Archive for Healthcare – Page 2

Heathcare and Biotech Updates

Axsome Therapeutics Investors Awaken to Positive Outcome in Phase 2 Narcolepsy Trial

By The Life Science Report

Source: Streetwise Reports   12/03/2019

Axsome Therapeutics shares traded 14% higher today after the company reported that its narcolepsy drug candidate AXS-12 achieved its primary endpoint in the Phase 2 CONCERT Study.

This morning before U.S. markets opened, clinical-stage biopharmaceutical company Axsome Therapeutics Inc. (AXSM:NASDAQ), a developer of novel therapies for the management of central nervous system disorders, announced that “AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the firm’s CONCERT Phase 2 trial.”

The company stated that in the trial “AXS-12 also significantly reduced excessive daytime sleepiness (EDS), and improved cognitive function, sleep quality and sleep-related symptoms.” Additionally, Axsome reported that AXS-12 was safe and well tolerated and that there were no serious adverse events reported in the trial.

Professor of Neurology at Albert Einstein College of Medicine Dr. Michael J. Thorpy commented, “Narcolepsy is a neurological disorder that interferes with mental and social functioning, increases work and driving related accidents, and results in a nearly two-fold higher mortality rate…Medications that have the potential to reduce cataplexy symptoms, promote wakefulness, and enhance cognitive function, such as AXS-12, if borne out in Phase 3 trials, could provide new treatment options for patients living with this debilitating disorder.”

Herriot Tabuteau, MD, CEO of Axsome, remarked, “We are very pleased with the results of the CONCERT trial, which demonstrated a strong effect of AXS-12 on both cataplexy and excessive daytime sleepiness symptoms, as well as on cognitive function, in narcolepsy patients. The improvement in the ability to concentrate with AXS-12 is especially relevant because the cognitive impairment associated with narcolepsy is one of the most distressing aspects of the disease for patients, as highlighted in the FDA’s The Voice of the Patient report on Narcolepsy…Based on these positive results, Axsome intends to initiate Phase 3 trials of AXS-12 in 2020 with the goal of bringing this differentiated experimental medicine to narcolepsy patients as soon as possible.”

The company’s SVP of Clinical Development and Medical Affairs Cedric O’Gorman, MD, added, “The CONCERT trial exemplifies Axsome’s commitment to accelerating the innovation of effective treatments for difficult-to-treat CNS disorders such as narcolepsy…Existing treatment options for narcolepsy are few, do not address all key symptoms, may not be well tolerated, and are mostly controlled substances. If successfully developed, AXS-12 may overcome these limitations and could make it a candidate as foundational therapy to meaningfully improve the lives of the many narcolepsy patients.”

The company advised that the CONCERT trial was a Phase 2, double-blind, randomized study of AXS-12 in 21 patients diagnosed with narcolepsy. The firm further explained that “narcolepsy afflicts an estimated 185,000 individuals in the U.S. and is a serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep.”

Axsome notes that “AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition.”

Axsome Therapeutics, headquartered in New York, is a clinical-stage biopharmaceutical company engaged in the development of novel therapies for the management of central nervous system (CNS) disorders. The firm states that its core CNS product candidate portfolio includes four clinical-stage candidates: AXS-05; AXS-07; AXS-09 and AXS-12. Ongoing studies include a phase 3 trial of AXS-05 in treatment resistant depression, a phase 3 trial in major depressive disorder, and a phase 2/3 trial in agitation associated with Alzheimer’s disease. The company also has two active phase 3 trials of its AXS-07 for the acute treatment of migraine, and a phase 2 trial of AXS-12 in narcolepsy.

Axsome Therapeutics has a market cap of about $1.4 billion with approximately 34.51 million shares outstanding and a short interest of 17.3%. AXSM shares opened today at $45.13 (+$5.51, +13.91%) over yesterday’s $39.62 closing price. The stock has traded between $42.34 to $47.24 per share today and currently is trading at $45.44 (+$5.82, +14.69%).

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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: AXSM:NASDAQ,
)

Kodiak Shares Soar on $225 Million Royalty Deal for Retinal Drug

By The Life Science Report

Source: Streetwise Reports   12/02/2019

Shares of Kodiak Sciences traded more than 100% higher at times after the company reported that it entered into a $225 million royalty agreement for the firm’s KSI-301 used in the treatment of retinal vascular diseases including age-related macular degeneration and diabetic eye diseases.

This morning, clinical stage biopharmaceutical company Kodiak Sciences Inc. (KOD:NASDAQ), which specializes in developing novel therapeutics to treat chronic, high-prevalence retinal diseases, announced that “it has entered into a funding agreement to sell a capped royalty right on global net sales of KSI-301 to Baker Bros. Advisors for $225 million.”

The company explains that KSI-301 is Kodiak’s investigational therapy being developed for the treatment of retinal vascular diseases including age-related macular degeneration and diabetic eye diseases.

Under the terms of the agreement, Baker Bros. Advisors (BBA) purchased a capped 4.5% royalty on net sales of Kodiak’s anti–vascular endothelial growth factor (anti-VEGF) medication. The royalty is to be paid upon marketing approval in exchange for $225 million in committed development funding payable to Kodiak Sciences. The report noted that the royalty “caps” or terminates when BBA has received an aggregate amount equal to 4.5 times the total funding amount paid to Kodiak.

According to the terms of the royalty agreement, BBA will pay Kodiak $100 million upon the closing of the funding transaction, which is expected to occur on January 10, 2020, with payment of the remaining $125 million predicated upon Kodiak achieving certain objectives. This includes, among other things, 50% enrollment in the firm’s two planned pivotal clinical studies of KSI-301 in patients with retinal vein occlusion estimated to occur in late 2020.

Kodiak Sciences Chairman and CEO Victor Perlroth, MD, commented, “In thinking through how best to finance our accelerating clinical, manufacturing and commercial plans for KSI-301 and our ABC platform, royalty funding is meaningfully less dilutive than equity and preserves both our future financing and strategic flexibility…This royalty financing provides the foundation to fund the KSI-301 development program through our 2022 Vision of pivotal read-outs in retinal vein occlusion, wet age-related macular degeneration and diabetic macular edema and our anticipated Biologics License Application (BLA) and supplemental BLA submissions.”

In the report, the firm identifies KSI-301 as an investigational anti-VEGF therapy built on the company’s Antibody Biopolymer Conjugate (ABC) Platform designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. “Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The company’s DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019.”

Kodiak Sciences is headquartered in Palo Alto, Calif., and describes its business as a clinical stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases. The firm states that “it has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, its bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component, and is expanding its early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and the neurodegenerative aspects of glaucoma.”

Kodiak Sciences began the day with a market capitalization of about $1.1 billion with approximately 37.06 million shares outstanding and a short interest of around 7.40%. KOD shares opened almost 20% higher today at $35.00 (+$5.40, +18.24%) over Friday’s $29.60 closing price, and then proceeded to take off setting a new 52-week intraday high price of $72.87. Since the open, the stock has traded between $35.00 to $72.87 per share and is presently trading at $48.72 (+$19.12, +64.59%).

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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: KOD:NASDAQ,
)

Coverage Initiated on Maker of Antibiotic-Free Supplement for Livestock Feed

By The Life Science Report

Source: Streetwise Reports   11/26/2019

The highlights of this investment story are outlined in a Zacks Small-Cap Research report.

In a Nov. 19 research note, analyst David Bautz reported that Zacks Small-Cap Research initiated coverage on Avivagen Inc. (VIV:TSX.V; CHEXF:OTCMKTS) with a US$2.50 valuation. The stock is currently trading at around US$0.39.

Avivagen is developing a line of animal products that promote growth and immunological health through its proprietary oxidized-carotene (OxBC) content. Its products reduce or eliminate animals’ need for antibiotics as a growth promoter. “Avivagen discovered that oxidized B-carotene (OxBC) contains a unique class of polymeric compounds that promote immunological health,” Bautz highlighted.

“Avivagen and its partners has shown that supplementation of feed with parts-per-million levels of OxC-beta Livestock can be used as a replacement for growth-promoting antibiotics while offering the same or better growth and health benefits without contributing to the development of antibiotic resistant organisms,” he commented.

Bautz pointed out another positive to the story, that the potential market for Avivagen’s OxC-beta Livestock is “enormous,” at about $1 billion. This estimate is derived from the fact that about 32,000 feed mills produce roughly 1.1 billion metric tons of feed every year, and the global feed market is forecast to hit roughly $37 billion in 2022.

Zacks’ model on Avivagen estimates sales of OxC-beta Livestock to reach CA$50 million in 2024. OxBC is approved in the U.S., the Philippines, Mexico, Thailand, Taiwan, New Zealand and Australia.

Further, Avivagen continues to gain market share in Asia, its priority target, which accounts for 35% of the total amount of animal feed produced each year globally, Bautz noted. Avivagen has several distribution partners in Asia, where the registration process is underway in a number of countries there, including China.

Lastly, indicated Bautz, Avivagen has and is following a set growth strategy. One part is to maximize its existing partnerships “by driving adoption and increasing new applications.” The second is to expand into new markets by getting approvals in additional countries. The third component is to make further distribution deals in approved markets.

As for potential competitors to Avivagen, Bautz wrote, “We were not able to uncover any other company that is developing technology similar to OxC-beta Livestock, however, there are a number of antibiotic alternative products that are available and could be considered competition to Avivagen and OxC-beta Livestock.”

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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 company mentioned in this article is a billboard sponsor of Streetwise Reports: Avivagen. 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 Avivagen. 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 Avivagen, a company mentioned in this article.

( Companies Mentioned: VIV:TSX.V; CHEXF:OTCMKTS,
)

ChemoCentryx Shares Spike 300% on Phase 3 ANCA Vasculitis Trial Results

By The Life Science Report

Source: Streetwise Reports   11/26/2019

Shares of ChemoCentryx Inc. opened greater than 330% higher today after the firm reported positive topline data from its pivotal Phase 3 ADVOCATE trial of Avacopan in treatment of ANCA-associated vasculitis.

After the U.S. markets closed yesterday, ChemoCentryx Inc. (CCXI:NASDAQ), a Mountain View, Calif.-based developer of new medications targeted at inflammatory and autoimmune diseases and cancer, and its Switzerland-based partner Vifor Fresenius Medical Care Renal Pharma (VFMCRP), part of the Vifor Pharma Group (CH0364749348:SIX Swiss Exchange), announced positive topline data from the pivotal Phase 3 ADVOCATE trial of avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).

The company notes that “avacopan is a first-in-class, orally-administered molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases.” The firm notes that it owns and retains the commercial rights to avacopan in the U.S. and that VFMCRP has an exclusive license to commercialize the drug in all countries outside the U.S.

The ADVOCATE trial of avacopan was a 52-week global randomized, double-blind Phase 3 trial of 331 patients in 20 countries with ANCA-associated vasculitis. The pre-specified primary endpoints, which were successfully met in the trial, were remission of acute vasculitis activity at week 26 and sustained remission at week 52. The company highlighted that subjects who received avacopan also experienced significant reduction in glucocorticoid-related toxicity, significant improvement in kidney function in patients with renal disease and improvements in health-related quality of life metrics.

David Jayne, director of the Vasculitis and Lupus Clinic at Addenbrooke’s Hospital, Cambridge, commented, “This is the transformational result that clinicians and patients all over the world had been hoping for…The ADVOCATE trial demonstrated clearly that avacopan effectively brought patients into a state of remission for their acute vasculitis symptoms and kept them there for the entire period of this study. Importantly, avacopan did this in the absence of the traditional sustained daily steroid therapy that is the current standard of care and against which avacopan was compared…The notable and significant improvements in quality of life, the reductions in overall glucocorticoid toxicities and especially the improvements in renal function with avacopan therapy when compared to the steroid-containing standard of care are remarkable…In addition to changing the landscape of ANCA vasculitis therapy, these results have ramifications for other inflammatory diseases beyond ANCA vasculitis.”

ChemoCentryx’s President and CEO Thomas J. Schall, Ph.D., remarked, “These results exceed our expectations…We have for the first time demonstrated that a highly targeted therapy aimed at the very center of the ANCA disease process is superior to the traditional approach of broad immune suppression therapy; a therapy which the present findings may make obsolete…Working with our partner VFMCRP, we plan to make regulatory submissions for full marketing approval to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in 2020.”

Stefan Schulze, Vifor Pharma’s president of the Executive Committee and COO, added, “We are delighted with the positive topline data from the Phase 3 ADVOCATE trial for the treatment of ANCA vasculitis…By successfully meeting both primary endpoints and establishing superiority at 12 months, it confirms our belief that avacopan is a novel and better way to provide vasculitis control while reducing the risks of current standard of care and improving patient experience. This outcome is of high clinical relevance and an eagerly awaited change in the long-term treatment paradigm.”

The company explains that “ANCA vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated.”

ChemoCentryx’s partner Vifor Pharma Group is headquartered in Switzerland and is a global specialty pharmaceuticals company focused on iron deficiency, nephrology and cardio-renal therapies. Vifor Pharma Group companies include Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, Relypsa and OM Pharma.

ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx is currently focusing on its late stage drug candidates for patients with rare diseases, avacopan (CCX168) and CCX140. CCX140 is currently being developed for patients with focal segmental glomerulosclerosis (FSGS), a debilitating kidney disease.

ChemoCentryx ended the trading day yesterday with a market capitalization of approximately $469.6 million with about 58.27 million shares outstanding along with a short interest of around 5.6%. CCXI shares opened greatly higher today at $34.82 (+26.76, +332.01%) over yesterday’s closing price of $8.06. The stock set a new 52-week high price this morning of $36.88/share and has traded today between $26.74 to $36.88 per share. The company’s shares closed at $30.73 (+22.67, +281.27%).

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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: CCXI:NASDAQ,
)

Intercept Pharma Shares Rise on FDA Acceptance of NDA for Liver Fibrosis Treatment

By The Life Science Report

Source: Streetwise Reports   11/25/2019

Shares of Intercept Pharmaceuticals rose today after the company reported that the U.S. Food and Drug Administration accepted its NDA for obeticholic acid (OCA) for the treatment of liver fibrosis due to NASH and granted priority review status.

This morning biopharmaceutical company Intercept Pharmaceuticals Inc. (ICPT:NASDAQ), which is engaged in the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, announced that “the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review.”

The company advised in the report that the FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 26, 2020, for the NDA. The firm noted that the NDA is supported by positive interim analysis results from the company’s Phase 3 REGENERATE study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH, and that “the FDA grants priority review to drugs that have the potential to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.” The company indicated that the REGENERATE Study is a Phase 3, randomized study of obeticholic acid (OCA) on more than 2,400 adult NASH patients worldwide.

Intercept’s President and CEO Mark Pruzanski, M.D., commented, “If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading cause of liver transplant in the U.S. as soon as 2020…It is exciting to achieve this critical regulatory milestone that brings us one step closer to our goal of delivering the first approved therapeutic to those living with this devastating disease. From OCA’s prior designation as a Breakthrough Therapy to the grant of priority review today, our work with FDA continues to set an important precedent for the field, and we look forward to working with the agency over the coming months as they review the first NDA in NASH.”

The firm explains in the report that “nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.”

Intercept states that “OCA is the only investigational therapy to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis, and that the NDA filing for OCA is supported by positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH.”

Intercept Pharmaceuticalsis a biopharmaceutical company headquartered in New York, NY. The firm operates in the U.S., Canada and Europe and is focused on the development and commercialization of therapeutics to treat non-viral, progressive liver diseases. These disease include primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

Intercept has a market capitalization of approximately $2.9 billion with about 32.73 million shares outstanding along with a short interest of around 17.2%. ICPT shares opened today at $93.50 (+4.61, +5.19%) over Friday’s closing price of $88.89. The stock has traded today between $93.11 to $100.00 per share and is currently trading at $96.00 (+$7.11, 8.00%).

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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: ICPT:NASDAQ,
)

EyeGate Pharma Shares Looking Up on Pivotal PRK Ocular Bandage Gel Study Data

By The Life Science Report

Source: Streetwise Reports   11/22/2019

EyeGate Pharmaceuticals shares opened nearly 85% higher today after the company reported select topline data demonstrating that it met its primary endpoint in its cornea wound repairs pivotal photorefractive keratectomy study using the firm’s Ocular Bandage Gel eye drop.

This morning, late-stage clinical specialty pharmaceutical company Eyegate Pharmaceuticals Inc. (EYEG:NASDAQ), which is focused on developing products for treating disorders of the eye, announced that “it has received select topline data, specifically the primary endpoint, demonstrating superiority over standard-of-care in its corneal wound repair pivotal study using the Ocular Bandage Gel (OBG) eye drop.”

The company reported that “the results of this critical study demonstrated that EyeGate’s OBG eye drop provided a greater improvement in corneal re-epithelialization than those treated with the standard-of-care, a bandage contact lens.” The firm advised that the study was composed of 234 randomized subjects who received a large 9 mm corneal epithelial wound required for photorefractive keratectomy (PRK) surgery. EyeGate noted that next week it expects to receive additional topline data along with the full data package in mid-December.

Vance Thompson M.D., of Vance Thompson Vision in Sioux Falls, S.D. commented, “The proven effectiveness and well tolerated safety profile of EyeGate’s OBG eye drop is a major step for the corneal wound repair market…I believe that the OBG eye drop will not only benefit patients with large corneal defects, but also patients with moderate to small corneal abrasions and epitheliopathies.”

EyeGate’s CEO Stephen From remarked, “We are thrilled with the results of this pivotal study…This allows us to submit a de novo application for commercialization, which we plan to do in H2/20. OBG, if approved, will be the first product indicated to repair corneal defects, as well as the first prescription Hyaluronic Acid (“HA”) eye drop in the U.S., providing a huge opportunity for EyeGate.”

EyeGate indicated that “its lead product, Ocular Bandage Gel (OBG), is based on a modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique properties providing hydration and healing when applied to the ocular surface…the objective of OBG is to re-epithelialize the cornea, reduce the risk of infection, improve symptoms, and improve ocular surface integrity. Often current treatments fall short as they are ineffective in protecting and enabling corneal re-epithelialization.”

The company stated in the release that “if EyeGate receives FDA approval following successful completion of the PRK pivotal study, it believes OBG will be the only prescription hyaluronic acid eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects.”

EyeGate Pharmaceuticals is headquartered in Waltham, Mass., and is a late-stage clinical specialty pharmaceutical company focused on developing and commercializing therapeutics and drug delivery systems for treating eye disorders. EyeGate’s leading product is Ocular Bandage Gel (OBG). The firm notes that it is currently working on clinical trials for two different patient populations: photorefractive keratectomy (PRK) surgery to demonstrate corneal wound repair; and punctate epitheliopathies (PE), which includes dry eye.

EyeGate is developing its other product EGP-437, which incorporates a topically active corticosteroid dexamethasone phosphate for treatment of various inflammatory conditions of the eye, including uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea such as the iris and/or ciliary body, and macular edema, an abnormal thickening of the macula associated with the accumulation of excess fluids in the extracellular space of the neurosensory retina. EGP-437 is delivered into the ocular tissues through the company’s proprietary innovative drug delivery system called the EyeGate II Delivery System, which is designed to deliver optimal quantities of drugs to the anterior or posterior segments of the eye.

EyeGate Pharmaceuticals started off today with a market capitalization of about $17.4 million with approximately 3.636 million shares outstanding. EYEG shares opened 85% higher today at $8.86 (+$4.79, +84.97%) over the prior day’s closing price of $4.79. The stock set a new 52-week high price this morning and has traded today between $6.64 to $9.50 per share on very high relative volume. The shares are currently trading at $6.88 (+$2.09, +43.63%).

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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: EYEG:NASDAQ,
)

Cannabis Firm’s Stock Poised for ‘Substantial Gains’

By The Life Science Report

Source: Clive Maund for Streetwise Reports   11/21/2019

Technical analyst Clive Maund charts how news from this company affects its investment thesis.

The reason for this brief update is that this is a good juncture to bring to your attention that the technical condition of Captiva Verde’s stock continues to improve, to the point that it now looks about ready to break out to new highs. If it does, it should go on to make substantial gains after its long period of consolidation from last March.

On its latest 14-month chart we can see that it is now nudging its way out of a bull flag on good volume, and is now in position to take on the resistance at the highs at CA$0.30 per share. Factors strongly supportive of a probable breakout are the bullish alignment of moving averages, with the rising 50-day set to quickly cross the rising 200-day in the event of breakout, and the positive volume pattern, with predominant upside volume in the recent past, which has driven the accumulation line steadily higher. The pattern that has formed since June is classified as a shallow head-and-shoulders bottom. This is, thus, a very positive picture indeed.

clivecaptiva

With respect to the fundamentals, in addition to what was set out in the last update on the 11th, there has since been news out about a week ago that Captiva Verde is to acquire Miss Envy, a development that has its competitors turning green. This looks like a sound growth strategy, and here it is worth recalling that the CEO of Captiva Verde, Jeff Ciachurski, grew Western Wind from a tiny outfit to a very valuable company when it was eventually sold/bought out. It seems likely he will do the same with Captiva Verde, especially as the regulatory environment in Mexico is moving very swiftly in the company’s favor.

Finally, the fundamental and technical outlook for this stock is so favorable that it is considered worth dumping some losers and stagnant stocks in your portfolio and regrouping into stocks like this. The stock trades in light, but improving and now acceptable, volumes on the US OTC market, where, as ever, limit orders should be employed. It is certainly worth noting that there has been a big build-up in upside volume in recent weeks on this market, which has driven the on-balance volume line sharply.

Captiva Verde Land Corp.; PWR:CSX, CPIVF:OTC; closed at CA$0.245, $0.18 on 20 November 2019.

Originally posted on CliveMaund.com at 8.35 am EST on 21 November 2019.

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. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Captiva Verde, a company mentioned in this article.

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: PWR:CSE,
)

Hepion Pharma Shares Climb 50% Higher on NASH Liver Disease Treatment Results

By The Life Science Report

Source: Streetwise Reports   11/21/2019

Shares of Hepion Pharmaceuticals opened higher today after the company reported that its anti-fibrotic agent CRV431 prevented the development of liver cirrhosis in a highly aggressive, preclinical liver disease model.

Edison, New Jersey-based biopharmaceutical company Hepion Pharmaceuticals Inc. (HEPA:NASDAQ), which focuses on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (NASH), yesterday announced that CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease.

The study was conducted by Physiogenex S.A.S., a Contract Research Organization (CRO) based in France. In the study, Hepion reported that “rats were administered the hepatotoxic compound, thioacetamide, for nine weeks to induce liver injury and fibrosis, in combination with either CRV431 or vehicle control for the entire study period, and that blinded, histopathological analysis of the livers was then conducted at the end of the study period.”

The firm noted that “in the vehicle control group, 50% of the 10 animals developed cirrhosis, a severe form of liver disease that includes maximum levels of fibrotic scarring (F4 fibrosis; Kleiner scoring system), and in contrast, none of the 10 CRV431-treated rats developed cirrhosis.”

Hepion’s CEO Dr. Robert Foster commented, “These findings are an important preclinical milestone for CRV431 because thioacetamide administration to rats is recognized to produce among the most severe liver disease of all experimental models. This model was a rigorous test of CRV431’s anti-fibrotic activity…The results align with previous findings in other experimental models and highlight the tremendous potential of CRV431 as a treatment for liver diseases, including NASH, where progression to cirrhosis is a primary medical concern. Every fibrosis study that we have conducted thus far, whether in animals or in human liver slices, has demonstrated CRV431’s strong anti-fibrotic activity, contributing to a body of preclinical efficacy data that complements our ongoing human clinical trials.”

Less than two weeks ago, the firm announced findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of liver fibrosis in a highly regarded, Western Diet (WD) animal model of NASH.

The firm noted in the release that this WD model, which was developed in the laboratory of Dr. Scott Friedman at Icahn School of Medicine at Mount Sinai, New York, employs a high-fat, high-fructose and high-cholesterol diet in combination with carbon tetrachloride (CCl4) to cause significant fibrosis and hepatocellular carcinoma in mice. The company claimed in the report that “the model replicates many of the metabolic and histologic features of human NASH.”

CEO Dr. Foster remarked, “CRV431 has potently and consistently reduced liver fibrosis in every experimental model in which CRV431 has been examined…A total of seven studies spanning four experimental models and three independent testing sites have now shown CRV431 to decrease liver fibrosis arising from a variety of dietary, chemical, and biochemical insults. These findings include previously reported positive results in human liver samples as examined by precision cut liver slice methodologies, or PCLS…Taken together, these studies suggest that CRV431 may be most effective in advanced stages of NASH where fibrotic activities are highly active. We are building one study upon another to drive our data portfolio, and the results continue to be outstanding. We plan to continue with many additional studies conducted in parallel with our clinical programs to develop a thorough understanding of this important mode of action in liver disease.”

Hepion Pharmaceuticals Inc., formerly ContraVir Pharmaceuticals Inc., is a clinical-stage biopharmaceutical company headquartered in Edison, New Jersey. The company indicates that it is focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). “Hepion’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease,” the company stated.

Hepion Pharmaceuticals Inc. began the day with a market capitalization of about $8.5 million with around 3.454 million shares outstanding. The stock has a 52-week price range of $2.00-39.20. This morning, HEPA shares opened greater than 75% higher at $4.30 (+$1.85, +75.51%) over yesterday’s $2.45 closing price. The stock has traded today between $3.51 and $4.55/share on extremely high volume and is currently trading at $3.52 (+$1.10, +45.39%).

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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: HEPA:NASDAQ,
)

Kiniksa Pharma Awarded FDA Breakthrough Therapy Status for Pericarditis Treatment Drug

By The Life Science Report

Source: Streetwise Reports   11/20/2019

Shares of Kiniksa Pharmaceuticals opened nearly 30% higher today after the firm reported that the FDA granted Breakthrough Therapy designation for Rilonacept for the treatment of recurrent pericarditis.

This morning, Hamilton, Bermuda based biopharmaceutical company Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ), which is focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical needs, announced that “the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis.”

The report indicated that “Kiniksa’s Breakthrough Therapy application was based on final data from an open-label Phase 2 clinical trial of rilonacept in a range of pericarditis populations that were included in a poster presentation at the American Heart Association Scientific Sessions on November 16, 2019.”

The firm explained that the “FDA defines Breakthrough Therapy designation as a process designed to expedite the development and review of drug candidates that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint.”

The company identifies Rilonacept as “a weekly, subcutaneously-injected, recombinant fusion protein that blocks inflammatory cytokines interleukin-1α (IL-1α) and interleukin 1β (IL-1β) signaling.” Rilonacept in recurrent pericarditis is at present still classified as an investigational drug.

Kiniksa exclusively licensed rilonacept from Regeneron Pharmaceuticals Inc. for recurrent pericarditis and certain other indications. The company noted that “rilonacept was discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes, which includes Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.”

Kiniksa’s CEO and Chairman Sanj K. Patel commented, “We are pleased that the FDA has granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis, a painful and debilitating autoinflammatory cardiovascular disease…The final Phase 2 data presented at AHA showed rilonacept treatment improved clinically meaningful outcomes associated with unmet need in recurrent pericarditis, including rapid resolution of pericarditis episodes, tapering and discontinuation of corticosteroids without pericarditis recurrence, reduction in recurrences of pericarditis episodes while on treatment, and improvement in quality of life scores. We continue to enroll RHAPSODY, our pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, and expect top-line data in the second half of 2020.”

The company describes the RHAPSODY study, which is taking place in the U.S., Australia, Israel and Italy, as an ongoing, global, randomized withdrawal (RW) design, pivotal Phase 3 clinical trial of rilonacept in patients with recurrent pericarditis. The firm advised that the study’s co-principal investigators are Dr. Allan Klein of Cleveland Clinic and Dr. Massimo Imazio of the University of Torino, Italy, and that top-line data from the study are expected in H2/20.

Kiniksa Pharmaceuticals is headquartered in Hamilton, Bermuda, and is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating autoinflammatory and autoimmune diseases with significant unmet medical need. Kiniksa’s pipeline of product candidates across various stages of development include Rilonacept for the potential treatment of recurrent pericarditis; Mavrilimumab for the potential treatment of giant cell arteritis; KPL-716 for the potential treatment of a variety of pruritic diseases, including prurigo nodularis, a chronic inflammatory skin condition; and several others.

Kiniksa has a market capitalization of around $380.9 million with about 58.88 million outstanding shares. KNSA shares opened nearly 30% higher today at $8.98 (+$2.04, +29.34%) over the prior day’s closing price of $6.94. The stock has traded today between $8.08 to $9.49 per share and currently is trading at $8.86 (+$1.92, +27.67%).

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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: KNSA:NASDAQ,
)

ICAN Leverages Leading California Brand with Expansion into Nevada, Introduces State-of-the-Art Pre-Roll Machine, for Aggressive Near-Term Growth

By The Life Science Report

Source: Knox Henderson for Streetwise Reports   11/20/2019

A recent acquisition is helping this company to expand its brand.

If a customer at any of the popular recreational outlet in California were to ask, “What’s your best pre-roll?” there is high probability that the answer would be “Tarantula.” That “happy” blend has helped to make ICAN the top infused brand in California with roughly US$3.3 million in sales January to July 2019, according to BDS Analytics. Since acquiring the brand and its Oakland operations, announced July 31 this year, ICAN (CSE: ICAN, OTCQB: ICNAF) has expanded its presence from 225 to 275 stores in California with the momentum to reach 300 by end of this year. Building on its brand equity, the company is bringing the popular ICAN brand to that other major recreational market, Nevada, with plans for a presence in more emerging friendly states.

The chart below tells a compelling story. In 2018 the newly merged companies independently produced a combined US $6.5 million of revenue and the new ICAN is well funded for at least 12 months. Sales are forecast to grow from $9.0 million in 2019 toward $25 million in 2021. It’s not an unrealistic target given past successes in brand recognition, and the current sales pipeline and momentum. As to profitably, ICAN historically, and plans to continue to, operate within and a gross margin hovering in the 30% range. In a totally beaten down market, the winner and losers are becoming clear. ICAN is a winner because it’s doing a better job of further penetrating existing markets where the real revenues are with focus on quality.

ICAN

And then there is ICAN’s amazing new state-of-the art patented rolling machine, the first of which has been delivered to the company’s Oakland operations. It’s so advanced ICAN is not currently disclosing its design and full capacity but be assured it has been painstakingly crafted by engineers from a top tier Silicon Valley pharmaceutical automation engineering firm with clients that include Fortune 100 companies such as Genetec, Telsa, Baxter and Johnson & Johnson. The prototype automated machine is able to produce 600 pre-rolls per hour and requires two personnel to operate, with much higher capacity in next versions of the product.

ICAN’s initial game plan is to leverage its well-known brand and introduce other products/SKUs into the California market. “We have this existing channel that knows, trusts and loves the ICAN product and brand,” says ICAN Chief Strategy Officer Gus Boosalis. “By introducing additional products into that channel, we’ll continue to have organic growth in California, and next we’re going to introduce the brand to the Nevada market through our licensed cultivation and manufacturing facility. In addition to building our market to California and Nevada, we’ve had interest from parties that are well established and well-funded that want to license the brand into other emerging states, such as Michigan, Massachusetts, Colorado and Arizona. Once the key components of this company are set, we’ll have the ability to scale quickly as a result of our proprietary rolling machine.”

The low hanging fruit for ICAN is the infused pre-roll market where it has the #1 product by a wide margin and is also the #3 best seller. Having this kind of reputation from a loyal customer base bodes well for the future adaption rate of the company’s addition SKUs and gives it a leg-up as it expands into in other markets. The pre-roll market is estimated to be 492.8 million pre-rolls sold in 2018 across the United States and Canada, and it’s gaining momentum. This past July, consumers in California alone spent $25 million on pre-rolled, a 46% increase compared to July 2018.

Boosalis says there is still plenty of room for future growth in the overall market California when you consider about $3.1 billion of revenue from the licensed market stacks up to an assumed $8 billion in the non-licensed black market, “and the state government definitely wants to tax that revenue, so there is a motivation for more and more licensed stores.” Currently there are 620 licensed shops in California.

By 2022, the “legit” market in California is projected to jump to $7.7 billion. Nevada offers a large rotating new customer base with 40 million tourist each year. Flagship stores have helped the state’s year-to-date sales through July reach $396 million, a 22% increase from 2018. 2020 revenues, primarily from the 11 states where recreational adult use is approved, is expected to reach $15 billion, en-route to $25 billion by 2025, according to New Frontier Data. At this point 33 states have approved medicinal use. This means 68% of Americans live in states where medical use is legal and 25% live were recreational use is legal.

A History of Quality

ICAN itself started with its own licensed manufacturing and cultivation facilities in Nevada in 2016, then had its eyes set on GanjaGold in Oakland. “We put together the separate deals through late last year, the early part of this year. It made a lot of sense to combine everything under a single umbrella. So, we combined our assets in Nevada, including the real estate, into ICAN and then brought in the Oakland store with a legacy California brand that has a strong market recognition as a connoisseur brand of pre-rolled,” said Boosalis.

The founder of the Oakland operation, Alex Patel, is a well-known engineering pioneer who started from the ground floor in 2009. “Alex worked as a receptionist of a compassion club, to being a salesperson of different brands to working storefront, to being a broker of flower, all the while learning every facet of the industry and became an industry-known connoisseur of the product, a product visionary and great touch point of the culture,” says Boosalis.

Patel later embarked on making his own original and branded products and introduced the Tarantula. This would be the first product of its kind that was focused on top-shelf products, infused with concentrates and coated with a layer of keif. The product shattered conventional price points and breathed new life into what a pre-roll can be. This achievement has nurtured ICAN with tremendous brand equity.

By the end of 2018 ICAN’s Oakland operation grew its reputation of being a premium product company in 95 of 300 licensed stores in California, then after the state expanded to 600 licenses, ICAN jumped into 225 and is now heading for 300 by year-end. Customer have grown fond of the brands for a few reasons, according to Boosalis.

“What Alex did from the outset was worry about the quality of the flower but he also paid huge attention to the quality of pre-roll, the structure, the infusion, the consistency, to smoke well with no canoeing. We spend an hour per pound to de-stem and grind our flower using our in-house proprietary grinding technology. Our quality controls with the newly installed machine brings consistency throughout the process. We needed to lock this down before we engage in any licensing deals.”

ICAN’s Oakland operations also brought transparency into its product lines, with proper pricing so customers know what to expect from pre-rolls ranging in price from $12 to $22: Blue is indoor, Green is greenhouse and Red is outdoor. “Infused” means the paper has oil infused on it, so it is much more powerful in terms of potency. According to Boosalis, the infused market is about 20-25% of the pre-rolled market, and ICAN is working to capture more of the demographic by leveraging its success in the infused pre-rolled market. “The plan will give us shelf space, which will increase our same-store sales once we roll this out. We can also automate pre-rolled, offering a manufacturing service.”

Currently the ICAN/GanjaGold Oakland operations include a 32,000 sq. ft. fully licensed cultivation facility and fully licensed 2,700 sq. ft. manufacturing facility with state-of-the-art proprietary, custom pre-roll manufacturing equipment recently installed on-site. In Nevada, ICAN owns a 4,000 sq. ft. fully licensed cultivation facility with 10,000 sq. ft. of expansion space onsite. There is a fully licensed 3,000 sq. ft. manufacturing facility with additional 2,000 sq. ft. of expansion space. In terms of real estate, this is housed in a 100% owned 17,000 sq. ft. facility building on a 1.5-acre parcel fully zoned and permitted.

Share Structure

ICAN currently has 135 million shares outstanding post Oakland acquisition, with a reasonable 11 million warrants and 13 million options. In the July 31 news release, the Oakland operation cost $12.4 million in all equity as ICAN issued 40 million shares at $0.31 with a one-year hold to July 31, 2020. It now looks like Ganja will earn another 40 million-share milestone payment at the same terms with the completion of the rolling machine delivered before the end of the year for a consideration for US$24.8 million, bringing the share count to 175 million outstanding, so the prudent investor may want to wait until these shares, which also have a one year hold, are distributed before jumping in.

The Takeaway

It will be fun to watch the growth of ICAN and the expansion of its brands unfold, especially if you are sitting on some cheap stock, which you may want to pick up this point. What’s appealing is the existing track record and sensible growth in already accelerating markets where it has strong brand recognition. The simple strategy now just relies on execution: growth in number of dispensaries that shelves its brands, and growth per dispensary with new SKUs. The expansion into emerging states relies on licensing deals due to cross-state restrictions and scalability will be enabled with its high-capacity rolling machine. As Boosalis insists, people have come to expect premium quality from the ICAN brands—and they do not intend to disappoint them.

Disclosure:
1) Knox Henderson: I, or members of my immediate household or family, do not 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: ICAN. My company has a financial relationship with the following companies mentioned in this article: None. 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. An affiliate of Streetwise Reports is conducting a digital media marketing campaign for this article on behalf of ICAN. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
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. 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.
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( Companies Mentioned: ICAN:CSE; ICNAF:OTCQB,
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