SAB BIO Reports Q3 2026 Financial Results and Provides Business Highlights

Adult and adolescent SAFEGUARD cohorts are fully enrolled, while pediatric enrollment continues toward a Q4 2026 completion target.

Rhea-AI Summary

SAB BIO (Nasdaq: SABS) reported a third-quarter 2026 net loss of $22.3 million while advancing SAB-142 clinical studies in type 1 diabetes. The company reported net income of $45.4 million a year earlier. Research and development expenses rose to $18.1 million from $9.0 million, while general and administrative expenses increased to $7.8 million from $3.7 million.

Cash, cash equivalents and investment securities totaled $205.3 million at September 30; SAB BIO expects operational runway through 2028. Adult and adolescent enrollment in the registrational Phase 2b SAFEGUARD study is complete, with children ages 5–11 enrolling. The company targets full enrollment in Q4 2026 and topline data in the second half of 2027. SAB-142 received FDA Fast Track designation in October for new-onset Stage 3 type 1 diabetes. The Phase 3 PRISE-hATG study expects to dose its first patient in Q4 2026.

8 points · 0 major

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0 major · 5 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.$205.3 million in cash, cash equivalents and investment securities supports expected operational runway through 2028.
• Moderate point$13.4 million gross proceeds received in Q3 from exercises of previously issued warrants. 4.6% of market cap
• Moderate pointAdult and adolescent SAFEGUARD cohorts are fully enrolled and closed for screening.
• Moderate point. Forward-looking: it has not happened yet and may not happen.SAFEGUARD enrollment completion remains targeted for Q4 2026, with topline data expected in second-half 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 3 PRISE-hATG expects first-patient dosing in Q4 2026, with seven clinical sites planned.

3 minor points

• Minor pointPediatric enrollment ages 5–11 is active following the monitoring committee’s September 2026 approval.
• Minor pointFDA Fast Track designation granted in October 2026 for SAB-142 in new-onset Stage 3 type 1 diabetes.
• Minor point. Forward-looking: it has not happened yet and may not happen.PRISE-hATG could support a future SAB-142 label covering patients up to two years after diagnosis.

Negative

• Moderate pointQ3 net loss of $22.3 million compares with net income of $45.4 million in Q3 2025.
• Minor pointQ3 research and development expenses rose to $18.1 million from $9.0 million a year earlier.
• Minor pointQ3 general and administrative expenses increased to $7.8 million from $3.7 million a year earlier.
• Minor pointQ3 other income fell to $3.6 million from $58.1 million, primarily reflecting 2025 warrant-liability valuation changes.
• Minor pointPRISE-hATG co-funding commits SAB BIO funding alongside a Breakthrough T1D grant.

News Explained

SAB BIO received $13.4 million in gross proceeds during Q3 2026 from exercises of previously issued Enrollment Date and Data Release Date warrants tied to its July 2025 private-placement financing; the release does not state the number of shares involved.

Key Figures

Cash, cash equivalents and investment securities: $205.3 million R&D expenses: $18.1 million vs. $9.0 million G&A expenses: $7.8 million vs. $3.7 million +5 more

Cash, cash equivalents and investment securities

$205.3 million

At September 30, 2026; operational runway through 2028

R&D expenses

$18.1 million vs. $9.0 million

Three months ended September 30, 2026 vs. September 30, 2025

G&A expenses

$7.8 million vs. $3.7 million

Three months ended September 30, 2026 vs. September 30, 2025

Net loss / net income

$22.3 million net loss vs. $45.4 million net income

Three months ended September 30, 2026 vs. September 30, 2025

SAFEGUARD planned enrollment

Approximately 159 patients

Stage 3 T1D patients ages 5–40

SAFEGUARD enrollment completion

Q4 2026

Full enrollment expected

SAFEGUARD topline data

2H 2027

Expected timing

FDA Fast Track designation

October 2026

Granted to SAB-142 for new-onset Stage 3 T1D

Previous Earnings Reports

2 past events · Latest: Aug 06

Same Type 2 events

1. Aug 06

   Q2 2026 earnings report

   24h Move

   +2.1%

   Reported $208.0 million in cash and securities, runway through 2028, and SAFEGUARD enrollment on track.

2. Nov 13

   Q3 earnings report

   24h Move

   +4.5%

   Reported Q3 R&D of $9.0M and net income of $45.4M, the current release's year-ago comparators.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fast track designation, double-blind, placebo-controlled, dose-ranging

4 terms

fast track designation regulatory

"In October 2026, the U.S. Food and Drug Administration (FDA) granted Fast Track designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

double-blind medical

"a randomized, double-blind, placebo-controlled multi-center Phase 2b study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"a randomized, double-blind, placebo-controlled multi-center Phase 2b study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

dose-ranging medical

"Part B is a randomized, double-blind, placebo-controlled, dose-ranging study"

A dose-ranging study is a clinical trial that tests multiple amounts of a drug to find what dose works best and is safest, much like trying different spice levels in a recipe to get the right balance. For investors, results clarify whether a medicine is effective at practical doses, how likely it is to win regulatory approval, what side effects to expect, and how the treatment might be priced and used in the market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Adult and adolescent cohorts fully enrolled in registrational SAFEGUARD study of SAB-142; Pediatric cohort (ages 5–11) actively enrolling with overall enrollment on track for completion in Q4 2026

Received FDA Fast Track designation for SAB-142 in new-onset Stage 3 T1D

Operational runway through 2028 to support registrational clinical development and pre-commercial activities of SAB-142 for Stage 3 T1D

Conference call today at 8:30 AM ET

MIAMI, Nov. 05, 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 third quarter ended September 30, 2026, and provided business highlights.

“We made solid progress advancing SAB-142 during the third quarter, driven by continued enthusiasm for the SAFEGUARD study. With the pediatric stepdown approved in September and our adult and adolescent cohorts fully enrolled and closed for screening, we remain on track to complete enrollment in the fourth quarter,” said Samuel J. Reich, Chief Executive Officer of SAB BIO. “The FDA's recent Fast Track designation is another important milestone, recognizing the significant unmet need in newly diagnosed Stage 3 type 1 diabetes and providing an opportunity for closer collaboration with the agency as we advance SAB-142 through clinical development. Our priorities are clear: complete SAFEGUARD enrollment, execute our clinical and regulatory strategy, and advance toward topline data in the second half of 2027. We believe SAB-142 has the potential to meaningfully change the treatment of type 1 diabetes, and we are focused on delivering on that promise.”

Recent Pipeline Achievements and Anticipated Milestones for SAB-142

Registrational Phase 2b SAFEGUARD study (NCT07187531)

• Adult and adolescent cohorts in SAFEGUARD are fully enrolled and closed for screening, with pediatric patients ages 5–11 actively enrolling.
  • In September 2026, the SAFEGUARD Study Data Monitoring Committee (DMC) approved the final stepdown, expanding enrollment to pediatric patients.
  • Enrollment continued to accelerate in Q3, and the pediatric stepdown is expected to further support enrollment.
• Over 60 clinical sites are actively enrolling across U.S., Australia, New Zealand, U.K. and European Union.
• The SAFEGUARD study will enroll approximately 159 Stage 3 T1D patients (ages 5-40) within 100 days of diagnosis.
  • Part A, a dose-ranging study in 12 adult T1D patients, completed enrollment in Q1 2026.
  • Part B is a randomized, double-blind, placebo-controlled, dose-ranging study enrolling approximately 147 pediatric, adolescent and adult T1D patients.
• SAFEGUARD is on track for full enrollment in Q4 2026 with topline data expected in 2H 2027.

Phase 3 PRISE-hATG study (NCT07670650)

• The PRISE-hATG study expects to dose the first patient in Q4 this year.
  • Seven clinical sites are planned across the United States, Europe and UK.
• This investigator-led study is funded through a grant from Breakthrough T1D and co-funded by SAB BIO.
  • The principal investigator of the study is Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida.
  • European co-principal investigators on the study are Prof. Dr. Chantal Mathieu at Katholieke Universiteit Leuven and UZ Leuven in Leuven, Belgium; Professor Tim Tree in the Department of Immunobiology at King’s College London, UK; and Dr. Loredana Marcovecchio at the University of Cambridge in Cambridge, UK.
• 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

• FDA Fast Track designation for SAB-142: In October 2026, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to SAB-142 for treatment of new-onset Stage 3 T1D. Fast Track designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need and to help bring important new treatments to patients earlier.  
  

Upcoming Events
SAB BIO plans to participate in the following investor events:

• UBS Global Biopharma Conference
  • Date: November 16-17, 2026
  • Location: London, United Kingdom
• Jefferies Global Healthcare Conference
  • Date: November 16-19, 2026
  • Location: London, United Kingdom
• 9th Annual Evercore Healthcare Conference
  • Date: November 30-December 2, 2026
  • Location: Coral Gables, FL
• Citi Global Healthcare Conference
  • Date: December 1-3, 2026
  • Location: Miami, FL

Q3 2026 Financial Highlights

• Cash Position: Cash, cash equivalents, and investment securities of $205.3 million at September 30, 2026, providing operational runway through 2028. This total includes $13.4 million in gross proceeds received in the third quarter from exercises of previously issued Enrollment Date and Data Release Date warrants from the July 2025 private placement financing.
• R&D Expenses: Research and development (R&D) expenses of $18.1 million and $9.0 million for the three months ended September 30, 2026, and September 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. R&D expenses include non-cash stock-based compensation expense of $3.9 million and $0.5 million for the three months ended September 30, 2026 and 2025, respectively.
• G&A Expenses: General and administrative (G&A) expenses of $7.8 million and $3.7 million for the three months ended September 30, 2026, and September 30, 2025, respectively. The increase is primarily driven by personnel related costs, including non-cash stock-based compensation. G&A expenses include non-cash stock-based compensation expense of $3.6 million and $0.3 million for the three months ended September 30, 2026 and 2025, respectively.
• Other income (expense): Other income of $3.6 million and $58.1 million for the three months ended September 30, 2026, and September 30, 2025, respectively. The decrease primarily reflects the change in fair value of warrant liabilities recognized in 2025.
• Net income (loss): Net loss of $22.3 million and net income of $45.4 million for the three months ended September 30, 2026, and September 30, 2025, respectively.
  

Webcast and Conference Call Information
SAB BIO will host a conference call to discuss its third quarter financial results and provide business updates on Thursday, November 5, 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-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 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 PRISE-hATG
Personalized 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 (up to 2 years) after diagnosis. 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 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 being evaluated in two clinical trials: the registrational Phase 2b SAFEGUARD study for those newly diagnosed with Stage 3 T1D and the investigator-led Phase 3 PRISE-hATG study for people up to two years following a Stage 3 T1D diagnosis. 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 expected timing of completion of enrollment and topline data for the SAFEGUARD study, the expected timing of first patient dosing in the PRISE-hATG study, the potential benefits of Fast Track designation for SAB-142, and the Company’s expected cash runway.

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. For example, Fast Track designation may not result in a faster development process, review or approval and does not increase the likelihood that SAB-142 will receive marketing approval. 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
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does SAB BIO expect SAFEGUARD enrollment and topline results?

SAB BIO expects full enrollment in Q4 2026 and topline data in the second half of 2027. Adult and adolescent cohorts are fully enrolled and closed for screening, while pediatric patients ages 5–11 are actively enrolling.

How long does SAB BIO expect its Q3 2026 cash position to fund operations?

SAB BIO expects its $205.3 million in cash, cash equivalents and investment securities at September 30, 2026, to provide operational runway through 2028. The balance includes $13.4 million in gross proceeds received during the quarter from exercises of previously issued warrants.

How is SAB BIO’s SAFEGUARD trial structured?

SAFEGUARD plans to enroll approximately 159 patients ages 5–40 within 100 days of Stage 3 type 1 diabetes diagnosis. Part A completed enrollment of 12 adults in Q1 2026. Part B is a randomized, double-blind, placebo-controlled dose-ranging study enrolling approximately 147 pediatric, adolescent and adult patients.

Who can enter SAB BIO’s SAFEGUARD extension study?

All SAFEGUARD patients, including placebo recipients, with residual beta cells at 12 months are eligible for the 12-month efficacy and safety extension after completing Parts A and B. In the initial study, participants receive two SAB-142 or placebo infusions six months apart.

What drove SAB BIO’s higher operating expenses in Q3 2026?

Higher clinical trial costs and related staffing primarily drove research and development expense growth, while personnel costs primarily drove general and administrative expense growth. Non-cash stock-based compensation included in those categories was $3.9 million and $3.6 million, respectively, versus $0.5 million and $0.3 million in Q3 2025.