Phase 1 SAB-142 data from SAB BIO (Nasdaq: SABS) highlight early T1D signal
Rhea-AI Filing Summary
SAB Biotherapeutics (SAB BIO) reported additional Phase 1 data for its lead Type 1 diabetes therapy SAB-142. In a small cohort of six adults with established Stage 3 T1D, four participants receiving SAB-142 at 2.5 mg/kg showed preserved or increased C-peptide levels at Day 120, while the single placebo completer showed a decline consistent with expected disease progression.
The company highlights biomarker evidence of T‑cell exhaustion supporting the drug’s intended mechanism and notes a previously established Phase 1 safety profile without serum sickness and with transient, reversible lymphopenia. These results supported advancing SAB-142 into the global registrational Phase 2b SAFEGUARD trial in newly diagnosed Stage 3 T1D patients, with topline data planned for the second half of 2027.
Positive
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Insights
Early Phase 1 T1D signal supports SAB-142’s move into a registrational Phase 2b trial.
SAB BIO presents exploratory Phase 1 data in six adults with established Stage 3 Type 1 diabetes. Four patients treated with SAB-142 2.5 mg/kg showed preserved or rising C‑peptide over 120 days, while the single placebo completer declined, matching modeled historical placebo trajectories.
The company also reports pharmacodynamic biomarkers, including T‑cell exhaustion signatures and transient lymphopenia that resolved within days, plus no serum sickness or anti‑drug antibodies across evaluated doses. This profile aligns with a disease‑modifying, immunomodulatory mechanism analogous to rabbit ATG but with potentially improved tolerability.
These findings underpinned direct progression into the global Phase 2b SAFEGUARD trial in newly diagnosed Stage 3 T1D patients aged 5–40, targeting C‑peptide and HbA1c outcomes over 12 months with two IV dosing courses. Topline results are planned for
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On March 10, 2026, SAB Biotherapeutics, Inc. (the “Company” or “SAB BIO”) issued a press release titled “SAB BIO Announces Additional Phase 1 Data for SAB-142 in Adult Patients with Established Autoimmune Type 1 Diabetes” (the “Release”). The Release announced additional data from the Company’s Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142. In addition, the Company made available a presentation that includes certain information regarding the Company’s Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142. A copy of the Release and the presentation are furnished herewith as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K. The presentation is also available on the investor relations section of the Company’s website. Information contained on the Company’s website is not incorporated by reference into this Current Report on Form 8-K, and you should not consider any information on, or that can be accessed from, the Company’s website as part of this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing
Item 8.01 Other Events.
On March 10, 2026, the Company announced additional data from its Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142. In the trial, the established T1D adult patient cohort demonstrated early signals of C-peptide preservation aligned with the anticipated mechanism of action of SAB-142. In the T1D cohort (n=6), SAB-142 treated study participants (n=4) showed no decrease in C-peptide levels at Day 120 compared to baseline. The placebo study participant showed a decrease in C-peptide compared to the baseline. The Phase 1 T1D cohort included six adult participants (n=6), with four receiving SAB-142 at 2.5 mg/kg (n=4) and two receiving placebo (n=2). Participants ranged in age from 19 to 40 years. All established T1D patients (Stage 3 T1D diagnosis within 28-40 months at the time of randomization) had residual beta function (C-peptide >0.2 nmol/L) and at least one T1D autoantibody at baseline. Phase 1 study efficacy endpoints were measured at the End of Study Day 120 post SAB-142 administration. One placebo participant (n=1) completed through Day 120 as the other placebo participant discontinued early due to personal reasons. Participants treated with SAB-142 (2.5 mg/kg) demonstrated preservation in C-peptide levels compared to baseline with mean values increasing above baseline by Day 120. In contrast, the placebo treated participant showed a decline in C-peptide consistent with the predicted rate of disease progression. For reference, the TN19 Placebo Cohort 1 is modeled using a historical C-peptide trajectory based on historical placebo arm from the TN19 study. By Day 120, SAB-142 shows divergence from both the study placebo arm and the TN19 modeled placebo cohort, supporting a pharmacodynamic effect consistent with the preservation of beta cell function in adult patients with established T1D.
Figure 1: T1D Cohort – MMTT C-Peptide Mean AUC (nmoI/L) / Min ± SEM
Note: Predicted decline was estimated using placebo MMTT C-peptide AUC data from TN19 (n=26), Weeks 48–96 (post-2 hour values masked). A linear slope (–0.6206) was applied to estimate the rate of decline: AUC_BL – (–0.6206 × [Study Day/7]). Source: Haller et al. Diabetes. 2019 Jun;68(6):1267-1276. MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error the Mean.
Forward-Looking Statements
Certain statements made in this Current Report on Form 8-K and in the 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. 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.
Item 9.01 Financial Statements and Exhibits.
Exhibit Number |
Description |
99.1 |
Press Release issued by SAB Biotherapeutics, Inc. dated March 10, 2026 (furnished herewith). |
99.2 |
Corporate Presentation dated March 10, 2026 (furnished herewith). |
104 |
Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SAB Biotherapeutics, Inc. |
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March 10, 2026 |
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/s/ Samuel J. Reich |
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Samuel J. Reich |
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EXHIBIT 99.1 |
SAB BIO Announces Additional Phase 1 Data for SAB-142 in Adult Patients with Established Autoimmune Type 1 Diabetes
Results demonstrated early signals of C-peptide preservation
T1D key opinion leader, Michael J. Haller, MD, provided a recorded webinar reviewing the SAB‑142 Phase 1 data
MIAMI, March 10, 2026 -- 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 additional data from the Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142. The established T1D adult patient cohort demonstrated early signals of C-peptide preservation which aligned with the anticipated mechanism of action of SAB-142. In the T1D cohort (n=6), SAB-142 treated study participants (n=4) showed no decrease in C-peptide levels at Day 120 compared to baseline. The placebo study participant showed a decrease in C-peptide at Day 120 compared to the baseline.
“People living with T1D need novel treatment options to alter the course of their disease, and we know that the preservation of C-peptide as the marker of endogenous insulin production has a positive clinical effect for patients. While exploratory and early, the initial C-peptide data are encouraging and exactly the type of signal I hope to see at this stage. Additionally, these clinical observations were supported by biomarker evidence of T cell exhaustion consistent with prior studies, strengthening confidence that the therapy is engaging its intended biological mechanism,” said Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida. “I am excited about SAB-142’s potential as a disease modifying therapy for T1D.”
The Phase 1 T1D cohort included six adult participants (n=6), with four receiving SAB-142 at 2.5 mg/kg (n=4) and two receiving placebo (n=2). Participants ranged in age from 19 to 40 years. All established T1D patients (Stage 3 T1D diagnosis within 28-40 months at the time of randomization) had residual beta cell function (C-peptide >0.2 nmol/L) and at least one T1D autoantibody at baseline. Phase 1 study exploratory efficacy endpoints were measured at the End of Study Day 120 post SAB-142 administration. One placebo participant (n=1) completed through Day 120 as the other placebo participant discontinued early due to personal reasons.
Participants treated with SAB-142 (2.5 mg/kg) demonstrated preservation in C-peptide levels compared to baseline with mean values increasing above baseline by Day 120. In contrast, the placebo-treated participant showed a decline in C-peptide consistent with the predicted rate of disease progression. For reference, the TN19 Placebo Cohort1 is
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modeled using a historical C-peptide trajectory based on historical placebo arm from the TN19 study1. By Day 120, participants receiving SAB‑142 show divergence from both the study’s placebo-treated participant and the TN19 modeled placebo cohort, supporting a PD effect consistent with the preservation of beta cell function in adult patients with established T1D.
Figure 1: T1D Cohort – MMTT C-Peptide Mean AUC (nmoI/L) / Min ± SEM
Note: 1 Predicted decline was estimated using placebo MMTT C-peptide AUC data from TN19 (n=31 at screening). Linear modeling of decline was based on Weeks 48, 72, and 96 (n=30, 26, and 26, respectively; post–2-hour values masked). A linear slope (–0.6108) was applied to estimate the rate of decline: AUC_BL – (–0.6108 × [Study Day/7]). Source: Haller et al. Diabetes. 2019 Jun;68(6):1267–1276.
MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error the Mean.
“We believe these Phase 1 data provide an opportunity to bring our early findings to investigators, clinicians, and patients, giving them greater visibility into the science behind SAB-142. By sharing this exploratory C-peptide trend openly, we aim to support informed engagement from the T1D community. While no statistical conclusions can be made, these findings align with our expectations and provide additional confidence as we clinically execute on SAFEGUARD, which is designed and powered to evaluate the safety and efficacy of SAB-142 for patients with new onset T1D,” said Samuel J. Reich, CEO, SAB BIO.
Previously, the Company announced the Phase 1 study met its primary objectives of establishing a safety profile and characterizing the PD activity for SAB-142. These results
1 Haller MJ, Long SA, Blanchfield JL, et al; Type 1 Diabetes TrialNet ATG‑GCSF Study Group. Low‑Dose Anti‑Thymocyte Globulin Preserves C‑Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T‑Cell Ratios in New‑Onset Type 1 Diabetes: Two‑Year Clinical Trial Data. Diabetes. 2019;68(6):1267‑1276. doi:10.2337/db19‑0057
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enabled SAB BIO to advance SAB-142 into the registrational Phase 2b SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial, which is evaluating SAB-142 in adult, adolescents, and pediatric patients with new-onset, Stage 3 T1D. The SAFEGUARD trial is enrolling and dosing participants at multiple sites around the world with topline data expected 2H 2027.
The Phase 1 data is available on the Company’s website in the SAB BIO Corporate Presentation, available in the Investors & Media section.
Webinar Details
T1D key opinion leader, Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida, provided a recorded webinar reviewing the SAB-142 Phase 1 data, available at: SAB-142 Phase 1 Data in Adult Patients with Autoimmune T1D: Expert Perspective Webinar. The webinar is also available on the Events page of the Company’s website.
About the Phase 1 HUMAN Trial of SAB-142
The Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose and redose, adaptive design clinical study among healthy volunteers and one cohort of adult participants with established 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 the SAFEGUARD Trial
SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial is a double-arm, multi-center Phase 2b study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with Stage 3 new onset T1D. 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, are eligible for the 12-month long-term extension study upon 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.
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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, timing, 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
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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.
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CONTACTS
Investors:
Cristi Barnett
ir@sab.bio
Media:
Sheila Carlson
media@sab.bio
Corporate Presentation Q1 2026 Targeting T1D Modifying Disease Moving Beyond Insulin EXHIBIT 99.2
The material in this presentation has been prepared by SAB Biotherapeutics, Inc., doing business as SAB BIO (“SAB”) and is general background information about SAB’s activities current as of the date of this presentation. This information is given in summary form and is not intended to be complete. Information in this presentation, including financial forecasts, should not be considered advice or a recommendation to investors or potential investors in relation to holding, purchasing, or selling securities or other financial products or instruments and does not take into account any particular investment objectives, financial situation or needs. This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities. This presentation may contain forward-looking statements including statements regarding our intent, belief, or current expectations with respect to SAB’s businesses and operations, market conditions, the exercise of outstanding warrants for cash, results of operations and financial condition, capital adequacy, specific provisions, and risk management practices. Readers are cautioned not to place undue reliance on these forward-looking statements. SAB does not undertake any obligation to update any information herein for any reason or to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events unless required by law. While due care has been used in the preparation of forecast information, actual results may vary in a materially positive or negative manner and the presentation may contain errors or omissions. Forecasts and hypothetical examples are subject to uncertainty and contingencies outside SAB’s control. Past performance is not a reliable indication of future performance. The forward-looking statements contained or implied in this presentation are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SAB’s most recent Annual Report on Form 10-K with the Securities and Exchange Commission (the “SEC”) and in other filings and reports that SAB makes with the SEC. Unless otherwise specified, information is current at the date hereof. The SAB logo and other trademarks of SAB appearing in this presentation are the property of SAB. All other trademarks, services marks, and trade names in this presentation are the property of their respective owners. Forward-Looking Statements
Transforming Treatment for People Living with Autoimmune Diseases through a Unique Disease-modifying Therapy At SAB BIO, 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 symptoms
Leading Clinical-Stage Company Focused on Autoimmune Type 1 Diabetes SAB BIO Investment Highlights Potential for Significant Value Creation and Patient Impact REDEFINING T1D TREATMENT LANDSCAPE SAB-142, our lead product candidate, is a potentially best-in-class, disease-modifying therapy with a de-risked mechanism of action Currently conducting a registrational Phase 2b SAFEGUARD study for newly diagnosed Stage 3 autoimmune type 1 diabetes (T1D) LARGE MARKET OPPORTUNITY WITH ESTABLISHED REGULATORY PATHWAY T1D is a multi-billion market opportunity with a global prevalence of ~9.5M SAB-142 is initially focused on Stage 3 T1D (U.S. incidence of 64K) where the treatment landscape is expanding towards disease-modifying therapies along an informed regulatory pathway established by Tzield UNIQUE MULTI-SPECIFIC ANTIBODY PLATFORM WITH HIGH BARRIERS TO ENTRY Proprietary, wholly-owned, discovered in-house platform capable of generating a diverse repertoire of multi-specific, targeted, fully human immunoglobulins (hIgG) This unique platform leverages a multi-level IP strategy with no biosimilar pathway creating high barriers to entry WELL CAPITALIZED WITH TOP-TIER INVESTORS Backed by a syndicate of life science specialist investors Current cash position is expected to fully fund SAB-142’s SAFEGUARD study with data expected 2H 2027 EXPERIENCED LEADERSHIP TEAM Led by management team and board of directors with deep, proven biopharma experience spanning global clinical development, regulatory strategy, and commercialization
SAB-142: Potential Disease-modifying Immunotherapy Being Developed to Delay the Onset and Progression of Type 1 Diabetes Early intervention is essential and life-long disease modification is possible with effective, safe, and reliable redosing Goal: develop a T1D therapy that immunomodulates T cells to preserve C-peptide while avoiding immunosuppression SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) disease-modifying immunotherapy to delay the onset and progression of T1D SAB-142 works by directly targeting multiple immune cells involved in destroying pancreatic beta cells, including the modulation of “bad acting” T-lymphocytes Mechanism of action, analogous to rabbit ATG (rATG), directly modulates multiple immune cells involved in destroying pancreatic beta cells SAB-142 provides a better safety profile resulting in no serum sickness and low/no immunogenicity – this offers the potential for life-long disease modification through redosing safely, preserving C-peptide, and delaying the onset or progression of T1D By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells C-peptide is a stable marker of endogenous insulin production Preserving beta cell function and thus insulin production as measured by C-peptide is key to delaying progression of T1D SAB-142 Anti-Thymocyte Globulin (Human)
SAB has a proprietary platform that can produce targeted, fully human, multi-specific polyclonal antibodies without the need for human donors through its Tc Bovine platform SAB-142 is Manufactured Using our Fully Human Immunoglobulin G (hIgG) to Treat and Prevent Autoimmune Disorders Upstream at SAB’s Biosecure Pharm Facility Downstream at SAB’s cGMP Facility Thymocytes Tc Bovine Transchromosomic (TC) bovine genetically designed to produce human antibodies Hyperimmunization Tc Bovine immunized with target disease antigen to generate antibodies Human Antibody Production Bovine produce fully human antibodies to disease target that circulate in the blood stream Plasmapheresis Tc Bovine™ are plasma donors, and antibodies are collected in the form of plasma hpAbs Purification Purification process isolates antibodies from plasma Human Antibodies Purified and formulated human multi-specific polyclonal antibodies
T1D Occurs in 3 Progressive Stages Identified by the Presence of Multiple Autoantibodies and Increasing Glycemic Levels T1D is associated with serious long-term complications, including diabetic nephropathy, neuropathy, and retinopathy, as well as increased risk of cardiovascular disease, peripheral arterial disease, cerebrovascular events, and diabetic foot complications. 100% Normal beta cell mass Stage 1 Stage 2 Stage 3 Intervention enables preservation of beta cells and C peptide Normoglycemia ≥2 Autoantibodies Dysglycemia ≥2 Autoantibodies Hyperglycemia ≥1 Autoantibodies2 Early intervention is essential. Life-long disease modification is possible with safe and reliable redosing PRESYMPTOMATIC CLINICAL Symptomatic requiring insulin 90% of Global T1D Market* 10% of Global T1D Market* SAB-142, currently in Phase 2b, has a de-risked MOA to delay the progression of T1D Normal beta cell mass decreases with progression of T1D *Based on Company estimates. Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC5321245/ American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2024. Diabetes Care. 2024;47(Suppl 1):S20—S42 ~75% risk of progression to Stage 3 in 5 years1 Intervention enables potentially delayed onset These complications exist even when patients are on insulin. With insulin as the only treatment option, patients lose all residual beta-cell function over time. Preservation of residual beta cell mass and endogenous insulin production, and by extension C-peptide, has been linked to improved long-term health outcomes in T1D
Significant Unmet Need in Type 1 Diabetes Source:: 1 Rogers MAM, Kim C, Banerjee T, Lee JM. Fluctuations in the incidence of type 1 diabetes in the United States from 2001 to 2015: a longitudinal study. BMC Med. 2017 Nov 8;15(1):199. doi: 10.1186/s12916-017-0958-6. PMID: 29115947; PMCID: PMC5688827. 2 Jacobsen LM, Schatz DA. Type 1 Diabetes: A Review. JAMA. Published online February 16, 2026. doi:10.1001/jama.2026.0048 3 https://www.t1dindex.org/ 9.5M People with T1D globally in 20253 2.0M People with T1D cases in the US2 14.7M People with T1D globally by 20403 64,000 U.S. Patients Diagnosed Annually1 $2.9B Sanofi acquisition of Provention Bio (Tzield in Phase 3 for Stage 3 at time of acquisition) Stage 2 (Delay Onset) Market Approved in Stage 2 patients to delay the onset of T1D Stage 3 (Newly Diagnosed) Market An evolving treatment landscape with a regulatory pathway informed by Tzield Tzield sBLA accepted with CNPV supported by PROTECT data 500,000 Patients WW Diagnosed Annually2
*Not measurable in healthy volunteers. 2013 2018 2025 2013 rATG Tested in Academic Setting (START Study) (Gitelman et al., 2013) Dosage 6.5mg/kg Lymphodepletion C-peptide HbA1c Serum Sickness Ability to redose 2018 rATG Tested in Academic Setting (TN-19 Study) (Haller et al., 2018) Dosage 2.5mg/kgg T-cell Exhaustion Lymphodepletion C-peptide HbA1c Serum Sickness Ability to redose 3Q 2025 rATG Tested in Academic Setting (MELD-ATG Study) (Mathieu et al., Lancet, 2025) Dosage Multiple C-peptide HbA1c Lymphodepletion not an efficacy driver Serum Sickness Ability to redose 4Q 2025 SAB-142 tested in Healthy Volunteers And T1D patients (January and December 2025) Dosage Multiple T-cell Exhaustion C-peptide* N/A HbA1c* N/A Serum Sickness Ability to redose Leveraged clinical findings showing low-dose rATG (2.5 mg/kg) effectively mitigates disease SAB applied the clinical findings that exhaustion correlated with efficacy rather than depletion SAB-142: hATG tested in healthy volunteers and T1D patients rATG has been tested across multiple studies in T1D patients SAB-142: A Clinically Validated De-risked Mechanism of Action
Confirm SAB-142 not immunogenic Immunogenicity Not observed to cause anti-drug antibodies Enables safe and reliable redosing Position SAB-142 for a convenient, potentially twice a year dosing regimen Safety and Tolerability No sustained lymphodepletion leading to immuno-suppression; no neutropenia observed No serum sickness Clinically validated by rATG and other T1D T-cell targeting biologics Demonstrated correlation with C-peptide preservation based on precedent rATG studies and natural course of T1D Demonstrate sustained “T-cell exhaustion” signature PK/PD SAB-142’s Phase 1 Data Demonstrated Encouraging Efficacy Signals with Clinically Validated, Multi-specific MOA with Sustained Immunomodulation Phase 1: HUMAN* Trial Study Design *HUman anti-thymocyte biologic in first-in-MAN clinical study Randomized, double-blind, placebo-controlled, single- and multiple- ascending dose, adaptive design clinical study HV Randomized 1.5 mg/kg n=6 0.5 mg/kg n=12 0.1 mg/kg n=6 0.03 mg/kg n=4 Placebo n=16 T1D Cohort 4.5 mg/kg n=6 2.5 mg/kg n=4 Placebo n=2 Redosing Cohort 1.5 mg/kg n=7 Placebo n=1 2.5 mg/kg n=12 Early C-peptide signal consistent with beta cell preservation Encouraging early signals of C-peptide preservation in established T1D patients Efficacy
*One placebo subject discontinued after Day 45 Note: SD = Standard deviation Adult Established T1D Cohort: Baseline Characteristics SAB-142 2.5 mg/kg T1D (n=4) Placebo T1D (n=2)* Age range (mean) 19-40 (28.75) 19-34 (26.5) Sex 2 Female & 2 Male 2 Female C-peptide AUC for 2-hr MMTT (nmol/L)/min n 4 1* Mean (SD) 0.302 (0.032) 0.432 Fasting Glucose (mmol/L) n 4 2 Mean (SD) 6.53 (1.773) 5.95 (1.344) Time in months from T1D diagnosis to randomization n 4 2 Mean (SD) 40.2 (11.39) 28 (9.9) Average Total Insulin per day by Weight (IU/day/kg) n 4 2 Mean (SD) 0.406 (0.287) 0.323 (0.225) GAD Autoantibodies Positive N (%) 4 (100%) 0 (0%) IA-2 Autoantibodies Positive N (%) 2 (50%) 2 (100%) ZNT8 Autoantibodies Positive N (%) 3 (75%) 0 (0%) Fasting Glucose (mmol/L) C-peptide AUC for 2-hr MMTT (nmol/L) / min Time in months from T1D diagnosis to randomization Average Total Insulin per day by Weight (IU/day/kg) GAD Autoantibodies Positive N (%) Age range (mean) IA-2 Autoantibodies Positive N (%) ZNT8 Autoantibodies Positive N (%) Sex Established T1D All study participants met SAFEGUARD inclusion criteria related to residual beta cell function and at least one T1D autoantibody at baseline
PBO 2.5 mg/kg TN19 Placebo Cohort1 N = 1 4 1 4 1 4 Day SAB-142 0.3 0.2 0.1 0.0 -0.1 -0.2 Adult Established T1D Cohort: C-Peptide Responses C-peptide demonstrated preservation over time in the SAB-142 T1D cohort vs. study placebo and TN19 placebo cohort1 Supports a PD effect consistent with preservation of beta cell function in adults with established T1D Established T1D Note: 1 Predicted decline was estimated using placebo MMTT C-peptide AUC data from TN19 (n=31 at screening). Linear modeling of decline was based on Weeks 48, 72, and 96 (n=30, 26, and 26, respectively; post–2-hour values masked). A linear slope (–0.6108) was applied to estimate the rate of decline: AUC_BL – (–0.6108 × [Study Day/7]). Source: Haller et al. Diabetes. 2019 Jun;68(6):1267–1276. MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error the Mean. Change from baseline in mean AUC C-peptide, nmoI/L per min MMTT C-Peptide Mean AUC (nmoI/L) / Min ± SEM Baseline 1 2 90 120
Phase 1 data confirmed advancement into a registrational Phase 2b study in newly diagnosed adult, adolescents, and pediatric T1D patients (age 5-40) Complete Phase 1 Safety Data Support Outpatient Dosing and Chronic Treatment Potential Note: AE = Adverse Events; SAE = Serious Adverse Events; CRS = Cytokine Release Syndrome; PD = Pharmacodynamics; RBCs = Red Blood Cells SEM = Standard Error of the Mean; SOI = Start of Infusion Safety profile enables outpatient dosing and redosing No serum sickness (0%, N=0/68) No ADA-related AEs at any dose or cohort (0%, N=0/68) No drug-related SAEs Headaches, a typical AE for T-cell modifying therapies Mild CRS (Grade 1 only) Transient infusion-site reactions (erythema, pruritus, tenderness, phlebitis) Transient lymphopenia indicative of target engagement, a desired PD effect Lymphopenia shown to self-resolve in 1–3 days No lymphocyte killing/sustained lymphodepletion, a key risk factor of immunosuppression – supports chronic redosing potential No reductions in RBCs, neutrophils, lymphopenia, or thrombocytopenia from Day 7 onward Key Safety Outcomes Observed AEs Transient On-Target PD Effects Hematologic Safety Mean Absolute Lymphocytes ± SEM Normalized to Original Pre-SOI in HV Placebo 0.5mg/kg 1.5mg/kg 2.5mg/kg 4.5mg/kg 2.5/1.5 mg/kg HV and T1D Lymphocytes were shown to fully recover to baseline across all doses including 4.5mg/kg and after repeat dosing
CD4+ exhaustion signature Treg preservation No sustained lymphodepletion (Tconv and/or Tregs) No anti-drug antibodies (ADAs) No serum sickness C-peptide preservation HbA1C Dosing 12 DAYS x 2 (Annual, not redosable) 1-2 DAYS (Not redosable) 2 DAYS x 2 (Annual, redosable) Infusing timing 1 HOUR 4-12 HOURS 4-6 HOURS Redosable (with potential for chronic dosing without ADAs) Age range 8-17 5-45 5-40* SAB-142: Potential for Broadest Use with Superior Safety, Efficacy, and Patient Convenience in a Broad Age Range of T1D Patients* * Not head-to-head studies. ** Potential benefits on HbA1c and C-peptide are informed by prior rATG outcomes, though this translatability to SAB-142 will be confirmed with the Phase 2b SAFEGUARD study results. Registrational Phase 2b SAFEGUARD trial includes T1D patients ages 5-40. *** Marketed by Sanofi through its $2.9bn acquisition of Provention Bio SAB-142 ** ** SAB-142 exhibits multi-specific T-cell exhaustion profile and Treg-sparing without sustained lymphodepletion mimicking immunologic cellular profiles that naturally occur during the initial spontaneous partial remission period (“honeymoon period”) T-cell exhaustion phenotype is universally linked to C-peptide preservation ***
SAFEGUARD: Multicenter, Global Phase 2b for SAB-142 in Stage 3 Type 1 Diabetes Patients Trial design: 159 pediatric, adolescent, and adult patients (5-40 years) Part A: 12 patients – dose-ranging study for 12 months Part B: 147 patients – randomized, double-blind, placebo-controlled, dose-ranging study for 12 months All patients, including placebo, eligible for 12-month long-term extension study (Part C) upon completion Inclusion criteria: New onset Stage 3 T1D: within 100 days of diagnosis Baseline C-peptide: ≥ 0.2 nmol/L Dosing regimen: Intravenous (IV) 0.5 mg/kg on Day 1 and remainder of dose Day 2 1st dose at study start and 2nd dose at month 6 Induction dose levels: 1.5 and 2.5mg/kg; Maintenance dose: 1.5mg/kg Phase 2b Study SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of Type 1 Diabetes Phase 2b Study Design 1.5 mg/kg n=49 Stimulated C-peptide following 2-hr MMTT at 12 months (detect at least 40% difference with 80% power) Leading Clinical Endpoint: HbA1C Primary Endpoint: Secondary Endpoint: Time in Tight Range, Time in Range, Time Above and Below Range Hypoglycemic episodes Safety Insulin use Other secondary Endpoints: Part A Part B 2.5 mg/kg n=6 1.5 mg/kg n=6 2.5 mg/kg n=49 Placebo n=49 United States (FDA) United Kingdom (MHRA) Europe (EMA) Australia (TGA) New Zealand (MEDSAFE) NCT07187531 Global study initiated with topline results expected 2H 2027 Stage 3 T1D Randomized 1:1 Stage 3 T1D Randomized 1:1:1
Strong Balance Sheet with Committed Strategic Partners Raised $175 million in July 2025 with the potential for an additional $284 million if milestone-based warrants are exercised in full Financial Snapshot: Cash* $144M Cash Runway* Through 2028 T1D Clinical Development Partner: SAB-142 clinical development plan designed in partnership with Breakthrough T1D (formerly JDRF) Recent Financing Fully Funds Phase 2b SAFEGUARD Study: Key Clinical and Strategic Partners: *Note: Cash, cash equivalents, and available for sale securities as of December 31, 2025.
Preclinical Phase 1 Phase 2 Phase 3 Milestones: Delaying progression of T1D in new onset T1D patients (Stage 3) Maintenance of Stage 3 T1D (LTE Part C SAFEGUARD) Delaying onset of Stage 3 T1D (Stage 2) Advancing a Pipeline in Autoimmune Diseases Led by SAB-142 In vivo and in vitro pre-clinical and Phase 1 SAB-142 data support direct progression into Phase 2 in other autoimmune indications Transplant Maintenance in Islet Cell Transplantation Celiac Disease SLE, Scleroderma, Polymyositis, Dermatomyositis Current Studies Potential future studies SAB is not currently funding Type 1 Diabetes Transplantation Autoimmunity Registrational Phase 2b Initiated registrational Phase 2b SAFEGUARD trial in Q4 2025
Strong 2025 Execution with Significant Catalysts Expected in 2026-2027 2025 2026 2027 2H 2025: Phase 2b SAFEGUARD Initiation Q2 2025: SAFEGUARD Type B FDA meeting Q3 2025: MELD Data at EASD Confirmed rATG efficacy, including HbA1c reduction and C-peptide preservation Q4 2025: SAB-142 Phase 1 redosing data demonstrated continued lack of lymphodepletion and immunogenicity on repeat dosing 2H 2027: Phase 2b SAFEGUARD topline data Cash balance of $144M as of December 31, 2025, with projected operational runway through 2028* Q4 2025: Dosed first patient in the SAFEGUARD trial Q4 2026: Complete enrollment of the SAFEGUARD trial of SAB-142 by end of 2026 *Note: Cash, cash equivalents, and available for sale securities as of December 31, 2025.
Leading Clinical-Stage Company Focused on Autoimmune Type 1 Diabetes SAB BIO Investment Highlights Potential for Significant Value Creation and Patient Impact REDEFINING T1D TREATMENT LANDSCAPE SAB-142, our lead product candidate, is a potentially best-in-class, disease-modifying therapy with a de-risked mechanism of action Currently conducting a registrational Phase 2b SAFEGUARD study for newly diagnosed Stage 3 autoimmune type 1 diabetes (T1D) LARGE MARKET OPPORTUNITY WITH ESTABLISHED REGULATORY PATHWAY T1D is a multi-billion market opportunity with a global prevalence of ~9.5M SAB-142 is initially focused on Stage 3 T1D (U.S. incidence of 64K) where the treatment landscape is expanding towards disease-modifying therapies along an informed regulatory pathway established by Tzield UNIQUE MULTI-SPECIFIC ANTIBODY PLATFORM WITH HIGH BARRIERS TO ENTRY First-ever, wholly-owned, discovered in-house platform capable of generating a diverse repertoire of multi-specific, targeted, fully human immunoglobulins (hIgG) This unique platform leverages a multi-level IP strategy with no biosimilar pathway creating high barriers to entry WELL CAPITALIZED WITH TOP-TIER INVESTORS Backed by a syndicate of life science specialist investors Current cash position is expected to fully fund SAB-142’s SAFEGUARD study with data expected 2H 2027 EXPERIENCED LEADERSHIP TEAM Led by management team and board of directors with deep, proven biopharma experience spanning global clinical development, regulatory strategy, and commercialization
Targeting T1D Modifying Disease Moving Beyond Insulin
Appendix
SAB-142 Offers Distinct Advantages Over rATG DISADVANTAGES Majority of patients develop grade 3 serum sickness Inability to safely and reliably redose due to serum sickness and antibodies Leads to lymphodepletion up to 2 years which may increase risk in immunosuppression Low/no immunogenicity due to fully human nature. Enables opportunity to safely and reliably redose Does not lead to lymphodepletion/ immunosuppression based on Phase 1 data Our Solution: SAB-142 is a human alternative to rATG (Thymoglobulin) SAB-142’s mechanism of action is comparable to the PD profile of rATG shown to correlate with C-peptide preservation SAB-142, like rATG, modulates immune function resulting in sustained exhaustion in T cells likely involved in destroying pancreatic beta cells SAB-142 / hATG Mechanism of Action: No risk of serum sickness due to fully human product. Enables opportunity to safely redose SAFETY EFFICACY LYMPHO- DEPELTION
SAB-142 Demonstrates a Comparable MOA to rATG, including Induction of Key T-cell Exhaustion Markers that have been Correlated with C-peptide Preservation in Prior rATG Studies Note: SAB-142: combined 1.5mg/kg and 2.5mg/kg dosed cohorts. Treg (CD3+ CD4+ CD127lo CD25+ FoxP3+) ± SEM Relative PD-1+ Tconv Cells ± SEM Increase in CD4 exhaustion Responders to low-dose ATG induce CD4+ T-cell exhaustion in type 1 diabetes - PubMed rATG Published Data: Placebo SAB-142 % of Pre-Infusion Day SAB-142 % of Pre-Infusion Placebo SAB-142 Day SAB-142 Treg preservation 1 2
SAB-142 Phase 1 Top-Line Data: SAB-142 Induces Operational Tolerance as Indicated by Single and Dual-Exhaustion Markers Note: SAB-142: combined 1.5mg/kg and 2.5mg/kg dosed cohorts. Placebo SAB-142 % of Pre-Infusion Day SAB-142 Tconv Median % Change from Baseline PDL-1/KLRG1 PD-1/TIGIT KLRG1/TIGIT D30 PBO SAB-142 D45 PBO SAB-142 D90 PBO SAB-142 D120 PBO SAB-142 200% 150% 100% SAB-142 CD4+ T Conv Cell Single Exhaustion Markers SAB-142 CD4+ T conv Cell Dual Exhaustion Markers Relative TIGIT+ Tconv Cells ± SEM SAB-142 induced sustained expression of inhibitory receptors (TIGIT+) on CD4+ T conv cells indicative of an exhausted phenotype SAB-142 induced persistent expression of co-inhibitory receptors on CD4+ Tconv cells 1 2
Transient Cytokine Increase Transient Lymphocyte Margination SAB-142: The Next Generation of Beta Cell Guardians Sustained Immunomodulation without Lymphodepletion Treg preservation & activation Initiation of memory phenotype shift Reprogramming Phase Sustained Immunomodulation Activation Phase Lymphocytes Activated Tregs T-Cell Exhaustion Signature Memory Shift Pharmacodynamic Profile of SAB-142: Mechanism of Action of SAB-142: Sustained T-cell exhaustion signature Supporting restoration of immune tolerance Cytokines SAB-142 Dosing
Rabbit ATG: De-Risked Mechanism of Action *Haller MJ, Long SA, Blanchfield JL, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Geyer SM, Warnock MV, Miller JL, Atkinson MA, Becker DJ, Baidal DA, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodriguez H, Russell WE, Wilson DM, Greenbaum CJ; Type 1 Diabetes TrialNet ATG-GCSF Study Group. Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data. Diabetes. 2019 Jun;68(6):1267-1276. TN-19: Low-Dose rATG* Preserved C-peptide in New Onset T1D 1 and 2 Years Post Treatment ATG Only – Mean & 95% CI Placebo – Mean & 95% CI 26 HbA1c Over Time by Treatment Group HbA1c (%[mmol/mol] Time on Study (months) ATG Only – Mean & 95% CI Placebo – Mean & 95% CI C-Peptide AUC Mean (nmol/L) (p=0.00005) Haller et al. Diabetes. 2019 Jun;68(6):1267-1276 Decline in C-peptide AUC Mean Over Time by Treatment Group (p=0.002) (p= 0.002) (p=0.011) TN-19 C-peptide, the cleavage product of proinsulin, released in equal amounts with insulin, reflects a person’s ability to produce endogenous insulin and is the standard biomarker of pancreatic β-cell function
Rabbit ATG: De-Risked Mechanism of Action MELD-ATG: Minimal Effective Low Dose of rATG* Preserved C-peptide in New Onset T1D 1 Year Post Treatment 27 ATG is the only mechanism of action that has consistently reproduced clinical data demonstrating preservation of C-peptide and improvements in glycemic control (Mathieu et al., Lancet. 2025 Sep 18:S0140-6736(25)01674-5) 2.5 mg/kg ATG 0.5 mg/kg ATG Placebo Change from baseline in mean In (AUC C-peptide +1), nmol/L per min Time since randomization (months) Change from baseline HbA1c (%) Decline in C-peptide AUC Mean Over Time by Treatment Group HbA1c Adjusted Mean Difference by Treatment Group (p=0·0028) (p=0.014) (p=0.11) (p=0.024) 2.5 mg/kg ATG 0.5 mg/kg ATG Placebo MELD-ATG replicated results from Haller’s TN19 study with ≤2.5 mg/kg with statistically significant C-peptide preservation and glycemic control MELD-ATG *Mathieu C, Wych J, Hendriks AEJ, Van Ryckeghem L, Tree T, Chmura P, Möller C, Casteels K, Danne T, Reschke F, Šmigoc Schweiger D, Battelino T, Johannesen J, Rami-Merhar B, Pieber T, De Block C, Evans M, Hilbrands R, Bosi E, Willemsen RH, Basu S, Pulkkinen MA, Knip M, Cnop M, Nitsche A, Schulte AM, Niemöller E, Peakman M, Wilhelm-Benartzi C, Gillespie D, Overbergh L, Mander AP, Marcovecchio ML; INNODIA. Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial. Lancet. 2025 Sep 18:S0140-6736(25)01674-5. doi: 10.1016/S0140-6736(25)01674-5. Epub ahead of print. PMID: 40976248.
Thymoglobulin’s Therapeutic and Dosing Profile is Superior to Tzield in Stage 3 T1D Patients* PHASE 3 (PROTECT) DATA PHASE 2 TN-19 and MELD DATA C-peptide Primary end point of C-peptide levels met at Month 18 Primary end point of C-peptide AUC met at Month 12 HbA1c Missed statistical significance Statistically significant at Month 12 Dosing Two courses of IV therapy: Each course is 12 days of consecutive IV therapy administered at Randomization and at Month 6 A single dose of IV administered over 2 days Patient Population Children and adolescents 8-17 years Adolescents and adults 12-45 years (TN-19) 5-25 years (MELD-ATG) Study Period 18 months 12 months Sample Size n = 200 on Tzield vs. 100 on placebo 29-34 on Thymoglobulin (per dose level) vs. 29-31 on placebo Statistically significant on C-peptide like Tzield Statistically significant on HbA1C where Tzield missed More Convenient Dosing Shown to work in Broader range of patients Required one course and less time to primary endpoint Superior statistically significant efficacy with smaller sample size ADVANTAGES * Not head-to-head studies.
FAQ
What did SAB Biotherapeutics (SABS) announce about SAB-142 in this 8-K?
What is SAB-142 and how is it intended to work in Type 1 diabetes?
What did the Phase 1 SAB-142 trial show in the adult T1D cohort?
How is the Phase 2b SAFEGUARD trial of SAB-142 designed?
What safety profile has SAB-142 shown so far in clinical testing?
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