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Cabaletta Bio Reports Second Quarter 2023 Financial Results and Provides Business Update Received second IND application clearance for CABA-201 in myositis as well as Fast Track Designation in SLE and LN Strengthened bal

Key Takeaway: Cabaletta Bio reported its second quarter financial results and business updates, highlighting significant advancements in its clinical programs. The company received clearance for a second IND application for CABA-201 in myositis and secured Fast Track Designation for its therapies in systemic lupus erythematosus and lupus nephritis. With a strengthened balance sheet thanks to a recent $100 million public offering, Cabaletta has extended its cash runway into the fourth quarter of 2025, supporting its ongoing efforts to develop targeted cell therapies for autoimmune diseases.

Market Sentiment Analysis

POSITIVE FACTORS

  • Secured second IND application clearance for CABA-201 in myositis.
  • Achieved Fast Track Designation in systemic lupus erythematosus and lupus nephritis.
  • Strengthened financial position with a $100M public offering extending cash runway to Q4 2025.

Full Press Release Details

Cabaletta Bio Reports Second Quarter 2023 Financial
Results and Provides Business Update
Received second IND application clearance for CABA-201 in myositis as well as Fast Track
Designation in SLE and LN
Strengthened balance sheet by closing $100M public offering extending cash runway into the
fourth quarter of 2025
PHILADELPHIA, Aug. 10, 2023 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
Chimeric AutoAntibody Receptor T (CAART) cells Strategy
to participate in the following upcoming investor conferences:
Second Quarter 2023 Financial Results
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.
Cabaletta 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 Statements
This 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
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.
SELECTED FINANCIAL DATA
(unaudited; in thousands, except share and per share data)
Statements of Operations
Three Months Ended June 30, Six Months Ended June 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
Chief Financial Officer
Stern Investor Relations, Inc.

Frequently Asked Questions

What recent FDA approvals did Cabaletta Bio receive?

Cabaletta Bio received IND clearance for CABA-201 in myositis and Fast Track Designation in SLE and LN.

What is CABA-201 used to treat?

CABA-201 is being developed as a potential treatment for autoimmune diseases like systemic lupus erythematosus and myositis.

How long is Cabaletta Bio's cash runway expected to last?

Cabaletta Bio extended its cash runway into the fourth quarter of 2025.

What are the main strategies of Cabaletta Bio's platform?

Cabaletta Bio's strategies include CARTA and CAART, focusing on engineered T cell therapies for autoimmune diseases.

When will initial data from CABA-201 trials be available?

Initial clinical data for patients treated with CABA-201 is expected by the first half of 2024.

Last updated: Aug 10, 2023