Senti Bio Announces Second Quarter 2024 Results and Reviews Recent Corporate and Pipeline Highlights

Rhea-AI Summary

Senti Biosciences (Nasdaq: SNTI) reported Q2 2024 results and pipeline updates. Key highlights include:

• Ongoing patient dosing in Phase 1 trial of SENTI-202 for relapsed/refractory hematologic malignancies including AML
• Commencement of $8 million CIRM grant for SENTI-202 clinical development
• Plans to initiate pilot trial of SENTI-301A for HCC in China through Celest partnership in Q4 2024
• Q2 2024 financial results: $15.9 million cash, $9.2 million R&D expenses, $4.2 million G&A expenses, $11.2 million net loss
• Completed 1-for-10 reverse stock split to maintain Nasdaq listing compliance

Initial SENTI-202 efficacy data expected by year-end 2024, with durability data in 2025.

Positive

• Commenced patient dosing in Phase 1 trial of SENTI-202 for AML
• Received $8 million grant from CIRM for SENTI-202 clinical development
• Planning to initiate pilot trial of SENTI-301A in China through partnership with Celest
• Holds $18.9 million in receivables from GeneFab transaction

Negative

• Net loss of $11.2 million in Q2 2024
• Cash position decreased to $15.9 million as of June 30, 2024
• R&D expenses increased to $9.2 million in Q2 2024 compared to $6.9 million in Q2 2023
• Implemented 1-for-10 reverse stock split to maintain Nasdaq listing compliance

Insights

Financial Analyst

Senti Bio's Q2 2024 results reveal a mixed financial picture. The company's cash position of $15.9 million, coupled with $18.9 million in potential receivables, provides some runway. However, the net loss of $11.2 million is concerning. R&D expenses increased to $9.2 million, reflecting investment in pipeline development, while G&A expenses decreased to $4.2 million due to headcount reduction. The 1-for-10 reverse stock split to maintain Nasdaq listing compliance signals financial challenges. Investors should monitor cash burn rate and potential dilution risks.

Oncology Doctor

The ongoing Phase 1 trial of SENTI-202 for relapsed/refractory AML is a significant clinical milestone. AML is a challenging disease with poor outcomes in relapsed/refractory settings. The Logic Gated off-the-shelf CAR-NK approach could potentially offer improved efficacy and safety. The $8 million CIRM grant underscores the potential of this therapy. However, investors should temper expectations as initial efficacy data won't be available until year-end 2024, with durability data following in 2025. The planned SENTI-301A trial for HCC in China expands the company's oncology pipeline, but results are distant.

Biotech Industry Analyst

Senti Bio's Gene Circuit platform represents an innovative approach in the competitive cell and gene therapy landscape. The progress with SENTI-202 and SENTI-301A demonstrates pipeline advancement. However, the company faces significant financial and developmental hurdles. The cash position is concerning given the high burn rate and the reverse stock split suggests potential future financing needs. The collaboration with Celest for HCC in China is strategic but adds complexity. Investors should closely monitor upcoming clinical readouts and the company's ability to secure additional funding or partnerships to support its ambitious pipeline.

08/13/2024 - 04:05 PM

– Dose finding ongoing in Phase 1 clinical trial of SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML –

– Commencement of $8 million grant award from CIRM for the clinical development of SENTI-202 –

SOUTH SAN FRANCISCO, Calif., Aug. 13, 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 second quarter of 2024 and provided a summary of recent corporate and pipeline highlights.

“We have demonstrated important progress year to date, dosing patients in our Phase 1 clinical trial of SENTI-202 in AML and continuing to execute on our development pipeline priorities,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “Additionally, we look forward to initiating our pilot trial of SENTI-301A in hepatocellular carcinoma (“HCC”) in China through our partnership with Celest later this year. These clinical milestones represent critical steps to bring our product candidates to patients and highlight the potential of our next-generation cell therapies in oncology.”

CORPORATE AND PIPELINE HIGHLIGHTS

CIRM Grant for Clinical Development of SENTI-202: In August, Senti Bio announced the commencement of an $8 million grant from the California Institute for Regenerative Medicines (“CIRM”). The grant will support the ongoing clinical development of SENTI-202, a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (“CAR-NK”) investigational cell therapy, for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (“AML”).

SENTI-202 for AML: The Company announced that patient dosing has commenced, and is ongoing, in the Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including AML. The Phase 1 trial will focus on relapsed/refractory AML patients in the U.S. and Australia. Initial efficacy data is anticipated by year-end 2024 and initial durability data is expected to follow in 2025.

SENTI-301A for HCC: Senti Bio is developing SENTI-301A to treat solid tumors in China through a strategic collaboration agreement with Celest Therapeutics (Shanghai) Co. Ltd (“Celest”). Celest will enroll patients initially through a pilot trial in mainland China and now expects to dose the first patient in the fourth quarter of 2024.

Reverse Stock Split: In July 2024, Senti Bio effected a one-for-ten (1-for-10) reverse stock split of its common stock to bring the Company into compliance with Nasdaq’s minimum bid price requirement for continued listing.

SECOND QUARTER 2024 FINANCIAL RESULTS

• Cash and Cash Equivalents: As of June 30, 2024, Senti Bio held cash and cash equivalents of $15.9 million. The Company also holds $18.9 million in receivables anticipated from the GeneFab transaction upon satisfaction of certain conditions.
• R&D Expenses: Research and development expenses were $9.2 million for the quarter ended June 30, 2024, compared to $6.9 million for the same period in 2023. The increase was primarily related to manufacturing costs to support development of Senti Bio’s wholly-owned programs.
• G&A Expenses: General and administrative expenses were $4.2 million for the quarter ended June 30, 2024, compared to $9.2 million for the same period in 2023. The decrease was mainly attributed to a reduction in headcount.
• Net Loss: Net loss was $11.2 million, or $2.45 per basic and diluted share, for the quarter ended June 30, 2024.

UPCOMING EVENTS

Senti Bio plans to participate in the following investment conferences:

• H.C. Wainwright 26th Annual Global Investment Conference
  September 9-11, 2024 – New York, NY
• Chardan’s 8th Annual Genetic Medicines Conference
  September 30-October 1, 2024 – New York, NY
  

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 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 CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio has also preclinically demonstrated the potential breadth of 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, expectations regarding Senti Bio’s growth, strategy, progress and timing of its clinical trials for SENTI-202, including the timing and the amount of grant from CIRM; 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; the growth, strategy, progress and timing of clinical trials for SENTI-301A through Celest in China; the amount of anticipated receivables under its agreements with GeneFab; expectations regarding the anticipated dosing of patients and availability of data from clinical trials, and the timing thereof; the ability to initiate new clinical programs; as well as statements about the potential attributes and benefits of Senti Bio’s platform technology and the progress and continuation of its collaborations with Celest, 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, (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 Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (“SEC”) on May 9, 2024, 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 X (formerly 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 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)
		June 30,			December 31,
		2024				2023
Cash and cash equivalents		$	15,860			$	35,926
GeneFab receivable – related party		18,624				17,592
GeneFab prepaid expenses – related party		7,663				14,787
Restricted cash		3,546				3,522
Property and equipment, net		23,253				25,338
Operating lease right-of-use assets		15,301				16,274
Total assets		86,913				119,484
Total liabilities		42,765				52,571
Total stockholders’ equity		44,148				66,913

Senti Biosciences, Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data)
		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
Total revenue		$	-			$	937			$	-			$	2,223
Operating expenses:
Research and development (included related party cost of $3,637, $ -, $7,269 and $ -, respectively)		9,151				6,876				17,929				13,936
General and administrative		4,205				9,249				11,728				18,440
Total operating expenses		13,356				16,125				29,657				32,376
Loss from operations		(13,356		)		(15,188		)		(29,657		)		(30,153		)
Total other income, net		2,153				938				6,343				2,050
Net loss from continuing operations		(11,203		)		(14,250		)		(23,314		)		(28,103		)
Net loss from discontinued operations		-				(4,447		)		-				(9,316		)
Net loss		(11,203		)		(18,697		)		(23,314		)		(37,419		)
Other comprehensive loss		-				(3		)		-				(1		)
Comprehensive loss		$	(11,203	)		$	(18,700	)		$	(23,314	)		$	(37,420	)
Net loss per share from continuing operations, basic and diluted		$	(2.45	)		$	(3.22	)		$	(5.10	)		$	(6.36	)
Net loss per share, from discontinued operations basic and diluted		-				(1.00		)		-				(2.11		)
Net loss per share, basic and diluted		$	(2.45	)		$	(4.22	)		$	(5.10	)		$	(8.47	)
Weighted-average shares outstanding, basic and diluted		4,572,010				4,427,726				4,571,377				4,417,411

All periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on July 17, 2024.

Senti Bio Contacts
Investors: investors@sentibio.com
Media: media@sentibio.com

FAQ

What were Senti Biosciences' (SNTI) Q2 2024 financial results?

Senti Biosciences reported a net loss of $11.2 million, or $2.45 per share, for Q2 2024. The company held $15.9 million in cash and cash equivalents as of June 30, 2024. R&D expenses were $9.2 million, and G&A expenses were $4.2 million for the quarter.

What is the status of SENTI-202 clinical trials?

Patient dosing is ongoing in the Phase 1 clinical trial of SENTI-202 for relapsed/refractory hematologic malignancies including AML. The trial is being conducted in the U.S. and Australia. Initial efficacy data is expected by year-end 2024, with durability data anticipated in 2025.

When will Senti Biosciences (SNTI) initiate the SENTI-301A trial in China?

Senti Biosciences expects to dose the first patient in the pilot trial of SENTI-301A for hepatocellular carcinoma (HCC) in China through its partnership with Celest Therapeutics in the fourth quarter of 2024.

What grant did Senti Biosciences (SNTI) receive for SENTI-202 development?

In August 2024, Senti Biosciences announced the commencement of an $8 million grant from the California Institute for Regenerative Medicines (CIRM) to support the clinical development of SENTI-202 for relapsed/refractory hematologic malignancies including AML.