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Sigilon Therapeutics, Inc. (NASDAQ: SGTX) is a biopharmaceutical company based in Cambridge, MA, dedicated to developing functional cures for a wide range of acute and chronic diseases. Utilizing its proprietary Shielded Living Therapeutics™ platform, the company engineers cell-based therapies designed to replace or supplement missing or deficient functions or molecules in patients.
Sigilon's innovative approach involves encapsulating engineered cells in its Afibromer™ biomaterials matrix, which protects them from immune rejection. These cells are then used to produce therapeutic molecules continuously, offering a potentially transformative treatment for diseases such as diabetes. The lead product candidate, SIG-002, aims to treat type 1 diabetes by sensing blood glucose levels and restoring insulin production.
In a significant development, Sigilon Therapeutics recently entered into a definitive agreement with Eli Lilly and Company (NYSE: LLY) for acquisition. This partnership, which has been in collaboration since 2018, focuses on developing encapsulated cell therapies, including SIG-002. Lilly will acquire Sigilon for approximately $34.6 million in cash, along with contingent value rights that could lead to additional payments, potentially totaling $309.6 million.
Rogerio Vivaldi, M.D., CEO of Sigilon, expressed optimism about the merger, emphasizing that Lilly's expertise in diabetes treatment will further advance SIG-002, potentially offering significant benefits to patients. The transaction, expected to close in the third quarter of 2023, will result in Sigilon becoming a wholly-owned subsidiary of Lilly.
Founded by Flagship Pioneering with input from renowned researchers at MIT, Sigilon has made remarkable strides in cell therapeutics. The company's mission is to harness the full power of cell therapy to offer innovative solutions to challenging medical conditions, aiming to improve the quality of life for millions worldwide.
The acquisition by Lilly is expected to enhance Sigilon's research and development capabilities, with both companies focusing on bringing innovative treatments to market. The merger also underscores Sigilon's potential in the biopharmaceutical sector, particularly in the field of diabetes care.
Sigilon Therapeutics, Inc. (NASDAQ: SGTX) announced that the Medicines and Healthcare Products Regulatory Agency has accepted its Clinical Trial Application for SIG-005, targeting Mucopolysaccharidosis Type I (MPS-1), a chronic lysosomal disease. SIG-005 utilizes a human cell line modified to express the enzyme a-L-iduronidase, essential for breaking down glycosaminoglycans. The company plans to initiate a Phase 1/2 study in the UK by late 2021 and has also filed a CTA in Brazil and intends to submit an Investigational New Drug Application to the FDA.
Sigilon Therapeutics (NASDAQ:SGTX), a biotech firm focused on functional cures for chronic diseases, announced participation in two healthcare investor conferences. CEO Rogerio Vivaldi will present at the Morgan Stanley 19th Annual Global Healthcare Conference on September 10, 2021, at 8:00 AM ET in a live fireside chat. He will also present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 AM ET through an on-demand corporate presentation. Webcasts will be available on the company's website.
Sigilon Therapeutics, Inc. (NASDAQ:SGTX) reported its Q2 2021 financial results, highlighting a net loss of $20.4 million compared to $13.5 million in 2020. While the company remains focused on resolving a clinical hold on its Phase 1/2 trial for hemophilia A, it has made advancements in its pipeline, including preclinical data on SIG-005 for MPS-1. The cash position decreased to $162.4 million from $202.2 million at year-end 2020. Sigilon aims to initiate a Phase 1/2 trial for SIG-005 in late 2021, with key leadership changes also announced.
Sigilon Therapeutics (NASDAQ:SGTX) announced its selection for an oral presentation at the 16th International Symposium on MPS and Related Diseases, highlighting the potential of SIG-005 for treating MPS-1. The study showed sustained production of active human alpha-L-iduronidase, necessary for breaking down glycosaminoglycans, for up to six months. Following a Clinical Trial Application in the UK, plans for IND submission in the US and Brazil are underway, targeting a Phase 1/2 trial initiation in late 2021.
Sigilon Therapeutics, Inc. (NASDAQ:SGTX) has appointed Ajay Rai as Senior Vice President, Head of Business Development. Rai brings over 20 years of experience from roles at Frequency Therapeutics, Takeda, and Biogen. His expertise includes business development, corporate strategy, and successful financing rounds. CEO Rogerio Vivaldi emphasized Rai's potential to advance Sigilon's Shielded Living Therapeutics™ platform and expand patient access. Sigilon focuses on developing non-viral engineered cell-based therapies for chronic diseases, with an emphasis on partnerships and innovative solutions.
Sigilon Therapeutics (NASDAQ:SGTX) has announced that the FDA has placed its Phase 1/2 study of SIG-001 for severe hemophilia A on clinical hold following a serious adverse event (SAE). One patient developed inhibitors to Factor VIII after receiving the highest dose of the study drug. The FDA has requested further information regarding the potential causes of this complication. Sigilon is committed to patient safety and is working with regulatory agencies to investigate the SAE while monitoring all enrolled patients.
Sigilon Therapeutics (NASDAQ:SGTX) announced the appointment of Brooke Story to its Board of Directors on June 16, 2021. Story, with extensive experience in commercial and operational roles, is expected to contribute valuable insights as the company advances its non-viral engineered cell-based therapies. Currently serving as President of BD Integrated Diagnostic Solutions, she previously held leadership positions at Medtronic. Story's expertise aligns with Sigilon's mission to develop functional cures for chronic diseases through its innovative Shielded Living Therapeutics™ platform.
Sigilon Therapeutics (NASDAQ:SGTX) has appointed Philip Ashton-Rickardt, Ph.D., as its new Chief Scientific Officer. With ample experience in cell therapy, he previously served at AZTherapies, leading immunology initiatives. His expertise is expected to enhance Sigilon's Shielded Living Therapeutics™ platform, aiding its progress in developing novel therapeutics for chronic diseases. Ashton-Rickardt's strong background, including founding Smith Therapeutics and a notable academic career, positions him as a valuable asset to advance the company’s innovative pipeline.
Sigilon Therapeutics (NASDAQ:SGTX) announced that its President and CEO, Rogerio Vivaldi, M.D., will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 8:00 a.m. EDT. The event will be held in a virtual format, and a live webcast will be available on the company's website under 'Events and Presentations.' Sigilon focuses on developing functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, utilizing non-viral engineered cell-based therapies.
Sigilon Therapeutics (NASDAQ:SGTX) reported Q1 2021 financial results, highlighting a cash position of $178.8 million as of March 31, 2021. R&D expenses rose to $16.0 million, primarily due to pipeline development. General and administrative expenses increased to $5.5 million, driven by public company operations and personnel costs. The net loss widened to $19.0 million from $12.7 million in Q1 2020. The company continues its Phase 1/2 study for SIG-001 in hemophilia A and anticipates filing for MPS-1 in Q2 2021.
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