Cabaletta Bio Reports Second Quarter 2023 Financial Results and Provides Business Update
10 8월 2023 - 8:00PM
Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology
company focused on developing and launching the first curative
targeted cell therapies for patients with autoimmune diseases,
today reported financial results for the second quarter ended June
30, 2023, and provided a business update.
“As we continue to pursue our vision of launching the first CD19
CAR-T product for patients with autoimmune diseases, we accelerated
the progress of CABA-201 in the first half of 2023 by securing FDA
clearance to initiate two separate and efficiently designed Phase
1/2 clinical trials in patients with systemic lupus erythematosus
and myositis. With separate parallel cohorts in each trial, we are
well positioned to rapidly evaluate and develop CABA-201 for
patients with autoimmune diseases,” said Steven Nichtberger, M.D.,
Chief Executive Officer of Cabaletta. “Backed by a strong balance
sheet that we believe positions us to deliver on our milestones, we
continue to expect 3-month clinical data for initial patients
treated with CABA-201 by the first half of 2024. With expanding
clinical evidence in the field, we look forward to building on our
momentum and advancing our mission to develop and launch the first
curative targeted cellular therapies for patients with autoimmune
diseases.”
Recent Operational Highlights and Upcoming Anticipated
Milestones
Chimeric Antigen Receptor T cells for Autoimmunity
(CARTA) Strategy
CABA-201: Autologous, engineered T cells with a
chimeric antigen receptor containing a fully human CD19 binder and
a 4-1BB co-stimulatory domain as a potential treatment for a broad
range of autoimmune diseases where B cells contribute to the
initiation and/or maintenance of disease.
- Preparations on track to initiate clinical trials of
CABA-201: The Company plans to initiate a Phase 1/2
clinical trial of CABA-201 for the treatment of systemic lupus
erythematosus (SLE), including two separate parallel cohorts of six
SLE patients with active lupus nephritis (LN) and six patients with
active SLE without renal involvement. In addition, the Company
plans to initiate a Phase 1/2 clinical trial of CABA-201 for the
treatment of idiopathic inflammatory myopathy (myositis), including
three separate parallel cohorts of six patients with
dermatomyositis (DM), six patients with anti-synthetase syndrome
(ASyS), and six patients with immune-mediated necrotizing myopathy
(IMNM). An initial CABA-201 dose of 1.0 x 106 is expected to be
used in both trials for SLE and myositis. Cabaletta anticipates
generating 3-month clinical data on efficacy and tolerability in
initial CABA-201 treated patients by the first half of 2024.
- Second IND application for CABA-201 cleared:
In May 2023, Cabaletta announced that the U.S. Food and Drug
Administration (FDA) cleared the Company’s second Investigational
New Drug (IND) application for CABA-201 for a Phase 1/2 study in
patients with active myositis.
- Granted Fast Track Designation in LN and SLE by
FDA: In May 2023, Cabaletta announced that the FDA granted
Fast Track Designation to CABA-201, which is designed to deplete
CD19-positive B cells and improve disease activity in patients with
LN and SLE. This designation may facilitate the potential for
expedited review and development of CABA-201 by conferring
potential benefits to the program, including the opportunity for
more frequent meetings and interactions with the FDA during the
clinical development period as well as eligibility for accelerated
approval and/or priority review, if relevant criteria are met.
- Presented new preclinical data at ASGCT 26th Annual
Meeting: In May 2023, Cabaletta presented IND-enabling
preclinical data for CABA-201 which characterized the specificity
and activity of CABA-201 in a poster presentation at the American
Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting.
Chimeric AutoAntibody Receptor
T (CAART) cells Strategy
- DSG3-CAART: Cabaletta is evaluating desmoglein
3 chimeric autoantibody receptor T (DSG3-CAART) cells as a
potential treatment for patients with mucosal pemphigus vulgaris
(mPV). Based on updated clinical and translational data from the
ongoing DesCAARTes™ trial that showed combination therapy with
intravenous immunoglobulin (IVIg) and cyclophosphamide modestly
increased DSG3-CAART persistence and activation, the Company has
initiated enrollment in an additional combination cohort where
patients are pre-treated with IVIg, cyclophosphamide and
fludarabine prior to DSG3-CAART infusion.
- MuSK-CAART: Cabaletta is evaluating
muscle-specific kinase (MuSK) chimeric autoantibody receptor T
(MuSK-CAART) cells as a potential treatment for patients with
MuSK-associated myasthenia gravis (MG). Based on emerging data from
the DesCAARTes™ study, clinical trial timelines are under
evaluation for the Phase 1, open-label MusCAARTes™ study of
MuSK-CAART in patients with MuSK autoantibody-positive MG.
Corporate Updates
- Raised $93.8 million in net proceeds from public
offering: In May 2023, Cabaletta closed an underwritten
public offering of 8,337,500 shares of its common stock, including
the exercise in full by the underwriters of their option to
purchase an additional 1,087,500 shares, at the public offering
price of $12.00 per share. The net proceeds raised in the offering,
after underwriting discounts and commissions and estimated expenses
of the offering, were approximately $93.8 million.
- Appointed Shawn Tomasello to Board of
Directors: In July 2023, Shawn Tomasello joined the
Company’s Board of Directors and became a member of the
Compensation and Science & Technology Committees. Ms. Tomasello
most recently served as the Chief Commercial Officer of Kite
Pharma, now part of Gilead Sciences, where she oversaw the global
commercialization of Yescarta®, the first approved CAR-T therapy
for non-Hodgkin lymphoma.
Upcoming Events
Cabaletta plans to participate in the following upcoming
investor conferences:
- Citi's 18th Annual BioPharma Conference, which is being held
September 6-7, 2023 in Boston, MA.
- Wells Fargo Healthcare Conference, which is being held from
September 6-8, 2023 in Boston, MA.
- Morgan Stanley 21st Annual Global Healthcare Conference, which
is being held from September 11-13, 2023 in New York, NY.
- H.C. Wainwright 25th Annual Global Investment Conference, which
is being held from September 11-13, 2023 in New York, NY.
- 2023 Cantor Global Healthcare Conference, which is being held
from September 26-28, 2023 in New York, NY.
Second Quarter 2023 Financial Results
- Research and development expenses were $11.8 million for the
three months ended June 30, 2023, compared to $9.5 million for the
same period in 2022.
- General and administrative expenses were $4.1 million for the
three months ended June 30, 2023, compared to $3.5 million for the
same period in 2022.
- As of June 30, 2023, Cabaletta had cash, cash equivalents and
short-term investments of $176.3 million, compared to $106.5
million as of December 31, 2022.
The Company expects that its cash, cash equivalents and
short-term investments as of June 30, 2023, will enable it to fund
its operating plan into the fourth quarter of 2025.
About Cabaletta BioCabaletta Bio (Nasdaq: CABA)
is a clinical-stage biotechnology company focused on the discovery
and development of engineered T cell therapies that have the
potential to provide a deep and durable, perhaps curative,
treatment for patients with autoimmune diseases. The CABA™ platform
encompasses two strategies: the CARTA (chimeric antigen receptor T
cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing
fully human CD19-CAR T, as the lead product candidate being
evaluated in systemic lupus erythematosus and myositis, and the
CAART (chimeric autoantibody receptor T cells) strategy, with
multiple clinical-stage candidates, including DSG3-CAART for
mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia
gravis. The expanding CABA™ platform is designed to develop
potentially curative therapies that offer deep and durable
responses for patients with a broad range of autoimmune diseases.
Cabaletta Bio’s headquarters and labs are located in Philadelphia,
PA.
Forward-Looking StatementsThis press release
contains “forward-looking statements” of Cabaletta Bio within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including without limitation, express or implied
statements regarding its expectations regarding: Cabaletta’s
ability to grow its autoimmune-focused pipeline; its plans around
CABA-201, including its ability to enroll the requisite number of
patients, dose each dosing cohort in the intended manner and
advance the separate Phase 1/2 clinical trials of CABA-201 in each
indication, as well as leverage the potential therapeutic benefits
from using the initial dose used in the September 2022 Nature
Medicine publication; Cabaletta’s ability to retain and recognize
the intended incentives conferred from the Fast Track Designation
for CABA-201; the Company’s business plans and objectives; the
progress and results of its DesCAARTes™ Phase 1 trial, including
Cabaletta’s ability to enroll the requisite number of patients in
the additional combination cohort, dose each dosing cohort in the
intended manner, and progress the trial; expectations for the
MusCAARTes™ Phase 1 trial, including potential trial timelines and
the therapeutic benefits of MuSK-CAART; statements regarding
anticipated significance of, and timing of release of, efficacy
endpoints and tolerability data for CABA-201 and its safety and
persistence data and combination sub-study cohort data for its
DesCAARTes trial; statements regarding regulatory filings for its
development programs, including the planned timing of such
regulatory filings and potential review by such regulatory
authorities; the expectation that Cabaletta Bio may improve
outcomes for patients suffering from SLE, mPV, MG, or other
autoimmune diseases as well as expected therapeutic benefits of the
Company’s product candidates; the ability to accelerate Cabaletta’s
pipeline and develop meaningful therapies for patients, including
in collaboration with academic and industry partners and the
ability to optimize such collaborations on its development
programs; use of capital, expenses, future accumulated deficit and
other financial results in the future; availability of funding for
existing programs; and ability to fund operations into the fourth
quarter of 2025.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs of future events,
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: risks
related to regulatory filings and potential clearance; the risk
that signs of biologic activity or persistence may not inform
long-term results; Cabaletta’s ability to demonstrate sufficient
evidence of safety, efficacy and tolerability in its preclinical
studies and clinical trials of DSG3-CAART, MuSK-CAART and CABA-201;
the risk that the results observed with the similarly-designed
construct employed in the recent Nature Medicine publication,
including due to the dosing regimen, are not indicative of the
results we seek to achieve with CABA-201; risks related to clinical
trial site activation or enrollment rates that are lower than
expected; risks related to unexpected safety or efficacy data
observed during clinical studies; risks related to volatile market
and economic conditions and public health crises; Cabaletta’s
ability to retain and recognize the intended incentives conferred
by Orphan Drug Designation and Fast Track Designation for its
product candidates, as applicable; risks related to Cabaletta’s
ability to protect and maintain its intellectual property position;
risks related to fostering and maintaining successful relationships
with Cabaletta’s collaboration and manufacturing partners;
uncertainties related to the initiation and conduct of studies and
other development requirements for its product candidates; the risk
that any one or more of Cabaletta’s product candidates will not be
successfully developed and/or commercialized; and the risk that the
initial or interim results of preclinical studies or clinical
studies will not be predictive of future results in connection with
future studies. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause Cabaletta’s actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in Cabaletta’s most recent annual report on Form 10-K as
well as discussions of potential risks, uncertainties, and other
important factors in Cabaletta’s subsequent and other filings with
the Securities and Exchange Commission. All information in this
press release is as of the date of the release, and Cabaletta
undertakes no duty to update this information unless required by
law.
CABALETTA BIO,
INC.SELECTED FINANCIAL DATA (unaudited;
in thousands, except share and per share data)Statements of
Operations
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
unaudited |
|
unaudited |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
11,797 |
|
|
$ |
9,514 |
|
|
$ |
24,232 |
|
|
$ |
18,684 |
|
General and administrative |
|
4,093 |
|
|
|
3,546 |
|
|
|
8,614 |
|
|
|
7,375 |
|
Total
operating expenses |
|
15,890 |
|
|
|
13,060 |
|
|
|
32,846 |
|
|
|
26,059 |
|
Loss
from operations |
|
(15,890 |
) |
|
|
(13,060 |
) |
|
|
(32,846 |
) |
|
|
(26,059 |
) |
Other
income: |
|
|
|
|
|
|
|
Interest income |
|
1,403 |
|
|
|
150 |
|
|
|
2,505 |
|
|
|
203 |
|
Net
loss |
|
(14,487 |
) |
|
|
(12,910 |
) |
|
|
(30,341 |
) |
|
|
(25,856 |
) |
Net loss per share of voting
and non-voting common stock, basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.81 |
) |
|
$ |
(0.89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet Data
|
June 30,2023 |
|
December 31,2022 |
|
(unaudited) |
|
|
|
|
Cash, cash equivalents and investments |
$ |
176,328 |
|
|
$ |
106,547 |
|
Total assets |
|
184,637 |
|
|
|
116,968 |
|
Total liabilities |
|
10,496 |
|
|
|
12,448 |
|
Total stockholders’ equity |
|
174,141 |
|
|
|
104,520 |
|
|
|
|
|
|
|
|
|
Contacts:Anup MardaChief Financial
Officerinvestors@cabalettabio.com
William GramigStern Investor Relations,
Inc.william.gramig@sternir.com
Cabaletta Bio (NASDAQ:CABA)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cabaletta Bio (NASDAQ:CABA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024