Welcome to our dedicated page for Statera Biopharma news (Ticker: STAB), a resource for investors and traders seeking the latest updates and insights on Statera Biopharma stock.
Statera Biopharma, Inc. (STAB) appears in news coverage as a clinical-stage biopharmaceutical company focused on immunotherapies that target autoimmune diseases, neutropenia/anemia, emerging viruses, and cancers. Its disclosures emphasize a proprietary platform of toll-like receptor (TLR) drugs designed to rebalance the body's immune system and restore homeostasis, which shapes the types of developments reported in STAB-related news.
News items about Statera Biopharma frequently highlight progress and challenges in its clinical and corporate trajectory. On the scientific side, releases describe programs such as STAT-201 for Crohn's disease, hematology applications involving Entolimod and STAT-600/Entolimod, STAT-401 for pancreatic cancer, STAT-300 series candidates for multiple cancers and inflammation, and STAT-205 for COVID-19, along with potential expansion into other autoimmune and inflammatory conditions.
Another recurring theme in STAB news is the company's TLR5 agonist program. A Business Wire announcement reported that Tivic Health Systems, Inc. acquired worldwide exclusive license rights from Statera Biopharma to the late-stage TLR5 agonist Entolimod for acute radiation syndrome, with options on additional indications and a derivative, Entalasta. That coverage also noted FDA Fast Track and Orphan Drug designations for Entolimod in radiation-related indications and described the transfer of certain Statera team members to Tivic Health.
Corporate and capital markets updates are also prominent in Statera Biopharma news. Releases have addressed Nasdaq listing determinations, notices of filing delinquency, the completion and filing of Form 10-K and Form 10-Q reports, and efforts to move from OTC Pink Sheets to the OTCQB Venture Marketplace. Additional items include financing-related agreements and the appointment of an independent registered public accounting firm.
Strategic collaboration announcements, such as a binding Memorandum of Understanding with Holobeam Technologies for access to holographic diagnostic imaging and therapeutic technology, and a non-binding letter of intent for a proposed merger with Worksite Labs, further contribute to the news flow. Investors and observers following STAB news can review these updates to understand how Statera Biopharma's immunotherapy platform, licensing arrangements, regulatory status, and potential transactions evolve over time.
Statera Biopharma (NASDAQ: STAB) announced a public offering of units consisting of common stock and warrants, correcting previous deal terms. The offering is underwritten by EF Hutton and registered under Form S-3 with the SEC. Each unit includes one year and five-year warrants. The preliminary prospectus supplement will be filed today. This offering aims to secure funds for advancing clinical programs targeting autoimmune diseases, cancers, and COVID-19. The company focuses on immune restoration therapies and holds a diverse platform of toll-like receptor agonists.
Statera Biopharma (NASDAQ: STAB) has initiated an underwritten public offering of units consisting of common stock and warrants. The offering is conducted under a shelf registration statement effective since May 29, 2020, with EF Hutton serving as the sole manager. The units include pre-funded options to purchase additional shares. The preliminary prospectus will be filed with the SEC, providing detailed terms of the offering. The press release emphasizes that this announcement does not constitute an offer to sell securities in jurisdictions where it would be illegal.
Statera Biopharma (NASDAQ: STAB) announced revised unaudited financial results for FY 2021, reporting revenues of $1,487,036, a 100% increase from 2020, driven by the acquisition of ImQuest Life Sciences. Operating costs surged to $31,587,009, up 191%, primarily due to research and development and general and administrative expenses. The company recorded a significant other expense of $68,667,633, largely from an expected goodwill impairment of $64,338,810. Despite challenges, Statera expects to report positive shareholders' equity.
Statera Biopharma (Nasdaq: STAB) is advancing its research on STAT-200 to enhance its immune modulation capabilities beyond opioid receptors, aiming to treat various inflammatory diseases. The company’s computational collaboration with MolSoft has led to the identification of hundreds of promising new drug compositions, with three currently undergoing synthesis for biologic validation. Statera, through its recent acquisition of ImQuest, plans to validate key compositions for safety and efficacy in treating multiple indications, tapping into the full potential of its proprietary platform.
Statera Biopharma (Nasdaq: STAB) has submitted a pilot study protocol to the FDA for STAT-205, targeting post-acute COVID-19. This critical milestone aims to explore STAT-205's efficacy in reducing fatigue and improving cognition in patients suffering from long COVID, with 84 patients expected to participate. Preliminary data suggests that STAT-205 may effectively combat SARS-CoV-2 progression. Statera is also conducting a Phase 1 trial of STAT-205 for treating mild COVID-19, projecting topline results in Q4.
Statera Biopharma (Nasdaq: STAB) has submitted a pilot study protocol to the FDA for its STAT-205 treatment, aimed at addressing post-acute COVID-19 syndrome, commonly known as long COVID. This Phase 1 clinical trial will evaluate the safety and efficacy of STAT-205 in reducing fatigue and improving cognitive function in approximately 84 participants. Preliminary in vitro data indicates the drug may slow the progression of the SARS-CoV-2 virus. The trial is a critical step in developing therapies for the significant health challenges posed by long COVID.
Statera Biopharma (NASDAQ: STAB) announced that Dr. Satish Chandran will join its Board of Directors as of February 24, 2022. Dr. Chandran, a seasoned biotechnology leader with over 30 years of experience, has held key roles at various biopharmaceutical companies. He replaces Steve Barbarick, who resigned from the board but will remain as an advisor. The company emphasizes its focus on advancing clinical milestones in immune therapies targeting conditions such as Crohn's disease and SARS-CoV-2 infections.
Statera Biopharma (NASDAQ: STAB) reported preliminary revenue of $1,487,036 for FY 2021, a 100% increase from 2020, attributed to the acquisition of ImQuest Life Sciences. However, operating costs surged 191% to $31,587,009, primarily due to increased R&D and administrative expenses. The net loss reached $34,892,762, a 189% rise from the previous year. The company anticipates significant clinical developments in 2022, including the submission of FDA protocols for their drug candidates.
Statera Biopharma announced that it has received approval from the Central Institutional Review Board to conduct a Phase 3 clinical trial for its drug STAT-201, aimed at treating pediatric Crohn’s Disease. The trial, set to begin in Q2 2022, will assess the safety and efficacy of STAT-201 in patients aged 12 to 17, with around 165 participants expected. Previous Phase 2 results showed a 67% remission rate without serious adverse events. The FDA has granted STAT-201 orphan drug designation for treating Crohn’s in pediatric patients, highlighting its potential in a growing patient demographic.
Statera Biopharma (NASDAQ: STAB) has successfully closed a registered direct offering, raising $2.0 million by selling approximately 2.0 million shares of its common stock along with warrants. Each warrant, exercisable at $1.00 per share and valid for five years, accompanies a share sold at the same price. The funds raised will support general corporate purposes, including critical studies for pediatric Crohn’s disease and acute COVID-19. EF Hutton was the sole placement agent for this offering.