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 email@example.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: firstname.lastname@example.org or telephone (212) 895-3745.
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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..