Company Description
Statera Biopharma, Inc. (STAB) is a clinical-stage biopharmaceutical company focused on research and development in biotechnology. According to multiple company disclosures, Statera Biopharma develops novel immunotherapies that target autoimmune conditions, neutropenia/anemia, emerging viruses, and cancers. Its work is based on a proprietary platform designed to rebalance the body's immune system and restore homeostasis.
Business focus and scientific platform
Statera Biopharma describes itself as a biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis. Across its news releases, the company highlights a platform centered on toll-like receptor (TLR) drugs. TLRs are a class of protein that plays a key role in the innate immune system, and Statera Biopharma reports having a large platform of TLR agonists and antagonists.
Company materials state that Statera Biopharma's platform includes TLR4 and TLR9 antagonists and TLR5 agonists such as Entolimod and GP532, with some disclosures also referencing TLR2 and TLR7. The company is developing therapies designed to elicit robust and durable responses of antigen-specific killer T-cells and antibodies, with the goal of activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers.
Clinical-stage programs and indications
Statera Biopharma reports several clinical and preclinical programs built on its immunotherapy platform. Across its public statements, the company has identified programs in:
- Crohn's disease under the designation STAT-201.
- Hematology, including applications of Entolimod and STAT-600/Entolimod.
- Pancreatic cancer under the designation STAT-401.
- Multiple cancers and inflammation under the STAT-300 series.
- COVID-19 under the designation STAT-205.
In addition, Statera Biopharma has referenced potential expansion of its programs into other autoimmune and inflammatory conditions, including fibromyalgia and multiple sclerosis, and has mentioned work related to cancer T-cell exhaustion and emerging viral diseases in some of its descriptions.
TLR5 agonist program and licensing
A notable element of Statera Biopharma's platform is its TLR5 agonist program. In a Business Wire announcement, Tivic Health Systems, Inc. reported that it entered into a broad licensing agreement with Statera Biopharma for the late-stage TLR5 agonist Entolimod for the treatment of acute radiation syndrome (ARS). Tivic Health stated that it acquired worldwide exclusive license rights from Statera Biopharma to Entolimod for ARS and an exclusive option to license additional indications and clinical use cases for Entolimod and its derivative Entalasta.
In that same disclosure, Entolimod and Entalasta were described as having been the subject of numerous animal and human trials and significant prior investment. The U.S. Food and Drug Administration (FDA) was reported to have granted Fast Track and Orphan Drug designations to Entolimod for the prevention or treatment of ARS and to prevent death following exposure to potentially lethal total body irradiation during or after a radiation disaster. Statera Biopharma's chief executive officer commented in that release that the agreement with Tivic Health could provide value for both Statera and Tivic shareholders and that select team members of Statera would join Tivic to help advance product candidates toward commercialization.
Strategic collaborations and diagnostic initiatives
Statera Biopharma has also described strategic steps to complement its immunotherapy work. In one announcement, the company reported signing a binding Memorandum of Understanding with Holobeam Technologies, Inc., an early-stage med-tech company focused on holographic medical imaging and therapeutic technologies. Under the terms described, Statera Biopharma would acquire an interest in Holobeam to gain access to its Holographic Energy Teleportation (HET) technology, with the stated goal of assisting in early cancer detection and in targeting Statera Biopharma's drugs to cancer sites.
Company statements around this MOU emphasize the potential for earlier cancer detection and more precise therapeutic targeting, aligning Holobeam's imaging and energy delivery capabilities with Statera Biopharma's immunotherapy programs. This reflects an effort to pair diagnostic innovation with immune-modulating drug candidates.
Regulatory and listing context
Public communications from Statera Biopharma have also addressed its trading and regulatory reporting status. The company has described itself as listed on Nasdaq under the symbol STAB in several releases and later as trading on the OTC markets, including references to OTCPK:STAB. Statera Biopharma has reported interactions with The Nasdaq Stock Market LLC related to filing delinquencies and listing criteria, including notices of non-compliance and a hearing process before a Nasdaq Hearings Panel.
In one announcement, the company stated that it completed the application process for moving from the OTC Pink Sheets to the OTCQB Venture Marketplace, describing this as part of its pursuit to regain a Nasdaq listing. Other communications have discussed the completion and filing of periodic reports such as the Form 10-K for a prior fiscal year and Form 10-Q filings, as well as work with independent auditors and financing counterparties. These disclosures underline that regulatory filings and exchange compliance have been significant corporate priorities.
Corporate identity and evolution
Statera Biopharma has noted in multiple releases that it was formerly known as Cytocom, Inc. The company consistently characterizes itself as a clinical-stage biopharmaceutical organization with a focus on immune restoration and homeostasis, and as having one of the larger platforms of TLR agonists in the biopharmaceutical industry. It has also described a proposed business combination with Worksite Labs, Inc. via a non-binding letter of intent, under which the post-transaction entities would be expected to carry on the business of Worksite Labs as a diagnostic testing company, subject to definitive agreements and regulatory and shareholder approvals. The company has explicitly stated that there can be no assurance that this proposed transaction would be completed.
Across these various disclosures, Statera Biopharma presents itself as a biotechnology company in the professional, scientific, and technical services sector, with activity spanning immunotherapy research, clinical development, licensing of TLR-based drug candidates, and exploration of diagnostic and imaging technologies that may complement its therapeutic pipeline.
STAB stock and investor considerations
The symbol STAB has been used to represent Statera Biopharma, Inc. in public markets, including references to Nasdaq and OTC quotations. Company communications have discussed efforts to address listing standards, complete required SEC filings, and manage financing arrangements. These aspects are relevant for investors researching STAB stock, as they provide context on the company's regulatory posture and capital markets activity alongside its scientific and clinical programs.
Frequently asked questions (FAQ)
The following FAQs summarize key points about Statera Biopharma, Inc. based on available company disclosures.
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