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Heathcare and Biotech Updates

AIM ImmunoTech Achieves 200% Increase in Survival Results in Late-Stage Pancreatic Cancer Study

Source: Streetwise Reports   09/22/2020

AIM ImmunoTech shares traded 20% higher after the firm reported it attained statistically significant, two-fold higher, survival results in pancreatic cancer from research conducted at Erasmus University Medical Center in the Netherlands.

AIM ImmunoTech Inc. (AIM:NYSE American), which focuses on research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced “receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands.”

AIM ImmunoTech advised that “Prof. Casper van Eijck, M.D., Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.”

Prof. van Eijck remarked, “The overall survival of the experimental group was compared to a large historical control cohort matched for age, gender, stage of disease, and number of cycles of Folfirinox chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls…Based on these data, I see the potential for Ampligen as a meaningful extension of the standard of care for advanced pancreatic cancer, which we are planning to investigate further.”

The company’s CEO Thomas K. Equels commented, “These exceptional results from Erasmus exceed even our most optimistic expectations. I am deeply grateful to Prof. Casper van Eijck, his team at Erasmus, and Ronald Brus, MD, the guiding hand at myTomorrows, for their vision and careful diligence in implementing this important analysis of Ampligen as a single-agent therapy for late-stage pancreatic cancer…Medical advances in lethal unmet medical needs depend on this sort of outstanding clinical and governmental cooperation and support. We could not have accomplished this but for the support of the Netherlands.”

The firm stated that it plans to work closely with Amarex Clinical Research LLC, its Contract Research Organization, in order to seek U.S. Food and Drug Administration (FDA) “fast-track” and perhaps even FDA “breakthrough” designations. In addition, AIM ImmunoTech intends to obtain IND authorizations to conduct a Phase 2/3 pancreatic cancer trial in the Netherlands at Erasmus MC under the supervision of Prof. van Eijck and at major cancer research centers in the U.S. to follow-up on the recent positive study results.

The company added that it also has plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with both the FDA and the European Medicines Agency (EMA).

AIM ImmunoTech is an immuno-pharma company based in Ocala, Fla., that is focused on developing therapeutics to treat immune disorders, viral diseases including COVID-19, the disease caused by the SARS-CoV-2 virus and multiple types of cancers. The company’s product offerings include rintatolimod (Ampligenо or Rintamodо) and the FDA-approved drug Alferon N Injectionо. The firm believes that its pre-clinical research studies and clinical trials suggest that Ampligen may have broad-spectrum anti-viral and anti-cancer properties. The firm has previously conducted clinical trials of Ampligen in cancer patients in the areas of advanced recurrent ovarian cancer, colorectal cancer, malignant melanoma, renal cell carcinoma and triple negative metastatic breast cancer.

AIM ImmunoTech. began the day with a market capitalization of around $81.0 million with approximately 39.69 million shares outstanding and a short interest of about 6.9%. AIM shares opened nearly 16% higher today at $2.36 (+$0.32, +15.69%) over yesterday’s $2.04 closing price. The company’s shares have traded today between $2.26 and $2.74 per share and are presently trading at $2.45 (+$0.41, +20.10%).

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.

FDA Grants Ampio Pharma IND and Approves Phase 1 Trial for Inhaled Ampion in COVID-19 Patients

Source: Streetwise Reports   09/21/2020

Ampio Pharmaceuticals traded 15% higher reaching a new 52-week high after the company reported that the U.S. FDA granted an IND and approved the clinical trial protocol for inhaled Ampion for use in COVID-19 patients with respiratory distress.

Coronavirus

Ampio Pharmaceuticals Inc. (AMPE:NYSE.American), which is focused on the development novel therapies to treat common inflammatory conditions with limited existing treatment options, today announced “the receipt of an Investigational New Drug (IND) from the U.S. Food and Drug Administration (FDA), allowing the company to proceed with clinical trials for the use of AmpionTM as an inhalation therapy for respiratory distress due to COVID-19 infection.”

The firm advised that it will build upon the positive results it recently achieved in its Phase 1 trial of Ampion that was administered intravenously to COVID-19 patients. The company indicated that unlike the recent Phase 1 study, the current Phase 1 trial will be for inhaled Ampion. The study plans to enroll 40 patients in a multi-center, randomized trial to evaluate the safety and efficacy of inhaled Ampion. The company stated that inhaled Ampion will be added to the existing standard of care protocol for hospitalized COVID-19 infected patients experiencing respiratory distress.

Ampio Pharmaceuticals stated that “Ampion will be delivered by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs that can lead to respiratory failure. This approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection. Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome (ARDS).”

The firm stated that the FDA utilized safety and efficacy data supplied by Ampio from comprehensive preclinical laboratory studies to grant this IND for inhaled Ampion. The company noted that toxicology studies demonstrated that Ampion is safe for inhalation and it can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications.

The company asserted that the newly issued IND along with its other active INDs that permit introduction of Ampion both intravenously and via intraarticular injection builds upon the firm’s potential as a platform drug capable of treating multiple conditions characterized by inflammation.

The company explained inflammation is a biological response to stimuli that the body interprets as having a potentially harmful effect. The firm pointed out that “inflammatory disorders that result in a dysregulated immune response by attacking the body’s own cells or tissues may result in chronic pain, tissue damage and loss of function.” Inflammation occurs in numerous severe medical conditions including allergy, asthma, autoimmune disorders, inflammatory bowel disease, transplant rejection and many other diseases.

Ampio Pharmaceuticals is a development stage biopharmaceutical company headquartered in Englewood, Colo. The firm is presently concentrating its efforts on the development of Ampion to treat highly prevalent inflammatory conditions for which there are limited treatment options. The company stated that “its lead product candidate, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).”

Ampio Pharmaceuticals started the day with a market capitalization of around $166.2 million with approximately 176.5 million shares outstanding and a short interest of about 9%. AMPE shares opened nearly 36% higher today at $1.28 (+$0.3386, +35.97%) over Friday’s $0.9414 closing price and reached a new 52-week high price this morning of $1.39. The stock has traded today between $1.03 to $1.39 per share and is currently trading at $1.09 (+$0.1486, +15.79%).

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.

Sorrento Receives FDA Clearance to Proceed with Phase 1 COVID-19 Neutralizing Antibody Trial

Source: Streetwise Reports   09/17/2020

Sorrento Therapeutics shares traded more than 10% higher after the company reported it received FDA approval to proceed with its Phase 1 clinical trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in hospitalized COVID-19 patients.

Coronavirus

Sorrento Therapeutics Inc. (SRNE:NASDAQ) yesterday announced that it received a “study may proceed letter from the U.S. Food and Drug Administration (FDA) for its phase 1 clinical trial for COVI-GUARD™ (STI-1499) in hospitalized COVID-19 patients.”

Sorrento stated that the letter from the FDA advised that the company may proceed with patient enrollment in the Phase 1 COVI-GUARD clinical study. The firm noted that it expects enrollment to gear up quickly and that it projects that this trial will be followed by larger trials targeting a potential Emergency Use Authorization (EUA) submission as early as the end of December 2020. The company noted that in anticipation of a potential EUA, it has already initiated cGMP manufacturing to produce 50,000 doses for this purpose.

The firm stated that the STI-1499 clinical program is being designed for rapid adaptive expansion in both the U.S. and Brazil.

The company indicated that it previously announced that “in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.”

The firm explained that “STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant and that in these preclinical studies the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.”

The company pointed out that the highest proposed Phase 1 trial dose of 200 mg per patient is lower than other known SARS-CoV-2 targeted antibodies or antibody cocktails currently being evaluated in active clinical studies due to the potentially high potency of its STI-1499 antibody. The firm believes that this will aid in its ability to rapidly scale up manufacturing operations.

Sorrento is a clinical stage biopharmaceutical company based in San Diego, Calif., that concentrates its efforts on the development of new therapies to treat cancers. The company noted that “its multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms.” These include fully human antibodies, clinical stage immuno-cellular therapies, antibody-drug conjugates and clinical stage oncolytic virus. The firm is also presently endeavoring to create potential antiviral therapies and vaccines against coronaviruses.

Sorrento has a market capitalization of around $2.1 billion with approximately 255.1 million shares outstanding and a short interest of about 28.8%. SRNE shares opened almost 26% higher today at $10.52 (+$2.16, +25.94%) over yesterday’s $8.36 closing price. The stock has traded today between $9.05 and $10.60 per share and is currently trading at $9.34 (+$0.98, +11.66%).

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.

Further Trial Data Analyses ‘Reinforce’ Profile of Biopharma’s Multiple Sclerosis Drug

Source: Streetwise Reports   09/16/2020

The confirmatory results concerning Immunic’s lead drug candidate IMU-838 are presented in an H.C. Wainwright & Co. report.

Pills

In a Sept. 14 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Immunic Inc.’s (IMUX:NASDAQ) re-analyses of the data from the EMPhASIS Phase 2 trial ‘reinforced IMU-838’s profile.” The study evaluated this immune modulator in patients with relapsing-remitting multiple sclerosis.

H.C. Wainwright has a $56 per share target price on Immunic, the developer of IMU-838, and the stock’s current share price is around $18.17.

In his report, Selvaraju presented the takeaways from Immunic’s additional examination of the EMPhASIS Phase 2 study results, which the biopharma had reported at the ACTRIMS-ECTRIMS conference last week.

For one, all EMPhASIS trial subgroups showed lesion suppression as evidenced on MRI, and this occurred whether or not patients had prior treatment, despite the number of pre-trial relapses they experienced and regardless of their enrollment country.

Two, lesion reduction occurred by six weeks, which indicates that a stable therapeutic drug level was achieved quickly, a characteristic for which IMU-838 is known.

Three, the IMU-838 groups did better than the placebo cohort in terms of the secondary endpoints of time to first relapse and annualized relapse rate. These, however, could not be evaluated officially given the trial’s short, 24-week duration.

“These data reinforce the value proposition for IMU-838 in relapsing-remitting multiple sclerosis and may increase the interest level of potential strategic partners in licensing the compound within the context of the multiple sclerosis indication,” Selvaraju commented.

He highlighted that the serum biomarker data from EMPhASIS also are “intriguing.” By the end of the study, serum neurofilament dropped significantly below baseline figures in both treated groups but increased by 6.5% in the placebo group.

“We believe that IMU-838’s impact on this biomarker may constitute a key component of the drug’s mechanism of action,” Selvaraju wrote, adding that over the past few years, this biomarker has become one of the most important for central nervous system tissue damage related to multiple sclerosis.

Selvaraju indicated the additional EMPhASIS data analyses also confirmed IMU-838’s robust safety profile. During the study, the drug did not cause hepatotoxicity, raise serum uric acid levels or increase the incidence of hematuria. In addition, fewer treated patients, about 4.3%, withdrew from the trial than placebo patients, 7.2%.

Looking forward, Selvaraju pointed out that Immunic has two potential stock-moving events likely to happen in the near term. One is interim clinical data from the CALVID-1 trial that shows IMU-838 weakens viral load in COVID-19-infected patients. The other is the outlicensing of IMU-838 for relapsing-remitting multiple sclerosis.

H.C. Wainwright has a Buy rating on Immunic.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the 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 from H.C. Wainwright & Co., Immunic, Inc., Company Update, September 14, 2020

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

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

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

As of August 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Immunic, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Immunic, Inc. for investment banking services within twelve months
before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report

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

Arrowhead Shares Point Higher on Positive Interim Data in Phase 2 Liver Disease Trial

Source: Streetwise Reports   09/16/2020

Shares of Arrowhead Pharmaceuticals traded 48% higher after the firm reported positive interim results from its Phase 2 study of ARO-AAT in patients with alpha-1 antitrypsin deficiency liver disease.

Arrowhead Pharmaceuticals Inc. (ARWR:NASDAQ), which is focused on developing medicines that treat intractable diseases by silencing the genes that cause them, today announced “positive interim 24-week liver biopsy results in four subjects from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT, the company’s second generation investigational RNA interference (RNAi) therapeutic being developed as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD).”

The company stated that the results obtained demonstrate meaningful pharmacodynamic effects by ARO-AAT that led to improvements in several relevant biomarkers. The firm indicated specifically that the results showed “substantial reductions in intra-hepatic mutant AAT protein (Z-AAT), both Z-AAT monomer and Z-AAT polymer, improvements in liver stiffness based on FibroScan and a decrease in alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), both serum biomarkers of liver injury.”

The company advised that in the pilot AROAAT2002 study of investigational ARO-AAT, serum and total intra-hepatic Z-AAT decreased in all four patients by up to 93% and 95%, respectively, following 24 weeks of treatment. In addition, the firm noted that all four patients showed reductions in ALT and GGT and three of four patients demonstrated reductions from baseline in intra-hepatic Z-AAT polymer, with a maximum reduction of 97%.

Arrowhead Pharmaceuticals Chief Medical Officer Javier San Martin commented, “While we had anticipated that 6 months of treatment with investigational ARO-AAT in the Phase 2 open label study would likely lead to substantial reductions in Z-AAT monomer, the improvements in additional clinically meaningful biomarkers, including reductions in Z-AAT polymer, improvements in FibroScan values, and decreases in ALT and GGT, were more substantial than we expected. These are very exciting results and provide us with increased confidence in the potential of this program. Based on these important data, we are actively assessing our clinical and regulatory path forward, including engaging with the U.S. Food and Drug Administration and other regulatory agencies, to identify areas where the program could potentially be streamlined and accelerated.”

AROAAT2002 trial investigator Professor Pavel Strnad, M.D., of University Hospital Aachen in Germany, remarked, “These data are very encouraging and suggest that ARO-AAT may rapidly ameliorate liver injury. It is particularly reassuring to see the decrease in liver enzymes, which suggests that elevations are related to proteotoxic stress that could be addressed with ARO-AAT therapy rather than reflecting co-morbidities. In addition, no major lung events have occurred in this study to date, which indicates that RNAi-based reduction of Z-AAT in the liver has not negatively affected lung function during the treatment period.”

Mark Brantly, M.D., scientific director of the Alpha-1 Foundation, added, “The Arrowhead ARO-AAT Phase 2 open label clinical trial is exciting for the Alpha-1 community as it brings forward an intervention for the liver disease associated with Alpha-1 Antitrypsin Deficiency. The interim result of this study demonstrates proof of principle that RNA interference is a promising therapy for the liver disease associated with Alpha-1 Antitrypsin Deficiency.”

The company explained that the Phase 2 AROAAT2002 trial is a multi-dose pilot study to assess the responses of around 16 patients with AATD associated liver disease to ARO-AAT. The firm stated that ARO-AAT is also presently being evaluated in an ongoing Phase 2/3 SEQUOIA trial that commenced in August 2019.

Arrowhead Pharmaceuticals, headquartered in Pasadena, Calif., stated that its therapies utilize RNA chemistries and efficient modes of delivery to trigger RNA interference (RNAi) mechanisms in order to induce rapid, deep and durable knockdown of target genes. The firm explained that RNAi is a response characteristic present in living cells that affects the production of a specific protein by inhibiting the expression of a specific gene. Arrowhead claimed that its RNAi-based therapeutics take advantage of this natural gene silencing pathway.

Arrowhead Pharmaceuticals started the day with a market capitalization of around $3.5 billion with approximately 102.3 million shares outstanding and a short interest of about 9.2%. ARWR shares opened 18.5% higher today at $40.05 (+$6.25, +18.49%) over yesterday’s $33.80 closing price. The stock has traded today between $40.05 and $53.12 per share and is currently trading at $49.90 (+$16.10, +47.63%).

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.

Amwell, with $100 Million Google Investment and Access to 80 Million Patients, Expected to Begin Trading on NYSE Sept. 17

Source: Streetwise Reports   09/15/2020

Virtual care company American Well Corp., which operates under the name Amwell®, is expected to begin trading on the New York Stock Exchange on Thursday, September 17, under the symbol AMWL.

While the SARS-CoV-2 pandemic has thrown the healthcare industry numerous and unique challenges this year, one clear winner over the last several months is telemedicine. Virtual healthcare has been growing by leaps and bounds and is gaining rapid acceptance due to perceived safety, efficiency, convenience and affordability.

Making a powerful move into this space with the support of a $100 million investment by Google Cloud is American Well Corp. (Amwell®) (AMWL:NYSE), which is now expected to begin trading on the New York Stock Exchange on Thursday, Sept. 17.

Amwell announced that it has filed a registration statement with the Securities and Exchange Commission to offer 35 million shares of its Class A common stock to the public. The initial public offering is expected to be priced between $14 and $16 per share, and is expected to raise around $525 million.

Amwell and Google Cloud recently announced that it entered into a multi-year, strategic partnership with Google Cloud to deliver transformative telehealth solutions across the global healthcare ecosystem. The two firms reported that they aim to “expand access to virtual care, improve patient and clinician experiences, and leverage their unique capabilities to deliver new, differentiated healthcare solutions—across the continuum of care.”

Specifically, the companies believe there is a great opportunity to improve patient and clinician telehealth interactions and take virtual care to the next level by employing automated technologies. These systems will serve to improve the waiting room experience and checkout process; offer language translation services; increase the availability of services to more patients, and assist payers and providers in routine tasks. Clinicians will have access to additional tools to intelligently triage cases and thus benefit by a reduction in clinician burnout.

Amwell and Google previously outlined the partnership terms stating that “Google Cloud selected Amwell as its preferred global telehealth platform partner, and Amwell selected Google Cloud as its preferred global cloud platform partner and will migrate its video performance capabilities onto Google Cloud’s superior cloud platform for both new and existing customers around the globe.”

Under the terms of the agreement, “Google Cloud will invest $100 million into Amwell structured as a concurrent private placement at a purchase price that will be the same as the price to the public in Amwell’s IPO and will be contingent upon the closing of its IPO.”

Google Cloud’s CEO Thomas Kurian commented in a recent news release, “This is a critical partnership for the healthcare industry and has the potential to dramatically transform the telehealth space through the use of modern cloud technologies.”

Ido Schoenberg, M.D., chairman and CEO of Amwell, remarked, “We chose Google Cloud as our strategic partner because of their phenomenal people, superior products, and open approach to partnering…Together, we will be able to offer an incredible array of integrated capabilities and help millions of people around the world access better care. Our collaborative work could literally democratize healthcare.”

Amwell operates a comprehensive global telehealth platform that connects providers, insurers, and patients in order to deliver increased access to more affordable, higher quality care. The company stated that its platform is designed to support all telehealth needs from urgent and acute care, chronic care management and healthy living. Amwell’s network ecosystem includes more than 2,000 hospitals and 50 health plan partners with over 40,000 employers, covering over 80 million individuals.

Google Cloud is a leading infrastructure, platform capabilities and industry solutions provider that serves organizations and businesses worldwide. The company delivers enterprise-grade cloud solutions that leverage Google’s cutting-edge technology to customers in more than 150 countries.

Editor’s Note: An earlier version of this article stated that Amwell was expected to begin trading on Sept. 16, but the expected date is now Sept. 17.

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.

Immunomedics’ Shares Double on Gilead’s $21 Billion Buyout Offer

Source: Streetwise Reports   09/14/2020

Shares of Immunomedics Inc. traded 100% higher after the company reported that it has agreed to be acquired by Gilead Sciences for $88 per share in cash.

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Biopharmaceutical company Immunomedics Inc. (IMMU:NASDAQ), which specializes in the area of antibody-drug conjugates and Gilead Sciences Inc. (GILD:NASDAQ) yesterday afternoon announced that “the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash.” The companies indicated that the transaction values Immunomedics at approximately $21 billion, is expected to close during Q4/20 and has already been unanimously approved by both company’s respective Boards of Directors.

The report noted that “the agreement will provide Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”

Immunomedics is currently planning to submit a supplemental Biologics License Application to support full approval of Trodelvy in the U.S. in Q4/20 and also plans to file for European regulatory approval in H1/21.

Immunomedics noted that “in the Phase 3 ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival (PFS) and overall survival (OS) in previously treated patients with advanced mTNBC.” Trodelvy is also being evaluated and studied for use in several other trials and indications including HR+/HER2- breast cancer, bladder cancer, non-small cell lung cancer and other solid tumor types.

Daniel O’Day, chairman and CEO of Gilead Sciences, remarked, “This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments…We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.”

Immunomedics’ Executive Chairman Behzad Aghazadeh Ph.D., commented, “We are very pleased that Gilead recognized the value of Trodelvy – both for the important role it has already begun to play for patients with metastatic triple-negative breast cancer and for its potential to help many other patients with cancer in the future…We are excited for the opportunities ahead of us as we join with Gilead to advance our shared mission in defeating cancer. By working with Gilead, we have the opportunity to accelerate our progress and improve care for patients in need of new therapies.”

The firms advised that the merger agreement terms stipulate that Gilead, through a wholly owned subsidiary, will commence a tender offer to acquire all of the outstanding shares of Immunomedics’ common stock for $88.00 per share. This price reportedly represents a 108% premium to Immunomedics’ share closing price on Friday, September 11, 2020. The tender offer is subject to acceptance by at least a majority of outstanding Immunomedics shares and other customary closing conditions as well as necessary regulatory approvals. Gilead indicated that it will fund the purchase by utilizing approximately $15 billion in cash on hand and the remaining $6 billion will come proceeds from newly issued debt.

The company explained that “Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed antibody-drug conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”

Immunomedics is a clinical-stage biopharmaceutical company headquartered in Morris Plains, N.J., that this focused on developing and advancing monoclonal antibody-based products for targeted cancer, autoimmune and other serious disease treatments.

Gilead, headquartered in Foster City, Calif., is a research-based biopharmaceutical company with operations in more than 35 countries. The company focuses on four primary therapeutic areas: HIV, Liver disease, Oncology and Inflammation.

Immunomedics started off the day with a market capitalization of around $9.8 billion with approximately 231.1 million shares outstanding and a short interest of about 11.3%. IMMU shares opened 105% higher today at $86.89 (+$44.64, +105.66%) over Friday’s $42.25 closing price and reached a new 52-week high price this morning of $86.91. The stock has traded today between $83.68 to $86.91 per share and is currently trading at $84.10 (+$41.84, +99.04%).

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.

Intra-Cellular Shares Soar on Positive Bipolar Depression Study Findings

Source: Streetwise Reports   09/09/2020

Shares of Intra-Cellular Therapies traded 77% higher after the company reported that positive data from its Phase 3 Study 402 will form the basis for its sNDA for lumateperone in treating bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy.

Microbiology

This morning biopharmaceutical company Intra-Cellular Therapies Inc. (ITCI:NASDAQ), which is focused on the development of therapeutics for central nervous system (CNS) disorders, announced “positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.”

The firm stated that in the Phase 3 Study 402, once daily lumateperone 42 mg successfully achieved the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score, and it additionally met the study’s secondary endpoint, the CGI-BP-S Depression Score. The company indicated that lumateperone demonstrated a favorable safety profile and was generally well tolerated in the trial.

The company noted that the data from this trial together with the results of its previously reported positive Phase 3 monotherapy study, Study 404, will form the basis for its Supplemental New Drug Application (sNDA) for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. The firm advised that it expects that it will submit the sNDA to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.

The company’s Chair and CEO Dr. Sharon Mates commented, “Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone’s label to include a second major neuropsychiatric disorder…With this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia.”

Dr. Roger McIntyre, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, remarked, “Bipolar disorders are serious and complex mental health conditions that affect millions of people, and depression is the most common presentation of these disorders. In this study, lumateperone demonstrated a robust effect, which is particularly significant considering patients were maintained on lithium or valproate…Lumateperone is the first treatment to demonstrate efficacy for bipolar depression as monotherapy and as adjunctive therapy to mood stabilizers in a study population including both Bipolar I and Bipolar II patients. This will be welcome news to the psychiatric community as there is a tremendous need for improved treatment options.”

The company noted that its Phase 3 Study 402 took place in the U.S. and four other countries and included 529 patients with moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder. Patients in the study were maintained on lithium or valproate as mood stabilizers and were randomized equally to either lumateperone 42 mg, 28 mg or placebo. The firm noted that the results showed that 42 mg dose of lumateperone met both the primary and secondary endpoints versus placebo at week 6 measured by change from baseline on the MADRS total score and the improvement on the CGI-BP-S Depression Score. Lumateperone 28 mg also displayed a trend for a dose-related improvement in symptoms of depression, but it was not formally tested against placebo though it did demonstrate a statistically significant improvement versus placebo on the CGI-BP-S Depression Score.

The company explained that “pharmacodynamics studies have shown lumateperone acts as a potent antagonist with high binding affinity at serotonin 5-HT2A receptors.” The firm added that “these receptors are believed to play an important role in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders.”

The company stated that lumateperone is presently being investigated for use in the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders, but has not yet been approved by FDA for these disorders. The firm’s CAPLYTA 42 mg (lumateperone) has already been approved by the FDA for use in treatment of adult schizophrenia.

The firm explained that Bipolar I and Bipolar II disorders are highly prevalent serious psychiatric conditions that effect approximately 6 million adults in the U.S. Bipolar I & II disorders occur nearly equally in patients suffering with bipolar disorders with symptoms that typically include recurrent episodes of mania or hypomania intermixed with episodes of serious depression, which is commonly referred to as Bipolar depression. The company advised that Bipolar depression episodes usually tend to recur more often, last longer and are associated with a worse prognosis than the manic or hypomanic episodes.

Intra-Cellular Therapies is a biopharmaceutical company headquartered in New York that focuses on understanding of how therapies affect the inner-workings of cells in the body. The company states it employs this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases to help reduce the burden on patients and their caregivers.

Intra-Cellular Therapies started the day with a market capitalization of around $1.2 billion with approximately 67.31 million shares outstanding and a short interest of about 7.4%. ITCI shares opened nearly 70% higher today at $31.10 (+$12.67, +68.75%) over yesterday’s $18.43 closing price. The stock has traded today between $27.87 and $33.74 per share and is currently trading at $32.57 (+$14.14, +76.72%).

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.

As COVID Is Turbocharging the Adoption of TeleHealth, Small Cap Is Growing Exponentially

Source: Streetwise Reports   09/09/2020

All three brokerage firms that cover the rapidly expanding CloudMD Software & Services rate the company a Speculative Buy, and now the company has gained a toehold in the U.S.

Interest in telehealth and virtual medical visits has been growing over the past few years, but demand has skyrocketed with the coronavirus pandemic.

Vancouver-based CloudMD Software & Services Inc. (DOC:TSX.V; DOCRF:OTCQB; 6PH:FSE) has been at the forefront of telemedicine in Canada, both through organic growth and acquisitions, and now has made a move into the U.S. market with a reseller agreement and the purchase of a clinic in the Southeast U.S region.

“The current COVID pandemic is the single largest public health crisis of our lifetime and it has accelerated the adoption of digital virtual health; it has opened up the ability for people across North America to access quality healthcare from home,” Dr. Amit Mathur, President of CloudMD, told Streetwise Reports. “Technology focused companies like ours, the right size, nimble, and with expertise in healthcare, are really in the right position to respond to the need that’s upon us.”

Company management believed pre-COVID that it would take years to significantly adopt telemedicine. “But that three to five year plan is three to five months today; we’re quite proud of what we’ve done,” Dr. Mathur said.

CloudMD just released second quarter 2020 results and announced a CA$13 million bought-deal financing, which was subsequently upsized to $18 million due to significant demand. For the quarter, total revenue was $2,789,987, a 163% increase year over year; revenue from medical clinics and pharmacies rose 223% to $2,330,412, while revenue from SAAS model digital services rose 35% to $459,575. The company reported the net loss and comprehensive loss in Q2 2020 was $2,768,117, resulting in a net loss per share (basic and diluted) of $0.03.

The company noted that it ended the quarter “with a strong balance sheet with cash and cash equivalents of $13.8 million and a working capital balance of approximately $12.6 million.”

Several investment houses cover CloudMD, including Canaccord Genuity, Echelon Capital Markets and Beacon Securities. All three have Speculative Buy ratings on the company and target prices that range from CA$1.70 to CA$2. The company’s shares are currently trading at CA$1.60.

Canaccord Genuity analyst Doug Taylor wrote on August 31, CloudMD “DOC released Q2 results after market close Monday that were slightly below top-line growth expectations given the challenging environment for on-premise sales, particularly early in the quarter. With that said, we continue to focus on the string of highly accretive M&A transactions recently announced which will begin contributing to CloudMD’s financial performance in Q3 and Q4. Recall that the company has announced 5 acquisitions since quarter-end which are expected to contribute annual revenue (pre-synergies) of ~$11M in aggregate. Based on the contributions from these acquisitions, we expect the company will approach breakeven EBITDA as it continues to aggressively consolidate and drive organic growth through innovations including its pharmacy telemedicine kiosks. Despite the high activity level, M&A remains a priority for management and represents an additional catalyst in the near term.”

Earlier, in Taylor’s initiation report on CloudMD on June 2 he wrote, “In Canada, where an increasing proportion of healthcare services is expected to be delivered through telemedicine applications, CloudMD has assembled the technology stack and footprint to capitalize on this secular trend. . .The factors driving a paradigm shift in how healthcare is delivered to Canadians have been galvanized by the COVID-19 pandemic and suggest, in our view, years of extraordinary growth ahead for industry participants. We believe this sets up CloudMD to produce significant returns for equity holders as it executes on both organic and inorganic growth opportunities.”

Gabriel Leung, an analyst with Beacon Securities, wrote that CloudMD is “at the forefront of the telehealth revolution” and describes the company as a “technology driven healthcare operator, allowing it to combine professional health expertise with advanced digital platforms to empower physicians and patients. The company’s goal is to digitize the delivery of healthcare by providing patients access to all points of their care from their phone, tablet or desktop computer… We believe the company is well positioned to capitalize on this opportunity given its extensive healthcare background, and strong B2C and B2B telehealth offering.”

On September 1, Leung added, “We believe near-term catalysts include the closing of the US-based chronic care medical clinic, Snapclarity and Re: Function, additional acquisitions, an update on the Save-On-Foods rollout, new kiosk pharmacy wins, and an update on the Snapclarity pipeline (which we believe includes several large enterprise/payor prospects).”

Echelon Capital Markets analyst Rob Goff wrote in a September 1 report, “With a modest capital outlay, the Company’s portfolio has emerged as an integrated healthcare platform with patient showcase capabilities and a significant competitive advantage in its low-cost B2B and B2C distribution capabilities. . .We highlight that the Company’s two clinic acquisitions over the past month are on-strategy, establishing key region representation for integrated healthcare while completed on attractive, accretive terms prior to synergies.”

Independent financial analyst Matt Badiali wrote on August 10, “Cloud MD is a digital medical service that offers routine care. Similar to Teledoc, it services customers across Canada. It recently bought a U.S.-based mental health and complex care clinic. The company’s growth looks great. Bloomberg estimates that Cloud MD will grow revenue by 111% from 2020 to 2021.”

What is behind all of this attention?

With the growth of telehealth, “a new company seems to be popping up every morning to participate in this boom and growth, but what CloudMD is doing is just a strategic march along our plan that was developed long before COVID. We’re able to accelerate it both with the capital that was raised, and, of course, we are in a good position with an experienced management and team who can distribute our suite of digital solutions,” Dr. Mathur said.

“The core, of course, is owning the proprietary technology, and that’s why we’re able to respond and grow,” Dr. Mathur explained. “We’ve been continuing with both inorganic and organic growth; we’re still continuing to acquire clinics and that provides us not only with patients who are going to use our technology, but we’re also able to onboard regional expertise.”

Over the last year or so, CloudMD has acquired medical clinics in British Columbia and Ontario, and also has acquired pharmacies and placed telemedicine kiosks in pharmacies. It is making its first foray into the United States with the acquisition of a chronic care medical clinic based in Mississippi, and plans to expand its services in the southeastern United States.

The company is also acquiring Snapclarity Inc., an enterprise mental health platform, which will allow its telehealth offerings to include mental wellness.

“A huge majority of mental health issues actually involve either chronic pain or physical issues,” Dr. Mathur explained. “A lot of times both of those two aspects have been completely siloed and fragmented. We see the opportunity to be one of the providers and telehealth companies that can address both the mental and physical health at the same time and in a longitudinal way providing continuity of care for our patients.”

Dr. Mathur points to the fact that, according to the Centers for Disease Control and Prevention, 90% of the $3.5 trillion expended annually in the U.S. on healthcare is spent on patients with chronic conditions and/or mental health issues.

“By providing a patient centered, longitudinal care team approach, we see better outcomes for patients and earlier intervention, making it possible for patients to take care of their own health, change their behavior, and stay away from emergency departments and the higher cost of seeing patients later when they’re sicker,” Dr. Mathur said. “For patients, payors and government, the excitement is in these ecosystem approaches.”

Dr. Mathur explained that CloudMD is starting in the southeastern region of the U.S. because the area “has the issue of access in rural communities and a greater population distribution of chronic disease and mental health issues, a population that struggles. The models that we have really provide better outcomes and patient care, and that in the end is the name of the game.”

In May, CloudMD announced that it was entered into a value added reseller agreement with IDYA4 Corp., “a leader in data interoperability and integration solutions within the government and private sectors.” Under the agreement, IDYA4 will resell CloudMD’s Livecare technology in the U.S. “IDYA4 provides revolutionary technology solutions within public safety, corrections, health and human services sectors,” the company noted. “IDYA4 has an impressive portfolio of clients including, the Bureau of Justice Assistance, U.S. Department of Justice, the U.S. Department of Homeland Security, U.S Health and Human Services, Centers for Disease Control, Experis US (Manpower Group) and Deloitte to name a few.”

“The value add is that IDYA4 is a true data integration and security specialist providing technology solutions for years at a high level of state and federal organizations, making it possible for our technologies to be on the government cloud,” Dr. Mathur explained. “It makes sense on a security, privacy and service level for our American expansion.”

As to the future, “eventually this pandemic is going to go away. But now that we’ve seen how convenient it is to see a doctor through a video call, why have the hassle of having to go down to the medical office, being in a waiting room with a bunch of sick people?” Dr. Mathur said. “I believe we will see a virtual first hybrid model, where a virtual video visit is, when necessary, followed up by a physical visit. The landscape has been transformed forever.”

CloudMD currently has around 114 million shares outstanding and just shy of 144 million fully diluted. On September 2, the company announced an increased $18 million bought-deal public offering led by Canaccord Genuity and Beacon Securities, for 13.1 million shares at a price of $1.38 per share. The offering is expected to close on September 22.

[NLINSERT]

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

Additional disclosures:

Disclosures from Echelon Wealth Partners, CloudMD Stofware & Services Inc., Sept. 1, 2020

Echelon Wealth Partners compensates its Research Analysts from a variety of sources. The Research Department is a cost centre and is funded by the business activities of Echelon Wealth Partners including, Institutional Equity Sales and Trading, Retail Sales and Corporate and Investment Banking.

I, Rob Goff, hereby certify that the views expressed in this report accurately reflect my personal views about the subject securities or issuers. I also certify that I have not, am not, and will not receive, directly or indirectly, compensation in exchange for expressing the specific recommendations or views in this report.

Important Disclosures:
Is this an issuer related or industry related publication? Issuer.

Does the Analyst or any member of the Analyst’s household have a financial interest in the securities of the subject issuer? No

The name of any partner, director, officer, employee or agent of the Dealer Member who is an officer, director or employee of the issuer, or who serves in any advisory capacity to the issuer. No

Does Echelon Wealth Partners Inc. or the Analyst have any actual material conflicts of interest with the issuer? No

Does Echelon Wealth Partners Inc. and/or one or more entities affiliated with Echelon Wealth Partners Inc. beneficially own common shares (or any other class of common equity securities) of this issuer which constitutes more than 1% of the presently issued and outstanding shares of the issuer? No

During the last 12 months, has Echelon Wealth Partners Inc. provided financial advice to and/or, either on its own or as a syndicate member, participated in a public offering, or private placement of securities of this issuer? Yes

During the last 12 months, has Echelon Wealth Partners Inc. received compensation for having provided investment banking or related services to this Issuer? Yes

Has the Analyst had an onsite visit with the Issuer within the last 12 months? No

Has the Analyst or any Partner, Director or Officer been compensated for travel expenses incurred as a result of an onsite visit with the Issuer within the last 12 months? No

Has the Analyst received any compensation from the subject company in the past 12 months? No

Is Echelon Wealth Partners Inc. a market maker in the issuer’s securities at the date of this report? No

Disclosures from Canaccord Genuity, CloudMD Software and Services Inc., August 31, 2020

Analyst Certification

Each authoring analyst of Canaccord Genuity whose name appears on the front page of this research hereby certifies that (i) the
recommendations and opinions expressed in this research accurately reflect the authoring analyst’s personal, independent and objective views about any and all of the designated investments or relevant issuers discussed herein that are within such authoring analyst’s coverage universe and (ii) no part of the authoring analyst’s compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed by the authoring analyst in the research, and (iii) to the best of the authoring analyst’s knowledge, she/he is not in receipt of material non-public information about the issuer.

 

CloudMD Software & Services Inc. currently is, or in the past 12 months was, a client of Canaccord Genuity or its affiliated
companies. During this period, Canaccord Genuity or its affiliated companies provided investment banking services to CloudMD
Software & Services Inc..br>
In the past 12 months, Canaccord Genuity or its affiliated companies have received compensation for Investment Banking services
from CloudMD Software & Services Inc.
In the past 12 months, Canaccord Genuity or any of its affiliated companies have been lead manager, co-lead manager or comanager of a public offering of securities of CloudMD Software & Services Inc. or any publicly disclosed offer of securities of CloudMD Software & Services Inc. or in any related derivatives.
Canaccord Genuity or one or more of its affiliated companies intend to seek or expect to receive compensation for Investment Banking services from CloudMD Software & Services Inc. in the next three months.

Disclosures are available here.

Disclosures from Beacon Securities, CloudMD Software & Services Inc., September 1, 2020

Does Beacon, or its affiliates or analysts collectively, beneficially own 1% or more of any class of the issuer’s equity securities? No

Does the analyst who prepared this research report have a position, either long or short, in any of the issuer’s securities? No

Has any director, partner, or officer of Beacon Securities, or the analyst involved in the preparation of the research report, received remuneration for any services provided to the securities issuer during the preceding 12 months? No

Has Beacon Securities performed investment banking services in the past 12 months and received compensation for investment banking services for this issuer in the past 12 months? Yes

Was the analyst who prepared this research report compensated from revenues generated solely by the Beacon Securities Investment Banking Department? No

Does any director, officer, or employee of Beacon Securities serve as a director, officer, or in any advisory capacity to the issuer? No

Are there any material conflicts of interest with Beacon Securities or the analyst who prepared the report and the issuer? No

Is Beacon Securities a market maker in the equity of the issuer? No

This report makes reference to a recent analyst visit to the head office of the issuer or a site visit to an issuer’s operation(s)? No

Did the issuer pay for or reimburse the analyst for the travel expenses? No

Beacon analysts are not permitted to own the securities they cover, but are permitted to have a position, either long or short, in securities covered by other members of the research team, subject to blackout conditions.

Analyst Certification: The Beacon Securities Analyst named on the report hereby certifies that the recommendations and/or opinions expressed herein accurately reflect such research analyst’s personal views about the company and securities that are the subject of the report; or any other companies mentioned in the report that are also covered by the named analyst. In addition, no part of the research analyst’s compensation is, or will be, directly or indirectly, related to the specific recommendations or views expressed by such research analyst in this report.

Matt Badiali
Matt Badiali does not own shares of CloudMD, and neither he nor his company has a financial relationship with the company.

U.S. Medical Device Firm to Acquire Developer of Dissection Stent

Source: Streetwise Reports   09/09/2020

The specifics of the deal and the next steps for CryoLife are presented in a Ladenburg Thalmann report.

Heart

In a Sept. 3 research note, Ladenburg Thalmann analyst Jeffrey Cohen reported that CryoLife Inc. (CRY:NYSE) agreed to acquire Ascyrus Medical for $200 million.

“We are highly encouraged by the Ascyrus acquisition and anticipate nominal revenues from ex-U.S. territories and improved margins in the near-term as well as clinical and regulatory updates,” commented Cohen.

Ascyrus Medical, a private medical device firm based in Florida, developed the Ascyrus Medical Dissection Stent (AMDS), “the first aortic arch remodeling device utilized for the treatment of type A aortic dissections (TAAD),” Cohen described. Having CE Mark and Health Canada approvals for the AMDS, the company has sold the device on a limited basis in Europe and Canada, generating pro forma revenue of about $3 million.

Of the total consideration for the acquisition, Georgia-based CryoLife is to pay Ascyrus Medical $80 million upfront, $60 million of it in cash and $20 million in common CryoLife shares. The biopharma will pay the remainder of the $200 million in increments when it achieves certain milestones related to AMDS, specifically regulatory approval in various regions.

Cohen highlighted that the current treatment for TAAD is hemi-arch repair, in which a graft is employed to close the ascending part of the aorta, and the use of an AMDS in addition to the hemi-arch repair greatly improves the result.

“Based upon the superior outcomes in patients treated with both, it is anticipated that utilizing AMDS could become the standard of care with a $540 million market opportunity,” he added, noting that an estimated 48,000 patients globally per year experience TAAD.

Cohen indicated that CryoLife expects that in the United States it will next get an investigational device exemption for the AMDS from the U.S. Food and Drug Administration. It would follow this with a pivotal trial starting in H2/21 and garner eventual device approval in the U.S. in 2024. Also, the biotech company is working to get the AMDS approved in Japan, hopefully by 2025.

CryoLife intends to capitalize on its sales force in Latin America, Europe and the Asia Pacific to now sell the AMDS in countries covered by the CE Mark.

Ladenburg Thalmann has a Buy rating and a $29.50 per share price target on CryoLife, the stock of which is currently trading at about $18.18 per share.

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Disclosures from Ladenburg Thalmann, CryoLife Inc., September 3, 2020

ANALYST CERTIFICATION: I, Jeffrey S. Cohen, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report, provided, however, that:

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

COMPANY SPECIFIC DISCLOSURES: N/A