FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39871 SAB BIOTHERAPEUTICS, INC. (Mark One) (Exact Name of Registrant as Specified in its Charter) Del ...

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]

Participation from strategic investor Sanofi, along with new investors RA Capital Management, Commodore Capital, Vivo Capital, Blackstone Multi-Asset Investing, Spruce Street Capital, Forge Life Science Partners and Woodline Partners LP, and existing investors Sessa Capital, the T1D Fund, and ATW Partners Proceeds expected to fully fund completion of pivotal Phase 2b SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune T1D in newly diagnosed T1D patients (Stage 3) Company expects procee ...

Core Viewpoint - SAB BIO is making significant progress in developing its immunotherapy platform aimed at delaying the onset or progression of type 1 diabetes (T1D), with recent positive Phase 1 topline data for its lead asset, SAB-142 [2][5]. Recent Pipeline Developments - In April 2025, SAB BIO completed patient dosing in the last cohort of the Phase 1 clinical study of SAB-142, indicating advancement in its clinical trials [2]. Corporate Updates from Q1 2025 - The company has implemented budget initiatives that are contributing to cost savings, particularly in manufacturing processes, which are expected to enhance financial performance in 2025 [7]. - SAB BIO has achieved a Qualified Person (QP) declaration for its in-house CMC manufacturing process for SAB-142, meeting European manufacturing standards for investigational medical drug products [7]. Q1 2025 Financial Results - As of March 31, 2025, SAB BIO held cash and equivalents of $12.9 million, down from $20.8 million as of December 31, 2024 [7]. - Research and development (R&D) expenses were $7.7 million for Q1 2025, a slight decrease from $8.1 million in Q1 2024, attributed to fluctuations in spending priorities for the SAB-142 program [7]. - General and administrative expenses decreased to $3.1 million in Q1 2025 from $4.2 million in Q1 2024, driven by reduced payroll and professional fees [7]. - Other income for Q1 2025 was $5.6 million, down from $6.4 million in Q1 2024, primarily due to changes in fair value of warrant liabilities and reduced net interest income [7]. - The company reported a net loss of $5.2 million for Q1 2025, compared to a net loss of $5.0 million for Q1 2024 [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ 777 W 41 St, Suite 401 st Miami Beach, Florida 33140 (Address of principal executive offices) (Zip Code) (I.R.S. Empl ...

Core Insights - SAB BIO announced positive topline data for SAB-142, indicating its potential as a best-in-class disease-modifying therapy for Type 1 Diabetes (T1D) [2][6] - The company is set to advance its development program and begin enrolling patients in a Phase 2b trial for SAB-142 in mid-2025 [2][6] Recent Pipeline Developments - The Phase 1 clinical trial of SAB-142 met its primary objectives related to safety and pharmacodynamic activity, allowing progression to Phase 2b [6] - The U.S. FDA granted clearance for the investigational new drug (IND) application for SAB-142 on May 21, 2024 [6] - A clinical advisory board was established to provide expert guidance for the development of SAB-142 [6] Corporate Updates from Fiscal Year 2024 - Lucy To was appointed as Chief Financial Officer on July 31, 2024 [6] - Jay Skyler, MD, MACP, FRCP, joined SAB BIO's Board of Directors on May 6, 2024 [6] - Samuel J. Reich expanded his role as Chief Executive Officer on February 2, 2024 [6] Fiscal Year 2024 Financial Results - SAB BIO reported cash and equivalents of $20.8 million as of December 31, 2024, down from $56.6 million a year earlier [6] - Research and development expenses increased to $30.3 million in 2024 from $16.5 million in 2023 [6] - General and administrative expenses decreased to $14.0 million in 2024 from $23.8 million in 2023 [6] - The company reported a net loss of $34.1 million for the year ended December 31, 2024, compared to a net loss of $42.2 million in 2023 [6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39871 SAB BIOTHERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 85-3899721 Securities registered purs ...

Summary of SAB Biotherapeutics (SABS) Conference Call Company Overview - **Company**: SAB Biotherapeutics (SABS) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company specializing in human IgG products for autoimmunity, particularly type one diabetes (T1D) [4][5] Key Milestones and Developments - **Clinical Trials**: Recently completed Phase 1 trial for an anti-thymocyte globulin asset, focusing on T1D [4][12] - **Mechanism of Action**: The product aims to replicate the efficacy of rabbit antithymocyte globulin (thymoglobin) without the associated immunogenicity and serum sickness [12][15] - **Phase 2 SAFE Guard Study**: Planned to start in mid-2025, targeting newly diagnosed T1D patients within 100 days of diagnosis [42][56] Proprietary Technology - **Transchromosomic Cow Platform**: Unique in the world, allowing for the production of human IgG from genetically engineered cows [6][7] - **Advantages**: Higher plasma yield (60 times more than humans), robust immune response, and established infrastructure for animal care [9][10] Clinical Data Insights - **Phase 1 Trial Results**: - Doses ranged from 0.003 mg/kg to 2.5 mg/kg, with a focus on serum sickness and T cell markers [13][14] - Demonstrated activation of T cells leading to exhaustion signals without long-term lymphodepletion [14][18] - **Safety Profile**: No significant lymphodepletion observed; transient lymphopenia was expected and not clinically significant [22][24] Future Plans and Expectations - **Next Steps**: - Continue with Phase 2 study focusing on preservation of C peptide at one year [42] - Potential for redosing based on favorable safety and immunogenicity data [49][50] - **Expected Data Timeline**: Interim analysis expected within a year of trial start, with top-line data anticipated in mid-2027 [56][57] Market and Competitive Landscape - **Unique Positioning**: SAB Biotherapeutics is positioned as a leader in the development of human IgG therapies for autoimmune diseases, with a focus on unmet medical needs where existing rabbit products are not suitable [39][54] - **Physician Feedback**: Positive feedback from key opinion leaders (KOLs) regarding the preservation of Tregs and the dual exhaustion of CD4 and CD8 T cells [53][54] Additional Considerations - **Regulatory Path**: The product's safety profile and lack of immunogenicity are expected to facilitate regulatory approval [49][50] - **Broader Applications**: Potential future indications include scleroderma, lupus nephritis, and celiac disease, expanding the therapeutic scope beyond T1D [39][40]

Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders [2] - The company's lead asset, SAB-142, targets type 1 diabetes (T1D) with a disease-modifying therapeutic approach aimed at delaying onset and potentially preventing disease progression [2] - SAB BIO utilizes advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, enabling the generation of a diverse repertoire of specifically targeted, high-potency human IgGs [2] Upcoming Events - SAB BIO management will participate in the Guggenheim SMID Cap Biotech Conference on February 6, 2025, with a fireside chat scheduled from 2:00 to 2:25 PM ET [1] - The company will also present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, from 10:00 to 10:30 AM ET [1] - Live webcasts and archived recordings of these events will be available on the SAB BIO investor relations website [1]

SAB-142 was generally well-tolerated among healthy volunteers; data from Phase 1 trial confirms SAB-142 does not cause serum sickness or anti-drug antibodies at target dose Study results support that SAB-142 is well-positioned for re-dosing in outpatient setting for type 1 diabetesResults will be presented in an R&D webinar event today at 8:00 am ET; registration details below MIAMI, Jan. 28, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), ("SAB BIO" or the "Company"), a clinical-stage biopharmaceutical co ...