Archive for Healthcare

Heathcare and Biotech Updates

Biotech Reports Positive Preclinical COVID-19 Study Results

Source: Streetwise Reports   06/16/2021

These data and next steps for Novan’s antiviral SB019 are provided in a ROTH Capital Partners report.

In a June 10 research note, ROTH Capital Partners analyst Jonathan Aschoff reported that Novan Inc.’s (NOVN:NASDAQ) preclinical study of the antiviral SB019 in SARS-CoV-2-infected hamsters showed positive results.

“Novan will likely explore a further development program with U.S. Food and Drug Administration (FDA) buy-in for SB019 as a potential intranasal treatment option for COVID-19,” Aschoff wrote.

Aschoff described the design and presented the results of the in vivo SB019 study. Uninfected golden Syrian hamsters were exposed to ones infected with SARS-CoV-2. All of the animals were administered, once daily, one of several low doses of SB019, which has berdazimer sodium as the active compound. The study objective was to reduce viral burden and/or deter virus spread. The results were compared to those of placebo controls.

As for SB019’s safety, the hamsters tolerated it well; no adverse events were observed.

“We note the consistency of highly favorable safety with berdazimer sodium across all of Novan’s development programs,” Aschoff wrote.

Regarding efficacy, the study showed that SB019 reduced viral burden in the hamsters to a statistically significant (p<0.0001) degree of greater than 99.99%. Further, following total treatment, more than half of the initially uninfected hamsters lacked any detectable pulmonary virus. Two independent studies demonstrated that SB019 prevented the viral infection from moving into the lungs after transmission.

Coronavirus

Based on these new results, Aschoff indicated, Novan is conducting dose ranging studies to determine an ideal sSB019 starting dose and treatment regimen for humans. Looking forward, Novan may advance the antiviral itself or with a partner. The company likely will move forward with development of SB019 as a potential COVID-19 treatment, in the form of an intranasal rinse (like that achieved with a Neti pot). To do so, the company will have to complete toxicology studies and either obtain financing or secure a partner.

“The positive results should allow Novan to file an investigational new drug application and potentially begin clinical trials in H2/21,” Aschoff wrote.

Finally, Aschoff noted that the most significant catalyst to date for Novan’s stock is on the horizon, and that is release of data from the Phase 3 study of SB206, a topical antiviral gel, for the skin infection molluscum contagiosum.

ROTH rates Novan Buy and has a target price on it of $26 per share. The stock is trading now at about $8.86 per share.

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 ROTH Capital Partners, Novan, Inc., Company Note, June 10, 2021

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

Disclosures:
ROTH makes a market in shares of Novan, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Novan, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

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

Clearside Biomed Shares Rise 37% on Positive Data in Phase 1/2a Wet AMD Trial

Source: Streetwise Reports   06/15/2021

Clearside Biomedical shares reached a new 52-week high after the company reported that the first cohort in its dose-escalating Oasis Trial of CLS-AX for treatment of neovascular age-related macular degeneration met all primary endpoints.

Clinical biopharmaceutical company Clearside Biomedical Inc. (CLSD:NASDAQ), which is focused on developing and providing treatments in order to restore and preserve vision for individuals with serious back of the eye diseases, today announced “positive safety results from Cohort 1 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector® in six patients (n=6) with neovascular age-related macular degeneration (wet AMD).”

The firm noted that the six subjects in Cohort 1, who were administered the initial lowest planned dose of 0.03 mg CLS-AX, successfully achieved all key primary endpoints in the study. Clearside advised that the drug was well tolerated in the trial and that patients in Cohort 1 demonstrated “no signs of inflammation, no vasculitis, no intraocular pressure (IOP) safety signals, no dispersion of drug into the vitreous or any other drug related adverse events.”

The company stated that the OASIS’ trial’s Safety Monitoring Committee has looked closely at the results and has given the go ahead to proceed with Cohort 2. The firm mentioned that this subgroup would be given a stronger dosage of 0.1 mg CLS-AX starting in June 2021 and be studied for a period of four months.

Clearside Biomedical’s Chief Medical Officer and Chief Development Officer Thomas A. Ciulla, M.D., MBA, commented, “We are very encouraged by the Cohort 1 results of the OASIS trial and we are immediately beginning Cohort 2 enrollment as planned…The initial data from Cohort 1 clearly achieved our safety and tolerability endpoints. While still early and recognizing there are a limited number of patients, we believe the Cohort 1 data supports our hypothesis that the combination of targeted and compartmentalized suprachoroidal delivery and the potent pan-VEGF attributes of axitinib may facilitate an effective treatment option for patients suffering from wet AMD.”

The company indicated that the average age of the Cohort 1 patients was 82, all of whom were confirmed to have persistent active disease and had previously undergone numerous anti-VEGF injection treatments before participating in the trial.

Mark R. Barakat, M.D., director of research for Retinal Consultants of Arizona and clinical assistant professor at University of Arizona College of Medicine in Phoenix, remarked, “CLS-AX was well-tolerated and these initial results in this heavily treatment-experienced group of wet AMD patients are promising. I look forward to the continued clinical advancement of CLS-AX at the planned higher doses to further explore potential benefits in visual acuity, ocular anatomy and durability.”

The company explained that the OASIS study is a Phase 1/2a single dose-escalation trial designed to evaluate the safety and tolerability of CLS-AX at increasing dosage levels in patients diagnosed with wet AMD. The firm noted that the drug is administered via suprachoroidal injection utilizing Clearside’s SCS Microinjector®.

Clearside stated, “Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity and that it believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade.”

Clearside is based in Alpharetta, Ga., and concentrates its efforts on the development of treatments that preserve and restore in those with serious back of the eye diseases. The firm stated that “its proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs.”

Clearside Biomedical began the day with a market cap of around $173.9 million with approximately 57.6 million shares outstanding and a short interest of about 1.4%. CLSD shares opened more than 30% higher today at $3.999 (+$0.979, +32.42%) over yesterday’s $3.02 closing price and reached a new 52-week high this morning of $4.70. The stock has traded today between $3.6167 and $4.80 per share and is currently trading at $4.16 (+$1.14, +37.78%).

 

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.

Enochian Bio’s Shares Rise 54% After FDA Accepts Pre-IND Request for Potential HIV Cure

Source: Streetwise Reports   06/14/2021

Shares of Enochian Biosciences Inc. traded higher after the company reported that the U.S. Food and Drug Administration accepted a pre-investigational new drug request for a potential functional cure or treatment for human immunodeficiency virus.

Gene-modified cellular and immune therapies firm Enochian Biosciences Inc. (ENOB:NASDAQ), which focuses on developing treatments for infectious diseases and cancer, today announced that “the U.S. Food and Drug Administration (FDA) has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of human immunodeficiency virus (HIV).” The company stated that it expects for receive written comments back from the FDA in the fall of 2021.

Enochian Biosciences Co-Founder Dr. Serhat Gumrukçu, who also serves as a director of the Seraph Research Institute (SRI), submitted the Pre-IND to the FDA. The company advised that the request was filed utilizing the data collected from studying a 54-year-old male HIV patient who was unable to suppress the virus using antiviral therapy.

The firm commented that subsequently “the patient achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person.” The company indicated that no antiviral drugs had been administered throughout the entire treatment period and now believes that “the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.”

HIV AIDS

The company explained that in May 2021 the findings were presented at the American Society of Gene and Cell Therapy conference.

Enochian stated in the report that it holds the exclusive license for the proprietary cellular therapy technology “that could be an important approach to achieve a ‘functional cure’ of HIV, potentially allowing persons with the virus to stop antiviral treatment for extended periods of time.”

The firm noted that the Pre-IND submission it submitted to the FDA included a request for allowing the novel strategic approach to be extended to HIV infected individuals who have previously demonstrated to have successfully achieved HIV suppression with antiviral treatment.

Enochian’s Executive Vice-Chair Dr. Mark Dybul remarked, “I am very excited by the FDA’s decision to provide responses to the Pre-IND submission. Because the promising early results are only in one person, it is important to study the approach in a larger population. In addition, because many people achieve suppression with antiviral treatment, it is key to extend the evaluation to that specific group.”

“It is important to explore any potential for persons with HIV to safely stop antiviral drugs and control the virus. Although the results so far are preliminary and in one person, if the NK-GDT therapy is proven to be effective in others, it could offer hope to many who experience significant side effects from, or have grown tired of, daily antiviral medication,” stated Dr. Peter Piot, the former head of UNAIDS and director of the London School of Hygiene and Tropical Medicine.

The company states on its website that in 2017, 36.9 million people throughout the world were living with HIV and 1 million AIDS related deaths were reported in that same year worldwide.

Enochian is a biopharmaceutical company based in Los Angeles, Calif. The firm focuses its efforts on discovering, developing, manufacturing and commercializing gene-modified cell therapies. The firm states on its website that “its clear mission is to develop definitive cures and provide effective prevention for infectious diseases and cancer.” The company claimed that its gene-modified cell therapy platform can be used for multiple indications, including HBV, HIV/AIDS and solid tumors in oncology.

Seraph Research Institute (SRI) was described as a non-profit research institution based in Los Angeles, Calif., that conducts basic science, translational and clinical research. The organization is primarily focused on finding cures and treatments for cancers, genetic disorders and chronic viral infections.

Enochian Biosciences began the day with a market cap of around $210.8 million with approximately 47.8 million shares outstanding and a short interest of about 4%. ENOB shares opened nearly 170% higher today at $11.88 (+$7.47, 169.39%) over Friday’s $4.41 closing price and reached a new 52-week high this morning of $12.99. The stock traded today between $6.71 and $12.99 per share and closed for trading at $6.80 (+$2.39, +54.20%).

 

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’s COVID Test Approved in Mexico

Source: Streetwise Reports   06/09/2021

This and other recent developments involving Sorrento Therapeutics’ pipeline and partners are covered in a Dawson James Securities report.

In a June 7 research note, Dawson James Securities analyst Jason Kolbert reported Sorrento Therapeutics Inc. (SRNE:NASDAQ) discussed a number of developments at the firm.

For one, Mexico’s health regulatory agency, the Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS, approved Sorrento’s COVI-STIX assay for the SARS-CoV-2 virus for emergency use, Kolbert noted. The California-based biopharma expects to have the test available in Mexico in a few weeks, having already started the process of rolling it out there.

“This approval is expected to form the foundation for similar clearances in other Latin American countries, including Brazil, in which Sorrento is currently conducting multiple therapeutic clinical trials,” wrote Kolbert.

Two, one of Sorrento’s license and development partners, Sichuan Kelun-Biotech Biopharmaceutical, presented data from its Phase 1 study of A166 at the recent American Society of Clinical Oncology (ASCO) meeting, Kolbert relayed. A166 is a site specific, third generation, HER-2 positive antibody drug conjugate.

Covid Testing

“Compared to its commercial competitors, A166 demonstrated a better safety profile in the initial study and potentially better efficacy,” he wrote. Specifically, A166’s overall response rate of 71.4% at a dose of 6 milligrams per kilogram (6 mg/kg) was higher than that of DS-8201, which is 60.9% at a dose of 5.4 mg/kg.

Three, another of Sorrento’s license partners, Lee’s Pharmaceutical Holdings, was greenlighted to proceed with a multicenter Phase 3 trial of the antibody Socazolimab as a potential firstline treatment for patients with extensive stage small cell lung cancer. The study’s principal investigator is Shun Lu with the Shanghai Chest Hospital.

Four, Sorrento completed its acquisition of ACEA Therapeutics, noted Kolbert. With this transaction, the biopharma gained two clinical candidates, Abivertinib (a tyrosine kinase inhibitor) and AC0058 (a next generation Bruton’s tyrosine kinase inhibitor), as well as preclinical candidate AC0939. The company also now has ACEA’s proprietary database of more than 1 million compounds and its sizable manufacturing facility in Quzhou, China, where Abivertinib and AC0058 were made for clinical studies.

Dawson James has a Buy rating on Sorrento Therapeutics. Based on its model that excludes the ACEA acquisition, the brokerage firm assigns a $19 per share price target to Sorrento. In comparison, the stock is trading now at about $9.25 per share.

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 for Dawson James Securities, Sorrento Therapeutics, June 7, 2021

The Firm does not make a market in the securities of the subject company(s). The Firm has NOT engaged in investment banking relationships with SRNE in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has NOT received any other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of May 31, 2021, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm’s investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Big Pharma Is Back! Biotech Skyrockets On Biogen’s New Alzheimer Drug Approval – But What Does BAN Say?

By TheTechnicalTraders 

The FDA issued an accelerated approval status for Biogen’s new Alzheimer drug with specific requirements related to consumer use and results.  In these cases, the FDA is allowing Biogen to move into a more open consumer trial where the results and side-effects of this new drug will be identified fairly quickly.

This new drug targets the plague in the heart and brain that is associated with Alzheimer’s.  Over five million Americans live with some form of Alzheimer’s currently.  The Alzheimers Association continues to provide detailed statistics related to how this disease relates to various segments of American society.  You can read more about how big this announcement is in terms of how Alzheimer’s affects Americans in this 2019 Alzheimer’s Disease Facts And Figures report.

This news of a new Biogen Alzheimer’s drug has sent XBI skyrocketing – yet the news may not be enough to continue to trend across an entire market sector.  The one thing that I would like to point out is that news of a single drug that has entered early-stage accelerated approval by the FDA does not make a new trend – it makes a news blip.

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Either way, the long-term results related to the potential success of this new drug may prompt a rally in Biogen and the Biotech sector over the next few months and years. Alzheimer’s is a big problem for many nations across the globe so the potential for this new solution, if priced well, may be huge for Biogen.

The Daily XBI chart below shows a clear downward price channel (CYAN line) that is acting as resistance.  XBI must rally above this level in order to prompt any bigger upside price trend.  As of right now, XBI has rallied up to that level but has stalled near that resistance.  It is likely that the news prompted a big upside trend, however, the reality is that we won’t know how successful this new drug is for Biogen for many months/years.  So, the real opportunity could be a ways away still.

The Weekly XBI chart below highlights recent support near 118.40 (the MAGENTA line) and continues to show the downward sloping resistance channel (the CYAN line).  We believe XBI will have to break out of these price boundaries before it starts any new trends.  Currently, the upside price rally is testing the upper resistance levels.  If it breaks above that level quickly, we may see some bigger upside trending.  If not, it will likely fall back into the range of these boundaries while attempting to find support again.

What does our proprietary BAN strategy say about this new XBI trigger?  Currently, XBI is reporting as BEARISH and is in a RISK OFF trend mode. XBI is also trending/ranking near the bottom of our BAN ETF sector list – meaning that XBI is showing very limited upward trend strength at the moment. This recent news may change that over the next few weeks.  Due to these factors, XBI is not something that BAN would be trading at the moment.

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Promising Psychedelic Drug Trials Show Potential for a New Biotech Boom

Source: McAlinden Research for Streetwise Reports   06/04/2021

McAlinden Research Partners notes that continued advances in psychedelic therapies show potential to drive an investment boom that could reshape the future of medicine and mental health therapies.

Encouraging results from recent clinical trials testing the efficacy of using psychedelics like arketamine, LSD, and psilocybin to treat mental health disorders have bumped up biotechnology firms working in the space. They’ve also pushed some states closer to decriminalization.

Public stigma toward this class of drugs is fading as continued advances in psychedelic therapies show potential to drive an investment boom that could reshape the future of medicine and mental health therapies.

Related Stocks: MindMed (MNMD), Compass Pathways (CMPS)

Psilocybin mushrooms

Market Poised to Grow as Mental Health Disorders Surge

According to Research and Markets, the global psychedelic market was valued at $4.75 billion in 2020, and that figure is projected to rise to $10.75 billion in 2027. Per Canaccord Genuity, the potential market opportunity for psychedelics may be as high as $100 billion globally.

To receive all of MRP’s insights in your inbox Monday–Friday, follow this link for a free 30-day trial. This content was delivered to McAlinden Research Partners clients on May 24.

In 2019, roughly 51.5 million adults in the United States were living with some form of mental illness. A report by the Institute for Health Metrics and Evaluation found that 10% of the world population suffers from mental health issues, and effects from the pandemic could drive that number higher.

D Magazine writes that number of potential patients for psychedelic treatment in the U.S. is estimated between two and four million, with annual sales ranging between $1 to $5 billion.

The New York Times reported that more than a dozen startups have recently jumped into the industry. Psychedelic firm atai Life Sciences AG, backed by early Facebook investor and Palantir Chairman Peter Thiel, has raised more than $362 million from private investors thus far. According to Financial Review, the company recently announced it will be raising $129 million in an upcoming IPO, which would make it the third psychedelic company to trade on U.S. stock exchanges.

atai’s leading candidate treatment, PCN-101, is being developed by a subsidiary for treatment resistant depression, or TRD. The company clams its product, which utilizes arketamine, will be more potent than Janssen’s esketamine nasal spray, Spravato, which made history last year as the first psychedelic-type substance approved by the U.S. Food and Drug Administration (FDA) for treatment resistant depression.

In February, the initial stage of Perception Neuroscience’s two-stage study of PCN-101 found intravenous infusions were safe and well tolerated at all doses up to the highest dose tested of 150mg among 58 healthy adult participants. Perception is a subsidiary of atai.

As we await atai’s public debut, MindMed (MNMD) and Compass Pathways (CMPS) are the only two psychedelic focused companies currently listed on the Nasdaq, both of which went public within the last year. Compass Pathways has raised roughly $117 million since its launch in 2016, which is higher than any other psychedelic firm.

Earlier this month, MindMed received Type C Meeting Responses from the FDA that will allow the company to move forward with its prospective LSD treatment, dubbed Project Lucy, for Generalized Anxiety Disorder. MindMed’s goal is to launch its Phase 2 Study MMED008, which will include 200 patients, in Q4 of this year.

Compass Pathways, meanwhile, is pursuing research into a synthesized formulation of psilocybin, known as COMP360, as a potential treatment for mental health disorders, including major depressive disorder.

A study from the Centre of Psychedelic Research at Imperial College London concluded that psilocybin therapy is just as, if not more, effective at reducing depression than the current leading antidepressants. The trial analyzed 59 people with moderate to severe depression and lasted six weeks.

The results, published in the New England Journal of Medicine, revealed that while depression scores were reduced in both groups, reductions from psilocybin therapy occurred much faster and were greater in magnitude.

Promising Results Shift Public Perception

The surge of investment interest is not just speculative, as the volume of psychedelic research has grown significantly over the last decade. Bloomberg recently reported that the number of papers focused on psychedelic drugs in the Web of Science database of has more than doubled from 339 in 2010 to 688 in 2019.

One paper from the Multidisciplinary Association for Psychedelic Studies, cited by Forbes, found that 67% of participants who received three treatments of MDMA assisted therapy no longer qualified for a PTSD diagnosis, while 88% experienced a clinically significant reduction in symptoms. The study recruited 90 PTSD patients and was done over an 18-week period.

The therapeutic benefits of psychedelic treatment have started to shift the public’s stigmatization as well. A recent survey conducted by Field Trip Health found, in a sample of over 2,000 adults, 37% said they would support the use of psychedelic therapies to treat mental health. Even though 70% of respondents have never tried these drugs, 24% would be open to psychedelic therapies, while 23% said they are curious to learn more about the process.

Further, current treatments for mental health disorders such as opioids have been largely unsuccessful. A study published in healthcare journal Medical Care found that the opioid addiction crisis has cost the U.S. economy more than $78 billion per year, and nearly 50,000 people die from an opioid overdose annually. According to the New York Times, numerous studies have proven psychedelics such as LSD and psilocybin are not addictive and do not cause organ damage in high doses.

A Path Towards Legalization

Psychedelic drugs still have a long way to go before they become broadly legal, but the success of psychedelic therapies have parts of the country changing their perception of the drugs. Cities including Denver, Oakland (CA) and Washington, D.C. have all decriminalized psilocybin. Further, New York City mayoral candidate Andrew Yang has been pushing for the legalization of psychedelic mushrooms, a stance he has held since 2019.

Marijuana Moment reports that California recently voted on a bill that would legalize possession of psychedelics, which is now headed to the senate floor. If enacted, the bill would remove criminal penalties for adults 21 and older holding drugs such as psilocybin mushrooms, LSD, MDMA and DMT. California would be the second state to pass such legislation, after Oregon legalized the drugs last November.

If psychedelic therapies continue to deliver encouraging results, the psychedelic market could reshape the future of medicine and transform the way we treat mental health.

MindMed and Compass

Originally published May 24, 2021.

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Kindred Bio Shares Rise 29% after Achieving 100% Survival Rate in Canine Parvovirus Study

Source: Streetwise Reports   06/03/2021 

Kindred Biosciences Inc. shares reached a new 52-week high after the company reported its parvovirus monoclonal antibody, KIND-030, demonstrated highly positive results in preventing deaths in dogs infected by parvovirus.

Biopharmaceutical company Kindred Biosciences Inc. (KIN:NASDAQ), which is focused on developing therapies that improve and save the lives of pets, yesterday announced “positive results from a pivotal efficacy study of KIND-030 in dogs infected by parvovirus.”

Kindred Biosciences indicated that in the randomized study, KIND-030 was administered to dogs that tested positive for canine parvovirus (CPV) infection. The firm explained that the pre-established primary endpoint in the study was animal survival and reported that the results from the trial showed a 100% survival rate in the treated group compared to a 43% survival rate in the control group. The company stated that the primary endpoint of the study was met, having successfully achieved a 0% mortality rate in the KIND-030 treated dogs versus a 57% mortality rate in the control dogs that were administered a placebo. The company noted that no other supportive care or other treatments were given in the study.

The firm listed that is partnered with Elanco Animal Health Inc. (ELAN:NYSE) to develop KIND-030, which was described as a monoclonal antibody that is currently being used to target CPV. The company advised that KIND-030 works by binding to critical portions of the virus, which prevents the virus from entering the cells.

Kindred Biosciences’ CEO Richard Chin, M.D., stated, “Parvovirus is a devastating disease currently without any available treatment…With 100% efficacy, we believe KIND-030 has the potential to revolutionize the care of these dogs. Instead of a lengthy and expensive hospitalization that is frequently ineffective and can leave the dog with permanent disabilities, the infected dogs can now be treated with a single injection without need for additional supportive care or hospitalization.”

Elanco Animal Health’s President and CEO Jeff Simmons commented, “We are excited to partner with Kindred Bio on this revolutionary treatment that can significantly improve the health and well-being of dogs… With our significant global reach and access to veterinarians and pet owners around the world, Elanco looks forward to leveraging our capabilities and skilled team of experts to advance and commercialize this novel treatment for pets globally.”

Puppy

The company stated that KIND-030 has now shown to be effective as both a prophylactic therapy to prevent clinical signs of canine parvovirus infection and now as a treatment of established parvovirus infection. The firm stated that it expects the data from the latest efficacy study for the therapeutic benefits to be submitted to the U.S. Department of Agriculture (USDA) in June and that approval may be possible prior to the end of 2021.

The firm explained that “CPV is the most significant and contagious viral cause of enteritis in dogs, especially puppies, with mortality rates as high as 91% if untreated and that there are currently no U.S. Food and Drug Administration (FDA) or USDA approved treatments for CPV, nor any other available treatment.”

CPV is most frequently observed in puppies younger than 6 months old, but also may occur in unvaccinated dogs regardless of age. The report listed that there are about 250,000 CPV cases recorded annually in the U.S.

Kindred Biosciences is a biopharmaceutical company based in Burlingame, Calif., that is engaged in developing biologics able to save and improve the lives of family pets. The firm stated that it aims to offer pets medicines that offer the same level of safety and effectiveness that their human family members expect and enjoy. Kindred noted that its strategic development approach is to identify therapeutics that have already proven to be safe and effective for humans and to investigate the use of those compounds to target treatments for cats and dogs.

Kindred Biosciences began the day with a market cap of around $246.3 million with approximately 45.27 million shares outstanding and a short interest of about 3.1%. KIN shares opened slightly lower today at $5.35 (-$0.09, -1.65%) over yesterday’s $5.44 closing price and reached a new 52-week high this afternoon of $7.45. The stock has traded today between $5.20 and $7.45 per share and is currently trading at $7.03 (+$1.59, +29.23%).

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.

Biotech Receives National Cancer Institute Resources Award for Ovarian Cancer Vaccine Program

Source: Streetwise Reports   06/02/2021

The award and other recent developments at Anixa Biosciences are covered in an H.C. Wainwright & Co. report.

In a May 27 research note, H.C. Wainwright & Co. analyst Yi Chen reported recent news concerning two of Anixa Biosciences Inc.’s (ANIX:NASDAQ) development programs.

One, the National Cancer Institute (NCI) awarded resources to Anixa to advance the preclinical studies of its ovarian cancer vaccine candidate targeting AMHR2-ED, Chen noted.

“In our view, the award provides peer validation of the company’s ovarian cancer vaccine program and non-dilutive resources to advance preclinical studies,” he stated.

Through its PREVENT program, the NCI will provide scientific and financial resources to the Cleveland Clinic, working with Anixa, through four milestones. The purpose of PREVENT is to support the preclinical development of innovative cancer interventions and biomarkers, moving them toward clinical trials.

Chen relayed that the first milestone is vaccine immunogenicity and efficacy testing in a mouse model. Anixa will begin this work after contracts are executed and experiments are designed.

The subsequent milestones are development of the expression vector for optimal vaccine production, then vaccine manufacturing following good manufacturing practices and a meeting with the U.S. Food and Drug Administration before an investigational new drug (IND) application filing, followed by good laboratory practice studies and an IND application submission.

Clinical trials of Anixa’s vaccine could commence in 2022, according to H.C. Wainwright estimates.

In other news, Chen indicated, the FDA, in reviewing the IND application for Anixa’s chimeric antigen receptor T-cell (CAR-T) therapy developed with Moffitt Cancer Center, asked for information about the chemistry, manufacturing and controls of the product. Anixa and Moffitt intend to provide the bulk of information within 30 days. As for any assays that may take longer than that to validate, the two firms will submit those when available.

“The agency has recently started to press cell and gene therapy developers to more consistently measure the characteristics of their therapies,” Chen commented. “Therefore, we believe a more rigorous standard would be applied to all players in the space of cell and gene therapies going forward.”

H.C. Wainwright forecasts that a Phase 1 trial of Anixa’s CAR-T could start by the end of this year, 2021.

The investment bank has a Buy rating and an $11 per share price target on Anixa whereas its current share price is $3.93.

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., Anixa Biosciences Inc., Company Update, May 27, 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.

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

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

As of April 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Anixa Biosciences, 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 received compensation from Anixa Biosciences, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Anixa Biosciences, 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 Anixa Biosciences, Inc. during the past 12 months.

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

Biotech Firm Confirms 100% Accuracy of COVID-19 Mutation Assays

Source: Streetwise Reports   06/02/2021

Applied DNA Sciences’ SARS-CoV-2 mutation panel and its validation are discussed in a ROTH Capital Partners report.

In a May 26 research note, ROTH Capital Partners analyst Jonathan Aschoff reported that Applied DNA Sciences Inc. (APDN:NASDAQ) technically validated, through testing, its seven COVID-19 mutation detection assays that comprise its Linea Selective Genomic Surveillance (SGS) SARS-CoV-2 Mutation Panel.

Aschoff described the validation process and provided the results.

Applied DNA tested more than 1,000 SARS-CoV-2-positive samples using its high throughput SGS assays. Then it conducted whole genome sequencing (WGS) on each of the samples. Then, to determine accuracy of all seven assays, the company compared the results of both methods.

“The accuracy was impressive, showing 100% concordance with WGS performed on the same samples,” Aschoff wrote.

The analyst noted that the concerning L452R and E484K mutations are among those that Applied DNA’s assays can detect. Most current Centers for Disease Control and Prevention-designated variants of concern contain one or both of these mutations, and the two can hamper the efficacy of certain emergency use authorization antibody treatments.

Aschoff pointed out that the U.S. desperately needs a better method than WGS for rapid mutation identification, and Applied DNA’s mutation panel can meet it.

“The broad mutant coverage of the SGS assay can be expanded as new concerning mutants arise, thereby avoiding the wasting of sequencing reagents by focusing their use on confirming actual variants rather than also being used to screen viruses of unknown genotype,” he wrote.

In fact, the molecular technology firm is currently developing an assay to detect the E484Q mutation that, together with L452R, comprise the highly infectious B.1.617, or Indian, variant. Once Anixa validates the new assay, it will add it to its mutation panel.

ROTH Capital Partners has a Buy rating on Applied DNA Sciences and a target price of $24 per share. The stock is currently trading at about $5.92 per share.

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 ROTH Capital Partners, Applied DNA Sciences, Inc., Company Note, May 26, 2021

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

Disclosures:
Within the last twelve months, ROTH has received compensation for investment banking services from Applied DNA
Sciences, Inc.
ROTH makes a market in shares of Applied DNA Sciences, Inc. and as such, buys and sells from customers on a principal
basis.

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

Constellation Pharma Shares Sparkle on $1.7 Billion Buyout Offer

Source: Streetwise Reports   06/02/2021

Shares of Constellation Pharmaceuticals Inc. traded 65% higher after the company reported it entered into an agreement to be acquired by MorphoSys AG in an all-cash transaction for $34 per share.

Clinical-stage biopharmaceutical company Constellation Pharmaceuticals Inc. (CNST:NASDAQ), which is focused on the development of novel therapeutics that selectively modulate gene expression for treatment of cancer patients, today announced that it has entered into a definitive agreement to be acquired by MorphoSys AG (MOR:NASDAQ; MOR:GSE).

The firms indicated that under the terms of the agreement, “MorphoSys will acquire Constellation for $34.00 per share in cash, which represents a total equity value of $1.7 billion.” The report advised that both MorphoSys’ Management and Supervisory Boards along with Constellation’s Board of Directors have already approved the transaction. The acquisition is expected to close in Q3/21 subject to Constellation shareholder and regulatory approvals.

Constellation stated that it utilizes its expertise in epigenetics to discover and develop new therapeutics to treat cancer patients with serious unmet medical needs. The report listed that that Constellation’s leading product candidates include pelabresib (CPI-0610), a BET inhibitor currently in Phase 3 clinical trials for myelofibrosis, a bone marrow cancer, and CPI-0209, a second-generation EZH2 inhibitor that is now being studied is a Phase 2 trial in treating hematological and solid tumors.

MorphoSys’ CEO Jean-Paul Kress, M.D., stated, “This transformational acquisition represents a major step forward for MorphoSys as we bolster our position in hematology-oncology…Both pelabresib and CPI-0209 have broad potential and we look forward to unlocking their full benefits for cancer patients. Our existing clinical and commercial expertise is ideally suited to accelerate Constellation’s programs, enabling us to maximize Constellation’s potential and bring these novel therapies to market. With Constellation’s high-potential product candidates, complementary R&D capabilities, and outstanding team, we can further advance our mission in the fight against cancer.”

Jigar Raythatha, president and CEO of Constellation Pharmaceuticals, remarked, “We are proud that MorphoSys has recognized the strength of our team, our expertise in epigenetics, and our high-potential oncology development pipeline and discovery programs…Becoming part of MorphoSys creates an industry leader with commercial capabilities, a deep R&D pipeline and complementary small molecule and biologics discovery and translational capabilities, as well as the financial strength to compete to win. Our shareholders will receive attractive, immediate and certain cash value for their shares, the employees of the combined entity will have a broader platform and greater opportunities, and patients will potentially benefit from innovative new therapies that address serious unmet needs.”

As part of MorphoSys business and funding strategy, MorphoSys also announced it entered into a long-term partnership with Royalty Pharma Plc. (RPRX:NASDAQ), which will coincide with the closing of the transaction with Constellation. The arrangement is set to include an upfront royalty payment of $1.425 billion from Royalty Pharma to MorphoSys that will support the financing of the Constellation purchase and the newly combined firm’s drug pipeline development and overall growth strategy.

In addition, Royalty Pharma will provide MorphoSys with access to up to $350 million in development funding and upon reaching clinical, regulatory and commercial milestones for otilimab, gantenerumab and pelabresib, will make additional payments of up to $150 million to MorphoSys.

In return, “Royalty Pharma will have the rights to receive 100% of MorphoSys’ royalties on net sales of Tremfya®, 80% of future royalties and 100% of future milestone payments on otilimab, 60% of future royalties on gantenerumab, and 3% on future net sales of Constellation’s clinical stage assets (pelabresib and CPI-0209).”

Furthermore, subject to corporate and regulatory approvals, Royalty Pharma is expected to invest $100 million in a cash capital increase of MorphoSys.

Royalty Pharma’s CEO Pablo Legorreta commented, “In acquiring Constellation, MorphoSys has a significant opportunity to drive clinical and commercial success…We are excited to join forces to further advance the combined company’s pipeline and positively impact patients.”

MorphoSys is based in Munich, Germany, and is a commercial-stage biopharmaceutical firm that concentrates its efforts on developing and commercializing treatments for cancer and autoimmune diseases. The company is advancing a pipeline of new drug candidates and has created antibodies which have been previously developed by partners in to meet unmet medical needs. The firm noted, “In 2017, Tremfya® (guselkumab) – developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis – became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.”

The company added that, in July 2020, “the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company’s proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.”

Constellation Pharma is a clinical-stage biopharmaceutical company based in Cambridge, Mass., that is engaged in creating novel therapeutics that selectively modulate gene expression in treating cancer patients. The firm stated that “it has a deep understanding of how epigenetic and chromatin modifications in cancer cells and in the tumor and immune microenvironment play a fundamental role in driving disease progression and drug resistance.”

Constellation Pharmaceuticals began the day with a market capitalization of around $969.8 million with approximately 47.92 million shares outstanding and a short interest of about 16.0%. CNST shares opened nearly 67% higher today at $33.71 (+$13.47, +67.19%) over yesterday’s $20.24 closing price. The stock has traded today between $33.695 and $33.87 per share and closed at $33.57 (+$13.33, +65.86%).

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.