Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a
biotechnology company developing a new generation of cell and gene
therapies for patients living with incurable diseases using its
proprietary Gene Circuit platform, today reported financial results
for the second quarter of 2023.
“With this month’s transaction establishing our new clinical
manufacturing partner, GeneFab, Senti has a sharpened focus on
advancing our internal oncology pipeline and partnered programs,”
said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of
Senti Bio. “By doing so, we have extended our cash runway into the
fourth quarter of 2024 while maintaining access to the right
people, technology, and facilities necessary to advance our
Gene-Circuit enhanced oncology cell therapies towards the clinic.
Additionally, our strong presence at ASGCT showcased the breadth of
Senti’s platform in a variety of therapeutic modalities, further
demonstrating the modularity of our Gene Circuit technology.”
CORPORATE & PIPELINE HIGHLIGHTS
Senti Bio and Celadon Partners Establish
GeneFab
Yesterday, the Company announced the establishment of GeneFab,
LLC (“GeneFab”), a newly formed, independent contract manufacturing
and synthetic biology biofoundry focused on next-generation cell
and gene therapies. The transaction provided Senti Bio with
additional capital and reduced longer-term operating expenses,
extending the Company’s cash runway into the fourth quarter of
2024.
- In connection with the transaction, Senti Bio will receive
approximately $38 million in cash before the end of 2025 from
GeneFab. Approximately $18.9 million was due at closing, which was
netted against an $18.9 million advanced payment owed by Senti Bio
to GeneFab for future manufacturing and support services. The
remaining $18.9 million will be paid to Senti Bio in installments
in 2024 and 2025, subject to satisfaction of certain
conditions.
- As part of the transaction, Senti Bio subleased its current
good manufacturing practice (cGMP) facility in Alameda, CA to
GeneFab, which will support the clinical manufacturing of Senti
Bio’s chimeric antigen receptor natural killer (CAR-NK) programs,
including SENTI-202.
- Philip Lee, Ph.D., Co-Founder and former Chief Technology
Officer of Senti Bio, assumed the role of Chief Executive Officer
of GeneFab. Employees who transfer from Senti Bio to GeneFab will
continue to be actively engaged in the CMC and manufacturing
components for the clinical manufacturing of Senti Bio’s Gene
Circuit product candidates.
- Senti will be entitled to receive 10% of the realized gains
arising and resulting from any cash or in-kind distributions from
GeneFab in connection with the dividend or sale event under the
economic share agreement.
CAR-NK Oncology Pipeline
- SENTI-202 for AML/MDS Senti Bio is
finalizing its Investigational New Drug (IND) application to the
FDA for SENTI-202 and is on track for its IND in the second half of
2023.
- The Company expects to initiate enrollment of patients into the
Phase 1 clinical trial for SENTI-202 in 2024, subject to allowance
of the IND by the FDA, focusing initially on relapsed/refractory
acute myeloid leukemia (AML) patients.
- SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell
therapy program designed to selectively target and eliminate CD33
and/or FLT3 expressing hematologic malignancies, such as AML and
myelodysplastic syndrome (MDS), while sparing healthy cells using a
NOT logic gate.
- SENTI-401 for CRC Senti Bio continues to
advance SENTI-401 through preclinical development for the treatment
of colorectal cancer (CRC) and other CEA+ solid tumors.
- SENTI-301A for HCC Senti Bio continues to
actively pursue strategic geographical partnerships for clinical
development of SENTI-301A in territories where hepatocellular
carcinoma (HCC) is more prevalent.
Collaboration Programs
At the most recent American Society of Gene and Cell Therapy
(ASGCT) annual meeting in May 2023, Senti Bio gave two oral
presentations and three poster presentations, showcasing the
potential applicability of Senti Bio’s Gene Circuit technology. Two
of the presentations summarized initial nonclinical data from the
Company’s ongoing collaborations with BlueRock Therapeutics
(BlueRock) and Spark Therapeutics (Spark). Additionally, BlueRock
presented one poster presentation utilizing Senti Bio’s Gene
Circuit platform. The presentations at ASGCT highlighted the
potential utility of Senti Bio’s technology across multiple
modalities, including NK cells, T cells, adeno-associated viruses
(AAVs), induced pluripotent stem cells (iPSCs), and
macrophages.
- BlueRock
Collaboration Oral presentation:
Engineering Pharmacologically Relevant, FDA-Approved
Small-Molecule-Regulated Gene Circuits for Therapeutic Applications
in the Brain
- Senti Bio designed a Regulator Dial intended to control the
expression of IL-12 using Tamoxifen, an FDA-approved small molecule
that can cross the blood brain barrier (BBB) and has favorable
pharmacokinetics.
- The Tamoxifen-based Regulator Dial enabled dose-dependent and
reversible reporter production in vivo which could potentially
provide a safer and more convenient way of regulating therapeutic
payloads even after they have been delivered to patients.
- Poster presentation: Designing Cell-State-Specific Synthetic
Promoters as Smart Sensors to Control Macrophage Polarization
- Senti Bio discovered and validated M1-state-specific macrophage
promoters that can potentially be rationally re-engineered to
improve promoter strength and M1 state-specific activity.
- The data demonstrated that state-specific promoters can be
built into Smart Sensor circuits to control macrophage polarization
logic.
- Spark Collaboration Oral
presentation: Massively Parallel and Systematic Engineering
Platform for Highly Compact, Cell-Type Specific, and Potent Smart
Sensor Promoters for Precision Retinal Gene Therapies
- Senti Bio’s Smart Sensors are designed to precisely target gene
expression in diseased cells and limit off-target expression using
compact promoters.
- The data demonstrated equivalent expression levels of
photoreceptor-specific synthetic promoters compared with strong
promoters currently used in other gene therapies in the clinic.
Synthetic promoters were compact and less than 500 base pairs in
length.
- We believe Senti Bio’s massively parallel and systematic
workflow for designing highly compact, specific, and potent
synthetic Smart Sensor promoters have the potential to be applied
across different cell types and diseases beyond retinal
applications.
SECOND QUARTER 2023 FINANCIAL RESULTS
- As of June 30, 2023, Senti Bio held cash, cash equivalents and
short-term investments of $59.6 million.
- Research & development expenses were $11.0 million for the
quarter ended June 30, 2023, compared to $9.2 million for the same
period in 2022. The increase was related to increased headcount and
facility costs to support the development of Senti Bio’s
wholly-owned programs.
- General and administrative expenses were $9.6 million for the
quarter ended June 30, 2023, compared to $13.9 million for the same
period in 2022. The decrease was mainly attributed to $4.7 million
expense reduction related to one-time equity awards granted in
connection with the SPAC transaction that occurred in Q2 2022.
- Net loss was $18.7 million, or $0.42 per basic and diluted
share, for the quarter ended June 30, 2023.
UPCOMING EVENTS
Senti Bio plans to participate in the following investment
conferences:
- H.C. Wainwright 25th Annual Global Investment Conference
September 12 – New York, NY
- Morgan Stanley 21st Annual Global Healthcare Conference
September 13 – New York, NY
Senti Bio also plans to participate in the following upcoming
scientific/medical conference:
- 20th Meeting of the Society for Natural Immunity (NK2023)
September 26-29 – Oslo, Norway
About Senti BioSenti Biosciences 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.
Senti Bio’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 ability and
intent to continue to advance its pipeline of preclinical programs
and product candidates, statements regarding the timing of patient
enrollment in clinical trials, statements regarding the formation
of and transaction with GeneFab, including financial elements of
the transaction, the relationship that Senti Bio will have with
GeneFab going forward, and the role of transferred employees,
statements about the potential attributes and benefits of Senti
Bio’s product candidates and platform technology, statements about
the submission, allowance, and timing of Senti Bio’s IND,
statements regarding participation in upcoming conferences and
financial condition, Senti Bio’s relationship with its existing and
future collaboration partners, and statements about Senti Bio’s
cash runway . 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 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
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 most recently filed periodic report, 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) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
36,752 |
|
$ |
57,621 |
Short-term investments |
|
|
22,883 |
|
|
40,942 |
Restricted cash |
|
|
3,336 |
|
|
3,366 |
Property and equipment,
net |
|
|
58,940 |
|
|
56,136 |
Operating lease right-of-use
assets |
|
|
17,469 |
|
|
18,418 |
Total assets |
|
|
143,630 |
|
|
180,792 |
Total liabilities |
|
|
46,214 |
|
|
53,529 |
Total stockholders’ equity
(deficit) |
|
|
97,416 |
|
|
127,263 |
|
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
937 |
|
|
$ |
1,358 |
|
|
$ |
2,223 |
|
|
$ |
2,462 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
10,952 |
|
|
|
9,247 |
|
|
|
22,270 |
|
|
|
16,849 |
|
General and administrative |
|
|
9,620 |
|
|
|
13,882 |
|
|
|
19,422 |
|
|
|
19,141 |
|
Total operating expenses |
|
|
20,572 |
|
|
|
23,129 |
|
|
|
41,692 |
|
|
|
35,990 |
|
Loss from operations |
|
|
(19,635 |
) |
|
|
(21,771 |
) |
|
|
(39,469 |
) |
|
|
(33,528 |
) |
Total other income, net |
|
|
938 |
|
|
|
10,219 |
|
|
|
2,050 |
|
|
|
10,168 |
|
Net loss |
|
|
(18,697 |
) |
|
|
(11,552 |
) |
|
|
(37,419 |
) |
|
|
(23,360 |
) |
Other comprehensive loss |
|
|
(3 |
) |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(18,700 |
) |
|
$ |
(11,552 |
) |
|
$ |
(37,420 |
) |
|
$ |
(23,360 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.85 |
) |
|
$ |
(2.80 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
44,278,427 |
|
|
|
13,446,622 |
|
|
|
44,175,274 |
|
|
|
8,336,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Find more information at sentibio.comFollow us on LinkedIn and
Twitter
Investor Contact: investors@sentibio.com
Media Contact: Kelli Perkins, kelli@redhousecomms.com
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