FORT COLLINS, Colo., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Statera Biopharma, Inc. (Nasdaq: STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced its support for Pancreatic Cancer Awareness Month, designated as the month of November. Recognizing the efforts by many organizations, foundations and associations around the world to raise awareness of the disease and advocate for patients, Statera joins with these groups in exploring new treatment options for a high need patient population.
According to the American Cancer Society, this year in the U.S., 60,430 new pancreatic cancer cases will be diagnosed, and the disease will claim 48,220 lives.1 In total, pancreatic cancer accounts for about 3 percent of all cancers in the U.S., yet it is the third-leading cause of cancer death behind lung and colon cancers.2 Detection is difficult as pancreatic cancer has no early symptoms, and there are currently no effective screening tests, so doctors often discover the disease after it has spread to other areas of the body.3
Statera is developing STAT-401 as an adjunct to standard of care therapy to extend the duration of disease remission in patients with pancreatic cancer. The U.S. Food and Drug Administration (FDA) granted STAT-401 Orphan Drug Designation for the disease. In August 2021, the company received feedback following a Type C meeting with the U.S. regulators regarding the STAT-401 clinical development program. The Company has established an advisory panel of oncology experts, and now expects to initiate a Phase 1b/2 clinical trial during the first half of 2022.
Michael K. Handley, President and CEO of Statera Biopharma, stated, “Pancreatic cancer remains a devastating disease despite the tremendous advances in cancer research. The American Cancer Society predicts that it could become the second-leading cause of cancer-related death behind lung cancer. We are harnessing our deep understanding of immune modulation to develop STAT-401 to help address this high need cancer population. With our advisory panel now in place, we look forward to advancing our clinical program and bringing hope to the patients and their families fighting this dreaded disease.”
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 or preclinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205) in addition to potential 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
1American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, Ga. 2021.
2American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, Ga. 2021.
3https://lustgarten.org/patient-journey/
