SABS

Interested in SAB Biotherapeutics, Inc.? Here are five stocks we like better. SAFEGUARD remains on schedule: SAB Biotherapeutics expects to complete enrollment in its Phase IIb trial of SAB-142 in the fourth quarter of 2026, with top-line results anticipated in the second half of 2027. More than 60 sites are recruiting, and the study is expanding to younger patients. PRISE will broaden the potential treatment population: The investigator-led Phase III study is expected to begin enrolling in the second half of 2026 and will evaluate patients diagnosed 100 days to two years earlier, with results projected for the first quarter of 2029. Cash runway extends through 2028: SAB ended the quarter with $208 million in cash and investments, despite a net loss of $22.5 million. The company also began construction of a second South Dakota farm facility to provide manufacturing redundancy and support potential commercial supply. Promising Upsides on these Biotech Penny Stocks SAB Biotherapeutics (NASDAQ:SABS) said its registrational Phase IIb SAFEGUARD trial of SAB-142 in newly diagnosed Stage 3 Type 1 diabetes remains on track to complete enrollment in the fourth quarter of 2026, with top-line data expected in the second half of 2027. Chief Executive Officer Samuel Reich said more than 60 clinical sites are actively recruiting for the study, supporting growth in patient screening and randomization. Part A enrollment was completed during the prior quarter, while Part B is continuing to enroll. The company has also received approval for the first step-down to adolescents aged 12 and older and expects to step down to patients age 5 and above during the current quarter. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth SAB-142 is a fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells and potentially slow disease progression in autoimmune Type 1 diabetes. The company produces the candidate using its Tc Bovine platform, which it said can generate fully human multispecific antibodies without human donors. Reich said the increase in SAFEGUARD enrollment has primarily been driven by the activation of additional clinical sites. The company is evaluating patients ages 5 to 40 who are within 100 days of a Stage 3 Type 1 diabetes diagnosis. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Chief Medical Officer Alexandra Kropotova said the SAFEGUARD protocol requires at least 36 patients ages 5 to 11, with two-thirds of the overall population below age 18. The trial also caps adult enrollment at 45 patients. She said the baseline characteristics of enrolled patients have been in line with the company’s protocol expectations. Kropotova noted that SAFEGUARD differs from the company’s Phase I trial in the timing of enrollment. SAFEGUARD enrolls patients within 100 days of disease onset, while patients in the Phase I study were beyond 100 days from diagnosis. Both populations require preserved C-peptide levels of at least 0.2 nanomoles per liter. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Management did not disclose SAFEGUARD screening-failure rates. Reich said the company has sufficient drug supply to support both the SAFEGUARD and PRISE studies. The company also discussed PRISE-hATG, an investigator-led Phase III study supported by a grant from Breakthrough T1D to Michael Haller, professor and chief of pediatric endocrinology at the University of Florida. SAB is co-funding the study, which will evaluate SAB-142 in patients with Stage 3 Type 1 diabetes who are 100 days to two years from diagnosis. Reich said PRISE is intended to address patients who remain capable of producing insulin but are outside the diagnosis window used in other protocols. He said the study is expected to begin enrolling during the second half of 2026. Kropotova said PRISE has seven sites, including four in the United States and three in Europe. While the study will begin after SAFEGUARD, she said top-line PRISE results are expected in the first quarter of 2029. The trial is designed to be adequately powered to detect a difference between active treatment and placebo on its primary endpoint, C-peptide at 12 months following a two-hour mixed-meal tolerance test. It is also powered for a key secondary endpoint related to glycemic control. According to Kropotova, the PRISE and SAFEGUARD inclusion and exclusion criteria are otherwise identical aside from the time since disease onset. She said the company does not expect PRISE participants to necessarily have lower baseline C-peptide levels, citing data indicating C-peptide can remain preserved for years after diagnosis. Reich said data from PRISE would follow SAFEGUARD and could potentially support a supplemental biologics license application for a label expansion covering patients up to two years after diagnosis, if the study is successful. Reich said the recent FDA approval of Tzield for children and adolescents recently diagnosed with Stage 3 Type 1 diabetes was positive for the Type 1 diabetes community and for SAB’s development program. He said the approval reinforces the role of early disease-modifying intervention and provides precedent for C-peptide as a basis for accelerated approval in Type 1 diabetes. Management said it was too soon to draw conclusions from Tzield’s Stage 3 launch. Reich noted that the majority of SAFEGUARD sites are in Europe and said Tzield’s approved label is limited to U.S. patients ages 8 to 17 within eight weeks of diagnosis, compared with SAFEGUARD’s population of patients ages 5 to 40 within 100 days of diagnosis. Reich said SAB believes SAB-142 could offer efficacy, safety and dosing advantages, citing its potential for redosing due to low-to-no immunogenicity and a two-day dosing schedule compared with Tzield’s 12-day regimen. Chief Financial Officer Lucy To said SAB ended the second quarter with $208 million in cash equivalents and investment securities as of June 30, 2026. The company said it expects its cash runway to extend through 2028. Research and development expense was $16.2 million, compared with $7 million in the second quarter of 2025, reflecting clinical trial costs and headcount supporting SAFEGUARD. General and administrative expense was $7.2 million, compared with $2.7 million a year earlier, due to higher headcount costs and stock-based compensation. Other income was $0.9 million, compared with an expense of $0.4 million in the prior-year period, driven primarily by higher interest and dividend income. Net loss was $22.5 million, compared with $10.1 million in the second quarter of 2025. Beyond clinical development, Reich said the company began construction of a second farm facility in South Dakota during the quarter. The facility is intended to establish a redundant herd, reduce operational risk and support potential long-term commercial supply of SAB-142. SAB Biotherapeutics, Inc is a clinical-stage biotechnology company headquartered in Sioux Falls, South Dakota, that focuses on developing fully human polyclonal antibody therapeutics. The company's proprietary platform, known as Tc Bovine®, uses genetically engineered cattle to generate large quantities of human antibodies tailored to target specific infectious agents or disease-related antigens. This approach is designed to combine the broad-spectrum coverage of polyclonal antibody therapies with the scalability and consistency required for clinical development and commercial use. The company's lead programs are directed primarily at infectious diseases. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "SAB Biotherapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Cash Position: $208 million in cash equivalents and investment securities as of June 30, 2026, with operational runway through 2028. R&D Expenses: $16.2 million for Q2 2026, up from $7 million in Q2 2025, driven by clinical trial costs and headcount for the SAFEGUARD study. G&A Expenses: $7.2 million for Q2 2026, up from $2.7 million in Q2 2025, due to higher headcount costs and stock-based compensation. Other Income: $0.9 million income in Q2 2026, compared to a $0.4 million expense in Q2 2025, driven by higher interest and dividend income. Net Loss: $22.5 million for Q2 2026, compared to $10.1 million in Q2 2025. Warning! GuruFocus has detected 2 Warning Signs with SABS. Is SABS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. SAB Biotherapeutics Inc (NASDAQ:SABS) is on track to complete enrollment in its registrational Phase 2b SAFEGUARD trial in Q4 2026, with top-line data expected in the second half of 2027. The company has over 60 active clinical sites, driving steady growth in screening and randomization for the SAFEGUARD study. Breakthrough T1D awarded a grant to support the PRIZE-HAPG study, providing external validation and co-funding for the company's approach in a broader patient population. The recent FDA approval of Tzield for Stage 3 type 1 diabetes validates the regulatory path for C-peptide as an accelerated approval endpoint, potentially benefiting SAB142's development. SAB Biotherapeutics Inc (NASDAQ:SABS) ended Q2 2026 with $208 million in cash, providing an operational runway through 2028 to support key clinical milestones. The company's SAB142 offers potential competitive advantages over Tzield, including a shorter two-day dosing regimen and low immunogenicity, which may support safe redosing. Construction of a second farm facility in South Dakota is underway to establish a redundant herd, reducing operational risks and supporting long-term commercial supply. Net loss widened to $22.5 million in Q2 2026, up from $10.1 million in the same period of 2025, reflecting increased R&D and G&A expenses. R&D expenses more than doubled year-over-year to $16.2 million, driven by higher clinical trial costs and headcount, which may pressure future cash flows. G&A expenses increased significantly to $7.2 million from $2.7 million, partly due to higher stock-based compensation, indicating rising operational costs. The PRIZE-HAPG study is expected to start enrolling in the second half of 2026, with top-line results not expected until Q1 2029, representing a long timeline for potential label expansion. The company did not disclose screening failure rates or other detailed enrollment metrics, limiting transparency on trial execution risks. The recent FDA approval of Tzield could increase competitive pressure, as it may set a higher bar for SAB142's differentiation and commercial adoption. The company's reliance on a limited number of sites for the PRIZE study (seven sites) may pose enrollment challenges, despite anticipated patient demand. Q: How does the recent FDA approval of Tzield for Stage 3 Type 1 diabetes impact the regulatory bar for SAB142's SAFEGUARD program, and what is SAB142's competitive profile relative to Tzield? A: Samuel Reich (CEO) stated that Tzield's approval is positive for both the T1D community and SAB, as it drives market awareness and confirms that C-peptide alone is sufficient for accelerated approval, establishing a clear regulatory precedent. He highlighted SAB142's competitive advantages, including low to no immunogenicity, which allows for safe redosing over the disease's lifetime, and a more convenient two-day dosing regimen compared to Tzield's 12-day course. He also noted that while Tzield missed secondary endpoints in the PROTECT study, the reference molecule Rabbit ATG has shown HbA1c reduction in other studies. Q: What drove the acceleration in enrollment for the Phase 2b SAFEGUARD trial, and can you provide details on the baseline characteristics of patients entering Part B? A: Samuel Reich (CEO) attributed the enrollment acceleration primarily to the activation of over 60 clinical sites, which has led to increased investigator and patient engagement, reflected in steady growth in screenings and randomizations. Alexandra Kropotova (CMO) added that baseline characteristics are tracking in line with protocol expectations, which require at least 36 patients aged 5-11 and two-thirds of the population under 18, with adults capped at 45 patients. She clarified that the Phase 1 population had a longer time from disease onset (beyond 100 days), making it more similar to the PRIZE trial population, while SAFEGUARD focuses on new-onset patients within 100 days. Q: What is the rationale behind the PRIZE-HAPG study, and how does its patient population and potential market opportunity compare to SAFEGUARD? A: Samuel Reich (CEO) explained that PRIZE extends the treatable patient population to those diagnosed up to two years prior, addressing a significant unmet need for patients who still produce C-peptide but missed the 100-day window. He noted that while there are 64,000 new T1D diagnoses annually, the 100-day window is often too short for patients to make treatment decisions, so PRIZE expands the opportunity for these patients to access therapy. Alexandra Kropotova (CMO) added that the inclusion/exclusion criteria are identical to SAFEGUARD, and epidemiological data shows C-peptide can be preserved for up to 15 years, so they do not expect lower baseline beta-cell function in this broader population. Q: Can you provide an update on the timing for the step-down to pediatric patients aged 5 and above in SAFEGUARD, and confirm the overall timeline for enrollment completion and top-line data? A: Samuel Reich (CEO) confirmed that the step-down to pediatric patients is anticipated within the current quarter (Q3 2026), and full enrollment of SAFEGUARD remains on track for completion in Q4 2026. He reiterated that with this timeline, top-line data is expected in the second half of 2027, and the company's guidance remains unchanged. Q: How is the PRIZE-HAPG study powered, and what is the expected timeline for its results? A: Alexandra Kropotova (CMO) stated that PRIZE is a registrational trial adequately powered to detect a difference between active and placebo for the primary endpoint of C-peptide at 12 months following a two-hour MMTT, and it is also powered for key secondary endpoints on glycemic control, similar to the SAFEGUARD trial. Samuel Reich (CEO) added that PRIZE is expected to start enrolling in the second half of 2026, with top-line results expected in Q1 2029, and the data would support a future sBLA for label expansion. Q: How many sites are planned for the PRIZE study, and how will enrollment be efficient given the larger patient population and fewer sites? A: Alexandra Kropotova (CMO) confirmed that PRIZE will have seven sites, with four in the U.S. and the rest in Europe. She explained that enrollment efficiency is driven by the fact that PRIZE is the only ongoing trial allowing patients up to 730 days from disease onset, creating significant demand from the patient community who are beyond the 100-day window and highly interested in the trial. Samuel Reich (CEO) added that the company has sufficient drug supply to support both trials. Q: Since the FDA approval of Tzield, have you seen increased interest from investigators or patients in enrolling in SAFEGUARD? A: Samuel Reich (CEO) noted that they haven't observed a direct measurable impact yet, as the majority of SAFEGUARD sites are in Europe, while Tzield is only approved in the U.S. He highlighted that Tzield's label is limited to patients aged 8-17 within eight weeks of diagnosis, whereas SAFEGUARD evaluates patients aged 5-40 within 100 days. He also mentioned that some U.S. patients have chosen to enroll in SAFEGUARD over using Tzield due to SAB142's more competitive dosing profile. Q: What is the company's current cash position, and how does it support the clinical development programs through key milestones? A: Lucy To (CFO) reported that the company ended Q2 2026 with $208 million in cash, equivalents, and investment securities, providing an operational runway through 2028. R&D expenses increased to $16.2 million in Q2 2026 from $7 million in Q2 2025, driven by clinical trial costs and headcount to support SAFEGUARD. G&A expenses rose to $7.2 million from $2.7 million, primarily due to higher headcount and stock-based compensation. The net loss for the quarter was $22.5 million, compared to $10.1 million in the prior-year period. Q: What are the key operational priorities for the remainder of 2026, and how is the company preparing for commercial readiness? A: Samuel Reich (CEO) stated that 2026 is the "year of trial execution," with the primary focus on completing enrollment in SAFEGUARD by Q4 and delivering key clinical milestones on time. Beyond clinical development, the company began construction of a second farm facility in South Dakota to establish a redundant herd, reducing operational risks and supporting long-term commercial supply for SAB142. He emphasized that the company is building the capabilities needed to support SAB142 over the long term and unlock the full value of the pipeline. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Over 60 clinical sites activated in registrational SAFEGUARD study of SAB-142 in Stage 3 new onset type 1 diabetes; Enrollment remains on track for completion in Q4 2026, with topline data expected in 2H 2027 Breakthrough T1D awarded a grant to PRISE‑hATG study of SAB‑142 in patients with Stage 3 type 1 diabetes who are 100 days to 2 years from diagnosis Operational runway through 2028 to support SAFEGUARD study, PRISE-hATG study and pre-commercial activities Conference call today at 8:30 AM ET MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced financial results for the second quarter ended June 30, 2026, and provided business highlights. “The second quarter was marked by strong execution as we advanced SAB-142 across key clinical and operational milestones. Enrollment in our registrational SAFEGUARD study remains on track for completion in Q4 this year, with more than 60 sites actively recruiting. Investigator and patient engagement continue to increase, reflected in steady growth of screening and randomization,” said Samuel J. Reich, Chief Executive Officer of SAB BIO. “The recent award from Breakthrough T1D supporting the PRISE-hATG study provides external validation and non-dilutive funding as we evaluate SAB-142 in an expanded patient population with significant unmet need. We also began construction of a second farm facility to establish a redundant Tc-Bovine herd, reducing operational risk and supporting long-term commercial supply for SAB-142. With an operational runway extending through 2028, we are well-positioned to execute our development strategy, advance pre-commercial activities, and deliver key milestones.” Recent Pipeline Achievements and Anticipated Milestones for SAB-142 Registrational Phase 2b SAFEGUARD study (NCT07187531) Over 60 activated clinical sites across U.S., Australia, New Zealand, U.K. and European Union for SAFEGUARD trial. The SAFEGUARD study will enroll a total of 159 Stage 3 T1D patients (ages 5-40) within 100 days of diagnosis. Topline data from SAFEGUARD is expected in 2H 2027. Phase 3 PRISE-hATG study (NCT07670650) As recently announced, the PRISE-hATG study, led by principal investigator Michael Haller, M.D., Professor and Chief of Pediatric Endocrinology at the University of Florida, has been awarded a grant from Breakthrough T1D and will be co-funded by SAB BIO. The PRISE-hATG study is a registrational clinical trial that could expand the potential future label of SAB-142 to patients with Stage 3 T1D with onset up to 2 years from diagnosis. Business Highlights Tc-Bovine platform production capacity to be expanded: During Q2, SAB BIO began construction of a second farm facility in South Dakota to increase manufacturing capacity and establish a redundant herd to support long-term commercial supply needs. This expansion is designed to reduce single-site operational risk and strengthen business continuity. SAB BIO’s wholly owned, proprietary Tc-Bovine platform is unique in its ability to produce targeted, fully human, multi-specific antibodies, such as SAB-142, without the need for human donors. SAB BIO added to Russell 3000® and Russell 2000® indexes: SAB BIO was included in the Russell indexes in June as part of the 2026 Russell indexes annual reconstitution, increasing SAB BIO’s visibility among institutional investors and the broader investment community. Upcoming EventsSAB BIO plans to participate in the following investor events and scientific congresses: Association of Diabetes Care & Education Specialists (ADCES) Annual ConferenceDate: August 7-10, 2026Location: Columbus, OH Citi Biopharma Back to School Conference Date: September 9-10, 2026Location: New York, NY Morgan Stanley 24th Annual Global Healthcare ConferenceDate: September 14-16, 2026Location: New York, NY 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD)Date: September 28-October 2, 2026Location: Milan, Italy Inaugural Breakthrough T1D Clinical & Research CongressDate: October 9-11, 2026Location: Philadelphia, PA Q2 2026 Financial Highlights Cash Position: Cash, cash equivalents, and investment securities of $208.0 million at June 30, 2026, providing operational runway through 2028. R&D Expenses: Research and development (R&D) expenses of $16.2 million and $7.0 million for the three months ended June 30, 2026, and June 30, 2025, respectively. The increase is primarily driven by ongoing clinical trial costs and related headcount to support the advancement of SAB-142 through the registrational SAFEGUARD study. G&A Expenses: General and administrative (G&A) expenses of $7.2 million and $2.7 million for the three months ended June 30, 2026, and June 30, 2025, respectively. The increase is primarily driven by higher headcount costs, including related stock-based compensation. Other income (expense): Other income of $0.9 million and expense of $0.4 million for the three months ended June 30, 2026, and June 30, 2025, respectively. This change is driven by an increase in interest and dividend income as a result of higher average balances in our investment portfolios, partially offset by changes in the fair value of warrant liabilities. Net loss: Net loss of $22.5 million and $10.1 million for the three months ended June 30, 2026, and June 30, 2025, respectively. Webcast and Conference Call InformationSAB BIO will host a conference call to discuss its second quarter financial results and provide business updates on Thursday, August 6, 2026 at 8:30 AM ET. A live webcast of the conference call can be accessed in the “Events” section of the Company’s website at ir.sab.bio. A replay will be available after the event. About SAB-142SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. About the SAFEGUARD TrialSAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial is a randomized, double-blind, placebo-controlled multi-center Phase 2b study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with new onset Stage 3 T1D. The SAFEGUARD trial is actively enrolling and dosing participants at multiple sites around the world. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat T1D by delaying the progression of disease. SAFEGUARD Part A is a dose-ranging study in adult patients. SAFEGUARD Part B is a randomized double-blind, placebo-controlled, dose-ranging study. Enrolled patients will receive two SAB-142 or placebo infusions six months apart. All patients, including the placebo-control group, with residual beta cells at 12 months are eligible for the 12-month long-term efficacy and safety extension study (Part C) upon Part A and B study completion. Additional details are available on www.clinicaltrials.gov (NCT07187531) and at https://safeguardstudy.com/. About PRISE-hATGPersonalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Extended New Onset T1D Treated with human Anti-Thymocyte Globulin is a randomized, double-blind, placebo-controlled investigator-led study. This study is designed to assess the safety, efficacy, and tolerability of SAB-142 in individuals in an extended time period after diagnosis (>100 days to 1 year, and 1 year to 2 years). Sampling procedures and analytical methods are harmonized with the Phase 2b SAFEGUARD trial, enabling cross-cohort comparisons. Additional details are available on www.clinicaltrials.gov (NCT07670650). About SAB BIOSAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. SAB-142 is currently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients in a registrational Phase 2b clinical trial called SAFEGUARD. For more information, visit www.sab.bio. Forward-Looking StatementsCertain statements made in this press release 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,” “to be,” “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, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs. These statements are based on the current expectations of SAB BIO 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, as may be amended or supplemented from time to time, 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 BIO 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:Christine [email protected] Media:Sheila [email protected]

This article first appeared on GuruFocus. Cash and Cash Equivalents: $217.6 million as of March 31, 2026. Gross Proceeds from Public Offering: Approximately $95 million. R&D Expenses: $13.4 million for Q1 2026, up from $7.7 million in Q1 2025. G&A Expenses: $6.6 million for Q1 2026, up from $3.1 million in Q1 2025. Other Income: $1.1 million for Q1 2026, down from $5.6 million in Q1 2025. Net Loss: $18.9 million for Q1 2026, compared to $5.2 million in Q1 2025. Warning! GuruFocus has detected 2 Warning Sign with SABS. Is SABS fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. SAB Biotherapeutics Inc (NASDAQ:SABS) has advanced its lead product candidate, SAB142, into a registrational Phase IIb trial called SAFEGUARD, with enrollment progressing on schedule. The company received written confirmation from the FDA that C-peptide may serve as a surrogate endpoint for accelerated approval, de-risking their regulatory path. SAB142's Phase I data showed promising results, including beta cell preservation and a favorable safety profile, with no serum sickness and low immunogenicity. SAB Biotherapeutics Inc (NASDAQ:SABS) has a strong cash position of $217.6 million, providing an operational runway through 2028. A multi-year agreement with Emergent BioSolutions has been executed to support the process development and manufacturing of SAB142, positioning the company for potential commercial launch. The company reported a net loss of $18.9 million for the first quarter of 2026, compared to $5.2 million for the same period in 2025. R&D expenses increased significantly to $13.4 million in Q1 2026 from $7.7 million in Q1 2025, driven by ongoing investments in the SAB142 program. G&A expenses also rose to $6.6 million in Q1 2026 from $3.1 million in Q1 2025, primarily due to higher non-cash stock-based compensation and personnel-related costs. Other income decreased to $1.1 million in Q1 2026 from $5.6 million in Q1 2025, driven by changes in the fair value of warrant liabilities. The company has not disclosed specific plans for releasing Part A data of the SAFEGUARD trial ahead of Part B, which may limit transparency for stakeholders. Q: Can you explain how SAB142 is differentiated from CD3 antibodies in terms of clinical activity and safety? A: Samuel Reich, CEO, explained that SAB142, a human anti-thymocyte globulin, is polyclonal and targets multiple T-cell receptors, preserving T-regs and inducing T-cell exhaustion at low doses. This approach avoids the counterproductive effects seen with monoclonal anti-CD3 antibodies, which can negatively impact T-regs. SAB142 also shows no immunogenicity or serum sickness, allowing for safe chronic dosing, potentially leading to better clinical outcomes. Q: Will you disclose Part A data of the SAFEGUARD trial before Part B? A: Samuel Reich, CEO, stated that there are no current plans to release Part A data ahead of Part B. The Phase 1 results in mature patients support the potential effectiveness of SAB142 in established Type 1 diabetes, which could expand the addressable market. Q: Can you elaborate on the FDA's feedback regarding C-peptide as a surrogate endpoint for accelerated approval? A: Samuel Reich, CEO, confirmed that the FDA has provided written confirmation that C-peptide is an acceptable surrogate endpoint for accelerated approval. This aligns with SAB's clinical regulatory plan and provides confidence in their path forward. Q: What data did the Study Data Monitoring Committee review to approve the step-down to patients 12 and older in the SAFEGUARD trial? A: Samuel Reich, CEO, explained that the committee reviewed four weeks of safety data from Part A, involving 12 patients, before approving enrollment for patients aged 12 and older. Q: What are the plans for chronic dosing in the SAFEGUARD trial and beyond? A: Samuel Reich, CEO, mentioned that the SAFEGUARD trial includes at least two doses for patients, with a long-term extension study allowing for up to four doses. The goal is to include chronic dosing in the label, enabling long-term preservation of C-peptide levels. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in SAB Biotherapeutics, Inc.? Here are five stocks we like better. SAB-142, SAB Biotherapeutics’ lead type 1 diabetes candidate, remains on track in the SAFEGUARD Phase 2b trial, with enrollment progressing as planned and top-line data still expected in the second half of 2027. The company said the FDA correspondence supports C-peptide as a surrogate endpoint for accelerated approval, which management described as a meaningful de-risking of its regulatory path. SAB Biotherapeutics highlighted early Phase 1 data showing potential clinical benefit, including C-peptide preservation and improved time-in-range glucose control, while emphasizing SAB-142’s potential for repeat dosing and chronic treatment use. Promising Upsides on these Biotech Penny Stocks SAB Biotherapeutics (NASDAQ:SABS) said its lead type 1 diabetes candidate, SAB-142, remains on track in a registrational Phase 2b trial, as the clinical-stage biopharmaceutical company reported a wider first-quarter loss alongside higher research and development spending. Chief Executive Officer Samuel Reich told investors on the company’s first earnings call that SAB BIO is focused on developing fully human anti-thymocyte immunoglobulin for type 1 diabetes and other autoimmune diseases. The company’s lead product candidate, SAB-142, is being developed as a potentially disease-modifying, re-dosable immunotherapy for autoimmune type 1 diabetes. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum “Our mission is to dramatically redefine what it means to be diagnosed with type 1 diabetes by developing a medicine to change the course of disease, not just treat the symptoms,” Reich said. Reich said enrollment in the company’s SAFEGUARD trial is progressing on schedule and remains on track for completion by the end of 2026, with top-line data expected in the second half of 2027. The trial is enrolling patients across the U.S., Australia, New Zealand, the U.K. and the European Union. → MercadoLibre Boldly Invests in Growth: Discount Deepens SAFEGUARD is designed to enroll 159 Stage 3 type 1 diabetes patients between the ages of five and 40, all within 100 days of diagnosis. The study includes two parts: Part A, a dose-ranging study in 12 adult patients, completed enrollment during the first quarter. Part B, a randomized, double-blind, placebo-controlled study enrolling 147 pediatric, adolescent and adult patients, began in the first quarter and is actively enrolling. Reich said the study data monitoring committee recently approved the first age step-down to enroll patients ages 12 and older. In response to an analyst question, he said the committee’s decision was based on Part A safety data up to four weeks from randomization in the 12 patients. He added that the company expects to step down to patients five and older “in the coming months,” depending on further safety review. → 3 Ways to Target the Resources Powering AI and Data Centers Reich said SAB BIO expects at least 20% of SAFEGUARD patients to be enrolled in the U.S., about 60% in Europe and the U.K., and the remainder in Australia, based on the company’s site footprint and enrollment trends to date. The company said it received written correspondence from the U.S. Food and Drug Administration confirming that C-peptide may serve as a surrogate endpoint for accelerated approval. Reich described the correspondence as “a meaningful de-risking” of SAB BIO’s regulatory path. During the question-and-answer portion of the call, Reich said the company developed SAFEGUARD and its broader clinical regulatory plan through correspondence with the FDA and believes it has alignment with the agency. He said the company is not disclosing detailed feedback from other regulators but characterized feedback across agencies as consistent. Asked whether SAB BIO would pursue accelerated approval outside the U.S., Reich said it was too early to say, but added that the company plans to seek approval globally, with the U.S. as its priority. Reich also reviewed new findings from SAB-142’s Phase 1 study that were presented at the Immunology of Diabetes Society Congress. He said the data highlighted the candidate’s mechanism of action and suggested that the mechanism translated into clinical benefit for people with type 1 diabetes. According to Reich, Phase 1 data showed preservation of C-peptide levels correlated with evidence of T-cell exhaustion. Of four SAB-142-treated participants, three showed what he called a “super responder profile,” with C-peptide levels at or above baseline at day 120. Treated participants also showed improved glycemic control, with mean time in range increasing from 73% at baseline to 85% at day 120, without an associated increase in exogenous insulin use. Reich cautioned that the results were early and exploratory but said they further support the company’s confidence in SAFEGUARD. Asked whether similar increases in C-peptide could be shown in SAFEGUARD, he said the company’s goal in the larger trial is preservation of C-peptide. “When we look at a larger group of patients over a longer period of time, the goal is to show preservation,” Reich said. “We’ll certainly be very happy if patients at one year have their C-peptide the same as it was when they started.” Reich also said the Phase 1 patients had more mature disease, having had type 1 diabetes for two years or more. He said the results provide support for potential development in more established type 1 diabetes, which the company intends to pursue. Responding to a question about how SAB-142 differs from CD3 antibodies, Reich said anti-CD3 antibodies are monoclonal and have a singular effect on one target, while SAB-142 is polyclonal and binds multiple targets across T cells. He said SAB-142 is designed to induce T-cell exhaustion at a low dose while preserving or possibly activating regulatory T cells. Reich said a key advantage of SAB-142 is its lack of immunogenicity and serum sickness observed in Phase 1, which he said supports the potential for repeat dosing. He contrasted that with rabbit anti-thymocyte globulin and Tzield, saying SAB-142 may be able to be dosed chronically to maintain T-cell exhaustion and preserve beta cells. Asked about repeat dosing in a potential pivotal program and FDA application, Reich said patients in SAFEGUARD receive at least two doses, and a long-term extension study allows patients who complete their 12-month visit and still have C-peptide to continue and receive four doses. He said the company hopes the resulting data will support chronic dosing in the label. Chief Financial Officer Lucy To said SAB BIO ended the first quarter with $217.6 million in cash, cash equivalents and available-for-sale securities as of March 31, 2026. She said that position provides an operational runway through 2028 and fully supports execution of SAFEGUARD and pre-commercial activities. The company completed a public offering in March, and following the underwriters’ exercise of the overallotment option, aggregate gross proceeds totaled approximately $95 million. Research and development expenses rose to $13.4 million in the first quarter of 2026 from $7.7 million in the same period of 2025. To said the increase was driven by investments in the SAB-142 program, including site activation and patient enrollment in SAFEGUARD. General and administrative expenses were $6.6 million, compared with $3.1 million a year earlier. To attributed the increase primarily to higher non-cash stock-based compensation and personnel-related costs tied to the company’s expanded team. Other income declined to $1.1 million from $5.6 million, driven by changes in the fair value of warrant liabilities. Net loss widened to $18.9 million from $5.2 million in the prior-year period. On the manufacturing front, Reich said SAB BIO executed a multi-year agreement on April 29 with Emergent BioSolutions to support process development and clinical and commercial manufacturing of SAB-142 in anticipation of regulatory approval. Asked about the scale of the agreement, Reich said the company has not disclosed a specific number of doses but expects the Emergent arrangement to support supply for a potential launch. “Our plan with Emergent does have us ready when we launch to have a strong launch and have more than enough drug supply to supply the demand,” Reich said. SAB Biotherapeutics, Inc is a clinical-stage biotechnology company headquartered in Sioux Falls, South Dakota, that focuses on developing fully human polyclonal antibody therapeutics. The company's proprietary platform, known as Tc Bovine®, uses genetically engineered cattle to generate large quantities of human antibodies tailored to target specific infectious agents or disease-related antigens. This approach is designed to combine the broad-spectrum coverage of polyclonal antibody therapies with the scalability and consistency required for clinical development and commercial use. The company's lead programs are directed primarily at infectious diseases. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "SAB Biotherapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Continued site activation in registrational SAFEGUARD trial of SAB-142; enrollment ongoing and on track to be completed by end of 2026 with topline data expected in 2H 2027 Reported additional Phase 1 data for SAB-142 demonstrating C-peptide preservation and improvement in glycemic control in established autoimmune type 1 diabetes Strong cash position, reflecting $95 million public offering proceeds, with operational runway through 2028 to support execution of SAFEGUARD and pre-commercial activities Conference call today at 8:30 AM ET MIAMI, May 12, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced financial results for the first quarter ended March 31, 2026, and provided recent business highlights. “The first quarter set a strong foundation for the year, as we executed according to plan across all fronts. I am encouraged to report that SAFEGUARD enrollment is progressing on schedule for completion by year-end. Our Phase 1 data demonstrate early C-peptide preservation and improved glycemic control with a favorable safety profile, and our recent public offering bolsters our financial runway through 2028 to support this program and pre-commercial activities,” said Samuel J. Reich, Chief Executive Officer of SAB BIO. “This year we are focused on enrolling SAFEGUARD with Part A fully enrolled and Part B well underway and proceeding as planned. The pace of enrollment and enthusiasm from investigators underscores the urgent need within the diabetes community for therapies that go beyond insulin management to address the underlying autoimmune disease.” Recent Pipeline Achievements and Anticipated Milestones for SAB-142 Phase 2b SAFEGUARD study Continued activation of multiple clinical trial sites in U.S., Australia, New Zealand, U.K. and European Union for SAFEGUARD (SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes) trial. The SAFEGUARD trial will enroll a total of 159 Stage 3 T1D patients (ages 5-40), within 100 days of diagnosis. Part A is a dose-ranging study in 12 adult T1D patients and has completed enrollment during the first quarter. Part B is a randomized, double-blind, placebo-controlled, dose-ranging study and will enroll 147 pediatric, adolescent and adult T1D patients. Part B was initiated during the first quarter. The SAFEGUARD Study Data Monitoring Committee (DMC) recently approved the first stepdown to patients ages 12 and older. SAFEGUARD is on track and expected to complete enrollment by end of 2026 as planned with topline data expected in 2H 2027. The Company has received written correspondence from the FDA confirming that C-peptide area under the curve (AUC) may serve as a surrogate endpoint for accelerated approval. This communication represents a significant de-risking of our regulatory path to market. Recent data presentation at 21st Immunology of Diabetes Society (IDS) Congress As recently announced, SAB BIO presented additional clinical and mechanistic data from the Stage 3 T1D patients enrolled in the Phase 1 trial of SAB-142 (n=4 treated, n=2 placebo). The results for SAB-142 highlighted C-peptide preservation, correlated with evidence of T cell exhaustion, which further validates SAB-142’s mechanism of action. Of the four SAB-142-treated participants, three demonstrated a super responder profile with C-peptide levels at or above baseline at Day 120. SAB-142 treated participants showed improved glycemic control, with mean time in range increasing from 73% at baseline to 85% at Day 120, without an associated increase in exogenous insulin use. Business Highlights Completed public offering raising $95 million in gross proceeds: On March 19, 2026, SAB BIO closed its public offering of common stock and pre-funded warrants. Following the initial closing, the underwriters exercised their over-allotment option to purchase additional shares, resulting in aggregate gross proceeds of approximately $95 million. Secured long-term strategic manufacturing agreement: On April 29, 2026, a multi-year agreement between SAB BIO and Emergent BioSolutions was announced to support the process development, and clinical and commercial manufacturing of SAB-142 following regulatory approval. Upcoming Events SAB BIO plans to participate in the following scientific congress: American Diabetes Association 2026 Scientific Sessions Date: June 5-8, 2026 Location: New Orleans, LA Q1 2026 Financial Highlights Cash Position: Cash, cash equivalents, and available for sale securities of $217.6 million at March 31, 2026, providing operational runway through 2028. R&D Expenses: Research and development (R&D) expenses of $13.4 million and $7.7 million for the three months ended March 31, 2026, and March 31, 2025, respectively. The increase is driven by the ongoing investments made to advance the SAB-142 program in the SAFEGUARD trial. G&A Expenses: General and administrative (G&A) expenses of $6.6 million and $3.1 million for the three months ended March 31, 2026, and March 31, 2025, respectively. The increase is primarily driven by higher non-cash stock-based compensation expenses and personnel-related costs associated with our expanded team. Other income: Other income of $1.1 million and $5.6 million for the three months ended March 31, 2026, and March 31, 2025, respectively. This decrease was driven by the change in fair value of warrant liabilities. Net loss: Net loss of $18.9 million and $5.2 million for the three months ended March 31, 2026, and March 31, 2025, respectively. Webcast and Conference Call Information SAB BIO will host a conference call to discuss its first quarter financial results and provide business updates on Tuesday, May 12, 2026 at 8:30 AM ET. A live webcast of the conference call can be accessed in the “Events” section of the Company’s website at ir.sab.bio. A replay will be available after the event. About the SAFEGUARD Trial SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial is a randomized, double-blind, placebo-controlled multi-center Phase 2b study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with new onset Stage 3 T1D. The SAFEGUARD trial is actively enrolling and dosing participants at multiple sites around the world. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat T1D by delaying the progression of disease. SAFEGUARD Part A is a dose-ranging study in adult patients. SAFEGUARD Part B is a randomized double-blind, placebo-controlled, dose-ranging study. Enrolled patients will receive two SAB-142 or placebo infusions six months apart. All patients, including the placebo-control group, with residual beta cells at 12 months are eligible for the 12-month long-term efficacy and safety extension study (Part C) upon Part A and B study completion. Additional details are available on www.clinicaltrials.gov (NCT07187531) and at https://safeguardstudy.com/. About SAB-142 SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. About SAB BIO SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. SAB-142 is currently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients in a registrational Phase 2b clinical trial called SAFEGUARD. For more information, visit www.sab.bio. Forward-Looking Statements Certain statements made in this press release 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,” “to be,” “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, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs. These statements are based on the current expectations of SAB BIO 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, as may be amended or supplemented from time to time, 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 BIO 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: Christine Ryan [email protected] Media: Sheila Carlson [email protected]

Advanced SAB -142 into registrational Phase 2b SAFEGUARD study with multiple patients dosed; enrollment ongoing and on track to complete enrollment by end of 2026 with topline data expected in 2H 2027 Reported Phase 1 clinical data, including healthy volunteer, redosing, and T1D cohorts supporting SAB-142’s favorable safety profile, redosability, and continued clinical development Raised $175 million in an oversubscribed private placement with leading institutional and strategic investors to fully fund SAFEGUARD Strong cash position with operational runway through 2028 MIAMI, March 09, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced financial results for the full year 2025 and provided business highlights. “2025 marked an important year of execution for SAB. We delivered Phase 1 clinical data for SAB-142, completed a $175 million oversubscribed financing with high quality investors including Sanofi, and advanced SAB-142 into our registrational Phase 2b SAFEGUARD study with the first patient dosed,” said Samuel J. Reich, CEO, SAB BIO. “In 2026, our focus is on enrolling SAFEGUARD. We are encouraged by current momentum and remain on track to complete enrollment by year end with topline data expected in the second half of 2027. We also expect to share additional Phase 1 data and support the initiation of an investigator led study as we continue to build the clinical foundation for SAB-142 in T1D.” Recent Pipeline Achievements and Anticipated Milestones for SAB-142 Phase 2b SAFEGUARD Study Initiated and dosed multiple patients in the SAFEGUARD (SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes) clinical trial of SAB-142 as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach in development to treat T1D by delaying the progression of disease. Activated multiple clinical trial sites in the U.S., Australia, and New Zealand. On May 29, 2025, the Company held a constructive Type B meeting with the U.S. Food and Drug Administration (FDA). The FDA provided guidance leading to alignment on the design and advancement of our Phase 2b SAFEGUARD study. SAB confirmed its intent with the FDA to utilize the data from the SAFEGUARD study as supportive evidence for future regulatory approval. Enrollment is ongoing and the Company is on track to complete enrollment in SAFEGUARD by the end of 2026 with topline data expected in 2H 2027. Phase 1 Data in Healthy Volunteer, Redosing, and T1D Cohorts Reported positive confirmatory clinical results from the Phase 1 study of SAB-142 in healthy volunteers, redosing, and T1D cohorts in December 2025. Data confirmed SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers. Transient lymphopenia, an on-target marker of target engagement and pharmacodynamic activity, was observed after dosing and rapidly corrected to baseline within 1-3 days in all participants. The lack of sustained lymphodepletion observed supports the chronic dosing of SAB-142 in an outpatient setting for the treatment of Stage 3 autoimmune type 1 diabetes. Business Highlights David Zaccardelli, Pharm.D., appointed to Board of Directors as Chair in January 2026: Dr. Zaccardelli is an accomplished biopharmaceutical executive with more than 20 years of experience leading companies through transformational growth, including leading companies from clinical to commercial stage. He most recently served as President and Chief Executive Officer of Verona Pharma until its acquisition by Merck & Co. Rita Jain, M.D., appointed to Board of Directors as Independent Director in January 2026: Dr. Jain is a rheumatologist who brings more than two decades of leadership experience in biopharmaceutical development, clinical strategy, and regulatory affairs across multiple therapeutic areas, including immunology, inflammation, nephrology, and rare diseases. Completed successful financing raising an upfront $175mm in gross proceeds: In July 2025, SAB BIO raised an upfront $175 million in oversubscribed private placement which included strategic investor Sanofi and top-tier biotech investors, enabling the Company to fully fund the Phase 2b SAFEGUARD study. In addition, the Company issued milestone-based warrants to purchase up to an aggregate of 1,500,000 shares of the Company’s Series B preferred stock, for up to an additional $284 million in gross proceeds if the warrants are exercised in full. Upcoming Events SAB BIO plans to participate in the following investor events and scientific congress: Leerink Partners Global Biopharma Conference Date: March 9, 2026 Time: 3:00 p.m. ET Format: Fireside Chat Location: Miami Beach, FL UBS Biotech Summit Miami, Catalyst for Change Date: March 10, 2026 Format: 1x1 Meetings Location: Miami Beach, FL Barclays 28th Annual Global Healthcare Conference Date: March 11, 2026 Time: 8:30 a.m. ET Format: Fireside Chat Location: Miami Beach, FL 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2026) Date: March 11-14 Location: Barcelona, Spain Fiscal Year 2025 Financial Results Cash Position: Cash, cash equivalents, and available for sale securities of $143.5 million at December 31, 2025, providing operational runway through 2028. R&D Expenses: Research and development (R&D) expenses of $34.4 million and $30.3 million for the years ended December 31, 2025, and December 31, 2024, respectively. G&A Expenses: General and administrative (G&A) expenses of $14.6 million and $14.0 million for the years ended December 31, 2025, and December 31, 2024, respectively. Other income: Other income of $62.2 million and $8.8 million for the years ended December 31, 2025, and December 31, 2024, respectively. This increase was driven by the change in fair value of warrant liabilities. Net income: Net income of $13.3 million and a net loss of $34.1 million for the years ended December 31, 2025, and December 31, 2024, respectively. About SAB-142 SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. About SAB BIO SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency hIgGs that can address a wide range of serious unmet needs in human diseases. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. SAB-142 is currently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients in a registrational Phase 2b clinical trial called SAFEGUARD. For more information, visit www.sab.bio. Forward-Looking Statements Certain statements made in this press release 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,” “to be,” “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, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs, the Company’s operational runway, and the future exercise of the Company’s outstanding warrants. These statements are based on the current expectations of SAB BIO 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, as may be amended or supplemented from time to time, 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 BIO 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 Investors: Cristi Barnett [email protected] Media: Sheila Carlson [email protected]

Phase 1 data confirms SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers Study results support the chronic dosing of SAB-142 in an outpatient setting for the treatment of stage 3 autoimmune type 1 diabetes Phase 2b SAFEGUARD trial underway and recruiting at multiple sites around the world MIAMI, Dec. 17, 2025 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced positive, confirmatory data from a Phase 1 trial of SAB-142 in a single- and multiple-ascending dose among healthy volunteers (n=62), including a re-dosed cohort, and T1D patients (n=6). The study met its primary objectives to establish a safety profile and characterize pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development in the SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial, now underway. In the Phase 1 trial, nine (9) cohorts of healthy volunteers (HVs) and one (1) cohort of T1D patients were dosed with a single 0.03-4.5mg/kg dose or multiple doses of SAB-142. SAB-142 was well-tolerated in both healthy volunteers and T1D patients. SAB-142 demonstrates a safety profile superior to rabbit anti-thymocyte immunoglobulin (rATG) as the data from the Phase 1 trial confirmed SAB-142 does not cause serum sickness (0%, N=0/68) and there were no adverse events (AEs) associated with anti-drug antibodies (ADAs; 0%, N=0/68) at any dose in any cohort, including in the redosed HVs. In all treated participants, there were no drug-related serious adverse events (SAE). Most AEs were mild and associated with day 1-2 infusions, with only Grade 1 flu-like symptoms and transient infusion-site reactions including pruritus and tenderness. The most common AE was headache, which is consistent with typical AEs for T-cell modifying therapies. Transient lymphopenia, an on-target marker of target engagement and pharmacodynamic activity, was observed after dosing and rapidly corrected to baseline within 1-3 days in all subjects (100%; N=68), including after the second administration in the redosed HV cohort (100%; n=8) and are comparable to placebo. Unlike other immunomodulatory drugs that deplete lymphocytes for up to two years, the lack of sustained lymphodepletion for SAB-142, as shown in Table 1 below, SAB-142 has the potential to be safely redosed. Table 1 “These promising Phase 1 data support our belief that SAB-142 is emerging as a potential best-in-class, redosable treatment for delaying progression of stage 3 T1D. All results have met or exceeded our expectations, allowing us to move swiftly into our registrational Phase 2b SAFGUARD study,” said Alexandra Kropotova, M.D., MBA, Chief Medical Officer, SAB BIO. “I would like to thank the clinical trial participants, their families, the clinicians, and our colleagues at collaborating institutions for their invaluable contributions to our clinical trials. We look forward to sharing updates from the SAFEGUARD trial over the next two years.” “This investigational therapy has been well-tolerated throughout the Phase 1 study, and we look forward to evaluating its effectiveness in new onset T1D. Novel treatment options that can meaningfully alter the course of disease are urgently needed,” said Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida. “I am excited about the prospect for benefit with SAB-142 in patients with T1D, and I look forward to leading the SAFEGUARD Phase 2b trial.” Based on these data, SAB BIO has advanced SAB-142 into a registrational Phase 2b trial SAFEGUARD to evaluate SAB-142 in adult and pediatric patients with new-onset, stage 3 T1D. The SAFEGUARD trial is enrolling at multiple sites around the world, and the Company is on track to dose the first patient by the end of the year. About the Phase 1 Trial of SAB-142 The Phase 1 trial of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The study objectives include establishing safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile for SAB-142 with a single 0.03-4.5mg/kg dose plus one cohort with an additional 1.5mg/kg dose. About SAB-142 SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes like cytotoxic T-cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. About SAB BIO SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. For more information, visit www.sab.bio. Forward-Looking Statements Certain statements made in this current report 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,” “to be,” “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, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs. These statements are based on the current expectations of SAB BIO 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, as may be amended or supplemented from time to time, 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 BIO 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: Cristi Barnett [email protected] Media: Sheila Carlson [email protected] A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/56c69165-5952-46ec-adb4-af37827914a8