SAB BIO Reports Second Quarter Financial Results and Highlights Company Updates
SAB BIO (Nasdaq: SABS) has announced significant developments in Q2 2025, highlighted by a $175 million oversubscribed private placement that included strategic investor Sanofi. The financing extends the company's operational runway until mid-2028 and will fully fund their pivotal Phase 2b SAFEGUARD study for SAB-142, their lead candidate for delaying type 1 diabetes progression.
The company achieved FDA alignment on the SAFEGUARD study design, scheduled to begin in Q3 2025. The private placement included issuing 1 million shares of Series B preferred stock at $1.75 per share conversion price, plus warrants for potential additional proceeds of $284 million.
Financial results showed cash position of $5.7 million as of June 30, 2025, with Q2 R&D expenses at $7.0 million and a net loss of $10.1 million.
SAB BIO (Nasdaq: SABS) ha annunciato importanti sviluppi nel secondo trimestre 2025, con un private placement da 175 milioni di dollari, oltre la domanda prevista, che ha visto la partecipazione dell'investitore strategico Sanofi. Questo finanziamento estende la capacità operativa dell'azienda fino a metà 2028 e coprirà completamente lo studio pivotale di Fase 2b SAFEGUARD per SAB-142, il loro candidato principale per rallentare la progressione del diabete di tipo 1.
L'azienda ha ottenuto l'approvazione della FDA sul disegno dello studio SAFEGUARD, previsto per iniziare nel terzo trimestre 2025. Il private placement ha previsto l'emissione di 1 milione di azioni privilegiate di Serie B a un prezzo di conversione di 1,75 dollari per azione, oltre a warrant che potrebbero generare ulteriori proventi per un totale di 284 milioni di dollari.
I risultati finanziari mostrano una posizione di cassa di 5,7 milioni di dollari al 30 giugno 2025, con spese di R&S nel secondo trimestre pari a 7,0 milioni di dollari e una perdita netta di 10,1 milioni di dollari.
SAB BIO (Nasdaq: SABS) ha anunciado avances significativos en el segundo trimestre de 2025, destacando una colocación privada sobresuscrita de 175 millones de dólares que incluyó al inversor estratégico Sanofi. Esta financiación extiende el periodo operativo de la empresa hasta mediados de 2028 y financiará completamente su estudio pivotal de Fase 2b SAFEGUARD para SAB-142, su candidato principal para retrasar la progresión de la diabetes tipo 1.
La compañía logró la aprobación de la FDA para el diseño del estudio SAFEGUARD, que está programado para comenzar en el tercer trimestre de 2025. La colocación privada incluyó la emisión de 1 millón de acciones preferentes Serie B a un precio de conversión de 1,75 dólares por acción, además de warrants para posibles ingresos adicionales de 284 millones de dólares.
Los resultados financieros mostraron una posición de caja de 5,7 millones de dólares al 30 de junio de 2025, con gastos en I+D en el segundo trimestre de 7,0 millones de dólares y una pérdida neta de 10,1 millones de dólares.
SAB BIO (나스닥: SABS)는 2025년 2분기에 중요한 발전을 발표했으며, 전략적 투자자인 Sanofi가 참여한 1억 7,500만 달러 초과 청약 사모 발행이 주요 내용입니다. 이번 자금 조달로 회사의 운영 기간이 2028년 중반까지 연장되었으며, 제1형 당뇨병 진행 지연을 목표로 하는 주력 후보물질 SAB-142의 중추적 2b상 SAFEGUARD 연구를 전액 지원할 예정입니다.
회사는 2025년 3분기 시작 예정인 SAFEGUARD 연구 설계에 대해 FDA와 합의를 이뤘습니다. 사모 발행에는 주당 전환가 1.75달러로 시리즈 B 우선주 100만 주 발행과 함께 최대 2억 8,400만 달러의 추가 자금 조달 가능성을 가진 워런트가 포함되었습니다.
재무 결과에 따르면 2025년 6월 30일 기준 현금 보유액 570만 달러이며, 2분기 연구개발비는 700만 달러, 순손실은 1,010만 달러였습니다.
SAB BIO (Nasdaq : SABS) a annoncé des développements importants au deuxième trimestre 2025, notamment un placement privé sursouscrit de 175 millions de dollars incluant l'investisseur stratégique Sanofi. Ce financement prolonge la trésorerie opérationnelle de la société jusqu'à mi-2028 et financera intégralement leur étude pivot de phase 2b SAFEGUARD pour SAB-142, leur principal candidat pour ralentir la progression du diabète de type 1.
L'entreprise a obtenu l'accord de la FDA sur le design de l'étude SAFEGUARD, prévue pour débuter au troisième trimestre 2025. Le placement privé comprenait l'émission de 1 million d'actions préférentielles de série B à un prix de conversion de 1,75 dollar par action, ainsi que des bons de souscription pouvant générer des recettes supplémentaires potentielles de 284 millions de dollars.
Les résultats financiers montrent une trésorerie de 5,7 millions de dollars au 30 juin 2025, avec des dépenses en R&D au deuxième trimestre de 7,0 millions de dollars et une perte nette de 10,1 millions de dollars.
SAB BIO (Nasdaq: SABS) hat im zweiten Quartal 2025 bedeutende Fortschritte bekannt gegeben, darunter eine überzeichnete Privatplatzierung in Höhe von 175 Millionen US-Dollar, an der der strategische Investor Sanofi beteiligt war. Die Finanzierung verlängert die operative Laufzeit des Unternehmens bis Mitte 2028 und wird die entscheidende Phase-2b-Studie SAFEGUARD für SAB-142, den führenden Kandidaten zur Verzögerung des Fortschreitens von Typ-1-Diabetes, vollständig finanzieren.
Das Unternehmen erzielte eine FDA-Zustimmung zum Design der SAFEGUARD-Studie, die im dritten Quartal 2025 starten soll. Die Privatplatzierung umfasste die Ausgabe von 1 Million Vorzugsaktien der Serie B zu einem Umwandlungspreis von 1,75 US-Dollar pro Aktie sowie Warrants, die potenziell zusätzliche Erlöse von 284 Millionen US-Dollar ermöglichen.
Die Finanzergebnisse zeigten zum 30. Juni 2025 eine Barkasse von 5,7 Millionen US-Dollar, mit F&E-Ausgaben im zweiten Quartal von 7,0 Millionen US-Dollar und einem Nettoverlust von 10,1 Millionen US-Dollar.
- Raised $175 million in oversubscribed private placement with strategic investor Sanofi
- Extended cash runway until mid-2028
- Secured FDA alignment on Phase 2b SAFEGUARD study design
- Additional $284 million potential proceeds from milestone-based warrants
- Reduced G&A expenses from $3.6M to $2.7M year-over-year in Q2
- Net loss increased to $10.1M in Q2 2025 from $7.3M in Q2 2024
- Cash position declined to $5.7M from $20.8M at end of 2024
- Other income decreased significantly year-over-year
Insights
SAB BIO secures $175M funding led by Sanofi, advancing T1D therapy to Phase 2b with runway extended to 2028.
SAB BIO has made significant strides in strengthening its financial position and advancing its clinical pipeline. The company recently closed an oversubscribed $175 million private placement that included strategic investor Sanofi and several top-tier biotech investors. This substantial cash infusion extends the company's operational runway until mid-2028, providing nearly three years of additional funding security.
The financing structure is particularly noteworthy - the company issued 1 million shares of Series B nonvoting convertible preferred stock (convertible at
On the clinical front, SAB-142, the company's lead candidate for delaying progression of type 1 diabetes, has received alignment from the FDA for its pivotal Phase 2b SAFEGUARD study, scheduled to initiate in Q3 2025. The therapy is being positioned as a potentially disease-modifying treatment for Stage 3 type 1 diabetes patients, where symptoms first appear. The Phase 1 study has completed randomization in healthy volunteers and successfully enrolled participants with T1D, with final data expected in Q4 2025.
However, the company's financial results reveal some challenges. SAB BIO reported a net loss of
The involvement of Sanofi as a strategic investor is particularly significant, as it provides validation from an established pharmaceutical company and potentially opens doors for future commercialization partnerships if the therapy proves successful in clinical trials.
Recently raised
Strong cash position with completed financing extending operational runway until the middle of 2028
Achieved alignment with FDA on the design and advancement of Phase 2b SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) study following a constructive Type B meeting
SAFEGUARD study to initiate in Q3 2025
MIAMI, Aug. 07, 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 autoimmune type 1 diabetes (T1D), today announced financial results for the second quarter ending June 30, 2025, and reported on recent developments.
Samuel J. Reich, Chairman and CEO of SAB BIO, stated, “We are extremely pleased to have recently raised
Mr. Reich continued, “Our recently completed financing is a testament to the strength of our science and the compelling and positive Phase 1 data shared in January. We look forward to advancing our novel disease-modifying multi-specific therapy, SAB-142, into a pivotal Phase 2b study in the third quarter of 2025 and moving us closer to potentially offering a disease-modifying therapy for patients with Stage 3 type 1 diabetes, the clinical diagnostic stage where patients start to exhibit symptoms.”
Recent Corporate Highlights
- On July 21, 2025, the Company announced that it entered into a securities purchase agreement (the “Agreement”) with certain accredited and institutional investors to raise
$175 million upfront in gross proceeds in an oversubscribed private placement financing. - Proceeds are expected to fully fund completion of a pivotal SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune T1D in newly diagnosed T1D patients 5-40 years of age (Stage 3). The Company expects these proceeds to extend its cash runway into the middle of 2028.
- Pursuant to the terms of the Agreement, SAB BIO issued an aggregate of up to 1,000,000 shares of the Company’s Series B nonvoting convertible preferred stock, which are convertible into up to an aggregate of 100,000,000 shares of the Company’s common stock at a conversion price of
$1.75 per share. In addition, the Company issued warrants to purchase up to an aggregate of 1,500,000 shares of the Company’s Series B preferred stock, for up to an additional$284 million in gross proceeds if milestone-based warrants are exercised in full. - The private placement closed on July 22, 2025 and further information regarding the private placement can be found in the Company’s filings with the Securities and Exchange Commission, including a current report on Form 8-K which was filed on July 21, 2025.
Recent Clinical and Regulatory Updates
- Completed full randomization of Phase 1 study in healthy volunteers and successfully enrolled a cohort of participants with T1D to assess safety, tolerability, PK, and immunogenicity of SAB-142. Final data for this study is expected Q4 2025. Recruitment for the T1D cohort was achieved with collaboration from the Australasian T1D Immunotherapy Collaborative (ATIC) and Veritus Research.
- In May 2025, SAB BIO had a Type B meeting with the United States Food and Drug Administration (FDA) where the Company received Agency feedback and aligned on the progression and design of SAB-142’s SAFEGUARD study, which is estimated to initiate in Q3 2025. Following the meeting, the company confirmed plans to use this study as supportive evidence for future regulatory approvals.
Q2 2025 Financial Results
- SAB BIO held cash and equivalents of
$5.7 million as of June 30, 2025, compared to$20.8 million as of December 31, 2024. - R&D expenses were
$7.0 million and$6.8 million for the three months ended June 30, 2025 and 2024, respectively. R&D expenses were$14.7 million and$14.8 million for the six months ended June 30, 2025 and 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
$2.7 million and$3.6 million for the three months ended June 30, 2025 and 2024, respectively. General and administrative expenses were$5.8 million and$8.0 million for the six months ended June 30, 2025 and 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 (loss) of
$(0.4) million and$2.9 million for the three months ended June 30, 2025 and 2024, respectively. Other income of$5.2 million and$9.2 million for the six months ended June 30, 2025 and 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
$10.1 million and$7.3 million for the three months ended June 30, 2025 and 2024, respectively, and a net loss of$15.3 million and$12.4 million for the six months ended June 30, 2025 and 2024, respectively.
About SAB BIO
SAB BIO is 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 immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D 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.
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 statements about the Company’s expectations regarding the potential exercise of warrants issued in the private placement, the intended use of the net proceeds from the private placement, the Company’s expected cash runway, statements regarding the Company’s ability to fully fund its Phase 2b SAFEGUARD study, and the development, clinical trial results, and potential commercialization of the Company’s T1D program and other discovery 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
FAQ
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