Archive for Healthcare – Page 2

Heathcare and Biotech Updates

Biotech ‘Thinking Several Steps Ahead with Optimizing IVR Quality Control’

By The Life Science Report

Source: Streetwise Reports   08/02/2019

The company’s latest science, presented at a recent conference, is discussed in a ROTH Capital Partners report.

In a July 31 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Daré Bioscience Inc. (DARE:NASDAQ) presented two posters on the use of FT-Raman spectroscopy in evaluating drug stability in its intravaginal rings (IVR), on July 22 and 23 at the 2019 Controlled Release Society Annual Meeting & Exposition in Spain.

The data that Daré shared strongly validated this approach and its ability to measure a drug’s release and concentration in intravaginal ring (IVR) therapies. This is significant because both measures are key to pharmacodynamics and efficacy of Daré’s IVR therapies, currently DARE-FRT1 for pregnancy maintenance and DARE-HRT1 for menopause symptoms.

There also is a need for measuring the stability of a drug or drugs in Daré’s IVR therapies because of a process used in developing them: hot melt extrusion (HME), which can alter a drug’s properties.

HME is used to allow delivery, through the IVR, of multiple drugs with varying molecular weights and drugs with lower solubility or bioavailability. This controlled delivery is one feature that sets apart Daré’s IVR platform from the competition.

“We view this as an important milestone assuring quality control on the road to commercialization for the two novel intravenous ring therapies,” Rahimi commented.

The first poster, “Use of FT-Raman Spectroscopy to Assess 17-Beta-Estradiol/Progesterone Ethylene Vinyl Acetate-Based Intravaginal Rings,” showed that spectroscopy effectively and reliably assayed levels of the two hormones in IVRs during manufacturing and after one and three months of storage.

The second poster, “Determination of Drug Crystallinity in Hot Melt Extruded Ethylene Vinyl Acetate Copolymer,” demonstrated that in an EVA IVR ring with 28% vinyl acetate, the contained compounds can be identified and their state determined.

“Based on these examples of strong, solid science, we are confident Daré has developed quality control steps to optimize IVR manufacturing,” noted Rahimi.

ROTH has a Buy rating and a $6 per share target price on Daré, whose current share price is around $0.76.

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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.

Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Company Note, July 31, 2019

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Daré Bioscience, Inc.

ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.

Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

Within the last twelve months, ROTH has managed or co-managed a public offering for Daré Bioscience, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: DARE:NASDAQ,
)

Biotech’s Mosquito Test ‘Gains Market Acceptance’

By The Life Science Report

Source: Streetwise Reports   08/02/2019

This West Nile virus test and others including cancer diagnostic tests in the Utah company’s pipeline are discussed in an H.C. Wainwright & Co. report.

In a July 31 research note, H.C. Wainwright & Co. analyst Yi Chen reported the market has increasingly adopted Co-Diagnostics Inc.’s (CODX:NASDAQ) Vector Smart North American Mosquito (NAM) test for the presence of West Nile virus, since the test’s launch earlier in the month.

Press reports indicate mosquito abatement districts are using the test and thereby improving public health, Chen noted. For instance, the presence of West Nile virus was reported as far west as Utah and as far east as New York this mosquito season.

Chen pointed out how Co-Diagnostics’ NAM-W test differentiates itself from other lab tests for the West Nile virus. With NAM-W, the test result is available within a day versus one to two weeks, and more affordably, “thus enabling mosquito control activities to be accurate, efficient and effective.”

NAM-W also can detect the presence of St. Louis encephalitis and western equine encephalitis in mosquito populations. Co-Diagnostics is developing a NAM-E test to identify mosquito-borne eastern equine encephalitis in humans. That potentially lethal virus was detected in Florida just this week.

The company also plans to develop a Vector Smart version of its Logix Smart ZDC (Zika-dengue-chikungunya) multiplex test optimized for mosquito populations.

“The company’s CoPrimer-based multiplex polymerase chain reaction (PCR) test solutions for mosquito-borne diseases are positioned to be the most competitive available on the market and should be increasingly adopted by abatement districts and research institutions alike across the U.S. in the coming months,” commented Chen.

Growth for the biotech also should come in increasing sales from Co-Diagnostics’ joint venture in India, CoSara Diagnostics. “This business ought to serve as the main driver of topline revenue growth in the near term,” Chen indicated.

Another area in which Co-Diagnostics is developing diagnostic products is cancer. Recently, the company achieved positive results from a study to detect cancer mutations, specifically 10 associated with nonsmall cell lung cancer, in circulating free DNA, using its CoPrimer technology. The CoPrimer-based PCR test showed high sensitivity, identifying the mutations at the lowest possible percentage available.

“These results indicate that CoPrimer-based PCR tests can be used for cancer diagnostics, including companion diagnostics for therapeutics as well as monitoring of treatment response and detection of drug resistance,” wrote Chen. Immediate uptake of and reimbursement for Co-Diagnostics’ cancer diagnostic tests are expected when they hit the market because of the technology’s level of sensitivity and specificity and the product’s affordability. CoPrimer tests can be conducted on PCR instruments already in the field; no investment in added equipment is needed.

Further updates from Co-Diagnostics on its cancer diagnosis programs are likely in 2019 with introduction of its first cancer test in 2020.

H.C. Wainwright has a Buy rating and a $2 per share price target on Co-Diagnostics, whose stock is currently trading at around $1.24 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.

Disclosures from H.C. Wainwright & Co., Co-Diagnostics Inc., Company Update, July 31, 2019

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, Yi Chen, Ph.D. CFA and 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 Co-Diagnostics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of June 30 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Co-Diagnostics, Inc.

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 did receive compensation from Co-Diagnostics, Inc. 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 Co-Diagnostics, Inc. during the past 12 months.

The Firm does not make a market in Co-Diagnostics, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: CODX:NASDAQ,
)

Led by Sales of HETLIOZ, Vanda Increases Quarterly Revenues by 25%

By The Life Science Report

Source: Streetwise Reports   08/01/2019

Shares of Vanda Pharmaceuticals traded nearly 30% higher after the company released Q2/19 earnings and positive sales trends for both HETLIOZ and Fanapt.

Biopharmaceutical maker Vanda Pharmaceuticals Inc. (VNDA:NASDAQ) yesterday announced financial and operational results for the second quarter ended June 30, 2019.

The company indicated in the report that total net product sales from HETLIOZ and Fanapt increased by 24% to $59.1 million in Q2/19 compared to $47.7 million in Q1/19 and were up 25% in the current quarter compared to $47.4 million in Q2/18. Net product sales for HETLIOZ increased by 31% to $37.8 million in Q2/19 versus $29.0 million in Q1/19 and were up 35% versus $28.0 million in Q2/18.

Net product sales for Fanapt were $21.2 million in the Q2/19, a 13% increase versus $18.8 million in Q1/19 and increased 10% over the $19.3 million for Q2/18. The firm reported that non-GAAP net income nearly doubled in the quarter to $15.0 million in Q2/19, or $0.28 per share, compared to a non-GAAP net income of $7.7 million, or $0.15 per share for Q2/18.

Vanda’s President and CEO Mihael H. Polymeropoulos, M.D. commented, “The exceptional commercial performance of HETLIOZ and Fanapt positions Vanda to continue on its path of growth and long term value creation…The recently announced positive results from the tradipitant motion sickness study further enhance the potentially broad therapeutic utility of tradipitant as a treatment option for the millions of patients with gastroparesis, motion sickness and atopic dermatitis.”

In the report the company also provided some full-year 2019 revenue guidance indicating it expects combined net product sales from both HETLIOZ and Fanapt in the range of $215 to $225 million. More specifically, it guided $137–143 million for HETLIOZ, and $78–82 million for Fanapt. The firm further raised its projected year-end cash position to greater than $275 million, up from prior guidance of $260 million.

Vanda provided key research and development highlights for Tradipitant, as well as both HETLIOZ and Fanapt. In July 2019, the company announced positive results from a Phase 2 clinical study (Motion Sifnos) of tradipitant in motion sickness, and further indicated that Vanda intends to initiate a Phase 3 program in motion sickness in 2019 with a plan to file for marketing authorization in 2020.

Vanda Pharmaceuticals describes itself as a biopharmaceutical company focused on the development and commercialization of therapies to address unmet medical needs. Its product portfolio includes HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake disorder (Non-24) and Fanapt (iloperidone) used for the treatment of schizophrenia. The firm’s pipeline includes Tradipitant (VLY-686), a small molecule neurokinin-1 receptor antagonist that is in clinical development for the treatment of chronic pruritus in atopic dermatitis; Trichostatin A, a small molecule histone deacetylase (HDAC) inhibitor; and AQW051, which is a Phase 2 alpha-7 nicotinic acetylcholine receptor partial agonist with indications for the treatment of central nervous system disorders.

Vanda’s shares opened nearly 20% higher today at $15.50 (+$3.05, +19.68%) over the prior day’s closing price of $12.45. In early trading shares traded up higher than 36% in the range of $14.72 to $17.00, and closed at $15.79 (+3.34, +26.83%).

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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.

( Companies Mentioned: VNDA:NASDAQ,
)

Gaia Grow Corp. Plants 1,494 Acres of Hemp in Canada and Plans First Harvest in 2 Months

By The Life Science Report

Source: Peter Epstein for Streetwise Reports   08/01/2019

Gaia Grow Corp. CEO Frederick Pels speaks with Peter Epstein of Epstein Research on the day his company begins trading on the TSX Venture Exchange.

Gaia Grow Corp. (GAIA:TSX.V) (formerly Spirit Bear Capital) announced that effective August 1, its shares will be trading on the TSX Venture Exchange. Shares outstanding = 200.2 million. A July, 2019 capital raise was completed at $0.10, market cap = $20.2 million. (Note: ~124.7 million [~62%] of outstanding shares are locked up under various escrow agreements). This company comes by way of a Reverse Take Over (RTO).

Investors should review all applicable SEDAR filings and company press releases before investing in a RTO.

Peter Epstein & Epstein Research [ER], together [ER], have no former or existing relationship with any person or company mentioned below. However, at the time this interview was posted, [ER] was negotiating to secure Gaia Grow as an advertising client. While Gaia is not an advertiser on [ER] as of August 1, 2019, please consider [ER] biased in favor of the company. As of Aug. 1, Peter Epstein owned no shares, options or warrants in Gaia, or its predecessor company, but he may acquire shares in the open market.

Quick, name the top 3 #hemp / #CBD players…

By now most investors know that there are [#cannabis / dispensary] stocks, and [#hemp / #CBD] stocks. Cannabis stocks include Licensed Producers (LPs) like Canopy Growth and Aurora Cannabis, and Multiple State Operators (MSOs)—that sell cannabis through dispensaries in the U.S.—companies like Curaleaf and Green Thumb Industries. A MSO is the U.S. version of a Canadian LP.

Then we have the hemp / CBD players…. wait, where are my hemp and CBD names? Ahh, oh, here we go, Charlotte’s Web, # 9 of the top 50 …. and next is …. silence. Unless one accepts processing companies like Medipharm, who primarily extract CBD from acquired hemp, there’s only one large publicly traded hemp cultivation company on the planet!

Addressable market, stupid

Cannabis companies outnumber hemp-focused names by 10 or 12 to 1, implying that demand and acceptance of cannabis by users and various legal and political entities must be very high. Yet this simply is not the case. Cannabis is still a tough sell in most of the world.

Think about the global market for CBD (with < 0.3% THC). What percentage of adults might use CBD in its many forms for preventative health measures, specific aliments, or health and wellness? I estimate 60%–75% could be consuming CBD regularly, or at least occasionally. By contrast, cannabis (with > 1% THC) is used in only two ways, recreationally and medically.

What percentage of adults might use cannabis? I estimate just 15%–30%. Zero % of children, Zero % of pets. Finally, CBD is legally available in far more countries and jurisdictions than cannabis. Therefore, in my opinion, CBD demand next decade could be > 5x that of medical and recreational cannabis combined.

With that in mind, I interviewed Frederick Pels, CEO, chairman & co-founder of Gaia Grow Corp. (TSX-V: GAIA). Fredrick is very active in the cannabis / hemp space in Canada. He and his partners were early champions of medical cannabis, successfully advocating for its wider use and acceptance.

His prior company, the Green Room, was a leader in medical cannabis supply, industry best practices and education. The Green Room helped form, and get passed, many of the rules and regulations that make medical cannabis safe, affordable and accessible today. Fredrick and his team made valuable connections with people and companies in agriculture, finance, legal / compliance, cannabis, hemp, extraction and related sectors. The following interview was conducted by phone & email from July 26 to July 31st. {corporate website}

Peter Epstein: Fredrick, thank you for your time. Please give readers the latest snapshot of Gaia Grow Corp.

Frederick Pels: Sure. We have a strong management team and board, supportive shareholders, deep roots in the community and tremendous contacts in agriculture, finance and banking. We have vast experience in the Canadian cannabis and hemp space dating back more than 5 years. We understand how to navigate the increasing number of rules & regulations that cannabis & hemp growers face, because in many cases we helped develop them!

Most important, although there are other hemp / cannabis assets and opportunities held by Gaia Grow, our only active operation is a 1,494-acre crop of hemp plants that are about a month old and a half foot (15 cm) tall. Harvest is expected at the end of September or early October.

Peter Epstein: Can you tell us about co-founder James Tworek?

Frederick Pels: Yes, of course. James is a director and co-founder. He has a strong background, over 20 years’ experience, in banking and finance. He was a partner at a mortgage brokerage and then in a commercial development fund. In 2016, James worked on corporate finance contracts in the Canadian Medical Cannabis sector, giving him hands-on experience in early-stage development financing and capital raising.

Those roles make him well versed in corporate finance, mezzanine funding, equity-based lending and business start-ups. James’ experience in raising capital has brought him success in structured finance (including global deals) and he has built strong business relationships with family offices, private equity and venture capital firms.

Peter Epstein: Your recent background and experience is in medical cannabis, yet Gaia Grow is actively pursuing hemp. Is hemp a better investment opportunity than cannabis?

Frederick Pels: First and foremost, I’m an entrepreneur, a business owner, so my aim is to satisfy an under-served or un-met need. To me, hemp seems better positioned than cannabis, but Gaia Grow is looking at various cannabis situations as well. We think the opportunities for a small company to grow very rapidly are much greater in the hemp space than in cannabis.

Peter Epstein: What can you tell us about Gaia Grow’s hemp crop in southern Alberta?

Frederick Pels: Everyone is excited, seeds arrived in the second week of June and it was a very rainy spring – great conditions for seed germination! The process of fertilizing, seeding & rolling the expansive 1,494.4 acres was spread out over two weeks. Thanks to intermittent rains, we are pleased to report that the crop has started off well.

I refer you to a quote from James in our most recent press release:

Gaia’s President James Tworek commented, “Gaia’s 2019 crop is planted and off to a great start. We will continue to monitor progress and work with our farmers, contract harvesting, and agronomy teams to optimize timing of harvest, currently estimated to be at the end of September / early October. In the meantime, Gaia’s management team is working diligently to firm up contracts with off-take partners to ensure a successful sale and extraction process of the harvest.”

Peter Epstein: What are your plans for your maiden hemp crop? Is there demand for 1,500 acres of hemp?

Frederick Pels: Yes, there’s tremendous demand! We can either sell the entire crop as biomass on a per acre basis, which would be the easy way to go, or get our biomass processed into higher value CBD extracts. We don’t have any extraction equipment, so a third party would have to do it. If the crop develops as expected, we think we could sell it for $3,000-$5,000 per acre.

Screen%20Shot%202019-08-01%20at%2010.06.00%20AM.png

However, if we choose a CBD extraction path, which is more complex and logistically difficult, then we could potentially generate a multiple of the revenue derived from selling the entire crop. Timing is a large part of the issue this year. Next year we fully expect to have an extraction path nailed down.

Peter Epstein: Is there a lot of crop risk between now and harvest?

Frederick Pels: Yes, there is certainly some degree of risk, there always is in agriculture. However, we have a well-respected consulting group managing the grow. And, most of the severe weather is behind us. Frost in late September or early October is a concern, but by then the plants should be fairly robust. We looked into crop insurance, but the first few quotes we received were unattractive. Recently we starting negotiating with a party that we think we could possibly come to terms with.

Peter Epstein: Is Gaia looking to acquire any properties or assets?

Frederick Pels: Yes, absolutely. Interesting opportunities are presented to us almost daily. We see great potential to acquire assets at very attractive valuations in the industrial heartland, where communities are suffering from high unemployment and a low tax base. Having a company like Gaia Grow come into a small town would go a long way towards revitalizing the area with new jobs and investment.

Peter Epstein: Gaia Grow recently raised over $4 million in equity capital. What will the funds be used for?

Frederick Pels: Some of that money was spoken for. We planted hemp seeds on just shy of 1,500 acres over the course of about two weeks and have a consulting group managing the crop. We have operating expenses to pay. But, make no mistake, we want to grow this company. Capital remaining from the $4 million raise will be added to cash flow generated from our crop.

Once we’re done with our maiden crop, April, 2020 is right around the corner, time to acquire genetics and get started all over again. Hopefully on a much larger scale.

Peter Epstein: Are you in talks with potential strategic or financial partners?

Frederick Pels: Strategic? Yes, definitely. But, we don’t need any financial partners at this time. A lot of eyes are on us, watching this crop, how well it goes for us. As a publicly traded company, we will see all the deal flow we could possibly want. The ability to quickly raise capital is extremely important in the initial years of a market boom (in hemp). We are fully funded for the foreseeable future.

Peter Epstein: Why should investors consider buying shares of Gaia Grow Corp.?

Frederick Pels: We strongly believe that now is the time to be investing in the cultivation of hemp at large commercial-scale. We are looking at opportunities all over North America, but first we need to deliver our first harvest, in about two months. Readers should know that companies can’t just buy land and start farming the next day. It takes many months to over a year to get all the permits and approvals, complete surveys and studies, etc. If you miss a growing season, you have no choice but to wait, wait for up to a year, for the next window of opportunity.

We are not waiting! We have a crop in the ground, a fairly large crop of 1,494 acres. If all goes reasonably as planned, it will comfortably fund Gaia Grow Corp. (TSX-V: GAIA) through to bigger and better crops next year. After that? The sky’s the limit. We could possibly become vertically integrated with CBD extraction equipment. We could potentially be growing hemp in multiple provinces of Canada and/or states in the U.S. {corporate website}

Peter Epstein: Fredrick, thank you so much for your time. I agree that hemp is a tremendous investment opportunity! I will be watching Gaia Grow closely for news on its maiden hemp crop. Good luck!

Peter Epstein is the founder of Epstein Research. His background is in company and financial analysis. He holds an MBA degree in financial analysis from New York University’s Stern School of Business.

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Disclosures: The content of this interview is for information only. Readers fully understand and agree that nothing contained herein, written by Peter Epstein of Epstein Research [ER], (together, [ER]) about Gaia Grow, including but not limited to, commentary, opinions, views, assumptions, reported facts, calculations, etc. is not to be considered implicit or explicit investment advice. Nothing contained herein is a recommendation or solicitation to buy or sell any security. [ER] is not responsible under any circumstances for investment actions taken by the reader. [ER] has never been, and is not currently, a registered or licensed financial advisor or broker/dealer, investment advisor, stockbroker, trader, money manager, compliance or legal officer, and does not perform market making activities. [ER] is not directly employed by any company, group, organization, party or person. The shares of Gaia Grows are highly speculative, not suitable for all investors. Readers understand and agree that investments in small cap stocks can result in a 100% loss of invested funds. It is assumed and agreed upon by readers that they will consult with their own licensed or registered financial advisors before making any investment decisions.

Readers understand and agree that they must conduct their own due diligence above and beyond reading this article. While the author believes he’s diligent in screening out companies that, for any reasons, are unattractive investment opportunities, he cannot guarantee that his efforts will (or have been) successful. [ER] is not responsible for any perceived, or actual, errors including, but not limited to, commentary, opinions, views, assumptions, reported facts, financial calculations, etc., or for the completeness of this interview or future content. [ER] is not expected or required to subsequently follow or cover events and news, or write about any particular company. [ER] is not an expert in any company, industry sector or investment topic.

Streetwise Reports Disclosure:
1) Peter Epstein’s disclosures are listed above.
2) The following companies mentioned in the article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. 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) 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.

Graphics provided by the author.

( Companies Mentioned: GAIA:TSX.V,
)

EMA Opinion Bodes Well for Biopharma’s Drug Getting Orphan Status

By The Life Science Report

Source: Streetwise Reports   07/31/2019

The designation, opinion and asset are discussed in a ROTH Capital Partners report.

In a July 29 research note, ROTH Capital Partners analyst Scott Henry reported that Anavex Life Sciences Corp. (AVXL:NASDAQ) is pursuing orphan status from the European Medicines Agency (EMA) for ANAVEX 2-73 as a treatment for Rett syndrome.

A positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP) was already issued, highlighted Henry. It means European regulators believe ANAVEX 2-73, a sigma-1 receptor agonist, for use in Rett syndrome patients meets the requirements for orphan drug designation. “This is a significant development milestone for the company,” Henry commented.

Specifically, Rett syndrome is a rare, life threatening disease without satisfactory treatment. With fewer than 5 cases per 10,000 occurring in Europe, this form of autism has an associated life expectancy of 20–40 years, described Henry. There is no current treatment for the cause of Rett syndrome itself, only for comorbid conditions, for which drugs are the standard of care. The second criterion for orphan status is that ANAVEX 2-73 could potentially provide significant benefit to Rett patients.

The EMA COMP opinion bodes well for Anavex being granted the orphan drug designation in the European market, the analyst pointed out. In fact, ROTH expects it to happen within 30 days. (ANAVEX 2-73 already has orphan drug status in the United States, as of 2016.)

The benefits of the designation in the European Union (EU), Henry pointed out, include decreased regulatory fees for the company, help with protocol and document filing and, potentially, a faster path to regulatory approval in Europe. Anavex 2-73 also would have exclusivity in the EU for 10 years.

ANAVEX 2-73 is currently being evaluated in Rett syndrome in two Phase 2 clinical trials, one in the U.S., the other in Australia. Topline data are expected around year-end 2019 and early 2020, with results from the U.S. likely being released first. “Provided ANAVEX 2-73 will achieve both primary safety and quality positive signal from the secondary efficacy measures, these studies could provide a commercial path for ANAVEX 2-73 as the first to market for the treatment of Rett syndrome in the U.S. and Europe,” Henry noted.

ROTH has a Buy rating and a $10 per share target price on Anavex, whose stock is currently trading at around $2.57 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.

Disclosures from ROTH Capital Partners, Anavex Life Sciences Corp., Flash Note, July 29, 2019

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Anavex Life Sciences Corp. and as such, buys and sells from customers on a principal basis.

Shares of Anavex Life Sciences Corp. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: AVXL:NASDAQ,
)

Mylan Gets a Shot in the Arm with Pfizer Merger Deal

By The Life Science Report

Source: Streetwise Reports   07/29/2019

EpiPen manufacturer Mylan N.V. announced today that the company will merge with Pfizer Inc.’s Upjohn Division, which holds Pfizer’s off-patent branded and generic drugs, forming a new company.

Mylan Inc. (MYL:NASDAQ) and Pfizer Inc. (PFE:NYSE) today announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company.

The report noted, “Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction.”

“The combination will be effected through a Reverse Morris Trust, under which Upjohn is expected to be spun off or split off to Pfizer’s shareholders and simultaneously combined with Mylan,” the release noted.

Plans for the merger have sent Mylan shares up more than 14% on the day. Mylan and Pfizer also issued second quarter earnings reports and Mylan further announced the retirement of CEO Heather Bresch effective upon the close of the above transaction in mid-2020.

In its quarterly earnings report Mylan announced total revenues for the three months ended June 30, 2019, were $2.85 billion, compared to $2.81 billion for the comparable prior year period, representing an increase of $43.2 million, or 2%. It further reported a U.S. GAAP diluted loss per ordinary share of ($0.33) as compared to earnings of $0.07 per ordinary share in the prior year period and adjusted diluted EPS of $1.03, as compared to $1.07 in the prior year period.

In a separate release, Mylan’s Board of Directors announced the retirement of CEO Heather Bresch, which will be effective upon the closing of the combination of Mylan and Upjohn, a division of Pfizer. The transaction is anticipated to close in mid-2020, subject to customary closing conditions, including receipt of regulatory approvals, and approval by Mylan shareholders. Board Chairman Robert J. Coury commented, “On behalf of Mylan’s Board of Directors, I extend my gratitude and respect for Heather Bresch’s years of extraordinary and passionate leadership at Mylan, which helped to pave the way for today’s historic announcement regarding the combination of Mylan and Upjohn.” He further pointed out that Bresch was named the first female CEO of a Fortune 500 global pharmaceutical company.

On a busy news day for both companies, Pfizer also posted second quarter earnings reporting Q2/19 revenues of $13.3 billion, reflecting 2% operational growth driven by 6% operational growth from Pfizer Biopharmaceuticals Group and Q2/19 reported diluted EPS of $0.89, and adjusted diluted EPS of $0.80.

Mylan N.V. is a global pharmaceutical company that develops, licenses, manufactures, markets and distributes generic, brand name and over-the-counter products in a range of dosage forms and therapeutic categories. Mylan is a maker of Epinephrine Auto-Injectors (EpiPens), which are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers; and for people who are at increased risk for these reactions.

Pfizer is a research-based global biopharmaceutical company engaged in the discovery, development and manufacture of healthcare products. Its global portfolio is composed of many household name brand prescription medications including Prevnar 13, Xeljanz, Eliquis, Lipitor, Celebrex, Pristiq and Viagra.

On the news, Mylan shares opened up higher today at $20.95 (+2.49, +13.49%) and are currently trading at $21.01/share. Pfizer shares opened down slightly at $42.17 (-$0.92, -2.14%) and have traded between $41.75 to $43.00 today.

( Companies Mentioned: MYL:NASDAQ,
PFE:NYSE,
)

Catasys: This Is Bigger Than You Think

By The Life Science Report

Source: Daniel Carlson for Streetwise Reports   07/26/2019

Daniel Carlson of Tailwinds Research examines the “blockbuster” implications of a recent announcement about this company’s OnTrak program.

Sometimes big news falls on deaf ears. Which, by the way, is one of the reasons I like the micro-cap space. With only a few analysts, if any, focused on a company, meaningful news can often be overlooked for days or weeks. What happened July 23 in Catasys Inc. (CATS:OTCBB) is a classic example of the market not fully grasping the importance of a press release.

In our opinion, the news out of Catasys was game-changing and deserving of a revaluation in the market. Instead, the stock went down. The result of this is a great buying opportunity for those who have yet to get their fill of CATS.

First off, a little background. We have been bullish on Catasys for a long time here at Tailwinds. The main thesis of our recommendation has been the incredible growth opportunity in front of them as they roll out their OnTrak program to larger patient populations. Based on historical numbers, if nothing changes, they are poised to earn $120 million or more in revenue in 2020, up from around $38 million this year. Catasys is a great growth story just starting to unfold.

However, what has always intrigued us, and why we have made this such a large holding here at Tailwinds, is the upside to the story. Yes, Catasys is making great progress in diagnosing and treating mental health disease, but there’s an even bigger opportunity here. As we wrote about over a year ago, Catasys is in the process of gaining more access to medical records, and outcomes, than any other company out there.

Here’s a portion of what we said at that time:

“If Catasys signs seven of the eight largest health insurers as clients, which they are well on their way to doing. . .and, if these clients continue to roll out OnTrak across their network. . .Catasys could, theoretically, have the patient healthcare data for well over half of all Americans.

“The implications of this are incredibly broad and extend well beyond their OnTrak program and its effectiveness. With more data on patients, including outcomes, Catasys will be able to create many different programs to offer to insurers. The potential of OnTrak is huge; the longer-term potential inherent in them having the most healthcare data on the planet is much bigger.”

The July 23 press release, in which the company discussed expanding their capabilities beyond behavioral health conditions, is the start of what we saw coming. Catasys is taking their unprecedented access to medical records and combining it with an industry-leading artificial intelligence (AI) team to start looking for more ways they can help diagnose disease and, thereby, help patients while saving insurers money.

As their CEO, Terren Peizer, stated in the press release:

“The data from healthcare delivery is complex, rarely interoperable and therefore underused. Using the latest techniques in AI and over a decade of research, Catasys has solved these challenges by creating what we believe to be the most valuable technology platform for populations that are care avoidant or not engaging in care. We can now predictively and rapidly identify care avoidant individuals with major chronic disease and those for whom targeted interventions will improve outcomes and reduce the cost of care.”

The implications of this are absolutely huge for investors in Catasys. The number of Americans who suffer major chronic disease is a much larger pool than those with only behavioral health disease. These people also cost the healthcare system a lot more money. This is the reason that Peizer said, “Catasys health plan partners have encouraged us to make these new AI capabilities available as soon as possible.”

By expanding their offering, Catasys has greatly expanded the number of potential enrollees in their programs. They have also given service providers an increased urgency to sign onto the platform and roll out new territories and diseases.

We believe Catasys will be announcing new programs with healthcare plans soon. OnTrak 2.0, which really leverages the data Catasys has at their fingertips, has been in development for a while. These newfound capabilities will be part of OnTrak 2.0, making it that much more compelling; I suspect we’ll start seeing adoption by insurers in the near future.

Meanwhile, the target outreach pool for Catasys has just grown exponentially. And this might only be the tip of the iceberg. What other products will they be able to develop with their AI capabilities? Catasys has access to more healthcare records than anyone, plus a team that knows how to leverage this information. One can imagine numerous other products over time.

Despite this blockbuster announcement, shares of Catasys are have traded down over the last week. What is causing this? I believe there are two reasons for the weakness in CATS. First, former board member David Smith has been a continual seller of shares. As of July 15, he still owned over 1 million shares, despite ongoing sales. This has certainly been an overhang for the stock.

More importantly, the short interest in CATS has been increasing, along with the borrowing rate for shares. I believe the shorts are hurting in this trade and are trying to push shares down. There’s been a persistent rumor of a secondary offering—a rumor that Peizer has continually refuted. However, as long as the company burns cash and there’s a short position, that rumor will persist.

From our perspective, the sales by Smith and a potential (albeit unlikely) secondary don’t worry us. We prefer to look at the big picture here. And, with the July 23 press release, the picture has gotten that much bigger.

Catasys is on the verge of being a powerful force in finding and treating mental, and now physical, health diseases. We eagerly look forward to watching the story unfold over the next several years as bigger rollouts happen, and as CATS continues to diagnose and treat more diseases. The current business is great, but the future remains even bigger than most investors can believe.

Daniel Carlson is the founder and managing member of Tailwinds Research Group and its parent company DFC Advisory Services, which is a licensed registered investment advisor (CRD # 297209). Tailwinds is a microcap focused research company that provides research on and consults to over 20 emerging growth companies in the technology and life sciences arenas. DFC Advisory Services is an RIA that manages money dedicated to investing in the companies covered by Tailwinds. For more information on these two companies and their track record, please see www.tailwindsresearch.com. Prior to founding these two entities, Dan spent many years working with small public companies, having been CFO of two public companies and helping finance many others. A 1989 graduate from Tufts University with a degree in Economics, Dan’s formative years in business were spent as an equity trader, first on the Pacific Coast Stock Exchange then on the buyside at several multi-billion dollar firms.

This article was submitted by Tailwinds Research. For more information on Tailwinds Research or on Catasys, please visit www.tailwindsresearch.com.

Tailwinds owns stock in Catasys. For a complete list of disclosures, please click here.

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Disclosure:
1) Daniel Carlson: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: Catasys. 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 referred to in this article: None. Additional disclosures and disclaimers are above. 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. 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.
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.

( Companies Mentioned: CATS:OTCBB,
)

eHealth Shares Up 25% as Quarterly Revenue Doubled and 2019 Guidance Raised

By The Life Science Report

Source: Streetwise Reports   07/26/2019

The prognosis for online exchange operator eHealth Inc. looks positive as the company reported a 101% increase in Q2/19 revenues over the prior year period and raised full year 2019 revenue estimates by $50 million to $365–385 million, compared with previous guidance of $315–335 million for 2019.

Private online health insurance exchange operator eHealth Inc. (EHTH:NASDAQ) posted better than expected results in its second quarter earnings report for the period ending June 30, 2019. The markets are reacting favorably to the news with the stock up over 25% following the report.

For Q2/19, the company indicated that Total Revenue increased by 101% to $65.8 million, compared to $32.7 million in Q2/18. The firm further reported a lower GAAP net loss of $5.8 million in Q2/19 versus a net loss of $12.0 million for the same period last year, and Adjusted EBITDA improved to $0.8 million in Q2/19 compared to ($10.1) million in Q2/18.

Revenue from the company’s Medicare segment was $52.3 million in Q2/19, representing a 105% increase compared to $25.5 million for Q2/18. During the same quarterly period the company noted that applications submitted for all Medicare products grew by 67% to 56,488, with approvals increasing by 78% to 52,559.

The company’s CEO Scott Flanders commented, “We delivered another strong quarter once again exceeding our expectations and building momentum in our Medicare business that has continued to scale rapidly accompanied by EBITDA margin expansion…Approved Medicare members grew 78% year-over-year, driving a 105% increase in Medicare revenue year-over-year and a significant increase in Medicare segment profit.”

The company updated its outlook for the full year ending December 31, 2019, noting, “Total revenue is expected to be in the range of $365 million to $385 million, compared with previous guidance of $315 million to $335 million. Revenue from the Medicare segment is expected in the range of $318 million to $333 million, compared with previous guidance of $281 million to $333 million. Revenue from the Individual, Family and Small Business segment is expected to be in the range of $47 million to $52 million, compared with previous guidance of $34 million to $38 million…assuming the impact of the non-cash charge related to an increase in fair value of the earnout liability in connection with eHealth’s acquisition of GoMedigap remains at $0.82 per diluted share, GAAP net income per diluted share for 2019 is expected to be in the range of $0.62 to $0.82 per share, compared with previous guidance of $0.60 to $0.79 per share”.

The company describes its business as a leading private online health insurance exchange where individuals, families and small businesses can compare health insurance products from brand-name insurers side by side and purchase and enroll in coverage online or by phone. Through its subsidiaries, eHealth is licensed to sell health insurance in all 50 states and the District of Columbia. Additionally, the firm offers educational resources, telephone support and online and pharmacy-based tools to help Medicare beneficiaries navigate Medicare health insurance options, choose the right plan and enroll in select plans online or over the phone through Medicare.com, eHealthMedicare.com GoMedigap and PlanPrescriber.com.

EHTH shares opened higher today at $101.99 (+16.51, +19.31%) from the prior day’s close of $85.48. Shares reached an intraday 52-week high price in early trading on higher than average volume and have traded between $98.50 to $108.48 today. Presently, shares are trading at $108.44 (+$22.96, +26.86%).

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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.

( Companies Mentioned: EHTH:NASDAQ,
)

Align Technology Reports Strong Q2 Growth but China Sales Worries Leave Investors Frowning

By The Life Science Report

Source: Streetwise Reports   07/25/2019

Orthodontic and GP Dental medical device maker Align Technology announced a 24.6% increase in sales volume of its Invisalign products in its Q2/19 earnings report, but investors are not smiling much over China growth concerns as the shares of the company have fallen more than 25%.

Orthodontic and GP dental medical device maker Align Technology Inc. (ALGN:NASDAQ) yesterday announced second quarter earnings ended June 30, 2019. The firm reported total revenues in Q2/19 were $600.7 million, up 22.5% year-over-year. Operating income in Q2/19 was $176.5 million, up 43.8% year-over-year, resulting in an operating margin of 29.4% and a net profit of $147.1 million in the quarter, or $1.83 per diluted earnings per share (EPS). The firm noted that Q2/19 operating expense included a $51 million benefit from the ClearCorrect settlement with Straumann, which increased Q2/19 operating margin by approximately 8 points and benefited EPS by $0.57.

Invisalign volume in Q2/19 was 377,000 cases, up 24.6% year-over-year, composed of 16% growth in the Americas and 36.7% in international regions. Invisalign volume for teenage patients in Q2/19 was 103,700 cases, up 32.2% year-over-year, and Q2/19 scanner and services revenues were $104.0 million, up 82.4% year-over-year.

Align Technology President and CEO Joe Hogan said, “Our Q2/19 revenues were at the high-end of our guidance, reflecting Invisalign volume growth primarily from international doctors, as well as very strong sales from iTero scanner and services with Q2/19 Invisalign volumes up 24.6% year-over-year. . .In Q2/19, total Invisalign case shipments were lower than expected, primarily due to a softness in China related to a tougher consumer environment and slower growth in young adult case in North America…given the uncertainty in China, our outlook for Q3/19 reflects a more cautious view for growth in the Asia Pacific region.”

The company further provided guidance for Q3/19 for Net revenues in the range of $585 million to $600 million, up approximately 16%-19% over Q3/18 and Diluted EPS in the range of $1.09 to $1.16. Align also stated in the outlook that it expects to repurchase at least $100 million of its stock (shares) in the open market in Q3/19.

Align Technology is a medical device company that designs, manufactures and markets the Invisalign system, which according to the company is the world’s leading invisible orthodontic product,and and the iTero Intraoral scanning systems and services. The Invisalign system and iTero Intraoral scanning system and OrthoCAD digital services are available to general practitioner dentists, orthodontists and other dental specialists, and the firm provides training, clinical education programs and the tools needed for dental industry adoption.

Align’s Clear Aligner segment consists of its Invisalign System, Express/Lite (Non-Comprehensive Products) and Vivera Retainers, along with its training and ancillary products for treating malocclusion (Non-Case). The firm’s Scanner and Services segment consists of intra-oral scanning systems and other services available with the intra-oral scanners that provide digital alternatives to the traditional cast models and includes its iTero scanner and OrthoCAD.

ALGN shares opened much lower today at $219.28 (-$55.88, -20.63%) from yesterday’s closing price of $275.16, and traded down more than 25%, closing at $200.90 (-$74.26, -26.99%).

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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.

( Companies Mentioned: ALGN:NASDAQ,
)

Anixa Licenses Another Potential Blockbuster

By The Life Science Report

Source: Daniel Carlson for Streetwise Reports   07/24/2019

Daniel Carlson of Tailwinds Research discusses a major collaboration with the Cleveland Clinic for his top pick stock of the year.

In January we proclaimed Anixa Biosciences Inc. (ANIX:NASDAQ) to be Tailwinds’ stock of the year. This designation was awarded due to potential major milestones in both the detection and the curing of cancer. With its Cchek prostate diagnostic shooting for CLIA approval in the next few months and with its CAR-T ovarian cancer therapeutic getting closer to an IND (investigational new drug) filing), ANIX is a stock with the possibility of a very rewarding second half in store for investors.

However, as much as we were already eagerly anticipating the next few months, with the announcement of the licensing of a potential breast cancer vaccine, Anixa has taken it one step further. By broadening its platform into cancer prevention, the company has proven the unique value and attractiveness of its platform and given investors another reason to be excited for the future. Dr. Amit Kumar and his team have demonstrated again that the company’s model of licensing cancer programs, outsourcing development, and keeping overhead and burn at a low level makes Anixa an attractive partner for clinicians while providing shareholders potential blockbusters without having to bear the typically significant development costs associated with product development.

Why did Angelina Jolie get a double mastectomy?

In a day and age where it seems that physical appearances are more valued than ever, particularly around the Hollywood elite, I remember finding it very interesting that one of the leading beauties of the big screen underwent breast removal…when she didn’t have cancer! What would cause someone to undergo voluntary surgery to pro-actively fight breast cancer? Isn’t breast cancer an area in which we have made significant strides in terms of both detection and cures?

Indeed, we have come a long way in battling cancer, however, like most diseases, cancer comes in many different forms and varieties. In the case of breast cancer, we have made great strides towards treating most strains. However, there exists a form of breast cancer called Triple Negative Breast Cancer (TNBC) that remains an elusive target to treatments. This cancer is particularly difficult to fight and is the deadliest form of breast cancer. It’s also not that uncommon, as 15–25% of breast cancer patients have TNBC. This disease remains a big problem.

TNBC is frequently found in people who carry a mutation in their BRCA1 gene. I guess that’s the “good news” about this cancer; it’s possible through genetic testing to know if someone has a natural propensity to develop the cancer. Angelina Jolie fell into this category. With an 87% chance of developing TNBC, she opted for the radical move of preemptive surgery. Several members of her family had died from TNBC breast cancer, and most likely they carried the mutations, which were passed on the Ms. Jolie.

Exciting Pre-clinical Data in TNBC Prevention

The bad news is that, despite great efforts, there hasn’t been the success in treating TNBC as has been seen in other breast cancers. On the other hand, there has recently been a lot of good news in pre-clinical work on developing a vaccine for TNBC. Most significant here is the work of Dr. Tuohy at the Cleveland Clinic.

In his work, Dr. Tuohy has targeted the α-Lactalbumin protein. Here’s an excerpt from an abstract he has published that explains why this represents such a great potential target.

“α-Lactalbumin’s expression in normal tissues is confined exclusively to the breast during late pregnancy and lactation, but is also expressed in the vast majority of human triple negative breast cancers (TNBC)—the most aggressive and lethal form of breast cancer and the predominant form that occurs in women at high genetic risk including those with mutated BRCA1 genes.”

Dr. Tuohy has been working on a cancer vaccine since 2002. His most recent efforts have culminated in very successful animal studies. By injecting mice with a vaccine, mice that have been bred such that they are guaranteed to develop breast cancer, Dr. Tuohy has shown an astounding success rate in preventing breast cancer. Fully one hundred percent of the mice that would have all normally gotten breast cancer never got the disease. A complete success in any program is virtually unheard of. Of course, the control mice, that were not treated with the vaccine, all contracted breast cancer.

Needless to say, these phenomenal results haven’t gone unnoticed. Through a Department of Defense program (believe it or not, the DoD is one of the biggest funders of breast cancer research, having spent $3.3 billion in a program started in 1992), Dr. Tuohy and the Cleveland Clinic have received a $6.2 million grant to develop the vaccine. This is enough funding to take the program through two phase 1 clinical trials.

Why Anixa?

With the addition of a potentially blockbuster vaccine for Triple Negative Breast Cancer, Anixa has pulled off its own triple play: it is working on products in cancer detection, treatment and now prevention. On the surface, this seems like a lot on its plate. When you realize that Anixa has six employees, it begs the questions of why would the Cleveland Clinic partner with Anixa and how does Anixa hope to move all three products forward?

The answer lies in the company’s unique business model. Dr. Kumar, Anixa’s CEO, has focused his attention on an asset light model since he joined the company just two years ago. In an interview with Tailwinds in late 2018, here’s what he had to say about this business model as it relates to its CAR-T program.

“We are working with collaborators at every step…By working with our current collaborators and others in the future we can potentially create an asset that is valued at factors of 100 or even 1000 times as much as we invest. So far, we and our collaborators have taken a really innovative science project almost to the starting line of clinical trials, all in less than one year and for only about $1 million dollars.”

That’s the Anixa business model in a nutshell. Finding innovative projects, working with partners to leverage their expertise, infrastructure and personnel, and developing these programs with minimal expense to existing shareholders.

While this business model is good for investors as it keeps dilution to a minimum, it is also quite attractive to potential licensors. By not simply taking over, and bringing in-house, development of a project, Anixa allows the initial creators to remain involved. This is attractive to places like the Cleveland Clinic and Dr. Tuohy as it enables them to remain in charge of a project that has been theirs all along. If this breast cancer vaccine is to become a blockbuster hit, Dr. Tuohy and the Cleveland Clinic will forever be associated with the product.

Another Shot on Goal

As we enter the second half of 2019, Anixa stands on the cusp of some major milestones. We can expect to see Cchek on the market, with CLIA approval, in the next few months. Additionally, its CAR-T program should be filing an IND with the FDA near the end of the year.

By licensing this vaccine from the Cleveland Clinic, Anixa has brought in house a third potential blockbuster product. Admittedly, a vaccine may be a few years from being approved by the FDA. Clinical trials to prove a vaccine is safe is a big step; to prove it prevents cancer in a large number of patients over a long period of time will require years of studies. That’s the negative to this story; it’s going to take a while. However, Dr. Kumar hopes after the early phase 1 studies or early phase 2, big commercial partners will be interested in licensing the technology and funding the downstream studies needed to understand long-term effectiveness. It’s important to note that while the phase 1 studies will be focused on safety, there are some specific measurements and analyses designed to provide indicators of long-term effectiveness.

On the positive side, Anixa has just brought in house a vaccine with a huge potential market and the potential to change women’s health forever. The pre-clinical results have been outstanding. With recent advances in immunology, the market is incredibly receptive to vaccines and Anixa and Cleveland Clinic’s timing couldn’t be better.

Meanwhile, this product comes at a minimal expense to Anixa. With the DoD grant of $6.2 million, the project is funded through the phase 1 human studies. Anixa and the Cleveland Clinic could file an IND, run a trial, receive positive results, and apply for a phase 2 trial without it costing the company much money at all. With the clinical fees all paid for, the total expense to Anixa is going to run around $250,000 per annum. That is a pittance for a potential multi-billion dollar product.

At Tailwinds, we continue to be impressed with the work done by Dr. Kumar and his team. Their ability to cost-effectively build out a cancer platform is impressive. With now three shots on goal, their stable is full of interesting product candidates. And, with their unique business model, they have the bandwidth to continue bringing in new products. We remain convinced that Anixa is a great risk/reward stock and it remains our top pick of the year.

Daniel Carlson is the founder and managing member of Tailwinds Research Group and its parent company DFC Advisory Services, which is a licensed registered investment advisor (CRD # 297209). Tailwinds is a microcap focused research company that provides research on and consults to over 20 emerging growth companies in the technology and life sciences arenas. DFC Advisory Services is an RIA that manages money dedicated to investing in the companies covered by Tailwinds. For more information on these two companies and their track record, please see www.tailwindsresearch.com. Prior to founding these two entities, Dan spent many years working with small public companies, having been CFO of two public companies and helping finance many others. A 1989 graduate from Tufts University with a degree in Economics, Dan’s formative years in business were spent as an equity trader, first on the Pacific Coast Stock Exchange then on the buyside at several multi-billion dollar firms.

This article was submitted by Tailwinds Research. For more information on Tailwinds Research or on Anixa Biosciences, please visit www.tailwindsresearch.com.

Tailwinds is engaged by Anixa Biosciences and owns stock in the company. For a complete list of disclosures, please click here.

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