Statera Biopharma, Inc. (STAB) is a clinical-stage biopharmaceutical company pioneering the development of innovative immunotherapies to address a wide range of autoimmune, inflammatory, infectious, and oncological diseases. With a deep understanding of the human immune system and its intricate balance, Statera is uniquely positioned to unlock the potential of the body's natural defenses and restore homeostasis, transforming the lives of patients in critical need.
Company Origins and Evolution
The company's origins can be traced back to June 2003 when it was incorporated in Delaware as Cleveland BioLabs, Inc. Initially, the company conducted business in the United States directly and in Russia through two subsidiaries. BioLab 612, LLC, which began operations in 2012, was dissolved in November 2020. Panacela Labs, Inc., formed in 2011 in partnership with Joint Stock Company RUSNANO, was the company's other subsidiary. Before the merger with Cytocom, Inc., Cleveland BioLabs focused exclusively on developing novel approaches to activate the immune system, with its most advanced product candidate being entolimod, an immune-stimulatory agent developed as a radiation countermeasure and for other indications in radiation oncology.
In June 2021, Cytocom Inc. completed the acquisition of ImQuest Life Sciences, Inc. and its subsidiaries, adding capabilities in the development of novel immunotherapies targeting autoimmune, inflammatory, infectious diseases, and cancers. The transformative merger between Cleveland BioLabs and Cytocom closed on July 27, 2021, resulting in the company being renamed Statera Biopharma, Inc. This strategic move, along with the acquisition of ImQuest Life Sciences, positioned Statera as a leading player in the burgeoning field of immunotherapies. The integration of these entities has enabled the company to leverage a diverse pipeline of proprietary technologies and a robust R&D platform to drive its mission forward.
Innovative Approach and Pipeline
At the heart of Statera's approach is its proprietary AIMS (Activated Immunomodulatory Signaling) platform, which is designed to rebalance the body's immune system and restore homeostasis. This multi-receptor platform elicits a robust and durable response of antigen-specific killer T-cells and antibodies, effectively activating the body's essential immune defenses against a wide range of diseases.
Statera's clinical and preclinical pipeline encompasses several promising candidates, including STAT-201 for Crohn's disease, STAT-205 for COVID-19, STAT-401 for pancreatic cancer, and the TLR5 agonist, entolimod, for the treatment of anemia and neutropenia in cancer patients. The company expects to initiate several clinical trials within the next 12 months, underscoring its commitment to accelerating the development of these transformative therapies.
Statera Biopharma 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. This diverse portfolio positions the company to address a wide range of unmet medical needs across various therapeutic areas.
Financials
The company's financial performance has been marked by significant challenges, as it has incurred recurring losses since inception and accumulated a deficit of approximately $144.1 million as of September 30, 2022. For the nine months ended September 30, 2022 and 2021, the company reported net losses of $14.6 million and $24.6 million, respectively. This is not uncommon for a clinical-stage biopharmaceutical company, as the path to commercialization often requires substantial investment in research and development.
In the most recent fiscal year (2021), Statera Biopharma reported a net loss of $101.85 million, with operating cash flow (OCF) of -$28.19 million and free cash flow (FCF) of -$28.38 million. The company's financial situation improved slightly in the third quarter of 2022, with revenue of $670,473 and a net loss of $5,159,285. The operating cash flow and free cash flow for Q3 2022 were both -$801,523.
Statera Biopharma's revenue has shown significant growth, particularly in its Clinical Research Organization (CRO) services segment. In the nine months ended September 30, 2022, CRO services revenue increased to $2.44 million, up substantially from $0.24 million in the same period of 2021. This growth is primarily attributed to the acquisition of ImQuest in June 2021. The cost of providing these CRO services also increased from $0.12 million to $0.72 million over the same time period.
Liquidity
To address these financial constraints, Statera has relied on a combination of private and public equity and debt financing, as well as the receipt of funded grants. However, the company's existing cash and cash equivalents are not expected to enable it to fund its operating expenses and capital expenditure requirements beyond the fourth quarter of 2022. This has raised substantial doubt about the company's ability to continue as a going concern, a common concern for early-stage biotech firms.
As of September 30, 2022, Statera Biopharma had $506,100 in cash and cash equivalents. The company's debt-to-equity ratio stood at -9.69, reflecting its challenging financial position. Statera has a $15 million credit facility with Avenue Venture Opportunities Fund, L.P., of which $6.2 million was outstanding as of September 30, 2022. The company's current ratio and quick ratio are both 0.37, indicating potential liquidity challenges in meeting short-term obligations.
Business Segments and Market Focus
Statera Biopharma operates in two main product segments:
1. Clinical Research Organization (CRO) Services: Through its ImQuest subsidiary, Statera provides preclinical research services to evaluate the potential of new and novel pharmaceutical products. These services include compound screening, efficacy analysis, drug target validations, mechanism of action research, and toxicity studies across multiple pharmaceutical areas. Revenue from CRO services is recognized when the final report is delivered to the customer.
2. Immunotherapy Product Candidates: The company is developing multiple immunotherapy candidates based on its proprietary AIMS platform. These therapies target autoimmune, inflammatory, infectious diseases, and cancers. While this segment has not yet generated significant revenue, it represents the core of Statera's long-term value proposition.
Geographically, Statera Biopharma primarily operates in the United States, focusing on addressing unmet medical needs in the domestic market.
Challenges and Outlook
Statera's journey has not been without its challenges, as it has faced legal proceedings and an involuntary bankruptcy petition in 2022. However, the company has remained resolute in its pursuit of its mission, and its recent panel decision from NASDAQ granting the company's request for continued listing, subject to certain interim milestones, demonstrates its commitment to meeting the exchange's stringent requirements.
The company faces typical risks associated with clinical-stage biopharmaceutical firms, including the ability to successfully develop, obtain regulatory approval for, and commercialize its product candidates. Statera expects to continue incurring losses for the foreseeable future as it advances its pipeline, necessitating additional financing to support its operations and research efforts.
Despite the financial and operational hurdles, Statera's innovative pipeline, experienced management team, and unwavering dedication to transforming patient outcomes position the company as a promising contender in the immunotherapy landscape. As the company continues to navigate the complexities of drug development and commercialization, investors and the broader medical community will closely follow its progress in bringing these groundbreaking therapies to the patients who need them most.