Core Viewpoint - Sanofi's Teizeild (teplizumab) has received a positive recommendation from the CHMP for EU approval to delay the onset of stage 3 type 1 diabetes (T1D) in patients aged eight years and older with stage 2 T1D [1][2]. Summary by Sections Clinical Study Results - The TN-10 phase 2 study demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo [2]. - At the end of the TN-10 study, 57% of patients in the Teizeild group remained in stage 2 T1D, compared to 28% in the placebo group [2]. - The safety profile of Teizeild was consistent with previous studies, with common adverse events including transient lymphopenia and rash [2]. Regulatory and Market Implications - If approved, Teizeild would be the first disease-modifying therapy for T1D in the EU [5]. - Sanofi is currently evaluating next steps regarding its application for recently diagnosed stage 3 T1D following the positive CHMP recommendation [3]. Background on T1D - T1D is a progressive autoimmune condition characterized by the destruction of insulin-producing beta cells, leading to dysregulation of blood sugar levels [4]. - The progression of T1D is categorized into four stages, with stage 2 indicating the presence of autoantibodies and abnormal blood sugar levels [6]. Study Design - The TN-10 study was a pivotal phase 2, randomized, placebo-controlled, double-blind trial involving 76 participants aged eight to 45, assessing the prevention or delay of stage 3 T1D [4][7].

Core Insights - SAB BIO recently raised $175 million in an oversubscribed private placement, which included participation from strategic investor Sanofi and top-tier biotech investors [1][4][7] - The financing extends the company's operational runway until mid-2028, allowing for the completion of the pivotal Phase 2b SAFEGUARD study for SAB-142, aimed at delaying the progression of type 1 diabetes [1][4][7] - The SAFEGUARD study is expected to initiate in Q3 2025 following alignment with the FDA on the study's design [2][6][7] Recent Corporate Highlights - The private placement closed on July 22, 2025, and involved the issuance of up to 1,000,000 shares of Series B nonvoting convertible preferred stock, convertible into up to 100,000,000 shares of common stock at a price of $1.75 per share [7] - The company also issued warrants for up to 1,500,000 shares of Series B preferred stock, potentially raising an additional $284 million if fully exercised [7] - SAB BIO's lead candidate, SAB-142, targets autoimmune type 1 diabetes with a disease-modifying approach [9] Recent Clinical and Regulatory Updates - The company completed full randomization of its Phase 1 study in healthy volunteers and successfully enrolled participants with type 1 diabetes to assess the safety, tolerability, pharmacokinetics, and immunogenicity of SAB-142, with final data expected in Q4 2025 [7] - A Type B meeting with the FDA in May 2025 provided feedback that aligned the company on the progression and design of the SAFEGUARD study, which will serve as supportive evidence for future regulatory approvals [7] Q2 2025 Financial Results - As of June 30, 2025, SAB BIO held cash and equivalents of $5.7 million, down from $20.8 million as of December 31, 2024 [12] - Research and development expenses were $7.0 million for Q2 2025, compared to $6.8 million in Q2 2024, reflecting a slight increase due to fluctuating spending priorities [12] - The company reported a net loss of $10.1 million for Q2 2025, compared to a net loss of $7.3 million for the same period in 2024 [12]