Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a
biotechnology company developing next-generation cell and gene
therapies using its proprietary Gene Circuit platform, today
reported financial results for the third quarter of 2023.
“The third quarter was highly productive for Senti as we
continued advancing SENTI-202 towards IND clearance and further
developed our platform technology,” said Timothy Lu, MD, PhD, Chief
Executive Officer and Co-Founder of Senti Bio. “Earlier this year,
we set out to partner SENTI-301A and are pleased to have
established a collaboration with Celest Therapeutics that could
provide a differentiated treatment option for patients with liver
cancer in China. The progress we made on Senti’s wholly-owned and
partnered programs, which were highlighted at the SITC annual
meeting, reinforces the potential applications of Gene Circuits to
battle cancer.”
PIPELINE HIGHLIGHTS
SENTI-202 for AML/MDS
Senti Bio remains on track for having the Investigational New
Drug (IND) application for SENTI-202 cleared by the FDA in the
fourth quarter of 2023.
- The Company expects to initiate the Phase 1 clinical trial for
SENTI-202 in early 2024, with a focus on relapsed/refractory acute
myeloid leukemia (AML) patients in the United States and
Australia.
- SENTI-202 is a first-in-class logic gated off-the-shelf
chimeric antigen receptor natural killer (CAR-NK) cell therapy
program designed to potentially overcome AML disease heterogeneity
by targeting leukemic stem cells while sparing healthy cells, a key
limitation of current therapies.
SENTI-301A for HCC
Last week, Senti Bio announced it has entered 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. The
Company has previously highlighted the significant prevalence of
HCC and market opportunities for HCC treatments in Asia.
- Through this collaboration, Celest will lead clinical
development, operations, and manufacturing for the advancement of
SENTI-301A with technical support from Senti Bio. Celest plans to
enroll patients initially through a pilot trial in mainland China
and expects to enroll the first patient in the first half of
2024.
- Under the terms of the collaboration, Senti Bio will be
eligible to receive up to $156 million in certain milestone
payments, in addition to potential tiered royalty payments. Other
terms of the transaction were not disclosed.
- SENTI-301A is a calibrated release (cr) IL-15 multi-armed
off-the-shelf CAR-NK cell therapy designed for the treatment of
GPC3 expressing tumors, including HCC, the most common type of
primary liver cancer.
MANUFACTURING
Senti Bio and Celadon Partners Establish
GeneFab
In August, the Company announced the transaction with GeneFab,
LLC (“GeneFab”), a newly formed, independent contract manufacturing
and synthetic biology biofoundry focused on next-generation cell
and gene therapies. 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.
- In connection with the transaction, Senti Bio will receive
total consideration of $37.8 million before the end of 2025 from
GeneFab. Approximately $18.9 million was payable at closing, which
was netted against an $18.9 million advanced payment owed by Senti
Bio to GeneFab for future manufacturing and research activities.
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. Approximately 35% of Senti Bio’s employees transitioned
from Senti Bio to GeneFab, which will support the clinical
manufacturing of Senti Bio’s chimeric antigen receptor natural
killer (CAR-NK) programs, including SENTI-202.
- Senti Bio 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 a dividend or sale event under the
economic share agreement. GeneFab was also granted an option to
purchase up to $20 million of Senti Bio’s common stock at a price
of $1.01867 per share.
PLATFORM HIGHLIGHTS
Four Presentations Highlighted at SITC Annual
Meeting
Last month, The Company announced four poster presentations at
the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Two
posters highlighted new preclinical data with BlueRock
Therapeutics, and two posters demonstrated the application of Senti
Bio’s proprietary Gene Circuit platform.
THIRD QUARTER 2023 FINANCIAL RESULTS
- As of September 30, 2023, Senti Bio held cash, cash equivalents
and short-term investments of $39.4 million. Inclusive of the
receivables from the GeneFab transaction upon satisfaction of
certain conditions, the Company expects to fund operations into Q4
2024.
- Research and development expenses were $9.1 million for the
quarter ended September 30, 2023, compared to $6.5 million for the
same period in 2022. The increase was primarily related to
manufacturing costs to support development of Senti Bio’s
wholly-owned programs.
- General and administrative expenses were $9.4 million for the
quarter ended September 30, 2023, compared to $10.0 million for the
same period in 2022. The decrease was mainly attributed to a
reduction in professional services costs.
- Net loss was $14.9 million, or $0.34 per basic and diluted
share, for the quarter ended September 30, 2023, which included a
non-recurring $21.7 million gain from discontinued operations, as
well as a non-recurring $25.7 million impairment for leasehold
improvements, both related to the GeneFab transaction.
- Going forward, the Company expects stabilization in operating
expenses, with higher spending on clinical expenses, offset by
reduced research and development expenses from the GeneFab
transaction.
UPCOMING EVENTS
Senti Bio plans to participate in the following upcoming
scientific/medical conference:
- 65th ASH Annual Meeting and ExpositionDecember 9-12 – San
Diego, CA
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. 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, statements about the
allowance of Senti Bio’s IND; statements about clinical trial
activities; statements about Senti Bio’s collaboration with Celest,
including financial elements of the collaboration; statements about
Senti Bio’s transaction with GeneFab, including financial elements
of the transaction; statements about Senti Bio’s cash flow and cash
runway; statements about Senti Bio’s participation in upcoming
conferences; 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 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)
| |
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
| |
|
|
|
|
| Cash and cash equivalents |
$ |
39,430 |
|
|
$ |
57,621 |
| Short-term investments |
|
— |
|
|
|
40,942 |
| GeneFab receivable – related
party |
|
18,482 |
|
|
|
— |
| GeneFab prepaid expenses –
related party |
|
17,314 |
|
|
|
— |
| Restricted cash |
|
6,398 |
|
|
|
3,366 |
| Property and equipment,
net |
|
26,433 |
|
|
|
51,361 |
| Operating lease right-of-use
assets |
|
17,018 |
|
|
|
18,418 |
| Total assets |
|
131,766 |
|
|
|
180,792 |
| Total liabilities |
|
48,830 |
|
|
|
53,529 |
| Total stockholders’ equity
(deficit) |
|
82,936 |
|
|
|
127,263 |
Senti Biosciences,
Inc.Unaudited Consolidated Statements of
Operations(in thousands, except share and per share
data)
| |
Three Months Ended |
|
Nine Months Ended |
| |
September 30, |
|
September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
Total revenue |
$ |
338 |
|
|
$ |
1,766 |
|
|
$ |
2,561 |
|
|
$ |
4,227 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
9,092 |
|
|
|
6,519 |
|
|
|
23,028 |
|
|
|
21,108 |
|
|
General and administrative |
|
9,431 |
|
|
|
9,995 |
|
|
|
27,871 |
|
|
|
28,409 |
|
|
Impairment of property and equipment |
|
25,691 |
|
|
|
— |
|
|
|
25,691 |
|
|
|
— |
|
|
Total operating expenses |
|
44,214 |
|
|
|
16,514 |
|
|
|
76,590 |
|
|
|
49,517 |
|
| Loss from operations |
|
(43,876 |
) |
|
|
(14,748 |
) |
|
|
(74,029 |
) |
|
|
(45,290 |
) |
|
Total other income (expense), net |
|
7,261 |
|
|
|
445 |
|
|
|
9,311 |
|
|
|
10,613 |
|
| Net loss from continuing
operations |
|
36,615 |
|
|
|
(14,303 |
) |
|
|
(64,718 |
) |
|
|
(34,677 |
) |
| Net income (loss) from
discontinued operations |
|
21,692 |
|
|
|
(2,337 |
) |
|
|
12,376 |
|
|
|
(5,323 |
) |
| Net loss |
|
(14,923 |
) |
|
|
(16,640 |
) |
|
|
(52,342 |
) |
|
|
(40,000 |
) |
|
Other comprehensive loss |
|
— |
|
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
| Comprehensive loss |
$ |
(14,923 |
) |
|
$ |
(16,640 |
) |
|
$ |
(52,343 |
) |
|
$ |
(40,000 |
) |
| |
|
|
|
|
|
|
|
| Net loss per share from
continuing operations, basic and diluted |
$ |
(0.83 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.73 |
) |
| Net income (loss) per share
from discontinued operations, basic and diluted |
|
0.49 |
|
|
|
(0.05 |
) |
|
|
0.28 |
|
|
|
(0.26 |
) |
| Net loss per share, basic and
diluted |
$ |
(0.34 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.18 |
) |
|
$ |
(1.99 |
) |
| Weighted-average shares
outstanding, basic and diluted |
|
44,473,400 |
|
|
|
43,424,172 |
|
|
|
44,275,741 |
|
|
|
20,150,459 |
|
Senti Bio ContactInvestors:
investors@sentibio.comMedia: media@sentibio.com
Senti Biosciences (NASDAQ:SNTI)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Senti Biosciences (NASDAQ:SNTI)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
