Washington, D.C. 20549



Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 10, 2021


(Exact name of registrant as specified in its charter)




(State or other jurisdiction


(IRS Employer

of incorporation)

File Number)

Identification No.)

100 Binney Street, Suite 600, Cambridge, MA


(Address of principal executive offices)

(Zip Code)

(Registrant’s telephone number, including area code): (617) 336-7540

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Name of each exchange

Title of each class




on which registered

Common Stock, $0.001 par value per share


The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 2.02 Results of Operations and Financial Condition.

On November 10, 2021, Sigilon Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2021. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Form 8 K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits





Press Release Issued by Sigilon Therapeutics, Inc. on November 10, 2021


Cover Page Interactive Data File (embedded within the Inline XBRL document)


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



/s/ Rogerio Vivaldi Coelho, M.D.

Rogerio Vivaldi Coelho, M.D.

President and Chief Executive Officer

Date: November 10, 2021

Exhibit 99.1


Sigilon Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights

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, MA—November 10, 2021—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)


September 30, 

December 31, 










Current assets:










Accounts receivable (inclusive of $27 and $63 from a related party at September 30, 2021 and December 31, 2020, respectively)





Prepaid expenses and other current assets





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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





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



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Total liabilities, convertible preferred stock and stockholders’ equity





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, 


















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SOURCE: Sigilon Therapeutics, Inc.

Investor Contact
Robert Windsor, Jr., J.D.

VP, Head of Investor Relations

Sigilon Therapeutics

Media Contacts
Amy Bonanno
Solebury Trout

Brandon Hagen

Manager, Communications

Sigilon Therapeutics