Senti Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Reviews Recent Highlights
- Successful clearance of IND for SENTI-202 by the U.S. FDA in December 2023.
- Strategic collaboration with Celest Therapeutics for clinical development of SENTI-301A in China.
- Financially sound with $35.9 million in cash and anticipated receivables from GeneFab transaction.
- Focus on advancing SENTI-202 in the U.S. and SENTI-301A in China to bring new treatments to patients.
- Resource allocation efforts to streamline business operations and extend cash runway into Q1 2025.
- Net loss of $18.7 million for the quarter ended December 31, 2023, and $71.1 million for the full year.
- Increase in research & development expenses from $7.0 million to $9.1 million for Q4 2023 compared to 2022.
- General and administrative expenses of $9.3 million for Q4 2023 and $37.2 million for the full year 2023.
- Non-recurring $12.3 million gain from discontinued operations and $25.7 million impairment related to the GeneFab transaction affecting net loss.
Insights
The FDA's clearance of the IND for SENTI-202, a novel CAR-NK cell therapy for AML, represents a significant milestone for Senti Biosciences. The transition from preclinical to clinical stages is a pivotal moment for biotech firms, as it validates the therapeutic's potential and can significantly influence investor sentiment. The anticipated initiation of dosing in a Phase 1 trial presents an inflection point where early efficacy and durability data will be scrutinized for signs of clinical benefit and safety profile.
AML, being a high unmet medical need and the novelty of Logic Gated CAR-NK cell therapies, which aim to enhance specificity and reduce off-target effects, could position SENTI-202 as a disruptive force if clinical outcomes are positive. The therapeutic's progress will likely be monitored closely, as success in early trials could lead to partnership opportunities, licensing deals, or even buyout speculation, each carrying implications for stock volatility and liquidity.
However, the high costs associated with R&D in biotech, particularly in the cell and gene therapy space, can strain financial resources. Senti Bio's reported increase in R&D expenses from 2022 to 2023 reflects the typical trajectory as programs advance, but it also underscores the importance of strategic partnerships and the necessity of a solid cash runway, which Senti Bio estimates to extend into the first quarter of 2025.
Senti Bio's financial results highlight a common narrative in the biotech industry: significant R&D investments leading to net losses. The reported net loss widening from 2022 to 2023 can be attributed to increased R&D spending and an impairment charge related to leasehold improvements. However, the non-recurring gain from discontinued operations suggests a one-time financial boost that investors should not expect to recur.
Investors should note the company's cash position of $35.9 million, bolstered by an anticipated $18.9 million receivable from the GeneFab transaction. This liquidity is critical for sustaining operations without the immediate need for dilutive financing. Nonetheless, the dependency on certain conditions being met for the GeneFab receivable introduces an element of risk.
The stock market reaction to such news typically involves weighing the potential of the clinical pipeline against the financial health of the company. While the extended cash runway is reassuring, the inherent risks of drug development, such as trial failures or regulatory setbacks, persist and can rapidly alter the investment thesis. Therefore, monitoring the burn rate and pipeline progress remains paramount for evaluating Senti Bio's financial trajectory.
The biotech sector is known for its volatility, driven by binary events such as clinical trial results and regulatory approvals. Senti Bio's IND clearance for SENTI-202 places it within a competitive landscape where innovation and speed to market are key. The potential 'first-in-class' status of SENTI-202 may provide competitive advantages in the AML treatment domain, but it also faces the challenge of proving its efficacy and safety against existing treatments and other therapies in development.
The strategic focus on SENTI-202 and SENTI-301A and the scaling back of other programs, indicates a targeted allocation of resources, which is often well-received by investors seeking clear strategic direction. However, the biotech market is sensitive to both clinical and financial milestones. As such, the collaboration with Celest Therapeutics in China opens up a significant market for SENTI-301A and success there could serve as a catalyst for the company's valuation.
It is essential to contextualize Senti Bio's updates within broader market trends, including the increasing interest in cell and gene therapies. The company's strategic partnerships and prioritization of resources may be seen as a proactive approach to navigating a challenging financial landscape while pursuing innovative treatments with the potential to address unmet medical needs.
– IND for SENTI-202, a potential first-in-class logic-gated treatment for AML, cleared by the U.S. FDA; First patient dosing anticipated in the second quarter of 2024 –
– Cash and anticipated receivables from GeneFab transaction expected to fund operations into the first quarter of 2025 –
SOUTH SAN FRANCISCO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter and full year ended December 31, 2023.
“In 2023, we achieved several critical milestones including clearing our first Investigational New Drug application (“IND”) for SENTI-202, entering into a strategic collaboration agreement with Celest Therapeutics for the clinical development of SENTI-301A to treat solid tumors in China, and establishing a manufacturing partnership with GeneFab that will support the manufacturing of our oncology programs,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “We also made strategic decisions to focus our resources on advancing SENTI-202 in the U.S. and SENTI-301A in China through our partnership with Celest, with the goal of bringing new treatments to patients.”
Dr. Lu continued, “We will continue to advance our pipeline programs to demonstrate the potential of Gene Circuits including the clinical-scale manufacturing of chimeric antigen receptor natural killer (“CAR-NK”) cells. Additionally, we are continuing our efforts to develop next-generation cell and gene therapies in areas outside of oncology through our collaborations with Spark Therapeutics and BlueRock Therapeutics.”
CORPORATE UPDATES
Prioritization of clinical programs: In January 2024, Senti Bio announced plans to streamline its business operations and prioritize the clinical development of SENTI-202, a potential first-in-class, off-the-shelf Logic Gated CAR-NK investigational cell therapy for the treatment of acute myeloid leukemia (“AML”). Additionally, the Company will continue to support the clinical development activities of SENTI-301A for the treatment of advanced glypican 3 (“GPC3”)-expressing hepatocellular carcinoma (“HCC”) in China through its partnership with Celest Therapeutics (Shanghai) Co. Ltd (“Celest”). Strategic steps included the scaling back of all other research and development initiatives while continuing to support ongoing partnerships with Spark Therapeutics and BlueRock Therapeutics. The Company expects that these resource allocation efforts, combined with other expected receivables, will extend its cash runway into the first quarter of 2025.
PIPELINE HIGHLIGHTS
SENTI-202 for AML: In December 2023, Senti Bio announced the IND application for SENTI-202 was cleared by the U.S. Food and Drug Administration (“FDA”). The Phase 1 clinical trial will focus on relapsed/refractory AML patients in the U.S. and Australia. The Company anticipates the following from the Phase 1 clinical trial:
- First patient dosed in the second quarter of 2024
- Initial efficacy data by year-end 2024
- Initial durability data in 2025
SENTI-301A for HCC: In November 2023, Senti Bio announced a strategic collaboration agreement with Celest, a China-based biotechnology company, for the clinical development of SENTI-301A to treat solid tumors in China. Celest plans to enroll patients initially through a pilot trial in mainland China and expects to dose the first patient in the second quarter of 2024. SENTI-301A is a calibrated release (cr) IL-15 multi-armed off-the-shelf CAR-NK cell therapy designed for the treatment of GPC3-expressing tumors, including HCC, the most common type of primary liver cancer.
Fourth Quarter and Full Year 2023 Financial Results
- Cash, Cash Equivalents and Short-term Investments: As of December 31, 2023, Senti Bio held cash, cash equivalents and short-term investments of
$35.9 million . Cash, combined with the$18.9 million receivable from GeneFab, which is payable upon satisfaction of certain conditions, are expected to fund operations into the first quarter of 2025. - R&D Expenses: Research & development expenses were
$9.1 million for the quarter ended December 31, 2023, compared to$7.0 million for the same period in 2022. Research and development expenses for the year ended December 31, 2023, were$32.2 million , compared to$28.1 million in 2022. - G&A Expenses: General and administrative expenses were
$9.3 million for the fourth quarter of 2023, compared to$9.8 million for the same period in 2022. General and administrative expenses for the year ended December 31, 2023, were$37.2 million , compared to$38.2 million in 2022. - Net Loss: Net loss was
$18.7 million , or$0.42 per basic and diluted share, for the quarter ended December 31, 2023. Net loss for the year ended December 31, 2023, was$71.1 million , or$1.60 per share, compared to a net loss of$58.2 million , or$2.23 per share, in 2022. Net loss for the year ended December 31, 2023 included a non-recurring$12.3 million gain from discontinued operations, as well as a non-recurring$25.7 million impairment for leasehold improvements, both related to the GeneFab transaction.
About Senti Bio
Senti Biosciences 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 a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. The Company’s wholly-owned pipeline utilizes off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio has also preclinically demonstrated the potential breadth Gene Circuits in other modalities, diseases outside of oncology, and continues to advance these capabilities through partnerships with Spark Therapeutics and BlueRock Therapeutics.
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, Senti Bio’s expected cash runway into the first quarter of 2025; its anticipated receivables under its agreements with GeneFab; expectations regarding its growth, strategy, progress and timing of its clinical trials, including the anticipated dosing of patients and availability of data, and the timing thereof; the ability to initiate new clinical programs; the extent, timing and financial aspects of the reduction in workforce; as well as statements about the potential attributes and benefits of Senti Bio’s platform technology and the continuation of its collaborations with Spark Therapeutics and BlueRock Therapeutics and other collaboration and strategic partners. 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, and (ix) 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 Quarterly Report on Form 10-Q, filed with the SEC on November 14, 2023, and other documents filed by Senti Bio from time to time with the 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 https://www.sentibio.com or follow Senti Bio on Twitter (@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 Twitter and LinkedIn. The information that we post on our website or on Twitter 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 Bio Contacts
Investors: investors@sentibio.com
Media: media@sentibio.com
| Senti Biosciences, Inc. Unaudited Selected Consolidated Balance Sheet Data (in thousands) | |||||||
| December 31, | December 31, | ||||||
| 2023 | 2022 | ||||||
| Cash and cash equivalents | $ | 35,926 | $ | 57,621 | |||
| Short-term investments | — | 40,942 | |||||
| GeneFab receivable – related party | 17,592 | — | |||||
| GeneFab prepaid expenses – related party | 14,787 | — | |||||
| Restricted cash | 3,522 | 3,366 | |||||
| Property and equipment, net | 25,338 | 51,361 | |||||
| Operating lease right-of-use assets | 16,274 | 18,418 | |||||
| Total assets | 119,484 | 180,792 | |||||
| Total liabilities | 52,571 | 53,529 | |||||
| Total stockholders’ equity (deficit) | 66,913 | 127,263 | |||||
| Senti Biosciences, Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Total revenue | $ | — | $ | 59 | $ | 2,561 | $ | 4,286 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 9,122 | 7,037 | 32,150 | 28,145 | |||||||||||
| General and administrative | 9,305 | 9,816 | 37,176 | 38,225 | |||||||||||
| Impairment of long-lived assets | 271 | — | 25,962 | — | |||||||||||
| Total operating expenses | 18,698 | 16,853 | 95,288 | 66,370 | |||||||||||
| Loss from operations | (18,698 | ) | (16,794 | ) | (92,727 | ) | (62,084 | ) | |||||||
| Total other income (expense), net | 10 | 1,806 | 9,321 | 12,419 | |||||||||||
| Net loss from continuing operations | (18,688 | ) | (14,988 | ) | (83,406 | ) | (49,665 | ) | |||||||
| Net income (loss) from discontinued operations | (28 | ) | (3,222 | ) | 12,348 | (8,545 | ) | ||||||||
| Net loss | (18,716 | ) | (18,210 | ) | (71,058 | ) | (58,210 | ) | |||||||
| Other comprehensive gain (loss) | — | 1 | (1 | ) | 1 | ||||||||||
| Comprehensive loss | $ | (18,716 | ) | $ | (18,209 | ) | $ | (71,059 | ) | $ | (58,209 | ) | |||
| Net loss per share from continuing operations, basic and diluted | $ | (0.42 | ) | $ | (0.35 | ) | $ | (1.88 | ) | $ | (1.90 | ) | |||
| Net income (loss) per share from discontinued operations, basic and diluted | — | (0.07 | ) | 0.28 | (0.33 | ) | |||||||||
| Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (0.42 | ) | $ | (1.60 | ) | $ | (2.23 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 44,658,522 | 43,823,607 | 44,372,223 | 26,110,785 | |||||||||||
FAQ
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