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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 societ脿 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鈥檃zienda ha riportato liquidit脿 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 societ脿 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 cos矛 di soddisfare gli standard europei di produzione per i prossimi trial clinici nell鈥橴E.

SAB BIO (NASDAQ: SABS) ha reportado sus resultados financieros del primer trimestre de 2025 y actualizaciones de la empresa. La compa帽铆a biofarmac茅utica en etapa cl铆nica complet贸 la dosificaci贸n de pacientes en la 煤ltima cohorte del estudio cl铆nico de Fase 1 de SAB-142, su novedosa inmunoterapia para retrasar la progresi贸n de la diabetes tipo 1. La empresa inform贸 de efectivo y equivalentes por 12,9 millones de d贸lares, una disminuci贸n desde los 20,8 millones en diciembre de 2024.

Los aspectos financieros destacados incluyen gastos en I+D por 7,7 millones de d贸lares (menos que 8,1 millones interanuales), gastos generales y administrativos reducidos a 3,1 millones de d贸lares (desde 4,2 millones interanuales) y otros ingresos por 5,6 millones de d贸lares. La compa帽铆a report贸 una p茅rdida neta de 5,2 millones de d贸lares. SAB BIO tambi茅n alcanz贸 un hito importante al obtener una declaraci贸n de Persona Calificada para su proceso de fabricaci贸n CMC interno, lo que les permite cumplir con los est谩ndares europeos de fabricaci贸n para los pr贸ximos ensayos cl铆nicos en la UE.

SAB BIO (NASDAQ: SABS)電� 2025雲� 1攵勱赴 鞛 瓴瓣臣鞕 須岇偓 鞐呺嵃鞚错姼毳� 氚滍憸頄堨姷雼堧嫟. 鞛勳儊 雼硠 氚旍澊鞓れ牅鞎� 須岇偓電� 1順� 雼闺嚚氤� 歆勴枆 歆鞐办潉 鞙勴暅 鞁犼皽雲� 氅挫棴旃橂鞝滌澑 SAB-142 1靸� 鞛勳儊鞁滍棙鞚� 毵堨毵� 頇橃瀽 韴棳毳� 鞕勲頄堨姷雼堧嫟. 須岇偓電� 毳� 氤搓碃頄堨溂氅�, 鞚措姅 2024雲� 12鞗旍潣 2,080毵� 雼煬鞐愳劀 臧愳唽頃� 靾橃箻鞛呺媹雼�.

鞛 欤检殧 雮挫毄鞙茧電� 鞐瓣惮臧滊皽牍勱皜 (鞝勲厔 霃欔赴 雽牍� 810毵� 雼煬鞐愳劀 臧愳唽), 鞚茧皹甏毽箘臧 (鞝勲厔 霃欔赴 雽牍� 420毵� 雼煬鞐愳劀 臧愳唽), 旮绊儉 靾橃澋鞚� 搿� 雮橅儉雮姷雼堧嫟. 須岇偓電� 靾滌啇鞁� 毳� 旮半頄堨姷雼堧嫟. SAB BIO電� 鞛愳泊 CMC 鞝滌“ 瓿奠爼鞐� 雽頃� 鞛愱博 鞛堧姅 雼措嫻鞛�(Qualified Person) 靹犾柛鞚� 須嶋摑頃橂姅 欷戩殧頃� 鞚挫爼響滊弰 雼劚頄堨溂氅�, 鞚措ゼ 韱淀暣 雼り皜鞓る姅 EU 鞛勳儊鞁滍棙鞚� 鞙勴暅 鞙犽熃 鞝滌“ 旮办鞚� 於╈”頃� 靾� 鞛堦矊 霅橃棃鞀惦媹雼�.

SAB BIO (NASDAQ : SABS) a publi茅 ses r茅sultats financiers du premier trimestre 2025 ainsi que des mises 脿 jour de l鈥檈ntreprise. La soci茅t茅 biopharmaceutique en phase clinique a termin茅 le traitement des patients dans la derni猫re cohorte de l鈥�茅tude clinique de phase 1 de SAB-142, leur nouvelle immunoth茅rapie visant 脿 retarder la progression du diab猫te de type 1. L鈥檈ntreprise a d茅clar茅 disposer de 12,9 millions de dollars en liquidit茅s et 茅quivalents, en baisse par rapport 脿 20,8 millions en d茅cembre 2024.

Les points financiers cl茅s incluent des d茅penses en R&D de 7,7 millions de dollars (en baisse par rapport 脿 8,1 millions sur un an), des frais g茅n茅raux et administratifs r茅duits 脿 3,1 millions de dollars (contre 4,2 millions sur un an) et d鈥檃utres revenus de 5,6 millions de dollars. La soci茅t茅 a enregistr茅 une perte nette de 5,2 millions de dollars. SAB BIO a 茅galement franchi une 茅tape importante en obtenant une d茅claration de Personne Qualifi茅e pour son processus de fabrication CMC interne, ce qui lui permet de respecter les normes europ茅ennes de fabrication pour les prochains essais cliniques dans l鈥橴E.

SAB BIO (NASDAQ: SABS) hat seine Finanzergebnisse f眉r das erste Quartal 2025 und Unternehmensupdates ver枚ffentlicht. 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 Verz枚gerung des Fortschreitens von Typ-1-Diabetes. Das Unternehmen meldete Barmittel und Zahlungsmittel盲quivalente in H枚he von 12,9 Millionen US-Dollar, was einem R眉ckgang von 20,8 Millionen US-Dollar im Dezember 2024 entspricht.

Zu den finanziellen Highlights z盲hlen F&E-Ausgaben von 7,7 Millionen US-Dollar (R眉ckgang von 8,1 Millionen US-Dollar im Jahresvergleich), reduzierte Verwaltungs- und Gemeinkosten von 3,1 Millionen US-Dollar (R眉ckgang 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-Erkl盲rung f眉r seinen internen CMC-Herstellungsprozess erhielt, wodurch die Einhaltung der europ盲ischen Herstellungsstandards f眉r bevorstehende EU-Studien gew盲hrleistet 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 鈥� down 26% from $4.2 million to $3.1 million 鈥� 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:聽), (鈥淪AB BIO鈥� or the 鈥淐ompany鈥�), 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, 鈥淲e 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.鈥�

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鈥檚 manufacturing processes for scaled-batch manufacturing. The Company anticipates these initiatives will contribute to continued efficiencies across the Company鈥檚 financial performance in 2025.
  • The Company has successfully obtained a Qualified Person (QP) declaration for SAB BIO鈥檚 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.聽

Q1 2025 Financial Results

  • SAB BIO聽held cash and equivalents of聽$12.9 million聽as of聽March 31, 2025, compared to聽$20.8 million聽as of December 31, 2024.
  • R&D expenses were聽$7.7 million听补苍诲听$8.1 million聽for the three months ended聽March 31, 2025听补苍诲听March 31, 2024,聽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聽$3.1 million听补苍诲听$4.2 million聽for the three months ended聽March 31, 2025听补苍诲听March 31, 2024,聽respectively. This decrease was driven by reduced payroll related costs and professional fees in order to prioritize the Company鈥檚 continued research activities and development of its product candidates.
  • Other income of聽$5.6 million听补苍诲 $6.4 million for the three months ended聽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聽BIO reported a net loss of聽$5.2 million听补苍诲听$5.0 million聽for the three months ended聽March 31, 2025听补苍诲听March 31, 2024,聽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鈥檚 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鈩�, the only transgenic animal with a human artificial chromosome, SAB BIO鈥檚 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 and .

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 鈥渂elieve,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渢o be,鈥� 鈥渆stimate,鈥� 鈥渃ontinue,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥渆xpect,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減otential,鈥� 鈥渟eem,鈥� 鈥渟eek,鈥� 鈥渇uture,鈥� 鈥渙utlook,鈥� 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鈥檚 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鈥檚 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鈥檚 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 鈥淩isk Factors鈥� 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

Investor Relations:
Kevin Gardner
LifeSci Advisors

Chris Calabrese
LifeSci Advisors


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.
SAB BIOTHERAPEUTICS INC

NASDAQ:SABS

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23.22M
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Biotechnology
Biological Products, (no Disgnostic Substances)
United States
MIAMI BEACH