SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
May 6, 2020
Date of Report (Date of earliest event reported)
CABALETTA BIO, INC.
(Exact name of Registrant as Specified in its Charter)
|(State or other jurisdiction
2929 Arch Street, Suite 600,
|(Address of principal executive offices)||(Zip Code)|
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Common Stock, par value $0.00001 per share||CABA||The Nasdaq Global Select Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 8.01|| |
Cabaletta Bio, Inc. (Cabaletta or the Company), 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for DSG3-CAART (Desmoglein 3 Chimeric AutoAntibody Receptor T cells), the Companys lead product candidate for treatment of mucosal pemphigus vulgaris (mPV), for improving healing of mucosal blisters in patients with mPV.
DSG3-CAART is designed to specifically target the cause of mPV, B cells that express pathogenic autoantibodies directed against the DSG3 protein, while preserving normal B cell immune function. The Company plans to initiate its Phase 1 DesCAARTes trial to evaluate the safety and tolerability of DSG3-CAART in relapsed and/or refractory patients in 2020. DSG3-CAART is based on technology licensed from and has been developed in collaboration with the University of Pennsylvania.
This 8-K contains forward-looking statements of 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 Cabalettas beliefs and expectations regarding its: expectations regarding the intended incentives conferred by Fast Track Designation for DSG3-CAART for the treatment of mPV; expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of its clinical trials, including the potential impacts on enrollment and initiation of its Phase 1 DesCAARTes trial; 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 in 2020; and statements regarding regulatory filings regarding its development programs.
Any forward-looking statements in this 8-K are based on managements 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; Cabalettas ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation for DSG3-CAART for the treatment of PV; risks related to Cabalettas ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; 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 Cabalettas actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Cabalettas most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabalettas other filings with the Securities and Exchange Commission. All information in this 8-K is as of the date hereof, and Cabaletta undertakes no duty to update this information unless required by law.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
|CABALETTA BIO, INC.|
|Date: May 6, 2020||By:|
|Steven Nichtberger, M.D.|
|President and Chief Executive Officer|