Earnings

SAB Biotherapeutics Posts $22.3 Million Loss as SAFEGUARD Costs Rise

The Tip Desk · November 11, 2026 · 4 min read

Research and development spending reached $18.1 million in the three months ended September 30, 2026, as the company advanced SAB-142 into the registrational Phase 2b study.

SAB Biotherapeutics (SABS), a clinical-stage biopharmaceutical company developing multi-specific human immunoglobulin G for immune and autoimmune disorders, reported a net loss of $22.3 million for the three months ended September 30, 2026, compared with net income of $45.4 million a year earlier.

The year-ago period included a $62.0 million gain on Release Date and Enrollment Date Warrants issued with the Series B Offering. Those warrants were remeasured through September 26, 2025, when they were reclassified to stockholders’ equity after stockholder approval, and are no longer remeasured. The company also recorded a $1.7 million gain on the change in fair value of Preferred Tranche C Warrants in the latest quarter.

Operating expenses were $25.9 million, producing an operating loss of the same amount, versus $12.7 million a year earlier. Research and development expenses were $18.1 million, up 101.5% from $9.0 million, which the company said was primarily due to increased clinical trial costs and related headcount to support advancement of SAB-142 into the registrational Phase 2b SAFEGUARD study. Clinical trial expense was $6.3 million and salaries and benefits were $8.3 million. General and administrative expenses were $7.8 million, up 110.9% from $3.7 million, primarily from higher headcount costs, including related non-cash stock-based compensation.

Sequentially, research and development rose to $18.1 million from $16.2 million in the three months ended June 30, 2026, and general and administrative rose to $7.8 million from $7.2 million. Total operating expenses were $25.9 million versus $23.4 million. The net loss was $22.3 million versus $22.5 million in the prior quarter, as the warrant fair-value swing helped offset the larger operating loss, while interest income declined slightly.

Interest income, net, was $1.6 million, up 162.7% from $0.6 million a year earlier, which the company attributed to higher average short-term and long-term investment balances after the March 2026 Public Offering and Release Date and Enrollment Date Warrant exercises. Other income, net, was $0.3 million, down 55.6% from $0.8 million, primarily from a decrease in the Australian research and development tax credit. Warrant issuance expense was zero, versus $4.9 million a year earlier, when Series B offering costs were expensed.

SAB-142, the company’s lead candidate, is a multi-specific, fully human anti-thymocyte globulin in development for autoimmune type 1 diabetes. SAFEGUARD is a registrational Phase 2b study in people newly diagnosed with Stage 3 T1D. In September 2026, the SAFEGUARD Study Data Monitoring Committee approved the second and final stepdown, expanding enrollment to pediatric patients ages 5–11. The adult and adolescent cohorts in SAFEGUARD were fully enrolled and closed for screening. Part A, a dose-ranging study in adults, had completed enrollment in the first quarter of 2026; Part B, a randomized double-blind, placebo-controlled, dose-ranging study, was actively enrolling.

In October 2026, the FDA granted Fast Track designation to SAB-142 for treatment of new-onset Stage 3 T1D. The company said the designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need, does not change the standards for approval, and does not ensure that SAB-142 will be approved or that the process will be faster than conventional FDA procedures.

An investigator-led Phase 3 study, PRISE-hATG, is planned in patients with Stage 3 T1D up to two years from diagnosis, with seven clinical sites planned in the U.S., Europe and the U.K. The study is supported by a grant from Breakthrough T1D awarded in July 2026 and is co-funded by the company. In April 2026, the FDA sent written correspondence confirming that C-peptide area under the curve may serve as a surrogate endpoint for accelerated approval.

During the three months ended September 30, 2026, the company received $13.4 million of gross proceeds before placement-agent fees from exercise of Release Date and Enrollment Date Warrants. The March 2026 Public Offering generated aggregate gross proceeds of approximately $95.0 million before underwriting discounts, commissions, and offering expenses; net proceeds are intended to fund the Phase 2b SAFEGUARD study and for general corporate purposes.

The accumulated deficit was $174.6 million as of September 30, 2026, versus $152.3 million as of June 30, 2026. The company said it expects to continue to incur operating losses for the foreseeable future and that, based on current operating expenses, existing resources will be sufficient to cover operating cash needs for at least one year from the date the condensed consolidated financial statements in the quarterly report are issued. It may seek additional funding through equity or debt financings or other arrangements. A shelf registration statement declared effective in January 2026 allows offerings of common stock, preferred stock, debt securities, warrants, rights or units up to an aggregate public offering price of $300.0 million.