Full Press Release Details
Cabaletta Bio Reports First Quarter 2020 Financial Results and Provides Business Update
PHILADELPHIA, PA -- May 12, 2020 Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused
on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced financial results for the first quarter ended March 31, 2020.
Following the recent Fast Track Designation from the FDA for our lead product candidate, DSG3-CAART, for the treatment of patients with mucosal
pemphigus vulgaris (mPV), our Phase 1 DesCAARTesTM trial is ready to launch as soon as COVID-19 related clinical trial activity restrictions are lifted. mPV
is a rare, serious, and sometimes fatal disease for which patients have limited treatment options. We are eager to explore the potential of our engineered T cell therapy to fulfill this unmet need, said Steven Nichtberger, M.D., Chief
Executive Officer and Co-founder of Cabaletta. We continue to closely monitor the unprecedented challenges and impact of the COVID-19 pandemic while working to
ensure that patients, our employees and collaborators remain safe. As evidenced by the recent Fast Track designation, despite working from home over the past two months, our dedicated team continues to make progress across our portfolio wherever
possible as we strive to develop potential cures for patients with severe autoimmune diseases.
Pipeline Highlights and Anticipated Upcoming
DSG3-CAART: Desmoglein 3 chimeric autoantibody receptor T cells as potential treatment for patients with mucosal pemphigus
MuSK-CAART: Muscle Specific Kinase (MuSK) chimeric autoantibody receptor T cells as potential treatment for MuSK-associated myasthenia gravis.
First Quarter 2020 Financial Results
The Company expects that its current cash and cash equivalents will enable it to fund its operating plan
through at least the third quarter of 2022.
Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B
cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta s proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to
selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company s lead product candidate, DSG3-CAART, is in development as a
potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris. For more information, visit www.cabalettabio.com.
Forward-Looking Statements
This press release contains
forward-looking statements of Cabaletta Bio, Inc. ( Cabaletta or the Company ) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are
not limited to, express or implied statements regarding Cabaletta s beliefs and expectations regarding its: expectations of the potential impact of COVID-19 on strategy, future operations, contract
manufacturing agreements, collaboration, and the timing of its clinical trials, as well as potential impacts on enrollment and initiation; plans to initiate patient dosing in an open-label Phase 1 clinical trial to evaluate DSG3-CAART safety and
tolerability in relapsed/refractory mPV patients, including the potential timing of the initiation of patient dosing; potential manner and timing of data readouts of its ongoing and planned clinical trials; plans to initiate IND-enabling studies of MuSK-CAART in 2020; planned potential timing and advancement of its preclinical studies and clinical trials and related regulatory submissions; ability and the potential to successfully
maintain or secure the necessary cell processing capacity and supply for its product candidates for clinical trials, including Cabaletta s planned development and timing of next generation T cell engineering tolls and process advancement;
ability to replicate results achieved in preclinical studies or clinical trials in any future studies or trials; ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its
operations and progress; ability to optimize the impact of its collaborations on its development programs; statements regarding the timing of regulatory filings regarding its development programs; use of capital, expenses, future accumulated deficit
and other financial results in the future; and ability to fund operations through the third quarter of 2022.
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 the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, which has been labelled a pandemic by the World Health Organization, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial
markets; risks related to Cabaletta s ability to protect and maintain its intellectual property position; risks related to Cabaletta s relationship with third parties, including its licensors and licensees; risks related to the ability of
protect and maintain their intellectual property position; 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 commercialized; and the risk that the 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 quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta s 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 March 31, | ||||||||
| 2020 | 2019 | |||||||
| Unaudited | ||||||||
| Operating expenses: | ||||||||
| Research and development | $ | 4,620 | $ | 2,761 | ||||
| General and administrative | 3,275 | 1,229 | ||||||
| Total operating expenses | 7,895 | 3,990 | ||||||
| Loss from operations | (7,895 | ) | (3,990 | ) | ||||
| Other income: | ||||||||
| Interest income | 410 | 458 | ||||||
| Net loss | (7,485 | ) | (3,532 | ) | ||||
| Deemed dividend | (5,326 | ) | ||||||
| Net loss attributable to common stockholders | $ | (7,485 | ) | $ | (8,858 | ) | ||
| Net loss per share of voting and non-voting common stock, basic and diluted | $ | (0.33 | ) | $ | (6.05 | ) |
Selected Balance Sheet Data
| March 31, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 131,003 | $ | 136,204 | ||||
| Total assets | 134,965 | 141,468 | ||||||
| Total liabilities | 3,256 | 3,147 | ||||||
| Total stockholders equity | 131,709 | 138,321 |
Chief Financial Officer
Stern Investor Relations, Inc.