Senti Biosciences(SNTI) - 2024 Q1 - Quarterly Results

Company Overview & Q1 2024 Highlights Senti Bio reported Q1 2024 operational and financial updates, highlighting clinical progress and upcoming conference participation Introduction and CEO Statement Senti Bio reported its operational updates and financial results for the first quarter of 2024, highlighting significant progress in its clinical development programs, SENTI-202 and SENTI-301A, both on track for patient dosing in Q2 2024. The company reaffirmed its commitment to leveraging synthetic biology to address unmet clinical needs - First patient dosing of SENTI-202, a logic-gated treatment for acute myeloid leukemia (AML), is on track for the second quarter of 2024[1] - The pilot trial of SENTI-301A in hepatocellular carcinoma (HCC) in China, through a partnership with Celest, is also on track to begin patient dosing in the second quarter of 2024[2] About Senti Bio Senti Bio is a biotechnology company focused on developing next-generation cell and gene therapies for incurable diseases. It utilizes a proprietary Gene Circuit platform to create therapies with enhanced precision and control, primarily through off-the-shelf CAR-NK cells for oncology, and explores broader applications via partnerships - Senti Bio develops cell and gene therapies using its proprietary Gene Circuit platform to create therapies with enhanced precision and control[9] - 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[9] - Senti Bio is advancing Gene Circuit capabilities through partnerships with Spark Therapeutics and BlueRock Therapeutics[9] Upcoming Events Senti Bio has scheduled participation in a key biotechnology conference in the upcoming quarter - Senti Bio plans to participate in the BIO International Convention 2024, scheduled for June 3-6 in San Diego, CA[11] Pipeline Development Highlights Senti Bio's clinical programs, SENTI-202 for AML and SENTI-301A for HCC, are on track for Q2 2024 patient dosing SENTI-202 for AML SENTI-202, a first-in-class Logic Gated CAR-NK cell therapy for relapsed/refractory AML, is on track to begin Phase 1 patient dosing in Q2 2024, with initial efficacy data anticipated by year-end 2024. Preclinical data supporting its selective targeting of leukemic cells was published in April 2024 - The Phase 1 clinical trial of SENTI-202 (NCT06325748) for relapsed/refractory AML patients in the U.S. and Australia is on track to initiate patient dosing in Q2 2024[3] - Initial efficacy data for SENTI-202 is anticipated by year-end 2024, with initial durability data expected in 2025[3] - Preclinical data published in April 2024 demonstrated SENTI-202's ability to selectively target and eliminate leukemic cells while sparing healthy stem cells[4] SENTI-301A for HCC Senti Bio has a strategic collaboration with Celest Therapeutics for the clinical development of SENTI-301A in China. This off-the-shelf CAR-NK cell therapy is designed for GPC3-expressing tumors, including HCC, and Celest expects to dose the first patient in a pilot trial in Q2 2024 - Senti Bio announced a strategic collaboration agreement with Celest Therapeutics (Shanghai) Co. Ltd for the clinical development of SENTI-301A to treat solid tumors in China[5] - Celest plans to enroll patients through a pilot trial in mainland China and expects to dose the first patient in the second quarter of 2024[5] - SENTI-301A is a calibrated release (cr) IL-15 multi-armed off-the-shelf investigational CAR-NK cell therapy designed for the treatment of GPC3-expressing tumors, including HCC[5] Platform Technology Advancements Senti Bio presented novel CAR discovery and synthetic biology advancements at ASGCT 2024, including macrophage polarization control ASGCT 2024 Presentations Senti Bio presented several platform and technology advancements at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting. These presentations covered the discovery of novel CARs for solid tumors using its REVEAL platform and progress in controlling macrophage polarization and IMiD-regulated therapeutic payload expression through collaborations - Oral Presentation: Discovery of Novel CARs for Solid Tumors Using Senti REVEAL™, a Massively Parallel Technology Platform (Abstract Number: 330, May 10, 2024)[6] - Poster Presentation (in collaboration with BlueRock Therapeutics and GeneFab, LLC): Iterative Engineering of Polarization-State Responsive Synthetic Promoters for Autonomous Control of Macrophage Polarization Logic (Abstract Number: 1799, May 10, 2024)[6] - Poster Presentation (in collaboration with BlueRock Therapeutics and GeneFab, LLC): Engineered IMiD Regulated Synthetic Transcriptional Switch for Controlled and Dose-Responsive Expression of Therapeutic Payload (Abstract Number: 1285, May 9, 2024)[7] First Quarter 2024 Financial Results Senti Bio reported a Q1 2024 net loss of $12.1 million, with increased R&D expenses and decreased G&A expenses Key Financial Highlights Senti Bio reported a net loss of $12.1 million for Q1 2024, an improvement from Q1 2023. Research and development expenses increased due to manufacturing costs, while general and administrative expenses decreased primarily due to a reduction in headcount. The company held $23.7 million in cash and cash equivalents as of March 31, 2024 - Cash and cash equivalents as of March 31, 2024, were $23.7 million[11] - Research and development expenses increased to $8.8 million for Q1 2024 from $7.1 million in Q1 2023, primarily due to manufacturing costs for wholly-owned programs[11] - General and administrative expenses decreased to $7.5 million for Q1 2024 from $9.2 million in Q1 2023, mainly due to a reduction in headcount[11] - Net loss for Q1 2024 was $12.1 million, or $0.26 per basic and diluted share[11] Consolidated Balance Sheet Data As of March 31, 2024, Senti Bio's total assets were $102.185 million, with cash and cash equivalents decreasing to $23.723 million from $35.926 million at the end of 2023. Total liabilities and stockholders' equity also saw decreases Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $23,723 | $35,926 | | GeneFab receivable – related party | $17,847 | $17,592 | | GeneFab prepaid expenses – related party | $11,300 | $14,787 | | Restricted cash | $4,028 | $3,522 | | Property and equipment, net | $24,354 | $25,338 | | Operating lease right-of-use assets | $15,797 | $16,274 | | Total assets | $102,185 | $119,484 | | Total liabilities | $46,091 | $52,571 | | Total stockholders' equity | $56,094 | $66,913 | Consolidated Statements of Operations For the three months ended March 31, 2024, Senti Bio reported no revenue, a loss from operations of $16.301 million, and a net loss of $12.111 million. This represents a significant improvement in net loss compared to Q1 2023, primarily due to higher other income and the absence of discontinued operations loss Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | | :---------------------------------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Total revenue | $— | $1,286 | | Research and development expenses | $8,779 | $7,059 | | General and administrative expenses | $7,522 | $9,191 | | Total operating expenses | $16,301 | $16,250 | | Loss from operations | $(16,301) | $(14,964) | | Total other income, net | $4,190 | $1,112 | | Net loss from continuing operations | $(12,111) | $(13,852) | | Net loss from discontinued operations | $— | $(4,870) | | Net loss | $(12,111) | $(18,722) | | Net loss per share, basic and diluted | $(0.26) | $(0.42) | | Weighted-average shares outstanding, basic and diluted | 45,708,601 | 44,070,974 | Forward-Looking Statements & Disclosures This section outlines Senti Bio's forward-looking statements, subject to risks and uncertainties, and advises investors to review SEC filings Forward-Looking Statements This section outlines Senti Bio's forward-looking statements regarding future events, including clinical trial timing, growth strategy, and collaborations. These statements are based on current expectations and assumptions but are subject to various risks and uncertainties that could cause actual results to differ materially. The company does not commit to publicly update these statements - Forward-looking statements include expectations regarding growth, strategy, progress and timing of clinical trials (patient dosing, data availability), ability to initiate new clinical programs, and the potential benefits of its platform technology and collaborations[10] - These statements are subject to risks and uncertainties, including changes in business conditions, regulatory landscape, ability to implement business plans, clinical trial uncertainties, dependence on third parties, macroeconomic events, and R&D success[12] - Investors are advised to carefully consider factors and risks described in Senti Bio's Annual Report on Form 10-K and other SEC filings[12] Availability of Other Information Senti Bio encourages investors, the media, and the public to regularly review information posted on its company website, Twitter, and LinkedIn, as these platforms are used for material disclosures and investor communications - Senti Bio communicates with investors and the public via its company website (www.sentibio.com), Twitter (@SentiBio), and LinkedIn (Senti Biosciences)[13] - Information posted on these platforms, including company disclosures, investor presentations, SEC filings, and press releases, could be deemed material information[13]