SAB Biotherapeutics Reports $34.1 Million Net Loss and Plans Phase 2b Trial for T1D Therapy

SAB Biotherapeutics, Inc. reported a net loss of $34.1 million for the fiscal year ended December 31, 2024, compared to a net loss of $42.2 million in 2023. Revenue decreased by $0.9 million (40.9%) to $1.3 million in 2024, primarily due to the termination of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPEO) Rapid Response Contract in 2022. The company expects no further revenue from this contract and does not anticipate pursuing additional funded research opportunities outside its primary focus on type 1 diabetes (T1D).

Research and development expenses increased by $13.7 million (83.2%) to $30.3 million in 2024, mainly due to increases in outside laboratory services, laboratory supplies, salaries and benefits, project consulting, and clinical trial costs. General and administrative expenses decreased by $9.8 million (41.3%) to $13.9 million, primarily due to lower administrative support fees, non-capitalized financing costs, and salaries and benefits, partially offset by increased project consulting costs. The company anticipates increased general and administrative expenses in the future as it expands its workforce and prepares for potential commercialization.

A significant development was the announcement of positive topline Phase 1 clinical trial results for SAB-142, the company's T1D therapy, on January 28, 2025. The trial demonstrated a favorable safety profile with no serum sickness or anti-drug antibodies reported across all doses, supporting chronic ambulatory dosing. SAB-142 also showed sustained immunomodulation and a mechanism of action analogous to rabbit ATG. Based on these results, the company plans to advance SAB-142 into a Phase 2b clinical trial in 2025. As of December 31, 2024, the company had 63 full-time employees, with 37 in research and development, 9 in clinical activities, and 17 in general and administrative roles.

The company's cash, cash equivalents, and investments decreased from $56.6 million at the end of 2023 to $20.8 million at the end of 2024. The company acknowledges substantial doubt about its ability to continue as a going concern due to its operating losses and anticipates seeking additional funding through equity or debt financing, collaborations, or other funding arrangements. The company's financial statements include an explanatory paragraph from its independent registered public accounting firm regarding this substantial doubt. The company's current patent portfolio includes over 40 issued patents or pending applications, with global patent protection expected to extend to 2041 and beyond.

The company's outlook is focused on advancing SAB-142 through clinical trials and preparing for potential commercialization. However, the company highlights numerous risk factors, including the uncertainties inherent in clinical drug development, regulatory approvals, manufacturing, market competition, and securing adequate financing. The company's ability to achieve profitability and sustain its operations remains dependent on the successful development and commercialization of its product candidates.