Statera Biopharma, Inc.

Statera reported third-quarter 2021 revenue of $236,000, all from ImQuest research services, versus no revenue in the same period of 2020. Gross profit was $120,000, implying a gross margin of about 51%. R&D expense was $3.4 million, down from $4.4 million year over year, while G&A expense rose to $6.3 million from $1.8 million, a 253% increase. The company posted a net loss from operations of $12.7 million, or $0.47 per share, compared with a net loss of $5.7 million, or $1.84 per share, in the prior-year quarter. Cash, cash equivalents and restricted cash totaled approximately $14.4 million at September 30, 2021. For guidance, management said it expects site activation for the pediatric Crohn’s Phase 3 trial by year-end and enrollment to start next year; first patient dosing in the acute COVID-19 Phase 1 pilot was expected this month, with preliminary data in mid-2022; and a Phase 1b/2 pancreatic cancer trial is expected in the first half of 2022.

Michael Handley framed the quarter as the start of a new Statera, emphasizing the rebrand, the merger-driven expansion of the toll-like receptor platform, and a focus on immune modulation across autoimmune disease, infectious disease, cancer and blood disorders. He highlighted recent alliance-building, including a five-year drug discovery agreement with La Jolla Institute of Immunology, and said the company is screening second-generation compounds to deepen the pipeline. His tone was optimistic and forward-looking, repeatedly pointing to multiple clinical and corporate milestones over the next 12 to 18 months.

Peter Aronstam focused on the unusual merger accounting and explained that the quarter’s reported numbers combine different entities only from their respective closing dates, so year-over-year comparisons are not fully meaningful until later periods. He said the company generated $236,000 of revenue from ImQuest, with $506,000 of deferred revenue on the balance sheet indicating roughly three quarters of a million dollars collected since early July, and noted $14.4 million of cash, cash equivalents and restricted cash at quarter-end. He also described financing resources and constraints: a $15 million Avenue loan, with $5 million still in escrow pending additional equity in excess of $20 million, plus an unused GEM equity line of credit of up to $75 million, while the company is also discussing up to $60 million of new debt and equity commitments.

There was no substantive analyst Q&A, as the operator announced no further questions. The closest thing to investor interaction was management’s detailed explanation of merger accounting, deferred revenue, the Avenue loan, the unused GEM facility, and the plan to seek additional financing by year-end. Management also addressed cash needs and said capital will be used to fund 2022 objectives, opportunistic asset acquisition, and pipeline development.