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Investor releaseQuarter not tagged2026-05-13SAB Biotherapeutics Inc (SABS) Q1 2026 Earnings Call Highlights: Strategic Advances Amid Rising ...
GuruFocus.com
SAB Biotherapeutics Inc (SABS) Q1 2026 Earnings Call Highlights: Strategic Advances Amid Rising ...
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 sa...
Investor releaseQuarter not tagged2026-05-13SAB Biotherapeutics Q1 Earnings Call Highlights
MarketBeat
SAB Biotherapeutics Q1 Earnings Call Highlights
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...
Investor releaseQuarter not tagged2026-05-12SAB BIO Reports Q1 2026 Financial Results and Recent Business Highlights
GlobeNewswire
SAB BIO Reports Q1 2026 Financial Results and Recent Business Highlights
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...
TranscriptFY2026 Q12026-05-12FY2026 Q1 earnings call transcript
Earnings source - 52 paragraphs
FY2026 Q1 earnings call transcript
Good morning, welcome to the SAB BIO's conference call to discuss first quarter 2026 financial results and business updates. Listeners are invited to review the full text of the forward-looking statements from the morning's quarterly earnings press release. Company management may provide projections during the call and actual results could differ materially due to several factors, including those outlined in the company's latest filings with the SEC. Currently, all participants are in a listen-only mode. Following management's remarks, we will open the call for questions. This call is being webcast live and can be accessed on the investor section of SAB BIO's website at ir.sab.bio, where a replay will be available. I'll now turn the call over to Samuel Reich, Chief Executive Officer of SAB BIO.
Thank you, Operator. Good morning. Thank you to everyone joining us for our first earnings call. We are excited to have you with us to share the progress our team has made in the first quarter, progress that sets a strong foundation for the rest of 2026. For those of you who may be new to our story, let me take a moment to introduce SAB BIO, our mission, and our focus. SAB BIO is a clinical stage biopharmaceutical company focused on developing fully human anti-thymocyte immunoglobulin for type 1 diabetes and other autoimmune diseases. 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. Our lead product candidate, SAB-142, is a potentially disease-modifying re-dosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes.
We produce SAB-142 using our proprietary Tc-Bovine platform, which allows us to generate fully human immunoglobulin without the need for human donors. SAB-142 works by directly targeting multiple immune cells involved in destroying insulin-producing beta cells. Its mechanism of action has been clinically validated in numerous clinical trials with rabbit anti-thymocyte globulin. We have generated highly positive phase I data demonstrating encouraging efficacy signals and a validated mechanism of action with sustained immunomodulation. SAB-142's phase I data showed early C-peptide signals demonstrating beta cell preservation and a favorable safety profile, resulting in no serum sickness and low or no immunogenicity, allowing for chronic re-dosing. Following these results, we advanced SAB-142 into a registrational phase II-B trial called SAFEGUARD, which was initiated last year, with the first patient dosed in December.
We believe SAB-142 has the potential to fundamentally change how type 1 diabetes is treated and address a major unmet medical need. In the U.S., there are over 2 million people diagnosed with Stage 3 or symptomatic type 1 diabetes and approximately 64,000 patients newly diagnosed each year. Now to the first quarter update. I'm thrilled with the progress our team has made this quarter. We executed on every front, and we're standing on business. The momentum is real, and it's building. Here's how. Starting with the SAFEGUARD trial, enrollment is progressing on schedule and remains on track to be completed by the end of this year, with top-line data expected in the second half of 2027. We are continuing to activate multiple clinical trial sites across the U.S., Australia, New Zealand, the U.K., and the European Union.
To remind everyone on the call, the SAFEGUARD trial will enroll a total of 159 Stage 3 type 1 diabetes patients between the ages of five and 40, all within 100 days of diagnosis. It is structured in two parts. Part A, our dose ranging study in 12 adult patients, completed enrollment during the first quarter, representing a notable milestone. Part B, our randomized double-blind, placebo-controlled study enrolling 147 pediatric, adolescent, and adult patients, was initiated in the first quarter and is actively enrolling now. Additionally, our study data monitoring committee recently approved the first step down to enroll patients ages 12 and older. The pace of enrollment and the enthusiasm from investigators reinforces the urgent and unmet need in the type 1 diabetes community for therapies that go beyond insulin management to actually address the underlying autoimmune disease.
Another significant highlight this quarter was that we received written correspondence from the FDA confirming that C-peptide may serve as a surrogate endpoint for accelerated approval. This represents a meaningful de-risking of our regulatory path. This written confirmation gives us greater confidence and clarity as we execute SAFEGUARD and plan our path to market. We also recently shared new findings from SAB-142's phase I study at the Immunology of Diabetes Society Congress. The data presented highlighted SAB-142's mechanism of action, along with demonstrating that the mechanism translates into clinical benefit for people with type 1 diabetes. The phase I data for SAB-142 showed preservation of C-peptide levels correlated with evidence of T-cell exhaustion. Of the four SAB-142 treated participants, three demonstrated a super responder profile with C-peptide levels at or above baseline at day 120.
Those treated participants showed improved glycemic control, with mean time and range increasing from 73% at baseline to 85% at day 120 without an associated increase in exogenous insulin use. While early and exploratory, these results are encouraging and further build confidence as we advance SAB-142 in the SAFEGUARD trial. For more details, you can explore the full data presentation on our website. Finally, on the business side, on April 29th, we executed a multi-year agreement with Emergent BioSolutions to support the process development as well as clinical and commercial manufacturing of SAB-142 in anticipation of regulatory approval.
This agreement positions us to scale manufacturing in support of a potential commercial launch. We are confident having such a capable and experienced partner like Emergent in place as we advance towards that milestone. With that, I'll turn the call over to Lucy To, our Chief Financial Officer, to review our first quarter earnings and financial updates.
Thanks, Sam. We ended the first quarter with $217.6 million in cash equivalents, and available for sale securities as of March 31st, 2026. The strong cash position provides us with an operational runway through 2028, fully supporting the execution of SAFEGUARD and our pre-commercial activities. Contrasting to this position was our public offering that was completed in March. Following the initial closing, the underwriters exercised their overallotment option, resulting in aggregate gross proceeds of approximately $95 million. We are well capitalized and well-positioned to execute our plan. Our R&D expenses were $13.4 million for the first quarter of 2026, compared to $7.7 million for the same period in 2025. The increase is driven by the ongoing investments made to advance the SAB-142 program in the SAFEGUARD trial, including site activation and patient enrollment.
This is exactly where we expect to be investing. G&A expenses were $6.6 million for the first quarter of 2026, compared to $3.1 million for the same period in 2025. The increase was primarily driven by higher non-cash stock-based compensation expenses and personnel-related costs associated with our expanded team. As we scale, these investments in our operational foundation are necessary and expected. Other income was $1.1 million for the first quarter of 2026, compared to $5.6 million for the same period in 2025.
This decrease was driven by the change in fair value of warrant liabilities. As a result of these factors, net loss was $18.9 million for the first quarter of 2026, compared to $5.2 million for the same period in 2025. The financial results reflect a company that has the resources, discipline, and runway to see SAFEGUARD through to completion and to begin building toward commercial readiness. With that, I can turn it back over to Sam for closing remarks before we open the call up for questions.
Thanks, Lucy. To close, I want to reiterate how much we believe in the mission we are pursuing. Type 1 diabetes affects millions of people globally, and today the standard of care is insulin, which treats the symptoms but does not address the underlying disease. SAB-142 has the potential to change that and transform what it means to have a type 1 diabetes diagnosis. We entered 2026 with a clear plan, and we are executing against it. Part A of SAFEGUARD is fully enrolled. Part B is underway. Our cash runway is secured through 2028.
Our regulatory path has been de-risked. We have a lot of work ahead of us, but we are exactly where we need to be, and we are focused on what matters most, completing SAFEGUARD enrollment and advancing SAB-142 toward the patients who need it. We are grateful for the support of our investors, our investigators, our patients, and our team. We look forward to continuing to update you on our progress. With that, we're ready to take any questions.
Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question comes from Michael Yee with UBS. Please state your question.
Hey, guys. This is Matt on for Mike. Thank you so much for taking our question. I wanted to ask if you could talk a little bit about mechanistically how SAB-142 and ATG probably is differentiated from CD3 antibodies, and how this translates to both clinical activity and safety tolerability, especially as it relates to immunodepletion and immunomodulation. Just how these work overall. That'd be great. Thank you so much.
Well, the anti-CD3 antibody is monoclonal, so it has a singular effect on one target. When that drug gets into the range at which it's inducing exhaustion, it also has an impact on Tregs, which can be a counterproductive mechanism, which works against T cell exhaustion. Tregs are essential for self-tolerance, and having a negative impact on Tregs will have a negative impact on the patient's autoimmune condition. The both Thymoglobulin, which is rabbit anti-thymocyte globulin, as well as SAB-142, which is human anti-thymocyte globulin, are able to be dosed because they're polyclonal and because they are binding multiple targets across the spectrum of T cells, we're able to induce T cell exhaustion at a very low dose in which Tregs are preserved or possibly even activated.
That is a cumulative benefit with the polyclonal approach rather than kind of a counterproductive effect, which happens, which appears to happen with anti-CD3. We believe that will lead to better clinical outcomes. I think something that's very important with the human anti-thymocyte globulin is that there's no immunogenicity and no serum sickness. We showed in phase I that we can safely redose and initiate that exhaustion. Another advantage which is unique to our drug in comparison to both Tzield as well as Thymoglobulin, is that we can safely chronically dose the patients, maintain exhaustion, and hopefully maintain preservation of beta cells indefinitely.
Does that answer your question, Michael?
That's great. Thank you so much.
The next question comes from Iris Gao with Guggenheim. Please state your question.
Hi. Good morning. This is Iris on for Yatin. Congratulations on the progress, and thank you for taking my questions. My first question is really quick. Like, would you plan to disclose the Part A data ahead of Part B? My second question is, like, I wonder if there is a pattern in the four patients from phase I that could probably guide the design of indication expansion studies into established type 1 diabetes patients. Thank you.
Sure. At this time, we don't have any plans on releasing patients from Part A. That's not in our current plans right now, we're not guiding to that. Your second question, certainly. The four patients dosed in phase I were mature patients. They had had the disease for two years or more. In that patient population, we showed the desired effect, a very exciting outcome. That does certainly provide support for this disease being effective in more mature patients, which we do intend to pursue. That certainly expands our addressable market if we're able to capture that label, which we hope to.
Got it. Thank you very much.
You're welcome.
Our next question comes from Thomas Smith with Leerink Partners. Please state your question.
Hey, guys. Good morning. Congrats on the progress, thanks for taking our questions. With respect to the written correspondence from FDA confirming C-peptide may be used as a surrogate endpoint for accelerated approval, obviously encouraging feedback. Can you just elaborate on the timing and the path for receiving that feedback and how this correspondence is similar or different from the feedback you received last year when you initiated SAFEGUARD?
Well, we have developed the SAFEGUARD study in our clinical regulatory plan along with correspondence with the FDA. This is a very important program to SAB, and so we believe we have full alignment and are very confident in our plan. Generally, our correspondence with FDA are written. You know, we updated as stated in that, in the last response. We did receive confirmation that C-peptide is sufficient endpoint for an accelerated approval. You know, we've developed SAFEGUARD and continued to work on our clinical regulatory plan with alignment with FDA and with confidence we're moving forward, you know, with the following the expectations of the agency.
Got it. That's encouraging. With respect to SAFEGUARD enrollment progress, nice to see Part A enrolled and the DMC approved the step-down to patients 12 and older. Can you just walk us through the path from here on Part A? What's sort of the process and expected timing for potentially stepping down to dosing children five and older? Thanks so much.
You're welcome. We expect to step down to patients five and older in the coming months. As we mentioned, we have stepped down to 12 and above, which is a great first step. We continue to, you know, look at safety out of the patients and follow the same path that we did to get to 12. As patients come in 12 and up and we collect enough patients, then we'll step down to five and older, and we-
Thank you. Our next question comes from Albert Lowe with Craig-Hallum. Please state your question.
Hi. Thanks. Maybe along the lines of what you were just saying, can you tell us a little bit more about what kind of data the study data monitoring committee got to see to approve the step-down?
Yes. The data monitoring committee decision is based on Part A safety data up to four weeks from randomization, so essentially looking at four weeks of safety data of those 12 patients. Based on that safety review, they approved opening enrollments to patients 12 and older.
Great. Thank you.
Our next question comes from Emily Bodnar with H.C. Wainwright. Please state your question.
Hi. Good morning. Thanks for taking the question. Maybe given the type 1 diabetes cohort from your phase I, where three of the patients had increased C-peptide at the end of the study, can you kind of walk through your thinking for if this is something you can feasibly show in the SAFEGUARD trial, or is your baseline just to show preserved C-peptide? Thanks.
Well, the expectation when we take a mean change in baseline from a larger group of patients with a from adults to adolescents and pediatrics, is to preserve C-peptide. Our goal is to preserve C-peptide. The fact that we had these super responders that increased C-peptide is very exciting and, you know, we're certainly thrilled that we got that result, which is evidence of the therapeutic effect that we propose that our drug has. When we look at a larger group of patients over a longer period of time, the goal is to show preservation, and we'll certainly be very happy if, you know, patients at one year have their C-peptide the same as it was when they started. That's the goal.
Great. Thanks.
Our next question comes from Leland Gershell with Oppenheimer & Co. Please state your question.
Yeah. Hey. Presuming success in SAFEGUARD, I wanted to ask if you could share your thoughts on further development plans, you know, for the pivotal program toward the FDA application. To what extent might you include repeat dosing, given, you know, the presumed advantage over rabbit ATG in terms of safety with repeat doses of 142? Thanks.
We hope chronic dosing will get into our label. The patients in the SAFEGUARD study are getting at least two doses. The long-term extension study allows every patient in every group, if they complete their 12-month visit and still have some C-peptide, to continue and get four doses. There will be data in the package which has some number of patients having gotten four doses and followed for two years. We hope that that's sufficient for chronic dosing on the label and for patients to be able to get this drug chronically and preserve C-peptide for many years.
Thank you. Our next question comes from Kumar Raja with Brookline Capital Markets. Please state your question.
Yeah. Good morning. Thanks for taking my questions. With regard to this 159 patients, how do you think it will split in terms of, you know, geographies where you'll be recruiting? You know, I just want to get a sense, how many patients would be here from the U.S. Thank you.
We have a substantial number of sites in the U.S., and we expect to have 20% or more of the patients enrolled in the U.S. 60% or so in Europe, based on the number of sites we have in Europe, and then the rest in Australia. Well, I'm counting U.K. in Europe, so U.K. and Europe. Based on the number of sites and the enrollment to date, we would expect to have 20% or more of the patients be U.S.-based.
Okay. Great. You made comments about feedback from the FDA. Can you share, you know, what kind of feedback you got from other regulatory agencies? Is the expectation very similar from EMA too? Thank you.
Yeah, I mean, I think it's consistent across the board. You know, we're not really sharing the intricate details of all the different things we've heard from the different agencies, but we're confident that we have alignment and, you know, there's similar feedback across the agencies.
Okay. Will you be pursuing accelerated approval process in the other regions too? Thank you. I'm all through.
I think it's a little too early to say, although what I will say is that we plan on, you know, seeking approval globally for this product or at least in the U.S., Europe, and other agencies. You know, our focus and our priority is the U.S., but this is a global program where we will eventually, you know, go to have the drug commercial globally.
Thank you. Our next question comes from Iris Gao with Guggenheim. Please state your question.
Yeah. Thank you very much for taking my question again. A quick one. Can you double-click on the scale of the manufacturing agreement with Emergent BioSolutions? Like how many doses could they supply post-commercialization? Thank you.
Well, we're currently planning to be able to supply the market, in year one with Emergent. In terms of specific number of doses, I don't think we've disclosed that to date. 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.
Great. Thank you.
Ladies and gentlemen, that concludes the question and answer session and the conference call of SAB BIO. Thank you for your participation. You may now disconnect your lines.
Investor releaseQuarter not tagged2026-05-05SAB BIO to Host First Quarter 2026 Financial Results Conference Call and Webcast on May 12, 2026, 08:30 AM ET
GlobeNewswire
SAB BIO to Host First Quarter 2026 Financial Results Conference Call and Webcast on May 12, 2026, 08:30 AM ET
MIAMI, May 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 that its first quarter 2026 financial results will be issued in the morning of Tuesday, May 12, 2026. Management will host a conference call and webcast at 8:30 AM ET to discuss the results and provide business updates. To access the live conference call, participants may register here. Conference Details: Conference Date: Tuesday, May 12, 2026 Conference Time: 8:30 AM ET Conference Dial-in: 1-877-704-4453 International Dial-in: 1-201-389-0920 Conference ID: 13760144 Conference Call Name: SAB BIO’s Q1 2026 Earnings Call Following the conference call, a replay of the audio webcast will be available under the Investors & Media section of the Company’s website at ir.sab.bio. 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. CONTACTS Investors: Christine Ryan [email protected] Media: Sheila Carlson [email protected]
Investor releaseQuarter not tagged2026-03-10SAB BIO Reports Full Year 2025 Financial Results and Business Highlights
GlobeNewswire
SAB BIO Reports Full Year 2025 Financial Results and Business Highlights
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...
Investor releaseQuarter not tagged2025-12-17SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D
GlobeNewswire
SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D
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. Un...
Investor releaseQuarter not tagged2025-11-14SAB BIO Reports Third Quarter Financial Results and Recent Business Highlights
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SAB BIO Reports Third Quarter Financial Results and Recent Business Highlights
Initiated registrational Phase 2b SAFEGUARD trial of SAB-142 in new-onset, Stage 3 autoimmune T1D patients Multiple SAFEGUARD trial sites activated; on-track to dose first patient by year-end Recent data presented at EASD and IPSAD provide further validation for SAB-142 as a novel, potentially best-in-class, disease-modifying, immunotherapeutic approach to redefine treatment of Stage 3 T1D Strong cash position with operational runway through 2028, enabling completion of registrational Phase 2b SAFEGUARD study MIAMI, Nov. 13, 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 financial results for the third quarter ending September 30, 2025, and provided business highlights. “We made significant progress this quarter, specifically executing on our clinical plans, and I am pleased that we initiated the registrational Phase 2b SAFEGUARD study of our lead candidate SAB-142. We have activated multiple sites around the world, and we are on-track to dose the first patient by year-end,” said Samuel J. Reich, Chairman and CEO, SAB BIO. “This quarter, we also showcased the results of our Phase 1 study in multiple presentations at EASD and ISPAD. These data, including a favorable safety profile and a competitive dosing regimen, continue to support the development of SAB-142 as a novel, potentially best-in-class, disease-modifying, immunotherapeutic approach for the treatment of Stage 3 T1D. We look forward to sharing additional Phase 1 data, including redosing data, later this year.” Recent Highlights and Achievements SAFEGUARD Initiated 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 onset or progression of disease. Activated multiple clinical trial sites in the US, Australia, and New Zealand. Enrollment is ongoing, and the Company is on-track to dose the first patient by year-end. The Company previously aligned with the U.S. Food and Drug Administration (FDA) on the design and advancement of the SAFEGUARD Phase 2b trial as a registrational trial following a c...
Investor releaseQuarter not tagged2025-08-07SAB Biotherapeutics, Inc. (SABS) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release
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SAB Biotherapeutics, Inc. (SABS) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release
SAB Biotherapeutics, Inc. (SABS) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.82 per share in its upcoming report, which represents a year-over-year change of -3.8%. Revenues are expected to be $0.5 million, up 92.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 9.57% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings E...
Investor releaseQuarter not tagged2025-08-07SAB BIO Reports Second Quarter Financial Results and Highlights Company Updates
GlobeNewswire
SAB BIO Reports Second Quarter Financial Results and Highlights Company Updates
Recently raised $175 million in oversubscribed private placement which included strategic investor Sanofi and top-tier biotech investors Strong cash position with completed financing extending operational runway until the middle of 2028 Achieved alignment with FDA on the design and advancement of Phase 2b SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) study following a constructive Type B meeting SAFEGUARD study to initiate in Q3 2025 MIAMI, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of autoimmune type 1 diabetes (T1D), today announced financial results for the second quarter ending June 30, 2025, and reported on recent developments. Samuel J. Reich, Chairman and CEO of SAB BIO, stated, “We are extremely pleased to have recently raised $175 million in capital with oversubscribed participation which will enable us to fully fund the completion of our pivotal Phase 2b SAFEGUARD study for our lead candidate, SAB-142 for delaying the progression of type 1 diabetes. The proceeds will also extend our runway for another three years. This financing included not just the most well-known, top-tier investors in biotech but also the strategic investor Sanofi.” Mr. Reich continued, “Our recently completed financing is a testament to the strength of our science and the compelling and positive Phase 1 data shared in January. We look forward to advancing our novel disease-modifying multi-specific therapy, SAB-142, into a pivotal Phase 2b study in the third quarter of 2025 and moving us closer to potentially offering a disease-modifying therapy for patients with Stage 3 type 1 diabetes, the clinical diagnostic stage where patients start to exhibit symptoms.” Recent Corporate Highlights On July 21, 2025, the Company announced that it entered into a securities purchase agreement (the “Agreement”) with certain accredited and institutional investors to raise $175 million upfront in gross proceeds in an oversubscribed private placement financing. Proceeds are expected to fully fund completion of a pivotal SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune T1D in newl...
Investor releaseQuarter not tagged2025-05-09SAB BIO Announces Q1 2025 Financial Results and Provides Company Updates
GlobeNewswire
SAB BIO Announces Q1 2025 Financial Results and Provides Company Updates
MIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced financial results for the quarter ending March 31, 2025, and reported on recent developments. Samuel J. Reich, Chairman and CEO of SAB BIO, stated, “We have made strong progress this quarter on our corporate strategy and mission to deliver a transformational therapy that can halt or delay the progression of type 1 diabetes. Based on our recent positive Phase 1 topline data for SAB-142, we have seen accelerating momentum across the T1D landscape regarding the therapeutic potential of SAB-142.” Recent Pipeline Developments In April 2025, SAB BIO concluded patient dosing in the last cohort of the Phase 1 clinical study of SAB-142. Corporate Updates from Q1 2025 FY 2024 budget initiatives are now contributing to cost savings focusing on improvements to the Company’s manufacturing processes for scaled-batch manufacturing. The Company anticipates these initiatives will contribute to continued efficiencies across the Company’s financial performance in 2025. The Company has successfully obtained a Qualified Person (QP) declaration for SAB BIO’s in-house CMC manufacturing process for SAB-142. This milestone represents a key cGMP compliance achievement enabling SAB BIO to meet European manufacturing standards for an investigational medical drug product (IMPD) designated for upcoming clinical trials in the EU. Q1 2025 Financial Results SAB BIO held cash and equivalents of $12.9 million as of March 31, 2025, compared to $20.8 million as of December 31, 2024. R&D expenses were $7.7 million and $8.1 million for the three months ended March 31, 2025 and March 31, 2024, respectively. The modest decline resulted from the fluctuation of priority spending for the SAB-142 program, a disease-modifying human hIgG aimed at preventing onset or disease progression of T1D. General and administrative expenses were $3.1 million and $4.2 million for the three months ended March 31, 2025 and March 31, 2024, respectively. This decrease was driven by reduced payroll related costs and professional fees in order to prioritize the Company’s continued research activities and developme...
Investor releaseQuarter not tagged2025-03-31SAB BIO Reports Full Year 2024 Operating and Financial Results
GlobeNewswire
SAB BIO Reports Full Year 2024 Operating and Financial Results
SAB-142 Phase 1 trial positive topline data announced at KOL event MIAMI, March 31, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced financial results for the fourth quarter of 2024 in addition to its full year financial results for the fiscal year ended December 31, 2024, and reported on recent accomplishments and anticipated milestones. Samuel J. Reich, Chairman and CEO of SAB BIO stated, “Our recent announcement of positive topline data for SAB-142, further strengthens our belief that SAB-142 has the potential to be the best in-class disease-modifying therapy for T1D. We are well-positioned to continue our positive momentum in 2025 as we advance our development program and begin enrolling patients into a Phase 2b trial for SAB-142. Moving forward, we will be focused on building strong development partnerships that help advance our autoimmune pipeline as we look to announce further data readouts in 2025.” Recent Pipeline Developments On January 28, 2025, SAB BIO announced positive topline data from Phase 1 clinical trials of SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of Type 1 Diabetes. The study met its primary objectives in healthy volunteers related to safety and pharmacodynamic activity. The trial enables SAB-142 to advance to Phase 2b clinical development which is anticipated to initiate mid-year 2025. SAB BIO hosted a virtual R&D event also on January 28, 2025, to discuss the topline results and featured presentations from SAB BIO’s management team and T1D Key Opinion Leader (KOL) Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology. A replay of the event can be accessed at this link or through the Events section of the SAB BIO company website. On May 21, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) provided clearance for the Company’s investigational new drug (IND) application to proceed with a Phase 1 clinical trial (the HUMAN trial – fully HUman anti-thymocyte biologic in first-in-MAN clinical...