In July 2020, the Company signed a gene editing research and collaboration agreement with Artisan Bio, Inc., a precision cell therapy engineering company, to accelerate development of next-generation CAAR T cell therapies with the potential for improved manufacturing and/or clinical outcomes for patients with B-cell mediated autoimmune diseases.
In May 2020, the Company expanded its Sponsored Research Agreement with the University of Pennsylvania. The agreement expands the scope of sponsored research to include three additional B cell-mediated autoimmune diseases under the direction of Aimee Payne, M.D., Ph.D., a Professor of Dermatology in the Perelman School of Medicine at the University of Pennsylvania, Director of the Penn Clinical Autoimmunity Center of Excellence, and a co-founder of Cabaletta and co-chair of the Scientific Advisory Board.
Upcoming August Events
Cabaletta will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 1:00 p.m. ET.
Cabaletta will participate in a fireside chat at the Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 8:35 a.m. ET.
Cabaletta will participate in a fireside chat at the 40th Annual Canaccord Genuity Growth Conference on Wednesday, August 12, 2020 at 11:30 a.m. ET.
Second Quarter 2020 Financial Results
Research and development (R&D) expenses for the three months ended June 30, 2020 were $5.3 million, compared to $2.7 million for the same period in 2019.
General and administrative (G&A) expenses for the three months ended June 30, 2020 were $2.9 million, compared to $1.1 million for the same period in 2019.
As of June 30, 2020, cash and cash equivalents and investments totaled $123.2 million, compared to $136.2 million as of December 31, 2019.
The Company expects that its cash and cash equivalents and investments as of June 30, 2020 will enable it to fund its operating plan through at least the third quarter of 2022.
About Cabaletta Bio
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 being evaluated in the DesCAARTesTM phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the clinical trial, please see www.clinicaltrials.gov. The Company’s lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.
Forward-Looking Statements
This press release contains “forward-looking statements” of Cabaletta 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, IND submissions, contract manufacturing agreements, collaboration, and the timing of its clinical trials, as well as potential impacts on enrollment and initiation; DesCAARTesTM phase 1 clinical trial, including the expected completion of its patient recruitment, the potential timing of the initiation of patient dosing, and the results and expected timing to report clinical acute safety data from the initial cohort by the first half of 2021; MuSK- CAART program, including the completion and expected results of its ongoing IND-enabling studies and plans to submit an IND application or equivalent regulatory filing for MuSK-CAART in the second half of 2021; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; expectations regarding the design, implementation, timing and success of its current and planned clinical trials and the successful completion of nonclinical studies; 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 tools 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 COVID-19 affecting countries or regions in which we have operations or do business, 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 its licensors to 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
