STAB

Statera Biopharma, Inc. (NASDAQ: STAB) (the “Company” or “Statera Biopharma”), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced unaudited, preliminary revenue and other financial results for its Fiscal Year ended December 31, 2021.

• Revenues for the year ended December 31, 2021 were $1,487,036 representing an increase of 100%, from $0 for the same period in 2020. The increase in revenues was due to the acquisition of ImQuest Life Sciences, Inc. and its subsidiaries (ImQuest) in June 2021 by Old Cytocom. ImQuest is a research and development company focused specifically on cancer, inflammation and infectious disease treatments. The Company reported no revenue in 2020.
• Cost of revenues for the year ended December 31, 2021 was $488,314, representing an increase 100% for the same period in 2020. The increase was due to the acquisition of ImQuest. Cost of revenues as a percentage of revenue was 33% for the year ended December 31, 2021.
• Operating costs for the year ended December 31, 2021 were $31,587,009, representing an increase of $20,086,619, or 191%, from $10,501,668 for the 2020. The increase in operating costs was principally due to increases in research and development expense (an increase of $6,566,403 or 125% year over year) and general and administrative expense (an increase of $14,441,905 or 276% year over year). The increase in research and development expense was the result of increased costs for the expansion in 2021 of clinical trial programs for Crohn’s disease and COVID-19. The increase in general and administrative expense reflects the costs incurred for the Merger and Old Cytocom’s acquisition of ImQuest, legal and other fees incurred to raise additional capital in 2021, increases in employee compensation, benefits and stock-based compensation, and insurance expense.
• Other expense for the year ended December 31, 2021 was $4,328,823, representing an increase of $2,736,630, or 172%, from other expense of $1,592,193 for the same period in 2020. The change is due to an increase of $5,458,954 in interest and other non-operating expense, offset by an increase of $2,722,324 in gains on extinguishment of debt.
• Net loss attributed to the Company for the year ended December 31, 2021 was $34,892,762, representing an increase of $22,798,701, or 189%, from $12,093,861 for the same period in 2020. The increase in net loss is principally due to the increase in operating expense for the reasons described above.

Michael K. Handley, the Company’s CEO, stated, “We have taken numerous steps to further the development of our clinical stage pipeline that has us well-positioned to achieve numerous milestones in 2022. Following the recent submission to the FDA of our Phase 3 clinical trial protocol for STAT-201 in the treatment of pediatric Crohn’s Disease, we plan to use proceeds from our recent registered direct offering to initiate patient enrollment in the second quarter. Additionally, use of proceeds will include the enrollment of patients with acute COVID-19 infection in our STAT-205 study, from which we are targeting to have preliminary data this year.”

About Statera BiopharmaStatera Biopharma, Inc. (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 a large platform of toll-like receptor (TLR) agonists 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 potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera, 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.

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 BiopharmaNichol OchsnerExecutive V.P. Investor Relations and Corporate Communications(732) 754-2545nichol.ochsner@staterabiopharma.com 

FINN PartnersGlenn Silver (Media)(973) 818-8198glenn.silver@finnpartners.com 

FINN PartnersDavid Carey (IR)(212) 867-1768David.carey@finnpartners.com