SGTX Sigilon Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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SIG-001
Hemophilia A
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Phase 1/2
Phase 1/2
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
SIG-005
MPS I
|
Phase 1/2
Phase 1/2
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Phase 1/2 trial to be initiated 2H 2021.
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Latest News
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CAMBRIDGE, Mass., Sept. 09, 2021 (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 announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has accepted the Company's Clinical Trial Application (CTA) for SIG-005 in Mucopolysaccharidosis Type I (MPS-1), a chronic, progressive lysosomal disease.
SIG-005 contains a human cell line genetically modified with a non-viral vector designed to express human a-L-iduronidase (IDUA), an enzyme which is missing or defective in patients with MPS-1. The IDUA enzyme is essential for the breakdown of glycosaminoglycans (GAGs) in the lysosomes of patients with MPS-1, as the progressive accumulation of GAGs results in multi-organ involvement.
"With its impact on many systems throughout the body, MPS-1 presents unique treatment challenges and presently requires regular maintenance therapy that can place a significant burden on patients and their families," said Rogerio Vivaldi, M.D., President and Chief Executive Officer of Sigilon. "Our goal with SIG-005 is to develop a non-viral, durable, redosable, and controllable approach that can deliver sustained levels of IDUA to patients with MPS-1. With this approval, we remain on track to initiate our Phase 1/2 study in the UK in the second half of this year."
The Company has also filed a CTA in Brazil and plans to submit an Investigational New Drug Application with the U.S. Food and Drug Administration.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases 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 factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon's Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. 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 the potential benefits of SIG-005, our ability to initiate the Phase 1/2 clinical trial of SIG-005 in MPS-1 by the end of 2021, if at all, and the status of our regulatory submissions related thereto. 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 favorable preclinical results are not predictive of clinical trial results, our ability to resolve the clinical hold on SIG-001, the FDA or other regulators may request additional preclinical studies or clinical trials beyond those that we currently anticipate, and the risks identified under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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. 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.
Investor Contact Robert Windsor, Jr., J.D. VP, Head of Investor Relations Sigilon Therapeutics robert.windsor@sigilon.com 617-586-3837 Media Contact Amy Bonanno Solebury Trout abonanno@soleburytrout.com 914-450-0349 Brandon Hagen Manager, Communications Sigilon Therapeutics brandon.hagen@sigilon.com 617-586-2851
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CAMBRIDGE, Mass., Sept. 02, 2021 (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 announced that its President and Chief Executive Officer, Rogerio Vivaldi, M.D., will participate in two upcoming healthcare investor conferences.
Presentation Details:
Event: Morgan Stanley 19th Annual Global Healthcare Conference
Date: Friday, September 10, 2021
Time: 8:00 AM ET
Details: Live Fireside ChatEvent: H.C. Wainwright 23rd Annual Global Investment Conference
Date: Monday, September 13, 2021
Time: 7:00 AM ET
Details: On Demand Corporate PresentationWebcasts of the Morgan Stanley fireside chat and the H.C. Wainwright corporate presentation will be accessible under "Events and Presentations" in the Investors & Media page of the Company's website at www.sigilon.com. A replay of each webcast will be available at the same location following the event.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases 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 factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon's Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.Investor Contact
Robert Windsor, Jr., J.D.
VP, Head of Investor Relations
Sigilon Therapeutics
robert.windsor@sigilon.com
617-586-3837Media Contacts
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349Brandon Hagen
Manager, Communications
Sigilon Therapeutics
brandon.hagen@sigilon.com
617-586-2851
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CAMBRIDGE, Ma., Aug. 10, 2021 (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 second quarter ended June 30, 2021 as well as certain other business highlights.
"While we remain focused on patient safety and resolving the clinical hold on our Phase 1/2 trial in hemophilia A, we are also taking important steps to advance our broad pipeline of product candidates," said Rogerio Vivaldi, M.D., M.B.A., Chief Executive Officer of Sigilon. "Last month, we had the opportunity to present preclinical data on our candidate, SIG-005, for MPS-1 – a rare genetic disorder – and are encouraged by these results. With our CTA recently filed in the UK and Brazil and an additional filing in the U.S. anticipated, we look forward to starting our clinical journey in lysosomal diseases. If these filings are approved, we plan to initiate our second trial before year-end. In addition, we are working to streamline the manufacturing process of SIG-005 by incorporating cryopreservation of the cell component, potentially reducing the manufacturing lead times by approximately 80 percent. We remain committed to realizing the promise of our platform technology and advancing our current pipeline of product candidates, which includes programs in diabetes and immune-mediated disease. We are also continuing to look for additional opportunities, including strategic partnerships, to grow our existing portfolio."
Recent Program Highlights
- In July 2021, the Phase 1/2 study of SIG-001 was placed on clinical hold by the U.S. Food and Drug Administration (FDA). The clinical hold was initiated following Sigilon's submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies. To date, three patients have been dosed with SIG-001 and are continuing to be monitored by study protocol. The third patient, who received the highest dose of study drug, developed inhibitors to FVIII, which is a well-known complication of FVIII therapy. The patient responded well to medical treatment. Among other things, the FDA has requested additional information and data on factors potentially contributing to the development of inhibitors in this patient as well as follow-up data relating to FVIII inhibitor and activity levels.
- Three scientific abstracts were selected for presentation—including an oral presentation on mucopolysaccharidosis type I (MPS-1)—at the 16th International Symposium on MPS and Related Diseases (MPS 2021), which took place July 23 – 25, 2021. The Company also presented initial results from preclinical studies of expanded pipeline programs in immune-mediated and metabolic disorders at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting in May.
- In June 2021, the Company filed a Clinical Trial Application (CTA) in the UK for SIG-005 for the treatment of MPS-1. In addition, the Company filed a CTA in Brazil for SIG-005 in July 2021.
- The Company plans to cryopreserve the cell component for the manufacture of SIG-005 in the Phase 1/2 clinical trial of MPS-1, allowing these cells to be produced in advance of the manufacture of drug product. This planned manufacturing change is expected to reduce the manufacturing lead times for patient doses of SIG-005 by approximately 80 percent.
Corporate Updates
- Deya Corzo, M.D., is stepping down as Chief Medical Officer. The Company entered into an agreement with Dr. Corzo providing for transition services until her separation on August 13, 2021. As Sigilon initiates a search for a CMO, the Board of Directors and management will work closely together on key clinical priorities.
- Philip Ashton-Rickardt, Ph.D., joined Sigilon as Chief Scientific Officer. Dr. Ashton-Rickardt is a highly regarded scientific leader in the field of immunology with a successful track record of developing cell therapies and platform technologies.
- Ajay Rai, M.B.A., joined the Company as Senior Vice President, Head of Business Development. Mr. Rai brings over two decades of business development, finance and partnering experience in the life sciences to Sigilon.
- Sigilon has initiated a search for a full-time Chief Financial Officer and, in the meantime, has engaged Michael Wyzga, M.B.A., former Chief Financial Officer of Genzyme, to provide finance-related services on an interim basis.
- Brooke Story, M.B.A., was appointed to the Company's Board of Directors. Ms. Story has more than 20 years of extensive commercial and operating experience in the healthcare industry.
Anticipated Milestones
- Sigilon expects to initiate a Phase 1/2 trial of SIG-005 in patients with MPS-1 in the second half of 2021.
- The Company expects to disclose up to 9 months of follow-up data for three patients from the Phase 1/2 safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia in the third quarter of 2021.
Financial Results
- Cash Position: Cash was $162.4 million as of June 30, 2021 compared to $202.2 million as of December 31, 2020.
- R&D Expenses: Research and development expenses were $17.8 million for the second quarter of 2021 compared to $12.5 million for the second quarter of 2020. The increase in research and development expenses was primarily related to ongoing platform, pipeline, and development activities related to Sigilon's SIG-005 and SIG-007 programs, which received orphan drug designation in December 2020 and March 2021, respectively. Personnel expenses increased primarily as a result of the increase in headcount in Sigilon's research and development function and increases in stock-based compensation. Stock-based compensation expense increased to $0.9 million from $0.3 million for the three months ended June 30, 2021 and 2020, respectively. These increases were partially offset by a reduction of $0.5 million and $0.6 million associated with Sigilon's SIG-001 and SIG-002 programs, respectively. The decrease in SIG-001-related expenses was due to the timing of manufacturing activities in the second quarter of 2020 and the decrease in SIG-002-related expenses was due to changes in the timeline for preclinical activities.
- G&A Expenses: General and administrative expenses were $5.0 million for the second quarter of 2021 compared to $2.8 million for the second quarter of 2020. The increase in general and administrative expenses was primarily driven by a $0.8 million in increased costs from operating as a public company in the second quarter of 2021. In addition, personnel expenses increased by $1.0 million primarily as a result of the increase in headcount in Sigilon's general and administrative function and increases in stock-based compensation. Stock-based compensation expense increased to $1.1 million from $0.4 million for the three months ended June 30, 2021 and 2020, respectively.
- Net Loss: Net loss was $20.4 million for the second quarter ended June 30, 2021 compared to $13.5 million for the same period of 2020.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases 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 factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon's Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. 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 the modularity of our pipeline programs and the potential benefits of our platform, the timing for the initiation of our Phase 1/2 clinical trial of SIG-005 in MPS-1 as well as the filings related thereto, our ability to cryopreserve cell components of SIG-005 and other product candidates and the associated impact on manufacturing lead times, the timing for the submission of regulatory filings for MPS-1 and other product candidates, and the timing and scope of disclosure of initial data relating to our Phase 1/2 clinical study of SIG-001 in Hemophilia A. 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 favorable preclinical results are not predictive of clinical trial results, our ability to resolve the clinical hold on SIG-001, the FDA or other regulators may request additional preclinical studies or clinical trials beyond those that we currently anticipate, manufacturing changes may not have the desired effect, and the risks identified under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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. 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
(in thousands, except share and per share amounts)
(Unaudited)June 30, December 31, 2021 2020 Assets Current assets: Cash $ 162,406 $ 202,229 Accounts receivable (inclusive of $63 and $63 from a related party at June 30, 2021 and December 31, 2020, respectively) 178 177 Prepaid expenses and other current assets 3,611 1,729 Restricted cash—current 75 75 Total current assets 166,270 204,210 Property and equipment, net 3,630 2,991 Right-of-use assets 14,928 16,731 Restricted cash 1,293 1,118 Total assets $ 186,121 $ 225,050 Liabilities, convertible preferred stock and stockholders' equity (deficit) Current liabilities: Accounts payable $ 4,661 $ 1,988 Accrued expenses and other current liabilities 8,693 7,892 Lease liabilities, current portion 5,075 5,361 Deferred revenue from related party, current portion 25,957 31,777 Total current liabilities 44,386 47,018 Deferred revenue from related party, net of current portion 272 — Lease liability, net of current portion 10,279 11,893 Long-term debt, net of discount 19,941 19,807 Other liabilities 176 176 Total liabilities $ 75,054 $ 78,894 Stockholders' equity Common stock, par value $0.001 per share; 175,000,000 shares authorized at June 30, 2021 and December 31, 2020; 31,864,020 and 31,464,989 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively 32 31 Preferred stock, par value $0.001 per share; 25,000,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at June 30, 2021 and December 31, 2020 — — Additional paid-in capital 286,373 282,053 Accumulated deficit (175,338 ) (135,928 ) Total stockholders' equity 111,067 146,156 Total liabilities, convertible preferred stock and stockholders' equity $ 186,121 $ 225,050 Sigilon Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(Unaudited)Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Revenue Collaboration revenue (inclusive of $2,662, $5,606, $1,951 and $5,417 from a related party for the three and six months ended June 30, 2021 and 2020, respectively) $ 2,704 $ 1,951 $ 5,662 $ 5,417 Operating expenses: Research and development 17,751 12,452 33,736 25,726 General and administrative 4,992 2,818 10,532 5,689 Total operating expenses 22,743 15,270 44,268 31,415 Loss from operations (20,039 ) (13,319 ) (38,606 ) (25,998 ) Other income (expense), net: Interest income 71 35 157 238 Interest expense (494 ) (196 ) (982 ) (404 ) Other expense 25 (11 ) 21 (27 ) Change in fair value of preferred stock warrant liability — 1 — (34 ) Total other expense, net (398 ) (171 ) (804 ) (227 ) Net loss and comprehensive loss $ (20,437 ) $ (13,490 ) $ (39,410 ) $ (26,225 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.65 ) $ (2.54 ) $ (1.25 ) $ (5.09 ) Weighted average common stock outstanding—basic and diluted 31,571,704 5,320,427 31,529,939 5,152,477 SOURCE: Sigilon Therapeutics, Inc.
Investor Contacts
Rob Windsor
Sigilon Therapeutics, Head of Investor Relations
robert.windsor@sigilon.com
617-586-3837
Media Contact
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349
- In July 2021, the Phase 1/2 study of SIG-001 was placed on clinical hold by the U.S. Food and Drug Administration (FDA). The clinical hold was initiated following Sigilon's submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies. To date, three patients have been dosed with SIG-001 and are continuing to be monitored by study protocol. The third patient, who received the highest dose of study drug, developed inhibitors to FVIII, which is a well-known complication of FVIII therapy. The patient responded well to medical treatment. Among other things, the FDA has requested additional information and data on factors potentially contributing to the development of inhibitors in this patient as well as follow-up data relating to FVIII inhibitor and activity levels.
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CAMBRIDGE, Mass., July 23, 2021 (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 results from several ongoing preclinical studies in the rare lysosomal diseases MPS-1, MPS-2, and MPS-6. Three scientific abstracts were selected for presentation—including an oral presentation on MPS-1—during the 16th International Symposium on MPS and Related Diseases (MPS 2021), which is being held virtually from July 23-25.
MPS-1 is a rare genetic disorder resulting from defects in the gene that encodes alpha-L-iduronidase (IDUA), an enzyme that breaks down glycosaminoglycans (GAGs). Eventually the progressive accumulation of GAGs results in multi-organ involvement.
"Despite approved therapies for MPS-1, including hematopoietic stem cell transplantation and enzyme replacement therapy, patients experience high treatment burden and long-term disease progression," said Rogerio Vivaldi M.D., M.B.A., President and Chief Executive Officer of Sigilon. "While still early in its development, we are highly encouraged by these results with SIG-005, which demonstrated active IDUA production for up to 6 months in vitro and in vivo, and a dose-response relationship with tissue GAG clearance in the MPS-1H mouse model."
Sigilon recently filed a Clinical Trial Application (CTA) in the United Kingdom for SIG-005 in MPS-1 and anticipates submitting an Investigational New Drug (IND) application and a CTA in the United States and Brazil, respectively. If approved, Sigilon expects to initiate a Phase 1/2 clinical trial of SIG-005 in patients with MPS-1 in the second half of 2021.
PRESENTATION DETAILS
Oral Presentation
Title: "SIG-005: Novel Encapsulated Non-Viral Cell-Based Therapy for MPS-1"
Date/Time: Friday, July 23rd at 12:25 PM EDT
QA Session: 12:35 PM EDTE-Poster Presentations
Title: "SIG-018: novel encapsulated non-viral cell-based therapy for MPS-2"
Date: Friday, July 23rd
QA Session: 1:30-2:30 PM EDTTitle: "Development of a novel encapsulated non-viral cell-based therapy for MPS-6"
Date: Friday, July 23rd
QA Session: 1:30-2:30 PM EDTFor more information and to access the presentations and Q&A sessions, please visit the MPS 2021 meeting virtual platform. The presentations will also be made available on the "Presentations" page of the "Science" section of the Sigilon corporate website at www.sigilon.com following the presentations.
Additionally, please visit Sigilon's booth in the virtual exhibit hall to learn more about the Company's technology and commitment to patients and caregivers.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases 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 factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon's Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. 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 the results and potential benefits of our preclinical studies, the timing for our regulatory submissions for SIG-005 and the timing for initiation of a Phase 1/2 clinical trial of SIG-005. 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 we have incurred significant losses since inception and our need for additional funding; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use; that we have only any results from the testing of any of our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials; we may be unable to obtain and maintain patent protection and other intellectual property rights for SIG-001 or any other product candidates and for our SLTx platform, or the scope of the patent and other intellectual property protection obtained may not be sufficiently broad; and the risks identified under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and in any subsequent filings with the Securities and Exchange Commission. 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. 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.Investor Contact
Rob Windsor
Sigilon Therapeutics, Head of Investor Relations
robert.windsor@sigilon.com
617-586-3837Media Contact
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349 -
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CAMBRIDGE, Mass., July 19, 2021 (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 announced the appointment of Ajay Rai, M.B.A., as Senior Vice President, Head of Business Development. Most recently, Mr. Rai served as Vice President, Corporate Development, Strategy & Alliance Management at Frequency Therapeutics where he was responsible for evolving the company's overall business and corporate strategy and played an integral role in executing several financing rounds, including an Initial Public Offering.
"We are pleased to welcome Ajay to our team, as he brings over two decades of business development, finance and partnering experience in the life sciences," said Rogerio Vivaldi, M.D., President and CEO of Sigilon. "At Sigilon, we are committed to discovering the full potential of our modular platform technology in hopes of reaching broader patient populations worldwide. Ajay has a strong track record of successfully expanding and accelerating access to novel therapeutics through targeted collaborations and strategic partnerships. We believe Ajay will play an important role in identifying and evaluating opportunities where Sigilon's technology and growing pipeline could potentially disrupt existing treatment paradigms for patients with chronic disease."
Prior to Frequency Therapeutics, Mr. Rai was Senior Director of Corporate Development for Takeda, where he was responsible for evaluating and leading mergers and acquisitions (M&A), divestments, joint ventures and new company formation. Previously, he spent more than a decade at Biogen, holding various roles of increasing responsibility including business planning, investor relations, corporate strategy, venture investment and business development/M&A. While there, he was responsible for leading business development activities for several therapeutic areas including immunology, pain and tissue injury, and fibrosis. Mr. Rai completed more than 15 transactions ranging from acquisitions to early-stage research partnerships and was instrumental in leading new and follow-on investments in multiple early-stage companies for Biogen's Venture Portfolio. Earlier in his career, he was an M&A advisor for Ernst & Young's M&A advisory practice, as well as was part of the Finance and Strategy Group of Roche Molecular Systems. Mr. Rai has been an advisor to multiple start-up life sciences companies, including Innovate Biopharma, Immunomic Therapeutics and Cayuga Therapeutics. He earned a B.S. in Finance from New York University's Stern School of Business and a M.B.A. from Case Western University.
Added Mr. Rai: "I am excited to be joining Sigilon, as I truly believe its platform technology has the ability to revolutionize the way patients living with chronic diseases are treated. I look forward to working with the talented Sigilon team in forging strategic partnerships with the goal of advancing the Company's pipeline and expanding access to its platform technology."
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases 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 factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon's Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. 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 the modularity of our platform technology, the potential benefits of our pipeline and product candidates and our ability to expand or accelerate access through collaborations and partnerships. 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 we have incurred significant losses since inception and our need for additional funding; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use; that we have only any results from the testing of any of our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials; we may be unable to obtain and maintain patent protection and other intellectual property rights for SIG-001 or any other product candidates and for our SLTx platform, or the scope of the patent and other intellectual property protection obtained may not be sufficiently broad; and the risks identified under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and in any subsequent filings with the Securities and Exchange Commission. 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. 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.Investor Contacts
Rob Windsor
Sigilon Therapeutics, Head of Investor Relations
robert.windsor@sigilon.com
617-586-3837Media Contact
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349