Senti Biosciences(SNTI) - 2023 Q4 - Annual Results

Recent Highlights and Strategic Focus Senti Bio achieved Q4 2023 milestones, including FDA IND clearance for SENTI-202 and strategic partnerships Corporate Updates Senti Bio streamlined operations, prioritizing key clinical programs and extending cash runway - Prioritization of clinical programs: Streamlining business operations to focus on SENTI-202 (AML in U.S.) and SENTI-301A (HCC in China via Celest partnership)3 - Resource allocation: Scaling back all other research and development initiatives while continuing support for ongoing partnerships with Spark Therapeutics and BlueRock Therapeutics3 - Cash runway extension: Expected to fund operations into the first quarter of 2025 due to resource allocation and anticipated receivables from the GeneFab transaction1 3 Pipeline Highlights Updates on key clinical programs SENTI-202 (AML) and SENTI-301A (HCC), detailing regulatory clearances and milestones SENTI-202 for AML The U.S. FDA cleared the IND for SENTI-202, a logic-gated CAR-NK cell therapy for relapsed/refractory AML - IND Clearance: U.S. FDA cleared the IND application for SENTI-202 in December 20231 4 - Clinical Trial Focus: Phase 1 trial will focus on relapsed/refractory AML patients in the U.S. and Australia4 - Anticipated Milestones4 - First patient dosed: Second quarter of 20244 - Initial efficacy data: By year-end 20244 - Initial durability data: In 20254 SENTI-301A for HCC Senti Bio partnered with Celest Therapeutics for SENTI-301A's clinical development in China, targeting HCC - Strategic Collaboration: Agreement with Celest Therapeutics (China-based) for clinical development of SENTI-301A in China, announced November 20232 4 - Trial Plans: Celest plans to enroll patients through a pilot trial in mainland China, with the first patient dosing anticipated in the second quarter of 20244 - Therapy Description: SENTI-301A is a calibrated release (cr) IL-15 multi-armed off-the-shelf CAR-NK cell therapy designed for GPC3-expressing tumors, including HCC4 Fourth Quarter and Full Year 2023 Financial Results Senti Bio reported Q4 and FY2023 financial results, showing decreased cash, increased R&D, and a higher net loss Key Financial Highlights As of December 31, 2023, Senti Bio held $35.9 million in cash, with increased R&D expenses and a $71.1 million net loss for FY2023 Cash, Cash Equivalents & Short-term Investments | Metric | As of Dec 31, 2023 | As of Dec 31, 2022 | | :-------------------------------- | :------------------- | :------------------- | | Cash, Cash Equivalents & Short-term Investments | $35.9 million | $98.6 million | | GeneFab receivable | $18.9 million | N/A | R&D and G&A Expenses (in millions) | Expense Category | Q4 2023 (in millions) | Q4 2022 (in millions) | FY 2023 (in millions) | FY 2022 (in millions) | | :----------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | R&D Expenses | $9.1 | $7.0 | $32.2 | $28.1 | | G&A Expenses | $9.3 | $9.8 | $37.2 | $38.2 | Net Loss (in millions) | Metric | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :-------------------------------- | :------ | :------ | :------ | :------ | | Net Loss (in millions) | $(18.7) | $(18.2) | $(71.1) | $(58.2) | | Net Loss per Share (basic & diluted) | $(0.42) | $(0.42) | $(1.60) | $(2.23) | - Net loss for FY 2023 included a non-recurring $12.3 million gain from discontinued operations and a non-recurring $25.7 million impairment for leasehold improvements, both related to the GeneFab transaction8 Unaudited Selected Consolidated Balance Sheet Data The balance sheet shows a decrease in total assets and stockholders' equity from 2022 to 2023, with new GeneFab-related items Balance Sheet Data (in thousands) | Item | December 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | 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 | Unaudited Consolidated Statements of Operations Consolidated statements show increased total operating expenses and a higher net loss in 2023, despite a gain from discontinued operations Consolidated Statements of Operations (in thousands) | Item | Three Months Ended Dec 31, 2023 (in thousands) | Three Months Ended Dec 31, 2022 (in thousands) | Year Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2022 (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------- | :------------------------------------- | | Total revenue | $— | $59 | $2,561 | $4,286 | | 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) | | 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) | | Net loss per share, basic and diluted | $(0.42) | $(0.42) | $(1.60) | $(2.23) | About Senti Bio Senti Biosciences develops next-generation cell and gene therapies using its Gene Circuit platform for oncology and other diseases - Mission: Developing a new generation of cell and gene therapies for patients with incurable diseases6 - Technology Platform: Leverages a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control6 - Pipeline Focus: 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 indications6 - Partnerships: Preclinically demonstrated breadth of Gene Circuits in other modalities and diseases outside of oncology, advancing capabilities through collaborations with Spark Therapeutics and BlueRock Therapeutics2 3 6 Forward-Looking Statements This section outlines Senti Bio's future expectations, subject to risks like market conditions, regulatory changes, and clinical trial outcomes - Nature of Statements: Identified by words like "expect," "anticipate," "will," and similar expressions