Atossa Reports Progress & Results Timeline For Male Breast Enlargement Trial

Seattle based Atossa Genetics Inc. (ATOS) (“Atossa”) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement.

Mayo Clinic Research

According to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen.  For example, in prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting in higher estrogen levels that usually triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.

 

 

 

 

 

Progress Announced!

Today, Atossa announced progress in its Phase 1 study of its proprietary topical Endoxifen in men as it has reported that it has completed dosing and clinical visits. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.

Steve Quay, Ph.D., M.D., President and CEO of Atossa stated, “We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data. We expect to report preliminary results from the study in the next quarter.”

Atossa Reaches Further

In addition to gynecomastia, Atossa is also developing its proprietary topical Endoxifen to reduce Mammographic Breast Density (MBD), which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 34 U.S. states have enacted laws requiring that findings of MBD be communicated to the patient. And according to the National Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RADS level C or D with “D” being the highest). Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of, oral tamoxifen. There is no FDA-approved treatment for MBD.

Atossa is planning a Phase 2 study of its topical Endoxifen in women with MBD. The study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

The primary endpoint of this study is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months. Secondary endpoints are safety and tolerability. The objective of the study is to determine the effect size on MBD between the placebo and active groups, which will permit sample size calculations in a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

Shares Surge

Shares of Atossa (ATOS) surged to as high as $3/share and traded ~2.62 million shares today and closed at $2.63/share up +5.2%.

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report and maintained his “Buy rating” and his $10/price target.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Atossa Genetics Completes all Dosing and Clinical Visits in its Phase 1 Study of Topical Endoxifen in Men

Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has completed dosing and clinical visits in its Phase 1 study of its proprietary..

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“Hello Volatility” Vista Partners Weekly Market Update 6-16-18

Vista Partners has published “Hello Volatility” Vista Partners Weekly Market Update 6-16-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies & “Investor Picks”, where we have begun to selectively add those companies/ideas that we are receiving from investors around the world.

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Breast Cancer Innovator Atossa Genetics Adds Former Pfizer & Janssen Pharmacuetica NV Execs To SAB

Seattle based Atossa Genetics Inc. (ATOS) (“Atossa”) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  This week, Atossa appointed two additional pharmaceutical executives to its strategic advisory board (“SAB”) as they named former Pfizer executive, Dr. Makarand (Mak) Jawadekar and Dr. Ajit Shetty, Chairman of the Belgium-based Flemish Institute of Biotechnology and former Janssen Pharmaceutica NV executive. The board is positioned to play a key role in a number of important strategic initiatives in accelerating the clinical development of Atossa’s programs.

Steven Quay, Ph.D., MD, President and CEO of Atossa stated, “We are very excited to have both Dr. Jawadeker and Dr. Shetty join our advisory board.  Each of these lauded industry veterans brings unique sets of talents and experiences to our company. Their insights and direction will be invaluable in developing our strategic initiatives to advance our therapeutics.

Dr. Mak Jawadekar’s professional career at Pfizer, Inc. spanned 28 consecutive years, most recently as a Director, Portfolio Management. During his career at Pfizer, he was responsible for the Drug Delivery Technology Assessment function involving external ‘Drug Delivery’ technologies and has extensive experience in creating and cultivating external partnerships and alliances in this area. He began his professional career at Pfizer Central Research in early 1982, after having completed his Ph.D. in Pharmaceutics at the University of Minnesota. Mak was honored with an honorary D.Sc. degree by DYP Mumbai University, recommended by the President of India in Feb 2011. His years of experience with Pfizer Global R&D includes Solids R&D, Drug Product Formulation/ Dosage Form/Drug Delivery development, Clinical Trials Supply Manufacturing, and Scale-up and Technology Transfer & Research Pharmacy functions. At Pfizer he was also a bench scientist, working on many challenging commercial formulations which became multibillion-dollar products.

Dr. Shetty spent his 40-plus year career at Janssen Pharmaceutica NV in Belgium (a Johnson & Johnson company) in which he drove the expansion of the Janssen Group of Companies through geographical expansion, new product introduction, and significant market share growth. In his prior capacity as President of Janssen Pharmaceutica USA, Dr. Shetty launched Janssen USA into the largest pharmaceutical market. Currently, Dr. Shetty is Chairman of the Belgium-based Flemish Institute of Biotechnology, one of the world’s top-ten research institutions. In 2008, he was awarded the title of Baron by the King of Belgium and in 2004 was elected Manager of the Year by Trends/Flemish Management Association. He is a member of the Board of Directors at Agile Therapeutics, Actinium Pharmaceuticals, and is a member of the Board of Trustees of Carnegie Mellon University.

 

 

 

 

 

 

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Atossa Genetics Appoints Two Additional Prominent Industry Executives to Strategic Advisory Board

Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced the appointment of two additional pharmaceutical executives to its strategic advisory..

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“Bullish in SoCal” Vista Partners Weekly Market Update 6-9-18

Vista Partners has published “Bullish in SoCal” Vista Partners Weekly Market Update 6-9-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies & Now “Investor Picks”, where we have begun to selectively add those companies/ideas that we are receiving from investors around the world.

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Read “Summer Moves” Vista Partners Weekly Market Update 6-2-18

Vista Partners has published “Summer Moves” Vista Partners Weekly Market Update 6-2-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies & Now “Investor Picks”, where we have begun to selectively add those companies/ideas that we are receiving from investors around the world.

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Atossa Genetics Closes Net Proceeds of $12.1M From Rights Offering- Sees CE0, CFO Insiders Participate

Seattle based Atossa Genetics Inc. (NasdaqCM: ATOS) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.

According to Atossa Genetic’s latest 8k filing, Atossa, on May 30, 2018,  completed its previously announced rights offering pursuant to its effective registration statement on Form S-1, as amended (Registration Statement No. 333-223949), previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”), and a prospectus filed with the SEC (the “Rights Offering”).

Pursuant to the Rights Offering, the Company sold an aggregate of 13,324 units consisting of an aggregate of 13,324 shares of Series B Preferred Stock and 3,784,016 warrants, with each warrant exercisable for one share of Common Stock at an exercise price of $4.05 per share, resulting in net proceeds to the Company of approximately $12.1 million, after deducting expenses relating to the Rights Offering, including dealer-manager fees and expenses, and excluding any proceeds received upon exercise of any warrants. In connection with the Rights Offering, the Company entered into a Warrant Agency Agreement with VStock Transfer, LLC. A copy of the agreement is filed as Exhibit 4.1 to this report and is incorporated by reference herein.

Also,  according to Form 4’s filed 5-31-18 with the SEC, Atossa realized insider buying as their CEO, Steven Quay &  their CFO Kyle Guse & an insider, Chen Shu-Chih, invested in this recent rights offering. Note that CFO Kyle Guse purchased stock in the Fall 2017.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

 

 

 

 

 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Vista Partners Publishes May’s FREE Macroeconomic & Investment Monthly Newsletter – “The Balancing Act”

Vista Partners (“Vista”) has published May’s FREE Macroeconomic & Investment Monthly Newsletter titled “The Balancing Act.”

Vista’s monthly newsletter contains investment considerations for Banks, Biotech, Cloud Services, Energy, Fintech, Healthcare, Manufacturing, Materials, Mining, Real Estate, SaaS, and Technology in addition to the Macroeconomic commentary.

Vista Partners centers its Coverage on the Dow 30 Components, Select Emerging Growth Companies & Vista’s Featured Companies, with exclusive, broad-based commentary from Managing Director, John F. Heerdink, Jr.

In May’s edition of the Macroeconomic & Investment Newsletter, Mr. Heerdink states, “The Federal Open Market Committee will hold its next meeting on June 12 to 13 and is still widely expected to raise short-term interest rates by a quarter percentage point. It’s a juggling act. On the one hand, ….” Read full newsletter.

Companies Featured in March’s Newsletter:

Companies Featured in April’s Newsletter: Atossa Genetics, Inc.(NASDAQ: ATOS) | Caterpillar (CAT) | Coca-Cola (KO) |  Fusion, Inc. (NASDAQ: FSNN) | & | United Technologies (UTX).

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“Kicking Off Summer” Vista Partners FREE Weekly Market Update 5-26-18

Vista Partners has published “Kicking Off Summer” Vista Partners FREE Weekly Market Update 5-26-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies & Now “Investor Picks”, where we have begun to selectively add those companies/ideas that we are receiving from investors around the world.

Each weekly update issue is sent out via email directly to the thousands of investors around the world that have elected to be updated each week. Please “Join us” Today!

 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Breast Cancer Innovator Atossa Genetics Accepts Subscriptions For ~$13.4MM Gross Proceeds Rights Offering

Seattle based Atossa Genetics Inc. (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast condition,  announced today that the Company’s previously announced rights offering (“the Rights Offering”) expired on Thursday, May 24, 2018 and these rights are no longer exercisable. The Company reports that it has accepted all valid subscriptions that were presented and estimates that the Rights Offering will result in ~$13.4MM in gross proceeds. The results of the Rights Offering and Atossa’s estimates regarding the aggregate gross proceeds of the Rights Offering to be received by Atossa are subject to finalization and verification by Atossa and its subscription agent. Atossa engaged Maxim Group LLC as dealer-manager in the offering. Questions about the rights offering may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745.

Atossa expects the closing of the Rights Offering will occur on or about May 30, 2018 subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book­-entry form or through the facilities of DTC, as applicable, shares of its Series B Convertible Preferred Stock and warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into 284 shares of common stock at a conversion price of $3.52 per share) and 284 warrants with an exercise price of $4.05. The warrants will be exercisable for 4 years after the date of issuance.

Atossa Genetics (ATOS) also recently received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement). The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects are to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight subjects) and concluded that the study may advance to the final dosing level.

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).  According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

Shares of ATOS are currently trading at $3.30, up +0.10/share  or +3.12% today.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

 

 

 

 

 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Atossa Announces $13.4 Million in Expected Gross Proceeds from Recently Expired Rights Offering

Atossa Genetics Inc. (“Atossa” or “the Company”) announced today that the Company’s previously announced rights offering (“the Rights Offering”) expired on Thursday, May 24, 2018, and these rights are no longer exercisable. The Company accepted all valid subscriptions that were presented…

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“Little Russell Rules The Week” Vista Partners Weekly Market Update 5-19-18

Vista Partners has published “Little Russell Rules The Week” Vista Partners Weekly Market Update 5-19-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies & Now “Investor Picks”, where we have begun to selectively add those companies/ideas that we are receiving from investors around the world.

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Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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