Sensei Biotherapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights
May 09 2023 - 7:30AM
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 first quarter ended March 31, 2023, and
provided recent business updates.
“We are pleased with the progress across our pipeline,
underscored by regulatory clearance to proceed with a Phase 1/2
clinical study of our lead candidate, SNS-101, in patients with
advanced solid tumors. We look forward to commencing this trial in
mid-2023 and expect to move swiftly to a recommended Phase 2 dose,”
said John Celebi, President and Chief Executive Officer of Sensei
Biotherapeutics. “We are also maintaining superb progress and
promising results from our other pipeline programs, each with
breakthrough potential within their target classes, as we advance
toward key decision points later this year.”
Highlights and Milestones
SNS-101
Sensei continues to advance SNS-101, a conditionally active
antibody targeting the immune checkpoint VISTA (V-domain Ig
suppressor of T cell activation), which is implicated in resistance
to cancer immunotherapy and whose expression correlates with poor
survival across numerous cancers. Recent updates for SNS-101
include:
- In April 2023, the U.S. Food and Drug Administration (FDA)
cleared Sensei’s Investigational New Drug (IND) application for the
planned Phase 1/2 clinical trial of SNS-101 in patients with
advanced solid tumors. The Phase 1/2 clinical trial is designed to
evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and
in combination with Regeneron’s PD-1 inhibitor Libtayo®
(cemiplimab) in advanced solid-tumor cancer patients. Sensei
expects to begin clinical trial enrollment and commence patient
dosing at a starting dose of 0.3 mg/kg in mid-2023.
- In February 2023, Sensei CSO Edward van der Horst presented key
preclinical data supporting the mechanism of SNS-101 at the
Keystone Symposia on Next Generation Antibody Therapeutics.
- Under the recently signed CRADA with the National Cancer
Institute (NCI), part of the National Institutes of Health, in
February 2023, preclinical studies are in progress with the goal of
further elucidating VISTA’s role in immune checkpoint resistance
and expanding the potential of SNS-101 as a combination therapy
beyond anti-PD-1. In addition, preparations are underway for the
NCI to participate as a trial site in the clinical investigation of
SNS-101.
- In a multi-dose GLP toxicology study, SNS-101 was well
tolerated and displayed a favorable multi-dose pharmacokinetic
profile, with linear elimination kinetics and an absence of
target-mediated drug disposition.
Additional TMAb™ Platform Updates
Through its Tumor Microenvironment Activated biologics (TMAb)
platform, Sensei is also 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 fourth program.
- SNS-102: Eight parental pH-sensitive VSIG4 antibodies have been
selected, which have undergone further lead optimization and are
currently being characterized.
- SNS-103: In April 2023, Sensei presented new preclinical data
on SNS-103 at the American Association for Cancer Research (AACR)
Annual Meeting. Eight parental pH-sensitive CD39 antibodies have
been selected, which have undergone further lead optimization and
are currently being characterized.
- Sensei remains on track to select product candidates for both
SNS-102 and SNS-103 in 2023.
- Sensei has initiated early discovery efforts for a fourth TMAB
program focused on developing a conditionally active bispecific
antibody.
- Upon successful candidate selection, Sensei expects to advance
one product candidate to IND-enabling studies.
First Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents and
marketable securities were $95.5 million as of March 31, 2023, as
compared to $107.1 million as of December 31, 2022. 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 $5.2 million for the quarter ended March 31,
2023, compared to $7.5 million for the quarter ended March 31,
2022. The decrease in R&D expenses was primarily attributable
to lower personnel costs due to the restructuring, lower expense
relating to lab supply purchases and lower manufacturing related
expense partially offset by higher expense associated with clinical
trials.
General and Administrative (G&A) Expenses:
G&A expenses were $5.8 million for the quarter ended March 31,
2023, compared to $5.0 million for the quarter ended March 31,
2022. The increase in G&A expense was primarily attributable to
external professional services, including $1.5 million of
non-recurring expenses associated with stockholder activism related
to our upcoming 2023 annual meeting of stockholders.
Net Loss: Net loss was $10.2 million for the
quarter ended March 31, 2023, compared to $12.4 million for the
quarter ended March 31, 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 |
(Unaudited, in thousands except share and per share
data) |
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,204 |
|
|
$ |
7,455 |
|
General and administrative |
|
|
5,804 |
|
|
|
5,032 |
|
Total operating expenses |
|
|
11,008 |
|
|
|
12,487 |
|
Loss from operations |
|
|
(11,008 |
) |
|
|
(12,487 |
) |
Total other income |
|
|
831 |
|
|
|
82 |
|
Net loss |
|
|
(10,177 |
) |
|
|
(12,405 |
) |
Net loss attributable to
common stockholders |
|
|
(10,177 |
) |
|
|
(12,405 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.40 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
30,866,087 |
|
|
|
30,647,679 |
|
Selected Condensed Balance Sheet Data |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,2023 |
|
|
|
December 31,2022 |
|
Cash and cash equivalents |
|
$ |
8,109 |
|
|
$ |
17,795 |
|
Marketable securities |
|
|
87,396 |
|
|
|
89,321 |
|
Total assets |
|
|
107,933 |
|
|
|
118,375 |
|
Total liabilities |
|
|
13,083 |
|
|
|
14,968 |
|
Total stockholders’
equity |
|
|
94,850 |
|
|
|
103,407 |
|
|
|
|
|
|
|
|
|
|
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 expected safety profile of
Sensei’s product candidates, the availability of data from Sensei’s
preclinical studies, the timing of Sensei’s planned Phase 1/2
clinical trial of SNS-101, 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 Annual Report on
Form 10-K filed with the U.S. Securities and Exchange
Commission (SEC) on March 29, 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
Sensei Biotherapeutics (NASDAQ:SNSE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sensei Biotherapeutics (NASDAQ:SNSE)
Historical Stock Chart
From Jul 2023 to Jul 2024