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SAB BIO Announces Q1 2025 Financial Results and Provides Company Updates

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SAB BIO (NASDAQ: SABS) has reported its Q1 2025 financial results and company updates. The clinical-stage biopharmaceutical company completed patient dosing in the last cohort of the Phase 1 clinical study of SAB-142, their novel immunotherapy for delaying type 1 diabetes progression. The company reported cash and equivalents of $12.9 million, down from $20.8 million in December 2024.

Financial highlights include R&D expenses of $7.7 million (down from $8.1 million YoY), reduced G&A expenses of $3.1 million (down from $4.2 million YoY), and other income of $5.6 million. The company reported a net loss of $5.2 million. SAB BIO also achieved a significant milestone by obtaining a Qualified Person declaration for their in-house CMC manufacturing process, enabling them to meet European manufacturing standards for upcoming EU clinical trials.

SAB BIO (NASDAQ: SABS) ha comunicato i risultati finanziari del primo trimestre 2025 e aggiornamenti aziendali. La società biofarmaceutica in fase clinica ha completato la somministrazione ai pazienti nell'ultimo gruppo dello studio clinico di Fase 1 di SAB-142, la loro nuova immunoterapia per rallentare la progressione del diabete di tipo 1. L’azienda ha riportato liquidità e equivalenti per 12,9 milioni di dollari, in calo rispetto ai 20,8 milioni di dicembre 2024.

I punti salienti finanziari includono spese di R&S per 7,7 milioni di dollari (in diminuzione rispetto a 8,1 milioni su base annua), spese generali e amministrative ridotte a 3,1 milioni di dollari (da 4,2 milioni su base annua) e altri ricavi per 5,6 milioni di dollari. La società ha registrato una perdita netta di 5,2 milioni di dollari. SAB BIO ha inoltre raggiunto un importante traguardo ottenendo una dichiarazione di Persona Qualificata per il proprio processo di produzione CMC interno, permettendo così di soddisfare gli standard europei di produzione per i prossimi trial clinici nell’UE.

SAB BIO (NASDAQ: SABS) ha reportado sus resultados financieros del primer trimestre de 2025 y actualizaciones de la empresa. La compañía biofarmacéutica en etapa clínica completó la dosificación de pacientes en la última cohorte del estudio clínico de Fase 1 de SAB-142, su novedosa inmunoterapia para retrasar la progresión de la diabetes tipo 1. La empresa informó de efectivo y equivalentes por 12,9 millones de dólares, una disminución desde los 20,8 millones en diciembre de 2024.

Los aspectos financieros destacados incluyen gastos en I+D por 7,7 millones de dólares (menos que 8,1 millones interanuales), gastos generales y administrativos reducidos a 3,1 millones de dólares (desde 4,2 millones interanuales) y otros ingresos por 5,6 millones de dólares. La compañía reportó una pérdida neta de 5,2 millones de dólares. SAB BIO también alcanzó un hito importante al obtener una declaración de Persona Calificada para su proceso de fabricación CMC interno, lo que les permite cumplir con los estándares europeos de fabricación para los próximos ensayos clínicos en la UE.

SAB BIO (NASDAQ: SABS)는 2025년 1분기 재무 결과와 회사 업데이트를 발표했습니다. 임상 단계 바이오제약 회사는 1형 당뇨병 진행 지연을 위한 신개념 면역치료제인 SAB-142 1상 임상시험의 마지막 환자 투여를 완료했습니다. 회사는 를 보고했으며, 이는 2024년 12월의 2,080만 달러에서 감소한 수치입니다.

재무 주요 내용으로는 연구개발비가 (전년 동기 대비 810만 달러에서 감소), 일반관리비가 (전년 동기 대비 420만 달러에서 감소), 기타 수익이 로 나타났습니다. 회사는 순손실 를 기록했습니다. SAB BIO는 자체 CMC 제조 공정에 대해 자격 있는 담당자(Qualified Person) 선언을 획득하는 중요한 이정표도 달성했으며, 이를 통해 다가오는 EU 임상시험을 위한 유럽 제조 기준을 충족할 수 있게 되었습니다.

SAB BIO (NASDAQ : SABS) a publié ses résultats financiers du premier trimestre 2025 ainsi que des mises à jour de l’entreprise. La société biopharmaceutique en phase clinique a terminé le traitement des patients dans la dernière cohorte de l’étude clinique de phase 1 de SAB-142, leur nouvelle immunothérapie visant à retarder la progression du diabète de type 1. L’entreprise a déclaré disposer de 12,9 millions de dollars en liquidités et équivalents, en baisse par rapport à 20,8 millions en décembre 2024.

Les points financiers clés incluent des dépenses en R&D de 7,7 millions de dollars (en baisse par rapport à 8,1 millions sur un an), des frais généraux et administratifs réduits à 3,1 millions de dollars (contre 4,2 millions sur un an) et d’autres revenus de 5,6 millions de dollars. La société a enregistré une perte nette de 5,2 millions de dollars. SAB BIO a également franchi une étape importante en obtenant une déclaration de Personne Qualifiée pour son processus de fabrication CMC interne, ce qui lui permet de respecter les normes européennes de fabrication pour les prochains essais cliniques dans l’UE.

SAB BIO (NASDAQ: SABS) hat seine Finanzergebnisse für das erste Quartal 2025 und Unternehmensupdates veröffentlicht. Das biopharmazeutische Unternehmen in der klinischen Phase hat die Patientendosierung in der letzten Kohorte der Phase-1-Studie von SAB-142 abgeschlossen, ihrer neuartigen Immuntherapie zur Verzögerung des Fortschreitens von Typ-1-Diabetes. Das Unternehmen meldete Barmittel und Zahlungsmitteläquivalente in Höhe von 12,9 Millionen US-Dollar, was einem Rückgang von 20,8 Millionen US-Dollar im Dezember 2024 entspricht.

Zu den finanziellen Highlights zählen F&E-Ausgaben von 7,7 Millionen US-Dollar (Rückgang von 8,1 Millionen US-Dollar im Jahresvergleich), reduzierte Verwaltungs- und Gemeinkosten von 3,1 Millionen US-Dollar (Rückgang von 4,2 Millionen US-Dollar im Jahresvergleich) und sonstige Einnahmen von 5,6 Millionen US-Dollar. Das Unternehmen meldete einen Nettoverlust von 5,2 Millionen US-Dollar. SAB BIO erreichte zudem einen bedeutenden Meilenstein, indem es eine Qualified Person-Erklärung für seinen internen CMC-Herstellungsprozess erhielt, wodurch die Einhaltung der europäischen Herstellungsstandards für bevorstehende EU-Studien gewährleistet ist.

Positive
  • Successful completion of Phase 1 clinical study patient dosing for SAB-142
  • Obtained QP declaration for in-house manufacturing, enabling EU clinical trials
  • Reduced G&A expenses by 26% YoY to $3.1 million
  • Slight decrease in R&D expenses while maintaining research priorities
Negative
  • Cash position decreased 38% from $20.8M to $12.9M in one quarter
  • Net loss increased to $5.2M from $5.0M YoY
  • Other income decreased from $6.4M to $5.6M YoY

Insights

SAB BIO's Q1 results show concerning cash burn despite cost reductions, with disappointing T1D pipeline progress and worsening net loss.

SAB BIO's Q1 2025 financials reveal several concerning trends despite management's positive framing. The company's $12.9 million cash position represents a significant 38% reduction from the $20.8 million reported just one quarter ago at the end of 2024. At the current quarterly burn rate, this suggests only about 2-3 quarters of operational runway without additional financing.

The modest 5% year-over-year reduction in R&D expenses (from $8.1 million to $7.7 million) is insufficient to meaningfully extend runway given their cash position. While their cost-saving initiatives yielded more substantial results in G&A – down 26% from $4.2 million to $3.1 million – these reductions weren't enough to prevent an increased net loss of $5.2 million compared to $5.0 million in Q1 2024.

The pipeline update lacks substantive clinical advancement details. While patient dosing concluded in the last cohort of their Phase 1 SAB-142 study, the company shared no efficacy signals or safety profile information, despite the CEO referencing "recent positive Phase 1 topline data." This vague characterization without supporting data points raises questions.

The QP declaration for in-house manufacturing processes represents regulatory progress, but this manufacturing optimization appears primarily cost-driven rather than enhancing product quality. While this could theoretically improve margins in the long term, the immediate priority should be addressing the rapidly diminishing cash reserves to sustain operations through meaningful clinical milestones.

MIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced financial results for the quarter ending March 31, 2025, and reported on recent developments.

Samuel J. Reich, Chairman and CEO of SAB BIO, stated, “We have made strong progress this quarter on our corporate strategy and mission to deliver a transformational therapy that can halt or delay the progression of type 1 diabetes. Based on our recent positive Phase 1 topline data for SAB-142, we have seen accelerating momentum across the T1D landscape regarding the therapeutic potential of SAB-142.”

Recent Pipeline Developments

  • In April 2025, SAB BIO concluded patient dosing in the last cohort of the Phase 1 clinical study of SAB-142.

Corporate Updates from Q1 2025

  • FY 2024 budget initiatives are now contributing to cost savings focusing on improvements to the Company’s manufacturing processes for scaled-batch manufacturing. The Company anticipates these initiatives will contribute to continued efficiencies across the Company’s financial performance in 2025.
  • The Company has successfully obtained a Qualified Person (QP) declaration for SAB BIO’s in-house CMC manufacturing process for SAB-142. This milestone represents a key cGMP compliance achievement enabling SAB BIO to meet European manufacturing standards for an investigational medical drug product (IMPD) designated for upcoming clinical trials in the EU. 

Q1 2025 Financial Results

  • SAB BIO held cash and equivalents of $12.9 million as of March 31, 2025, compared to $20.8 million as of December 31, 2024.
  • R&D expenses were $7.7 million and $8.1 million for the three months ended March 31, 2025 and March 31, 2024, respectively. The modest decline resulted from the fluctuation of priority spending for the SAB-142 program, a disease-modifying human hIgG aimed at preventing onset or disease progression of T1D.
  • General and administrative expenses were $3.1 million and $4.2 million for the three months ended March 31, 2025 and March 31, 2024, respectively. This decrease was driven by reduced payroll related costs and professional fees in order to prioritize the Company’s continued research activities and development of its product candidates.
  • Other income of $5.6 million and $6.4 million for the three months ended March 31, 2025 and March 31, 2024, respectively. This decrease was primarily due to the change in fair value of warrant liabilities and reduced net interest income.
  • SAB BIO reported a net loss of $5.2 million and $5.0 million for the three months ended March 31, 2025 and March 31, 2024, respectively.

About SAB BIO

SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing 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 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 BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, 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 BIO, visit: https://www.SAB.bio/ and follow SAB BIO on Twitter/X and LinkedIn.

Forward-Looking Statements

Certain statements made in this current report 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 data, development, clinical results, and efficacy of our T1D program and other discovery programs, the Company’s ability to raise additional funds on favorable terms, financial projections and future financial and operating results (including estimated cost savings and cash runway), the impact of existing or potential tariffs or changes to federal government priorities on the Company’s business and operations, and the outcome of current or potential future government and other third-party collaborations or funded programs.

These statements are based on the current expectations of SAB BIO 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, 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 BIO 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

Media Relations:
Kaelan Hollon
Vice President of Communications
khollon@sab.bio

Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com


FAQ

What were SAB BIO's (SABS) key financial results for Q1 2025?

SAB BIO reported cash and equivalents of $12.9M, R&D expenses of $7.7M, G&A expenses of $3.1M, and a net loss of $5.2M for Q1 2025.

What is the status of SAB BIO's SAB-142 clinical trials?

SAB BIO completed patient dosing in the last cohort of the Phase 1 clinical study of SAB-142, their immunotherapy treatment for type 1 diabetes.

How much did SAB BIO's (SABS) cash position change in Q1 2025?

SAB BIO's cash position decreased from $20.8 million as of December 31, 2024, to $12.9 million as of March 31, 2025.

What regulatory milestone did SAB BIO achieve for European trials?

SAB BIO obtained a Qualified Person (QP) declaration for their in-house CMC manufacturing process, enabling them to meet European manufacturing standards for clinical trials in the EU.

How did SAB BIO's operating expenses change in Q1 2025 compared to Q1 2024?

G&A expenses decreased from $4.2M to $3.1M, and R&D expenses slightly decreased from $8.1M to $7.7M compared to Q1 2024.
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