Archive for Healthcare

Heathcare and Biotech Updates

Phase 2 Study Begins for German Biopharma’s Cancer Drug Candidate

By The Life Science Report

Source: Streetwise Reports   01/16/2019

A LifeSci Capital report discussed two current trials in which this therapeutic is being evaluated.

In a Jan. 14 research note, analyst Sam Slutsky reported the Phase 2 EMERGE clinical trial evaluating 4SC AG’s (VSC:FSE Prime Standard) domatinostat with Bavencio (avelumab) in patients with microsatellite-stable esophagogastric cancer and colorectal cancer.

Enrollment of patients, which will total up to 70, started at the first study locations. The goal of the trial is to show safety of the combination therapies and generate proof-of-concept data. Initial results could be released in H2/19.

“This event marks continuing progress in the development of domatinostat,” Slutsky pointed out. This selective histone deacetylase inhibitor is now being evaluated in combination with Keytruda in SENSITIVE, an ongoing Phase 1b/2 trial in melanoma that is refractory/unresponsive to anti-PD-1. A third dose cohort in SENSITIVE got underway recently, after the second dose group showed a positive safety profile and the Safety Review Committee, in December 2018, recommended proceeding. Topline results from SENSITIVE are expected in mid-2019.

Should data from EMERGE and SENSITIVE be positive, 4SC plans to pursue a trial evaluating the combination of domatinostat and a checkpoint inhibitor in advanced Merkel cell carcinoma (MCC), wrote Slutsky. Preclinical MCC data are expected in H1/19.

4SC’s stock is currently trading at around €3.10 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 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 LifeSci Capital, 4SC AG, Company Update, January 14, 2019

Analyst Certification: The research analyst denoted by an “AC” on the cover of this report certifies (or, where multiple research analysts are primarily responsible for this report, the research analyst denoted by an “AC” on the cover or within the document individually certifies), with respect to each security or subject company that the research analyst covers in this research, that: (1) all of the views expressed in this report accurately reflect his or her personal views about any and all of the subject securities or subject companies, and (2) no part of any of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst(s) in this report.

DISCLOSURES
Neither the research analyst(s), a member of the research analyst’s household, nor any individual directly involved in the preparation of this report has a financial interest in the securities of the subject company.
LSC (or an affiliate) has received compensation from 4SC AG for producing this research report. LSC is paid a monthly payment of $1,000 from the Affiliate for preparing and distributing research pertaining to each subject company under contract with the Affiliate. The subject company of this report is covered by this arrangement between LSC and the Affiliate, and LSC has therefore indirectly received compensation from the subject company for publishing this report. No explicit or implicit promises of favorable research coverage have been made to the subject company by LSC or the Affiliate. Neither LSC nor the Affiliate has promised any specific research content as an inducement for the receipt of business or compensation.
LSC (or an affiliate) has also provided non-investment banking securities-related services, non-securities services, and other products or services other than investment banking services to 4SC AG and received compensation for such services within the past 12 months.
Neither LSC nor any of its affiliates beneficially own 1% or more of any class of common equity securities of the subject company.
This research contains the views, opinions and recommendations of LifeSci Capital, LLC (“LSC”) research analysts.
Additionally, LSC expects to receive or intends to seek compensation for investment banking services from the subject company/ companies in the next three months.
LSC does not make a market in the securities of the subject company/companies.

Please visit http://www.lifescicapital.com/equity-research/ for disclosures related to each company that is a subject of this report.

( Companies Mentioned: VSC: FSE Prime Standard,
)

Biotech’s Flu Vaccine Shows ‘Superiority to Market Leader’ in Data

By The Life Science Report

Source: Streetwise Reports   01/11/2019

Study findings that differentiate this product from competitors were reviewed in a Ladenburg Thalmann research report.

In a Jan. 10 research note, analyst Michael Higgins with Ladenburg Thalmann reported that Novavax Inc. (NVAX:NASDAQ) just released updated Phase 2 data that show NanoFlu’s “superiority to the market leader” Fluzone HD in several H3N2 strains that cause the most deaths.

In the trial, Novavax’s eggless flu vaccine was assessed against two comparators, including Fluzone HD, in adults aged 65 and older. Newly released results were from day 28 of the study.

Higgins highlighted the significant advantages of NanoFlu. One, a finding that was revealed in the newly released data, is its efficacy against “drifted strains” that can be deadly, as well as against homologous strains.

“Efficacy against drifted strains is likely the most difficult to get and is the best indication of how a vaccine will handle the annual variability that stumps so many flu vaccines,” Higgins added. “The mismatching between the recommended strains and the actual flu strains produces the sharp year-to-year differences in flu deaths.”

Another benefit of NanoFlu is it eliminates the potential for “virus egg adaptations” through its egg-free manufacturing of the product, the analyst stated.

Higgins concluded that “based on Phase 2 results, we believe that NanoFlu could become the new standard of care for older adults.”

Next for NanoFlu are further data releases from the Phase 2 study. Also, Novavax will meet with the FDA, likely in April, to discuss the Phase 2 study results, a Phase 3 trial design and the potential for faster approval of the vaccine. An accelerated pathway would mean the Phase 3 study could launch in Q4/19 and end in early Q1/20. “We believe such a path is possible,” indicated Higgins.

Ladenburg Thalmann has a Buy rating and a $3.50 per share price target on Novavax, whose stock is currently trading at around $2.17 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 Ladenburg Thalmann, Novavax, Inc., January 10, 2019

ANALYST CERTIFICATION: I, Michael Higgins, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, 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, provided, however, that:

The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.

COMPANY SPECIFIC DISCLOSURES
Ladenburg Thalmann & Co. Inc. makes a market in Novavax, Inc.
Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Novavax, Inc. within the next 3 months.
Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc had an investment banking relationship with Novavax, Inc. within the last 12 months.

( Companies Mentioned: NVAX:NASDAQ,
)

Healthcare Solutions Provider to Acquire Medical Software Firm

By The Life Science Report

Source: Streetwise Reports   01/10/2019

The merger will allow the Canadian company to expand its online technology platform.

Premier Health Group Inc. (PHGI:CSE; PHGRF:OTCQB; 6PH:FSE) announced in a news release it signed a definitive agreement to acquire the outstanding securities of Cloud Practice Inc., a national medical software company.

Cloud’s products include a cloud-based electronic medical records application, a medical billing software program and an online patient portal. The company’s clients encompass medical practices, licensed health care providers, cannabis clinics and registered patients.

In the merging of the two companies, Cloud Practice’s CEO Jordan Visco and team of software developers and salespeople will stay on with the combined entity that will have a base of more than 300,000 patients.

“With this acquisition, we now have a medical software company with national reach, thus enabling us to build on our patient-centric technology platform that will integrate telemedicine, online booking and other premium services with our electronic medical records system,” Premier CEO Dr. Essam Hamza said in the release.

Per the agreement terms, Premier will pay the Cloud Practice shareholders up to $5 million in cash in tranches. Initially, it will pay CA$500,000 as refundable deposit when the binding letter of intent (LOI) is signed. Another CA$500,000 will be due on closing of the transaction, with a third CA$500,000 due 90 days after. Within six months of the LOI signing and once certain integration milestones are met, it will pay another CA$500,000. Lastly, Premier will pay an aggregate of CA$3 million in common Premier shares at $0.76 apiece.

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

( Companies Mentioned: PHGI:CSE; PHGRF:OTCQB; 6PH:FSE,
)

Target Raised on Nutraceutical Firm After It Inks ‘Marquee Partnership’

By The Life Science Report

Source: Streetwise Reports   01/09/2019

The agreement terms and benefits of the partnership to this pharmaceutical company were relayed in an H.C. Wainwright & Co. report.

In a Jan. 7 research note, analyst Ram Selvaraju reported that H.C. Wainwright & Co. increased its price target on ChromaDex Corp. (CDXC:NASDAQ) to $7 per share from $6 after the nutraceutical company entered into a license and supply agreement with Nestlé Health Science, which develops and commercializes science-based nutritional health solutions. ChromaDex’s current share price is about $3.52.

Per the agreement, Nestlé gains the exclusive right to include ChromaDex’s Tru Niagen, a form of nicotinamide riboside, in its branded medical nutrition, and it gets the co-exclusive right to incorporate Tru Niagen in specific products in its consumer health segment. The agreement covers the geographical regions of North America, Europe, Latin America, Australia, Japan and New Zealand.

In exchange, Nestlé will pay ChromaDex $4 million upfront. It also will make payments when commercial milestones are reached, as well as tiered royalty payments to ChromaDex. Selvaraju estimates the latter to be in the mid-single-digit percent range.

Selvaraju pointed out the primary benefit of the new partnership is Nestlé affords ChromaDex entry into the medical nutrition arena, and that market is sizable. It will surpass $6 billion in size by 2025 in solely the United States, as estimated by Persistence Market Research. “ChromaDex now has a partner with the heft and breadth needed to effectively position Tru Niagen within the medical nutrition domain,” he added.

Another advantage for ChromaDex is Nestlé could complement the nutraceutical company’s existing commercial partner, Watsons, in the consumer products arena. “Tru Niagen may thus eventually become a key component in a broad array of consumer products marketed through both the Nestlé Health Science and Watsons channels, while ChromaDex retains the ability to pursue its own consumer products initiatives based on the nonexclusive structure of the Nestlé Health Science partnership,” noted Selvaraju.

H.C. Wainwright reiterated its Buy rating on ChromaDex.

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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., ChromaDex Corp., Target Price Revision, January 7, 2018

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

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

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

As of December 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of ChromaDex Corporation.

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 not receive compensation from ChromaDex Corporation for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in ChromaDex Corporation 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: CDXC:NASDAQ,
)

Potential Tenbagger Biopharma Displays ‘Strong Start to New Year’

By The Life Science Report

Source: Streetwise Reports   01/04/2019

A ROTH Capital Partners report discussed the recent trial launch and provided upcoming catalysts for the stock.

In a Jan. 2 research note, analyst Yasmeen Rahimi reported that Allena Pharmaceuticals Inc. (ALNA:NASDAQ) recently initiated its URIROX-2 trial evaluating reloxaliase (ALLN-177) in patients with enteric hyperoxaluria after it reached agreement with the FDA on the study design and the biologics license application submission plan.

“Especially with the full Phase 3 program underway and shares undervalued in our opinion, we believe this is a buying opportunity” for Allena, Rahimi added. In fact, ROTH’s $61 per share price target on this company reflects a potential nearly tenbagger return as the stock is currently trading at around $6.46 per share.

ROTH anticipates 2019 will be transformative for Allena, with numerous catalysts expected to occur, each of which should present a buying opportunity. These events include interim clinical data in H1/19 from the Phase 2 basket trial study; topline results in H2/19 from URIROX-1 and from study 206; and filing of an investigational new drug application for ALLN-346 in gout, which presents in chronic kidney disease patients, sometime this year.

In its discussions with the FDA on URIROX-2, Allena “got what it wanted” in terms of trial design, Rahimi noted. The primary endpoint will be the percent difference from the baseline reading in 24-hour urate oxidase measured during weeks one through four and 16 to 24.

“We believe this morning’s announcement of the FDA’s agreement with these key design and approval strategy elements represent a big win for Allena,” wrote the analyst.

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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 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, Allena Pharmaceuticals Inc., Company Note, January 2, 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 Allena Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis.

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: ALNA:NASDAQ,
)

Biotech Enters License Agreement to Validate Biomarker as Alternative NASH Diagnostic

By The Life Science Report

Source: Streetwise Reports   01/05/2019

The background and justification for the deal was covered in an H.C. Wainwright & Co. report.

GENFIT SA (GNFT:PA; GNFTF:OTC.MKTS) signed a license agreement with Covance, LabCorp’s clinical drug research and development division, for it to expand access to GENFIT’s proprietary biomarker diagnostic test for nonalcoholic steatohepatitis (NASH), analyst Ed Arce reported in a Jan. 3 research report. The deal terms have not been released.

However, Arce pointed out, the companies made clear the main purpose of the arrangement is to gain further proof GENFIT’s NIS4 is a valid, preferred way to identify and characterize NASH patients and to yield new insights into how NASH develops through Covance’s deployment of it in the clinical research space via its central laboratories.

“This agreement represents a critical step in both validating and ultimately commercializing a simple, noninvasive alternative to liver biopsy for screening and identifying the most appropriate patients for therapeutic intervention,” Arce commented, adding that liver biopsy currently is the current test for diagnosing NASH and fibrosis stage.

Arce highlighted that accurate diagnosis of NASH represents an unmet need recognized by the FDA. “There are simply not enough specialists to enable biopsy as a widely available test,” he noted, and the failure rate of diagnostic NASH through clinical trial screening is above 50%. Further, liver biopsy is expensive, “highly invasive,” and has significant associated risks.

GENFIT anticipates, relayed Arce, that in the 2020–2021 time frame it will receive FDA approval and a CE mark for its NIS4 serum biomarker for NASH and will launch the test across the United States and Europe.

H.C. Wainwright & Co. has a Buy rating and a €105 per share price target on GENFIT, whose stock is currently trading at around €18.15 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., Genfit S.A., First Take, January 3, 2019

I, Ed Arce, 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 Avenue Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of December 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Galectin Therapeutics, 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 not receive compensation from GENFIT S.A for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in GENFIT S.Aas of the date of this research report.

( Companies Mentioned: GNFT:PA; GNFTF:OTC.MKTS,
)

Texas-Based Biopharma Gets PDUFA Date for Lead Orphan Disease Asset

By The Life Science Report

Source: Streetwise Reports   01/02/2019

An H.C. Wainwright & Co. report covered the potential timeline to market and subsequent estimated revenue for this therapeutic, which addresses a rare disorder in collagen production.

In a Dec. 27, 2018, research note, analyst Ram Selvaraju reported that a new drug application for Acer Therapeutics’s (ACER:NASDAQ) Edsivo (celiprolol) has been accepted by the FDA and assigned a PDUFA date of June 25, 2019. “We believe that the drug could be launched in summer 2019, if approved,” he added.

Selvaraju noted that Edsivo, Acer’s most advanced drug, is enough to move the company into profitability. Expected revenue is about $8.7 million in 2019, and roughly $74.1 million in 2020. “The company could reach cash flow break-even during the first half of 2020 (i.e.,) within a time frame that may be covered by its existing capital resources,” he wrote.

To commercialize Edsivo, Acer hired Salma Jutt as its chief commercial officer. She has more than 20 years’ experience in the life sciences industry at companies that include Allergan, Boehringer Ingelheim and Nalpropion Pharmaceuticals. “Ms. Jutt should not only be able to optimize the launch strategy for Edsivo but also potentially craft the strategy for an array of other products that Acer may advance to market in the future,” Selvaraju commented.

Looking forward, catalysts expected to occur in the coming months include publication, in a peer reviewed journal, of the Edsivo patient registry data in vascular Ehlers-Danlos syndrome. Other catalyst include developing the infrastructure to commercially launch Edsivo, advancing clinical development of ACER-001 for treatment of urea cycle disorders and initiating additional programs.

H.C. Wainwright & Co. has a Buy rating and a 12-month target price of $55 per share on Acer, whose stock is currently trading at around $20.58 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 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., Acer Therapeutics Inc., Company Update, December 27, 2018

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

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

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

As of November 30, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Acer Therapeutics, 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 Acer Therapeutics, 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 Acer Therapeutics, Inc. during the past 12 months.

The Firm does not make a market in Acer Therapeutics, Inc. as of the date of this research report.

( Companies Mentioned: ACER:NASDAQ,
)

Coverage Initiated on Pharma ‘Leveraging Large Markets with Differentiated Products’

By The Life Science Report

Source: Streetwise Reports   12/29/2018

A Ladenburg Thalmann report outlined the investment thesis for this Colorado-based life sciences firm.

In a Dec. 20 research note, analyst Jeffrey Cohen reported that Ladenburg Thalmann initiated coverage on Aytu Bioscience Inc. (AYTU:NASDAQ) with a Buy rating and a $3.75 per share price target. In comparison, the company’s current share price is $0.78. “We believe that Aytu BioScience should be valued in comparison with other innovative technological companies within the medical technology and biotechnology sectors and more specifically based on multiples to revenue at some time in the future,” he added.

Cohen described this specialty pharmaceutical company’s focus, strategy and opportunities. Aytu develops and globally commercializes products for hypogonadism, male infertility and insomnia. Specifically, it sells three products approved by the FDA and for which is has U.S. licenses: Tuzistra XR, a prescription cough medicine; Zolpimist, an insomnia remedy in an oral spray form; and Natesto, a nasal gel for men with hypogonadism, or low testosterone.

Aytu currently is evaluating Natesto’s impact on men’s health and reproductive system in a clinical trial that is underway. It is slated for completion in H1/19, after which final data will be released. “The interim data provide an additional benefit, beyond reduced concern of transference, to support utilization of Natesto as compared to alternative treatments,” indicated Cohen.

Aytu is pursuing FDA approval of another product, MiOXSYS, which it sells in Canada, Australia and Mexico. It is an in vitro diagnostic test to measure oxidative stress in men with infertility. “We believe the company will continue to actively search and pursue various acquisition and licensing opportunities going forward,” Cohen noted.

The company’s strategy has been to concentrate on therapies for “conditions that can be assessed by primary care physicians and specialists,” Cohen described. Aytu markets and sells its products through its domestic sales force of about 35 people and a network of distribution partners in roughly 50 countries, which it continues to bolster.

Aytu’s current products are part of “large addressable markets of approximately $6.5–7 billion,” into which the biopharma can expand by leveraging its “established commercial infrastructure,” Cohen explained.

Further, these specific markets are growing, presenting additional opportunity for Aytu. For example, the testosterone replacement therapy market is expected to reach $3.4 billion by 2022. The sleep aid market, both prescription and over the counter, is anticipated to reach $101.9 billion by 2021. The cold and cough market is forecasted to reach $3 billion in solely the U.S. As for Aytu and its revenue overall, Ladenburg Thalmann estimates it will generate about $30.9 million in 2022.

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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 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 Ladenburg Thalmann, Aytu BioScience, Inc., December 18, 2018

ANALYST CERTIFICATION: I, Jeffrey S. Cohen, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, 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, provided, however, that:

The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.

COMPANY SPECIFIC DISCLOSURES
Ladenburg Thalmann & Co. Inc. makes a market in Aytu BioScience, Inc.
Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Aytu BioScience, Inc. within the past 12 months.

Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Aytu BioScience, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc had an investment banking relationship with Aytu BioScience, Inc. within the last 12 months.

( Companies Mentioned: AYTU:NASDAQ,
)

Coverage Initiated on Vaccine Developer with ‘Transformational’ Data Expected

By The Life Science Report

Source: Streetwise Reports   12/24/2018

A Ladenburg Thalmann report discussed this biotech’s late-stage clinical assets in RSV and influenza.

In a Dec. 18 research note, analyst Michael Higgins reported that Ladenburg Thalmann has initiated coverage on the vaccine company Novavax Inc. (NVAX:NASDAQ) ahead of an expected Q1/19 release of “transformational” data, with a Buy rating and a $3 per share price target. In comparison, the biotech is currently trading at around $1.83 per share.

Higgins reviewed the company’s near-term vaccine data catalysts and their potential implications, along with his firm’s expectations for, and the potential market for, each product.

Novavax intends to release study results from two of its vaccine platforms: ResVax, for respiratory syncytial virus (RSV), and NanoFlu, for the flu. “We believe both will be effective,” Higgins added, “leading to a biologics license applicant filing and PDUFA for ResVax in Q1/20 and Q3/20, respectively, as well as advancement to potential pivotal stage for NanoFlu in H2/19,” he added.

ResVax data to come in Q1/19 will be from its most advanced component of the program, the version for infants (given via the mother), currently in Phase 3 of the PREPARE trial. “We feel confident that final efficacy could also surpass 40%,” Higgins commented. Further, he said, ResVax “could become the first vaccine against RSV.” The virus is the second leading cause of infant death globally and the primary cause of infant hospitalization in the United States. The potential market size worldwide, Higgins highlighted, is estimated to be about $1.5 billion, roughly $750 million of that in the U.S.

Novavax also is working on ResVax for adults ages 60 and above, which has completed Phase 2. That market offers “significant upside potential,” wrote Higgins. Another version is for children between ages six months and five years, which has finished Phase 1.

As for NanoFlu, Novavax’s egg-free flu vaccine, data expected in Q1/19 will be from Phase 2, in which single injections of a quadrivalent NanoFlu will be tested against two approved flu vaccines—trivalent Fluzone HD and an undisclosed quadrivalent vaccine and trivalent. “We believe [NanoFlu] could become the new standard of care,” Higgins said. Ladenburg Thalmann projects 2022 revenues from NanoFlu to reach $525 million based on premium pricing and a 10–15% U.S. market 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 sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. 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 Ladenburg Thalmann, Novavax, Inc., December 18, 2018

ANALYST CERTIFICATION: I, Michael Higgins, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, 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, provided, however, that:

The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.

COMPANY SPECIFIC DISCLOSURES
Ladenburg Thalmann & Co. Inc. makes a market in Novavax, Inc.
Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Novavax, Inc. within the next 3 months.
Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc had an investment banking relationship with Novavax, Inc. within the last 12 months.

( Companies Mentioned: NVAX:NASDAQ,
)

Therapeutics Developer Secures Patents, Continues Phase 3 Trial Planning

By The Life Science Report

Source: Streetwise Reports   12/24/2018

An H.C. Wainwright & Co. report provided an update on the Q3/18 activities and achievements of this company targeting NASH.

In a Dec. 19 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Galectin Therapeutics Inc. (GALT:NASDAQ) continues to advance its corporate programs while working to finalize the plan for a Phase 3 trial of its galectin-3 inhibitor, GR-MD-02, in patients with nonalcoholic steatohepatitis (NASH) cirrhosis without esophageal varices.

Those efforts pertaining to the Phase 3 study, Arce summarized, include incorporating and refining advice and guidance from the FDA and outside NASH experts. Additionally, the company’s strategic adviser, Back Bay Life Science Advisors, continues discussions with potential partners about securing the rights to GR-MD-02. Galectin’s management indicated it will announce the Phase 3 trial design and specifics, including cost and timeline, once planning is done and a protocol is in place that the FDA deems acceptable.

As for its financial standing, at the end of Q3/18, Galectin had $10.1 million in cash, Arce relayed. That, along with access to a $10 million credit line, is enough to fund operations and research and development activities through September 2019, management estimates.

H.C. Wainwright & Co. is confident Galectin will obtain the required capital for the Phase 3 trial. “We believe it likely,” Arce noted, “that management finalizes and announces some type of agreement for longer-term financial stability (and perhaps a cleaner balance sheet) as well as sufficient funding to complete the Phase 3 NASH trial and, if successful, submit a new drug application.”

Arce reported that in other news, the biotech expanded its collection of intellectual property during Q3/18, during which it was granted or allowed patents for:

1. Galactose-pronged carbohydrate compounds for treatment of diabetic nephropathy and related conditions (in Europe, Australia and China)
2. Composition of a unique carbohydrate drug for treatment of human disease (in Japan)
3. A method for enhancing certain immunotherapies (in China, Israel and Japan)
4. Compositions of distinctive carbohydrate drugs for treatment of NASH and nonalcoholic fatty liver disease (in Mexico and South Africa)

About this activity, Arce commented, “We view this as an incremental positive as it can only help with discussions with potential partners.”

H.C. Wainwright affirmed its Buy rating and $13 per share target price on Galectin, which is currently trading at about $3.65 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 sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. 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., Galectin Therapeutics Inc., Earnings Update, December 19, 2018

I, Ed Arce, 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 Avenue Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of November 30, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Galectin Therapeutics, 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 not receive compensation from Galectin Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Galectin Therapeutics, Inc. as of the date of this research report.

( Companies Mentioned: GALT:NASDAQ,
)