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 operational updates and financial results for the
first quarter of 2024.
“Over the past quarter, we have continued to execute on our
research and clinical development milestones. We are on track to
begin dosing patients in our Phase 1 clinical trial of SENTI-202 in
AML and our pilot trial of SENTI-301A in hepatocellular carcinoma
(“HCC") in China through our partnership with Celest,” said Timothy
Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
“This important progress positions us to further advance our
partnered and wholly-owned programs. Looking ahead, we remain
committed to leveraging the power of synthetic biology to drive
transformative changes in medicine across a wide range of unmet
clinical needs.”
PIPELINE HIGHLIGHTS
SENTI-202 for AML: The Phase 1 clinical trial
of SENTI-202 (NCT06325748), a first-in-class, off-the-shelf Logic
Gated CAR-NK investigational cell therapy for the treatment of AML,
will focus on relapsed/refractory AML patients in the U.S. and
Australia. The Company is on track to initiate patient dosing in
the second quarter of 2024, with initial efficacy data anticipated
by year-end 2024, and initial durability data in 2025.
SENTI-202 Preclinical Data Published in Peer-Reviewed
Journal: In April 2024, Senti Bio announced the
publication of preclinical data demonstrating the ability of
natural killer (“NK”) cells engineered with multi-input Gene
Circuits to selectively target and eliminate leukemic cells,
including both blasts and leukemic stem cells, while sparing
healthy stem cells. The publication, titled “Precision
off-the-shelf natural killer cell therapies for oncology with
logic-gated gene circuits,” highlights the activity of logic-gated
NK cells in in vitro and in vivo preclinical studies, and supports
the design of the Phase 1 clinical trial of SENTI-202.
SENTI-301A for HCC: In November 2023, Senti Bio
announced a strategic collaboration agreement with Celest
Therapeutics (Shanghai) Co. Ltd (“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
investigational CAR-NK cell therapy designed for the treatment of
GPC3-expressing tumors, including HCC, the most common type of
primary liver cancer.
PLATFORM HIGHLIGHTS
Three Presentations at ASGCT 2024 Annual
Meeting
The Company is presenting on several platform and technology
advancements at the American Society of Gene and Cell Therapy
(ASGCT) Annual Meeting being held May 7-11, 2024, in Baltimore, MD.
The oral presentation describes the discovery of novel CARs for
solid tumors using Senti’s high-throughput REVEAL™ platform.
Two poster presentations, in collaboration with BlueRock
Therapeutics and GeneFab LLC, highlight continued progress in
control over macrophage polarization and IMiD-regulated therapeutic
payload expression. Details are as follows:
- Oral
Presentation: Discovery of Novel CARs for Solid Tumors
Using Senti REVEAL™, a Massively Parallel Technology Platform
Comprising Pooled Screening, Machine Learning, and Lab
AutomationAbstract Number: 330Date and
Time: May 10, 2024, 5:15 p.m. ET
- Poster
Presentation: Iterative Engineering of Polarization-State
Responsive Synthetic Promoters for Autonomous Control of Macrophage
Polarization LogicIn collaboration with BlueRock Therapeutics and
GeneFab, LLCAbstract Number: 1799Date and
Time: May 10, 2024, 12:00 pm - 7:00 pm ET
- Poster
Presentation: Engineered IMiD Regulated Synthetic
Transcriptional Switch for Controlled and Dose-Responsive
Expression of Therapeutic Payload within FDA-Approved Drug DosesIn
collaboration with BlueRock Therapeutics and GeneFab,
LLCAbstract Number: 1285Date and
Time: May 9, 2024, 12:00 pm - 7:00 pm ET
Following the presentations, copies of materials will be
available on the Scientific Presentations & Publications
section of the Company’s website.
FIRST QUARTER 2024 FINANCIAL RESULTS
- Cash and Cash
Equivalents: As of March 31, 2024, Senti Bio held cash and cash
equivalents of $23.7 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 $8.8 million for the quarter
ended March 31, 2024, compared to $7.1 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 $7.5 million for the
quarter ended March 31, 2024, compared to $9.2 million for the same
period in 2023. The decrease was mainly attributed to a reduction
in headcount from the reduction in force in early January
2024.
- Net Loss: Net loss
was $12.1 million, or $0.26 per basic and diluted share, for the
quarter ended March 31, 2024.
UPCOMING EVENTS
Senti Bio plans to participate in the following upcoming
biotechnology conference:
- BIO International
Convention 2024June 3-6 – San Diego, CA
About Senti BioSenti 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 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 StatementsThis 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 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; 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, 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 Annual
Report on Form 10-K, filed with the SEC on March 21, 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 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 Biosciences, Inc.Unaudited Selected
Consolidated Balance Sheet Data(in thousands) |
|
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
2023 |
|
|
|
|
|
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 |
|
Senti Biosciences, Inc.Unaudited
Consolidated Statements of Operations(in thousands, except
share and per share data) |
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
Total revenue |
|
$ |
— |
|
|
$ |
1,286 |
|
Operating expenses: |
|
|
|
|
Research and development (included related party cost of $3,632 and
$ -, respectively) |
|
8,779 |
|
|
7,059 |
|
General and administrative |
|
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 |
) |
Other comprehensive gain |
|
— |
|
|
2 |
|
Comprehensive loss |
|
$ |
(12,111 |
) |
|
$ |
(18,720 |
) |
|
|
|
|
|
Net loss per share from
continuing operations, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.31 |
) |
Net loss per share from
discontinued operations, basic and diluted |
|
— |
|
|
(0.11 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.42 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
45,708,601 |
|
|
44,070,974 |
|
|
Senti Bio Contacts Investors:
investors@sentibio.com Media: media@sentibio.com
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