1型糖尿病治疗方案 - 公司正在开发一种名为SAB-142的首创性人源多靶点抗体治疗方案,用于预防或延缓1型糖尿病的进展[136,141] - SAB-142有望通过维持C肽水平来保护胰岛素分泌功能,并且可以安全可靠地重复给药,避免了动物源性抗体所带来的血清病风险[141,142] - 公司计划在2024年中期前向全球监管机构提交SAB-142的IND和CTA申请,以扩大临床试验的地域覆盖[143] 流感预防和治疗 - 公司的另一候选药物SAB-176是一种针对高危人群的广谱中和性人源多价免疫球蛋白,可用于预防和治疗流感[144,145] 收入和研发费用 - 公司目前的收入主要来自政府和其他组织的研发补助金,尚未有任何商业化产品上市[147] - 政府补助总收入在2024年6月30日结束的三个月和六个月分别约为26.3万美元和120万美元，而2023年6月30日结束的三个月和六个月分别为8.6万美元和66.7万美元[148] - 公司与美国国防部的快速响应合同于2022年终止,公司正在与国防部就此进行谈判和结算[149] - 研发费用在2024年6月30日结束的三个月和六个月分别增加了3.16百万美元(86.3%)和6.57百万美元(80.0%),主要是由于外部实验室服务、薪资福利、间接费用、项目咨询、临床试验成本和实验材料等方面的增加[167][168] - 公司预计未来收入将会下降,因为其主要管线1型糖尿病仍由独立资金支持,公司正在探索潜在的合作、合作开发和许可安排[166] - 公司获得的政府补助包括NIH-NIAID、国防部JPEO等,这些补助项目大部分已于2023年6月30日前完成[148] - 公司一般及行政费用预计将继续增加,主要是由于业务增长带来的人员增加以及作为上市公司的合规成本[152] - 公司的研发活动包括平台开发和适应症研究,其中SAB-142正在进行1期临床试验[150] - 公司的研发费用主要包括薪资福利、实验材料、动物实验、临床试验、外部实验服务、项目咨询和设施费用等[150][151] - 公司的其他收入主要来自于可退还的澳大利亚研发税收抵免[154] - 公司的利息收入来自于债券、现金和现金等价物的投资收益[155] - 研发费用同比增加80.2%,达1,476.9万美元[169][170] - 一般及行政费用同比增加26.5%,达803.1万美元[176][177][178] - 非经营收入同比增加3201.9%,达852.8万美元[181][182] - 利息收入同比增加908.0%,达87.2万美元[189][190] 财务状况和未来展望 - 公司预计未来将继续产生亏损,需要寻求额外资金支持[191] - 公司获得了8%无担保可转换票据融资,金额约542,000美元[193][194] - 公司获得了保险融资,金额约765,000美元[195] - 经营活动现金流出同比增加1,200万美元[197] - 投资活动现金流出同比增加2,010万美元[198] - 公司未来12个月内现有资源将不足以支持运营[191] - 公司预计将继续产生亏损,并且预计亏损将随着产品候选物的开发或监管批准以及产品商业化的开始而增加[1] - 公司需要筹集额外资金以支持长期计划,未来可能通过股权或债务融资、其他第三方融资、合作或其他融资安排来寻求额外资金[1] - 公司目前预计截至2024年6月30日的现金、现金等价物和短期投资为3,720万美元,不足以支持超过12个月的运营费用和资本要求[1] 会计政策 - 公司的短期投资包括美国国债证券和交易所交易基金,公司定期评估是否存在信用损失[2][3] - 公司将研发费用在发生时计入费用,并跟踪使用特定项目代码的补助金[4][5] - 公司根据ASC 718确认股份支付费用,采用Black-Scholes模型确定期权公允价值[6][7] - 公司将公开认股权证归类为第1层公允价值计量,将私募认股权证归类为第3层公允价值计量[8][9] - 公司确定私募认股权证和优先认股权证的公允价值变动分别为5千美元和780万美元[10][11] - 公司将股票激励相关的费用按照授予日的公允价值计量和确认[1] - 公司自2018年1月1日起根据ASC 842准则确认使用权资产和租赁负债[2] - 公司作为"新兴成长公司"可享受JOBS法案下的一些减免披露要求[3] - 公司目前100%收入来自政府机构的补助金,没有发生坏账[4] - 公司现金、现金等价物和投资组合的利率风险较小,10%利率变动不会产生重大影响[5] - 公司主要业务以美元计价,外汇风险较小,10%汇率变动不会产生重大影响[6]

MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (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 the founding of a clinical advisory board to provide expert insight and guidance to the Company in the clinical development of SAB-142, its leading therapeutic candidate. The newly formed bo ...

MIAMI, July 31, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), ("SAB" or the "Company"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced that Lucy To has been named Chief Financial Officer effective August 12, 2024. Ms. To brings over 18 years of investment banking and strategic operational expertise to SAB and will l ...

With new brand identity, SAB BIO continues drive towards serious unmet needs in type 1 diabetes 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 preve ...

MIAMI, June 18, 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 that it will present a poster at the ADA 84th Scientific Sessions on June 21-24, 2024 in Orlando, Florida. The poster will be presented by SAB's Senior Program Manager, Eric Sandhurst, Ph.D, and p ...

MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), today announced that the U.S. Food and Drug Administration (FDA) has provided clearance for the Company's investigational new drug (IND) application to proceed for its phase 1 clinical trial for type 1 diabetes (T1D) therapy SAB-142. SAB is a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progressio ...

MIAMI, May 20, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), ("SAB" or the "Company"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today reported financial results for the first quarter ended March 31, 2024, and provided a company update. "As we work towards upcoming SAB-142 milestones, I remain enthusiastic about our ongoing pr ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 29, 2024 SAB BIOTHERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-39871 85-3899721 (State or Other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification No .) 2100 East 54th Street North Sioux Falls, South Dakota 57104 (A ...

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, 2023 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) Delaware 85-3899721 (State or other ...