1. CAMBRIDGE, Mass., May 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 first quarter ended March 31, 2021 as well as certain other business highlights.

    "We are continuing to execute on our business plan in 2021, as we advance the clinical development of our lead product candidate for hemophilia A, while at the same time working to strengthen our team, expanding our pipeline and further validating the potential of our Shielded Living Therapeutics™, or SLTx, platform," commented Rogerio Vivaldi, M.D., Chief Executive Officer of Sigilon. "As we…

    CAMBRIDGE, Mass., May 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 first quarter ended March 31, 2021 as well as certain other business highlights.

    "We are continuing to execute on our business plan in 2021, as we advance the clinical development of our lead product candidate for hemophilia A, while at the same time working to strengthen our team, expanding our pipeline and further validating the potential of our Shielded Living Therapeutics™, or SLTx, platform," commented Rogerio Vivaldi, M.D., Chief Executive Officer of Sigilon. "As we increased dose levels in our Phase 1/2 safety and dose ranging study of SIG-001, we completed planned manufacturing changes designed to, among other things, increase cell potency and enhance cell function. These changes have been cleared by the MHRA and FDA and we look forward to reporting initial data from this study in the third quarter of this year."

    Continued Dr. Vivaldi: "In addition to our clinical initiatives with SIG-001, we continue to focus on advancing our growing pipeline, which currently consists of product candidates targeting rare blood, lysosomal and endocrine diseases. Leveraging the modularity of our platform, we believe our novel approach may provide treatment solutions for other diseases and, as we are presenting at ASGCT this week, we are actively exploring SLTx's potential in additional therapeutic areas with large unmet needs, such as immune-mediated diseases."

    Recent Program Highlights

    • The Phase 1/2 safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia A remains ongoing, with sites initiated in the United Kingdom and United States. Recently, Sigilon cleared amendments to its CTA and IND for SIG-001 with the MHRA and FDA, respectively, to incorporate planned manufacturing changes.



    • Four abstracts were selected for poster presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting, which will take place May 11 – 14, 2021. The presentations will include initial results from the Company's preclinical studies in immune-mediated hepatitis and hypoparathyroidism, which reflect the modularity and expansion of the Company's pipeline programs.



    • Several scientific abstracts outlining ongoing preclinical studies in a range of lysosomal diseases, including an oral presentation on mucopolysaccharidosis type II (MPS-2), were presented at the 17th Annual WORLDSymposium™.



    • In March 2021, the FDA granted Orphan Drug designation for SIG-007 for the treatment of Fabry disease.

    Corporate Updates

    • In April 2021, Martha Rook, Ph.D., was promoted from SVP, Head of CMC and Analytics to Sigilon's Chief Technical Operations Officer. Dr. Rook has more than 20 years of experience in analytics and bioprocessing including more than 10 years in the development of cell and gene therapy manufacturing processes. In her new role, she will oversee all technical operations for the Company, including manufacturing, supply chain, quality, bioanalytical and CMC analytical development teams at Sigilon.



    • In the first week of May 2021, Robert Windsor, Jr., J.D., joined Sigilon as Vice President, Head of Investor Relations. Mr. Windsor has more than 15 years of experience working in equity capital markets, including institutional equity sales at several large investment banks.

    Anticipated Milestones

    • The Company is on track to file a CTA and/or IND for MPS-1 in the second quarter of 2021 and anticipates additional regulatory filings before the end of 2022.



    • The Company is continuing its Phase 1/2 safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia:



      • Sigilon expects to disclose up to 9 months of follow up data for 3-4 patients in the third quarter of 2021; and



      • Sigilon expects to complete enrollment of the study in the second half of 2021.

    Financial Results

    • Cash Position: Cash was $178.8 million as of March 31, 2021.



    • R&D Expenses: Research and development expenses were $16.0 million for the first quarter of 2021 compared to $13.3 million for the first quarter of 2020. The increase in research and development expenses was primarily related to ongoing pipeline development activities and advances in our SIG-005 and SIG-007 programs both of which received orphan drug designation in December 2020 and March 2021, respectively. Stock-based compensation expense increased to $0.8 million from $0.2 million for the three months ended March 31, 2021 and 2020, respectively. These increases were partially offset by a reduction of $0.7 million associated with our SIG-001 due to the timing of manufacturing activities in the first quarter of 2020.



    • G&A Expenses: General and administrative expenses were $5.5 million for the first quarter of 2021 compared to $2.9 million for the first quarter of 2020. The increase in general and administrative expenses was primarily driven by $1.0 million in increased costs from operating as a public company in the first quarter of 2021. In addition, personnel expenses increased by $1.1 million primarily as a result of the increase in headcount in our general and administrative function and increases in stock-based compensation. Stock-based compensation expense increased to $0.9 million from $0.4 million for the three months ended March 31, 2021 and 2020, respectively.



    • Net Loss: Net loss was $19.0 million for the first quarter ended March 31, 2021 compared to $12.7 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 disorders 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 effect of manufacturing changes on cell potency and cell function, the modularity of our pipeline programs and the potential benefits of our platform, the timing for the submission of INDs and/or CTAs and additional regulatory filings for MPS-1 and other product candidates, and the timing and scope of disclosure of initial data relating to, and the completion of enrollment for, 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, those related to our clinical and preclinical research, product candidates, the enrollment and timeline for our clinical trials and the regulatory filings related thereto, and the risks identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, and filed with the Securities and Exchange Commission, 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)
           
      March 31,  December 31, 
      2021 2020
    Assets      
    Current assets:      
    Cash $178,789  $202,229 
    Accounts receivable (inclusive of $83 and $63 from a related party at March 31, 2021 and December 31, 2020, respectively)  140   177 
    Prepaid expenses and other current assets  4,058   1,729 
    Restricted cash—current  75   75 
    Total current assets  183,062   204,210 
    Property and equipment, net  3,107   2,991 
    Right‑of‑use assets  16,098   16,731 
    Restricted cash  1,118   1,118 
    Total assets $203,385  $225,050 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)      
    Current liabilities:      
    Accounts payable $2,006  $1,988 
    Accrued expenses and other current liabilities  6,912   7,892 
    Lease liabilities, current portion  5,427   5,361 
    Deferred revenue from related party, current portion  20,134   31,777 
    Total current liabilities  34,479   47,018 
    Deferred revenue from related party, net of current portion  8,725    
    Lease liability, net of current portion  11,099   11,893 
    Long‑term debt, net of discount  19,874   19,807 
    Other liabilities  176   176 
    Total liabilities $74,353  $78,894 
    Commitments and contingencies (Note 9)      
    Stockholders' equity      
    Common stock, par value $0.001 per share; 175,000,000 shares authorized at March 31, 2021 and December 31, 2020; 31,501,952 and 31,464,989 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively  32   31 
    Preferred stock, par value $0.001 per share; 25,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding at March 31, 2021 and December 31, 2020      
    Additional paid‑in capital  283,901   282,053 
    Accumulated deficit  (154,901)  (135,928)
    Total stockholders' equity  129,032   146,156 
    Total liabilities, convertible preferred stock and stockholders' equity $203,385  $225,050 



     
    Sigilon Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (Unaudited)
           
      Three Months Ended March 31, 
         2021 2020
    Revenue      
    Collaboration revenue (inclusive of $2,932 and $3,466 from a related party for the three months ended March 31, 2021 and 2020, respectively) $2,958  $3,466 
    Operating expenses:      
    Research and development (inclusive of related party payments to MIT of $66 and $220 for the three months ended March 31, 2021 and 2020, respectively)  15,985   13,274 
    General and administrative  5,540   2,871 
    Total operating expenses  21,525   16,145 
    Loss from operations  (18,567)  (12,679)
    Other income (expense), net:      
    Interest income  86   203 
    Interest expense  (488)  (208)
    Other expense  (4)  (16)
    Change in fair value of preferred stock warrant liability     (35)
    Total other expense, net  (406)  (56)
    Net loss and comprehensive loss $(18,973) $(12,735)
    Net loss per share attributable to common stockholders—basic and diluted $(0.60) $(2.55)
    Weighted average common stock outstanding—basic and diluted  31,487,710   4,984,527 



            
    Sigilon Therapeutics, Inc.

    Condensed Consolidated Statements of Cash Flows

    (in thousands)

    (Unaudited)
          
     Three Months Ended March 31, 
     2021 2020
    Cash flows from operating activities:     
    Net loss$(18,973) $(12,735)
    Adjustments to reconcile net loss to net cash (used in) provided by operating activities:     
    Stock-based compensation expense 1,704   667 
    Deferred revenue (2,918)  (3,298)
    Other non-cash expenses, net 1,511   987 
    Other changes in assets and liabilities (3,997)  (823)
    Net cash used in operating activities (22,673)  (15,202)
    Cash flows from investing activities:     
    Purchase of property and equipment (290)  (190)
    Net cash used in investing activities (290)  (190)
    Cash flows from financing activities:     
    Proceeds from issuance of convertible preferred stock, including deemed dividend, net of issuance costs    26,946 
    Other financing activities, net (477)  120 
    Net cash provided by financing activities (477)  27,066 
    Net increase in cash and restricted cash (23,440)  11,674 
    Cash and restricted cash at beginning of period 203,422   76,645 
    Cash and restricted cash at end of period$179,982  $88,319 
          
    Cash$178,789  $87,743 
    Restricted cash-current 75    
    Restricted cash-non-current 1,118   576 
    Total cash and restricted cash$179,982  $88,319 

    SOURCE: Sigilon Therapeutics, Inc.

    Investor Contacts

    Rob Windsor

    Sigilon Therapeutics, Head of Investor Relations



    617-257-0573

    Mike Biega

    Solebury Trout



    617-913-8890

    Media Contact

    Amy Bonanno

    Solebury Trout



    914-450-0349



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  2. CAMBRIDGE, Mass., May 10, 2021 /PRNewswire/ -- Flagship Pioneering today unveiled Laronde, a platform company developing Endless RNA™ (eRNA), a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body. Flagship initially committed $50 million to support the development of Laronde's platform and initial pipeline of new medicines.

    eRNA technology was invented at Flagship Labs by a team led by Flagship Pioneering General Partner, Avak Kahvejian, Ph.D., who was also the founding CEO of Laronde. The company began in 2017 as FL50 (the 50th such life science platform developed within Flagship Labs) and has since operated as part of the broader Flagship enterprise. In 2017, the…

    CAMBRIDGE, Mass., May 10, 2021 /PRNewswire/ -- Flagship Pioneering today unveiled Laronde, a platform company developing Endless RNA™ (eRNA), a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body. Flagship initially committed $50 million to support the development of Laronde's platform and initial pipeline of new medicines.

    eRNA technology was invented at Flagship Labs by a team led by Flagship Pioneering General Partner, Avak Kahvejian, Ph.D., who was also the founding CEO of Laronde. The company began in 2017 as FL50 (the 50th such life science platform developed within Flagship Labs) and has since operated as part of the broader Flagship enterprise. In 2017, the team began to explore the therapeutic applicability of long non-coding RNA (lncRNA), naturally abundant in circular form within mammalian cells. Unlike natural messenger RNA (mRNA), which initiates translation by recruiting ribosomes through interaction with proteins bound to the mRNA's 5' region, natural circular lncRNA does not readily interact with ribosomes. The Flagship team's exploration led to the invention of eRNA, a proprietary, closed-loop RNA construct engineered to be translatable. Having no free ends, eRNA are not recognized by the innate immune system or exonuclease enzymes, and are highly stable, enabling a prolonged therapeutic effect. In addition, the therapeutic protein expression capabilities of eRNA are modular and programmable. Switching the eRNA "protein-coding cassette" directs the body to make different peptides, enzymes, antibodies, channels, and receptors, both inside and outside of the cell.

    "In the past decade, Flagship Labs has created multiple transformational companies based on programmable therapeutic modalities which allow for the more intentional and predictable creation of medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering, co-founder of Laronde, and Chairman of its Board of Directors. "With Endless RNA we have created a  new class of medicines that can be programmed to persistently express therapeutic proteins in the body, at tunable levels, without generating an unwanted immune response, in a continuously redosable manner, with very simple delivery. The possible applications of this platform are very broad, with applications that have the potential to replace or augment many drug modalities currently in use."

    Dr. Kahvejian added: "Flagship leveraged its unique combination of scientific expertise in RNA biology and experience building platforms to create and develop Laronde as the next breakthrough, multi-product platform company. eRNA therapeutics have the potential to be an essential and widespread class of medicines, expanding beyond small molecules and antibodies in their therapeutic applicability and utility. We can program eRNA medicines to code for a wide variety of therapeutic modalities." "We asked 'What if the circular nature of certain lncRNAs makes them ultra-stable in the body? Could we benefit from that stability to make a new class of therapeutic by making an RNA that has no free ends, but is translatable?' These insights led to our inventing and optimizing eRNA, to demonstrate its ability to generate prolonged protein expression in vitro and eventually in vivo, and to establishing a strong foundational IP estate around this new class of medicine."

    In January, Dr. Diego Miralles joined Flagship Pioneering as CEO-Partner and assumed the role of CEO of Laronde. "This is a once-in-a-lifetime opportunity to join a company like Laronde, which will advance such a groundbreaking therapeutic platform capable of biological applications we could only dream of a few years ago," said Dr. Miralles. "Because the programmable platform is so scalable, we have the potential to parallel process the development of multiple programs at the same time that, if successful, could help millions of people around the world. We look forward to recruiting the best talent in the industry to build a great company that will fully realize the potential of eRNA."

    To support the development and launch of multiple eRNA-based medicines, Laronde plans to build a modular and scalable eRNA Gigabase Factory to accommodate the clinical and commercial manufacture of up to 100 products and drug programs in the next 10 years. The company expects to hire more than 200 people over the next two years to support the advancement of its programs and platform.

    About Laronde

    Laronde is pioneering a platform that offers a completely novel way of modulating human biology. Endless RNA™ (eRNA), is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. It is persistent, non-immunogenic, allows for repeat dosing, and offers flexibility in formulation and delivery. Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. The company is rapidly scaling to support the parallel development of multiple programs across many disease areas. To learn more, please visit the company's website at www.laronde.bio or Twitter and LinkedIn.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ: AXLA), Codiak BioSciences (NASDAQ: CDAK) Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology (NASDAQ: SANA), Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/flagship-pioneering-unveils-laronde-to-advance-endless-rna---a-new-class-of-programmable-medicines-capable-of-expressing-therapeutic-proteins-inside-the-body-301287088.html

    SOURCE Flagship Ventures

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  3. CAMBRIDGE, Mass., May 06, 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 present a corporate overview during the BofA Securities 2021 Healthcare Conference. The presentation will take place on Wednesday, May 12 at 3:30 p.m. EDT, in a virtual format.

    A live webcast of the 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 the presentation will be available at the same location for 90 days following…

    CAMBRIDGE, Mass., May 06, 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 present a corporate overview during the BofA Securities 2021 Healthcare Conference. The presentation will take place on Wednesday, May 12 at 3:30 p.m. EDT, in a virtual format.

    A live webcast of the 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 the presentation will be available at the same location for 90 days 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 disorders 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 Contacts

    Glenn Reicin

    Sigilon Therapeutics, Chief Financial Officer



    646-696-4344

    Mike Biega

    Solebury Trout



    617-913-8890

    Media Contact

    Amy Bonanno

    Solebury Trout



    914-450-0349



    Primary Logo

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  4. CAMBRIDGE, Mass., April 27, 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 four abstracts were selected for presentation at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting, which will take place virtually from May 11-14, 2021. Among the presentations, are initial results from the study of Sigilon's novel Shielded Living TherapeuticsTM (SLTx) technology in animal models of immune-mediated hepatitis and hypoparathyroidism, which reflects the modularity and expansion of Sigilon's pipeline programs. Overall, SLTx demonstrated the potential to overcome…

    CAMBRIDGE, Mass., April 27, 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 four abstracts were selected for presentation at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting, which will take place virtually from May 11-14, 2021. Among the presentations, are initial results from the study of Sigilon's novel Shielded Living TherapeuticsTM (SLTx) technology in animal models of immune-mediated hepatitis and hypoparathyroidism, which reflects the modularity and expansion of Sigilon's pipeline programs. Overall, SLTx demonstrated the potential to overcome limitations associated with current therapies for these immune-mediated and metabolic disorders.

    The presentations will be made available on the ASGCT website starting on May 11th, 2021 at 8:00 AM EDT. The posters will also be made available in the Publications section of Sigilon's corporate website following the presentations.    

    POSTER PRESENTATION DETAILS

    Title: "A Scaled and Semi-Automated Cell Encapsulation Process for a Shielded Cell-Based Platform for Chronic Diseases"

    Abstract Number: 865

    Session: 531 – Cell Therapy Product Engineering, Development or Manufacturing

    Title: "Continuous Delivery of IL-10 Using the Shielded Living TherapeuticsTM Platform Leads to Modulation of Immune Cell Function and Prevents Liver Damage in Preclinical Model of Immune-Mediated Hepatitis"

    Abstract Number: 704

    Session: 523 – Hematologic and Immunologic Diseases

    Title: "Tunable Delivery of Parathyroid Hormone with the Shielded Living TherapeuticsTM Platform Provides a New Modality for Treatment of Hypoparathyroidism"

    Abstract Number: 510

    Session: 512 – Metabolic, Storage, Endocrine, Liver and Gastrointestinal Disease

    Title: "Analytical Development Considerations for the Shielded Living TherapeuticsTM Platform: A Novel Encapsulated Cell-Based, Non-Viral Platform for Delivery of Therapeutic Proteins"

    Abstract Number: 864

    Session: 531 – Cell Therapy Product Engineering, Development or Manufacturing

    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 disorders 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 our ability to overcome limitations associated with current therapies for immune-mediated and metabolic disorders. 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, those related to our clinical and preclinical research, product candidates and the regulatory filings related thereto, and the risks identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, and filed with the Securities and Exchange Commission, 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.

    SOURCE: Sigilon Therapeutics, Inc.

    Investor Contacts

    Glenn Reicin

    Sigilon Therapeutics, Chief Financial Officer



    646-696-4344

    Jennifer Porcelli

    Solebury Trout



    646-378-2962

    Media Contact

    Amy Bonanno

    Solebury Trout



    914-450-0349



    Primary Logo

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  5. CAMBRIDGE, Mass., April 08, 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 present a corporate overview during the 20th Annual Needham Virtual Healthcare Conference. The presentation will take place on Thursday, April 15 at 9:30 a.m. EDT, in a virtual format.

    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…

    CAMBRIDGE, Mass., April 08, 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 present a corporate overview during the 20th Annual Needham Virtual Healthcare Conference. The presentation will take place on Thursday, April 15 at 9:30 a.m. EDT, in a virtual format.

    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 disorders 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 Contacts

    Glenn Reicin

    Sigilon Therapeutics, Chief Financial Officer



    646-696-4344

    Jennifer Porcelli

    Solebury Trout



    646-378-2962



    Media Contact

    Amy Bonanno

    Solebury Trout



    914-450-0349

     



    Primary Logo

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  6. David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development…

    David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development of multiple therapeutic programs.

    "David, Hari and Lin all bring a wealth of strategic leadership and deep expertise to Tessera at an exciting time in our growth," said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera. "Together and alongside our current senior leadership team, they will be instrumental in advancing Tessera's mission to bring forth innovative and curative medicines that go beyond the limitations of current technologies."

    Dr. Davidson brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy to his new role as Tessera's Chief Medical and Development Officer. For nearly a decade, Dr. Davidson served as Chief Medical Officer of bluebird bio, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering multiple first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird, Dr. Davidson led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy. He completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine, and an endocrinology research fellowship at the University of Chicago Hospitals. Dr. Davidson received his M.D. from New York University and B.A. from Columbia University.

    "I have been privileged to lead the clinical development of gene therapy programs from inception through approval to deliver these transformative medicines to patients with life-threatening diseases. I am excited to join the team at Tessera Therapeutics to bring innovative Gene Writing therapies into the clinic," said Dr. David Davidson. "By harnessing the power of mobile genetic elements, Tessera's Gene Writing platform is poised to realize the full potential of genetic medicine and make an unprecedented impact on human health. I am honored to help move this vision forward."

    Dr. Pujar, an Operating Partner at Flagship Pioneering since October 2020, will also serve as Tessera's Chief Operating Officer. Dr. Pujar brings more than 20 years of drug development, manufacturing and commercialization experience spanning AAV gene therapy, mRNA vaccines and therapeutics, and traditional vaccines and biologics. Most recently, Dr. Pujar served as Chief Technology Officer at Spark Therapeutics, a pioneer in AAV gene therapy, and Head of Technical Development and Manufacturing at Moderna, where he led mRNA and lipid nanoparticle development and manufacturing. Previously, Dr. Pujar spent 18 years at Merck & Co., developing and commercializing vaccines and biologics. Dr. Pujar received his Ph.D. in Chemical Engineering from the University of Delaware and his M.B.A. from the University of Pennsylvania.

    "As medicine continues to move up the central dogma of molecular biology from proteins to mRNA to DNA, the opportunity to cure diseases will continue to expand. I'm excited to help shape Tessera Therapeutics, whose Gene Writing technology has the potential to address many of the limitations of current genetic medicine technologies," said Dr. Hari Pujar.

    Dr. Guey, Tessera's Senior Vice President of Rare Diseases Program Strategy and Operations, will oversee the execution of Tessera's genetic medicine programs in Rare Diseases. Dr. Guey brings over 13 years of drug development experience in program leadership, research and nonclinical development, pharmacogenomics and epidemiology. Prior to joining Tessera, Dr. Guey served in senior leadership roles for Moderna, Xilio Therapeutics, Shire, and Pfizer. Dr. Guey received her Ph.D. in Statistics and B.S. in Mathematics from Stony Brook University.

    "With its pioneering and versatile Gene Writing technology, Tessera Therapeutics is at the very forefront of genetic medicine," said Dr. Lin Guey. "I look forward to working with the Tessera team to find new ways to cure rare genetic diseases at their source."

    For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.

    About Tessera Therapeutics

    Tessera Therapeutics is a life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

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  7. CAMBRIDGE, Mass., March 31, 2021 /PRNewswire/ -- Flagship Pioneering today announced the expansion of its senior leadership team with the appointment of Michael T. Nally as CEO-Partner. In this role, Nally will bring his considerable expertise in biopharma to help achieve the highest possible value creation for Flagship and its companies. He will also serve as CEO of Generate Biomedicines, a company focused on pioneering a versatile Generative Biology platform to create a broad array of breakthrough therapeutics.

    Nally previously spent 18 years at Merck, where he was most recently Executive Vice President and Chief Marketing Officer of its Human Health division. In this role, he led Merck's global marketing strategy, commercialization model, and long-term growth strategy across its product portfolio.

    "Mike is a singular talent in life sciences and pharma, and our companies will benefit tremendously from his leadership, experience, and knowledge," said Noubar Afeyan, Founder and CEO of Flagship Pioneering. "Mike's appointment to this unique hybrid role is the latest example of Flagship's commitment to bringing on the highest caliber industry executives with track records of exceptional performance to drive growth for our companies."

    "I am excited to join Flagship Pioneering's world class team. Flagship companies are bettering patient health at increasing scale, as well as delivering extraordinary value," added Michael T. Nally, CEO-Partner, Flagship Pioneering. "I look forward to working closely with my Flagship colleagues and leading the team at Generate to bring to market new, disruptive innovations that improve human lives."

    "Mike is joining at an important time for Generate, which leverages AI and Machine Learning to enable a fundamental shift in therapeutic development," said Avak Kahvejian, Founding Co-CEO of Generate Biomedicines and General Partner, Flagship Pioneering. "I look forward to partnering with Mike to advance our work creating breakthrough medicines that realize the breadth of this platform's potential."

    "Generate's platform enables it to leapfrog existing discovery methods to develop novel biologic drugs for potentially any target," said Geoffrey von Maltzahn, Founding Co-CEO of Generate Biomedicines and General Partner at Flagship Pioneering. "I am delighted to welcome Mike to the Generate team; he will bring his deep strategic and operational expertise to help us deliver on the promise of this remarkable platform."

    About Michael T. Nally

    Nally previously served as President of Merck's Global Vaccines division where he and his team increased the reach and public health impact of its portfolio of pediatric, adolescent, and adult vaccines resulting in significant business growth. He also led Merck's business in Sweden and the UK, and developed innovative, customer-centered approaches that improved business results and accelerated patient access to the company's medicines and vaccines. Additionally, he held a variety of senior positions at Merck in commercial operations, business development, and investor relations.

    Mike received an M.B.A. from Harvard Business School, a degree in Accounting and Finance from the London School of Economics, and a B.A. in Economics from Middlebury College.

    About Generate Biomedicines

    Generate Biomedicines is pioneering the field of Generative Biology, where novel therapeutics are computationally generated, instead of being discovered. Generate has built a machine learning–powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities—from short peptides to complex antibodies, enzymes, cytokines, and heretofore undiscoverable therapeutics. This platform represents a potentially fundamental shift in what's possible in the field of biotherapeutic development, addressing key challenges of drug discovery and drastically expanding the available search space for novel biomedicines. Generate Biomedicines is based in Cambridge, MA, and was founded in 2018 by Flagship Pioneering.

    About Flagship Pioneering 

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ: AXLA), Codiak BioSciences (NASDAQ: CDAK) Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology (NASDAQ: SANA), Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

    Media: 

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    SOURCE Flagship Pioneering

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  8. CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Invaio Sciences, Inc., a Flagship Pioneering company focused on unlocking the potential of the planet's interdependent natural systems to solve pressing agriculture, nutrition and environmental challenges, announced today the appointment of Peleg Chevion as President and Chief Commercial Officer.  Chevion, who joined the company in late 2020, will focus on accelerating the commercial activities of the company.

    "Our goal at Invaio is to accelerate the transition in agriculture from a chemical-based industry to a biological-based industry that addresses the needs of farmers and society, while protecting the environment," said Ignacio Martinez, Co-Founder and CEO, Invaio. "The company is now transitioning from an R&D-focused organization to a full commercial enterprise."

    Martinez continued, "Peleg has already made a significant impact at Invaio since he joined the company in late 2020. He brings a very unique set of experiences, commercial leadership, and an entrepreneurial mindset perfectly suited for the next phase of the company."

    Prior to joining Invaio, Chevion was President and Chief Commercial Officer of Blendhub, a global leader in food and ingredients production. Before Blendhub, Peleg worked with Lindsey Goldberg, a leading global private equity firm based in New York. Chevion also worked for seven years as a senior executive at Syngenta where he started and then led the Abiotic Stress Management indication across the spectrum of chemical, biological, genetics and digital platforms. Prior to Syngenta, Chevion spent several years leading Business Development at Crucell before the company was acquired by J&J.

    Chevion began his career as an officer in the Israeli Air Force, and later held diverse roles in the Israeli startup ecosystem.  Chevion graduated from the IDF Computer Academy. He received an L.L.B from Tel Aviv University, an MBA from INSEAD and is a licensed attorney in Israel.

    "Since joining Invaio last year, I have been impressed by the breakthrough platform technologies we are developing, our integrated solutions approach and the commercial traction of the company," said Peleg Chevion, President and Chief Commercial Officer, Invaio. "We are curing diseases like Greening in Citrus and Xylella in Olives, significantly reducing the use of chemicals with our precision delivery systems, and discovering biological products with consistent performance using proprietary Artificial Intelligence and Machine Learning technologies"

    Chevion continues, "We are laser focused on developing unique solutions for our partner growers and other stakeholders in three segments: perennials, row crops and vegetable crops. We see the opportunity and have a sense of urgency to deliver."

    About Invaio Sciences:

    Invaio Sciences is a multi-platform technology company that unlocks the potential of the planet's interdependent systems to address pressing agricultural, nutritional, and environmental challenges. Founded by Flagship Pioneering in 2018, Invaio leverages discoveries from diverse fields including human therapeutics, agriculture, environmental science, and advanced manufacturing. The company's deep understanding of the physiology of insects, plants and trees, together with its novel integrated solutions approach, promises to refine agricultural practices and reduce the need for pesticides globally. Invaio Sciences is dedicated to developing solutions that are mindful of beneficial insects, bad for pests, and safer for us all.  For more information, please visit www.invaio.com

    About Flagship Pioneering:

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Inari Agriculture, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/invaio-sciences-strengthens-leadership-team-with-appointment-of-peleg-chevion-as-president-and-chief-commercial-officer-301258544.html

    SOURCE Invaio Sciences

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  9. CAMBRIDGE, Mass., March 18, 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 fourth quarter and full year ended December 31, 2020 as well as certain other business highlights.

    "2020 was a transformational period for Sigilon marked by the achievement of numerous key regulatory, clinical, and financial milestones, which we believe have positioned us to deliver on our commitments over the next several years," commented Rogerio Vivaldi, M.D., Chief Executive Officer of Sigilon. "The modularity of our Shielded Living Therapeutics™ platform has enabled…

    CAMBRIDGE, Mass., March 18, 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 fourth quarter and full year ended December 31, 2020 as well as certain other business highlights.

    "2020 was a transformational period for Sigilon marked by the achievement of numerous key regulatory, clinical, and financial milestones, which we believe have positioned us to deliver on our commitments over the next several years," commented Rogerio Vivaldi, M.D., Chief Executive Officer of Sigilon. "The modularity of our Shielded Living Therapeutics™ platform has enabled us to build a robust pipeline spanning a diverse range of chronic disorders, including rare blood, lysosomal and endocrine diseases. Notably, in 2020, our lead product candidate SIG-001 received IND and CTA clearance and we dosed the first patients in our Phase 1 /2 safety and dose-ranging study in severe to moderate-severe hemophilia A—a significant milestone for both our platform technology and the hemophilia community."

    Continued Dr. Vivaldi: "While our immediate priority is developing SIG-001, looking ahead, we are also leveraging our platform to advance several additional candidates—including SIG-005 for MPS-1, SIG-007 for Fabry disease and SIG-002 for Type 1 Diabetes—into the clinic over the next two years. Having successfully completed an upsized Initial Public Offering in December, which attracted a breadth of healthcare specialists and long-term focused shareholders, we are well-positioned to execute across each of these initiatives as we work to provide functional cures for patients."

    Recent Program Highlights
         
     In the fourth quarter, the Company dosed the first two patients in its Phase 1/2 safety and dose-ranging study with SIG-001 in severe to moderate-severe hemophilia A. No serious adverse events have been reported. At the initial dose levels for this study, tested in the first two patients, the Company has observed FVIII activity levels in the low- to mid-single digits.
       
     As dose levels increase, Sigilon initiated planned manufacturing changes in the first quarter of 2021 designed to, among other things, increase cell potency and enhance cell function. The Company has filed amendments to its CTA and IND for SIG-001 with the MHRA and FDA, respectively, to incorporate these changes.
       
     In December 2020, the FDA granted Orphan Drug designation to SIG-005 for the treatment of mucopolysaccharidosis type I (MPS-1), a chronic, progressive lysosomal disease.
       
     Four scientific abstracts outlining several ongoing preclinical studies in a range of lysosomal diseases were selected for presentation – including an oral presentation on mucopolysaccharidosis type II (MPS-2) – at the 17th Annual WORLDSymposium™. In all these preclinical studies, platform cells produced high levels of biochemically active enzyme having characteristics nearly identical to the enzyme replacement therapies. Significant reduction in substrates across tissues were observed.
       
     In March 2021, the FDA granted Orphan Drug designation for SIG-007 for the treatment of Fabry disease, which is also a progressive, life-threatening lysosomal disease.
         
    Corporate Updates
         
     • In December 2020, the Company raised $144.9 million in gross proceeds from an initial public offering of 8,050,000 shares of common stock at a public offering price of $18.00 per share.
         
     • Devyn Smith, Ph.D., will step down as Chief Operating Officer of Sigilon, effective on April 26, 2021, to assume a CEO role within the biotech industry.
         
    Anticipated Milestones
         
     • The Company is planning to file a CTA and/or IND for MPS-1 in the second quarter of 2021 and anticipates additional regulatory filings before the end of 2022.
         
     • Phase 1/2 safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia:
         
       Sigilon expects to disclose up to 9 months of follow up data for 3-4 patients in the third quarter of 2021; and
         
       Sigilon expects to complete enrollment of the study in the second half of 2021.
         
    Financial Results
         
     Cash Position: Cash was $202.2 million as of December 31, 2020.
         
     R&D Expenses: Research and development expenses were $14.3 million for the fourth quarter of 2020 compared to $15.0 million for the fourth quarter of 2019. For the full year of 2020, research and development expenses were $53.5 million compared to $48.1 million for the same period in 2019. The increase in research and development expenses as compared to the prior year period was related to increased costs associated with Sigilon's lead programs, increased costs associated with platform and pipeline development, an increase in personnel expenses costs due to headcount additions and an increase in stock-based compensation associated with stock option grants.
         
     G&A Expenses: General and administrative expenses were $3.5 million for the fourth quarter of 2020 compared to $2.9 million for the fourth quarter of 2019. For the full year of 2020, general and administrative expenses were $12.5 million compared to $10.2 million for the same period in 2019. The increase in general and administrative expenses as compared to the prior year period was primarily driven by an increase in professional fees and insurance costs that are primarily due to the costs of operating as a public company, an increase in personnel related costs due to increased headcount and an increase in stock-based compensation associated with stock option grants.
         
     Net Loss: Net loss was $15.2 million for the quarter ended December 31, 2020 compared to $14.7 million for the same period of 2019. For the full year 2020, Sigilon reported a net loss of $54.6 million, compared to a net loss of $43.9 million for the full year 2019.

    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 disorders 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 effect of manufacturing changes on cell potency and cell function, the timing for the submission of INDs or CTAs for MPS-1 and other product candidates and the timing for patient enrollment and dosing, disclosure of data and the completion of 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, those related to our clinical and preclinical research, product candidates, the enrollment and timeline for our clinical trials and the regulatory filings related thereto, and the risks identified under the heading "Risk Factors" in our Prospectus filed with the Securities and Exchange Commission on December 7, 2020, 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)

     December 31, 
     2020    2019
    Assets       
    Current assets:       
    Cash$202,229  $76,069 
    Accounts receivable 177   136 
    Prepaid expenses and other current assets 1,729   732 
    Restricted cash—current 75    
    Total current assets 204,210   76,937 
    Deferred offering costs    65 
    Property and equipment, net 2,991   2,949 
    Right‑of‑use assets 16,731   9,851 
    Restricted cash 1,118   576 
    Total assets$225,050  $90,378 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)       
    Current liabilities:       
    Accounts payable$1,988  $2,005 
    Accrued expenses and other current liabilities 7,892   5,852 
    Lease liabilities, current portion 5,361   3,378 
    Deferred revenue from related party, current portion 31,777   29,140 
    Total current liabilities 47,018   40,375 
    Deferred revenue from related party, net of current portion    15,550 
    Lease liability, net of current portion 11,893   6,808 
    Long‑term debt, net of discount 19,807   14,868 
    Preferred stock warrant liability    333 
    Other liabilities 176    
    Total liabilities$78,894  $77,934 
    Commitments and contingencies       
    Preferred stock, par value $0.001 per share; 25,000,000 and no shares authorized at December 31, 2020 and 2019, respectively; no shares issued and outstanding at December 31, 2020 and 2019     
    Convertible preferred stock (Series A, A‑1, A‑3 and B), par value $0.001 per share; no and 35,536,001 shares authorized at December 31, 2020 and 2019, respectively; no and 31,836,001 issued and outstanding at December 31, 2020 and 2019, respectively; liquidation preference of $0 and $90,461 at December 31, 2020 and 2019, respectively    90,206 
    Stockholders' equity (deficit)       
    Common stock, par value $0.001 per share; 175,000,000 and 60,000,000 shares authorized at December 31, 2020 and December 31, 2019, respectively; 31,464,989 and 5,221,628 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively 31   5 
    Additional paid‑in capital 282,053   3,553 
    Accumulated deficit (135,928)  (81,320)
    Total stockholders' equity (deficit) 146,156   (77,762)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$225,050  $90,378 



    Sigilon Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (Unaudited)

     Three Months Ended December 31,  Year Ended December 31, 
     2020    2019    2020    2019
    Revenue               
    Collaboration revenue$3,756  $3,098  $13,374  $14,155 
    Operating expenses:           
    Research and development 14,337   15,014   53,488   48,108 
    General and administrative 3,505   2,900   12,528   10,170 
    Total operating expenses 17,842   17,914   66,016   58,278 
    Loss from operations (14,086)  (14,816)  (52,642)  (44,123)
    Other income (expense), net:               
    Interest income 44   277   312   1,058 
    Interest expense (505)  (188)  (1,202)  (650)
    Other expense (42)     (89)  (6)
    Change in fair value of preferred stock warrant liability (600)  (2)  (644)  (204)
    Loss on extinguishment of debt       (343)   
    Total other income (expense), net (1,103)  87   (1,966)  198 
    Net loss and comprehensive loss$(15,189) $(14,729) $(54,608) $(43,925)
    Net loss per share attributable to common stockholders—basic and diluted$(1.15) $(3.17) $(7.55) $(10.74)
    Weighted average common stock outstanding—basic and diluted 13,230,224   4,642,290   7,229,626   4,090,691 



    Sigilon Therapeutics, Inc.

    Condensed Consolidated Statements of Cash Flows

    (in thousands)

    (Unaudited)

     Year Ended December 31, 
     2020     2019

    Cash flows from operating activities:       
    Net loss$(54,608) $(43,925)
    Adjustments to reconcile net loss to net cash (used in) provided by operating activities:      
    Stock-based compensation expense 3,127   2,073 
    Deferred revenue (12,913)  (13,172)
    Other non-cash expenses, net 5,293   2,668 
    Other changes in assets and liabilities (2,547)  2,282 
    Net cash used in operating activities (61,648)  (50,074)
    Cash flows from investing activities:       
    Purchase of property and equipment (972)  (1,209)
    Net cash used in investing activities (972)  (1,209)
    Cash flows from financing activities:       
    Proceeds from issuance of common stock in connection with the initial public offering, net of underwriting discounts and commissions 132,527   (65)
    Proceeds from issuance of convertible preferred stock, including deemed dividend, net of issuance costs 51,723   53,136 
    Repayment of debt (15,000)  (1,000)
    Proceeds from long term debt 19,788   11,000 
    Other financing activities, net 359   171 
    Net cash provided by financing activities 189,397   63,242 
    Net increase in cash and restricted cash 126,777   11,959 
    Cash and restricted cash at beginning of period 76,645   64,686 
    Cash and restricted cash at end of period$203,422  $76,645 
          
    Cash$202,229  $76,069 
    Restricted cash-current 75    
    Restricted cash-non-current 1,118   576 
    Total cash and restricted cash$203,422  $76,645 
     

    SOURCE: Sigilon Therapeutics, Inc.

    Investor Contacts

    Glenn Reicin

    Sigilon Therapeutics, Chief Financial Officer



    646-696-4344

    Jennifer Porcelli

    Solebury Trout



    646-378-2962

    Media Contact

    Amy Bonanno

    Solebury Trout



    914-450-0349



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  10. CAMBRIDGE, Mass., March 04, 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 present a corporate overview during the Barclays Global Healthcare Conference. The presentation will take place on Thursday, March 11 at 10:55 a.m. EST, in a virtual format.

    A live webcast of the 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 the webcast will be available following the event on the Sigilon website.

    CAMBRIDGE, Mass., March 04, 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 present a corporate overview during the Barclays Global Healthcare Conference. The presentation will take place on Thursday, March 11 at 10:55 a.m. EST, in a virtual format.

    A live webcast of the 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 the webcast will be available following the event on the Sigilon website.

    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 disorders 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 Contacts
    Glenn Reicin
    Sigilon Therapeutics, Chief Financial Officer
    
    646-696-4344
    
    Jennifer Porcelli
    Solebury Trout
    
    646-378-2962
    
    Media Contact
    Amy Bonanno
    Solebury Trout
    
    914-450-0349

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  11. CAMBRIDGE, Mass., Feb. 25, 2021 /PRNewswire/ -- Cellarity, a life sciences company founded by Flagship Pioneering to develop a new method of drug discovery targeting the cell, announced today that it raised $123 million in Series B financing. The round included contributions from funds and accounts managed by BlackRock, The Baupost Group, Banque Pictet on behalf of their clients and eight other investors alongside Flagship Pioneering.

    Founded in 2017 within Flagship Labs, Cellarity's new approach to drug discovery is based on the computational modeling of cell behavior, leading to a more complete understanding of system and network biology to uncover cell-behavior-targeted medicines for a wide variety of diseases.

    Cellarity's medicines are developed to address disease at the level of the cell and are not aimed at single molecular targets, the approach pursued in much of traditional drug discovery. The successful financing round validates the strength of Cellarity's science and its potential to redefine drug discovery through its cell-centric approach.

    "All diseases stem from a disorder at the cellular level, but until now most drug discovery efforts have relied upon single molecular targets that overlook the potent networked relationships of biology," said Fabrice Chouraqui, CEO of Cellarity and a CEO-Partner at Flagship Pioneering. "By working at the level of the entire cell, Cellarity's drug discovery platform harnesses the complexity of human biology to uncover breakthrough treatments in a wide range of disease areas."

    Cellarity is generating unprecedented biological insights by combining its unique expertise in network biology, high-resolution data, and machine learning. The result is a new understanding of the cell's trajectory from health to disease, and how cells relate to one another in tissues. Because the cell and its network of transcripts and proteins offer a more complete view of the complexity of human biology than any individual molecular target, Cellarity's approach allows for more efficient drug discovery and is designed to drive higher rates of clinical success. Already, the company has seven drug discovery programs underway in diverse therapeutic areas that range from metabolic disease to immuno-oncology.

    "Cellarity's cell-centric platform has the potential to engineer a shift in how the world approaches the discovery of medicine," said Noubar Afeyan, CEO of Flagship Pioneering and Co-founder and Chairman of the Board of Cellarity. "It is another example of Flagship Pioneering's relentless efforts to push the boundaries of the life sciences to uncover breakthrough technologies and identify innovative treatments that will change the lives of patients."

    About Cellarity

    Cellarity's mission is to bring breakthrough medicines to patients by completely redefining the way drugs are discovered. Founded by Flagship Pioneering in 2017, Cellarity is designing medicines against the cell as opposed to a single molecular target. The company has developed a unique combination of expertise across system and network biology, high-resolution data, and machine learning to unlock treatments in a large number of therapeutic areas.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $50B in aggregate value. To date, Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak Biosciences (NASDAQ:CDAK), Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

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