Senti Bio Reports First Quarter 2025 Financial Results and Provides a Corporate Update on Positive SENTI-202 Clinical Development
The trial showed SENTI-202 was well-tolerated with 4 out of 7 patients achieving composite Complete Remission (cCR). All cCR patients were MRD negative and maintained responses ranging from 4+ to 8+ months. The preliminary recommended Phase 2 dose was identified at 1.5 x 109 CAR NK cells.
Financial results for Q1 2025 showed cash and cash equivalents of $33.8 million. R&D expenses increased to $9.3 million from $8.8 million year-over-year, while G&A expenses decreased to $7.1 million from $7.5 million. The company reported a net loss of $14.1 million ($1.41 per share).
Lo studio ha dimostrato che SENTI-202 è stato ben tollerato con 4 pazienti su 7 che hanno raggiunto una remissione completa composita (cCR). Tutti i pazienti con cCR erano negativi per MRD e hanno mantenuto la risposta da oltre 4 fino a oltre 8 mesi. La dose preliminare raccomandata per la fase 2 è stata identificata in 1,5 x 10^9 cellule CAR NK.
I risultati finanziari del primo trimestre 2025 hanno mostrato liquidità e equivalenti di cassa per 33,8 milioni di dollari. Le spese di ricerca e sviluppo sono aumentate a 9,3 milioni di dollari rispetto agli 8,8 milioni dell'anno precedente, mentre le spese generali e amministrative sono diminuite a 7,1 milioni rispetto a 7,5 milioni. La società ha riportato una perdita netta di 14,1 milioni di dollari (1,41 dollari per azione).
El ensayo mostró que SENTI-202 fue bien tolerado con 4 de 7 pacientes logrando remisión completa compuesta (cCR). Todos los pacientes con cCR fueron negativos para MRD y mantuvieron respuestas que oscilaron entre más de 4 y más de 8 meses. La dosis preliminar recomendada para la fase 2 se identificó en 1.5 x 10^9 células CAR NK.
Los resultados financieros del primer trimestre de 2025 mostraron efectivo y equivalentes de efectivo por 33.8 millones de dólares. Los gastos en I+D aumentaron a 9.3 millones desde 8.8 millones año tras año, mientras que los gastos generales y administrativos disminuyeron a 7.1 millones desde 7.5 millones. La compañía reportó una pérdida neta de 14.1 millones de dólares (1.41 dólares por acción).
임상시험에서 SENTI-202는 잘 견뎌졌으며 7명 중 4명이 복합 완전 관해(cCR)를 달성했습니다. 모든 cCR 환자는 MRD 음성이었으며 4개월 이상에서 8개월 이상까지 반응을 유지했습니다. 2상 권장 초기 투여 용량은 1.5 x 10^9 CAR NK 세포로 확인되었습니다.
2025년 1분기 재무 결과는 현금 및 현금성 자산 3,380만 달러를 보여주었습니다. 연구개발비는 전년 동기 대비 880만 달러에서 930만 달러로 증가했으며, 일반관리비는 750만 달러에서 710만 달러로 감소했습니다. 회사는 1,410만 달러(주당 1.41달러)의 순손실을 보고했습니다.
L’essai a montré que SENTI-202 était bien toléré avec 4 patients sur 7 ayant atteint une rémission complète composite (cCR). Tous les patients en cCR étaient négatifs pour la maladie résiduelle minimale (MRD) et ont maintenu leur réponse entre plus de 4 et plus de 8 mois. La dose préliminaire recommandée pour la phase 2 a été identifiée à 1,5 x 10^9 cellules CAR NK.
Les résultats financiers du premier trimestre 2025 ont révélé 33,8 millions de dollars en liquidités et équivalents de trésorerie. Les dépenses en R&D ont augmenté à 9,3 millions de dollars contre 8,8 millions l’an passé, tandis que les frais généraux et administratifs ont diminué à 7,1 millions contre 7,5 millions. La société a enregistré une perte nette de 14,1 millions de dollars (1,41 dollar par action).
Die Studie zeigte, dass SENTI-202 gut verträglich war, wobei 4 von 7 Patienten eine zusammengesetzte komplette Remission (cCR) erreichten. Alle cCR-Patienten waren MRD-negativ und hielten die Ansprechraten von über 4 bis über 8 Monate aufrecht. Die vorläufig empfohlene Dosis für Phase 2 wurde mit 1,5 x 10^9 CAR-NK-Zellen festgelegt.
Die Finanzergebnisse für Q1 2025 zeigten Barmittel und Zahlungsmitteläquivalente in Höhe von 33,8 Millionen US-Dollar. Die F&E-Ausgaben stiegen im Jahresvergleich von 8,8 auf 9,3 Millionen US-Dollar, während die Verwaltungs- und Vertriebskosten von 7,5 auf 7,1 Millionen US-Dollar sanken. Das Unternehmen meldete einen Nettoverlust von 14,1 Millionen US-Dollar (1,41 US-Dollar pro Aktie).
- Strong efficacy data with 4 of 7 patients achieving composite Complete Remission (cCR)
- All cCR patients maintained responses for 4+ to 8+ months and were MRD negative
- SENTI-202 demonstrated good tolerability with no dose limiting toxicities
- 3 patients successfully proceeded to bone marrow transplant after SENTI-202 treatment
- Increased R&D expenses by $0.5 million year-over-year
- Net loss of $14.1 million in Q1 2025
- Limited cash position of $33.8 million may require additional funding
Insights
Senti's SENTI-202 shows promising early efficacy in AML with 4/7 patients achieving complete remission and MRD negativity with 4-8+ months durability.
The Phase 1 results for SENTI-202 in relapsed/refractory AML represent a potentially significant development. The 57% complete remission rate (4 of 7 patients) is noteworthy for this difficult-to-treat population. Even more impressive is that all 4 responders achieved MRD negativity as assessed by local standard of care, which correlates with better long-term outcomes in AML.
The durability of responses ranging from 4+ to 8+ months ongoing is particularly encouraging. For context, many patients with relapsed/refractory AML typically progress within months of treatment. The fact that 3 patients proceeded to bone marrow transplant after SENTI-202 suggests it may serve as an effective bridge to potentially curative therapy - a valuable clinical pathway.
The identification of a preliminary recommended Phase 2 dose of 1.5 x 109 CAR NK cells administered on Days 0, 7, 14 in 28-day cycles following lymphodepletion represents an important milestone. The favorable safety profile with no dose-limiting toxicities is notable for a cell therapy, as many similar approaches often encounter significant toxicity challenges.
Senti's Logic-Gated approach is designed to enhance specificity by engineering cells to recognize multiple cancer-associated antigens while sparing healthy tissues. This potentially addresses a fundamental challenge in cell therapy - reducing on-target/off-tumor effects. The potential application to both liquid and solid tumors could significantly expand the platform's value if further validated.
While these results are promising, it's important to recognize the small patient sample and early nature of the data. However, the combination of response rate, MRD negativity, and durability in this difficult disease setting certainly warrants continued development and close attention.
Positive clinical data supports Senti's platform technology, but $33.8M cash position with $16.4M quarterly burn creates near-term financing pressure.
Examining Senti's Q1 2025 financials reveals both opportunities and challenges. With $33.8 million in cash and a net loss of $14.1 million for the quarter, the company's runway appears constrained without additional financing. The combined R&D and G&A expenses of $16.4 million per quarter suggests approximately two quarters of operational funding remains.
The slight increase in R&D expenses ($9.3 million vs $8.8 million YoY) reflects continued investment in their clinical programs, while the reduction in G&A costs ($7.1 million vs $7.5 million YoY) demonstrates some operational efficiency efforts. The $1.41 loss per share indicates significant dilution will likely be required for future financing rounds.
Despite these financial constraints, the promising SENTI-202 clinical data represents a significant validation of their Gene Circuit platform technology. The demonstration of efficacy in a challenging indication like AML potentially increases the company's partnering value and could attract strategic investment.
The company's increased investor relations activities, including joining the Webull Corporate Connect Service and participating in KOL discussions, suggests management is working to build market awareness - typically a precursor to financing activities.
The broader application potential of their Logic-Gated cell therapy approach across liquid and solid tumors could enhance long-term value creation if successfully developed. However, the capital-intensive nature of advancing multiple clinical programs will require substantial additional funding.
The key near-term catalyst remains continued data from the SENTI-202 program, particularly confirmation of the preliminary RP2D and results from the expansion cohorts. Success could strengthen the company's position for financing or partnership discussions, which will be essential for continued operations beyond 2025.
Positive Phase 1 data from lead program, SENTI-202, recently presented at the AACR Annual Meeting:
SENTI-202 was generally well tolerated, preliminary RP2D identified;
4 of 7 patients achieved composite Complete Remission (cCR) (3 CR, 1CRh), all 4 cCR patients were measurable residual disease (MRD) negative as assessed by local standard of care;
All cCR patients maintaining responses, from 4+ to 8+ months ongoing
Ongoing enrollment in Phase 1 SENTI-202 study to confirm the preliminary recommended Phase 2 dose (RP2D) followed by disease specific expansion cohorts
Logic-Gated cell therapy approach may have the potential for broad liquid and solid tumor applications, providing multiple pipeline expansion opportunities
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the first quarter of 2025 and provided a summary of recent pipeline and corporate highlights.
“We continue to be encouraged by our SENTI-202 data and strongly believe in its potential to provide a much-needed treatment option for patients with AML. Notably, our recent data at AACR showed early deep responses seen with SENTI-202 across dose levels, with 4+ to 8+ months of durability noted and growing. We are pleased with the progress made to date, with our team remaining focused on the successful execution of this trial and further SENTI-202 development,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “Beyond our prioritized SENTI-202 program in AML, we are continuing to advance our potential best-in-class Logic-Gated programs with additional discovery efforts for solid tumors, in order to continue building value in the near and long-term.”
RECENT PIPELINE AND CORPORATE UPDATES
New Positive Data for Lead Program SENTI-202 Drives Confidence as a Potential Treatment Option for Acute Myeloid Leukemia (AML): The Company presented positive data from its ongoing Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including AML at the recently held American Association for Cancer Research (AACR) Annual Meeting 2025. The presented data also included correlative data from patients and preclinical data supporting Logic Gate mechanism of action.
As previously announced, SENTI-202 was well-tolerated with no dose limiting toxicities and a maximum tolerated dose was not reached. The preliminary recommended Phase 2 dose (RP2D) was identified based on the totality of clinical data, including efficacy, as 1.5 x 109 CAR NK cells administered on Days 0,7,14 in 28-day Cycles following lymphodepleting chemotherapy. 2 of 3 patients in the preliminary RP2D cohort achieved a composite Complete Remission (cCR); 5 of the 7 best overall response evaluable patients achieved an ORR (cCR + morphologic leukemia-free state) outcome and 4 of the 7 achieved cCR (3 CR with full hematologic recovery, and 1 CRh (CR with partial hematologic recovery)). 4 of 4 cCR patients were MRD- (Measurable Residual Disease Negative) as assessed by local standard of care. All cCR patients continue in remission with follow-ups ranging from 4+ to 8+ months ongoing, and 3 patients received a bone marrow transplant after treatment with SENTI-202. To access a replay of the webcast, click here.
Continued Activities Towards Building Market Awareness and Increasing Visibility Among Investors:
- Joined the Webull Corporate Connect Service (CCS) platform to provide an additional line of communication for shareholders and interested investors and to enhance transparency with its growing shareholder base. Connect with the Company on Webull here.
- Participated in moderated discussion with Stephen Strickland, MD, MSCI, internationally respected leukemia researcher, Director of Leukemia Research for Sarah Cannon Research Institute and Kanya Rajangam, MD, PhD, President, Head of R&D and Chief Medical Officer of Senti Bio. The KOL Connect segment replay is available here.
- Participated in a Virtual Investor Closing Bell segment where Dr. Lu, and Dr. Rajangam provided a corporate overview with a question and answer session. The Closing Bell replay is available here.
FIRST QUARTER 2025 FINANCIAL RESULTS
- Cash and Cash Equivalents: As of March 31, 2025, Senti Bio held cash and cash equivalents of approximately
$33.8 million . - R&D Expenses: Research and development expenses were
$9.3 million and$8.8 million for the three months ended March 31, 2025 and 2024, respectively. The increase of$0.5 million was primarily due to an increase of$1.4 million in external services and supplies cost, offset by a decrease of$0.8 million in personnel-related expenses, including stock-based compensation and$0.2 million in facilities and other costs. - G&A Expenses: General and administrative expenses were
$7.1 million and$7.5 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of$0.4 million was primarily due to a decrease of$0.9 million in personnel-related expenses offset by an increase of$0.5 million in external services and supplies costs. - Net Loss: Net loss was
$14.1 million , or$1.41 per basic and diluted share, for the three months ended March 31, 2025.
About Senti Bio
Senti Bio is a biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging its synthetic biology platform to engineer Gene Circuits into new medicines with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. The Company’s wholly-owned pipeline is comprised of cell therapies engineered with Gene Circuits to target challenging liquid and solid tumor indications. Senti’s Gene Circuits have been shown preclinically to work in both NK and T cells. Senti Bio has also preclinically demonstrated the potential breadth of Gene Circuits in other modalities and diseases outside of oncology, and continues to advance these capabilities through partnerships.
Forward-Looking Statements
This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s growth, strategy, progress and timing of its clinical trials for SENTI-202;the timing of availability of data from the ongoing Phase 1 clinical trial of SENTI-202; the ability of any product candidate to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; expectations regarding the anticipated dosing of patients and availability of data from clinical trials, and the timing thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s clinical trial start up, clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of the grant from CIRM, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Availability of Other Information About Senti Biosciences, Inc.
For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (@SentiBio) and LinkedIn (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
| Senti Biosciences, Inc. Unaudited Selected Consolidated Balance Sheet Data (in thousands) | |||||
| March 31, | December 31, | ||||
| 2025 | 2024 | ||||
| Cash and cash equivalents | $ | 33,802 | $ | 48,277 | |
| Total assets | 82,778 | 97,841 | |||
| Total liabilities | 44,919 | 47,086 | |||
| Series A redeemable convertible preferred stock | — | 25,106 | |||
| Total stockholders’ equity | 37,859 | 25,649 | |||
| Senti Biosciences, Inc. Unaudited Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| Operating expenses: | |||||||
| Research and development (including related party costs of | $ | 9,281 | $ | 8,779 | |||
| General and administrative | 7,116 | 7,522 | |||||
| Total operating expenses | 16,397 | 16,301 | |||||
| Loss from operations | (16,397 | ) | (16,301 | ) | |||
| Other income: | |||||||
| Interest income | 394 | 331 | |||||
| GeneFab sublease income - related party | 1,713 | 1,461 | |||||
| Other income | 178 | — | |||||
| Change in fair value of GeneFab Option - related party | — | 2,314 | |||||
| Change in fair value of GeneFab Economic Share - related party | — | 55 | |||||
| Change in fair value of GeneFab Note Receivable - related party | — | 29 | |||||
| Total other income | 2,285 | 4,190 | |||||
| Net loss | $ | (14,112 | ) | $ | (12,111 | ) | |
| Comprehensive loss | $ | (14,112 | ) | $ | (12,111 | ) | |
| Basic and diluted net loss | $ | (14,112 | ) | $ | (12,111 | ) | |
| Basic and diluted net loss per share | $ | (1.41 | ) | $ | (2.65 | ) | |
| Basic and diluted weighted-average number of shares used in computing net loss per share | 10,012,908 | 4,570,744 | |||||
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
SNTI@jtcir.com
FAQ
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