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Heathcare and Biotech Updates

Oncology Vaccine Developer’s Lead Programs ‘On Track or Better’

By The Life Science Report

Source: Streetwise Reports   05/22/2019

The biopharma’s two assets are discussed and Q1/19 financial results are provided in a BTIG research report.

In a May 13 research note, BTIG analyst Thomas Shrader reported that Gritstone Oncology Inc.’s (GRTS:NASDAQ) lead clinical programs, GRANITE and SLATE, are “on track or better.”

As for GRANITE, interim data are expected in Q4/19 from the Phase 1/2 study of GRANITE-001 plus nivolumab/ipilimumab (GO-004), Shrader relayed.

In Part A of the Phase 1 study, patients are getting an adenovirus-based prime with escalating doses of an RNA-based boost vaccine in combination with anti-PD1 therapy. Patients in Part B are receiving the prime and the boost vectors at the selected dose in combination with Bristol-Myers Squibb’s nivolumab + ipilimumab.

GRANITE is assessing patients with advanced solid tumors, including metastatic nonsmall cell lung, bladder, microsatellite stable colorectal and gastroesophageal cancers.

Regarding SLATE, Gritstone intends to submit an investigational new drug application to the U.S. Food and Drug Administration in Q2/19 and follow that in Q4/19 with a preliminary data readout at an annual scientific meeting, indicated Shrader.

In other news, Gritstone reported advances made in predicting HLA-II bound peptide antigens, which “may help augment responses to HLA-I peptides that are at the heart of GRANITE and SLATE,” Shrader pointed out.

MHC-1 peptides are structurally constrained, allowing for straightforward predictions of the peptides that bind to them, the analyst explained. Gritstone’s GRANITE and SLATE vaccines are based on these predictions.

MHC-II peptides, on the other hand, have a binding groove that is open ended, making predications more complex. “As a result, this more challenging calculation seems likely to provide Gritstone the opportunity to leverage its deep-learning algorithms and design best-in-class neoantigen vaccines,” the analyst commented.

Also in the report, Shrader reviewed the company’s Q1/19 results. Net loss was $18 million, more than BTIG’s forecasted $14.1 million. Research and development costs were higher than expected at $15.9 million versus BTIG’s $12.6 million, mostly likely due to increased head count, professional services, and lab supplies and consumables. At the quarter’s end, Gritstone had $132.2 million in cash and equivalents.

BTIG has a Buy rating and a $31 per share target price on Gritstone, whose stock is currently trading at around $10.82 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 BTIG, Gritstone Oncology Inc., Equity Research, May 13, 2019

Analyst Certification I, Thomas Shrader, PhD, CFA, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
I, Julian Harrison, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.

The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues.

BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: Gritstone Oncology Inc. (GRTS)

BTIG LLC has received compensation for investment banking services in the past 12 months from: Gritstone Oncology Inc. (GRTS)

BTIG LLC had an investment banking services client relationship during the past 12 months with: Gritstone Oncology Inc. (GRTS)

BTIG LLC managed or co-managed a public offering of securities in the past 12 months for: Gritstone Oncology Inc. (GRTS)

( Companies Mentioned: GRTS:NASDAQ,
)

Immuno-oncology Firm to Co-Develop Companion Diagnostic for Cervical Dysplasia

By The Life Science Report

Source: Streetwise Reports   05/22/2019

The partnership news and upcoming data readouts are reviewed in an H.C. Wainwright & Co. report.

In a May 17 report, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Inovio Pharmaceuticals Inc. (INO:NASDAQ) will collaborate with QIAGEN, a molecular testing solutions company, to develop a companion diagnostic test to identify cervical dysplasia patients most likely to respond to VGX-3100, an immunotherapy targeting precancerous lesions.

The liquid biopsy-based test will be based on “novel microRNA biomarkers discovered in the past by Inovio via QIAGEN Genomic Services,” Selvaraju noted. Financial arrangements between the two companies concerning the collaboration have not been released to the public.

“Given QIAGEN’s expertise in precision medicine in immuno-oncology and particularly human papillomavirus (HPV)-related molecular testing, we believe this collaboration is likely to produce a convenient and accurate test that would increase absolute efficacy of VGX-3100 among 30 million HPV-infected women who have progressed to the stage of precancerous cervical lesions,” commented Selvaraju.

Looking further out, Selvaraju highlighted, commercialization of VGX-3100 along with a companion diagnostic test should enhance uptake of the immunotherapy in the market.

In other news, Selvaraju pointed out that the REVEAL Phase 3 trials of Inovio’s VGX-3100 in HPV 16 and 18 are on schedule for data readout in 2020, which means the biopharma could submit a biologic license application to the U.S. Food and Drug Administration in 2021. REVEAL 1 should finish enrollment of 198 patients by mid-2019, and the confirmatory REVEAL 2 began recruiting patients in March 2019. “If approved, VGX-3100 would be the first immunotherapy for women with cervical dysplasia,” the analyst added.

Also noteworthy about VGX-3100 is that it is being evaluated as well, in two Phase 2 trials in HPV-related vulvar and anal dysplasia in the U.S. Interim efficacy results from those studies could be released by year-end 2019. Also, the European Medicines Agency has granted VGX-3100 an advance therapy medicinal product certification for quality and nonclinical data.

Selvaraju indicated that Inovio has multiple other immuno-oncology studies underway with results due to be announced this year. They include the Phase 1/2 study evaluating MEDI0457 in combination with Imfinzi (durvalumab) in metastatic HPV-associated head and neck squamous cell cancer as well as three AstraZeneca studies of MEDI0457 in HPV-associated cancers.

Two others are Inovio’s Phase 1/2 trial of INO-5401 plus INO-9012 in combination with cemiplimab (REGN2810) from Regeneron in glioblastoma and the Phase 1/2a study of INO-5401 plus INO-9012 in combination with Genentech’s Tecentriq (atezolizumab) in bladder cancer. These two trials could release interim results in H2/19. “Positive efficacy data from any of the studies mentioned above could drive the valuation of the company meaningfully higher from the current level,” he wrote.

H.C. Wainwright has a Buy rating and a $13 per share price target on Inovio, whose stock is trading now at around $3.45 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., Inovio Pharmaceuticals Inc., Company Update, May 17, 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, Raghuram Selvaraju, Ph.D. and Yi Chen, Ph.D. CFA, 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 Inovio Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Inovio Pharmaceuticals, 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 Inovio Pharmaceuticals, 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 Inovio Pharmaceuticals, Inc. during the past 12 months.

 

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

( Companies Mentioned: INO:NASDAQ,
)

U.S. Biopharma’s ‘Biggest Stock Moving Event’ Imminent

By The Life Science Report

Source: Streetwise Reports   05/22/2019

With study results from this company due out shortly, an analysis of the possible outcomes was provided in a ROTH Capital Partners report.

In a May 17 research note, ROTH Capital Partners analyst Yasmeen Rahimi reviewed possible data readout scenarios of Enanta Pharmaceuticals Inc.’s (ENTA:NASDAQ) Phase 2 respiratory syncytial virus (RSV) challenge and their potential resulting stock reaction. The study results are expected within the next two weeks.

Rahimi outlined that the most likely scenario according to ROTH is that Enanta’s EDP-938 performs superiorly to Johnson & Johnson’s ALS-008176 in terms of reducing viral load and improving symptoms, and thus Enanta’s shares rise 30%.

The reasons for this outcome are that Enanta’s EDP-938, with its mechanism of action, attacks the infection’s root cause, which is replication, thereby allowing for more flexibility in the ideal treatment window. Also, EDP-938’s safety profile affords higher dosing and thus attainment of efficacy. Further, EDP938 pushes for an efficacy at a higher level than other products, leading the virus to clear more quickly and avoid drug resistance.

“We are confident EDP-938 will set the highest efficacy bar in an RSV challenge study, with 90%-plus reduction in viral load compared to placebo (ALS-008176 showed only 73–88% and [Gilead’s] GS-5806 showed 38–67%).

In a second case, Rahimi indicated, results are mixed, in other words viral load is reduced but symptoms do not improve by Day 12. Likely confusing to the Street, this would result in the share price remaining the same or dropping by up to 10%. “We view the bar of EDP-938 is to achieve 10x fold reduction in symptoms,” the analyst wrote.

A third possibility is that EDP-938 fails in either efficacy or safety, the latter being unlikely, the analyst purported.

Rahimi noted that as of March 31, 2019, Enanta had $386.7 million in cash, cash equivalents and short- and long-term marketable securities, “enough to fund business and development programs for the foreseeable future.”

ROTH has a Buy rating and a $130 per share target price on Enanta, whose stock is currently trading at around $90.96 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, Enanta Pharmaceuticals Ltd., Company Note, May 17, 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 Enanta 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: ENTA:NASDAQ,
)

Cancer Fighter Sesen Bio Leaps 13% on FDA Decision

By The Life Science Report

Source: Streetwise Reports   05/21/2019

Shares of this biotech stock were up significantly at the close of trading on Tuesday, May 21, attributed to the announcement of some good news from the FDA.

Sesen Bio Inc. (SESN:NASDAQ) announced in a press release early Tuesday morning that the U.S. Food and Drug Administration (FDA) accepted the company’s analytical comparability plan to support the biologic license application and commercialization of its lead asset, Vicinium.

Investors welcomed the news, as the NASDAQ-listed, cancer-fighting biotech stock gained 13.14% by the close of trading that day.

Sesen is a late-stage clinical company whose lead program, Vicinium, aims to “effectively kill cancer cells while sparing healthy cells.”

Commenting on the news, Seson Bio President and CEO, Dr. Thomas Cannell, said, “This is a very positive outcome and brings us one step closer to regulatory approval of Vicinium, and our ability to help save and improve the lives of patients.”

The health care company has a $150 million market cap, and shares closed at $1.98 on May 21, 2019, with a gain of $0.23.

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Disclosure:
1) Kevin Jaillet compiled this article for Streetwise Reports LLC and is an employee of Streetwise Reports. 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. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
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: SESN:NASDAQ,
)

Why Did ImmunoGen Plummet 32%?

By The Life Science Report

Source: Streetwise Reports   05/16/2019

This biotechnology company, which focuses on the treatment of cancer, received some feedback from the FDA that upset investors on Wednesday.

ImmunoGen Inc.’s (IMGN:NASDAQ) shares closed down 32.06% on the NASDAQ Wednesday after announcing the United States Food and Drug Administration (FDA) requested the company run a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine.

According to the press release: “The FDA has recommended that the company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week.”

Despite the negative sentiment from investors, ImmunoGen executives see the meeting with the FDA as enabling them “to clarify a regulatory path forward for mirvetuximab,” as they are “encouraged by the consistent signal of anti-tumor activity and the favorable benefit-risk profile in patients with high FRα expression in the Phase 3 FORWARD I trial.”

The NASDAQ-listed biotech company aims to fight cancer using antibody-drug conjugates, which attach a cancer-killing substance to “a specific antibody using a biodegradable linker.” Mirvetuximab soravtansine is ImmunoGen’s lead program in Phase 3 development for platinum-resistant ovarian cancer.

Shares closed at $2.14 on Wednesday, May 15th.

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Disclosure:
1) Kevin Jaillet compiled this article for Streetwise Reports LLC and is an employee of Streetwise Reports. 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. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
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: IMGN:NASDAQ,
)

Women’s Wellness Device Developer Posts In-Line Quarter, Catalysts Looming

By The Life Science Report

Source: Streetwise Reports   05/15/2019

A review of this Colorado company’s first numbers of the year was provided in a Ladenburg Thalmann report.

In a May 13 research note, Ladenburg Thalmann analyst Jeffrey Cohen reported that Viveve Medical Inc.’s (VIVE:NASDAQ) Q1/19 “reads fine.”

Q1/19 revenue, net loss and loss per share were $3 million, $10 million and $0.22 versus Ladenburg’s projections of $3.3 million, $8.6 million and $0.27, respectively. During the quarter, Viveve sold 43 systems and 2,300 disposable treatment tips, the latter still accounting for most of the revenue. Revenue from tips sales grew to 19% from 6% of total revenue in two years’ time.

Viveve developed an internal care team whose members will be the main point of contact for its customers. The company also launched programs in which they provide physicians with best practices and peer experiences globally.

Operating expenses during Q1/19 were $9.8 million, higher than Ladenburg’s estimated $9.3 million, mostly due to higher-than-expected selling, general and administrative costs. Those came in at $6.6 million, above the financial services company’s $6.1 million forecast. On the other hand, research and development expenses were less than anticipated, at $2.5 million versus $3.2 million.

Gross margins for Q1/19 were less than Ladenburg predicted, at 36% compared to 45%. Cohen commented that Viveve likely will increase revenue through sales of its system’s 2.0 version and from partners manufacturing the various components at a lower cost.

Upcoming catalysts, Cohen noted, are a full data readout in July 2019 from the LIBERATE International trial, Viveve’s ex-U.S. stress urinary incontinence study. Q3/19 could potentially bring U.S. Food and Drug Administration clearance of Viveve’s system domestically.

Ladenburg has a Buy rating and a price target of $2.50 per share on Viveve, whose current share price is around $0.46.

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

Disclosures from Ladenburg Thalmann, Viveve Medical Inc., May 13, 2019

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 Viveve Medical, Inc.

Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Viveve Medical, Inc. within the past 12 months.

Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Viveve Medical, Inc. within the past 12 months.

Ladenburg Thalmann & Co. Inc had an investment banking relationship with Viveve Medical, Inc. within the last 12 months.

( Companies Mentioned: VIVE:NASDAQ,
)

FDA Approval of Antibiotic for Bacterial Pneumonia Expected in Late Summer

By The Life Science Report

Source: Streetwise Reports   05/15/2019

An update on this biopharma’s two lead drug candidate programs was provided in an H.C. Wainwright report.

In a May 13 research note, H.C. Wainwright & Co. analyst Ed Arce reported that for Nabriva Therapeutics Plc (NBRV:NASDAQ), “all eyes [are] on [its] Aug. 19, 2019 lefamulin PDUFA date,” around which time the U.S. Food and Drug Administration (FDA) is expected to approve the antibiotic for the treatment of community-acquired bacterial pneumonia.

Approval will be based on positive Phase 3 data from the LEAP 1 and LEAP 2 trials and the FDA not requiring an advisory committee (Ad Com) meeting, Arce pointed out. Additionally, the fact that lefamulin can be delivered in an outpatient setting, orally or intravenous-to-orally, is significantly advantageous in that it eliminates the need for hospitalization of these pneumonia patients, which can cost about $2,500 a day. Also, the FDA accepted Nabriva’s new drug applications for lefamulin in both formulations based on a six-month priority review target.

Were the FDA to approve lefamulin, Nabriva likely would launch U.S. sales soon after and reach domestic peak sales of an estimated $460 million by 2026, highlighted Arce.

With respect to the commercialization of lefamulin in Europe, Nabriva submitted in early May amarketing authorization application to the European Medicines Agency for approval, Arce noted. If approval is secured, which H.C. Wainwright expects, the antibiotic would likely hit the European Union market in about mid-2020.

Regarding another Nabriva asset, Contepo (fosfomycin), an injected treatment for complicated urinary tract infections, Arce indicated the company most likely will request a Type A meeting with the FDA to address the complete response letter it issued regarding the company’s market application for approval.

If the meeting is granted, the FDA would likely “discuss concerns and potential remedies of the manufacturing deficiencies” and decide whether to categorize Contepo’s new drug application resubmission as a Class 1, which has a two-month target review time frame, or as a Class 2, with a six-month window, Arce explained. It’s expected that Nabriva, at the meeting, would address all of the FDA’s concerns to resume the regulatory approval process of Contepo.

Finally, Arce reported that Nabriva ended Q1/19 with $91.3 million in cash and cash equivalents, enough to cover operations through Q2/20, according to management. Also, during the first quarter, the company generated $9.7 million in net proceeds from the sale of common shares.

H.C. Wainwright has a Buy rating and a $7 per share price target on Nabriva, whose stock is currently trading at around $2.76 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., Nabriva Therapeutics plc, Earnings Update, May 13, 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, Ed Arce and Thomas Yip, 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 Nabriva Therapeutics plc (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Nabriva Therapeutics plc.

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 does not make a market in Nabriva Therapeutics plc 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: NBRV:NASDAQ,
)

Trial Milestone Reached; U.K.-Based Biopharma Gets $15 Million

By The Life Science Report

Source: Streetwise Reports   05/08/2019

The first patient has been treated in the second cohort of a Phase 2 study of a gene therapy targeting Parkinson’s disease, explained an H.C. Wainwright & Co. report.

In an April 30 research note, analyst Joseph Pantginis reported that Oxford Biomedica Plc (OXB:LSE) received a $15 million milestone payment from its partner Axovant.

The achievement that triggered the payment was Axovant having treated the first patient in the second cohort of the Phase 2 SUNRISE-PD clinical trial, in which the AXO-Lenti-PD gene therapy is being evaluated in Parkinson’s disease patients. Up to six patients are to be enrolled in this group, with initial data expected in Q4/19, Pantginis explained.

That first patient of the second cohort, whom Axovant recently dosed, did not suffer any complications from surgery or administration of the therapeutic and was subsequently discharged, relayed Pantginis. There were not any associated serious adverse events.

This initial safety report is encouraging, the analyst wrote, and if further substantiated, could potentially result in efficacy data being gathered quickly and development of AXO-Lenti-PD being accelerated. “Overall, we are confident the PD program is going to generate meaningful data,” he noted.

Pantginis added that due to a paucity of any existing therapy that effectively slows or reverses Parkinson’s disease progression, AXO-Lenti-PD could be a potential new gene therapy for it.

H.C. Wainwright has a Buy rating and a £14.50 per share target price on Oxford Biomedica, whose current share price is around £6.96.

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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, Oxford Biomedica Plc, First Take, April 30, 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, Joseph Pantginis, 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 Oxford BioMedica PLC (including, without limitation, any option, right, warrant, future, long or short position).

As of March 31, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Oxford BioMedica PLC.

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 Oxford BioMedica PLC 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 Oxford BioMedica PLC 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: OXB:LSE,
)

Price Target Raised on Biopharma Ahead of Leukemia Trial Update

By The Life Science Report

Source: Streetwise Reports   05/08/2019

The expected data and their implications were addressed in a ROTH Capital Partners report.

In an April 29 research report, analyst Jotin Marango reported that ROTH Capital Partners raised its price target on ArQule Inc. (ARQL:NASDAQ) to $10 per share in anticipation of a clinical update on its ARQ531 dose escalation study in chronic lymphocytic leukemia (CLL) patients, to be given at the European Hematology Association (EHA) Congress this June.

“This spring, we are increasingly bullish on ArQule,” and “remain high conviction buyers of ARQL shares,” Marango wrote. The stock is currently trading at around $6.10 per share.

The study results ArQule will present in six weeks will likely be from the sizeable group of CLL patients treated at higher doses of ARQ531, a BTK inhibitor, Marango noted. This would include cohort 6, whose dose was increased to 65 milligrams (65 mg) from 45 mg, and the expanded cohort 7, which received 65 mg. (Data from cohort 8, which is receiving 75 mg, likely will not be ready in time for the EHA meeting.)

Marango highlighted that a positive update could elicit a favorable market reaction, particularly if patients experienced tumor shrinkage. The new data could move ArQule closer to determining the recommended dose and positioning of a Phase 2 study. Also, a positive report could “rekindle mergers and acquisitions speculation around ARQ531,” he noted.

Were the latter to happen, Marango purported, the interest would likely come from a handful of larger companies: AbbVie Inc. (ABBV:NYSE), Celgene Corp. (CELG:NASDAQ), Bayer AG (BAYRY:OTCMKTS; BAYN:XETRA), Daiichi Sankyo Co. (4568:TYO; DSKYF:OTCPK) and Jazz Pharmaceuticals Plc (JAZZ:NASDAQ). “Overall, we note that there certainly appear to be more potential apt buyers than there are reversible BTK inhibitors in development,” he added.

ROTH has a Buy rating on ArQule.

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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, ArQule Inc., Company Note, April 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.

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

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

Within the last twelve months, ROTH has managed or co-managed a public offering for ArQule, 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: ARQL:NASDAQ,
)

Shares of Plant-Based Meat Company Spike 53% (and It’s Not Beyond Meat)

By The Life Science Report

Source: Streetwise Reports   05/06/2019

This small-cap nutrascience stock hit a new 52-week high on May 6th, extending a run that has the stock up 147% over a five-day period.

The buzz around Beyond Meat has been strong since the company’s IPO last week, and subsequent 63% surge in stock price. Perhaps the warm reception has investors looking to uncover value in other, lesser-known plant-based protein stocks, as Burcon NutraScience Corp. (BU:TSX) has seen its own shares vault more than 53% on Monday, May 6th for a 5-day gain of 147%.

The company’s most recent report of financial results state: “As at December 31, 2018, Burcon has not yet generated any significant revenues from its technology. For the three and nine months ended December 31, 2018, the company recorded a loss of $1,155,000 and $3,532,000 ($0.03 and $0.08 per share), respectively. . .The commercial success of any of Burcon’s products will depend on whether they receive public and industry acceptance as a food ingredient and dietary supplement.”

The company holds 66 U.S. patents for its extraction technologies and product uses, with an additional 45 under review by the United States Patent and Trademark Office. Burcon successfully commercialized CLARISOY, the company’s flagship soy-based protein product, and is currently working to commercialize several other plant-based nutrition products, including Peazazz, Puratein, Supertein and Nutratein, each with a distinct functional and nutritional attribute.

Burcon NutraScience Corp. closed at $0.89 on May 6th, up from $0.36 on May 1st.

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Disclosure:
1) Kevin Jaillet compiled this article for Streetwise Reports LLC and is an employee of Streetwise Reports. 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. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
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.