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): March 18, 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

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

SGTX

The Nasdaq Global Select Market

share

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 March 18, 2021, Sigilon Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter and fiscal year ended December 31, 2020. 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

Exhibit

No.

Description

99.1

Press Release Issued by Sigilon Therapeutics, Inc. on March 18, 2021


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: March 18, 2021


Exhibit 99.1

Graphic

Sigilon Therapeutics Reports Fourth Quarter and

Full Year 2020 Financial Results and Business Highlights

Cambridge, MA—March 18, 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 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:

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

oSigilon 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
glenn.reicin@sigilon.com
646-696-4344

Jennifer Porcelli
Solebury Trout
jporcelli@soleburytrout.com
646-378-2962

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