SAB Biotherapeutics, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing human, multi-specific, high-potency immunoglobulins (IgGs), 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 human IgG (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 (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.

Previous wording

Our wholly owned lead product candidate, SAB-142 is a human anti-thymocyte globulin (ATG) focused on preventing or delaying the progression of T1D. SAB-142 is a first-in-class, human, multi-target ATG 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). In addition, data from more than 700 human subjects treated with antibodies produced by our platform support expectation of a zero-serum sickness rate and 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 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.

Previous wording

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. Next, we intend to advance 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.

Current wording

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 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 our in vivo and in 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 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.

Previous wording

There was no revenue recognized for the three and six months ended June 30, 2025. Total revenue recognized from government grants was approximately $0.3 million and $1.2 million for the three and six months ended June 30, 2024, respectively. The Company had various grants from the US Department of Defense that terminated in 2022. The Company satisfied all obligations under these arrangements as of December 31, 2024.

Current wording

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 wording

For the three and six months ended June 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 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.

Previous wording

Research and development expenses by component for the three and six months ended June 30, 2025 and 2024:

Current wording

Research and development expenses by component for the three and nine months ended September 30, 2025 and 2024:

Previous wording

The following tables set forth our results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following tables set forth our results of operations for the nine months ended September 30, 2025 and 2024:

Previous wording

Comparison of the three and six months ended June 30, 2025 and 2024

Current wording

Comparison of the three and nine months ended September 30, 2025 and 2024

Previous wording

Revenue decreased by $1.2 million, or 100.0%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to the JPEO Rapid Response Contract Termination. There was no revenue recognized for the six months ended June 30, 2025. Included in revenues for the six months ended June 30, 2024, are closeout activities and charges of $1.2 million due to outside services for laboratory supply disposal.

Current wording

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 wording

Research and development expenses increased by $0.2 million, or 2.6%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to an increase in salaries and benefits (year-over-year increase of $0.8 million, 33.0%) and clinical trial costs (year-over-year increase of $1.2 million, 204.3%), offset by decreases in outside lab services (year-over-year decrease of $1.2 million, 85.8%), overhead (year-over-year decrease of $0.3 million, 16.7%), animal care (year-over-year decrease of $0.1 million, 62.4%), and laboratory supplies (year-over-year decrease of $0.2 million, 71.8%). 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 $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.

Previous wording

Research and development expenses decreased by $0.1 million, or 0.8% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The year-over-year change includes a decreases in outside lab services (year-over-year decrease of $2.2 million, 70.2%), overhead (year-over-year decrease of $1.5 million, 26.5%), project consulting (year-over-year decrease of $0.1 million, 26.5%), laboratory supplies (year-over-year decrease of $0.3 million, 50.7%), animal care (year-over-year decrease of $0.1 million, 54.5%), offset by an increase in salaries and benefits (year-over-year increase of $1.7 million, 37.1%) and clinical trial costs (year-over-year increase of $2.4 million, (167.7%). 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 $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 wording

General and administrative expenses decreased by $0.9 million, or 24.9%, in the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to salaries and benefits (year-over-year decrease of $0.4 million, 19.9%), insurance costs (year-over-year decrease of $0.1 million, 19.7%), other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $0.6 million, 51.7%), offset by an increase in project consulting (year-over-year increase of $0.2 million, 103.2%).

Current 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%).

Previous wording

General and administrative expenses decreased by $2.2 million, or 27.2%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to salaries and benefits (year-over-year decrease of $0.9 million, 22.6%), insurance costs (year-over-year decrease of $0.2 million, 22.6%) and other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $1.2 million, 42.5%) offset by an increase in project consulting (year-over-year decrease of $0.1 million, 15.6%).

Current wording

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 wording

Total non-operating income decreased by $3.3 million, or (38.43)%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to the change in fair value of warrant liabilities (year-over-year decrease of $3.3 million, 42.6%). The Australian research and development tax credit and dividend income for the six months ended June 30, 2025 was consistent with the Australian research and development tax credit and dividend income for the six months ended June 30, 2024.

Current wording

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 wording

Interest expense in the six months ended June 30, 2025 was consistent with interest expense in the six months ended June 30, 2024.

Current wording

Interest expense in the nine months ended September 30, 2025 was consistent with interest expense in the nine months ended September 30, 2024.

Previous wording

Interest income decreased by $0.8 million, or (91.28)%, during the six months ended June 30, 2025, as compared to the six months ended June 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 $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.

Previous wording

Interest income decreased by $0.4 million, or 96.4%, during the three months ended June 30, 2025, as compared to the three months ended June 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 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.

Previous wording

The Company has experienced net losses, negative cash flows from operations and, as of June 30, 2025, had an accumulated deficit of $139.5 million. The Company anticipates that it will continue to generate losses for the foreseeable future, and expects the losses to increase as the Company continues the development of, or seeks regulatory approvals for product candidates, and begins commercialization of products. As a result, the Company will require additional capital to fund operations in order to support long-term plans.

Current 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.

Previous wording

On July 21, 2025, the Company entered into the July 2025 Purchase Agreement with certain accredited investors, pursuant to which the Company 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. The Company 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 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.

Previous wording

See Note20, Subsequent Events, in our condensed consolidated financial statements for more information about the Series B Offering.

Current wording

See Note10, Stockholder’s Equity, in our condensed consolidated financial statements for more information about the Series B Offering.

Previous wording

Based on the Company’s current level of operating expenses, existing resources will be sufficient to cover operating cash needs through the twelve months following the date of this report. In the future, the Company may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Current wording

Based on our current level of operating expenses, existing resources will be sufficient to cover operating cash needs through the twelve months following the date of this report. In the future, we may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements.

Previous wording

We did not have an insurance financing note payable at June 30, 2025. At December 31, 2024, we recognized approximately $276 thousand, as an insurance financing note payable in our condensed consolidated balance sheets. We incurred $1 thousand and $6 thousand of interest expense related to the insurance financing note for the three and six months ended June 30, 2025, respectively, and $4 thousand and $12 thousand for the three and six months ended June 30, 2024, respectively. Our current insurance financing agreement was repaid through installment payments, with the final payment on June 22, 2025.

Current wording

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 wording

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 six months ended June 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

Current wording

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 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, 2025 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.

Current 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.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Net cash used in operating activities decreased by $3.5 million in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to a decrease in cash used in operating activities related to change in our operating assets and liabilities of $4.5 million, offset by an increase in our net loss adjusted for non-cash items of $1.0 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 $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.

Previous wording

Net cash used by investing activities decreased by $30.0 million in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to decreased purchases of short-term investments. Capital expenditures were minimal through the six months ended June 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 $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.

Previous wording

We continue to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $4.5 million during the six months ended June 30, 2025. We have not recognized any reserves for uncertain tax positions.

Current wording

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.