Announcement • 6h
Atossa Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million. Atossa Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,363,631
Security Name: Series A Warrants
Security Type: Equity Warrant
Securities Offered: 1,363,631
Security Name: Series B Warrants
Security Type: Equity Warrant
Securities Offered: 1,363,631
Transaction Features: Registered Direct Offering New Risk • 6h
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$37.9m market cap). Announcement • May 08
Atossa Therapeutics Announces Publication of KARISMA Endoxifen Trial Demonstrating Significant Reduction in Mammographic Breast Density in Healthy Premenopausal Women Atossa Therapeutics, Inc. had announced the publication of results from the KARISMA Endoxifen trial in the Journal of the National Cancer Institute. The randomized, double-blind, placebo-controlled Phase 2 study evaluated daily oral Endoxifen and demonstrated that low-dose Endoxifen significantly reduced mammographic breast density, a key risk factor for breast cancer. The article titled "Endoxifen for Mammographic Density Reduction – Results from the KARISMA Endoxifen Trial" highlighted data collected by investigators at Karolinska Institutet (Stockholm, Sweden) and collaborators, from a study funded by Atossa. The study evaluated placebo, 1 mg, and 2 mg Endoxifen administered daily for six months in 240 healthy premenopausal women enrolled through the Swedish national mammography screening program. Elevated mammographic breast density is an established risk factor for breast cancer and a recognized pharmacodynamic marker of response to endocrine risk-reduction therapy. In the KARISMA Endoxifen trial, both the 1 mg and 2 mg Endoxifen dose levels produced statistically significant reductions in mammographic breast density compared with placebo. The 1 mg dose reduced mammographic breast density by 19.3% versus placebo (p=0.004), while the 2 mg dose reduced mammographic breast density by 26.5% (p<0.001) versus placebo. These reductions were comparable to those previously reported with standard-dose tamoxifen, but were achieved using direct administration of Endoxifen, the most therapeutically active metabolite of tamoxifen. Both levels demonstrated a favorable tolerability profile. The similar tolerability profile between the 1 mg dose and placebo with effective mammographic breast density reduction is significant for potentially addressing future breast cancer risk reduction. Discontinuations due to adverse events considered related to the study drug were similar between placebo and 1 mg Endoxifen, occurring in 4 placebo participants and 5 participants receiving 1 mg Endoxifen, compared with 11 participants receiving 2 mg Endoxifen. No clinically significant changes in hematologic safety tests, serum chemistry, coagulation, urinalysis, blood pressure, heart rate, or physical examination findings were observed during the trial. Adverse events were generally vasomotor in nature, consistent with those previously reported for tamoxifen. The study also provides important dose-selection insight. Investigators observed that meaningful mammographic breast density reduction appeared to occur at relatively low Endoxifen plasma concentrations, with the response reaching an approximate 20% decrease at concentrations of roughly 3–4 ng/mL, and with no substantial additional density reduction at higher concentrations. In contrast, vasomotor symptoms appeared more prominent at higher concentrations, supporting the 1 mg dose as the preferred candidate for future prevention studies. The authors concluded that both 1 mg and 2 mg Endoxifen significantly reduced mammographic breast density to a degree comparable to the established 20 mg dose of tamoxifen, and that the 1 mg dose indicated superior tolerability. The authors also noted that future studies are needed to determine whether Endoxifen reduces incidences of breast cancer in women at increased risk. Atossa believes these results strengthen the rationale for advancing Endoxifen as a potential mammographic breast density reduction therapy, particularly for women with elevated mammographic breast density or other risk factors who may benefit from endocrine risk reduction but are reluctant to use currently available options. The KARISMA Endoxifen trial was a proof-of-concept, dose-determining, double-blind, randomized, placebo-controlled Phase 2 clinical trial conducted in Sweden. The study enrolled 240 healthy premenopausal women aged 40 to 55 years who were participating in the national mammography screening program in Stockholm, Sweden. Participants were randomized 1:1:1 to receive placebo, 1 mg Endoxifen, or 2 mg Endoxifen daily for six months. The primary objective was to evaluate the effect of Endoxifen on mammographic breast density. Safety and tolerability were also assessed. The study is registered at www.ClinicalTrials.gov under identifier NCT05068388. 
