Core Insights - SAB Biotherapeutics has appointed Lucy To as Chief Financial Officer, effective August 12, 2024, bringing over 18 years of investment banking and strategic operational expertise to the company [6] - The company is focused on developing SAB-142, a therapeutic aimed at delaying the onset and progression of type 1 diabetes (T1D), with top-line Phase 1 data expected by the end of 2024 [1][6] - SAB utilizes a novel immunotherapy platform that generates human immunoglobulins without the need for human donors, targeting serious unmet needs in immune and autoimmune disorders [2] Company Overview - SAB BIO is a clinical-stage biopharmaceutical company developing high-potency immunoglobulins (IgGs) to treat immune and autoimmune disorders [2] - The lead asset, SAB-142, employs a disease-modifying therapeutic approach to change the treatment paradigm for T1D [2] - The company’s DiversitAb™ drug development system leverages advanced genetic engineering to produce a diverse range of specifically targeted human IgGs [2] Leadership and Strategy - Lucy To's role will encompass corporate finance, corporate strategy, and broader strategic business relationships [6] - The company aims to deliver value to shareholders while transforming the landscape of T1D treatment [1]

New name, logo and website updates, stock symbol will remain SABS MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced its new name, SAB BIO, and visual identity to more closely align with its mission to treat and prevent immune and autoimmune disor ...

Core Viewpoint - SAB Biotherapeutics is advancing its clinical-stage biopharmaceutical product, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D) and will present findings at the ADA 84th Scientific Sessions in June 2024 [1][2] Company Overview - SAB Biotherapeutics focuses on developing human immunoglobulins (IgGs) for treating immune and autoimmune disorders without relying on human donors or convalescent plasma [12] - The company's lead asset, SAB-142, is designed to modify the disease progression of T1D, potentially changing the treatment paradigm [12] Product Details - SAB-142 is a fully human alternative to rabbit anti-thymocyte globulin (ATG), which has shown efficacy in slowing disease progression in clinical trials for T1D [3][10] - The mechanism of action for SAB-142 involves targeting immune cells that destroy pancreatic beta cells, aiming to preserve insulin production [4] - Unlike rabbit ATG, SAB-142 is expected to minimize adverse immune reactions, allowing for safer and more consistent re-dosing [4] Clinical Development - Following FDA IND clearance in May 2024, the company is expanding its clinical program for SAB-142 [11] - The ADA 84th Scientific Sessions will feature a poster presentation on the assessment of tolerance and safety for SAB-142, highlighting its potential in diabetes treatment [2][9]

Core Insights - SAB Biotherapeutics announced the departure of CFO Michael King, who will take on a CEO role at a privately-held oncology company, effective June 4, 2024, while remaining an advisor until the end of the year [1][3] - The Board of Directors has initiated a search for a permanent CFO, with Mark Conley serving as Interim CFO during this transition [2] - The company reaffirmed its fiscal year 2024 outlook and upcoming milestones, including a topline data readout from its Phase 1 study of lead candidate SAB-142 [4] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) for treating immune and autoimmune disorders, specifically targeting type 1 diabetes (T1D) with its lead asset SAB-142 [5] - The company utilizes advanced genetic engineering and antibody science to produce a diverse range of specifically targeted, high-potency human IgGs without the need for human donors or convalescent plasma [5]

Core Insights - The U.S. FDA has cleared SAB Biotherapeutics' IND application for SAB-142, a therapy aimed at treating type 1 diabetes (T1D) [1][3] - The ongoing HUMAN trial will generate data for a future Phase 2B trial, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142 [2][3] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hIgG) to delay T1D onset or progression [1][7] - The company utilizes advanced genetic engineering to produce high-potency immunoglobulins without the need for human donors or convalescent plasma [7][8] Trial Design - Phase 1 of the SAB-142 trial is a randomized, double-blind, placebo-controlled study with a dose range from 0.03 mg/kg to 2.5 mg/kg [3] - The trial aims to validate the safety and immunogenicity profile of SAB-142, with no observed serum sickness in the third cohort [3][4] Mechanism of Action - SAB-142 is designed to target immune cells that destroy pancreatic beta cells, similar to rabbit anti-thymocyte globulin (ATG), but aims to avoid adverse immune reactions associated with animal-derived treatments [6][4] - Previous clinical trials have shown that rabbit ATG can slow beta cell destruction and preserve insulin production, which is critical for blood sugar regulation [5][6]

Core Insights - SAB Biotherapeutics, Inc. is focused on developing human anti-thymocyte immunoglobulin (hIgG) to delay the onset or progression of type 1 diabetes (T1D) [1][5] - The company reported financial results for Q1 2024, highlighting a net loss of $4.0 million and a cash position of $45.2 million as of March 31, 2024 [4][6] Company Updates - The company appointed Dr. Jay Skyler, a renowned T1D expert, to its Board of Directors, increasing the board size to 11 members, with 9 being independent [2] - SAB has transitioned its corporate headquarters to Miami, FL, while maintaining its Research and Development Campus in South Dakota [2] Pipeline and Milestones - SAB's partnership with INNODIA was showcased at an annual meeting in Belgium, where updates on SAB-142 were presented to global T1D partners [3] - The Phase 1 clinical development of SAB-142 is on track, with the third cohort fully enrolled and dosed without any observed serum sickness [3] Financial Performance - Cash, cash equivalents, and available-for-sale securities totaled $45.2 million as of March 31, 2024, down from $56.6 million as of December 31, 2023, primarily due to ongoing research expenses [6] - Research and Development expenses increased to $7.1 million in Q1 2024 from $4.5 million in Q1 2023, reflecting a focus on the autoimmunity space with SAB-142 [6] - General and Administrative expenses rose to $4.2 million in Q1 2024 from $3.4 million in Q1 2023, driven by increased headcount to support research activities [6] - Non-operating income surged to $6.4 million in Q1 2024 from $48,000 in Q1 2023, mainly due to changes in fair value of warrant liabilities and an Australian research and development tax credit [6] - The net loss for Q1 2024 was $4.0 million, translating to an earnings per share of $(0.43), compared to a net loss of $7.4 million and $(0.15) per share in Q1 2023 [6]

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, 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) De ...

[FORM 8-K Filing Details](index=1&type=section&id=FORM%208-K%20Filing%20Details) This section details the registrant's identity, contact information, and securities filing status [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides the core identification details for SAB Biotherapeutics, Inc. as the registrant, including its legal name, jurisdiction of incorporation, and primary contact information - Registrant Name: **SAB BIOTHERAPEUTICS, INC.**[2](index=2&type=chunk) - Jurisdiction of Incorporation: **Delaware**[2](index=2&type=chunk) - Principal Executive Offices: **2100 East 54th Street North, Sioux Falls, South Dakota 57104**[2](index=2&type=chunk) - Registrant's Telephone Number: **605 679-6980**[2](index=2&type=chunk) [Securities and Filing Status](index=1&type=section&id=Securities%20and%20Filing%20Status) This section outlines the company's registered securities and confirms its status as an emerging growth company, indicating specific regulatory considerations Registered Securities | Title of each class | Symbol(s) | Name of each exchange on which registered | | :------------------ | :-------- | :---------------------------------------- | | Common stock, $0.0001 par value per share | SABS | The Nasdaq Stock Market LLC | | Warrants, each exercisable for one share of Common Stock | SABSW | The Nasdaq Stock Market LLC | - **SAB Biotherapeutics, Inc.** is an Emerging Growth Company[5](index=5&type=chunk) - The registrant has elected not to use the extended transition period for complying with new or revised financial accounting standards[6](index=6&type=chunk) [Current Report Items](index=3&type=section&id=Current%20Report%20Items) This section details the company's financial results announcement and lists accompanying exhibits [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) SAB Biotherapeutics, Inc. issued a press release on March 29, 2024, to announce its financial results for the year and quarter ended December 31, 2023, along with a corporate update. This press release is furnished as Exhibit 99.1 - Date of Report: **March 29, 2024**[2](index=2&type=chunk) - Press Release Date: **March 29, 2024**[7](index=7&type=chunk) - Content of Press Release: Financial results for the year and quarter ended **December 31, 2023**, and a corporate update[7](index=7&type=chunk) - Exhibit Reference: The press release is furnished as **Exhibit 99.1**[7](index=7&type=chunk) - Filing Status: The information in this item, including Exhibit 99.1, is furnished and not deemed 'filed' for Section 18 of the Exchange Act[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, which include the press release detailing financial results and the interactive data file for the cover page Exhibits Filed | Exhibit Number | Description | | :------------- | :----------------------------------------------------------------------- | | 99.1 | Press Release of the Company, dated March 29, 2024 | | 104 | Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document. | [SIGNATURES](index=4&type=section&id=SIGNATURES) This section confirms the official signing of the Form 8-K report by the authorized executive [Report Signatures](index=4&type=section&id=Report%20Signatures) The Form 8-K report was duly signed on behalf of SAB Biotherapeutics, Inc. by its Chief Executive Officer, Samuel J. Reich, on March 29, 2024 - Signatory: **Samuel J. Reich**[13](index=13&type=chunk) - Title: **Chief Executive Officer**[13](index=13&type=chunk) - Date of Signature: **March 29, 2024**[13](index=13&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 October 12 SAB BIOTHERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) 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, 2023 Delaware 85-3899721 (State or other ...

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 (Mark One) For the transition period from ___________________ to ___________________ Commission File Number: 001-39871 (Exact Name of Registrant as Specified in its Charter) Delaware 85-3899721 (Sta ...