: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participants with COVID-19.

Start Date20 Aug 2020

Sponsor / Collaborator

SAB Biotherapeutics, Inc.

[+1]

NCT04518410 / CompletedPhase 2/3IIT

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Start Date19 Aug 2020

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+7]

NCT04468958 / CompletedPhase 1

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.

Start Date01 Jul 2020

Sponsor / Collaborator

SAB Biotherapeutics, Inc.

[+1]

100 Clinical Results associated with SAB-185

100 Translational Medicine associated with SAB-185

100 Patents (Medical) associated with SAB-185

Literatures (Medical) associated with SAB-185

01 Oct 2023·iScience

Transchromosomic bovine-derived anti-SARS-CoV-2 polyclonal human antibodies protects hACE2 transgenic hamsters against multiple variants

Article

Author: Li, Rong ; Wang, Zhongde ; Lundy, Jeneveve ; Wu, Hua ; Alcorn, Maria D H ; Bausch, Christoph ; Klimstra, William B ; Vasilatos, Shauna ; Nambulli, Sham ; Sullivan, Eddie ; Egland, Kristi ; Duprex, Paul ; Luke, Thomas ; Terada, Yutaka ; Gilliland, Theron ; Liu, Yanan ; Dunn, Matthew ; Larson, Deanna

Pandemic SARS-CoV-2 has undergone rapid evolution resulting in the emergence of many variants with mutations in the spike protein, some of which appear to evade antibody neutralization, transmit more efficiently, and/or exhibit altered virulence. This raises significant concerns regarding the efficacy of anti-S monoclonal antibody-based therapeutics which have failed against variant SARS-CoV-2 viruses. To address this concern, SAB-185, a human anti-SARS-CoV-2 polyclonal antibody was generated in the DiversitAb platform. SAB-185 exhibited equivalent, robust in vitro neutralization for Munich, Alpha, Beta, Gamma, and Δ144-146 variants and, although diminished, retained PRNT₅₀ and PRNT₈₀ neutralization endpoints for Delta and Omicron variants. Human ACE2 transgenic Syrian hamsters, which exhibit lethal SARS-CoV-2 disease, were protected from mortality after challenge with the Munich, Alpha, Beta, Delta, and Δ144-146 variants and clinical signs after non-lethal Omicron BA.1 infection. This suggests that SAB-185 may be an effective immunotherapy even in the presence of ongoing viral mutation.

14 Jul 2023·The Journal of infectious diseases

Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19

Article

Author: Currier, Judith S ; Tsiatis, Anastasios A ; Fletcher, Courtney V ; Hoover, Keila ; Meintjes, Graeme A ; Taiwo, Babafemi O ; Murtaugh, William ; Aldrovandi, Grace ; Bausch, Christoph ; Olefsky, Maxine ; Hessinger, Diane ; Gutzman, Howard ; Giganti, Mark J ; Volberding, Paul A ; Glidden, David ; Ray, Stuart Campbell ; Rolla, Valeria Cavalcanti ; Javan, Arzhang Cyrus ; Dragavon, Joan ; Daza, Glenda ; Cooper, Marlene ; Luke, Thomas ; Roa, Jhoanna ; Chew, Kara W ; Moser, Carlee ; Li, Jonathan Z ; Kimmelman, Jonathan ; Erhardt, Bill ; Degli-Angeli, Emily ; Wohl, David Alain ; Smith, Davey M ; Murray, Barbara E ; Hosey, Lara ; Coombs, Robert ; Hughes, Michael D ; Daar, Eric S ; Hunsberger, Sally ; Harb, Socorro ; Neytman, Gene ; Eron, Joseph J ; Patel, Nilam ; Saloojee, Haroon ; Knowles, Kevin ; Waring, Lorraine ; Greninger, Alexander L ; Goecker, Erin

Abstract:

Background:

SAB-185, a novel fully human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for nonhospitalized adults with mild-moderate coronavirus disease 2019 (COVID-19).

Methods:

Participants received intravenous SAB-185 3840 units/kg (low-dose) or placebo, or 10 240 units/kg (high-dose) or placebo. Primary outcome measures were nasopharyngeal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA < lower limit of quantification (LLOQ) at study days 3, 7, and 14, time to symptomatic improvement, and safety through day 28.

Results:

Two-hundred thirteen participants received low-dose SAB-185/placebo (n = 107/106) and 215 high-dose SAB-185/placebo (n = 110/105). The proportions with SARS-CoV-2 RNA < LLOQ were higher for SAB-185 versus placebo at days 3 and 7 and similar at day 14, and significantly higher at day 7 for high-dose SAB-185 versus placebo only, relative risk 1.23 (95% confidence interval, 1.01–1.49). At day 3, SARS-CoV-2 RNA levels were lower with low-dose and high-dose SAB-185 versus placebo: differences in medians of −0.78 log10 copies/mL (P = .08) and −0.71 log10 copies/mL (P = .10), respectively. No difference was observed in time to symptom improvement: median 11/10 days (P = .24) for low-dose SAB-185/placebo and 8/10 days (P = .50) for high-dose SAB-185/placebo. Grade ≥3 adverse events occurred in 5%/13% of low-dose SAB-185/placebo and 9%/12% of high-dose SAB-185/placebo.

Conclusions:

SAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk nonhospitalized adults with COVID-19.Clinical Trials Registration. NCT04518410.

01 Oct 2022·Journal of medical virology

Transchromosomic bovines‐derived broadly neutralizing antibodies as potent biotherapeutics to counter important emerging viral pathogens with a special focus on SARS‐CoV‐2, MERS‐CoV, Ebola, Zika, HIV‐1, and influenza A virus

Review

Author: Dhama, Kuldeep ; Grudlewska‐Buda, Katarzyna ; do Nascimento Rangel, Adriano Henrique ; Saied, AbdulRahman A. ; Metwally, Asmaa A. ; Abdeen, Ahmed ; Skowron, Krzysztof ; Nascimento, Manuela Sales Lima ; Ahmed, Hassan ; El‐Mayet, Fouad S. ; Shah, Jaffer

Abstract:

Historically, passive immunotherapy is an approved approach for protecting and treating humans against various diseases when other alternative therapeutic options are unavailable. Human polyclonal antibodies (hpAbs) can be made from convalescent human donor serum, although it is considered limited due to pandemics and the urgent requirement. Additionally, polyclonal antibodies (pAbs) could be generated from animals, but they may cause severe immunoreactivity and, once "humanized," may have lower neutralization efficiency. Transchromosomic bovines (TcBs) have been developed to address these concerns by creating robust neutralizing hpAbs, which are useful in preventing and/or curing human infections in response to hyperimmunization with vaccines holding adjuvants and/or immune stimulators over an extensive period. Unlike other animal‐derived pAbs, potent hpAbs could be promptly produced from TcB in large amounts to assist against an outbreak scenario. Some of these highly efficacious TcB‐derived antibodies have already neutralized and blocked diseases in clinical studies. Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has numerous variants classified into variants of concern (VOCs), variants of interest (VOIs), and variants under monitoring. Although these variants possess different mutations, such as N501Y, E484K, K417N, K417T, L452R, T478K, and P681R, SAB‐185 has shown broad neutralizing activity against VOCs, such as Alpha, Beta, Gamma, Delta, and Omicron variants, and VOIs, such as Epsilon, Iota, Kappa, and Lambda variants. This article highlights recent developments in the field of bovine‐derived biotherapeutics, which are seen as a practical platform for developing safe and effective antivirals with broad activity, particularly considering emerging viral infections such as SARS‐CoV‐2, Ebola, Middle East respiratory syndrome coronavirus, Zika, human immunodeficiency virus type 1, and influenza A virus. Antibodies in the bovine serum or colostrum, which have been proved to be more protective than their human counterparts, are also reviewed.

News (Medical) associated with SAB-185

16 Oct 2023

·www.fiercebiotech.com

After 'live fire exercise' with COVID-19, SAB turns tactical experience back to diabetes program

The pandemic gave SAB the chance to revolve through the clinical cycle, from phase 1 to 2 to 3 in the space of about three years. In September 2019, a tiny company named SAB Biotherapeutics signed a little contract with the U.S. Department of Defense (DOD) that included the test development of an antibody treatment into phase 1 for “an unknown threat.” There's no way that SAB CEO Eddie Sullivan, Ph.D., could have seen what was coming next. The contract would be completed not as a test but as a real-life scramble to find a treatment to address a rapidly spreading global pandemic. SAB’s journey could be a cautionary tale of a biotech that jumped in to help fight a global threat but ultimately lost when the pandemic moved faster than anyone could have predicted. After all, the same thing happened to companies that launched into testing Ebola meds, only to have the health emergency pass before the drugs ever reached the shelf. But the pandemic gave SAB the chance to revolve through the clinical cycle, from phase 1 to 2 to 3 in the space of about three years. That’s experience not a lot of companies get—and now SAB is hoping to parlay that once-in-a-lifetime whirlwind into its next act. Live fire The original three-stage contract with the DOD included a six-month challenge to demonstrate the SAB platform’s ability to develop cGMP material at scale, then increase production to meet a prespecified target with fully demonstrated readiness, and then, finally, the biotech needed to produce an antibody treatment to the unknown threat, to be selected by the agency as a “live fire” exercise. The prototype had to demonstrate efficacy through phase 1. In announcing the full details of the contract in March 2020, Sullivan said, perhaps ominously, “If we can perform under the most demanding of scenarios to challenging targets, it builds confidence that translates to a broader array of therapeutic programs.” But instead, everything went sideways. “Before we ever got to those various stages, of course, the pandemic hit and the DOD came to us and said, ‘Okay, just make us a polyclonal antibody to the SARS-CoV-2 virus. And we did exactly that,” Sullivan told Fierce Biotech in an interview, reflecting on the early days of the pandemic. The tiny company, which had just 48 employees when the pandemic hit, churned out the antibody treatment SAB-185 and was dosing healthy volunteers in a phase 1/2 study by August 2020. By that point, the DOD and BARDA had thrown even more contracts SAB’s way, totaling $72 million. “We felt it was our responsibility to at least put forward a significant effort in the response of the disease without knowing, ultimately, what would become of it,” Sullivan said. Almost everything else SAB had been working on was paused. That meant a collection of fully human polyclonal antibodies for autoimmunity, infectious diseases, inflammation and oncology, plus a Type 1 diabetes treatment—more on that later. The COVID treatment rolled through the clinic. SAB used the goodwill to go public in June 2021 through a special purpose acquisition company deal valued at $118 million. SAB-185 hit phase 3 by September 2021 in a trial sponsored by the National Institutes of Health comparing the treatment with Regeneron’s monoclonal antibodies. Everything seemed to be going well with the COVID-19 polyclonal antibody. Then came omicron. The NIH cut the sponsored phase 3 trial as hospitalizations waned and the pandemic changed course. Regeneron’s antibodies became inactive and so the trial couldn’t be conducted as designed. SAB, which wasn't the only biotech to get snarled up as the government programs ended, tried to go it alone with late-stage testing but ultimately was unsuccessful. According to Sullivan, SAB-185 worked. It reduced symptoms seven days faster in an active comparator trial and offered a different mechanism of action to the drugs currently being used to treat patients with COVID-19. “When you're dealing with the uncertainties of an emerging disease and a pandemic, it does make it risky, but given the fact that the world was facing a worldwide pandemic, we felt like it was our responsibility to at least offer the opportunity,” Sullivan said. The new (old) SAB Sullivan might do it all again if called on: “We would never say we would not do it.” But SAB now has a new focus—or a new, old focus, to be more accurate. The company has turned back to its original pipeline, which included infectious disease treatments and one for Type 1 diabetes. The latter is the new lead indication as COVID and SAB-185 falls into the rearview. SAB announced a $130 million private placement on Oct. 2 to fund SAB-142, a fully-human alternative to rabbit anti-thymocyte globulin (rATG), for patients with new or recent onset of stage 3 T1D. Sullivan says the therapy has the potential to slow down disease progression—a disease modifying treatment, in biotech parlance—instead of just addressing symptoms. SAB-142 targets the immune cells involved in the destruction of pancreatic beta cells with the aim of protecting these insulin-producing cells. Sullivan said the therapy is similar to a rATG candidate previously tested by Sanofi, which is derived from rabbits. But SAB’s fully-human option means it should be possible to safely re-dose, which is key for the chronic, life-long condition of T1D. Animal-based immunoglobulin G antibodies can cause major immune reactions. But previous testing of these similar candidates has shown that a single dose of rATG can modulate the body’s immune response to slow down beta cell destruction and preserve insulin production. SAB hopes to move its lead candidate into the clinic this quarter. While Sullivan acknowledges that his biotech probably can’t propel itself into the clinic with quite the speed of the government-sponsored COVID trials, he’s happy to be in the driver’s seat this time around. The funding for the trial was raised by SAB through a clutch of new investors, led by RA Capital Management plus BVF Partners, Sessa Capital, Commodore Capital, RTW Investments, Marshall Wace, and the JDRF T1D Fund. “It's important to understand that government priorities may shift … particularly [when] answering a pandemic,” Sullivan said. But for T1D, which can be diagnosed as early as 13 years old, the opportunity never really goes away to find a better treatment—particularly one that might address the underlying cause of the disease. So as SAB came off the pandemic wave, T1D was an easy choice for the new lead indication. The company is not the same as it was before, even if the SAB-142 program isn’t brand new. Sullivan said his team now knows how to quickly grow manufacturing capacity, speed from phase 1 to phase 3 and more. The new funding has paved a runway into 2026 through phase 2 testing for SAB-142, according to Sullivan. SAB also has a flu program, SAB-176, that managed to continue on through the pandemic and for which it’s seeking partners. The company remains small—while its ranks swelled during the immediate COVID response, the head count now sits around 56 people—but whether the term “emerging biotech” applies to SAB anymore is up for debate. “We developed capacities well beyond what we were prior to the pandemic, just based upon the experience that we had in developing SAB-185, ” Sullivan said. “And so, certainly, all of that lends itself to the opportunity to use that experience and the things that we gained as a company in the development of SAB-142 for Type 1 diabetes.”

Phase 3AcquisitionPhase 2

21 Aug 2023

·www.globenewswire.com

SAB Biotherapeutics Provides Company Update for Q2 2023 Financial Results

SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update. "We are pleased to share the significant progress achieved during the second quarter of 2023. Our commitment to advancing transformative immunotherapies remains unwavering, with a renewed strategic focus on Type 1 Diabetes through our SAB-142 program, a first-in-class fully human immunotherapeutic being developed for delaying onset and progression of Type 1 Diabetes. SAB-142 is a purified, fully human polyclonal anti-thymocyte globulin (hATG), which we believe is a promising solution for the limitations and side effects often associated with existing rabbit-derived ATG treatments. The promising safety and pharmacologic data from the GLP toxicology study for SAB-142, presented at the Federation of Clinical Immunology Societies conference, underscored its potential to reshape diabetes treatment," said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “Our recent R&D Day, featuring SAB-142 as a centerpiece, further solidified our dedication to addressing autoimmune disorders with significant unmet needs. Furthermore, our influenza therapy, SAB-176, was highlighted at prominent industry events like the BIO 2023 International Convention and the International Society for Influenza and Other Respiratory Virus Diseases conference. Additionally, we achieved a regulatory milestone with FDA approval for five sections of our New Animal Drug Application (NADA), a pivotal step for our DiversitAb™ production system and hIgG antibody investigational drugs. As we continue to navigate dynamic medical landscapes, we remain steadfast in our mission to deliver impactful immunotherapies for the betterment of patients worldwide.” Pipeline Updates and Anticipated Milestones SAB continues to execute on its strategy for the development of proprietary immunotherapeutic fully-human antibodies, or fully-human immunoglobulins (hIgGs), to treat and prevent immune and autoimmune disorders with a strategic focus on Type-1 Diabetes disease modification. SAB-142: Type 1 Diabetes Presented positive safety and pharmacologic data from a GLP toxicology study for SAB-142, a first in class fully human immunotherapeutic being developed for delaying onset and progression of Type 1 Diabetes (T1D), at the Federation of Clinical Immunology Societies (FOCIS) in Boston. Results from the IND-enabling GLP tox study confirmed that SAB-142 affects the same subsets of immune cells associated with T1D as commercially available rabbit-derived anti-thymocyte globulin (rATG) in vivo.Hosted 2023 R&D Day virtual and in-person events, affirming SAB’s strategic focus in the autoimmunity space with SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of Type 1 Diabetes, and subsequently can be expanded into other immunology indications. SAB-142 therapeutic highlights from the R&D Day event included: SAB-142, a purified, fully human polyclonal anti-thymocyte globulin (hATG), is a validated therapeutic approach with support from clinicians, key opinion leaders, and the Juvenile Diabetes Research Foundation (JDRF).Safety and immunogenicity databases of more than 700 human subjects treated with the SAB antibodies supports an anticipated 0% serum sickness rate and zero neutralizing anti-drug antibodies with SAB-142 in upcoming trials.Special guest KOL speaker Dr. Michael Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, Gainesville and SAB Scientific Advisory Board member, presented his important research on low-dose ATG and Type 1 diabetes and SAB-142's potential in the T1D space.Clinical development plan designed in partnership with JDRF.IND approval and First-in-man Phase 1 clinical trials expected in Q4 2023 with interim data expected Q2 2024Topline data expected in Q4 2024.Established regulatory path for T1D indication and the SAB-142 modality. SAB-176: Influenza Presented "Therapeutic Immunoglobulin (hIgG) for Pre- and Post-Exposure Prophylaxis and Treatment of Influenza" at the BIO 2023 International Convention in Boston, with a primary focus on SAB-176 as an effective treatment option for influenza, along with insights into the recent Breakthrough Therapy and Fast Track Designations granted by the U.S. Food and Drug Administration (FDA).Presented favorable safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176, at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV-AVG) conference.Received Breakthrough Therapy Designation (BTD) and Fast Track designation from the US Food and Drug Administration (FDA) for post-exposure prophylaxis for Type A and Type B influenza illnesses in high-risk patients for SAB-176.Received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development, including a Phase 2b trial study design to evaluate the safety and efficacy of SAB-176 in high-risk patients with Type A or Type B influenza illness, including those who have anti-viral treatment resistant strains.FDA guidance for SAB-176 alignment with SAB’s manufacturing approach to address multiple strains of influenza through hyperimmunization of seasonal strains on an annual basis. SAB-185: COVID-19 Released top-line Phase 3 clinical data results for our hIgG antibody therapeutic candidate, SAB-185, which demonstrated sustained symptom resolution in patients with COVID-19 caused by the Omicron variant compared to those who received REGEN-COV® in a Phase 3 NIH trial. Specifically, 66% of participants treated with SAB-185 reached full symptom resolution for at least four consecutive days by Day 28 vs. 50% of participants on REGEN-CO.® The median time to symptom resolution for at least four consecutive days was seven days shorter for SAB-185. Regulatory: Provided a regulatory update announcing the approval by the FDA for five of seven sections required for a pending New Animal Drug Application (NADA) for our antibody-generating platform in Transchromosomic (Tc) bovine, which will be used for approval in support of Biologics License Applications (BLAs) with the FDA Center for Biologics Evaluation and Research (CBER) for our hIgG antibody investigational drugs. Audit/Compliance: On August 21, 2023, we announced that EisnerAmper LLP was appointed as our independent registered public accounting firm for the fiscal year ending December 31, 2023, effective August 22, 2023. Q2 2023 Financial Results Financial Guidance: Based on its current operating plans, SAB reaffirms that it expects its existing business plan, cash and cash equivalents, and anticipated cash flows will be sufficient to fund its operating expenses and capital expenditure requirements through October 2023. Cash Position: Cash and cash equivalents were $7.8 million as of June 30, 2023, compared to $15.0 million on December 31, 2022, were driven primarily by continued net operating losses as we advance our lead therapeutic candidates.Research and Development (R&D) Expenses: R&D expenses were $3.7 million for three months ended June 30, 2023, compared to $8.6 million for the three months ended June 30, 2022. R&D expenses were $8.2 million for the six months ended June 30, 2023, compared to $21.9 million for the six months ended June 30, 2022. The decrease was primarily due to targeted cost reduction measures pausing certain unfunded research activities for our COVID-19 therapeutic and prioritizing our focus in the autoimmunity space with SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of Type 1 Diabetes.General and Administrative (G&A) Expenses: G&A expenses were $2.9 million for the three months ended June 30, 2023, compared to $4.3 million for the three months ended June 30, 2022. G&A expenses were $6.3 million for the six months ended June 30, 2023, compared to $9.5 million for the six months ended June 30, 2022. The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.Net Loss: Net loss was $6.9 million for the three months ended June 30, 2023, for an earnings per basic and diluted share of $(0.14), as compared to a net loss of $4.8 million for the three months ended June 30, 2022, for an earnings per basic and diluted share of $(0.11). Net loss was $14.2 million for the six months ended June 30, 2023, for an earnings per basic and diluted share of $(0.28), as compared to a net loss of $3.8 million for an earnings per basic and diluted share of $(0.09). About SAB Biotherapeutics, Inc. SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn. Forward-Looking Statements Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, the development and efficacy of our influenza program, C. diff. program, type 1 diabetes program, and other discovery programs, the results, including timing, of the development of SAB-176, SAB-185, and SAB-142, including SAB-176 Fast Track designation and Breakthrough Therapy designation, and the outcome of potential future government and other third-party collaborations or funded programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Investor Relations:Matt@milestone-advisorsllc.com Media Relations:SABPR@westwicke.com

Clinical ResultPhase 2Fast TrackBreakthrough TherapyImmunotherapy

16 May 2023

·www.biospace.com

SAB Biotherapeutics Provides Company Update for Q1 2023 Financial Results

SIOUX FALLS, S.D., May 16, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, yesterday reported financial results for the first quarter ended March 31, 2023, and provided a company update. "Our first quarter 2023 results demonstrate that we continue to execute on our strategy to develop and deliver powerful immunotherapeutic treatments to patients with significant unmet needs. We recently announced Breakthrough Therapy Designation and Fast Track designation for SAB-176 from the FDA further validating the potential of our immunotherapy platform to treat a wide range of serious infectious diseases specifically impacting high-risk patients most in need of improved treatment options. We remain committed to advancing our programs and delivering much-needed therapies to patients worldwide,” said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “Additionally, we presented favorable safety and efficacy data from Phase 1 and 2a clinical trials of SAB-176, our fully-human, broadly neutralizing immunoglobulin antibody therapeutic, designed to prevent or reduce severe outcomes of Type A and Type B influenza infection in high-risk and immunocompromised patients. Lastly, we are pleased with the results of the Phase 3 NIH trial that showed our antibody therapeutic candidate, SAB-185, demonstrated sustained symptom resolution in patients with COVID-19 caused by the Omicron variant compared to those who received REGEN-COV®," concluded Dr. Sullivan. Pipeline Updates and Anticipated Milestones SAB is committed to advancing its strategy of developing a unique immunology platform focused on Type 1 diabetes, and respiratory and gastrointestinal diseases, that particularly impact individuals at high-risk with compromised immune systems or autoimmune disorders. In the following section, we highlight noteworthy accomplishments and milestones achieved during the quarter: Received Breakthrough Therapy Designation (BTD) and Fast Track designation from the US Food and Drug Administration (FDA) for post-exposure prophylaxis for Type A and Type B influenza illnesses in high-risk patients for SAB-176. SAB's influenza therapy is the first fully-human multi-epitope binding broadly neutralizing immunoglobulin antibody therapeutic developed for treating high-risk patients and post-exposure prophylaxis of Type A and Type B influenza. The FDA's Breakthrough Therapy designation process is designed to expedite the development and review of a medicine that is intended to treat a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug, SAB-176, may demonstrate substantial improvement over therapies currently available on a clinically significant endpoint. Received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development, including a Phase 2b trial study design to evaluate the safety and efficacy of SAB-176 in high-risk patients with Type A or Type B influenza illness, including those who have anti-viral treatment resistant strains. Received FDA guidance for SAB-176 aligned with SAB’s manufacturing approach to address multiple strains of influenza through hyperimmunization of seasonal strains on an annual basis. Provided a regulatory update announcing the approval by the FDA for five of seven sections required for a pending New Animal Drug Application (NADA) for our antibody-generating platform in Transchromosomic (Tc) bovine. SAB is in the process of completing the remaining two sections of the NADA. Upon formal acceptance of the seven-step safety and effectiveness evaluation, we will use this approval in support of Biologics License Applications (BLAs) with the FDA Center for Biologics Evaluation and Research (CBER) for our hIgG antibody investigational drugs. Presented favorable safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176, at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV-AVG) conference. The Phase 2a trial in healthy adults showed that SAB-176 was safe, well-tolerated, and demonstrated a significant reduction in symptoms as well as viral load compared to placebo. Released top-line Phase 3 clinical data results for our hIgG antibody therapeutic candidate SAB-185 which demonstrated sustained symptom resolution in patients with COVID-19 caused by the Omicron variant compared to those who received REGEN-COV® in a Phase 3 NIH trial. Specifically, 66% of participants treated with SAB-185 reached full symptom resolution for at least four consecutive days by Day 28. Only 50% of participants on REGEN-COV® met this endpoint, and the median time to symptom resolution for at least four consecutive days was seven days shorter for SAB-185. The study's primary endpoint was the composite of all-cause hospitalizations and deaths, considered inconclusive for non-inferiority in non-Omicron and Omicron patients. Welcomed Erick Lucera to our Board of Directors. Lucera, a 30-year veteran of the biotechnology and medical device industry, has held executive positions at several healthcare companies, most recently as chief financial officer of AVEO Oncology. We expect Lucera's experience in corporate finance to be valuable as SAB advances its programs through essential milestones. Q1 2023 Financial Results Financial Guidance: Based on its current operating plans, SAB reaffirms that it expects its existing business plan, cash and cash equivalents, and anticipated cash flows will be sufficient to fund its operating expenses and capital expenditure requirements through December 2023. Cash Position: Cash and cash equivalents were $13.1 million as of March 31, 2023, compared to $15.0 million on December 31, 2022, were driven primarily by continued net operating losses as we advance our lead therapeutic candidates. Research and Development (R&D) Expenses: R&D expenses were $4.5 million for three months ended March 31, 2023, compared to $13.3 million for the three months ended March 31, 2022. The decrease was primarily due to targeted cost reduction measures pausing certain unfunded research activities for our COVID-19 therapeutic, and prioritizing our earlier stage lead therapeutic candidates in Type 1 diabetes, respiratory and gastrointestinal diseases. General and Administrative (G&A) Expenses: G&A expenses were $3.4 million for the three months ended March 31, 2023, compared to $5.2 million for the three months ended March 31, 2022. The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as the company continues to mature as a publicly traded company. Net Income: Net loss was $7.3 million for the three months ended March 31, 2023, for an earnings per basic and diluted share of $(0.15), as compared to a net income of $1.0 million for the three months ended March 31, 2022, for an earnings per basic and diluted share of $0.02. About SAB Biotherapeutics, Inc. SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: and follow SAB on Twitter and LinkedIn. Forward-Looking Statements Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, the development and efficacy of our influenza program, C. diff. program, type 1 diabetes program, and other discovery programs, the results, including timing, of the development of SAB-176, SAB-185, SAB-142 and SAB-195, including SAB-176 Fast Track designation and Breakthrough Therapy designation, and the outcome of potential future government and other third-party collaborations or funded programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at . Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Investor Relations: SABIR@westwicke.com Media Relations: SABPR@westwicke.com

Clinical ResultBreakthrough TherapyPhase 2Fast TrackFinancial Statement

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 1	US	SAB Biotherapeutics, Inc.	01 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Phase 2	COVID-19	-	SAB-185 3,840 units/kg	haahwalsfo(qymgowiyhu): relative risk = 1.23 (95% CI, 1.01 - 1.49) View more	Positive	20 Jan 2023
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