Teleconferência de Resultados do 3T 2026 da SAB Bio (SABS): Recrutamento do SAB-142 e Autonomia de Caixa

Principais destaques

• A SAB Bio encerrou o terceiro trimestre de 2026 com US$ 205 milhões em caixa, equivalentes de caixa e títulos para investimento. A administração espera que os recursos existentes financiem as operações até 2028.
• O prejuízo líquido no terceiro trimestre foi de US$ 22,3 milhões, em comparação com o lucro líquido de US$ 45,4 milhões no terceiro trimestre de 2025, refletindo principalmente a redução de outras receitas relacionadas a warrants e despesas operacionais mais elevadas.
• As despesas com P&D dobraram em relação ao mesmo período do ano anterior, atingindo US$ 18,1 milhões, à medida que a SAB Bio avançou com o SAB-142 no estudo registracional de Fase 2b SAFEGUARD.
• As coortes de adultos e adolescentes do estudo SAFEGUARD estão totalmente recrutadas. A administração reiterou os planos de concluir o recrutamento total no quarto trimestre de 2026 e projeta a divulgação dos dados preliminares no segundo semestre de 2027.
• A FDA concedeu ao SAB-142 a designação Fast Track em outubro de 2026 para diabetes tipo 1 em Estágio 3 de início recente. A designação viabiliza uma interlocução mais frequente com a agência e potencial análise contínua (rolling review), mas não altera os critérios de aprovação.
• O estudo de Fase 3 PRIZE, conduzido por pesquisadores independentes, deve administrar a dose no primeiro paciente no quarto trimestre de 2026 e avaliará o SAB-142 em pacientes com até dois anos após o diagnóstico de diabetes tipo 1 em Estágio 3.

Principais dados financeiros

Desempenho operacional e dos negócios

O SAB-142 é uma imunoglobulina antitimócito totalmente humana desenvolvida para preservar as células beta produtoras de insulina e retardar a progressão do diabetes tipo 1 autoimune. A SAB Bio afirmou que sua plataforma TC Bovine produz anticorpos multiespecíficos totalmente humanos sem doadores humanos, o que potencialmente permite novas dosagens a longo prazo com menor imunogenicidade.

No estudo SAFEGUARD, o Comitê de Monitoramento de Segurança de Dados aprovou o recrutamento de crianças de 5 a 11 anos em setembro. A administração informou que a redução de faixa etária (step-down) ocorreu sem atrasos e que as análises cumulativas de segurança sem mascaramento não identificaram novos sinais de segurança nos grupos de adultos, adolescentes e pediátricos.

O estudo PRIZE incluirá sete centros planejados nos Estados Unidos, Europa e Reino Unido. Suas coortes cobrem pacientes com até 100 dias após o diagnóstico, de 100 a 365 dias após o diagnóstico e de um a dois anos após o diagnóstico. O estudo conta com o apoio de uma subvenção da Breakthrough T1D e é cofinanciado pela SAB Bio.

Guidance da administração

• A SAB Bio espera concluir o recrutamento do estudo SAFEGUARD no quarto trimestre de 2026.
• Os dados preliminares (top-line) do SAFEGUARD são esperados para o segundo semestre de 2027.
• A previsão é que o primeiro paciente do estudo PRIZE receba a dose no quarto trimestre de 2026.
• A administração projeta que os recursos de caixa atuais financiarão as operações até 2028.
• Os custos do estudo PRIZE já estavam incluídos no orçamento da empresa e não alteram a previsão informada para a autonomia de caixa (cash runway).
• A empresa não divulgou um cronograma específico para os dados do estudo PRIZE, mas a administração espera que a apresentação ocorra após os resultados do SAFEGUARD.

Riscos e pontos de atenção

A designação Fast Track não garante a aprovação nem flexibiliza as exigências de aprovação da FDA. O diretor médico da SAB Bio apontou a preservação estatisticamente significativa da área sob a curva do peptídeo C em relação ao braço de controle como o desfecho primário do estudo SAFEGUARD relevante para uma via de aprovação acelerada.

O programa também precisa demonstrar desfechos de controle glicêmico, incluindo HbA1c e medições de monitoramento contínuo de glicose. Segurança, imunogenicidade e durabilidade da resposta a doses repetidas continuam sendo elementos essenciais na proposta de diferenciação do SAB-142.

Os dados de durabilidade a mais longo prazo do conjunto inicial de Fase 1, com quatro pacientes, são limitados, já que o estudo terminou aos 120 dias e não coletou dados de acompanhamento subsequentes.

Destaques da sessão de perguntas e respostas com analistas

A administração afirmou que a adesão ao Tzield corrobora o interesse de médicos e pacientes por terapias que preservem a função pancreática. A SAB Bio acredita que o SAB-142 pode se diferenciar por exigir menos dias de administração, apresentar um perfil de anticorpo totalmente humano e permitir potencial reaplicação a longo prazo, embora a eficácia ainda precise ser comprovada nos resultados clínicos.

Para o estudo PRIZE, a administração afirmou que o peptídeo C basal e a idade serão fatores centrais de estratificação. A empresa acredita que resultados positivos poderão respaldar o tratamento além da janela imediata pós-diagnóstico e expandir potencialmente a população elegível para pacientes diagnosticados há até dois anos.

A administração relatou forte interesse médico no PRIZE, destacando a procura de médicos e pacientes excluídos por janelas mais estreitas de tratamento ou pesquisa pós-diagnóstico. Diferentemente do processo inicial de redução gradual de faixa etária do SAFEGUARD, espera-se que o PRIZE comece a recrutar coortes de faixas etárias mais jovens com base nos dados de segurança já acumulados no programa do SAB-142.

Transcrição completa da teleconferência de resultados

Transcrição completa da teleconferência de resultados

Comentários da administração

Operator

Good morning, and welcome to SAB Bio's conference call to discuss third quarter 2026 financial results and business updates. Listeners are invited to review the full text of the forward-looking statements from this morning's quarterly earnings press release. Company management may provide projections during this call, and actual results could differ materially due to several factors, including those outlined in the company's latest filings with the SEC. Currently all participants are in a listen-only mode. Following management's remarks, we will open the call for questions. This call is being webcast live and can be accessed on the Investors section of SABbio's website at ir.sab.bio where a replay will be available. I'll now turn the call over to Samuel Reich, Chief Executive Officer of SAB Bio.

Samuel Reich

Thank you, operator. Good morning and thank you to everyone joining us for our third quarter 2026 earnings call. I'm joined today by Lucy Stow, our Chief Financial Officer, who will review the third quarter financial results. I'm also joined by Eddie Sullivan, our co-founder and president, and Alexandra Kropotova, our chief medical officer. As we begin November, we recognize Diabetes Awareness Month and focus attention on the millions of people living with type 1 diabetes. We remain committed to advancing new medicines with the potential to change the course of the disease improve the lives of those affected. That focus continues to drive our work at SAB Bio, and we're pleased to have you with us today to review the progress we made during the third quarter. We continue to execute on our priorities for SAB 142 with strong momentum in safeguard enrollment and the FDA granting fast track designation to SAB 142 for the treatment of new onset stage three type one diabetes.

For context, SAB142 is a fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells in order to slow disease progression in autoimmune type 1 diabetes. It was developed using our proprietary TC Bovine platform, which allows us to generate fully human, multi-specific antibodies without the need for human donors. Because SAB 142 is fully human, it has the potential to overcome key limitations of non-human approaches and enable safe redosing over the long term. We believe SAB 142 represents an opportunity to help people with type 1 diabetes redefine what a stage 3 diagnosis can mean. SAB 142 is currently being evaluated in two clinical trials, the Registrational Phase 2B Safeguard Study for those newly diagnosed with Stage 3 T1D and the investigator-led phase three prize study for people up to two years from a stage three T1D diagnosis. Let's start with an enrollment update for Safeguard. The performance of our clinical team this quarter has been exemplary.

In September, the study's Data Safety Monitoring Board approved the final step down to children ages 5 to 11. helping to further accelerate enrollment. We continue to see strong interest in Safeguard from both patients and investigators, and we're excited to share that the adult and adolescent cohorts are now fully enrolled and closed for screening. With that, we are reaffirming our guidance to complete enrollment of Safeguard in Q4 with top line data expected in the second half of 27. Building on that progress, the PRIZE study expects to dose the first patient this quarter. There are seven clinical sites planned across the United States, Europe, and the UK. Prize is an important extension of the SAB 142 clinical program, as it would potentially allow a future label expansion for SAB 142 to T1D patients up to two years from a stage three diagnosis. As a reminder, PRISE is an investigator-led study supported by a grant from Breakthrough T1D and co-funded by SABbio.

We are grateful to Breakthrough T1D for its support and to Dr. Michael Haller at the University of Florida, who serves as the study's principal investigator. We also want to recognize Dr. Chantal Mathieu at KU Leuven and Dr. Timothy Tree at King's College London as co-principal investigators for their important contribution to the study. Beyond our clinical progress, we reached an important regulatory milestone in October when the FDA granted fast track designation to SAB 142 for the treatment of new onset stage 3 type 1 diabetes. This designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need with the goal of bringing important new treatments to patients earlier.

For SAB 142, this designation gives the program some serious aura. And importantly, it provides valuable procedural benefits as we advance our program. These include opportunities for more frequent meetings and written communications with the FDA, eligibility for rolling review of the future BLA, and potential eligibility for priority review if the applicable criteria are met. While fast track designation does not change the FDA's standards for approval or ensure that SAB 142 will ultimately be approved, we believe the benefits are meaningful as we move toward top line data. We will continue to work closely with the FDA as we advance the SAB 142 clinical program. And we believe this designation represents meaningful progress toward our goal of bringing SAB 142 to people living with type 1 diabetes as quickly as possible. And with that, I will hand the call over to Lucy Tao, our Chief Financial Officer, for a recap of our third quarter financials.

Unknown Speaker

Thanks, Sam. We ended the third quarter with $205 million in cash, cash equivalents, and investment securities as of September 30, 2026. We maintain a strong cash position and project that our existing cash balance will fund our operations through 2028. This total includes $13.4 million in gross proceeds received in the third quarter from the exercise of our previously issued enrollment and data release warrants from our July 2025 pipe. R&D expenses were $18.1 million for the third quarter of 2026, compared to $9 million for the same period in 2025. The increase is primarily driven by ongoing clinical trial costs and related headcount to support the advancement of SAB 142 through the Registrational Safeguard Study. R&D expenses include non-cash stock-based compensation expense of $3.9 million for the third quarter of 2026 compared to $0.5 million for the same period in 2025. G&A expenses were $7.8 million for the third quarter of 2026 compared to $3.7 million for the same period in 2025.

The increase is primarily driven by personnel-related costs, including non-cash stock-based compensation. G&A expenses include non-cash stock-based compensation expense of $3.6 million for the third quarter of 2026 compared to $0.3 million for the same period in 2025. Other income was $3.6 million for the third quarter of 2026 compared to $58.1 million for the same period in 2025. The decrease primarily reflects the change in fair value of warrant liabilities recognized in 2025. As a result, net loss was $22.3 million for the third quarter of 2026, compared to the net income of $45.4 million for the same period in 2025. Overall, we reaffirm our position to support SAB 142's clinical development in the safeguard and prize studies through key milestones while preparing for commercial readiness for SAB 142. And with that, I can turn it back over to Sam for closing remarks before we open the call for questions.

Samuel Reich

Thanks, Lucy. We're pleased with the progress we made during the third quarter and enter the final months of the year with a clear focus, completing enrollment in Safeguard and continuing to advance SAB 142 toward top line data. We are incredibly grateful to our team, our investigators and clinical collaborators, the patients and families participating in Safeguard, and the broader diabetes community. Their commitment and engagement continue to drive our work and reinforce the importance of developing new therapies for people living with type 1 diabetes. As we look to 2027, we're excited to move toward top line data from Safeguard while continuing to build the capabilities and infrastructure needed to support SAB 142 over the long term. We believe SAB 142 has the potential to meaningfully change the treatment of Type 1 diabetes, and we are focused on delivering on that promise. We look forward to sharing our progress as we continue advancing SAB 142 across our clinical programs and executing on our strategy. And with that, we're ready to take any questions.

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. The first question is from Michael Yee from UBS.

Please go ahead.

Perguntas e respostas

Michael Yee

Hey, guys. Good morning. Congrats on the progress on enrollment. as we think about the data ahead at next year could you sort of comment or reiterate your framing of expectations on that result in terms of C-peptide and A1C and how important each of those are to hit for differentiation to T-Zield. And secondly, given that T-Zield now has a new Stage 3 indication, While we've been talking with different docs, what are you hearing out there? What are you seeing? And is that perhaps a pretty good indication of what the opportunity could be, although it's still early there? Thank you.

Unknown Speaker

Thanks Mike. I'll answer the second part first and then hand it to Alexandra to answer the first question. So the second part on T-Zield, we're very encouraged by what we're seeing with T-Zield. The uptake in the community shows the importance of new medicines, and it's paving the way and establishing a pattern with doctors and patients to get treatment, to get a prescription, to preserve the pancreas when a patient is diagnosed. So we're encouraged by what we're seeing, and I think it bodes well for SAB 142 as it's as we believe strongly that it's a competitive product with fewer days of dosing. We'll see where the results the efficacy, but also will overall have a better profile. So I think everything we're seeing with T-fields is good news for the field and for SAB 142. And for the first part, I'll hand it over to our Chief Medical Officer, Alexander, to answer the question.

Alexandra Kropotova

Thank you very much, Sam. We are very hopeful about our upcoming data release next year. Of course, the primary endpoint of the preservation of the beta cell function as measured by the area under the curve C-peptide is our primary endpoint and we'll be reporting the results on that where the statistically significant results versus control arm will guarantee us the accelerated path to the approval for the test. Now, ATG is a clinically validated mechanism of action where previous multiple clinical trials showed the important improvement in the glycemic control needed for the full approval of the medications in the disease-modifying therapies, and we will be releasing the data. on the glycemic control as well based on the HbA1c and the continuous glucose monitoring. Now third component of a very important differentiation profile of the SAB142 versus Tzield is the low immunogenicity due to the full human nature of the antibody that will allow drug to provide the disease-modifying therapy over a lifetime of the disease of the patients where the product can be redosed to continue maintaining the C-peptide and preserving the residual beta cells, not only over one or two courses, but for over a much longer period. Efficacy data and the safety data associated with the long-term redosing will be part of our top line as well. Great, thanks.

Operator

The next question is from Ellie Merle from Barclays. Please go ahead.

Tejas Wein

Hi, this is Tejasan for Ellie. Thanks for taking our question. My first one, just for the study in the patient's two years from diagnosis, could you expand on just some of the different cohorts of patients across that two-year timeframe and what you're looking to see in each of those? And then I have a follow-up.

Unknown Speaker

Sure. So it's a sister study to the safeguard study. The protocol is exactly the same with one exception, which is the time from diagnosis. One cohort is age match from the safeguard population that's effectively the control and that's patients within 100 days of diagnosis. One cohort is from 100 days to 365 days, which is that window out to a year. And what we call cohort three or the third cohort is from one year to two years. And the importance of that and that data is to prove that the thing that matters most with a patient is the amount of beta cells they have and our ability to preserve those. And the T1D community and SAB want as many patients as possible to be able to get access to SAB-142.

And the prize study is designed to show that we can provide a benefit to patients up to two years from diagnosis.

Tejas Wein

Great, and then just a quick follow up on timing. When could we expect to get data from any of these cohorts and how could that be used to support a label expansion or inform a registrational trial in those various populations?.

Unknown Speaker

Well, so on the timing, I don't know that we're guiding to a specific time yet as it's an investigator led study. I think we would expect it to be subsequent to safeguard data, but we'll see and we'll keep you posted on that. As far as the label. good outcome, you know, we would hope to and have the potential to have time not be a basis for diagnosis and just beta cells. So if a patient with type 1 diabetes has adequate beta cells for preservation, there's a possibility that that might be that's all required for being able to get treated and covered. And maybe if you step it back to just one step more conservative, perhaps it's up to two years from diagnosis, which will, you know, markedly expand the, um, the available total addressable market, as well as have the ability to increase market penetration by not having this kind of a gun to the head of a patient with you have to get it now or you're not going to be able to get it. Yes, really helpful. Thank you. You're welcome.

Operator

The next question is from Roger Song from Jefferies. Please go ahead.

Unknown Speaker

Hi, guys, this is Chacha on for Roger. I was hoping that you could give us more color in regards to the September DMC approval. Can you share more on what safety parameters were particularly important in supporting the expansion to the pediatric population?.

Alexandra Kropotova

Sure, I'll let Alexandra answer that. Thanks, Sam. So we have the Independent Data Monitoring Committee that has been a part of the SAB 142 development program for over the last two years. The DMC consists of the one adult endocrinologist and two pediatric endocrinologists along with the independent biostatistician. For... pre-scheduled predefined DMC meetings, cumulative data for the SAB 142, which means that all data that were accumulated from the beginning, the very first patient of enrolled in a trial all the way until the DMC scheduled meeting were provided, the data were provided in 2014. to the DMC in an unblind fashion. It means that the DMC committee saw the data by treatment arm versus control. And it's all available safety data across populations broken also down by the age groups, adult versus adolescent and versus pediatric population. We had the DMC meetings that approved the step-down as planned without any delays, indicating that the product behaves very consistently, and there is no new safety signal identified in the ongoing safeguard trial.

So we're very, very pleased with how the product behaves. And it's, again, very, very consistent safety profile across all age groups.

Operator

Thanks, that's helpful. The next question is from Yatin Sunedja from Guggenheim Securities. Please go ahead.

Hanxing Gao

Hi, good morning. This is Iris Gao, on for Yatin. Thank you for taking our questions and congratulations on the progress with both studies. So my first question would be like, is there an update on how many patients have been redosed so far and is the drug still clean on ADAs? And my second question would be about like, how does the PRICE study affect the burn rate going forward? Thank you.

Unknown Speaker

We haven't disclosed to date how many patients have been redosed, but it's going according to plan. And then the second part was, I'm sorry, could you repeat it? I didn't hear it. Oh, yes.

Hanxing Gao

is how do you expect the price study to affect the burn rate going forward?.

Unknown Speaker

We had included that study in our budgeting process. So the burn as guided is, has, is, accounted for the trial expenses and doesn't change. Thank you. The next question is from Thomas Smith from Leerink Partners. Please go ahead.

Thomas Smith

Hey guys, good morning. This is Brian on for Tom. Congrats on all the progress and thanks for taking our questions. So first, given adult and adolescent cohorts here are fully enrolled in Safeguard, Can you comment on if there's anything notable on the baseline characteristics of the patients in these cohorts relative to your expectations? And then we have a quick follow-up. I'll let Alexander answer that.

Alexandra Kropotova

Our baseline characteristics for both cohorts are comparable to the baseline characteristics of the respective age cohorts in previous trials, TN-19 and ML-DTG. So the data is very consistent, again, even at the baseline.

Thomas Smith

Got it. Thanks so much. And our second question... just on the prize trial, you know, understanding that in safeguard, we needed to have that step down from adults to pediatric patients. But can we expect a similar dynamic in prize, even at least some of the overlap in patient population? Or can you begin enrolling those pediatric patients once the study begins recruitment, given the safety data you've generated to date?.

Alexandra Kropotova

Yes, excellent question. And yes, we are starting enrollment in the prize ATG study with the early age cohorts, considering that we already have a very significant amount of the safety data accumulated through Safeguard and the DMC, independent DMC committee across the program, so it's the same DMC, who already has seen all the data from the ACB-142 in previous trials, will be guiding and monitoring the safety in PRIZE. Great, thanks.

Operator

from Samantha Semenkow from Citi. Please go ahead.

Samantha Lynn Semenkow

Hello, this is Ben on for Sam. Thanks so much for taking the question. Can you describe the level of physician interest in the prize study? What kind of feedback are you receiving based on the site interactions? And then I have a separate question, if I may.

Unknown Speaker

Yes, physician interest is very high. I think that we mentioned that Dr. Haller at University of Florida, Dr. Matthew in Belgium, and Dr. Tim Tree at King's College proposed this study design because of the tremendous interest. If you can imagine that both all the clinical research done with immunomodulation, as well as now the first approved therapy, the field limits a patient's ability to get dosed to the first up to eight weeks. The safeguard has been the most inclusive up to 100 days so far. There's a huge pent up demand and frustration both at physician level and the patient level of people who are being excluded from from the ability to get therapy or participate in clinical research.

So interest is high, demand is high, and it really is inbound interest from the T1D community and the academic community to SAB that we're gladly collaborating with and accommodating.

Samantha Lynn Semenkow

And then what is the turning back to safeguard? What is the pace of the pediatric screening and enrollment? Is it tracking with your expectations?.

Unknown Speaker

Yes, it's good. We're pleased by how it's going. And we're reiterating that we expect to complete enrollment this quarter. Thank you.

Operator

The next question is from Ki Nekai from Chardon. Please go ahead.

Kaey Nakae

Good morning. With respect to prize to court C patients, How do you – it's not clear to me from the inclusion-exclusion. How do you best handicap which patients at that duration of onset might be best suited to show a positive result?.

Unknown Speaker

I think it's all about C-peptide at baseline. It's the same study design as Safeguard. The only difference is that time from diagnosis. So the amount of C-peptide, which, you know, meeting the inclusion criteria for baseline C-peptide is that. And Alexandra, do you have anything to add? No.

Alexandra Kropotova

And then the additional parameter is the age groups, similar to safeguard, we have predefined parameters for the sample size across the adult, adolescent and pediatric population. in approximately similar one third of each population fashion since the disease progression may be dependent on the age as well. So baseline C-peptide and age are two parameters that participate in the stratification randomization at the baseline of the RAISE ATG participants. All right, thanks. Next question.

Operator

is from Seema Shah and from Rodman Financial. Please go ahead.

Seema Sheoran

Hi, thank you for taking my questions and congrats on the progress. So in April, you presented impressive four patient data where three patients described as super responders, showing C-peptide levels above baseline at 120 days or four months. My understanding is that this cohort is not receiving additional doses, whereas Safeguard includes redosing. I'm just curious to know how C-peptide levels have evolved with longer follow-up in these four patients and what that suggests about the durability of response without redosing.

Unknown Speaker

Thank you. So the data we presented from the Phase 1 study was the complete data set. The data, the study was 120 days long. That was the last study visit. And so we have not collected data beyond that.

Operator

I see. Okay. Thank you. This concludes the question and answer session, as well as today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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