Breast Cancer Focused Biotech Atossa Genetics Issues Letter to Stockholders

Dr. Steven C. Quay, President & CEO of Seattle, WA biotech firm Atossa Genetics, issued the following letter to stockholders on December 28th, 2017 highlighting the key accomplishments to date and outlining the milestones for 2018.

Dear Valued Stockholders:

Over the past two years, we have transformed Atossa into a pure play pharmaceutical company focused on the development of novel therapeutics and delivery methods aimed at both treating breast cancer as well as preventing breast cancer. We now have a remarkable opportunity to transform the field of breast cancer and substantially reduce the incidence of this deadly disease.

The current standard of care for most breast cancer patients is a 5-10 year regimen of an FDA-approved drug called Tamoxifen. Unfortunately, not all patients benefit from Tamoxifen and it can have serious side effects. For these reasons, we are developing a new drug called Endoxifen, which is the most active metabolite of Tamoxifen. We are also developing our proprietary intraductal microcatheters with the potential ability to deliver drugs and Chimeric Antigen Receptor Therapy, or CAR-T, cells directly to the site of breast cancer.

Clinical Trial Achievements. Over the past two years we have been developing two proprietary formulations of Endoxifen: oral Endoxifen for the more than one million breast cancer survivors and topical Endoxifen as a potential treatment for a conditions called mammographic breast density (or MBD). There is no FDA-approved treatment for MBD, which affects more than ten million women in the U.S. It is well accepted that MBD increases the risk of breast cancer, which is why 30 states now require that a finding of MBD be reported to the patient, physician or both. It is believed that not only does MBD make mammography less effective because MBD can hide cancerous tumors, but also the tissue itself may be more prone to develop cancer. Over the past year, we secured a manufacturer for Endoxifen, retained a clinical research organization for a Phase 1 study and completed this study in the last quarter of 2017.

Preliminary results of the Phase 1 study show that both arms of the study (oral and topical) were fully and successfully completed: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level.

These promising Phase 1 results have paved the way for our upcoming Phase 2 studies, which are planned to open in the first quarter of 2018. We are developing our proprietary topical Endoxifen for the treatment of women with MBD which will be conducted by Stockholm South General Hospital in Sweden. We are also planning a Phase 2 study using our proprietary oral Endoxifen to treat patients who are not responding to Tamoxifen. That study should also open in the first quarter of 2018.

We have started a new program to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer. This is a novel approach using our proprietary intraductal microcatheter technology for the potential transpapillary, or “TRAP,” delivery of T-cells that have been genetically modified to attack breast cancer cells. We believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells; improved efficacy by placing the T-cells in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. This approach is in the R&D stage and is currently not FDA approved. In 2018 we intend to commence studies that will help demonstrate safety and efficacy of this novel approach. We are also using our intraductal microcatheters in a Phase 2 study at Montefiore Medical Center in New York where we are targeting the delivery of Fulvestrant to the site of early stage breast cancer and ductal carcinoma in situ. That study is ongoing.

Capital Raising Achievements. In 2017 we made significant improvements to our balance sheet by raising approximately $12 million in capital, which strengthened our balance sheet and improved our stockholder base with the addition of institutional biotech-focused investors. We now have sufficient capital recourses to execute on our upcoming Endoxifen Phase 2 study of MBD and our upcoming Endoxifen Phase 2 study of “refractory” patients who are not responding to Tamoxifen.

Market Opportunities. We are developing our products for large market opportunities. A study conducted by Defined Health, a leading market research firm, estimates that the potential market for Endoxifen exceeds $1 billion in annual sales and the potential market for our intraductal microcatheters to delivery therapeutics exceeds $800 million as a treatment and replacement for surgery.

CAR-T has been the subject of much attention recently. In October 2017, pioneer CAR-T company Kite Pharma was acquired for $11.9 billion by Gilead and in August 2017 Novartis received the first FDA approval in the CAR-T field for Kymriah for the treatment of B-cell Acute Lymphoblastic Leukemia. Other companies in the clinical-stage in the field of CAR-T include Blue Bird Corporation, and Juno Therapeutics, which trades on Nasdaq with a multi-billion dollar market capitalization.

2018 Milestones. We are now well positioned to execute our strategies in 2018, which include the following potential milestones

First quarter of 2018 – commencing the Phase 2 Study of topical Endoxifen to treat MBD at Stockholm South General Hospital in Sweden (which we plan to complete in 2018).
First quarter of 2018 – commencing the Phase 2 Study of oral Endoxifen to treat patients who are not responding to Tamoxifen (which we plan to complete in 2018).
Second half of 2018 – commencing one or more studies administering TRAP CAR-T with our microcatheters.
Throughout 2018 – continuing our Phase 2 study administering Fulvestrant with our microcatheters.
Breast Cancer Statistics. The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 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 the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.

We look forward to reporting our progress on these priorities throughout the year and we thank you for your continued support of Atossa.

Sincerely,

Dr. Steven C. Quay, MD, Ph.D.
President and Chief Executive Officer

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

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Atossa Genetics President and CEO Issues Letter to Stockholders Highlighting Key Accomplishments and Outlines Milestones for 2018

SEATTLE, Dec. 28, 2017– Atossa Genetics Inc. today announced it has issued the following letter by Dr. Steven C. Quay, President and CEO, to Atossa stockholders:. Over the past two years, we have transformed …..

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Have You Read “Sunny Skies Ahead?” Vista Partners Weekly Market Update 12-23-17

Vista Partners has published  “Sunny Skies Ahead?” Vista Partners Weekly Market Update 12-23-17 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 and Select Emerging Growth Companies.

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Breast Cancer Treatment Innovator Atossa Genetics (ATOS) Adds to Scientific Advisory Board & Balance Sheet

Atossa Genetics Inc. (ATOS) a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced that Carl Novina, MD, PhD, has been appointed as Scientific Advisor.

Dr. Novina is one of the leading researchers in the field of RNAi therapeutics.  He is an Associate Professor of Medicine at the Dana-Farber Cancer Institute and Harvard Medical School and an Associate Member of the Broad Institute of Harvard and MIT. He is currently the Principal Investigator of the Novina Lab at the Dana-Farber Cancer Institute. His laboratory has made several important discoveries into the biology of noncoding RNAs, their dysregulation in cancers, and their development as biomedical tools.

Dr. Novina received his M.D. from Columbia University, College of Physicians and Surgeons in 2000 and his Ph.D. from Tufts University, Sackler School of Graduate Biomedical Sciences in 1998. His graduate work has resulted in 10 publications examining transcriptional regulation of TATA-less promoters. In 2014 he received the coveted National Institutes of Health Pioneer Award, which funds bold and innovative research proposals to attack challenging biomedical problems. Dr. Novina has established many collaborations between industry partners and physicians to facilitate his goal of bringing biomedical innovations from bench to bedside.

Dr. Steve Quay, President and CEO of Atossa Genetics stated, “We are delighted to welcome Dr. Novina to our Scientific Advisory Board which is composed of world-class experts in Breast Cancer research. Dr. Novina’s immunology expertise will be invaluable as we develop our proprietary microcatheters for delivery of CAR-T cell therapies for the treatment of the deadlier forms of breast cancer.”

 Earlier this week, Wednesday, December 20, 2018  Atossa also announced that it has entered into a securities purchase agreement with certain accredited investors to purchase approximately $1.4 million of its common stock in a registered direct offering and concurrent private placement. Under the terms of the purchase agreement, Atossa has agreed to sell approximately 5.3 million shares of its common stock. In a concurrent private placement, Atossa has agreed to issue Class A and Class B warrants to purchase up to approximately 5.3 million shares of common stock each. The warrants will be exercisable six months following the date of issuance and have an exercise price of $0.315. The warrants cannot be exercised on a cashless basis unless there is no effective registration statement covering the common shares issuable upon exercise of the warrants. The Class A and Class B warrants will expire on the 8-month and 12-month anniversary of the initial issuance date, respectively. The combined purchase price for one share of common stock, one Class A warrant and one Class B warrant will be $0.27. The gross proceeds to Atossa from the registered direct offering and concurrent private placement are estimated to be approximately $1.4 million before deducting the placement agents’ fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about December 22, 2017, subject to the satisfaction of customary closing conditions. Maxim Group LLC acted as sole placement agent for the offering. The common stock being sold pursuant to the registered direct offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-220572), previously filed with the Securities and Exchange Commission (the “SEC”) on September 22, 2017 and declared effective on October 5, 2017. Such securities are being offered only by means of a prospectus. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the registered direct offering will be filed with the SEC. The Class A and Class B warrants, along with the underlying common stock have not been registered under the Securities Act of 1933, as amended.

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

Atossa Genetics Announces Pricing of $1.4 Million Registered Direct Offering

SEATTLE, Dec. 20, 2017– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced today …..

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Have You Read Vista Partners Weekly Update Market 12-16-17?

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“Too Close For Comfort” Vista Partners Weekly Market Update

Vista Partners has published its Weekly Market Update for the week of December 2, 2017, titled “Too Close For Comfort” Vista Partners Weekly Market Update 12-9-2017 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 and Select Emerging Growth Companies.

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How Do You Like The Sound of “24K”?

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“Will the Bull Market Continue to Run?” Vista Partners Publishes November Macroeconomic & Investment Newsletter

Vista Partners (“Vista”) has published November’s FREE Macroeconomic & Investment Monthly Newsletter, “Will the Bull Market Continue to Run?”

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Companies Featured in November’s Newsletter: Apple, Inc. (AAPL) | Atossa Genetics, Inc. (NASDAQ: ATOS) | Fusion, Inc. (NASDAQ: FSNN) | Merck & Co., Inc. (MRK), & Visa Inc. (V).

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“Simply Solid Delivery?” Vista Partners Weekly Market Update 11-26-2017

Vista Partners has published its Weekly Market Update for the week of November 11, 2017, titled “Simply Solid Delivery?” Vista Partners Weekly Market Update 11-26-2017 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 and Select Emerging Growth Companies.

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 and Select Emerging Growth Companies.

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“500+ Days & Counting…” Vista Partners Weekly Market Update 11-18-2017

Vista Partners has published its Weekly Market Update for the week of November 11, 2017, titled “500+ Days & Counting…” Vista Partners Weekly Market Update 11-18-2017 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 and Select Emerging Growth Companies.

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 and Select Emerging Growth Companies.

Each weekly update issue is sent out via email directly to the thousands of investors around the world that have freely elected to be updated each week.  Please “Join us” to Stay Informed and Stay Competitive. It’s Free & Easy to sign up.

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Breast Cancer Innovative Firm Atossa Genetics (ATOS) Publishes Q3 Results

SEATTLE, WA 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.

ATOS recently reported its Q3 2017 results. Steve Quay, President and CEO, stated, “We are very pleased with our recent clinical progress with our Endoxifen programs. Preliminary results from our Phase 1 study show that all objectives of both our proprietary topical and oral formulations of Endoxifen have been met. We recently raised capital to support advancement of our Endoxifen programs into Phase 2 trials.”

ATOS Published the following Recent Corporate Developments

  • Completed a public offering of common stock with gross proceeds of $5.5 million.
  • Announced the preliminary results from the Phase 1 study of oral Endoxifen with all objectives successfully met: there were no clinically significant safety signals and no clinically significant adverse events; oral Endoxifen was well tolerated; and study participants exhibited dose-dependent Endoxifen levels consistent with the therapeutic ranges identified in published reports.
  • Announced a new program using Chimeric Antigen Receptor Therapy, or CAR-T. Atossa plans to use its proprietary intraductal microcatheter technology to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer.
  • Announced an upcoming Phase 2 Study of proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD, which will be conducted by Stockholm South General Hospital in Sweden. The study will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.
  • Announced the preliminary results from the Phase 1 study of topical Endoxifen with all objectives successfully met: there were no clinically significant safety signals and no clinically significant adverse events; the topical Endoxifen was well tolerated; and there were low but measurable Endoxifen levels detected in the blood in a dose-dependent fashion.

To learn more about Atossa Genetics (ATOS) please visit the Vista Partners ATOS Coverage Page.

Atossa Genetics Announces Third Quarter 2017 Financial Results And Provides Company Update

SEATTLE, Nov. 14, 2017– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced …..

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