Anti-thymocyte Globulin (Rabbit)

Raises combined $67.1M in private placement plus Tranche warrant exercise with syndicate of leading investors Received approval by the Human Research Ethics Committee (HREC) to commence a First-in-Human Phase 1 clinical trial investigating SAB-142 in Australia Appoints Michael G. King Jr. as new Chief Financial Officer SIOUX FALLS, S.D., Nov. 14, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today reported financial results for the third quarter ended October 31, 2023, and provided a company update. “The third quarter of 2023 was a pivotal growth point for SAB as we advance SAB-142, our T1D immunotherapy. The recently-announced private placement offering has paved the way for advancement of SAB-142 in clinical trials, sustaining our operations through 2026 and topline Phase 2 results,” said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “We continue to add senior expertise to our team, including the hiring of Mike King as our Chief Financial Officer and the election of Andrew Moin of Sessa Capital to our Board of Directors. Given this growth and our recent clinical milestones, I am confident in our mission to provide critical immunotherapeutic options to T1D patients.” Pipeline Updates and Anticipated Milestones SAB continues to execute on its strategy for the development of proprietary immunotherapeutic fully-human antibodies, or fully-human immunoglobulins (hIgGs), to treat and prevent immune and autoimmune disorders with a strategic focus on T1D disease modification. Clinical/Regulatory Update: Received approval by the Human Research Ethics Committee (HREC) to commence a First-in-Human Phase 1 clinical trial investigating SAB-142 in Australia. The Phase 1 trial will evaluate the company’s lead therapeutic candidate, SAB-142, a first in-class hIgG being developed as a disease-modifying treatment to delay the onset and progression of T1D. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142. Approval by the HREC is confirmation that SAB has successfully completed all pre-clinical safety and efficacy testing required to commence a Phase 1 clinical trial.Received Acknowledgement of a Clinical Trial Notification (CTN) from the Australian Government Department of Health Therapeutic Goods Administration (TGA) submitted for the Phase 1 study.Successfully registered the Phase 1 trial with the Australian New Zealand Clinical Trials Registry (ANZCTR). More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here.Phase 1 First-in-Human trial expected to commence Q42023 in Australia.US IND filing anticipated in 2024. Strategy Update: Announced the Company has entered into a private placement offering that will provide up to $110 million in gross proceeds to SAB, which will used to clinically advance SAB-142, and is expected to advance to clinical trials in Q4 2023. SAB-142 is a fully-human alternative to rabbit anti-thymocyte globulin (rATG). SAB-142’s mechanism of action is similar to that of rATG, which has been clinically validated in multiple clinical trials for T1D, demonstrating the ability to slow down disease progression in patients with new or recent onset of Stage 3 T1D.The full proceeds, when funded, are expected to fund the company through 2026 and through topline Phase 2 results. Participating investors include Sessa Capital, BVF Partners, RTW Investments, Marshall Wace, ATW and the JDRF T1D Fund. The Offering will include several tranches as outlined in the Company’s filings with the SEC (including a current report on Form 8-K being filed on October 2, 2023).Two tranches have been completed to date: Issuance of Series A-1 Preferred Stock, the first tranche of the $110 million in private financing, totaling approximately $7.5 million of gross proceeds was closed on October 5, 2023.Issuance of Series A-1 Preferred Stock or Series A-3 Preferred Stock, the second tranche of the $110 million in private financing, totaling approximately $59.6 million of gross proceeds was completed on November 10, 2023. Management Updates: Announced Michael G. King Jr. as new Chief Financial Officer. Mr. King has extensive experience and prior success as an award-winning biotechnology research analyst and senior advisor with more than 25 years of experience with investors, banking institutions and thought leaders in various pharmaceutical disciplines. His record of achievement includes successful engagements with Hambrecht & Quist, Alex Brown & Sons, Robertson Stephens, Vector Securities, Bank of America, Rodman & Renshaw, JMP Securities, and HC Wainwright. Most recently, Mr. King was Co-Head of Healthcare Research at EF Hutton Group.Appointed Andrew Moin, Partner and Analyst at Sessa Capital, a New York based investment advisor registered with the SEC, to the SAB Board of Directors. Mr. Moin has been with Sessa since 2012, where he works on idea generation, research, and investment implementation. He has also been deeply involved in the type 1 diabetes community for over 20 years, including as a volunteer and member of the Young Leadership Committee of the New York City Chapter of the JDRF and an early supporter of multiple fundamental diabetes research and innovation projects.Russell P. Beyer, former EVP and Chief Financial Officer, departed the Company effective October 27, 2023. Q3 2023 Financial Results Financial Guidance: Based on its current operating plans, SAB reaffirms that it expects its existing business plan, cash and cash equivalents, and anticipated cash flows will be sufficient to fund its operating expenses and capital expenditure requirements through the third quarter of fiscal year 2025. Research and Development (R&D) Expenses: R&D expenses were $4.0 million for three months ended September 30, 2023, compared to $7.4 million for the three months ended September 30, 2022. R&D expenses were $12.2 million for the nine months ended September 30, 2023, compared to $29.3 million for the nine months ended September 30, 2022. The decrease was primarily due to targeted cost reduction measures pausing certain unfunded research activities for our COVID-19 therapeutic and prioritizing our focus in the autoimmunity space with SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of Type 1 Diabetes.General and Administrative (G&A) Expenses: G&A expenses were $2.6 million for the three months ended September 30, 2023, compared to $4.0 million for the three months ended September 30, 2022. G&A expenses were $8.9 million for the nine months ended September 30, 2023, compared to $13.5 million for the nine months ended September 30, 2022. The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.Net Loss: Net loss was $5.1 million for the three months ended September 30, 2023, for an earnings per basic and diluted share of $(0.10), as compared to a net loss of $7.1 million for the three months ended September 30, 2022, for an earnings per basic and diluted share of $(0.16). Net loss was $19.4 million for the nine months ended September 30, 2023, for an earnings per basic and diluted share of $(0.38), as compared to a net loss of $10.9 million for the nine months ended September 30, 2022, for an earnings per basic and diluted share of $(0.25). About SAB Biotherapeutics, Inc.SAB Biotherapeutics (SAB) is a clinical-stage biopharmaceutical company focused on developing fully human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The company’s lead asset, SAB-142, targets type 1 diabetes (T1D) with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, fully-human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn. Forward-Looking StatementsCertain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of our T1D program, and other discovery programs, the closing of each tranche of the Company’s private placement offering, the timely funding to the Company by each investor in the private placement offering, financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government, and other third-party collaborations or funded programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, as amended, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Investor Relations:Matt@milestone-advisorsllc.com Media Relations:SABPR@westwicke.com

The pandemic gave SAB the chance to revolve through the clinical cycle, from phase 1 to 2 to 3 in the space of about three years. In September 2019, a tiny company named SAB Biotherapeutics signed a little contract with the U.S. Department of Defense (DOD) that included the test development of an antibody treatment into phase 1 for “an unknown threat.” There's no way that SAB CEO Eddie Sullivan, Ph.D., could have seen what was coming next. The contract would be completed not as a test but as a real-life scramble to find a treatment to address a rapidly spreading global pandemic. SAB’s journey could be a cautionary tale of a biotech that jumped in to help fight a global threat but ultimately lost when the pandemic moved faster than anyone could have predicted. After all, the same thing happened to companies that launched into testing Ebola meds, only to have the health emergency pass before the drugs ever reached the shelf. But the pandemic gave SAB the chance to revolve through the clinical cycle, from phase 1 to 2 to 3 in the space of about three years. That’s experience not a lot of companies get—and now SAB is hoping to parlay that once-in-a-lifetime whirlwind into its next act. Live fire   The original three-stage contract with the DOD included a six-month challenge to demonstrate the SAB platform’s ability to develop cGMP material at scale, then increase production to meet a prespecified target with fully demonstrated readiness, and then, finally, the biotech needed to produce an antibody treatment to the unknown threat, to be selected by the agency as a “live fire” exercise. The prototype had to demonstrate efficacy through phase 1. In announcing the full details of the contract in March 2020, Sullivan said, perhaps ominously, “If we can perform under the most demanding of scenarios to challenging targets, it builds confidence that translates to a broader array of therapeutic programs.” But instead, everything went sideways. “Before we ever got to those various stages, of course, the pandemic hit and the DOD came to us and said, ‘Okay, just make us a polyclonal antibody to the SARS-CoV-2 virus. And we did exactly that,” Sullivan told Fierce Biotech in an interview, reflecting on the early days of the pandemic. The tiny company, which had just 48 employees when the pandemic hit, churned out the antibody treatment SAB-185 and was dosing healthy volunteers in a phase 1/2 study by August 2020. By that point, the DOD and BARDA had thrown even more contracts SAB’s way, totaling $72 million. “We felt it was our responsibility to at least put forward a significant effort in the response of the disease without knowing, ultimately, what would become of it,” Sullivan said. Almost everything else SAB had been working on was paused. That meant a collection of fully human polyclonal antibodies for autoimmunity, infectious diseases, inflammation and oncology, plus a Type 1 diabetes treatment—more on that later. The COVID treatment rolled through the clinic. SAB used the goodwill to go public in June 2021 through a special purpose acquisition company deal valued at $118 million. SAB-185 hit phase 3 by September 2021 in a trial sponsored by the National Institutes of Health comparing the treatment with Regeneron’s monoclonal antibodies. Everything seemed to be going well with the COVID-19 polyclonal antibody. Then came omicron. The NIH cut the sponsored phase 3 trial as hospitalizations waned and the pandemic changed course. Regeneron’s antibodies became inactive and so the trial couldn’t be conducted as designed. SAB, which wasn't the only biotech to get snarled up as the government programs ended, tried to go it alone with late-stage testing but ultimately was unsuccessful. According to Sullivan, SAB-185 worked. It reduced symptoms seven days faster in an active comparator trial and offered a different mechanism of action to the drugs currently being used to treat patients with COVID-19. “When you're dealing with the uncertainties of an emerging disease and a pandemic, it does make it risky, but given the fact that the world was facing a worldwide pandemic, we felt like it was our responsibility to at least offer the opportunity,” Sullivan said. The new (old) SAB   Sullivan might do it all again if called on: “We would never say we would not do it.” But SAB now has a new focus—or a new, old focus, to be more accurate. The company has turned back to its original pipeline, which included infectious disease treatments and one for Type 1 diabetes. The latter is the new lead indication as COVID and SAB-185 falls into the rearview. SAB announced a $130 million private placement on Oct. 2 to fund SAB-142, a fully-human alternative to rabbit anti-thymocyte globulin (rATG), for patients with new or recent onset of stage 3 T1D. Sullivan says the therapy has the potential to slow down disease progression—a disease modifying treatment, in biotech parlance—instead of just addressing symptoms. SAB-142 targets the immune cells involved in the destruction of pancreatic beta cells with the aim of protecting these insulin-producing cells. Sullivan said the therapy is similar to a rATG candidate previously tested by Sanofi, which is derived from rabbits. But SAB’s fully-human option means it should be possible to safely re-dose, which is key for the chronic, life-long condition of T1D. Animal-based immunoglobulin G antibodies can cause major immune reactions. But previous testing of these similar candidates has shown that a single dose of rATG can modulate the body’s immune response to slow down beta cell destruction and preserve insulin production. SAB hopes to move its lead candidate into the clinic this quarter. While Sullivan acknowledges that his biotech probably can’t propel itself into the clinic with quite the speed of the government-sponsored COVID trials, he’s happy to be in the driver’s seat this time around. The funding for the trial was raised by SAB through a clutch of new investors, led by RA Capital Management plus BVF Partners, Sessa Capital, Commodore Capital, RTW Investments, Marshall Wace, and the JDRF T1D Fund. “It's important to understand that government priorities may shift … particularly [when] answering a pandemic,” Sullivan said. But for T1D, which can be diagnosed as early as 13 years old, the opportunity never really goes away to find a better treatment—particularly one that might address the underlying cause of the disease. So as SAB came off the pandemic wave, T1D was an easy choice for the new lead indication. The company is not the same as it was before, even if the SAB-142 program isn’t brand new. Sullivan said his team now knows how to quickly grow manufacturing capacity, speed from phase 1 to phase 3 and more. The new funding has paved a runway into 2026 through phase 2 testing for SAB-142, according to Sullivan. SAB also has a flu program, SAB-176, that managed to continue on through the pandemic and for which it’s seeking partners. The company remains small—while its ranks swelled during the immediate COVID response, the head count now sits around 56 people—but whether the term “emerging biotech” applies to SAB anymore is up for debate. “We developed capacities well beyond what we were prior to the pandemic, just based upon the experience that we had in developing SAB-185, ” Sullivan said. “And so, certainly, all of that lends itself to the opportunity to use that experience and the things that we gained as a company in the development of SAB-142 for Type 1 diabetes.”