SAB Biotherapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 12, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 12, 2026
SABS$3.03+3.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-280572
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-218195
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 90 previous paragraphs and 71 current paragraphs.
38 unchanged; 23 reworded; 9 added; 24 removed; 5 previous and 1 current paragraphs rearranged.
Tables are not compared: 16 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Our proprietary platform holds the potential to generate additional novel therapeutic candidates to expand our pipeline, utilizing the human immune response to generate the optimal repertoire of hIgG for drug targets of interest. Our drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders and address a wide range of serious unmet needs in human diseases.
Current report
There is an established regulatory path for T1D indications using the SAB-142 modality. Our regulatory pathway has also been established with the United States Food and Drug Administration (FDA), the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), and the Therapeutic Good Administration (TGA) in Australia. The FDA regulates polyclonal hIgG and mAbs differently, as mAbs are regulated through the Center for Drug Evaluation and Research (CDER) while pAbs are regulated by the Center for Biologics Evaluation and Research (CBER). CBER has approved more than 30 immunoglobulin products from both human- and animal-derived plasma. Further, CBER is very familiar with our production platform and pAb products. We have navigated three SAB drug products through seven clinical trials with one product having advanced to Phase 3, building our safety database as well as positive efficacy data. As our lead program SAB-142 advances, we intend to expand our pipeline in complementary indications through strategic utilization of our platform.
Current report
We received an Investigational New Drug (IND) clearance from the FDA in May 2024 and announced positive topline data from our Phase 1 clinical trial of SAB-142 in January 2025, and December 2025. We initiated our pivotal Phase 2b clinical trial, called the SAFEGUARD study, in Q3 2025 and dosed the first patient in December 2025 with enrollment ongoing across multiple clinical trial sites in U.S., Australia, New Zealand, U.K. and European Union. Further, we are planning an additional clinical study of SAB-142 in individuals with T1D beyond 100 days of diagnosis.
Current report
In March 2026, we announced additional Phase 1 data demonstrating early signals of C-peptide preservation in adult patients with established autoimmune T1D, consistent with SAB-142's anticipated mechanism of action. In April 2026, we presented additional clinical and mechanistic data from our Phase 1 clinical trial of SAB-142 in adult patients with established autoimmune 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 participants with established T1D (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 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. The results for SAB-142 highlighted C-peptide preservation, 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. SAB-142 treated participants showed improved glycemic control, with mean time in range increasing from 73% at baseline to 85% at Day 120, without an associated increase in exogenous insulin use.In May 2025, SAB confirmed its intent with the FDA to utilize the data from the SAFEGUARD study as supportive evidence for future regulatory approval. In April 2026, we received written correspondence from the FDA confirming that C-peptide area under the curve (AUC) may serve as a surrogate endpoint for accelerated approval.
Current report
In May 2025, we confirmed our intent with the FDA to utilize the data from the SAFEGUARD study as supportive evidence for future regulatory approval. In April 2026, we received written correspondence from the FDA confirming that C-peptide area under the curve (AUC) may serve as a surrogate endpoint for accelerated approval.
Current report
Nonoperating Income (Expense)
Current report
Non-operating Income (Expense)
Current report
Total other non-operating income, not including interest income and interest expense, decreased by $5.4 million, or (97.41)%, in the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This decrease was primarily driven by the change in fair value of warrant liabilities (year-over-year decrease of $5.5 million, (109.58)%). Total other income increased by $0.1 million, primarily driven by an increase in dividend income (year-over-year increase of $0.4 million, 361.0%), offset by a decrease in the Australian research and development tax credit (year-over-year decrease of $0.3 million, 76.4%).
Current report
On March 17, 2026, we entered into the March 2026 Public Offering with the underwriters, pursuant to which we agreed to issue and sell, in the March 2026 Public Offering, (i) 19,324,677 Firm Shares at a public offering price of $3.85 per share and (ii) Pre-Funded Warrants to purchase up to 2,753,246 shares of common stock at a public offering price of $3.8499 per Pre-Funded Warrant. We also granted the underwriters a 30-day option to purchase up to an additional 3,311,688 Optional Shares, which the underwriters partially exercised as of March 31, 2026 to purchase 2,000,000 Optional Shares. We generated aggregate net proceeds of approximately $86.4 million from the March 2026 Public Offering and an additional $7.2 million of net proceeds from the underwriters’ purchase of additional shares, after deducting underwriting discounts and commissions and offering expenses. The net proceeds are intended to fund the Phase 2b SAFEGUARD study of SAB-142 and for general corporate purposes.
Removed paragraphs (24)
Previous report
We received an Investigational New Drug (IND) clearance from the FDA in May 2024 and announced positive topline data from our Phase 1 clinical trial of SAB-142 in January 2025. We are advancing SAB-142 into a Phase 2b clinical trial called the SAFEGUARD study. On May 29, 2025, the Company held a constructive Type B meeting with the FDA. The meeting followed positive topline data from a Phase 1 single-ascending dose trial in healthy volunteers for SAB-142. The primary discussion centered on questions related to all aspects of SAB-142’s Phase 2b SAFEGUARD clinical trial design and chemistry, manufacturing, and controls processes. The FDA provided clear, constructive, and actionable guidance during the discussion leading to alignment on the design and advancement of our Phase 2b SAFEGUARD study. SAB confirmed its intent with the FDA to utilize the data from this study as supportive evidence for future regulatory approval.
Previous report
Revenue
Previous report
Government grants
Previous report
There was no revenue recognized for the three and nine months ended September 30, 2025. There was no revenue recognized from government grants for the three months ended September 30, 2024 and approximately $1.2 million recognized from government grants for the nine months ended September 30, 2024. We had various grants from the US Department of Defense that terminated in 2022. We satisfied all obligations under these arrangements as of December 31, 2024.
Previous report
Major components within our research and development expenses are salaries and benefits (laboratory & animal care), laboratory supplies, animal care, contract manufacturing, clinical trial expense, outside laboratory services, project consulting, and facility expense.
Previous report
Nonoperating (Expense) Income
Previous report
Revenue
Previous report
We did not recognize revenue for the three months ended September 30, 2025 and 2024.
Previous report
Revenue decreased by $1.2 million, or 100.0%, in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to the JPEO Rapid Response Contract Termination. There was no revenue recognized for the nine months ended September 30, 2025. Included in revenues for the nine months ended September 30, 2024, are closeout activities and charges of $1.2 million due to outside services for laboratory supply disposal.
Previous report
As a result of the JPEO Rapid Response Contract Termination, we do not expect to generate revenues during the development phase of our primary pipeline development target of Type 1 diabetes, which remains independently financed as we explore potential partnerships, co-development opportunities, and licensing arrangements.
Previous report
General and administrative expenses decreased by $2.0 million, or 16.9%, in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to a decrease in salaries and benefits (year-over-year decrease of $1.5 million, 23.6%), insurance costs (year-over-year decrease of $0.1 million, 11.4%) and other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $0.4 million, 10.6%).
Previous report
Non-operating Income
Previous report
Total non-operating income increased by $56.8 million, or 7459.3%, in the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. This increase was primarily driven by a $62 million gain related to the change in fair value of warrant liabilities related to the Series B Offering and the overall change in fair value of warrant liabilities, which increased year-over-year by $61.6 million 998,099.78%). These gains were partially offset by warrant issuance costs associated with the Series B Offering of $4.9 million. The Australian research and development tax credit and dividend income for the three months ended September 30, 2025 was consistent with the Australian research and development tax credit and dividend income for the three months ended September 30, 2024.
Previous report
Total non-operating income increased by $53.5 million, or 575.68%, in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. This increase was primarily driven by a $62.0 million gain related to the change in fair value of warrant liabilities related to the Series B Offering and the overall change in fair value of warrant liabilities, which increased year-over-year by $58.3 million, 758.2%. These gains were partially offset by warrant issuance costs associated with the Series B Offering of $4.9 million. The Australian research and development tax credit and dividend income for the nine months ended September 30, 2025 was consistent with the Australian research and development tax credit and dividend income for the nine months ended September 30, 2024.
Previous report
Since our inception, we have financed our operations primarily from revenue in the form of government grants and from equity financings.
Previous report
Notes Payable
Previous report
Insurance Financing Note
Previous report
We obtained financing for certain Director & Officer liability insurance policy premiums. In 2024, we entered into an agreement that assigned to AFCO Direct (the “Lender”) a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies including (a) all returned or unearned premiums, (b) all additional cash contributions or collateral amounts assessed by the insurance companies in relation to the financed policies and financed by Lender, (c) any credits generated by the financed policies, (d) dividend payments, and (e) loss payments which reduce unearned premiums. If any circumstances exist in which premiums related to any Financed Policy could become fully earned in the event of loss, Lender shall be named a loss-payee with respect to such policy.
Previous report
The total premiums, taxes, and fees financed under the current insurance financing agreement are approximately $516 thousand for AFCO Direct, with an annual interest rate of 7.37%. In consideration of the premium payment by the Lender to the insurance companies or the Agent or Broker (as defined in the agreement with the Lender), we unconditionally promise to pay the Lender the amount financed plus interest and other charges permitted under the agreement.
Previous report
We did not have an insurance financing note payable at September 30, 2025. At December 31, 2024, we recognized approximately $276 thousand, as an insurance financing note payable in our consolidated balance sheets. We incurred less than $1 thousand and $6 thousand of interest expense related to the insurance financing note for the three and nine months ended September 30, 2025, respectively, and less than $1 thousand and $13 thousand for the three and nine months ended September 30, 2024, respectively. Our current insurance financing agreement was repaid through installment payments, with the final payment on June 22, 2025.
Previous report
In 2023, we entered into an agreement with First Insurance Funding, which assigned them a first-priority lien on the security interest in the financed policies and associated rights. During the nine months ended September 30, 2024, we made payments on the prior insurance financing agreement with First Insurance Funding with an original principal balance of $765 thousand and an annual interest rate of 7.96%. This prior agreement, structured with similar lien and collateral terms, was fully repaid upon the final installment on September 22, 2024.
Previous report
Please refer to Note 9, Notes Payable, in our condensed consolidated financial statements for additional information on our debt.
Previous report
Due to current and prior year losses we do not expect to have any Income Tax Provision.
Previous report
We continue to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $7.1 million during the nine months ended September 30, 2025. We have not recognized any reserves for uncertain tax positions.
Reworded paragraphs (23)
Previous wording
This Quarterly Report on Form 10-Q (this “Quarterly Report” or “Form 10-Q”) includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Exchange Act of 1934, as amended (the "Exchange Act"), that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected and projected. All statements, other than statements of historical fact included in this Form 10-Q including, without limitation, statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements involved known and unknown risks, relate to future events or future performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. In addition, historic results, including but not limited to those related to IND enabling GLP safety/toxicology of SAB-142; and Phase 1 & Phase 2a results of SAB-176; do not guarantee that future research or trials will suggest the same conclusions, nor that historic results referred to herein will be interpreted in the same manner due to future preclinical and clinical trial results or otherwise. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the sections entitled “Risk Factors” in this Quarterly Report, our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission (the “SEC”) and available at https://www.sec.gov/. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as expressly required by applicable law, we disclaim any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.
Current wording
This Quarterly Report on Form 10-Q (this “Quarterly Report” or “Form 10-Q”) includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Exchange Act of 1934, as amended (the "Exchange Act"), that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected and projected. All statements, other than statements of historical fact included in this Form 10-Q including, without limitation, statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements involve known and unknown risks, relate to future events or future performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. In addition, historic results, including but not limited to those related to IND enabling GLP safety/toxicology of SAB-142; and Phase 1 & Phase 2a results of SAB-176; do not guarantee that future research or trials will suggest the same conclusions, nor that historic results referred to herein will be interpreted in the same manner due to future preclinical and clinical trial results or otherwise. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the sections entitled “Risk Factors” in this Quarterly Report, our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission (the “SEC”) and available at https://www.sec.gov/. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as expressly required by applicable law, we disclaim any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.
Previous wording
We are a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgGs), without the need for human donors or convalescent plasma, to treat and prevent autoimmune disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs. We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases, including type 1 diabetes (T1D) and other autoimmune disorders. Our internally discovered antibodies are multi-specific, meaning they are comprised of multiple hIgG and can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders.
Current wording
We are a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs. We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases, including type 1 diabetes (T1D) and other autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.
Previous wording
Our proprietary platform holds the potential to generate additional novel therapeutic candidates to expand our pipeline, utilizing the human immune response to generate the optimal repertoire of hIgG for drug targets of interest. We believe it is the only technology capable of producing disease-targeted, hIgG in large quantities without the need for human plasma donors. We have optimized genetic engineering in the development of transchromosomic cattle, or Tc Bovine, which produce hIgG. Our engineering of our production platform drives IgG1 production across our pipeline. In addition, this differentiated approach using polyclonal antibodies has no biosimilar pathway, which provides a significant barrier to competitive polyclonal approaches.
Current wording
We have optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. Our engineering of our production platform drives IgG1 production across our pipeline. In addition, this differentiated approach using polyclonal antibodies has no biosimilar pathway, which provides a significant barrier to competitive polyclonal approaches.
Previous wording
Our wholly owned lead product candidate, SAB-142 is a human anti-thymocyte globulin (hATG) focused on preventing or delaying the progression of Stage 3 T1D. SAB-142 is a first-in-class, multi-target hATG treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D. SAB-142 is expected to reduce autoimmune β-cell destruction and delay progression or onset of T1D in patients with Stage 3 or Stage 2 T1D, respectively. The mechanism of action of SAB-142 has been clinically validated in numerous clinical trials with a rabbit anti-thymocyte globulin (rATG), and rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new or recent onset of Stage 3 T1D. In addition, data from more than 700 human subjects treated with antibodies produced by our platform support the expectation of a zero-serum sickness rate and a zero incidence of neutralizing anti-drug antibodies (ADA) within the upcoming SAB-142 clinical trials.
Current wording
Our wholly owned lead product candidate, 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. The mechanism of action of SAB-142 has been clinically validated in numerous clinical trials with a rabbit anti-thymocyte globulin (rATG). In addition, data from more than 800 human subjects have been treated with antibodies produced by our platform, including in the Phase 1 study of SAB-142, and we have seen no serum sickness rate and no incidence of neutralizing anti-drug antibodies (ADA). We expect this finding to continue through the clinical development of SAB-142.
Previous wording
T- and B-cells are multifunctional lymphocytes whose dysregulation was shown to have a central role in the pathogenesis of more than 80 autoimmune diseases, including T1D, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS) and celiac disease. The therapeutic success to date of lymphocyte-mediating therapies in variety of autoimmune diseases and ourin vivo andin vitro pre-clinical and Phase 1 work from SAB-142 in T1D will support direct progression into Phase 2 clinical trials in other autoimmune indications.
Current wording
T- and B-cells are multifunctional lymphocytes whose dysregulation was shown to have a central role in the pathogenesis of more than 80 autoimmune diseases, including T1D, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS) and celiac disease. The therapeutic success to date of lymphocyte-mediating therapies in a variety of autoimmune diseases and ourin vivo andin vitro pre-clinical and Phase 1 work from SAB-142 in T1D support direct progression into Phase 2 in other autoimmune indications.
Previous wording
Research and development activities consist of discovery research for our platform development and the indications we are working on. For SAB-142, Avance Clinical PTY, Ltd (“Avance”), acts as the contract research organization (“CRO”) overseeing our Phase 1 safety study. This study started in December 2023 and the terms of that agreement are subject to confidentiality and the status of the agreement is that it is current. Pursuant to an agreement between the Company and Fortrea Holdings Inc. (“Fortrea”). Fortrea will act as the CRO overseeing our Phase 2b efficacy and safety study for SAB-142. The study is expected to start in December 2025.
Current wording
Research and development activities consist of discovery research for our platform development and the indications we are working on. For SAB-142, Avance Clinical PTY, Ltd (“Avance”), acts as the contract research organization (“CRO”) overseeing our Phase 1 safety study. This study started in December 2023 and the terms of that agreement are subject to confidentiality and the status of the agreement is that it is current. Pursuant to an agreement between the Company and Fortrea Holdings Inc. (“Fortrea”). Fortrea is acting as the CRO overseeing our Phase 2b efficacy and safety study for SAB-142. The study began enrolling patients in December 2025.
Previous wording
For the three and nine months ended September 30, 2025 and 2024, we continued to incur costs to advance our progress towards commercialization of SAB-142. We expect to continue to incur substantial research and development expenses as we conduct discovery research to enhance our platform and work on our indications. We expect to hire additional employees and continue research and development and manufacturing activities. As a result, we expect that our research and development expenses will continue to increase in future periods and vary from period to period.
Current wording
For the three months ended March 31, 2026 and 2025, we continued to incur costs to advance our progress towards commercialization of SAB-142. We expect to continue to incur substantial research and development expenses as we conduct discovery research to enhance our platform and work on our indications. We expect to hire additional employees and continue research and development and manufacturing activities. As a result, we expect that our research and development expenses will continue to increase in the future and vary from period to period.
Previous wording
Research and development expenses by component for the three and nine months ended September 30, 2025 and 2024:
Current wording
Research and development expenses by component for the three months ended March 31, 2026 and 2025:
Previous wording
General and administrative expenses primarily consist of salaries, benefits, and stock-based compensation costs for employees in our executive, accounting and finance, project management, corporate development, office administration, legal and human resources functions as well as professional services fees, such as consulting, audit, tax and legal fees, general corporate costs and allocated overhead expenses. General and administrative expenses also include rent and facilities expenses allocated based upon total direct costs. We anticipate that general and administrative expenses will rise as we expand our workforce and invest in the advancement of our lead therapeutic candidate in preparation for potential commercialization. Additionally, as our operations grow in complexity and we progress toward commercialization, we may incur higher costs related to accounting, audit, legal, regulatory compliance, director and officer insurance, and investor relations. We expect these expenses to vary from period to period in absolute terms and as a percentage of revenue.
Current wording
General and administrative expenses primarily consist of salaries, benefits, and stock-based compensation costs for employees in our executive, accounting and finance, project management, corporate development, office administration, legal and human resources functions as well as professional services fees, such as consulting, audit, tax and legal fees, general corporate costs and allocated overhead expenses. General and administrative expenses also include rent and facilities expenses allocated based upon total direct costs. We anticipate that general and administrative expenses will increase as we expand our workforce and invest in the advancement of our lead therapeutic candidate in preparation for potential commercialization. Additionally, as our operations grow in complexity and we progress toward commercialization, we may incur higher costs related to accounting, audit, legal, regulatory compliance, director and officer insurance, and investor relations. We expect these expenses to vary from period to period in absolute terms and as a percentage of revenue.
Previous wording
Comparison of the three and nine months ended September 30, 2025 and 2024
Current wording
Comparison of the three months ended March 31, 2026 and 2025
Previous wording
Research and development expenses increased by $1.1 million, or 14.5%, for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to an increase in salaries and benefits (year-over-year increase of $0.5 million, 20.7%),animal care (year-over-year increase of $0.2 million, 161.0%) and clinical trial costs (year-over-year increase of $1.9 million, 132.7%), offset by decreases in outside lab services (year-over-year decrease of $1.3 million, 91.6%), overhead (year-over-year decrease of $0.1 million, 69.1%), and project consulting (year-over-year decrease of $0.1 million, 69.1%). We expect research and development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Current wording
Research and development expenses increased by $5.7 million, or 75.0%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The year-over-year change includes an increase in salaries and benefits (year-over-year increase of $3.7 million, 114.7%) and clinical trial costs (year-over-year increase of $1.3 million, 65.9%), outside lab services (year-over-year increase of $0.1 million, 20.3%), overhead and facility expense (year-over-year increase of $0.2 million, 17.5%), animal care (year-over-year increase of $0.3 million, 441.2%), and laboratory supplies (year-over-year increase of $0.2 million, 75.0%), offset by a decrease in project consulting (year-over-year decrease of $0.1 million, 47.0%). We expect research and development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Previous wording
General and administrative expenses increased by $0.2 million, or 6.6%, in the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to an increase in administrative support fees relating to IT and human resources (year-over-year increase of $0.8 million, 93.1%), offset by salaries and benefits (year-over-year decrease of $0.5 million, 25.4%), and a decrease in project consulting (year-over-year increase of $0.1 million, 31.2%).
Current wording
General and administrative expenses increased by $3.5 million, or 111.9%, in the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to an increase in salaries and benefits (year-over-year increase of $2.8 million, 170.4%), project consulting (year-over-year increase of $0.2 million, 65.3%), and other immaterial administrative support fees relating to IT and human resources (year-over-year increase of $0.6 million, 53.7%), offset by a decrease in insurance costs (year-over-year decrease of $0.1 million, 10.3%). As our operations grow in complexity and we progress toward commercialization, we may incur higher costs related to accounting, audit, legal, regulatory compliance, director and officer insurance, and investor relations.
Previous wording
Interest income decreased by $0.4 million, or (36.39)%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to interest earned on our investments in debt securities, and lower interest earning cash, and cash equivalent balances.
Current wording
Interest income increased by $1.0 million, or 1,575.57%, during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to interest earned on our investments in debt securities, and higher interest earning cash, and cash equivalent balances.
Previous wording
As of September 30, 2025, we had an accumulated deficit of $94.0 million. We anticipate that it will continue to generate losses for the foreseeable future, and expects the losses to increase as we continue the development of, or seeks regulatory approvals for product candidates, and begins commercialization of products. As a result, we will require additional capital to fund operations in order to support long-term plans.
Current wording
As of March 31, 2026, we had an accumulated deficit of $129.8 million. We anticipate that we will continue to generate losses for the foreseeable future, and expect the losses to increase as we continue the development of, or seeks regulatory approvals for product candidates, and begin commercialization of products. As a result, we will require additional capital to fund operations in order to support long-term plans.
Previous wording
On July 21, 2025, we entered into the July 2025 Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in the Series B Offering, (i) 1,000,000 Series B Shares, convertible into 100,000,000 Series B Conversion Shares, (ii) the Release Date Warrants to purchase up to 500,000 the Release Date Warrant Shares, and (iii) the Enrollment Date Warrants to purchase up to 1,000,000 Release Date Warrant Shares. We generated approximately $175 million in gross proceeds, before fees and expenses, from the Series B Offering. The Series B Preferred Stock is convertible into common stock, subject to stockholder approval. The net proceeds are intended to fund the Phase 2b SAFEGUARD study of SAB-142 and for general corporate purposes.
Current wording
On July 21, 2025, we entered into the July 2025 Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in the Series B Offering, (i) 1,000,000 Series B Shares, convertible into 100,000,000 Series B Conversion Shares, (ii) the Release Date Warrants to purchase up to 500,000 the Release Date Warrant Shares, and (iii) the Enrollment Date Warrants to purchase up to 1,000,000 Enrollment Date Warrant Shares. We generated approximately $175 million in gross proceeds, before fees and expenses, from the Series B Offering. The Series B Preferred Stock is convertible into common stock, subject to stockholder approval.
Previous wording
See Note10, Stockholder’s Equity, in our condensed consolidated financial statements for more information about the Series B Offering.
Current wording
See Note 8, Stockholders’ Equity, in our condensed consolidated financial statements for more information about the Series B Offering and March 2026 Public Offering.
Previous wording
On May 3, 2023, we filed a Registration Statement on Form S-3 (Registration No. 333-271768) (the “Shelf Registration Statement”), declared effective on May 17, 2023 by the SEC, which includes a base prospectus that allows us to offer and sell, from time to time, in one or more offerings, common stock, preferred stock, debt securities, warrants, rights or units up to an aggregate public offering price of $50.0 million. The Shelf Registration Statement is intended to preserve our flexibility to raise capital from time to time, if and when needed. On January 26, 2024, we entered into a Controlled Equity Offering℠ Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), relating to shares of our common stock registered for sale under the Shelf Registration Statement. In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $20.0 million from time to time through Cantor, acting as our sales agent. We do not currently plan to issue or sell any shares under the Sales Agreement.
Current wording
On December 29, 2025 we filed a Registration Statement on Form S-3 (Registration No. 333-292482) (the “Shelf Registration Statement”), declared effective on January 7, 2026 by the SEC, which includes a base prospectus that allows us to offer and sell, from time to time, in one or more offerings, common stock, preferred stock, debt securities, warrants, rights or units up to an aggregate public offering price of $300 million. The Shelf Registration Statement is intended to preserve our flexibility to raise capital from time to time, if and when needed.
Previous wording
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:
Current wording
The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:
Previous wording
Net cash used in operating activities increased by $3.2 million in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to an increase in our non-cash items of $7.3 million, offset by a decrease in cash used in operating activities related to change in our operating assets and liabilities of $4.1 million. Year-over-year changes in cash used by operating activities is explained by shifts in the working capital balances as we continue to invest in the development of our lead product candidate, SAB-142.
Current wording
Net cash used in operating activities increased by $6.5 million in the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This increase was primarily driven by a $3.3 million increase in net cash used before changes in operating assets and liabilities, reflecting a higher net loss due to increased research and development expenses, with higher non-cash adjustments, including stock-based compensation and changes in fair value of warrant liabilities. In addition, cash used in operating activities increased by $3.2 million due to changes in operating assets and liabilities. The year-over-year increase in cash used reflects working capital fluctuations as we continue to invest in the development of our lead product candidate, SAB-142.
Previous wording
Net cash used by investing activities increased by $98.7 million in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to increased purchases of short-term investments. Capital expenditures were minimal through the nine months ended September 30, 2025. We do not anticipate a significant increase in capital asset purchases in the near term, as our investment focus remains on advancing our lead therapeutic candidate through Phase 2 clinical trials.
Current wording
Net cash used by investing activities increased by $70.3 million in the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to increased purchases of short-term investments and increase in capital expenditures. We anticipate to increase capital expenditures in the near term as we continue to invest in the development of our lead therapeutic candidate through Phase 2 clinical trials.
Previous wording
Net cash provided by financing activities increased by $169.7 million in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to the Series B Offering.
Current wording
Net cash provided by financing activities increased by $90.1 million in the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to the March 2026 Public Offering.
Previous wording
Our most critical accounting estimates and assumptions are included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025 and our most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025. There have been no significant changes to our critical accounting policies during the three months ended September 30, 2025. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further details.
Current wording
Our most critical accounting estimates and assumptions are included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 9, 2026. There have been no significant changes to our critical accounting policies during the three months ended March 31, 2026. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further details.
Previous wording
We may use these provisions until the last day of our fiscal year in which the fifth anniversary of the completion of our initial public offering occurred. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue exceeds $1.235 billion, or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.
Current wording
We may use these provisions until the last day of our fiscal year in which the fifth anniversary of the completion of our initial public offering occurred. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue exceeds $1.235 billion, or we issue more than $1.07 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Using advanced genetic engineering and antibody science, we 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. We believe it is the only technology capable of producing disease-targeted, hIgG in large quantities without human plasma donors.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
The following tables set forth our results of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
Research and development expenses increased by $1.0 million, or 4.5%, for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The year-over-year change includes an increase in salaries and benefits (year-over-year increase of $2.3 million, 31.1%) and clinical trial costs (year-over-year increase of $4.4 million, (150.0%), offset by a decrease in outside lab services (year-over-year decrease of $3.5 million, 77.1%), overhead (year-over-year decrease of $1.6 million, 37.4%), project consulting (year-over-year decrease of $0.3 million, 37.4%), and laboratory supplies (year-over-year decrease of $0.3 million, 28.3%). We expect research and development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Previous report — wording carried elsewhere
While administrative support and non-capitalized financing costs declined as of September 30, 2025, as compared to September 30, 2024, we anticipate that general and administrative expenses will rise as we expand our workforce and invest in the advancement of our lead therapeutic candidate in preparation for potential commercialization. Additionally, as our operations grow in complexity and we progress toward commercialization, we may incur higher costs related to accounting, audit, legal, regulatory compliance, director and officer insurance, and investor relations.
Previous report — wording carried elsewhere
Interest expense in the nine months ended September 30, 2025 was consistent with interest expense in the nine months ended September 30, 2024.
Previous report — wording carried elsewhere
Interest income increased by $0.4 million, or 136.4%, during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to interest earned on our investments in debt securities.