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Emerging SARS-COv-2 Variant Is Revenue Growth Opportunity for Vaccine Developer

Source: Streetwise Reports   11/30/2021

Just a few days after the WHO deemed the COVID-19 Omicron variant a serious global health concern, leading mRNA-based vaccine developers BioNTech and Pfizer, along with rival Moderna, advised that if needed, the companies would be capable of developing a vaccine for the new mutating strains within roughly 100 days. H.C. Wainwright & Co. commented in a research note that it reiterates its “Buy” rating for BioNTech SE.

COVID-19 Omicron variant covid covid19

In a November 29 research note, H.C. Wainwright & Co. LLC Healthcare Analysts Robert Burns and Raghuram Selvaraju, Ph.D. commented that as the novel SARSCoV-2 Omicron variant spreads, biotechnology company BioNTech SE’s (BNTX:NASDAQ) development partner Pfizer Inc. (PFE:NYSE) claimed that “it could produce a tailor-made vaccine in roughly 100 days.”

The H.C. Wainwright & Co. report mentioned that within the last couple of days, the World Health Organization (WHO) officially designated Omicron (B.1.1.529) as a variant of concern (VOC). Since the WHO made its announcement, the Omicron variant has been detected in several additional countries.

The analysts stated that at present only a limited amount of scientific data is available regarding the Omicron variant’s transmissibility, disease severity and the effectiveness of existing vaccines in combating the new strain. The WHO reported that it suspects that mutation occurring within Omicron may carry the potential to increase transmission and disease severity.

H.C. Wainwright commented that, “preliminary evidence suggests an increased risk of reinfection with this variant.” The research firm added that with the rising concern associated with Omicron, BioNTech expects that it will receive the lab test results for the Omicron variant within two weeks.

The report noted that if the new data gathered for Omicron demonstrates significantly lower vaccine efficacy or resistance to existing vaccines, BioNTech and its partner Pfizer, as well as Moderna Inc. (MRNA:NASDAQ), believe that they would be able to develop a targeted vaccine for use against Omicron within about 100 days.

H.C. Wainwright advised that if this scenario were to occur, then it anticipates that the resulting increased demand for new or updated vaccines would have positive impact on BioNTech’s top-line revenue. The analysts commented that they expect the Omicron strain is highly likely to continue its global spread over the coming weeks. H.C. Wainwright stated that it believes that mRNA-based vaccines such as Pfizer/BioNTech’s would be more amenable to adaptations to confront new emerging virus strains compared to peptide- or protein-based vaccines.

The report pointed out that late last week, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion for COMIRNATY vaccine deployment for children from ages five to eleven years old. H.C. Wainwright advised that it is expected that the European Commission (EC) will issue a final decision on a variation to the Conditional Marketing Authorization (CMA) very soon.

The analysts explained that positive data collected in a Phase 2/3 clinical study offer strong support for a positive ruling by the EC. The report mentioned that in the referenced study, “two doses of COMIRNATY 10μg administered 21 days apart resulted in a vaccine efficacy rate of 90.7% in participants without prior SARSCoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalent strain.”

H.C. Wainwright also advised that earlier this month, the FDA amended the COMIRNATY’s booster dose Emergency Use Authorization (EUA) and approved the booster shot for adults 18 years of age or older. The report listed that the expanded EUA was authorized based upon a randomized Phase 3 trial of more than 10,000 individuals who were administered a 30μg COMIRNATY booster dose.

Importantly, the top-line data from this study applied to participants that were given a booster and previously had completed the two-dose series of COMIRNATY vaccine and that testing was performed at a time when the Delta variant was the prevalent strain. The analysts indicated that in the study, the COMIRNATY booster group demonstrated vaccine efficacy of 95.6%.

H.C. Wainwright stated that from its perspective, broad-based booster deployment is an important key step in the process of achieving and maintaining herd immunity and is an integral part of COMIRNATY’s long-term commercial success.

The analysts advised that their valuation methodology for BioNTech is based upon a tiered discounted cash flow (DCF) model employing a 9% discount rate, 3% terminal growth rate and 31% projected effective tax rate. Using these metrics results in a market value of approximately $88.7 billion, or $360/share based on an estimated 246.5 million shares outstanding at the end of Q3/22.

H.C. Wainwright & Co. LLC stated that it is reiterating its “Buy” rating and 12-month price target of $360/share for BioNTech SE. The company’s American Depository Receipt (ADR) shares trade on the Nasdaq Exchange under the symbol “BNTX” and last closed for trading at $362.50 on Monday, November 29, 2021.

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

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

Important Disclaimers for H.C. WAINWRIGHT & Co., BioNTech SE, Nov. 29, 2021

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.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

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

A research analyst of the firm and/or the research analyst’s household has a financial interest in and own the securities of BioNTech SE (including, without limitation, any option, right, warrant, future, long or short position).

As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioNTech SE.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest 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 BioNTech SE for investment banking services within 12 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 BioNTech SE as of the date of this research report.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.

H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation, and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in 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.

The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.

Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

Biopharma Launches COVID Vaccine Program in South Africa & Mexico

Source: Streetwise Reports   11/30/2021

Oramed Pharmaceuticals’ oral vaccine offers “convenience and safety advantages as well as coverage of emergent variant strains,” noted a Nov. 29, 2021 H.C. Wainwright & Co. report.

Coronavirus

New developments regarding Oramed Pharmaceuticals Inc.’s (ORMP:NASDAQ) COVID-19 vaccine are advancing the program outside the U.S., and the company continues making strides in testing its insulin product in types 1 and 2 diabetes, reported H.C. Wainwright & Co. analyst Ram Selvaraju in a Nov. 29 research note.

Also, H.C. Wainwright raised its 12-month price target on Israel-based Oramed to $32 per share from $17 after revising its model assumptions pertaining to the biopharma’s lead drug candidates, ORMD-0801 and ORMD-0901.

Regarding its COVID-19 vaccine, Selvaraju reported that Oramed’s subsidiary, Oravax Medical Inc., is preparing to begin a Phase 1 trial of its oral, virus-like particle vaccine technology in South Africa after recently receiving approval to proceed.

The vaccine “targets three SARS-CoV-2 coronavirus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID-19 virus,” Selvaraju pointed out.

In addition, Oravax recently formed a 50/50 joint venture with Genomma Lab to develop and commercialize Oravax’s COVID-19 vaccine candidate in Mexico. Based there, Genomma is a pharmaceutical and personal care products firm.

“We believe that there remains ample room for additional vaccine approaches, particularly those that offer both convenience and safety advantages as well as coverage of emergent variant strains, as could be achieved with Oravax,” Selvaraju commented. “The total COVID-19 vaccine market could approach $100 billion in 2022, in our view.”

As for Oramed’s flagship product, an oral insulin capsule, ORMD-0801, the biopharma “continues to achieve key milestones,” Selvaraju reported.

Specifically, the company has enrolled and randomized more than three-quarters of the 675 patients to be included in its most advanced trial, the Phase 3 ORA-D-013-1. The study will continue evaluating ORMD-0801 in type 2 diabetes.

The ORMD-0801 trial consists of two components. One, ORA-D-013-1, taking place at 75 U.S. locations, will test the insulin product in patients who are taking two or three oral glucose-lowering agents.

The second component, ORA-013-2, will test ORMD-0801 in 450 patients, in the U.S., Europe and Israel, who have subpar glycemic control and are either are on a modified diet but no medication or are on Metformin as sole treatment.

As far as a timeline to market for ORMD-0801, Selvaraju outlined that commercial launch could occur in the U.S. and Europe in 2024. Leading up to that, completion of enrollment and data readout should occur for both Phase 3 studies next year. Oramed could apply for a biologics license application for the insulin product in 2023, and the U.S. Food and Drug Administration could approve it in 2024.

Also, Selvaraju noted, H.C. Wainwright expects Oramed to partner on commercialization of ORMD-0801 outside of China.

“Revenue to Oramed derived from sales of ORMD-0801 could thus drive meaningful upside to our forecasts,” he added.

Disclosures:
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 decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Important Disclaimers for H.C. Wainwright & Co., Oramed Pharma. Inc., Nov. 29, 2021 
This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules.
H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with  owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon.
Price objectives are subject to external factors including industry events and market volatility.

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.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

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.
A research analyst of the firm and/or the research analyst’s household has a financial interest in and own the securities of BioNTech SE (including, without limitation, any option, right, warrant, future, long or short position).
As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioNTech SE.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Oramed Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Oramed Pharmaceuticals, Inc.. Affiliates of H.C. Wainwright beneficially own 1% or more of the common equity securities of Oravax Medical Inc., a joint-venture that is majority-owned by Oramed Pharmaceuticals Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Oramed Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from BioNTech SE 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 or its affiliates did receive compensation from Oramed 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 Oramed Pharmaceuticals, Inc. during the past 12 months.
The Firm does not make a market in Oramed Pharmaceuticals, Inc. and BioNTech SE as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.
H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in 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.
The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.
Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

RNA Silencing Platform Firm Receives US$3.3 Billion Buyout Offer From Novo Nordisk

Source: Streetwise Reports   11/18/2021

Shares of Dicerna Pharmaceuticals Inc. traded 78% higher after the company reported it entered into a definitive agreement to be acquired by Novo Nordisk A/S of Denmark for $38.25 per share in cash.

pill

Prior to the open of U.S. markets today, biopharmaceutical company, Dicerna Pharmaceuticals Inc. (NASDAQ:DRNA), which utilizes RNA interference (RNAi) to create medicines that silence or turn off the genes that cause or contribute to diseases, announced that it entered into a definitive agreement to be acquired by Novo Nordisk (NVO:NYSE) for $38.25 per share in cash.

The company stated that the price represents a total equity value of US$3.3 billion and is 80% higher than the closing price of Dicerna’s shares on Wednesday, November 17, 2021. The report indicated that the Boards of Directors at both companies have already approved the transaction.

The company noted that the two firms formed a research collaboration in 2019 in order to discover and develop RNAi therapies employing Dicerna’s GalXC™ RNAi platform technology. The company claimed that “its RNAi technology platform enables access to intracellular disease targets across hepatic and extrahepatic cell and tissue types, complementing Novo Nordisk’s existing technology platforms.”

The report mentioned that since the partnership was established, “the collaboration between Novo Nordisk and Dicerna encompassed the exploration of more than 30 liver cell targets with the potential to deliver multiple clinical candidates for disorders including chronic liver disease, non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases.”

Based upon the results obtained from the joint development work performed, Novo Nordisk is now planning to proceed with clinical studies in 2022 for the first investigational RNAi therapeutic developed as a result of collaboration.

Novo Nordisk’s EVP and Chief Scientific Officer Marcus Schindler stated, “The acquisition of Dicerna accelerates Novo Nordisk’s research within RNAi and expands the usage of the RNAi technology…We build on our successful collaboration and by combining Dicerna’s state-of-the-art RNAi drug engine and intracellular delivery with our deep capabilities in disease biology understanding and tissue targeting through peptides and proteins we have the potential to expand our pipeline and deliver life-changing precision medicines for people living with chronic diseases such as diabetes, obesity, cardiovascular disease and NASH, as well as rare diseases like endocrine disorders and bleeding disorders.”

Dicerna Pharmaceuticals’ Founder, President and CEO Douglas Fambrough, Ph.D., commented, “Since the start of our collaboration two years ago, the Dicerna and Novo Nordisk teams have established a strong rapport built on a foundation of mutual respect for one another’s capabilities, culture and expertise…The combination of Dicerna’s expertise in RNAi and oligonucleotide therapeutics and highly skilled employees with Novo Nordisk’s industry leadership in developing and commercializing medicines to treat serious chronic diseases, has the potential to significantly accelerate and expand our mission to deliver GalXC RNAi therapies for the benefit of patients and all our stakeholders.”

The transaction is expected to close in Q4/21, subject to approval by Dicerna’s shareholders, ordinary closing conditions and regulatory approval and waiting periods provided under the Hart-Scott-Rodino Antitrust Improvements Act.

Dicerna Pharmaceuticals is a biopharmaceutical firm based in Lexington, Mass. that aims to create, develop and commercialize medicines that that use ribonucleic acid interference (RNAi) to selectively inhibit genes that cause various diseases. The firm utilizes its proprietary GalXC™ and GalXC-Plus™ RNAi technologies to create RNAi-based therapies that work to silence disease-causing genes to address both common and rare diseases.

The company’s initial focus has been centered around disease-causing genes in the liver but noted that its technology presents opportunities for treating tissues and cell types outside the liver and to treat other diseases across multiple therapeutic areas. Dicerna listed that in addition to its work with Novo Nordisk A/S, Roche, it has entered into collaborative partnerships with several other leading firms including Eli Lilly and Co. (LLY:NYSE), Alexion Pharmaceuticals Inc. and others.

The firm advised that RNAi offers some unique advantages compared to other disease inhibitor technologies such as small-molecule pharmaceuticals or monoclonal antibodies. These approached are designed to target proteins after they have already been produced and released, whereas “RNAi silences the genes themselves via the specific destruction of the messenger RNA (mRNA) made from the gene.”

Novo Nordisk is a large global healthcare company headquartered in Bagsvaerd, Denmark. The firm is focused on developing treatments for several diseases and chronic conditions including diabetes, obesity and rare blood and endocrine disorders. The company’s ADR shares trade on the NYSE in the U.S. under the symbol “NVO”. The company has a market cap of $198.5 billion and employs around 47,000 in 80 countries.

Dicerna Pharmaceuticals started off the day with a market cap of around $1.7 billion with approximately 77.9 million shares outstanding and a short interest of about 5.5%. DRNA shares opened 78% higher today at $37.95 (+$16.67, +78.34%) over yesterday’s $21.28 closing price. The stock has traded today between $37.90 and $38.14 per share and is currently trading at $38.05 (+$16.77, +78.81%).

 

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

Advanced Medical Genetics Co. Notches 66% YoY Increase in Q3 Revenue

Source: Streetwise Reports   11/12/2021

Invitae Corp. reported Q3/21 financial results that highlighted an 89% YoY increase in billable volume to 296,000 tests. Ladenburg Thalmann & Co. Inc. stated in a research note that it has a “Buy” rating for the company with a $55.00/share price target.

In a November 9 research note, Healthcare & Medical Technologies
Analyst Jeffrey S. Cohen of Ladenburg Thalmann & Co. Inc. stated
that advanced medical genetics company Invitae Corp. (NVTA:NYSE) announced Q3/21 financial results on November 8, 2021.

Invitae reported that in Q3/21 revenue totaled $114.4 million, which represents a 66% increase over Q3/20. The firm indicated that this included $111.7 million from test revenue and $2.7 million in other revenue.

The company also supplied a breakdown of revenue by product type and listed that in Q3/21, Data and Platform contributed $10.0 million, Rare Disease accounted for $15.0 million, Women’s Health brought in $21.0 million and Oncology generated $69.0 million.

The firm listed in the news release that billable volume in Q3/21 increased by 89% year-over-year to 296,000.

According to Invitae, Q3 operations often experience seasonality issues, which were exacerbated this year due to COVID-19 disruptions. The reported that in Q3/21, average selling price (ASP) decreased to $377, versus $388 during Q2/21. The firm noted that the $11 decrease in ASP was primarily due to changes in the product mix, most notably greater testing in women’s health and international sales. The company added that the average cost per test was $249.

The firm mentioned that R&D expenses in Q3/21 rose 46% y-o-y to $75 million due to costs associated with acquisitions, staffing and program collaborations. The company advised that its non-GAAP gross margin in the latest quarter was 36% and said that this will be a key area of focus going forward as the company expands.

During Q3/21, Invitae posted a net loss of $198.2 million, or a net loss per share of $0.91 and stated that at the end of Q3/21 it held $1.3 billion in cash on its balance sheet.

Ladenburg Thalmann advised that Invitae lowered the ranges for its FY/21 revenue estimates to $450-475 million, from previous guidance of $475-$500 million. The analyst noted that revised estimates represent annual y-o-y revenue growth of 60-70%. Ladenburg Thalmann stated that its forecasts call for Q4/21 revenue of $131.6 million and FY/21 revenue of $465.9 million.

The analyst discussed some of the specific business updates and clinical developments at the company and stated that the data the firm presented at a recent international conference “demonstrated that genetic findings informed clinical management changes, such as alterations to antiseizure medication, led to improved seizure control in epilepsy patients as reported by nearly 50% of the patients and 75% of patients had a change in clinical management within three months of receiving test results.”

The report noted that Professor Charles Swanton of UCL and the Francis Crick Institute presented new data from the TRACERx lung cancer research collaboration to the International Society of Liquid Biopsy Congress. Prior data demonstrated that “monitoring of cancer circulating tumor DNA based minimal residual disease detected relapse of non-small cell lung cancer nearly three years earlier than traditional imaging surveillance.” The analyst commented that “the new data presented further validates the importance and overall value of liquid biopsy as a minimally invasive mechanism of detecting disease.”

The research firm stated that it believes Invitae Corp. should be valued based upon multiples of future revenue similar to the way other firms in the biotech and medical technology sectors are valued. As a result, Ladenburg Thalmann advised that it has adjusted the company’s valuation metrics to be more in-line with its peers. The firm said that utilizing a multiple of 11.5x FY/24 revenue and applying a discount rate of 11%, it arrived at a value of $55.00/share for the company. While the price target is $3.00/share lower than its prior estimate of $58.00, it is still significantly higher than current stock price.

Ladenburg Thalmann & Co. has a “Buy” rating and $55.00 per share price target for Invitae Corp. The company’s shares trade on the New York Stock Exchange under the ticker symbol “NVTA” and last closed for trading at $21.86/share on Wednesday, November 10, 2021.

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

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

Disclosures for Ladenburg Thalmann & Co., Invitae Corp., Nov. 8, 2021.

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.

RISKS: These risk factors (competition, regulatory, reimbursement, litigation, product liability, healthcare reform, international expansion and privacy regulations) do not constitute all the potential risks of investing in the subject company’s shares. Investors should refer to the company’s SEC filings including the most recent forms 10-K and 10-Q for further details on the risks associated with an investment in the subject company’s shares.

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Contakt World Technologies Partnership Will Help Satisfy Demand for Vaccine Passport Technology

Source: Streetwise Reports   11/12/2021

Contakt World plans to build a diversified health technology SaaS platform and address inequity of health access through technology.

Contakt passport covid covid19 covid-19

Inequity in healthcare access came into sharp focus during the
pandemic, as did the need for contact tracing technology.
Contakt World Technologies Corp. (HELP:CSE; TLOOF:OTC) was founded to deliver solutions that target marginalized communities and try to level the playing field, according to the company. Contakt World’s latest move provides access to vaccine passport technology through a partnership with Portum announced October 14.

“We anticipate launching a new version of the HealthCheck app in December of this year, adding the vaccine passport and testing tracking features. We have been experiencing a significant demand for these features as business race to meet the federal  vaccine mandate from the U.S. government.”

With COVID and the widespread Delta variant, symptom screening, vaccine passports, vaccine validation, vaccine wallets, vaccine credentials, and other methods to improve population safety and reduce liability to restoring everyday business, travel, and social life are needed more than ever by employers and institutions.

Portum’s vaccine passports and wallets provide a secure proof of vaccination for monitoring guests’ access to events or venues. Contakt World will offer the Portum platform to commercial and government customers to meet and monitor vaccine mandates in public and private settings, exposure notification, symptom checker, secure vaccine wallet, and distancing notifications.

The revenue-sharing partnership with Portum will leverage Portum’s technology across Contakt World’s private and public sector clients.

Contakt World was formed in 2020 as a contact tracing company with health equity in mind, explains interim CEO Zayn Kalyan. At first, people could access the decentralized early exposure notification App pioneered by Google and Apple called GAEN that would only run in the latest digital devices, excluding a wide swath of underserved communities. The company believes that “technology has the ability to address inequity with solutions that can be deployed and used by people in marginalized communities who do not have the latest devices,” he says.

“When we acquired HealthCheck we were concerned about how sustainable the business might be. I was pleasantly surprised in the growth,” recognizing it is now clear that COVID will have a lasting effect on the health technology needs surfaced during the pandemic.

Smart Health RM, a relationship management software built from the ground-up  with public health in mind, was Contakt’s first SaaS software application. Initiated to aid public health agencies with tracking and containing the spread of COVID, Smart Health has a particular focus on contact tracing and community engagement communication channels leveraging AI technology (smart text surveys).

The long lead-time selling into the public sector led the company in the direction of private organizations that rely of technology to protect its workforce, targeting companies with as many as 10,000 employees with its newer health technologies. “Public health agencies have a very long sales cycle and we have realized our efforts should be on private enterprises, such as private real estate companies, private schools, event venues with a large on-site staff and daily visitors,” Kalyan says.

Contakt World acquired its second platform, HealthCheck, in August, a symptom management tool that helps HR departments and healthcare professionals monitor the well-being of those who report to work or school each day. Organizations can screen, approve, and protect visitors, as well as customers, employees, or students using the Health Check platform. Over 100,000 people across 1,000 client organizations currently use the platform.

HealthCheck’s positive cash flow, existing client base, and the market demand for symptom management made the company an attractive target to “not only grow the HealthCheck business but to expand its offering to further meet the needs of its existing and new customers,” explains Kalyan.

“We anticipate launching a new version of the HealthCheck app in December of this year, adding the vaccine passport and testing tracking features. We have been experiencing a significant demand for these features as business race to meet the federal  vaccine mandate from the U.S. government for employers with 100 or more employees.”

The one-year-old company went public in July 2021. VC firm Altus Capital is one of the founding investors and Kalyan is an Altus partner serving as CEO on an interim basis. He said the company is currently planning the Portum rollout to Contakt World customers.

“When we acquired HealthCheck we were concerned about how sustainable the business might be. I was pleasantly surprised in the growth,” recognizing it is now clear that COVID will have a lasting effect on the health technology needs surfaced during the pandemic. “We want to build a more diversified health care platform,” he says.

Contakt World is looking at a number of strategic acquisitions in the coming months, setting its sights on a durable model that extends well beyond COVID. “The goal is to build a diversified group of healthcare and health tech businesses and use the platform to cross-sell the different offerings.” Areas of interest beyond COVID include long-term care, chronic care delivery, digital pharmacy, and telehealth, he said. He said the company intends to build it into a comprehensive health tech platform.

“We have existing clients and wanted to be able to offer a greater suite of services to them,” Kalyan states. Portum is known for delivering vaccine passports for events, such as concerts, sports competitions, and other events. Vaccine passports for events is their core. Contakt World wants to deliver Portum technology to its existing customers, who are looking for digital resources that keep their visitors and employees safe.

Symptom screening, vaccine passports, vaccine validation, vaccine wallets, vaccine credentials and other methods are employed to improve population safety and reduce liability. In light of COVID-19 and its Delta variant, the technology is becoming key to everyday business, travel, and social life.

In the Portum partnership, “we own the customer; they deliver the solution via a SaaS subscription model,” which Kalyan calls affordable. For example, a private school with 200–300 people may pay $4,000–$5,000 a year.

The pace is quickening for vaccine passport technology. Many large employers and state agencies may build their own, and there are other players in the space, such as Clear, the travel services company. “It’s a massive marketplace and that’s where we see the opportunity to build on our own client base and scale out from there,” Kaylan concludes.

Disclosure:
1) Gerri Leder compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor/employee. He/she or members of his/her household own securities of the following companies mentioned in the article: None. He/she or members of his/her household are paid by the following companies mentioned in this article: None. His/her company has a financial relationship with the following companies referred to 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 Contakt World Technologies Corp. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) 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.

4) 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 decision to publish an article until three business days after the publication of the 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 Contakt World Technologies Corp., a company mentioned in this article.

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

 

Trial of Psilocybin Therapeutic in Treatment Resistant Depression Yields Positive Topline Results

Source: Streetwise Reports   11/14/2021

“We believe this data begins to form the basis of an approvable program for Compass Pathways’ COMP360” in this indication, noted a BTIG report.

Topline results were positive from Compass Pathways Plc’s (CMPS:NASDAQ) Phase 2b clinical trial of its novel version of psilocybin, COMP360, in treatment resistant depression, and these data are “important for the company and for the psychedelic field,” BTIG analyst Bert Hazlett wrote in a Nov. 9 research note.

Hazlett reviewed the basics of the 233-patient study. It tested 25 milligrams (25 mg) and 10mg of COMP360 against an ineffective 1 mg COMP360 dose, administered once. After, patients were monitored for 12 weeks. The study’s primary endpoint was a reduction in patients’ total Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline, at week three.

Hazlett presented the key findings from three data sets, efficacy, sustained response and remission, all of which showed 25 mg of COMP360 produced results. He wrote that these all of these data will be important for the acceptance of COMP360, and they should help inform Phase 3 work.

In terms of efficacy, the analyst relayed, primary endpoint data showed the 25 mg dose to have a statistically significant result of minus 6.6 points (p<0.001) when compared to results of patients given 1 mg. Also, 25 mg showed a rapid and durable response from day two through week six as well as evidence of antidepressant activity to week 12.

Sustained responder results revealed that more patients in the 25 mg dose cohort than in the 1 mg cohort achieved this state, 24.1% versus 10.1%, respectively. Sustained responders met MADRS response criteria at weeks three and 12, met it at least once in weeks six or nine and did not start new depression treatments.

MADRS responders were patients who experienced a greater than 50% decrease in their total MADRS score. At week three, 36.7% of the 25 mg dose recipients fell into that category and at week 12, 32.9% did. In comparison, MADRS responders among the 1 mg dose recipients at the same time points were 17.7% and 16.5%, respectively.

The final set of results pertained to remission, or having a MADRS score of less than 10 at weeks three and 12. Of the 25 mg cohort, 29.1% and 26.6% showed remission at week three and week 12 respectively, compared to 7.6% and 11.4% of the 1 mg cohort

Regarding the safety of COMP360, patients in the 10 mg cohort experienced the most serious treatment-emergent adverse events (8% of them), followed by the 25 mg patients (6.3%) and lastly, the 1 mg patients (1.3%). When it came to suicidal behavior one month out from dosing, all of the patients who experienced it were in the 25 mg group (3.8% of them).

In other news, Hazlett reported, Compass Pathways reported results of another study of COMP360, this one evaluating 25 mg in 30 cancer patients with depression. Two to four of the patients received both psilocybin and one-on-one therapy. On average, patients’ MADRS score dropped 19.1 points from baseline, 24 patients were sustained responders and 15 achieved remission.

BTIG has a Buy rating and a $63 per share target price on Compass Pathways, the current share price of which is about $43.06.

Disclosures:
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 decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for BTIG, Compass Pathways, Nov. 9, 2021

Analyst Certification
I, Robert “Bert” Hazlett, 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.

BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: COMPASS Pathways plc (CMPS)
BTIG LLC had an investment banking services client relationship during the past 12 months with: COMPASS Pathways plc (CMPS)
BTIG LLC managed or co-managed a public offering of securities in the past 12 months for: COMPASS Pathways plc (CMPS)
BTIG LLC has received compensation for investment banking services in the past 12 months from: COMPASS Pathways plc (CMPS)

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.

Facts, views or opinions presented in this report have not been reviewed by, and may not reflect information known to, employees or other professionals in the “BTIG Group” (BTIG Group includes, but is not limited to, BTIG and its parents, subsidiaries and/ or affiliates). BTIG Group employees, including Sales Representatives and Traders, may provide oral or written commentary or advice that may be inconsistent with the opinions and/or views expressed in this research report. BTIG Group employees and/or its affiliates not involved in the preparation of this research report may have investments in securities or derivatives of securities of companies mentioned in this report that are inconsistent with the views discussed in this report.

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Robotic Surgical Systems Co.’s Shares Gain 21% on Q3 Earnings and Forward Revenue Outlook

Source: Streetwise Reports   11/11/2021

Stereotaxis Inc. shares traded higher after the company reported Q3/21 financial results and confirmed its FY/21 revenue guidance. The company added that it is sufficiently funded and is on pace towards doubling its system revenue in FY/22.

Robotic surgical technologies firm Stereotaxis Inc. (STXS:NYSE.American), which designs innovative robotic devices
and technologies used in the treatment of cardiac arrhythmia, today announced financial results for the third quarter of 2021 ended September 30, 2021.

The company’s Chairman and CEO David Fischel led off the report by commenting, “We are proud of the progress made on multiple fronts in the third quarter…We continue to demonstrate year-over-year and sequential revenue growth while improving commercial execution, establishing key strategic collaborations, advancing a wave of upcoming innovations, and enhancing our infrastructure and team.”

Fischel continued, “Renewed global adoption of robotic systems drove revenue growth in the quarter. We received orders for two Genesis systems in the U.S. and Europe since our last call. Progress on multiple other capital opportunities supports our confidence in additional near-term orders and an approximate doubling of robotic system revenue next year.”

The company advised that it is gaining traction in China due to its strategic collaboration with MicroPort EP, which provides commercial infrastructure and a robust product ecosystem that offers potential for long-term value creation.

“Our proprietary robotically-navigated magnetic ablation catheter overcame initial supply chain disruptions and we remain on track for completion of the required testing needed for a European regulatory submission and U.S. pivotal trial early next year,” Fischel added.

The company reported that revenue in Q3/21 rose by 5% to $9.1 million, compared to $8.7 million in Q3/20. The firm said that this included $3.5 million in system revenue and $5.3 million in recurring revenue, versus $3.0 million and $5.5 million respectively in Q3/20.

Stereotaxis indicated that Gross margin on a combined basis was 52% in Q3/21. Gross margin for systems revenue was 5%, while recurring revenue gross margin came in much higher at 86%.

The firm noted that adjusted operating expenses in Q3/21 increased to $6.8 million, compared to $5.5 million during Q3/20. The company stated that the increase was primarily due to higher R&D spending, measured investment and additional hiring in key areas.

The company posted an operating loss of $4.6 million and a net loss of $1.6 million in Q3/21. The firm stated that excluding non-cash stock compensation expenses, it posted an adjusted operating loss and adjusted net loss in the latest quarter of $2.0 million, compared to an adjusted operating loss and adjusted net loss of $0.8 million during the same period in the prior year.

The firm advised that it held cash and cash equivalents in the amount of $42.8 million on its balance sheet as of September 30, 2021.

The company offered some forward guidance and stated that it is maintaining it FY/21 estimates for around $11 million in system revenue for 2021, which it expects will double from that level in FY/22. The firm added that its strong cash position will allow it to achieve profitability without any additional financing.

Stereotaxis is based in St. Louis, Mo. and is a developer of surgical robotic technologies. The firm’s products are designed and engineered for purposes of enhancing arrhythmia treatment and perform endovascular procedures.

The company’s instruments, robotic systems and information solutions are created for use in interventional medicine. Stereotaxis devices and tools provide physicians conducting procedures with robotic precision equipment that is safe, productive and efficient. The company advised that its Robotic Magnetic Navigation technology is presently being used in the U.S., Asia and Europe.

Stereotaxis started the day with a market cap of around $414.3 million with approximately 74.5 million shares outstanding and a short interest of about 1.2%. STXS shares opened 2.5% higher today at $5.70 (+$0.14, +2.52%) over yesterday’s $5.56 closing price. The stock traded today between $5.56 and $6.87 per share and closed at $6.74 (+$1.18, +21.22%).

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

EyePoint Pharma Reduces Wet AMD Treatment Burden by 79% after 6 Mo.’s in Phase 1 Trial

Source: Streetwise Reports   11/15/2021

Shares of EyePoint Pharmaceuticals Inc. reached a new 52-week intraday high after the company reported positive data from its Phase 1 DAVIO study of EYP-1901 in Wet AMD and announced plans to move forward to additional Phase 2 clinical trials in 2022.

Commercial-stage pharmaceutical company EyePoint Pharmaceuticals Inc. (EYPT:NASDAQ), which is engaged in developing and commercial-
izing therapeutics for serious eye disorders, announced “six-month interim data from the Phase 1 Durasert® and Vorolanib in Ophthal-
mology (DAVIO) clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting wet age-related macular degeneration (wet AMD).”

The company advised that the data was presented during the American Academy of Ophthalmology’s Annual Meeting on the Retina Subspecialty Day held in New Orleans on Saturday, November 13, 2021. The presentation was delivered by David S. Boyer, M.D., Sr. Partner at Retina-Vitreous Associates Medical Group and adjunct clinical professor of Ophthalmology with the USC/Keck School of Medicine.

EyePoint Pharmaceuticals stated that after six months of treatment with EYP-1901 in the study, there were no dose limiting toxicities or any ocular or drug-related serious adverse events recorded. The company highlighted that in the trial, “76% and 53% of patients were rescue-free up to four and six months, respectively, following a single injection of EYP-1901.”

The company’s CEO Nancy Lurker stated, “We are very encouraged by these data that reinforce EYP-1901’s positive safety profile and its durable anti-VEGF activity up to six months so far in the majority of enrolled patients after a single intravitreal injection…Wet AMD is a leading cause of blindness, and these data bring us one step closer to potentially changing the standard of care for patients by offering an in-office sustained delivery treatment option with the potential for up to every six-month dosing.”

The company described EYP-1901 as “a sustained delivery anti-VEGF (voralanib) investigational treatment that utilizes a bioerodible formulation of its Durasert® drug delivery technology.” The firm noted that Durasert® has already been approved for use in four other products by the U.S. Food and Drug Administration (FDA) including its YUTIQ® for treating chronic non-infectious uveitis which affects the posterior segment of the eye.

The Phase 1 DAVIO clinical study of EYP-1901 enrolled a total of 17 patients who had previously undergone treatment for wet AMD. There were no adverse effects experienced in the study, nor were there reports of any other adverse results such as endophthalmitis, implant migration in the anterior chamber, posterior segment inflammation, vitreous floaters, retinal detachments or retinal vasculitis.

EyePoint Scientific Advisory Board Member and DAVIO Clinical Investigator David S. Boyer, M.D., commented, “We are very encouraged by today’s data results, which demonstrated the safety and sustained anti-VEGF activity of EYP-1901 in wet AMD patients…Seeing treatment improvements for these patients is very promising, and we look forward to starting the next phase of this development program next year.”

EyePoint Pharma’ COO Jay S. Duker, M.D., remarked, “Our clinical trial includes patients with previously treated wet AMD, who received frequent anti-VEGF injections prior to entering DAVIO. We were thrilled to see how well tolerated the EYP-1901 inserts appear to be and how well patients responded to EYP-1901 for both vision and anatomical endpoints over the six-month interim report of this 12-month study. These results are not only promising as we plan to move EYP-1901 into Phase 2 in wet AMD, but also for the potential to change the treatment paradigm for many wet AMD patients…We are encouraged by responses to date and will continue to monitor the progress of these patients as they complete the second half of this trial.”

The firm indicated that it intends to launch a Phase 2 wet AMD clinical trial during 2022 and has lined up a Type C meeting at the beginning of December with the U.S. Food and Drug Administration (FDA) to present its plans and obtain guidance regarding potential EYP-1901 registration trials. The firm noted that it also plans to proceed with additional clinical studies for EYP-1901 clinical trials for treating diabetic retinopathy (DR) and retinal vein occlusion.

According to the company, the two basic types of age-related macular degeneration, “dry” (atrophic) and “wet” (exudative), combined impact up to 11 million people in the U.S. The firm noted that approximately 15% of those individuals are afflicted with wet AMD, which can often lead to blindness. Currently, the standard approach to wet AMD treatment is administering intravitreal injections monthly or bi-monthly which presents ongoing challenges for both patients and doctors.

EyePoint is a pharmaceutical company headquartered in Watertown, Mass. that is focused on developing and commercializing medicines for treating serious eye disorders. The form has developed proprietary intraocular drug delivery technology which it calls Durasert® that it is using in its drug pipeline candidate, EYP-1901, as a potential semi-annual intravitreal anti-VEGF treatment designed to address wet AMD. The firm’s FDA approved products include YUTIQ®, for chronic non-infectious uveitis and DEXYCU® for treatment postoperative inflammation after ocular surgery.

EyePoint Pharmaceuticals began the day with a market cap of around $403.1 million with approximately 28.77 million shares outstanding and a short interest of about 5.3%. EYPT shares opened 37% higher today at $19.25 (+$5.24, +37.40%) over Friday’s $14.01 closing price and reached a new 52-week high price this morning of $21.50. The stock has traded today between $14.10 and $21.50 per share and closed at $14.30 (+$0.29, +2.07%).

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

Microbiome Therapeutics Co.’s Shares Rise on Q3 Earnings & Partnership With Swiss Manufacturing Firm

Source: Streetwise Reports   11/10/2021

Shares of Seres Therapeutics Inc. traded 20% higher after the company reported Q3/21 financial results and announced it is partnering with Bacthera in Switzerland to manufacture medicine for use in c.Diff treatment.

c diff

Microbiome therapeutics company Seres Therapeutics Inc. (MCRB:NASDAQ) Seres Therapeutics Inc. (MCRB:NASDAQ), which is focused on development a consortia of novel multifunctional bacteria that interact with host cells and tissues to treat disease, today announced financial results for the third quarter of 2021 ended September 30, 2021. In addition, the company provided detailed
updates regarding its business operations and clinical pipeline.

Seres Therapeutics’ CEO Eric Shaff led off the report by commenting, “We have made considerable progress across our organization, highlighted by the achievement of target enrollment in our investigational SER-109 recurrent C. difficile infection (rCDI) open-label study, and continued preparations for a BLA filing with the U.S. Food and Drug Administration (FDA). Along with our commercialization collaborator Nestlé Health Science and its Aimmune business, our organization continues to prepare for a successful launch of SER-109.”

“Recently, we entered into a collaboration with Bacthera A.G., a global leader in biopharmaceutical product manufacturing, that expands our existing capabilities for commercial product supply. We intend to offer, pending approval, the first approved microbiome therapy to individuals living with rCDI, a patient group in urgent need of safe and effective new treatment options,” CEO Shaff added.

The company indicated that for Q3/21 it posted total revenue of $126.7 million, compared to $1.4 million in Q3/20. The firm reported that it earned net income of $68.2 million in Q3/21, versus a net loss of $30.3 million during Q3/20.

Seres advised that the increase in net income was primarily attributed to its revenues recognized from its co-commercialization license agreement with Nestlé Health Science.

The company stated that it increased its research and development expenses in Q3/21 to $39.9 million, up from $23.9 million in Q3/20. The firm said this was due to expenses related to its late-stage SER-109 clinical development program and associated manufacturing costs along with additional personnel expenses.

The firm advised that it had about $353.2 million in cash and other liquid securities on its balance sheet as of September 30, 2021.

The company stated that in the Phase 3 ECOSPOR III study of SER-109 in treatment of recurrent C. difficile infection (rCDI), SER-109 successfully met its primary endpoint identified as “superiority to placebo in reducing C. difficile infection recurrence at week 8 in patients with rCDI.”

The firm explained that SER-109 is an investigational oral, live microbiome therapeutic that is engineered to prevent recurrences of CDI in patients by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The company advise that “the FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI.”

The company stated that it believes that the Phase 3 ECOSPOR III trial’s efficacy results should support a BLA filing as a single pivotal study and therefor the company plans to meet with the FDA to begin a rolling submission of the BLA for SER-109 in H1/22.

The company stated that there are about 170,000 rCDI cases reported each year in the U.S. which results in an average of around $34,000 in annual direct healthcare expenses per case. The explained that “CDI causes severe diarrhea and colitis, an inflammation of the colon and has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC).”

The company listed that it entered into agreement with Nestlé Health Science in July 2021, and is partnering with its Aimmune division, to commercialize SER-109 in the U.S. and Canada. The agreement included an upfront license payment of $175 million to Seres and provides for another $125 million if approved by the FDA and in Canada. There are also various sales milestones that if realized could total up to $225 million.

The firm added that it is also preparing to initiate a Phase 1b clinical study of SER-155. The company identified SER-155 as “an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).”

In a separate news release today, the company together with Bacthera, a specialized contract development and manufacturing organization (CDMO), announced “a collaboration to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI).”

For its part, Bacthera will be establishing “a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of LBPs located on Lonza’s Ibex® campus in Visp, Switzerland.”

Bacthera’s CEO Lukas Schüpbach remarked, “Bacthera’s ambition is to enable our customers such as Seres Therapeutics to bring life-changing treatments to patients by pioneering the Live Biotherapeutic Product industry. With this significant agreement, we are one step closer to making that happen, and we are proud to be part of bringing an entirely new class of medicines to people who have a profound need for it. With our new Microbiome Center of Excellence in Visp, we are looking forward to supporting the manufacturing of potentially life-saving microbiome-based treatments, such as SER-109.”

Seres Therapeutics is microbiome therapeutics platform company based in Cambridge, Mass. The firm focuses on developing novel multifunctional bacterial consortia that interact with host cells and tissues for the purpose of treating diseases. Seres claimed that “its SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate.” In addition to its SER-109 program for treatment of recurrent C. difficile infection, the company is also evaluating its SER-301 in a Phase 1b ulcerative colitis study and its SER-155 in a Phase 1b trial designed to address gastrointestinal infections, bacteremia and graft-versus-host disease.

Seres Therapeutics began the day with a market cap of around $630.1 million with approximately 91.7 million shares outstanding and a short interest of about 9.5%. MCRB shares opened nearly 7% higher today at $7.34 (+$0.47, +6.84%) over yesterday’s $6.87 closing price. The stock has traded today between $7.34 and $9.2236 per share and closed for trading at $8.27 (+$1.40, +20.38%).

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

US DEA OKs Use of Psychedelics by This Mental Health Network

Source: Streetwise Reports   11/09/2021

Clinics that deliver novel psychiatric treatment and host clinical trials of psychedelic medicine have positioned Novamind for breakthroughs in mental health treatment.

mental health

News Flash, Nov. 10: Novamind announced today that it has been green-lighted to directly bill four major insurance providers for IV ketamine treatments. The approval represents a major advance for psychotherapy and long-term outcomes for patients who experience treatment-resistant depression. Read more here.

Since 2016, the company has provided ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry Clinics. It also operates Cedar Clinical Research, a contract research organization specializing in clinical trials and evidence-based research for psychedelic medicine.

“As an investor, I don’t often get involved at the board level, but this is a company worth that effort.”

— Jesse Kaplan, Novamind Director

Just last month, the U.S. Drug Enforcement Administration (DEA) granted Novamind Schedule 1 licenses for psilocybin, a naturally occurring psychedelic compound produced by fungi.
While there are thousands of sites for clinical research trials in oncology, respiratory, and other disorders, Novamind’s CEO, Yaron Conforti, told Streetwise Reports “there are currently few clinical research sites focused on psychedelic medicine, and only a select group with the DEA licensing and expertise that are required to host clinical trials using psilocybin.
Novamind’s chief medical officer, Reid Robison, MD, added, “This milestone reflects our expertise and enables us to continue on our mission to create breakthroughs in mental health treatment.”
The company anticipates announcing its first clinical research trial for psilocybin-assisted psychotherapy in 2022 according to Conforti.
That trial will be launched at Novamind’s third clinical research site, in Murray, Utah, which opened in September 2021. The Murray clinic is also the company’s sixth integrative psychiatry clinic. Two more clinics are slated to open between this year and early 2022, in Salt Lake City and Park City, Utah. This will increase the company’s clinic footprint to eight. The Park City clinic, designed to offer a “retreat-like setting,” will also facilitate increased capacity for the company’s group therapy services.
“Bringing cost-effective and innovative psychedelic therapies to market requires a large base of patients,” Conforti said. To that end, Novamind saw over 20,000 visits to its clinics in 2020, and Conforti expects continued growth at both its clinics and clinical research sites as the company expands  its footprint to other states in 2022.

“Psychedelic medicine generally has fewer side effects [standard anti-depression and anti-anxiety treatments] and acts more quickly.”

Paul Thielking, MD, Chief Scientific Officer, Novamind

The DEA licenses also support Novamind’s newest service offering: psychedelic palliative care, a first-of-its-kind program to support the mental health of patients and families struggling with serious illness. The palliative care program combines psychedelic medicine with psychotherapy, multiday immersive retreats, and group support for patients and families.
“Patients receiving palliative care have higher rates of depression than the general population. Unfortunately, standard anti-depression and anti-anxiety treatments do not work for everyone, can cause side effects, and can take up to eight weeks to work,” Paul Thielking, MD, Novamind’s chief scientific officer told Streetwise Reports.
In contrast, psychedelic medicine generally has fewer side effects and acts quickly, two advantages for patients who may have limited life expectancy.
Novamind’s latest investment underscores its “radically different” approach to mental health treatment: an investment of US$1 million in Alto Neuroscience, a clinical-stage biopharmaceutical company.

“Alto’s model for precision psychiatry has enormous potential to help remove the trial-and-error process associated with the diagnosis and treatment of mental health conditions.”

— Reid Robison, MD, Chief Medical Officer, Novamind

Alto is developing personalized and highly effective medicines to help patients get better, faster.
Its artificial-intelligence-enabled platform
measures biomarkers including electroencephalography, as well as wearable data monitors, behavioral patterns, genetics, and other real-world data, to match patients with the treatment they are most likely to respond to. Its pipeline includes 11 clinical-stage drug candidates.
“Alto’s model for precision psychiatry has enormous potential to help remove the trial-and-error process associated with the diagnosis and treatment of mental health conditions,” Dr. Robison noted.
Novamind’s combined business model of clinical research operations and integrative psychiatric clinics and its accelerated timeline appeal to Jesse Kaplan, a Novamind director and a cofounder and partner at Plaza Capital Ltd.
“As an investor, I want exposure to the growing psychedelic-assisted psychotherapy sector, but I want to reduce the risk that comes with drug development that may — or may not — pay off in 10 years. Alongside its longer-term research efforts, Novamind has a proven, scalable business model that already earns millions in revenue each quarter.”
Novamind’s combined business model of clinical research operations and integrative psychiatric clinics, as well as its accelerated timeline, have a unique appeal to Kaplan. “I don’t often get involved at the board level, but this is a company worth that effort.”
Kaplan and Conforti previously worked together on the startups Abacus Health Products (sold to Charlotte’s Web) and IM Cannabis. That history, Kaplan told Streetwise Reports, “gives us a level of trust in each other. We are comfortable disagreeing, having tough discussions to reach the right decisions.”
Novamind benefits from a resurgence of scientific and popular interest in psychedelics. Johns Hopkins Medicine recently received the first federal grant for psychedelic research in 50 years to explore the potential impact of psilocybin on tobacco addiction. Books like This Is Your Mind on Plants, by bestselling author Michael Pollan, have captured the public imagination.
Kaplan also suggested that “deregulation has made people more comfortable and curious about the medicinal properties of these substances. Marijuana was legalized, and the world didn’t fall apart. Indeed, it may have gotten better.”
As of September 24, 2021, Novamind shares became eligible for electronic clearing and settlement through the Depository Trust Company in the U.S., a move toward more liquidity for the stock.
With a $CA36.545 million market cap and no debt, the company has 42.8 million shares outstanding and 37% insider ownership. Revenue in Q3 2021 reached CA$1.85, a 43% rise over Q3 2020.
 
Disclosures:
1) Diane Fraser compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor/employee. He/she or members of his/her household own securities of the following companies mentioned in the article: None. He/she or members of his/her household are paid by the following companies mentioned in this article: None. His/her company has a financial relationship with the following companies referred to 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 Novamind Inc. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) 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.
4) 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 decision to publish an article until three business days after the publication of the 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 Novamind Inc., a company mentioned in this article.

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