Announcement • Jul 28
Atossa Therapeutics Announces Publication of Novel (Z)-Endoxifen-Related Compounds Demonstrating Potent Anti-Cancer Activity in Er-Positive Breast Cancer Atossa Therapeutics, Inc. announced the publication of a peer-reviewed preclinical study in npj Breast Cancer evaluating five novel chemical entities structurally related to (Z)-endoxifen. The study titled, "Novel (Z)-endoxifen-related new chemical entities exhibit potent anti-cancer activity in ERa+ breast cancer," reported anti-estrogenic and anti-cancer activity across multiple estrogen receptor-positive breast cancer models, including models harboring clinically relevant activating mutations in ESR1. The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen - AT416E, AT416Z, AT402E, AT402Z and AT300 - alongside (Z)-endoxifen in a broad panel of laboratory assays. The studies assessed two- and three-dimensional tumor-cell growth, apoptosis, cell-cycle progression, migration, invasion, estrogen receptor transcriptional activity, gene-expression changes and activity in combination with the CDK4/6 inhibitor abemaciclib. Several compounds demonstrated potent anti-estrogenic effects, and affected multiple anti-cancer processes including apoptosis, cell-cycle progression, migration, invasion and estrogen receptor-driven transcription. In certain experimental settings and models, selected compounds combined with abemaciclib demonstrated additive to synergistic activity that was comparable to or greater than the activity observed with abemaciclib plus (Z)-endoxifen. The compounds also showed activity in models containing activating ESR1 mutations, which are associated with endocrine resistance and recurrent or metastatic estrogen receptor-positive breast cancer. RNA-sequencing analyses identified shared anti-estrogenic effects as well as distinct compound-specific transcriptional programs that may help differentiate the candidates. The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease. These findings are preclinical and do not establish safety or efficacy in patients. Estrogen receptor-positive breast cancer is the most common molecular subtype of breast cancer. Although endocrine therapies are effective for many patients, recurrence and late relapse remain important clinical challenges. Activating mutations in ESR1 can allow estrogen receptor signaling to continue despite estrogen deprivation and are a recognized mechanism of acquired resistance in advanced disease. New therapies capable of inhibiting estrogen receptor signaling in ESR1-mutant tumors, alone or in rational combinations, may help address this unmet need. Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide. New Risk • Jun 11
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 • Jun 11
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
Price\Range: $3.3
Discount Per Security: $0.231
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 
