Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage
immuno-oncology company focused on the discovery and development of
next-generation therapeutics for cancer patients, today reported
financial results for the second quarter ended June 30, 2023, and
provided recent business updates.
“The second quarter of 2023 was momentous for Sensei as we moved
expeditiously from the FDA’s clearance of our SNS-101 trial in
April to the enrollment of six patients by the end of July. We’re
encouraged by the rapid clinical enrollment activity we’ve observed
so far, which suggests that we may be able to accelerate the start
of the combination arm of this study,” said John Celebi, President
and Chief Executive Officer of Sensei Biotherapeutics. “We’re
grateful for the efforts of the clinical investigators, patients,
and families without whom this clinical trial would not be
possible.”
Highlights and Milestones
SNS-101
Sensei’s lead investigational candidate is SNS-101, a
conditionally active antibody targeting the immune checkpoint VISTA
(V-domain Ig suppressor of T cell activation), which is implicated
in numerous cancer indications and whose expression correlates with
low survival rates.
Recent updates for SNS-101 include:
- An Investigational New Drug (IND) application for SNS-101 was
cleared by the U.S. Food and Drug Administration (FDA) in April
2023. The cleared starting dose of 0.3 mg/kg was substantially
higher than other anti-VISTA antibodies.
- On June 1, 2023, Sensei reported the first patient dosed in the
dose escalation portion of the SNS-101 multi-center Phase 1/2
clinical trial. To date, Sensei has enrolled a total of 6 patients,
clearing its first patient cohort at 0.3 mg/kg and its second
patient cohort at 1.0 mg/kg, and is currently dosing patients in
its third cohort at 3.0 mg/kg.
- As a result of the pace of enrollment to date, Sensei expects
to dose the first patient in combination with Regeneron’s PD-1
inhibitor Libtayo® (cemiplimab) in Q4 2023.
- Sensei now expects to report initial pharmacokinetic (PK) and
safety data by year-end 2023, and topline monotherapy data and
initial combination data for the Phase 1/2 clinical trial in
2024.
- On June 27, 2023, Sensei provided an overview of SNS-101 and
its Phase 1/2 clinical trial in a virtual KOL event entitled “A New
VISTA for Cancer Care: Exploring SNS-101’s Potential as a
Transformative Treatment Option for Patients with Solid Tumors.” A
link to the event recording can be accessed on the Sensei website.
For this event, Sensei welcomed James Gulley, M.D., Ph.D.,
Co-Director of the Center for Immuno-Oncology, and Clinical
Director at the National Cancer Institute (NCI), part of the
National Institutes of Health, to provide an overview of today’s
immuno-oncology treatment landscape and discuss NCI’s Cooperative
Research & Development Agreement (CRADA) with Sensei, which
includes ongoing research to further elucidate the role of VISTA in
immune checkpoint resistance, research to expand the potential of
SNS-101 as a combination therapy beyond anti-PD-1, and NCI serving
as a clinical site for the SNS-101 Phase 1/2 clinical trial.
Other TMAb™ Platform Updates
Through its Tumor Microenvironment Activated biologics (TMAb)
platform, Sensei is advancing several conditionally active antibody
programs, including SNS-102 targeting VSIG4 (V-Set and
Immunoglobulin Domain Containing 4), SNS-103 targeting ENTPDase1
(ecto-nucleoside triphosphate diphosphohydrolase-1, also known as
CD39) and a recently initiated bispecific antibody program.
Recent updates include:
- Sensei has completed lead optimization for its programs SNS-102
(targeting VSIG4) and SNS-103 (targeting CD-39) and is currently
characterizing potential lead antibodies for each program. Sensei
remains on track to select product candidates for both SNS-102 and
SNS-103 in 2023.
- Sensei’s early discovery bispecific antibody program has
generated an initial set of conditionally active bispecific
antibodies that are currently being characterized.
- Upon successful candidate selection, Sensei expects to advance
one product candidate to IND-enabling studies.
Additional Updates
Robert Schreiber, Ph.D., Professor of Pathology & Immunology
and Director of the Center for Human Immunology and Immunotherapy
Programs at Washington University, has been appointed Chair of
Sensei’s Immuno-Oncology Advisory Board. Dr. Schreiber was largely
responsible for defining the concept of cancer immunoediting and
his research focuses on elucidating the biochemistry and molecular
cell biology of immune responses to developing and established
tumors. He is an expert on VISTA, the target of Sensei’s lead
program SNS-101, and his laboratory at Washington University in St.
Louis, MO has partnered with Sensei to support the continued
clinical development of SNS-101.
Second Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents and
marketable securities were $78.8 million as of June 30, 2023, as
compared to $107.1 million as of December 31, 2022. The decrease is
due to cash used to fund operations and $7.8 million relating to
shares repurchased within the period. Sensei expects its current
cash balance to fund operations into the second half of 2025.
Research and Development (R&D) Expenses:
R&D expenses were $4.8 million for the quarter ended June 30,
2023, compared to $6.4 million for the quarter ended June 30, 2022.
The decrease in R&D expenses was primarily attributable to
lower personnel costs due to the Company’s December 2022
restructuring, lower expense relating to lab supply purchases and
lower manufacturing-related expenses, partially offset by increased
expense relating to outside research fees and higher expense
associated with clinical trials.
General and Administrative (G&A) Expenses:
G&A expenses were $5.4 million for the quarter ended June 30,
2023, compared to $4.3 million for the quarter ended June 30, 2022.
The increase in G&A expense was primarily attributable to
external professional services, including $1.56 million of
non-recurring expenses associated with stockholder activism related
to our 2023 annual meeting of stockholders, partially offset by
lower recruiting expense.
Net Loss: Net loss was $9.4 million for the
quarter ended June 30, 2023, compared to $10.5 million for the
quarter ended June 30, 2022.
About Sensei BiotherapeuticsSensei
Biotherapeutics (Nasdaq: SNSE) is a clinical stage immuno-oncology
company focused on the discovery and development of next-generation
therapeutics for cancer patients. Through its TMAb™ (Tumor
Microenvironment Activated biologics) platform, Sensei develops
conditionally active therapeutics designed to disable
immunosuppressive signals or activate immunostimulatory signals
selectively in the tumor microenvironment to unleash T cells
against tumors. Sensei’s lead investigational candidate is SNS-101,
a conditionally active antibody designed to block the V-domain Ig
suppressor of T cell activation (VISTA) checkpoint selectively
within the low pH tumor microenvironment, where VISTA acts as a
suppressor of T cells by binding the receptor PSGL-1. The company
is also developing SNS-102, a conditional binding monoclonal
antibody targeting V-Set and Immunoglobulin Domain Containing 4
(VSIG-4), as well as SNS-103, also a conditionally active
monoclonal antibody targeting ecto-nucleoside triphosphate
diphosphohydrolase-1 (ENTPDase1), also known as CD39. For more
information, please visit www.senseibio.com, and follow the
company on Twitter @SenseiBio and LinkedIn.
Condensed Statements of Operations |
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(Unaudited, in thousands except share and per share
data) |
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Three Months Ended June 30, |
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2023 |
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2022 |
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Operating expenses: |
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|
|
|
Research and development |
|
|
$ |
4,784 |
|
|
$ |
6,393 |
|
General and administrative |
|
|
|
5,393 |
|
|
|
4,319 |
|
Total operating expenses |
|
|
|
10,177 |
|
|
|
10,712 |
|
Loss from operations |
|
|
|
(10,177 |
) |
|
|
(10,712 |
) |
Total other income |
|
|
|
791 |
|
|
|
177 |
|
Net loss |
|
|
|
(9,386 |
) |
|
|
(10,535 |
) |
Net loss per share, basic and diluted |
|
|
$ |
(0.31 |
) |
|
$ |
(0.34 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
|
30,507,018 |
|
|
|
30,701,758 |
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Selected Condensed Balance Sheet Data |
(Unaudited, in thousands) |
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June 30, 2023 |
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December 31, 2022 |
Cash and cash equivalents |
|
$ |
10,226 |
|
$ |
17,795 |
Marketable securities |
|
|
68,614 |
|
|
89,321 |
Total assets |
|
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89,580 |
|
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118,375 |
Total liabilities |
|
|
10,379 |
|
|
14,968 |
Total stockholders’ equity |
|
|
79,201 |
|
|
103,407 |
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Cautionary Note Regarding Forward-Looking
StatementsAny statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may
be identified by words and phrases such as “believe”, “designed
to,” “expect”, “may”, “plan”, “potential”, “will”, and similar
expressions, and are based on Sensei’s current beliefs and
expectations. These forward-looking statements include expectations
regarding the development and potential therapeutic benefits of
Sensei’s product candidates, the timing of Sensei’s Phase 1/2
clinical trial of SNS-101, including reporting of data therefrom,
the timing of selection of product candidates, and its belief that
its existing cash and cash equivalents will be sufficient to fund
its operations at least into the second half of 2025. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the
development of therapeutic product candidates, such as the risk
that any one or more of Sensei’s product candidates will not be
successfully developed or commercialized; the risk of delay or
cessation of any planned clinical trials of Sensei’s product
candidates; the risk that prior results, such as signals of safety,
activity or durability of effect, observed from preclinical trials,
will not be replicated or will not continue in ongoing or future
studies or clinical trials involving Sensei’s product candidates;
the risk that Sensei’s product candidates or procedures in
connection with the administration thereof will not have the safety
or efficacy profile that we anticipate; risks associated with
Sensei’s dependence on third-party suppliers and manufacturers,
including sole source suppliers, over which we may not always have
full control; risks regarding the accuracy of our estimates of
expenses, capital requirements and needs for additional financing;
and other risks and uncertainties that are described in Sensei’s
Quarterly Report on Form 10-Q filed with the U.S.
Securities and Exchange Commission (SEC) on or about August 3, 2023
and Sensei’s other Periodic Reports filed with the SEC. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Sensei as of the
date of this release, and Sensei assumes no obligation to, and does
not intend to, update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Investor Contact:Michael
BiegaSenior Director, Investor RelationsSensei
Biotherapeuticsmbiega@senseibio.com
Media Contact:Chris RaileyTen
Bridge Communicationschris@tenbridgecommunications.com
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