Statera Biopharma, Inc. (NASDAQ:STAB) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses, and cancers. The company has a diverse pipeline of product candidates based on its proprietary platform designed to rebalance the body's immune system and restore homeostasis. However, Statera's financial performance has been a significant concern, with the company reporting substantial net losses and negative cash flows in recent years.

Business Overview

Statera Biopharma is leveraging its extensive platform of toll-like receptor (TLR) agonists, including TLR4 and TLR9 antagonists, as well as the TLR5 agonists Entolimod and GP532. The company's therapies are designed to directly elicit 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's pipeline includes several promising product candidates.

STAT-201

is being developed for the treatment of Crohn's disease,

STAT-205

is targeting 'long haul' COVID-19,

STAT-401

is in development for pancreatic cancer, and the TLR5 agonist

Entolimod

is being evaluated for the treatment of anemia and neutropenia in cancer patients. The company expects to initiate several clinical trials for these candidates in the next 12 months.

Financial Performance

Statera's financial performance has been a significant concern for investors. For the fiscal year ended December 31, 2022, the company reported an annual net loss of $174.4 million, with no revenue generated. The company's annual operating cash flow was -$28.2 million, and its annual free cash flow was -$28.4 million.

On a quarterly basis, Statera's financial results have been equally challenging. In the third quarter of 2022, the company reported a net loss of $33.6 million, with no revenue generated. The company's quarterly operating cash flow was -$4.7 million, and its quarterly free cash flow was -$4.8 million.

Liquidity

As of September 30, 2022, Statera had cash and cash equivalents of $0.5 million, which the company has stated is not sufficient to fund its projected operating requirements or allow it to fund its operating plan beyond the fourth quarter of 2022. The company will need to secure additional financing to support its continuing operations and clinical development activities.

Statera has historically funded its operations through the sale of equity and debt securities, as well as the receipt of funded grants. The company has outstanding debt obligations, including a $6.4 million short-term note payable to Avenue Ventures. In April 2022, Avenue declared the company in default under the loan agreement and purported to accelerate the balance due, which the company is currently disputing.

Risks and Challenges

Statera faces several significant risks and challenges that could impact its future performance. The company's ability to continue as a going concern is in doubt, as it has incurred substantial losses and negative cash flows, and its existing cash resources may not be sufficient to fund its operations beyond the fourth quarter of 2022. The company will need to secure additional financing, which may not be available on favorable terms, or at all.

Additionally, Statera's pipeline of product candidates is still in the clinical development stage, and there is no guarantee that any of these candidates will receive regulatory approval or be successfully commercialized. The company also faces competition from other immunotherapy developers, and its technologies may not be able to achieve the desired therapeutic effects or safety profiles.

Outlook

Statera has not provided any formal financial guidance or outlook for the upcoming fiscal year. The company's focus remains on advancing its pipeline of immunotherapy candidates through clinical development and seeking additional financing to support its operations.

Conclusion

Statera Biopharma is a promising biopharmaceutical company with a diverse pipeline of immunotherapy candidates targeting a range of diseases. However, the company's financial performance has been a significant concern, with substantial net losses, negative cash flows, and limited liquidity. Statera will need to secure additional financing to continue its operations and clinical development activities, and there is no guarantee that its product candidates will ultimately be successful. Investors should carefully consider the risks and challenges facing the company before making any investment decisions.

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