8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 9, 2021

SIGILON THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-39746	47-4005543
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

100 Binney Street, Suite 600, Cambridge, MA	02142
(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:

	Trading	Name of each exchange
Title of each class	Symbol(s)	on which registered
Common Stock, $0.001 par value per share	SGTX	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 2.05 Costs Associated with Exit or Disposal Activities.

On December 9, 2021, the Board of Directors of Sigilon Therapeutics, Inc. (the “Company”) approved a strategic reprioritization and workforce reduction to enable the Company to focus on MPS-1 and diabetes in addition to platform optimization. In connection with this decision, the Company announced a reduction in its workforce by approximately 38% of its current workforce. The Company expects to substantially complete the reduction in its workforce in the fourth quarter of 2021. Following the changes, the Company expects to have approximately 65 full-time employees.

The Company estimates that, in connection with these changes, it will incur aggregate charges of approximately $1.8 million, all of which are anticipated to result in future cash expenditures, primarily for one-time employee severance and benefit costs that are expected to be incurred in the fourth quarter of 2021.

This report includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “will,” “estimate,” and other words of similar meaning. These forward-looking statements address various matters, including the size and timing of the Company’s workforce reduction, the number of the Company’s employees following the workforce reduction, and the amount and timing of the charges and cash expenditures resulting from the workforce reduction. Each forward-looking statement contained in this Current Report on Form 8-K 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 contemplated, and the risks identified under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2021 and in any subsequent filings with the Securities and Exchange Commission. The forward-looking statements in this Current Report on Form 8-K speak only as of the date of this filing, and the Company undertakes no obligation to update or revise any of these statements.

Item 7.01 Regulation FD Disclosure.

On December 13, 2021, the Company issued a press release related to a strategic reprioritization to focus on MPS-1 and diabetes. A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information in Item 7.01 of 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, 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, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.	Description
99.1	Press Release Issued by Sigilon Therapeutics, Inc. on December 13, 2021
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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.

SIGILON THERAPEUTICS, INC.
By:	/s/ Rogerio Vivaldi Coelho, M.D.
	Rogerio Vivaldi Coelho, M.D.
	President and Chief Executive Officer

Date: December 13, 2021

EX-99.1

Exhibit 99.1

Sigilon Therapeutics Announces Strategic Reprioritization

- 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, MA — December 13, 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 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 ContactRobert Windsor, Jr., J.D.

VP, Head of Investor Relations

Sigilon Therapeutics
robert.windsor@sigilon.com
617-586-3837

Media Contacts
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349

Brandon Hagen

Manager, Communications

Sigilon Therapeutics

brandon.hagen@sigilon.com

617-586-2851

XML

Document and Entity Information	Dec. 09, 2021
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Dec. 09, 2021
Entity File Number	001-39746
Entity Registrant Name	SIGILON THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-4005543
Entity Address, Address Line One	100 Binney Street
Entity Address, Adress Line Two	Suite 600
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02142
City Area Code	617
Local Phone Number	336-7540
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	SGTX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Central Index Key	0001821323
Amendment Flag	false