- SENTI-202 on track for IND filing in 2023; clinical plans for SENTI-202 expand beyond AML to CD33
and/or FLT3 expressing hematologic malignancies including MDS -
- Selected development candidate for program to treat GPC3-expressing solid tumors including HCC, SENTI-301A; expected IND filing in 2023 -
- Preclinical data from two solid tumor CAR-NK programs highlighted at SITC -
- Cash position of
In addition, Senti Bio’s data presentation at the
“I am proud of our continued progress toward the clinic with our CAR-NK cell therapy oncology programs for both hematologic malignancies and solid tumors. With SENTI-202, we believe that we have generated compelling preclinical data demonstrating the killing of primary AML and MDS tumor cells, while maintaining protection of healthy hematopoietic stem cells, to support a clinical trial aimed at both cancer types, and we remain on track to file an IND in 2023,” said
Lu added, “Our scientists continue to generate exciting data across our pipeline; data from SENTI-301A and SENTI-401 are being highlighted today at the SITC Annual Meeting, and we are extremely excited to preview new data on SENTI-202 at the
RECENT PIPELINE HIGHLIGHTS
CAR-NK Cell Oncology Pipeline and Gene Circuit Platform Highlights:
SENTI-202: A Logic Gated off-the-shelf CAR-NK cell therapy development candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and MDS, while sparing the healthy bone marrow.
- Announced the acceptance of an abstract for presentation at the
American Society of Hematology (ASH) meeting inDecember 2022 ; preclinical data to highlight the use of Logic Gating gene circuits to target and eliminate AML cells while sparing healthy hematopoietic stem cells. - Outlined plans for a proposed Phase 1 clinical trial, including a dose-finding phase in patients with relapsed and/or refractory CD33 and/or FLT3 expressing hematologic malignancies. Disease-specific expansion cohorts would include relapsed and/or refractory AML. Multiple doses of SENTI-202 administration following standard fludarabine/cyclophosphamide (Flu/Cy) lymphodepleting chemotherapy is planned along with a potential to receive multiple cycles. Clinical trial endpoints would evaluate safety and identification of a recommended Phase 2 dose of SENTI-202, as well as efficacy using standard disease-specific response criteria.
- Manufacturing efforts and GMP facility buildout remain on track towards enabling flexible clinical manufacturing of CAR-NK cells in 2023.
- An IND application for SENTI-202 is expected to be submitted to the
U.S. Food and Drug Administration (FDA) in 2023.
SENTI-301A: A Multi-Armed off-the-shelf CAR-NK cell therapy development candidate designed for the treatment of GPC3 expressing tumors, including HCC.
- Selected a development candidate, SENTI-301A, based on extensive optimization using Senti Bio’s proprietary screening platform for off-the-shelf CAR-NK cells with potent anti-tumor activity. SENTI-301A uses the following components:
- Engineered NK cells that target glypican 3 (GPC3), which is highly expressed in 70% to 90% of HCCs and has low or no expression on normal adult tissues.
- Calibrated release interleukin-15 (crIL-15), a multi-functional immuno-stimulatory payload designed to simultaneously stimulate surrounding immune cells and promote CAR-NK cell expansion, persistence and tumor killing.
- Preclinical data presented today at the SITC Annual Meeting demonstrates the use of gene circuits to improve the cytotoxicity and persistence of GPC3 targeting CAR-NK cells in treating HCC. Senti Bio’s novel GPC3 targeting activating CAR combined with crIL-15 technology provide the CAR-NK cells multi-arming to enhance persistence and killing activity of the NK cells, and to leverage the endogenous immune system for increased anti-tumor activity. The data presents evidence of robust in vitro and in vivo killing of relevant tumor cells with SENTI-301A.
- An IND application for SENTI-301A is expected to be submitted to the FDA in 2023
The presentation at the SITC Annual Meeting also includes data from ongoing development of
SENTI-401: A Logic Gated, Multi-Armed off-the-shelf selective CAR-NK cell therapy development program designed to precisely target CEA positive solid tumors (e.g., colorectal, pancreatic and lung cancers) while sparing healthy cells using the NOT Logic Gate.
- Presented preclinical proof-of-concept data at the SITC Annual Meeting that demonstrates the robust anti-cancer functionality of Logic Gated, Multi-Armed CAR-NK cells against a variety of colorectal cancer models:
- Evaluated ways to enhance NK cell persistence and function using a combination of crIL-15 and IL-21, a previously undisclosed Multi-Arming combination, resulting in significantly enhanced and durable killing of CEA positive target cells in vitro and in vivo.
- Long-term anti-tumor responses: a single dose of CEA targeting CAR-NK cells armed with crIL-15+IL-21 resulted in durable anti-tumor activity in human CRC xenograft models that express CEA, including complete tumor regressions.
- CAR-NK cells equipped with an optimized inhibitory CAR (iCAR) suppressed activating CAR (aCAR)-mediated killing of healthy cells that co-expressed VSIG2-and CEA without diminishing aCAR-mediated anti-tumor activity of CEA expressing tumor cells.
THIRD QUARTER 2022 FINANCIAL RESULTS
- Cash and Cash Equivalents: As of
September 30, 2022 , Senti Bio held cash and cash equivalents of$114.9 million , which the Company believes is sufficient to fund operations into 2024. - R&D Expenses: Research & development expenses were
$8.1 million for the quarter endedSeptember 30, 2022 , compared to$5.4 million for the same period in 2021. The increase includes an additional$0.5 million in non-cash stock-based compensation expense. - G&A Expenses: General and administrative expenses were
$10.8 million for the quarter endedSeptember 30, 2022 , compared to$7.1 million for the same period in 2021. The increase includes an additional$1.2 million in non-cash stock-based compensation expense. - Net Loss: Net loss was
$16.6 million , or$0.38 per basic and diluted share, for the quarter endedSeptember 30, 2022 . - CapEx: Capital expenditures were
$14.2 million for the quarter endedSeptember 30, 2022 , primarily driven by the GMP manufacturing facility buildout and related equipment purchases.
About Senti Bio
Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches. To accomplish this, we are building a synthetic biology platform that may enable us to program next-generation cell and gene therapies with what we refer to as Gene Circuits. These novel and proprietary Gene Circuits are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We aim to design Gene Circuits to improve the intelligence of cell and gene therapies in order to enhance their therapeutic effectiveness, precision, and durability against a broad range of diseases that conventional medicines do not readily address.
Our synthetic biology platform utilizes off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cells, outfitted with
Forward-Looking Statements
This document contains 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,” “explore,” “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, statements regarding estimates and forecasts of financial and cash runway and the sufficiency of such cash runway, Senti Bio’s ability to continue to advance its pipeline of preclinical programs and product candidates, Senti Bio’s research and development activities, the generation and release of additional preclinical data, commencement of IND-enabling studies and the timing of submission of IND filings, plans for a Phase 1 clinical trial, and GMP manufacturing start up activities, as well as statements about the potential attributes and benefits of Senti Bio’s product candidates and platform technology. 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 events 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 preclinical studies, IND filings, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with preclinical and IND-enabling studies, IND filings, and GMP manufacturing buildout and startup activities, (viii) risks related to delays and other impacts from the COVID-19 pandemic, 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 registration statement on Form S-1 (File No. 333-267390), and other documents filed by Senti Bio from time to time with the
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Unaudited Selected Consolidated Balance Sheet Data
(in thousands)
2022 | 2021 | ||||||
Cash and cash equivalents | $ | 114,940 | $ | 56,034 | |||
Restricted cash | 3,295 | 3,257 | |||||
Property and equipment, net | 47,259 | 12,368 | |||||
Operating lease right-of-use assets | 18,883 | 20,708 | |||||
Total assets | 189,441 | 96,702 | |||||
Total liabilities | 49,098 | 36,326 | |||||
Redeemable convertible preferred stock | — | 171,833 | |||||
Total stockholders’ equity (deficit) | 140,343 | (111,457 | ) |
Unaudited Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Total revenue | $ | 1,766 | $ | 1,103 | $ | 4,227 | $ | 1,968 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 8,056 | 5,410 | 24,904 | 15,548 | ||||||||||||
General and administrative | 10,795 | 7,116 | 29,936 | 15,981 | ||||||||||||
Total operating expenses | 18,851 | 12,526 | 54,840 | 31,529 | ||||||||||||
Loss from operations | (17,085 | ) | (11,423 | ) | (50,613 | ) | (29,561 | ) | ||||||||
Total other income (expense), net | 445 | 17 | 10,613 | (14,854 | ) | |||||||||||
Net loss | $ | (16,640 | ) | $ | (11,406 | ) | $ | (40,000 | ) | $ | (44,415 | ) | ||||
Net loss per share, basic and diluted | $ | (0.38 | ) | $ | (3.90 | ) | $ | (1.99 | ) | $ | (15.33 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 43,424,172 | 2,925,957 | 20,150,459 | 2,897,850 |
Senti Bio Contacts: Investors: investors@sentibio.com Media:Kelli Perkins kelli@redhousecomms.com
Source:
2022 GlobeNewswire, Inc., source