November 10, 2022 07:30 ET | Source: Sigilon Therapeutics, Inc. Sigilon Therapeutics, Inc.
Cambridge, Massachusetts, UNITED STATES
Identified important optimization features for its platform to mitigate PFO risks in current and future programs
Advanced iPS cell differentiation protocol for the diabetes program in preparation for anticipated IND-enabling studies in 2023
Continued optimization of the MPS-1 program, with plans to initiate IND-enabling studies in the second half of 2023
CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) — Sigilon Therapeutics, Inc. (NASDAQ: SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today reported financial results for the third quarter ended September 30, 2022 as well as certain other business highlights.
“This year, we have made significant progress advancing our SLTx platform, including key improvements to our cross-linking chemistry designed to strengthen the stability of our spheres. In addition, we have developed preclinical models designed to predict pericapsular fibrotic overgrowth, including macrophage attachment assays and humanized mouse models, which we believe will be key to mitigating risk of an allogeneic immune response and accelerate product development,” said Rogerio Vivaldi, M.D., President and CEO of Sigilon. “I am grateful for the extraordinary effort put forth by our team to identify these important optimization features for the platform and to incorporate them into our diabetes and MPS-1 programs. We look forward to providing additional preclinical data for both programs showcasing the potential of the SLTx platform in the coming months.”
Recent Program Highlights and Anticipated Milestones
Financial Results
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for patients with a broad range of chronic diseases by harnessing the power of the human cell through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or other therapeutic molecules needed by patients living with chronic diseases such as lysosomal diseases and diabetes. The engineered cells are encapsulated by Sigilon’s Afibromer™ biomaterials matrix, which is designed to shield them from immune rejection. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.
Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. These forward-looking statements address various matters, including our expectations related to mitigation strategies for PFO, the initiation and timing of IND-enabling studies and an IND submission for SIG-002, the timing of an IND submission for a product candidate for our MPS-1 program and our expected cash runway. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, that if we fail to achieve the expected financial and operational benefits of our corporate restructuring, our business and financial results may be harmed; negative results of preclinical or clinical studies of any of our product candidates could adversely affect our business and may require us to discontinue or delay development of other product candidates, which are all based on the same SLTx platform; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use and the approaches we are taking to discover and develop novel therapeutics are unproven; we may not be successful in our efforts to identify and develop product candidates; if clinical trials of our current and future product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates; if we are unable to obtain and maintain patent and other intellectual property protection our product candidates, our SLTx platform may be adversely affected, and the risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and filed with the Securities and Exchange Commission (the “SEC”), as well as the other information we file with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements, except as required by law. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Sigilon Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)
Sigilon Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except share and per share amounts)
SOURCE: Sigilon Therapeutics, Inc.
Investor Contact
Robert Windsor, Jr., J.D.
VP, Head of Investor Relations
Sigilon Therapeutics
robert.windsor@sigilon.com
617-586-3837
Media Contacts
Amy Bonanno
Solebury Strategic Communications
abonanno@soleburystrat.com
914-450-0349