Atossa Genetics Receives IRB Approval for Phase 2 Breast Cancer Study Using Intraductal Technology

Susan Love, M.D., inventor of the technology, will advise Atossa on the study

SEATTLE, WA and ENCINO, CA –(Marketwired) – October 16, 2019 — Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, and The Dr. Susan Love Research Foundation, announced today that the Institutional Review Board (IRB) has approved a Phase 2 clinical study of Atossa’s intraductal microcatheter technology for the administration of fulvestrant in patients with early-stage breast cancer or ductal carcinoma in situ (DCIS). Susan Love, M.D., inventor of the technology, will advise Atossa as it conducts the trial.

“We have contracted with a world-class teaching, research and healthcare organization based in the United States to conduct this study,” commented Steven C. Quay, Ph.D., M.D., CEO and President of Atossa. “Atossa’s intraductal technology was invented by Dr. Love and subsequently acquired by Atossa. We are honored that Dr. Love has agreed to work with us on this important new study. This work begins as Atossa increases its corporate focus on its proprietary Endoxifen for the reduction of mammographic breast density.”

For the past 20 years, Dr. Love has dedicated her career to the eradication of breast cancer and pioneered some of the world’s more innovative research. From spearheading a partnership with NASA’s Jet Propulsion Laboratory to mapping the breast ductal system, to harnessing the power of artificial intelligence to develop a handheld, self-reading ultrasound for breast cancer screening in underserved populations, Dr. Love’s goal is to end breast cancer.

“While the origin of breast cancer is still not well understood, we do know a few things,” stated Dr. Love. “Each breast is comprised of six to 12 duct-lobule units that develop from one or a few stem cells at the time of puberty. In the vast majority of cases, when a woman gets breast cancer it is one and only one of those units; the rest of the breast is without disease. It was on the basis of this understanding that, years ago, I began to envision treatments that focused on the ‘sick duct’ only. Over the years a number of clinical trials have been conducted that demonstrate this approach leads to strong tumor treatment effects, because of the local delivery, and reduced systemic exposure, which hopefully produces fewer side effects. I am pleased that Atossa Genetics and a leading institution are carrying on the research I began and I look forward to advising on this important clinical trial.”

Intraductal Breast Cancer Treatment: The Phase 2 Study

Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two injections, typically into the buttocks. The AstraZenica branded drug, Faslodex, had worldwide sales of over $1 billion US in 2018.

This trial is a Phase 2 study in women with Stage 1 or 2 breast cancer (invasive ductal carcinoma) or DCIS scheduled for mastectomy or lumpectomy within 14 to 45 days. This study will assess the safety, tolerability, cellular activity and distribution of fulvestrant when delivered directly into breast milk ducts via Atossa’s intraductal technology, compared to those who receive the same drug by injection. Of the 30 patients required for full enrollment, six will receive the standard intramuscular injection of fulvestrant and 24 will receive fulvestrant with Atossa’s intraductal technology.

The primary endpoint of the clinical trial is to compare the safety, tolerability and distribution of fulvestrant between the two routes of administration (intramuscular injection or through Atossa’s intraductal technology). The secondary endpoint of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimens. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. This Phase 2 study is currently underway at Montefiore Medical Center, which will transition all future work to the new study site.

Additional information can be found in our SEC filings at:
https://www.sec.gov/Archives/edgar/data/1488039/000143774919020029/atos20191011_8k.htm

And in the NIH website at:
https://www.clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2#contacts

Atossa Genetics is the owner of issued patents, pending patent applications, and medical device FDA 510(k) premarket notifications related to the treatment of breast conditions, including breast cancer and DCIS.

About Dr. Susan Love Breast Foundation for Research
The Dr. Susan Love Foundation for Breast Cancer Research’s mission is to end breast cancer. It challenges the status quo to end breast cancer and improve the lives of people impacted by it now through education and advocacy. The Foundation drives collaborative, cutting-edge research with nontraditional partners, brings to light the collateral damage of treatment and seeks ways to diminish it, and interprets science to empower patients. Fast, flexible, and project-based, the Foundation actively engages the public in scientific research to ensure that it produces accurate and meaningful results.

For more information please visit https://drsusanloveresearch.org/.

About Atossa Genetics
Atossa Genetics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.

Forward-Looking Statements
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Atossa Genetics Company Contact:
Atossa Genetics, Inc.
Kyle Guse
CFO and General Counsel
Office: 866-893-4927
moc.scitenegassotanull@esug.elyk

Investor Relations Contact:
Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
moc.RIeroCnull@gttocs

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