenue from SaaS (software as a service) licensing.
  • Airbeam Wireless Technologies: Blockchain owns a 13% equity stake in Airbeam Wireless Technologies. Airbeam is a private, Canada-based company that is a manufacturer of 5G semiconductors and a small-cell network innovator. Airbeam recently completed an equity financing at a price of US$1.00 per share (~CA$1.38/sh), which values Blockchain’s equity interest at ~CA$13.5 million. Blockchain sees large upside from its passive investment in Airbeam.

Note: As Newman points out, the size of the government market is large but the potential size of the corporate sector is much, much larger, as shown in the slide below taken from a recent presentation from TraceSafe. With the Toronto Wolfpack contract, TraceSafe has only just begun to tap into the enterprise/corporate market.

Chart

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Disclosure:
1) Bill Newman: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. Mackie Research does not have a banking relationship with any company mentioned in this article. I determined which companies would be included in this article based on my research and understanding of the sector.
2) Mackie Research: This article is not research and any companies mentioned are not rated.
3) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Blockchain Holdings. Please click here for more information. Within the last six months, an affiliate of Streetwise Reports has disseminated information about the private placement of the following companies mentioned in this article: Blockchain Holdings.
4) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
5) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
6) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Blockchain Holdings, a company mentioned in this article.

( Companies Mentioned: BCX:CSE,
)

Immunotherapy Firm Releases Data Showing Treatment Potential Against Sepsis

By The Life Science Report

Source: Streetwise Reports   06/03/2020

Recently presented results from Enlivex Therapeutics’ Phase 1b study in sepsis and their implications are reviewed in an H.C. Wainwright & Co. report.

In a June 1 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Enlivex Therapeutics Ltd.’s (ENLV:NASDAQ) Allocetra demonstrated multifaceted immune system rebalancing in sepsis patients during a Phase 1b trial.

Selvaraju relayed that these results were presented by Enlivex at the International Society for Cellular Therapy conference held last week virtually. Along with a recap of safety and efficacy data, the data included a new endpoint analysis that “demonstrated the potential of Allocetra to resolve cytokine storms with heterogeneous underlying pathologies,” he wrote.

The analyst reviewed the findings presented at the conference. Enlivex’s Phase 1b study compared the levels after receiving Allocetra to baseline of more than 30 immune modulators in the participants, all sepsis patients. Results showed that after treatment with Allocetra, abnormal immune modulators either returned to or toward homeostasis. For instance, white blood cells and neutrophils returned to within normal limits in all evaluated patients.

“The fact that trends towards normalization were observed not only across multiple inflammatory markers, spanning different categories, as well as immune cell counts, but across all patients assessed, gives us confidence that these data prove the hypothesis that Allocetra achieves broad resetting of the immune system,” Selvaraju highlighted.

This return to homeostasis led to decreased or resolved inflammation, improvements in sequential organ failure assessment and reduced hospital and intensive care unit (ICU) stays. “We believe that the close relationship between observed reductions in inflammatory biomarkers and the clinical outcomes observed bodes very well for future development of Allocetra as a treatment for sepsis,” commented Selvaraju.

In Q4/20, Enlivex intends to follow up its Phase 1b study with a controlled, randomized Phase 2b trial. If the study starts as planned, topline data could be available by late 2021.

“Positive data could prove sufficient to support regulatory approval, in our view, given the unmet need in severe sepsis, which carries a 50% mortality rate, accounting for the deaths of 270,000 Americans each year,” indicated Selvaraju.

As such, an accelerated approval pathway for Allocetra in sepsis is likely as is the potential for “lucrative” pricing given that its use would decrease the time patients spent in a hospital intensive care unit.

Potential stock moving events for Enlivex in 2020 are the release of additional data on sepsis and graft versus host disease and results from its COVID-19 trial.

“We feel investors should consider investment in Enlivex given the context of the plethora of near- and medium-term clinical development-related catalysts for Allocetra,” Selvaraju noted.

H.C. Wainwright & Co. has a Buy rating and a 12-month target price of $22 per share on Enlivex Therapeutics. The stock is currently trading at about $5.35 per share.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Enlivex Therapeutics Ltd., Company Update, June 1, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Enlivex
Therapeutics Ltd. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Enlivex Therapeutics Ltd.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Enlivex
Therapeutics Ltd. for non-investment banking services in the
previous 12 months.

The Firm or its affiliates did receive compensation from Enlivex Therapeutics Ltd. for investment banking services within twelve
months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

 

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Enlivex Therapeutics Ltd. during the
past 12 months.

The Firm does not make a market in Enlivex Therapeutics Ltd. as of the date of this research report.

( Companies Mentioned: ENLV:NASDAQ,
)

Cassava Shares Rise on Updated Phase 2b Alzheimer’s Drug Trial Data

By The Life Science Report

Source: Streetwise Reports   06/03/2020

Shares of Cassava Sciences traded 70% higher after the firm provided updates from its Phase 2b study of PTI-125 for use in treating Alzheimer’ disease.

Clinical-stage biotechnology company Cassava Sciences Inc. (SAVA:NASDAQ), which focuses on neurodegenerative diseases including Alzheimer’s disease, today announced that “its management is scheduled to present at the Jefferies Virtual Healthcare Conference today, June 3, 2020, at 3:00 p.m. EST.”

The firm provided an update that included discussion pertaining to “recently announced top-line results of a Phase 2b randomized, placebo-controlled study of PTI-125 in patients with Alzheimer’s disease.” The company stated that it feels that “high variability in levels of biomarkers over 28 days in placebo-treated patients, and other possible factors, may drive a reassessment of overall results for its Phase 2b study.”

The company’s President & CEO Remi Barbier commented, “We think it’s worth reflecting on what can be learned from our Phase 2b study by closely examining the clinical data, methods used to generate the data and drug effects on cognition…These on-going analyses may teach us how to move forward with our drug development plans for PTI-125 in Alzheimer’s disease.”

Cassava Sciences listed some of the key elements to its strategy to better understand the overall outcome of the Phase 2b study of PTI-125. The firm plans to re-analyze cerebrospinal samples from all study participants, analyze lymphocyte & plasma samples from all study participants and evaluate the effects of PTI-125 on cognition. The company indicated that it expects to announce the results of these analyses in H2/20.

The firm explained that PTI-125 is its lead therapeutic product candidate for the treatment of Alzheimer’s disease. According to the company, “PTI-125 is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A, a scaffolding protein, in the brain.”

The company noted that “Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills and that presently, there are no drug therapies to halt Alzheimer’s disease or to reverse its course.” The firm reported that there are approximately 5.8 million people in the U.S. who are currently living with Alzheimer’s disease.

Cassava Sciences Inc. is a clinical-stage biopharmaceutical company based in Austin, Tex. The company focuses its efforts on detecting and treating neurodegenerative diseases, such as Alzheimer’s disease. The firm stated that “it has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease, and owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technology, without royalty obligations to any third-party.” The firm mentioned that is also working on developing an investigational diagnostic called SavaDx in order to detect Alzheimer’s disease with a simple blood test.

Cassava Sciences started off the day with a market capitalization of around $50.6 million with approximately 24.78 million shares outstanding and a short interest of about 10.00%. SAVA shares opened nearly 17% higher today at $2.38 (+$0.34, +16.67%) over yesterday’s $2.04 closing price. The stock has traded today between $2.26 and $3.90 per share and is currently trading at $3.48 (+$1.44, +70.59%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: SAVA:NASDAQ,
)

Micro-Cap Pharma Moving Ahead with Plans for Phase 3 US Trial of a Repurposed Drug for Covid-19

By The Life Science ReportSource: Streetwise Reports   06/03/2020

Revive Therapeutics is focused on infectious diseases as well as treatments using psilocybin-based formulations.

Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS), a company that focuses on repurposing drugs for infectious diseases and rare disorders, is preparing to submit to the U.S. Food and Drug Administration (FDA) an Investigational New Drug (IND) application for a Phase 3 confirmatory trial to evaluate Bucillamine in patients with mild to moderate Covid-19.

The drug has a long history, having been used in Japan and South Korea for over 30 years for rheumatoid arthritis. Revive has a clinical history with the drug, repurposing it to conduct a Phase 2 trial in the United States in 2015 for acute gout flares and cystinuria, a form of kidney stones. While it never went to market, Revive possesses substantial data on its safety and efficacy.

“Bucillamine as an agent has a lot of strength in terms of anti-inflammatory advantages,” Michael Frank, chairman and CEO of Revive Therapeutics, told Streetwise Reports. “From its long use in Japan and South Korea, it has a lot of good history, and good safety and efficacy background. Additionally, from our Phase 2 study for gout, we had a lot of data to support its safety as well as its inflammation treatment properties.”

Earlier this year, with the advent of the Covid-19 pandemic, Revive looked at Bucillamine again. “There’s a lot of data to support that Bucillamine is much more powerful as an anti-inflammatory. It can help restore glutathione, which is an amino acid in the body that can help reduce inflammation. Bucillamine has a strong indication of possibly treating symptoms like lung inflammation caused by infectious diseases from specific strains of influenza, H1N1 and coronavirus, namely Covid-19,” Frank explained.

Revive in April filed a pre-investigational new drug meeting request with the FDA for Bucillamine for the treatment of Covid-19 to proceed to a Phase 2 clinical study. The FDA recommended that the company submit its IND for a Phase 3 confirmatory trial.

The basis of the clinical study will analyze if “Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs and to help treat Covid-19 manifestation,” Frank stated.

“The FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the Covid-19 Phase 3 trial and, therefore, the company did not have to perform any Phase 1 or Phase 2 clinical studies,” the company reported.

“Because of our history with Bucillamine, and that Bucillamine has been around 30 years and it’s been effective in South Korea and Japan treating rheumatoid arthritis, and because of the data, we were asked to provide an IND to go directly to a Phase 3 trial—a much bigger trial,” Frank said.

“FDA’s support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of Covid-19,’ noted Frank. “Entering into a Phase 3 study is a major milestone for the company, and we are excited to unlock the full potential of Bucillamine not only for this virus but also for other infectious diseases that we will investigate in the future.”

Revive has also stated that it intends to conduct a clinical study of Bucillamine in Covid-19 patients in Canada and today announced that it has submitted a Pre-Clinical Trial Application (Pre-CTA) to Health Canada and will have its Pre-CTA meeting with Health Canada this week.

“Unlike many micro caps in Canada and in the United States, getting to Phase 3 trial is a substantial plateau, and that’s what sets us apart,” Frank added.

Revive is also actively investigating psilocybin-based therapeutics. The firm, which acquired Psilocin Pharma Corp., is investigating “novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on the company’s wholly owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation.”

“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” Frank said. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”

The company is targeting rare diseases, mental health and addiction with the psilocybin formulations.

Revive has approximately 189 million shares outstanding, 267 million fully diluted.

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Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Revive Therapeutics. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Revive Therapeutics, a company mentioned in this article.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: RVV:TSX.V; RVVTF:OTCMKTS,
)