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Statera Biopharma (Nasdaq: STAB) has submitted its Phase 3 clinical trial protocol for STAT-201 to the FDA aimed at treating pediatric patients with Crohn's Disease. This milestone highlights the potential of STAT-201 to address debilitating symptoms in children, including growth failure and malnutrition. The trial will assess the drug's safety and efficacy in 12 to 17-year-olds, with enrollment expected in early 2022. Previous Phase 2 results indicated a 67% remission rate and no serious adverse events, alongside orphan drug designation from the FDA.
Statera Biopharma (Nasdaq: STAB) announced the enrollment of the first patient in a clinical study for STAT-205, an immune-modulating treatment aimed at mitigating COVID-19 progression. The randomized, placebo-controlled trial will assess the pharmacokinetics, biomarkers, and safety of STAT-205. The study targets 24 patients with mild symptoms and high disease progression risk. Preliminary results are expected in 2022. This development emphasizes Statera's commitment to innovative therapies that address COVID-19 and enhance immune response.
Statera Biopharma (NASDAQ: STAB) announced that the FDA has lifted the clinical hold on its Entolimod research related to acute radiation syndrome (ARS). This decision allows the company to resume clinical work and explore new applications, including treatment for neutropenia and anemia in cancer patients. Statera plans to evaluate ongoing development needs and is initiating discussions with a U.S. academic institution for further studies in oncology and hematology starting in 2022.
Statera Biopharma, Inc. (Nasdaq: STAB) reported third-quarter results for 2021, following its merger with Cytocom Inc. The company focuses on immune therapies and is preparing to initiate various clinical trials in 2022, including a Phase 3 trial for STAT-201 in pediatric Crohn’s disease. For Q3 2021, Statera recorded revenues of $0.24 million and a net loss of $12.7 million, up from $5.7 million the previous year. Research and development expenses decreased by 21.6%, while general and administrative expenses surged by 252.8% to $6.3 million. The company aims to strengthen its cash position for future growth.
Statera Biopharma (Nasdaq: STAB) will host a conference call on November 15, 2021, at 5:30 p.m. ET to discuss its Q3 2021 financial results. Stakeholders can participate via the audio webcast at here. Statera focuses on developing immunotherapies for various conditions, including autoimmune diseases and cancers, using a proprietary platform of toll-like receptor agonists. This call will provide updates crucial for investors and market analysts.
Statera Biopharma (NASDAQ: STAB) has announced the approval of a Phase 1 pilot study to evaluate the safety and pharmacokinetics of its immune-modulator, STAT-205, aimed at mitigating COVID-19 progression. The study will enroll 24 high-risk patients with mild symptoms of SARS-CoV-2. Early studies suggest STAT-205 may inhibit viral replication and reduce severe lung inflammation. Additionally, Statera plans a Phase 2 study targeting post-acute COVID-19 syndrome, addressing the significant need for effective treatments for long hauler patients. The company aims to explore STAT-205’s therapeutic potential further.
Statera Biopharma, Inc. (Nasdaq: STAB) has announced its participation in the Alliance Global Partners Biotech and Specialty Pharma Conference scheduled for October 13, 2021. CEO Michael K. Handley and the management team will be available for one-on-one meetings with attendees. The company, previously known as Cytocom, emerged following a merger completed on July 27, 2021. Statera specializes in developing immune therapies targeting autoimmune diseases, cancers, and emerging viruses, utilizing a proprietary platform that rebalances the immune system.
Statera Biopharma (Nasdaq: STAB) is set to present at the 2nd Annual B & T Cell-Mediated Autoimmune Disease Drug Development Summit on October 7, 2021. CEO Michael K. Handley will discuss innovative immune-modulation approaches aimed at restoring balance within the immune system, particularly focusing on Th2 lymphocytes' role in autoimmune diseases. The company's clinical pipeline includes therapies targeting Crohn’s disease, COVID-19, pancreatic cancer, and hematology. Attendees can access Mr. Handley’s presentation on the summit platform and a recording will be available on the Statera website post-event.
Statera Biopharma (Nasdaq: STAB) will participate in the Benzinga Virtual Healthcare Small Cap Conference on September 29-30, 2021. CEO Michael K. Handley will present on September 29, 2021, from 3:40 - 4:00 p.m. ET. The conference registration can be accessed online. Following the presentation, a webcast will be available in the Investor Relations section of Statera's website. Statera, formerly known as Cytocom, focuses on innovative therapies targeting immune restoration and homeostasis, with clinical programs addressing various diseases.
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