Statera Biopharma, Inc. Announces Institutional Review Board Approves Study of STAT-205 for Acute COVID-19

Researchers at Loma Linda University Health to Evaluate Pharmacokinetics, Biomarkers and Safety of STAT-205

FORT COLLINS, Colo., Oct. 19, 2021 (GLOBE NEWSWIRE) — Statera Biopharma, Inc. (Nasdaq: STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, announced today that it has received Institutional Review Board (IRB) approval to conduct a Phase 1 pilot study at Loma Linda University Health to evaluate STAT-205 as a treatment to mitigate SARS-CoV-2 progression, the virus that causes COVID-19. STAT-205 is an immune-modulator designed to decrease elevated inflammatory responses associated with viral infection and inhibit viral replication in human lung cells.

“This represents an important step for Statera and potentially also the millions of people who may become infected with COVID-19 and its highly contagious Delta variant,” stated Michael Handley, President and CEO of Statera Biopharma. “We believe there is compelling preclinical and early clinical data that demonstrate the therapeutic capabilities of STAT-205 in acute COVID-19 and support our belief that it could play a pivotal role in the treatment of the disease. We look forward to working with the researchers at Loma Linda University Health to further explore STAT-205’s potential and address the growing need for therapeutic options to treat COVID-19.”

The randomized, single-blind, placebo-controlled study will enroll 24 patients that are age 18 years or older who test positive for acute SARS-CoV-2 and show symptoms of mild infection that are at high risk for disease progression. The study is designed to assess the pharmacokinetics (PK), early predictive biomarkers, and safety of STAT-205.

During preclinical in vitro studies, STAT-205 demonstrated an ability to inhibit the replication of coronaviruses in human lung cells. Previous data also suggest that STAT-205 could prevent life-threatening lung inflammation caused by COVID-19, as well as lessen the risk of reinfection.

Statera is also developing STAT-205 as a treatment for patients with post-acute COVID-19 syndrome (PACS), also known as “long haulers.” Approximately 30% of patients with acute COVID-19 develop “long haul” syndrome, and these patients also represent a significant unmet medical need. A Phase 2 study in post-acute COVID-19 patients is expected to commence by year-end 2021.

About Statera Biopharma

Statera Biopharma (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and GP532. TLRs are a class of protein that plays a key role in the innate immune system. Statera is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Statera has clinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205) in addition to expansion into fibromyalgia and multiple sclerosis. To learn more about Statera Biopharma, please visit www.staterabiopharma.com.

Forward Looking Statements:

This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the Company’s expected clinical development timeline for the Company’s product candidates, future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “should,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “will,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond the Company’s control. The company’s actual future results may differ materially from those discussed here for various reasons. The Company discusses many of these risks under the heading “Risk Factors” in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cleveland BioLabs and Cytocom; unexpected costs, charges or expenses resulting from the merger; the Company’s need for additional financing to meet the Company’s business objectives; the Company’s history of operating losses; the Company’s ability to successfully develop, obtain regulatory approval for, and commercialize the Company’s products in a timely manner; the Company’s plans to research, develop and commercialize the Company’s product candidates; the Company’s ability to attract collaborators with development, regulatory and commercialization expertise; the Company’s plans and expectations with respect to future clinical trials and commercial scale-up activities; the Company’s reliance on third-party manufacturers of the Company’s product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to serve those markets; the rate and degree of market acceptance of the Company’s product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of the Company’s third-party suppliers and manufacturers; the success of competing therapies that are or may become available; the Company’s ability to attract and retain key scientific or management personnel; the Company’s historical reliance on government funding for a significant portion of the Company’s operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over the Company’s company by the Company’s largest individual stockholder; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company’s business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; the Company’s ability to obtain and maintain intellectual property protection for the Company’s product candidates; the Company’s potential vulnerability to cybersecurity breaches; and other factors discussed in the Company’s SEC filings, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

Contacts:
Statera Biopharma
Nichol Ochsner
Executive V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@staterabiopharma.com
    
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors) 
(212) 375-2664 
mmcenroe@tiberend.com  

Johanna Bennett (Media) 
(212) 375-2686  
Jbennett@tiberend.com