SGTX Sigilon Therapeutics Inc.

1.81
-0.06  -3%
Previous Close 1.87
Open 1.94
52 Week Low 1.66
52 Week High 45
Market Cap $58,479,849
Shares 32,309,309
Float 19,591,162
Enterprise Value $-44,527,500
Volume 44,454
Av. Daily Volume 159,189
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Drug Pipeline

Drug Stage Notes
SIG-001
Hemophilia A
Phase 1/2
Phase 1/2
Phase 1/2 clinical hold announced July 9, 2021. Phase 1/2 reported that fibrosed spheres were observed during a retrieval procedure in a patient, noted November 29, 2021.
SIG-005
MPS I
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 2H 2021.

Latest News

  1. - Company plans to prioritize MPS-1 and diabetes with continued focus on platform optimization –

    - Workforce reduction of approximately 38%

    - Anticipated cash runway extended into 2024

    CAMBRIDGE, Mass., Dec. 13, 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 a strategic reprioritization to enable the Company to focus on MPS-1 and diabetes.

    "There have been key learnings in our Phase 1/2 trial of SIG-001 for Hemophilia A. While we continue to investigate the findings from our SIG-001 study to help inform our development of the platform, following a review of our programs…

    - Company plans to prioritize MPS-1 and diabetes with continued focus on platform optimization –

    - Workforce reduction of approximately 38%

    - Anticipated cash runway extended into 2024

    CAMBRIDGE, Mass., Dec. 13, 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 a strategic reprioritization to enable the Company to focus on MPS-1 and diabetes.

    "There have been key learnings in our Phase 1/2 trial of SIG-001 for Hemophilia A. While we continue to investigate the findings from our SIG-001 study to help inform our development of the platform, following a review of our programs, we have made the strategic decision to refocus our pipeline. We will be prioritizing MPS-1—a rare lysosomal disease—with our product candidate that is designed to produce the same enzyme as the native human structure, and Type 1 diabetes, alongside our partner, Eli Lilly, with a program that utilizes iPSC-derived islets," said Rogerio Vivaldi, President and CEO of Sigilon. "As part of our plan to refocus our pipeline, we will also make workforce reductions, which are expected to extend our cash runway."

    In November, Sigilon reported that fibrosed spheres were observed during a retrieval procedure for the third patient enrolled in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A. The Company plans to update regulatory agencies following the SIG-001 Safety Review Committee meeting scheduled in December and continue to follow all three patients per study protocol. In addition, the Company does not expect to initiate patient dosing in the Phase 1/2 clinical trial of SIG-005 for MPS-1 until further investigation is complete.

    The Company will reduce its full-time workforce by approximately 38%. The positions eliminated are primarily related to research, manufacturing, and general and administrative services. The significant reduction in expenses associated with the strategic reprioritization is expected to extend the Company's cash runway into 2024.

    "We believe that prioritizing our MPS-1 and diabetes programs puts Sigilon in the best position for success," said Dr. Vivaldi. "I want to thank our valued employees who will be departing Sigilon for their important contributions to the Company."

    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 lysosomal diseases and diabetes. The engineered cells are encapsulated by Sigilon's Afibromer™ biomaterials matrix, which is designed to shield 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 benefits and potential impact of this portfolio prioritization, expected charges and cost savings from these changes and our expected extended 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 the workforce reduction may be larger than currently anticipated, the Company may incur additional costs not currently anticipated, 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 period ended September 30, 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

    Robert Windsor, Jr., J.D.

    VP, Head of Investor Relations

    Sigilon Therapeutics



    617-586-3837

    Media Contacts

    Amy Bonanno

    Solebury Trout



    914-450-0349

    Brandon Hagen

    Manager, Communications

    Sigilon Therapeutics



    617-586-2851



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  2. CAMBRIDGE, Mass., Nov. 29, 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 that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A.

    The SIG-001 trial had been placed on clinical hold by the FDA in July 2021 following Sigilon's submission of a serious adverse event report relating to the development of inhibitors to Factor VIII in one of three patients treated. This patient underwent a laparoscopic procedure prescribed by the investigator to retrieve implanted spheres. Upon…

    CAMBRIDGE, Mass., Nov. 29, 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 that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A.

    The SIG-001 trial had been placed on clinical hold by the FDA in July 2021 following Sigilon's submission of a serious adverse event report relating to the development of inhibitors to Factor VIII in one of three patients treated. This patient underwent a laparoscopic procedure prescribed by the investigator to retrieve implanted spheres. Upon inspection, it was determined that the spheres placed in the patient had fibrosed and that cells within the spheres were no longer viable.

    While the Company investigates the fibrosed spheres in this patient, all three patients enrolled in the SIG-001 trial will continue to be followed per study protocol. These findings may have an impact on the timing of initiating dosing of patients in its planned Phase 1/2 clinical trial of SIG-005 for mucopolysaccharidosis type I (MPS-1).

    "Patients' safety and welfare are our highest priority. We are gathering information in order to understand these observations," said Rogerio Vivaldi, M.D., President and CEO of Sigilon. "We will be working closely with the FDA, other regulators, and advisors to determine the impact of these observations on our programs."

    The status of Sigilon's clinical hold investigation, including these findings, will be reviewed by the Safety Review Committee for SIG-001 at its next meeting in December.

    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 encapsulated by Sigilon's Afibromer™ biomaterials matrix, which is designed to shield 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 impact of this observation on our programs, including our ability to resolve the clinical hold of the Phase 1/2 clinical trial of SIG-001 and our timeline for the 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 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, the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use, and the risks identified under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended September 30, 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

    Robert Windsor, Jr., J.D.

    VP, Head of Investor Relations

    Sigilon Therapeutics



    617-586-3837

    Media Contacts

    Amy Bonanno

    Solebury Trout



    914-450-0349

    Brandon Hagen

    Manager, Communications

    Sigilon Therapeutics



    617-586-2851

     



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  3. Company expects to complete its investigation of the clinical hold on its Phase 1/2 trial of SIG-001

    in hemophilia A by year-end

    On track to initiate a Phase 1/2 trial of SIG-005 for MPS-1 in the fourth quarter of 2021

    Company appoints May Orfali, M.D., M.B.A, as Chief Medical Officer

    CAMBRIDGE, Mass., Nov. 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 third quarter ended September 30, 2021 as well as certain other business highlights.

    "In the third quarter, we made meaningful progress advancing the development of our…

    Company expects to complete its investigation of the clinical hold on its Phase 1/2 trial of SIG-001

    in hemophilia A by year-end

    On track to initiate a Phase 1/2 trial of SIG-005 for MPS-1 in the fourth quarter of 2021

    Company appoints May Orfali, M.D., M.B.A, as Chief Medical Officer

    CAMBRIDGE, Mass., Nov. 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 third quarter ended September 30, 2021 as well as certain other business highlights.

    "In the third quarter, we made meaningful progress advancing the development of our lysosomal disease program, while strengthening our leadership team to bolster our clinical and R&D capabilities," said Rogerio Vivaldi, M.D., President and CEO of Sigilon. "Most recently, we welcomed Dr. May Orfali as Chief Medical Officer. We believe May's insights will have an immediate impact on our Company's operations and overall development strategy."

    Continued Dr. Vivaldi: "We remain committed to working with regulators to resolve the clinical hold on our Phase 1/2 trial of SIG-001 in hemophilia A and we anticipate completing our thorough investigation by year-end. In parallel, we have made meaningful progress advancing the development of our lysosomal disease program. Of note, our CTA for SIG-005 in MPS-1 was accepted in the UK and we received our second orphan drug designation for this product candidate, underscoring the global need for new treatment options to manage patients with this rare lysosomal disease. Each of these milestones represents an important step in advancing the development of SIG-005."

    Recent Program Highlights

    • In July 2021, the Phase 1/2 study of SIG-001 in hemophilia A was placed on clinical hold by the U.S. Food and Drug Administration (FDA). To date, three patients have been dosed with SIG-001 and are continuing to be monitored by study protocol. 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 relating to the development of inhibitors to FVIII in the third patient. The Company expects to complete its investigation of this event before year-end.



    • In September 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom accepted the Company's Clinical Trial Application (CTA) for SIG-005 in mucopolysaccharidosis type I (MPS-1). In addition, the Company filed a CTA in Brazil for SIG-005 in July 2021 and plans to submit an Investigational New Drug Application to the FDA.



    • In October 2021, the European Commission granted orphan drug designation to SIG-005 for the treatment of MPS-1.



    • Sigilon presented results from several ongoing preclinical studies in the rare lysosomal diseases MPS-1, MPS-2 and MPS-6 at the 16th International Symposium on MPS and Related Diseases (MPS 2021), which took place July 23 – 25, 2021.

    Corporate Updates

    • May Orfali, M.D., M.B.A., will join the Company as an EVP and Chief Medical Officer (CMO), effective as of November 29, 2021, to lead the Company's clinical development and medical affairs functions. Dr. Orfali has over 25 years of drug development experience across all phases of clinical development. Prior to joining Sigilon, Dr. Orfali held a number of executive leadership roles, most recently as president of Rare Disease & Oncology Consulting, LLC where she served as interim CMO for multiple small biotech companies in the rare disease and oncology space. Prior to that, she was the CMO of CANbridge Life Sciences, where she led the clinical development and medical affairs group, and Executive Director, Global Product Development at Pfizer, where she was responsible for patient-focused drug development across multiple rare disease assets including hemophilia.



    • Susan Drapeau, Ph.D., was promoted from SVP, Head of Pre-clinical Development to EVP, Chief Pre-clinical Operations Officer. Dr. Drapeau has over 20 years of industry experience in cell therapy, biologics, biomaterials, protein therapies and medical device development.



    • In July, Ajay Rai, M.B.A., joined the Company as SVP, Head of Business Development. Mr. Rai brings over two decades of business development, finance and partnering experience in the life sciences industry to Sigilon.



    • Sigilon has initiated a search for a full-time Chief Financial Officer (CFO). In the meantime, the Company has entered into a consulting agreement with Michael Wyzga, M.B.A. Previously, Mr. Wyzga served in various senior management positions, including CFO at Genzyme Corporation for over a decade.

    Anticipated Milestones

    • Sigilon expects to initiate a Phase 1/2 trial of SIG-005 for MPS-1 in the fourth quarter of 2021.



    • The Company expects to provide up to 12 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 A in the fourth quarter of 2021.

    Financial Results

    • Cash Position: Cash was $140.4 million as of September 30, 2021 compared to $202.2 as of December 31, 2020.



    • R&D Expenses: Research and development expenses were $16.6 million for the third quarter of 2021 compared to $13.4 million for the third 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. During the third quarter of 2021, expenses increased for SIG-005 as the Company's CTA was accepted by MHRA in the United Kingdom and the Company filed a CTA in Brazil. The Company expects to initiate a Phase 1/2 trial of SIG-005 for MPS-1 in the fourth quarter of 2021. 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. These increases were partially offset by a reduction of $2.9 million associated with Sigilon's SIG-002 program. The decrease in SIG-002 related expenses was due to timing of preclinical activities.



    • G&A Expenses: General and administrative expenses were $5.0 million for the third quarter of 2021 compared to $3.3 million for the third quarter of 2020. The increase in general and administrative expenses was driven by a $1.2 million increase in personnel expenses, which was primarily the result of an increase in headcount and an increase in stock-based compensation. Stock-based compensation expense increased to $1.2 million from $0.4 million for the three months ended September 30, 2020. In addition, the increase in general and administrative expenses was driven by a $0.8 million in the expansion of personnel and internal infrastructure to support our operations as a public company.



    • Net Loss: Net loss was $20.2 million for the third quarter ended September 30, 2021 compared to $13.2 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 timing for the initiation of our Phase 1/2 clinical trial of SIG-005 in MPS-1, the impact and timing of our CMO hiring, the timing of our investigation of the clinical hold of our Phase 1/2 clinical study of SIG-001 in Hemophilia A including the timing of our meeting with the FDA and other regulatory agencies and anticipated follow-up data for three patients from our Phase 1/2 clinical study of SIG-001. 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 September 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)

      September 30,  December 31, 
         2021

       2020

    Assets        
    Current assets:        
    Cash $140,393  $202,229 
    Accounts receivable (inclusive of $27 and $63 from a related party at September 30, 2021 and December 31, 2020, respectively)  27   177 
    Prepaid expenses and other current assets  3,531   1,729 
    Restricted cash—current  75   75 
    Total current assets  144,026   204,210 
    Property and equipment, net  3,910   2,991 
    Right‑of‑use assets  14,568   16,731 
    Restricted cash  1,293   1,118 
    Total assets $163,797  $225,050 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)        
    Current liabilities:        
    Accounts payable $3,226  $1,988 
    Accrued expenses and other current liabilities  7,657   7,892 
    Lease liabilities, current portion  5,673   5,361 
    Deferred revenue from related party, current portion  24,310   31,777 
    Total current liabilities  40,866   47,018 
    Lease liability, net of current portion  9,442   11,893 
    Long‑term debt, net of discount  20,009   19,807 
    Other liabilities  176   176 
    Total liabilities $70,493  $78,894 
    Stockholders' equity        
    Common stock, par value $0.001 per share; 175,000,000 shares authorized at September 30, 2021 and December 31, 2020; 32,201,338 and 31,464,989 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively  32   31 
    Preferred stock, par value $0.001 per share; 25,000,000 shares authorized at September 30, 2021 and December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020      
    Additional paid‑in capital  288,766   282,053 
    Accumulated deficit  (195,494)  (135,928)
    Total stockholders' equity  93,304   146,156 
    Total liabilities, convertible preferred stock and stockholders' equity $163,797  $225,050 

    Sigilon Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited, in thousands, except per share data)

                 
      Three Months Ended September 30,  Nine Months Ended September 30, 
         2021     2020     2021     2020 
    Revenue                
    Collaboration revenue $1,947  $4,201  $7,609  $9,618 
    Operating expenses:            
    Research and development  16,645   13,425   50,381   39,151 
    General and administrative  5,041   3,334   15,572   9,023 
    Total operating expenses  21,686   16,759   65,953   48,174 
    Loss from operations  (19,739)  (12,558)  (58,344)  (38,556)
    Other income (expense), net:                
    Interest income  56   30   212   268 
    Interest expense  (499)  (293)  (1,481)  (697)
    Other income (expense)  26   (20)  47   (47)
    Change in fair value of preferred stock warrant liability     (10)     (44)
    Loss on extinguishment of debt     (343)     (343)
    Total other expense, net  (417)  (636)  (1,222)  (863)
    Net loss and comprehensive loss $(20,156) $(13,194) $(59,566) $(39,419)
    Net loss per share attributable to common stockholders—basic and diluted $(0.63) $(2.47) $(1.88) $(7.56)
    Weighted average common stock outstanding—basic and diluted  32,055,551   5,338,177   31,707,068   5,214,818 

    SOURCE: Sigilon Therapeutics, Inc.

    Investor Contact

    Robert Windsor, Jr., J.D.

    VP, Head of Investor Relations

    Sigilon Therapeutics



    617-586-3837

    Media Contacts

    Amy Bonanno

    Solebury Trout



    914-450-0349

    Brandon Hagen

    Manager, Communications

    Sigilon Therapeutics



    617-586-2851



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  4. CAMBRIDGE, Mass., Nov. 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 its President and Chief Executive Officer, Rogerio Vivaldi, M.D., will participate in a fireside chat during the upcoming Jefferies London Healthcare Conference. The prerecorded fireside chat will we available on-demand starting Thursday, November 18, 2021 at 8:00 a.m. GMT.

    A webcast of the Jefferies fireside chat will be accessible under "Events and Presentations" in the Investors & Media page of the Company's website at www.sigilon.com. A replay of the fireside chat will be available at the…

    CAMBRIDGE, Mass., Nov. 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 its President and Chief Executive Officer, Rogerio Vivaldi, M.D., will participate in a fireside chat during the upcoming Jefferies London Healthcare Conference. The prerecorded fireside chat will we available on-demand starting Thursday, November 18, 2021 at 8:00 a.m. GMT.

    A webcast of the Jefferies fireside chat will be accessible under "Events and Presentations" in the Investors & Media page of the Company's website at www.sigilon.com. A replay of the fireside chat 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
    
    617.586.3837
    
    Media Contacts
    Amy Bonanno
    Solebury Trout
    
    914-450-0349
    
    Brandon Hagen
    Manager, Communications
    Sigilon Therapeutics
    
    617-586-2851

    Primary Logo

    View Full Article Hide Full Article
  5. 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…

    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
    
    617-586-3837
    
    Media Contact
    Amy Bonanno
    Solebury Trout
    
    914-450-0349
    
    Brandon Hagen
    Manager, Communications
    Sigilon Therapeutics
    
    617-586-2851

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