REMINDER & UPDATE: Atossa Genetics (ATOS) Proposed Rights Offering ***Record Date Is May 9, 2018***

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 conditions, published a reminder today that confirmed the record date for its proposed rights offering is May 9, 2018. In order to be a shareholder of record for this offering, Atossa stock must be purchased by market close on May 7, 2018 (TODAY), to account for two-day settlement.

Atossa has engaged Maxim Group LLC as dealer-manager in the offering. Further questions about the rights offering or requests for copies of the prospectus, when available, 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.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at https://www.sec.gov/Archives/edgar/data/1488039/000161577418002120/s109466_s1.htm. Copies of the preliminary and final prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, email: syndicate@maximgrp.com or telephone (212) 895-3745.

 

 

 

 

 

 

Atossa also offered the following summary of the rights offering:

Under the proposed rights offering, Atossa will distribute one non-transferable subscription right for each share of common stock held on the record date. Each right will entitle 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.

The subscription rights are non-transferable and may only be exercised during the anticipated subscription period of Thursday, May 10, 2018 through 5:00 PM ET on Thursday, May 24, 2018, unless extended by Atossa.

Investors are advised to ensure they own Atossa’s stock as of 4:00 PM ET on Monday, May 7, 2018 to be considered a stockholder of record on Wednesday, May 9, 2018, to take into account two-day settlement.

The expected calendar for the rights offering is as follows:

  • Monday, May 7, 2018: Ownership Day — in order to be considered a stockholder of record on Wednesday, May 9, 2018, shares should be acquired by this date
  • Wednesday, May 9, 2018: Record Date
  • Thursday, May 10, 2018: Distribution Date; Subscription Period Begins
  • Thursday, May 24, 2018: Subscription Period Ends 5:00 PM ET (unless extended at Atossa’s sole discretion)
  • Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other shareholders, on a pro-rata basis and subject to ownership limitations.

Maxim Group LLC issued an updated research report Thursday, May 3, 2018, which contained a $10 target price.

Atossa (ATOS) shares are currently trading at $4.17 up 5.23% today.

 

 

 

 

 

Atossa announced recently that it had received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density or MBD.

The Phase 2 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. Atossa plans to open the study for enrollment this quarter.  The primary endpoint is individual change in MBD, which will be measured after three and six months of entering the study, and the secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups on different doses of topical Endoxifen) with 30 participants per group. The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study. (Read Full Story)

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 Reminds Investors of Today’s Deadline to be a Shareholder of Record

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 issued a reminder to shareholders that the record date for its proposed rights offering is May..

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Breast Cancer Innovator Atossa Genetics Adds Former Pfizer & Boehringer Ingelheim Execs To New Strategic Advisory Board

Seattle based Atossa Genetics Inc. (ATOS) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. Today Atossa announced the formation of a strategic advisory board (SAB) comprised of prominent executives from the pharmaceutical industry. The first two exciting additions to Atossa’s SAB included:

  1. Bob Miglani who worked at Pfizer Inc. in roles of increasing responsibility over the course of 23 years, spanning many functions including sales, marketing research, pricing and reimbursement, communications, patient advocacy, market access, partnership development, strategy and external medical affairs. Bob’s leadership helped Pfizer develop strong partnerships with organizations such as the World Medical Association and AARP. In addition, Bob served as Chief of Business Development for a disruptive startup, Applied DNA Sciences, where he helped bring in a large strategic partner to help grow the company’s business in life sciences. As a thought leader, Bob speaks to organizations globally on new and exciting technologies in healthcare, global change and embracing disruption.

2. Prof. Joseph M. Chalil, MD, MBA, FACHE, is an expert in Pharmaceutical and Biotechnology Clinical Development and Medical Affairs with over 17 years’ experience in the field. Dr. Chalil is a member of Healthcare Advisory Board and an Adjunct Professor at Nova Southeastern University in Florida. He is the current Chairman of the Global Clinical Trial Network of American Association of Physicians of Indian Origin (AAPI), the second largest physician organization in the U.S., second only to AMA. Bob was also a Physician Executive at Boehringer Ingelheim and a veteran of the U.S. Navy Medical Corps, Dr. Chalil is also board certified in healthcare management, and has been awarded Fellowship by the American College of Healthcare Executives, an international professional society of more than 40,000 healthcare executives who lead hospitals, healthcare systems, and other healthcare organizations.

Steven Quay, Ph.D., MD, President and CEO of Atossa stated, “Our strategic advisory board will play a key role in a number of important initiatives, including seeking partners in the pharmaceutical industry to accelerate the clinical development of our Endoxifen programs. Mr. Miglani and Dr. Chalil have demonstrated success with numerous partnerships and business development efforts at two of the largest and most highly-regarded companies in the pharmaceutical industry. We believe they will make valuable contributions to our strategic advisory board as we identify and execute arrangements to help bring our therapeutics to market.”

Earlier in the week, Atossa saw their shares jump significantly hitting an intraday high of $4.59/share & then closed up +29.97% at $4.38/share on ~4,150,000 in trading volume. This move came after Atossa announced that it had received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density or MBD.

The Phase 2 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. Atossa plans to open the study for enrollment this quarter.  The primary endpoint is an individual change in MBD, which will be measured after three and six months of entering the study, and the secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups on different doses of topical Endoxifen) with 30 participants per group. The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study.

The company also reported that studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.

Dr. Steven C. Quay, CEO and President of Atossa stated, “Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention. He is heading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen. We are honored to be working with Dr. Hall and his colleagues on our Phase 2 study of MBD as their unique experience and qualifications are simply unmatched anywhere in the world.”

The Medical Products Agency is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing, and sale of medicinal drugs, medical devices, and cosmetics. & is a government body under the aegis of the Swedish Ministry of Health and Social Affairs. Its operations are largely financed through fees. Approximately 750 people work at the agency; most are pharmacists and doctors.

Stockholm South General Hospital is one of the largest hospitals in Sweden, offering care to more than two million Stockholmers. It is one of four hospitals collaborating with Karolinska on the KARMA project. For more information, please visit http://www.sodersjukhuset.se/Functions/InEnglish/.

Karolinska Institutet, located in Stockholm, Sweden, is one of the world’s foremost medical universities. Its vision is to make a significant contribution to the improvement of human health; its mission is to conduct research and education and to interact with the community. As a university, KI is Sweden’s single largest center of medical academic research and offers the country’s widest range of medical courses and programs. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology or Medicine. For more information, please visit www.ki.se/en and www.KARMAstudy.org.

The American Cancer Society (ACS) estimates that approximately 268,000 women will be diagnosed with breast cancer in the United States this year and that approximately 41,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that in 2018 2,550 new cases of invasive breast cancer will be diagnosed in men, and 480 men will die from breast cancer.

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 Forms Strategic Advisory Board to Accelerate Growth

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 formation of a strategic advisory board comprised of prominent executives from the..

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HIIQ Beats Earnings Estimates – Cantor Fitzgerald Reaffirms Buy Rating & $60 Target Price

Health Insurance Innovations, Inc. (HIIQ), a leading cloud-based technology platform and distributor of affordable individual and family health insurance and supplemental plans, announced financial results for the first quarter ended March 31, 2018 today. The Company reaffirmed its annual guidance of revenue for 2018 to be between $290M and $300M or grow approximately 15% to 20% year-over-year, adjusted EBITDA to be between $54M and $57M or grow approximately 20% to 25% YOY and adjusted EPS to be between $2.45 and $2.55 or grow approximately 48% to 55%YOY.  These guidance numbers are based on the Company’s current method of accounting for revenue.  As an emerging growth company, it will be adopting the revised revenue recognition standard, known as ASC 606, in the fourth quarter of 2018.

Gavin Southwell, HIIQ’s Chief Executive Officer and President stated, “Following a Q4 of 2017 that exceeded all expectations due to the shortened open enrollment period, the first quarter of 2018 has performed as expected, and we have record policies in force coupled with an outstanding compliance performance. As our market continues to evolve our first quarter provides an excellent foundation for the launch of our next generation of technology and the rest of 2018.”

HIIQ Reported These Q1 2018 Financial Highlights

  • Revenue was $67.8M, compared to $55.9M in the first quarter of 2017, an increase of 21.3%.
  • Total collections from members (premium equivalents) of $105M compared to $90.9M in the first quarter of 2017, an increase of 15.5%.
  • Net income was $6M, compared to $8.5M in the first quarter of 2017, a decrease of 29.4%. Drivers include higher stock-based compensation in the first quarter of 2018 and a one-time tax benefit in the first quarter of 2017.
  • Adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization) was $11.9M, compared to $9.7M in the first quarter of 2017, an increase of 22.7%.
  • GAAP diluted earnings per share were $0.33, compared to $0.58 in the first quarter of 2017, a decrease of 43.1%. Drivers are consistent with the change in net income.
  • Record adjusted earnings per share also referred to as adjusted net income per share, or adjusted EPS was $.52 compared to $.36 in the first quarter of 2017, an increase of 44.4%.
  • Record policies in force as of March 31, 2018, totaled approximately 383,200, compared to 345,000 in the first quarter of 2017, an increase of 11.1%.

The investment bank Cantor Fitzgerald issued and update report post HIIQ posting results and manintained their overweight buy rating and their price target of $60/share.

HIIQ shares closed at $27.65/share.

To learn more about HIIQ and to track its ongoing progress please visit the Vista Partners HIIQ 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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Health Insurance Innovations, Inc. Reports First Quarter 2018 Financial and Operating Results

Revenues of $67.8 million, up 21.3% YOY Record Policies in Force totaled approximately 383,200, up 11.1% YOY GAAP Diluted Earnings per Share of $0.33, down 43.1% YOY Record Adjusted Earnings per Share …..

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Merck Surpasses Q1 Earnings Estimates

Merck & Co., Inc.  (MRK) is a global healthcare solutions provider that has been working towards bringing forward medicine and vaccines for some the of the world’s most challenging diseases for more than a century.  They are committed to increasing health care access and continue to be at the leading edge of research.

Merck surpassed the earnings estimates of $1.004/share with reported earnings of $1.05 on May 1, 2018. The company also reported Q1  global sales of $10B, which was a 6% increase from Q1 2017. The Q1 2018 GAAP EPS of $.27 directly reflected a $1.4B aggregate charge that was related to the formation of the Merck’s collaboration with Eisai.

With a relatively 2% positive impact from foreign exchange, Merck has narrowed and raised the 2018 full-year revenue range to $41.8B – $43B.

Net income was reported at $736M which is down from Q1 last year.

Kenneth C. Frazier, Merck Chairman, and CEO“Merck had a strong start to the year driven by KEYTRUDA, GARDASIL, BRIDION and Animal Health. This provides good momentum as we continue to execute on our pillars of growth and look to deliver innovative medicines and vaccines that address unmet needs for patients around the world.”

To learn more about Merck (MRK) and to track its ongoing progress please visit the Vista Partners Merck Coverage Page. 

 

Photo of a Person Holding a Cup

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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High Angle View of Suspension Bridge Against Sky

 

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Shares of Atossa Genetics Jump Post Mammographic Breast Density Phase 2 Trial Announcement

Seattle based Atossa Genetics Inc. (ATOS),  a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, saw their shares jump significantly today hitting an intraday high of $4.59/share & then closed up +29.97% at $4.38/share on ~4,150,000 in trading volume. This move came after Atossa announced that it had received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density or MBD.

The Phase 2 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. Atossa plans to open the study for enrollment this quarter.  The primary endpoint is individual change in MBD, which will be measured after three and six months of entering the study, and the secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups on different doses of topical Endoxifen) with 30 participants per group. The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study.

The company also reported that studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.

Dr. Steven C. Quay, CEO and President of Atossa stated, “Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention. He is heading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen. We are honored to be working with Dr. Hall and his colleagues on our Phase 2 study of MBD as their unique experience and qualifications are simply unmatched anywhere in the world.”

The Medical Products Agency is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing, and sale of medicinal drugs, medical devices, and cosmetics. & is a government body under the aegis of the Swedish Ministry of Health and Social Affairs. Its operations are largely financed through fees. Approximately 750 people work at the agency; most are pharmacists and doctors.

Stockholm South General Hospital is one of the largest hospitals in Sweden, offering care to more than two million Stockholmers. It is one of four hospitals collaborating with Karolinska on the KARMA project. For more information, please visit http://www.sodersjukhuset.se/Functions/InEnglish/.

Karolinska Institutet, located in Stockholm, Sweden, is one of the world’s foremost medical universities. Its vision is to make a significant contribution to the improvement of human health; its mission is to conduct research and education and to interact with the community. As a university, KI is Sweden’s single largest center of medical academic research and offers the country’s widest range of medical courses and programs. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology or Medicine. For more information, please visit www.ki.se/en and www.KARMAstudy.org.

The American Cancer Society (ACS) estimates that approximately 268,000 women will be diagnosed with breast cancer in the United States this year and that approximately 41,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that in 2018 2,550 new cases of invasive breast cancer will be diagnosed in men, and 480 men will die from breast cancer.

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.
Stay Informed! Stay Competitive!
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Atossa Genetics Receives Approval from the Swedish Medical Products Agency for Phase 2 Topical Endoxifen Study

SEATTLE, April 30, 2018– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, announced …..

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Schedule Set For HIIQ To Announce Q1 Earnings After Market Closes Wed., May 2

A leading cloud-based technology platform and distributor of affordable health plans, Health Insurance Innovations, Inc. (HIIQ),  is scheduled to announce its Q1 2018 earnings after the market close Wednesday, May 2, 2018.

HIIQ will host an earnings conference call on Thursday, May 3, 2018, at 8:30 a.m. Eastern time. The dial-in numbers are: (877) 407-9039 (domestic), (201) 689-8470 (international). The conference passcode is 13679140. This call will be webcast and can be accessed using the conference passcode 13679140, on the Investor Relations section of the company’s website at http://investor.hiiquote.com/. The online replay will be available for a limited time beginning immediately following the call.

Post last quarters results, HIIQ announced that it expects annual revenue for 2018 to be between $290 million and $300 million or grow approximately 15% to 20% year-over-year, adjusted EBITDA to be between $54 million and $57 million or grow approximately 20% to 25% year-over-year and adjusted EPS to be between $2.45 and $2.55 or grow approximately 48% to 55% year-over-year. These guidance numbers were based on the Company’s current method of accounting for revenue.

To learn more about HIIQ and to track its ongoing progress please visit the Vista Partners HIIQ 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.
Stay Informed! Stay Competitive!
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Health Insurance Innovations, Inc. to Announce First Quarter 2018 Financial and Operating Results on Wednesday, May 2, 2018

TAMPA, Fla., April 24, 2018– Health Insurance Innovations, Inc., a leading cloud-based technology platform and distributor of affordable health plans, will announce its first quarter 2018 financial and …..

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Atossa Genetics Receives Positive Interim Review in Phase 1 Topical Endoxifen Dose Escalation Study in Men & Updates Shareholders On 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 conditions, announced this week that it has received a positive interim review on its Phase 1 study of topical endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), which is a common condition in patients being treated for prostate cancer. The Independent Safety Committee reviewed the blinded data generated from the first group in the study (eight subjects) and concluded that the study may advance to the next 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). There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.

“This positive safety determination is on the critical path for a successful outcome of this Phase 1 study in men,” stated Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa. “It is the first assessment of our clinical safety and tolerability data and it indicates that proceeding to the next dosing level with our proprietary topical endoxifen is warranted. We can now advance to the next level of the study which is to escalate the dosage in a new cohort of subjects as we continue to monitor safety and tolerability in the first cohort of the study.” Dr. Quay added, “We believe this is the first clinical trial ever conducted of a topical pharmaceutical for the treatment of gynecomastia. There are no approved drugs, either topical or oral, for this important, unmet medical need which affects 25% of men ages 50-69.”

The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is 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.

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.

ATOSSA RIGHTS OFFERING UPDATE

Atossa also provided an informational update to stockholders regarding its rights offering and the key dates and terms relative to the offering which is below:

Stockholders are advised to ensure they complete their open market purchases of Atossa common stock by 5:00 PM ET on Monday, May 7, 2018, to be considered a stockholder of record on Wednesday, May 9, 2018. Holders of the Company’s warrants issued on December 22, 2017, are also invited to participate in the rights offering on the same terms as the stockholders. Stockholders or interested parties are advised to direct all questions and information requests to the contacts listed below.

Under the proposed rights offering, Atossa will distribute one non-transferable subscription right for each share of common stock held on the record date. The subscription rights will be exercisable for up to an aggregate of $20.0 million of units. Each right will entitle 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) and 284 warrants with an exercise price of $4.05. The warrants will be exercisable for 4 years after the date of issuance.

The subscription rights are non-transferable and may only be exercised during the anticipated subscription period of Thursday, May 10, 2018, through 5:00 PM ET on Thursday, May 24, 2018, unless extended by Atossa.

The expected calendar for the rights offering is as follows:

  • Monday, May 7, 2018: Ownership Day — in order to be considered a stockholder of record on
  • Wednesday, May 9, 2018: Shares should be acquired by this date.
  • Wednesday, May 9, 2018: Record Date
  • Thursday, May 10, 2018: Distribution Date; Subscription Period Begins
  • Thursday, May 24, 2018: Subscription Period Ends 5:00 PM ET (unless extended at Atossa’s sole discretion)

Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other shareholders, on a pro rata basis and subject to ownership limitations.

Atossa has engaged Maxim Group LLC as dealer-manager in the offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, 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.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at https://www.sec.gov/Archives/edgar/data/1488039/000161577418002120/s109466_s1.htm. Copies of the preliminary and final prospectuses for the rights offering may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, email: syndicate@maximgrp.com or telephone (212) 895-3745.

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.
Stay Informed! Stay Competitive!
Join us at Vista Partners! It’s FREE to receive email updates.

Atossa Genetics Receives Positive Interim Review from Independent Safety Committee in Phase 1 Topical Endoxifen Dose Escalation Study 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 received a positive interim review on its Phase 1 study of topical endoxifen..

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Learn More About The AACR Annual Meeting 2018: “Driving Innovative Cancer Science to Patient Care”

The mission of the American Association for Cancer Research (AACR) is to prevent and cure cancer through research, education, communication, and collaboration. Through its programs and services, the AACR fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

The AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attract the premier researchers in the field. The programs and services of the AACR foster the exchange of knowledge and new ideas among scientists dedicated to cancer research, provide training opportunities for the next generation of cancer researchers and increase public understanding of cancer.

Currently, AACR is holding its AACR Annual Meeting for 2018 in Chicago, Illinois (April 14-18, 2018). This event is one of the main international oncology events highlighting the best cancer science and medicine from institutions all over the world. This years’ Annual Meeting is called “Driving Innovative Cancer Science to Patient Care.” Scientists are harnessing the power of mathematics, engineering, and artificial intelligence to diagnose cancer at an earlier stage. They are also concentrating their efforts on cancer in minorities and the medically underserved, working to eliminate the persistent disparities in cancer outcomes. All of these developments are reflected in the theme.

Four companies under coverage at Vista Partners that have businesses with concerns that relate directly or indirectly to cancer are as follows: Atossa Genetics (ATOS),  Health Insurance Innovations (HIIQ), Johnson & Johnson (JNJ), Merck (MRK) & Pfizer (PFE). Please visit our Coverage section to learn more 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 Therapy Innovator Atossa Genetics Announces Progress in Phase 1 study of Topical Endoxifen in Men

Recently, breast cancer therapy innovator, Seattle based Atossa Genetics (NasdaqCM: ATOS), announced that it has fully enrolled the first of three cohorts in its Phase 1 study of its proprietary topical Endoxifen in men. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of proprietary 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. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.

Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa, commented that “We are very impressed with the speed at which this program is progressing. The first of three cohorts is now enrolled and we expect to enroll the other two cohorts this quarter. This study should serve as a basis for future development into mens’ breast health, including male breast cancer and gynecomastia, which affects 1 in 4 men between ages 50-69 and up to 90% of men taking androgen deprivation therapy for prostate cancer. Men being treated for prostate cancer currently have limited options to address the gynecomastia that is associated with their cancer treatment, such as breast-bud irradiation, estrogen suppression therapy and surgery.”

Gynecomastia is male breast enlargement and accompanying pain. There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia. 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 in 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.

Similar to women, the treatment for male breast cancer is typically surgery (with or without radiation) and chemotherapy. Breast cancer in men is deadlier than breast cancer in women: men with early-stage breast cancer have a lower five-year survival rate than women and breast cancer in men tends to be detected at a later stage of development than women (Jon M. Greif, DO, FACS, et al., May 2012, American Society of Breast Surgeons). Although tamoxifen is the standard of care for women to prevent new and recurrent breast cancer, there is no FDA-approved treatment for male breast cancer.

Oral tamoxifen has been widely used for over 40 years to both treat and prevent breast cancer. Tamoxifen, however, has significant drawbacks: First, it can cause side effects including headaches, nausea and early menopausal symptoms as well as rare but serious side effects such as cataracts, strokes, and cancer of the uterus. Second, tamoxifen is a “pro-drug,” meaning that it must be processed by the liver in order to produce therapeutic (“active”) metabolites. The metabolite in tamoxifen that accounts for most of its therapeutic activity is called Endoxifen. Unfortunately, up to 50% of breast cancer survivors who are taking tamoxifen do not produce therapeutic levels of Endoxifen (meaning they are “refractory”) for a number of reasons, including that they, due to their genotype, do not have the requisite liver enzymes. Additionally, it can take from 50-200 days for tamoxifen to reach “steady-state” meaning that the drug may be providing little or no benefit for up to several months after starting treatment.

 

Atossa is developing topical Endoxifen for women with mammographic breast density or MBD, and for men with gynecomastia or breast cancer. There is no FDA-approved therapeutic for gynecomastia and male breast cancer. Atossa estimates that approximately ten million women in the United States have MBD, for which there is no FDA-approved treatment. Although oral tamoxifen is approved to prevent breast cancer in “high-risk” women, it is used by less than 5% of women with an increased risk of developing breast cancer because of the actual or perceived side effects and risks of tamoxifen.

Atossa believes their topical Endoxifen may provide an effective treatment for MBD because, unlike an oral medication, it is applied directly to the breast and penetrates the skin; it does not require metabolism by the liver, and it may produce fewer side effects than tamoxifen. Moreover, our topical Endoxifen may improve mammography accuracy and patient care by unmasking cancerous tumors that are otherwise hidden by breast density, and reduce the risks of over-diagnosing potential tumors when more highly sensitive imaging methods are used.

Atossa is also developing oral Endoxifen for breast cancer patients who are refractory to tamoxifen. Approximately one million breast cancer patients take tamoxifen to prevent recurrent and new breast cancer; however, up to 50% of those patients are refractory to tamoxifen. Atossa believes our their  Endoxifen may provide an effective treatment supplement or option for these refractory patients because Endoxifen, unlike tamoxifen, does not require liver metabolism.

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 Enrolls First Cohort of Eight Subjects in Endoxifen Study of Male Subjects

SEATTLE, April 12, 2018– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced today …..

finance.yahoo.com

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J&J Vision Announces “First of Its Kind” Contact Lenses

Dow 30 component Johnson & Johnson (JNJ) is a worldwide healthcare focused company that embraces research and science so that it can provide customers with innovative ideas, products, and services.

With the clearance from the U.S. Food and Drug Administration, Johnson & Johnson Vision has announced its first of its kind contact lens ACUVUE OASYS® with Transitions® Light Intelligent Technology™ . The new contact lenses give the wearer vision correction as well as a dynamic photochromic filter that works to constantly balance the amount of light that enters the eye. The contact lenses can quickly and smoothly adjust from clear to dark in a change of light conditions and exposure. They feature a blue filtering light and block UV rays.

With its automatic adjusting capabilities, the ACUVUE OASYS® with Transitions® Light Intelligent Technology™ assists the human eye in managing all different types of lighting situations and brightness intensities all day long.

Johnson & Johnson Vision’s partnership with Transitions Optical works to blend the strengths of each company. With ACUVUE®, the Johnson & Johnson brand, as the world leader in contacts, and Transitions Optical as the leading provider of smart adaptive lenses, the companies are coming together to research and develop the very best-in-class innovative vision care.

To learn more about Johnson & Johnson (JNJ) and to continue to track its progress visit the Vista Partners Johnson & Johnson 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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