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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): November 10, 2022

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 2.02 Results of Operations and Financial Condition.

On November 10, 2022, Sigilon Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2022. 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 7.01 Regulation FD Disclosure.

On November 10, 2022, the Company updated its corporate presentation, attached as Exhibit 99.2 to this Current Report on Form 8-K. The corporate presentation will also be available in the investor relations section of the Company’s website at https://ir.sigilon.com/news-and-events/events-and-presentations. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time. The Company plans to use its website to disseminate future updates to the presentation and may not necessarily file or furnish a Current Report on Form 8-K alerting investors if the presentation is updated.

The information in this Form 8 K (including Exhibit 99.2 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 November 10, 2022

99.2

Sigilon Therapeutics, Inc. Corporate Presentation

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: November 10, 2022

Exhibit 99.1

A picture containing logo

Description automatically generated

SIGILON THERAPEUTICS REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND BUSINESS HIGHLIGHTS

Identified important optimization features for its platform to mitigate PFO risks in current and future programs

Advanced iPS cell differentiation protocol for the diabetes program in preparation for anticipated IND-enabling studies in 2023

Continued optimization of the MPS-1 program, with plans to initiate IND-enabling studies in the second half of 2023

Cambridge, MA—November 10, 2022—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, 2022 as well as certain other business highlights.

“This year, we have made significant progress advancing our SLTx platform, including key improvements to our cross-linking chemistry designed to strengthen the stability of our spheres. In addition, we have developed preclinical models designed to predict pericapsular fibrotic overgrowth, including macrophage attachment assays and humanized mouse models, which we believe will be key to mitigating risk of an allogeneic immune response and accelerate product development,” said Rogerio Vivaldi, M.D., President and CEO of Sigilon. “I am grateful for the extraordinary effort put forth by our team to identify these important optimization features for the platform and to incorporate them into our diabetes and MPS-1 programs. We look forward to providing additional preclinical data for both programs showcasing the potential of the SLTx platform in the coming months.”

Recent Program Highlights and Anticipated Milestones

After the development of inhibitors and the discovery of pericapsular fibrotic overgrowth (PFO) in a hemophilia A patient last year, Sigilon evaluated ways to optimize its SLTx platform. This resulted in improvements to the Company’s proprietary cross-linking chemistry, which has the potential to strengthen the spheres. Sigilon also developed allogeneic PFO prediction methods designed to rapidly evaluate the potential PFO response to encapsulated cell products. The Company has used these models to evaluate the allogeneic immune response to its current product candidates for diabetes and MPS-1. In addition, the Company expects to use these models to develop product candidates


designed to avoid an allogeneic immune response and mitigate the risk of PFO, which the Company refers to as ImmunoQuiet™ cell therapies.

At the Cell and Gene Therapy Meeting on the Mesa in October 2022, the Company presented data showing its proprietary iPS cell differentiation protocol for SIG-002, its product candidate for type 1 diabetes, which generates stem cell-derived islets that are similar to human cadaveric islets with a high percentage of beta cells, high levels of insulin content and glucose-regulated insulin secretion. In addition, the Company demonstrated that SIG-002 was efficacious in an STZ-induced diabetes mouse model after 10 weeks. The treated mice cleared an oral glucose challenge similar to clearance levels shown in non-diabetic control mice and maintained blood glucose levels at time zero after an overnight fast. The Company expects to initiate Investigational New Drug (IND)-enabling studies for SIG-002 in the second half of 2023 and expects to file an IND application for SIG-002 in 2024.

Sigilon is optimizing its MPS-1 program to penetrate the blood brain barrier to address neurological manifestations, as well as to extend plasma half-life for the non-neurological manifestations. The Company expects to withdraw its Clinical Trial Applications (CTA) for its first MPS-1 product candidate, SIG-005, before year-end and plans to initiate IND-enabling studies for its optimized MPS-1 program in the second half of 2023. Sigilon also plans to file an IND application for a product candidate in its MPS-1 program in 2024.

The Company submitted a Clinical Hold Response to the FDA for its hemophilia A program and withdrew its IND application for SIG-001. Sigilon also received approval to withdraw its CTA for SIG-001 for hemophilia A in the United Kingdom and plans to finalize activities pertaining to these regulatory filings before year-end.

Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $78.3 million as of September 30, 2022 compared to $123.4 million as of December 31, 2021. The decrease was primarily driven by cash used for operating activities. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2022 will support its currently anticipated operating expenses and capital expenditure requirements into 2024.

R&D Expenses: Research and development expenses were $8.3 million for the third quarter of 2022 compared to $16.6 million for the third quarter of 2021. The decrease in research and development expenses was primarily related to decreased activity in ongoing platform and other early-stage program development, personnel expenses, facility-related expenses, which were offset by increased expenses related to the Company’s diabetes program. The decrease in platform and other early-stage program activity and personnel expenses was primarily due to the Company’s reprioritization of the development of the MPS-1 program, diabetes program and platform optimization following the Company’s restructuring activities in December 2021. The decrease in facility-related expenses was primarily due to the sublease of a portion of its facility.


G&A Expenses: General and administrative expenses were $4.4 million for the third quarter of 2022 compared to $5.0 million for the third quarter of 2021. The decrease in general and administrative expenses was primarily related to decreased personnel expenses primarily as a result of the Company’s reprioritization and restructuring activities that occurred in December 2021 and the sublease of a portion of its facility.

Net Loss: Net loss was $8.7 million for the third quarter of 2022 compared to $20.2 million for the third quarter of 2021. The decline in net loss as compared to the prior year was primarily due to savings realized from the Company’s reprioritization and corporate restructuring in December 2021.

About Sigilon Therapeutics

Sigilon Therapeutics seeks to develop functional cures for patients with a broad range of chronic diseases by harnessing the power of the human cell 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 other therapeutic molecules 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. 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 our expectations related to mitigation strategies for PFO, the initiation and timing of IND-enabling studies and an IND submission for SIG-002, the timing of an IND submission for a product candidate for our MPS-1 program and our expected 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 if we fail to achieve the expected financial and operational benefits of our corporate restructuring, our business and financial results may be harmed; negative results of preclinical or clinical studies of any of our product candidates could adversely affect our business and may require us to discontinue or delay development of other product candidates, which are all based on the same SLTx platform; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use and the approaches we are taking to discover and develop novel therapeutics are unproven; we may not be successful in our efforts to identify and develop product candidates; if clinical trials of our current and future product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates; if we are unable to obtain and maintain patent and other intellectual property protection our product candidates, our SLTx platform may be adversely affected, and the risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, 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, except as required by law. 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

(Unaudited, in thousands, except share and per share amounts)

September 30, 

December 31, 

    

2022

    

2021

Assets

  

 

  

Current assets:

  

 

  

Cash and cash equivalents

$

32,925

$

107,143

Marketable securities

45,344

16,213

Accounts receivable

 

23

 

59

Prepaid expenses and other current assets

 

2,084

 

2,729

Restricted cash—current

 

250

 

250

Total current assets

 

80,626

 

126,394

Property and equipment, net

 

3,053

 

3,994

Right-of-use assets

 

9,908

 

12,863

Restricted cash

 

1,031

 

1,118

Total assets

$

94,618

$

144,369

Liabilities and stockholders’ equity (deficit)

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

1,408

$

2,344

Accrued expenses and other current liabilities

 

5,947

 

8,998

Lease liabilities, current portion

 

4,462

 

4,845

Current portion of long-term debt

 

6,667

 

1,667

Deferred revenue from related party, current portion

 

12,071

 

17,034

Total current liabilities

 

30,555

 

34,888

Deferred revenue from related party, net of current portion

 

 

5,333

Lease liability, net of current portion

 

5,856

 

8,577

Long-term debt, net of discount and current portion

 

13,621

 

18,411

Other liabilities

 

176

 

Total liabilities

50,208

67,209

Stockholders’ equity

 

  

 

  

Common stock, par value $0.001 per share; 175,000,000 shares authorized at September 30, 2022 and December 31, 2021; 32,454,237 and 32,359,895 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

32

 

32

Preferred stock, par value $0.001 per share; 25,000,000 shares authorized at September 30, 2022 and December 31, 2021; no shares issued and outstanding at September 30, 2022 and December 31, 2021

 

 

Additional paid-in capital

 

295,129

 

290,377

Accumulated other comprehensive loss

(636)

(10)

Accumulated deficit

 

(250,115)

 

(213,239)

Total stockholders’ equity

 

44,410

 

77,160

Total liabilities and stockholders’ equity

$

94,618

$

144,369


Sigilon Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited, in thousands, except share and per share amounts)

Three Months Ended September 30, 

Nine Months Ended September 30, 

  

2022

2021

2022

2021

Revenue

 

  

 

  

 

  

 

  

Collaboration revenue

$

4,252

$

1,947

$

10,300

$

7,609

Operating expenses:

 

 

 

  

Research and development

8,280

 

16,645

 

31,775

 

50,381

General and administrative

4,395

5,041

14,461

 

15,572

Total operating expenses

12,675

 

21,686

 

46,236

 

65,953

Loss from operations

(8,423)

 

(19,739)

 

(35,936)

 

(58,344)

Other income (expense), net:

  

 

  

 

  

 

  

Interest income

300

56

542

212

Interest expense

(606)

(499)

(1,640)

(1,481)

Other income, net

58

26

158

47

Total other expense, net

(248)

 

(417)

 

(940)

 

(1,222)

Net loss attributable to ordinary shareholders

$

(8,671)

$

(20,156)

$

(36,876)

$

(59,566)

Net loss per share attributable to common stockholders—basic and diluted

$

(0.27)

$

(0.63)

$

(1.14)

$

(1.88)

Weighted average common stock outstanding—basic and diluted

32,399,855

32,055,551

32,389,771

31,707,068

SOURCE: Sigilon Therapeutics, Inc.

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

VP, Head of Investor Relations

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

Media Contacts
Amy Bonanno
Solebury Strategic Communications
abonanno@soleburystrat.com
914-450-0349

##


Exhibit 99.2

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Pioneering A Cell Therapy Powerhouse ©2022 Sigilon Therapeutics, Inc. November 2022

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Disclaimer This presentation has been prepared by Sigilon Therapeutics, Inc. (“we,” “us,” “our,” “Sigilon” or the “Company”) and is made fo r informational purposes only and not for any other purpose. Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third - party sources and the Company’s own internal estimates and research. The Company has not inde pendently verified, and Sigilon makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third - party sources. The Company’s internal research has not been verified by any independent source. This presentation contains forward - looking statements. All statements other than statements of historical facts contained in thi s presentation are forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipa te,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar ex pre ssions, although not all forward - looking statements contain these words. Forward - looking statements include, but are not limited to, statements concerning: our current c ash runway; our plans to withdraw our IND and CTAs and to close out activities for our Hemophilia Type A program in the second half of 2022; our expectations related t o o ur manufacturing strategy and expansion strategy; the initiation, timing, progress and results of our research and development programs, preclinical studies and clin ica l trials, including the submission or withdrawal of INDs or CTAs for our product candidates and our expectations that SIG - 002 will be a low PFO product candidate; our ability to ad vance any product candidates that we may develop and successfully complete any clinical studies, including the manufacture of any such product candidates; our ability to leverage our initial programs to develop additional product candidates using our SLTx platform; and our ability to successfully scale our manufacturing capabilities. Any forward - looking statements represent the Company’s views only as of today and should not be relied upon as representing its views as of any subsequent date. The Compa ny explicitly disclaims any obligation to update any forward - looking statements, except as required by law. The Company’s business is subject to substantial risks and uncertaint ies that could cause these statements to be inaccurate. Applicable risks and uncertainties include, among others, that we have incurred significant losses since inceptio n a nd our need for additional funding; if we fail to achieve the expected financial and operational benefits of our corporate restructuring, the results of our investigation of o ur Phase 1/2 clinical trial in Hemophilia A or failure in clinical development of our diabetes or MPS - 1 programs could adversely effect our business and may require us to discontinue or delay development of other product candidates, which are all based on the same SLTx platform; there may be SAEs in addition to the SAE reported in our Phase 1/2 clinical trial of SIG - 001 in Hemophilia A, other undesirable side effects related to our product candidates or clinical studies, or limited efficacy of product candidates ari sin g from our SLTx platform; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use; that we do not have any results from t he testing of any of our product candidates in clinical trials other than SIG - 001 and any favorable preclinical results are not predictive of results that may be observed in c linical trials; the FDA or other regulators may request additional preclinical studies or clinical trials beyond those that we currently anticipate for our product candidate s; and other risks and uncertainties identified under the heading “Risk Factors” and in our Quarterly Report on Form 10 - Q for the quarter ended June 30, 2022 and in any subsequent fi lings with the Securities and Exchange Commission. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. 2 Non - Confidential

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MISSION: We aim to deliver functional cures to patients by harnessing the power of the human cell 3 Non - Confidential

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Strong Foundation to Support Sustained Growth • Seminal work at MIT by Langer & Anderson with the discovery of Afibromer ™ • Sigilon created by Flagship Pioneering (2016) • Lilly partnership for T1D w/ $75M upfront + up to $415M milestones (2018) • NASDAQ: SGTX; IPO $145M (Dec 2020) • FIH in hemophilia A (Oct 2020) • Strong intellectual property • Cash runaway anticipated into 2024 Non - Confidential 4 Company Background Our Potential Attributes Host genome unaltered 1 Shielded allogeneic cells 2 Retrievable and redosable 3 Multiple tissue applicability 4 Established GMP manufacturing 5

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5 Shielded Living Therapeutics ( SLTx ) Platform + + Manufacturing Placement Cells Sphere Non - Confidential

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Industry Leaders with a Proven Track Record of Driving Value Non - Confidential Rogerio Vivaldi, MD, MBA President, Chief Executive Officer Matthew Kowalsky , JD Chief Legal & Administrative Officer Rogerio Vivaldi, MD, MBA CEO S i g i l o n T h e r ap e u t i c s Robert Ruffolo, Jr., PhD Former Head of R&D, W y e t h Pha r ma c e u t i c a l s Eric Sh a ff, MB A CEO Seres Therapeutics Stephen Oesterle MD Former CTO, M e d t r on i c PLC Kavita P a t el MD T he B r ook i n g s Institution Board of Directors Philip Ashton - Rickardt , PhD Chief Scientific Officer Ajay R ai SVP, Head of Business Development Doug C ole , MD Chairman , F l a gs h i p P i on ee r i n g John Cox Former CEO Repertoire Josias Pontes, MBA SVP, Acting Chief Financial Officer Sarah Yuan, PhD Chief Technical Operations Officer Olivia Kelly, PhD S VP, Head of Diabetes Research Robert Windsor Jr, J.D. VP, Investor Relations May Orfali , MD, MBA Chief Medical Officer Bernd Kullmann , MBA VP, Head of Operations & Project Management 6

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• No definitive link between SIG - 001 and inhibitors was established • No other tolerability or safety issues • Evidence of sustained FVIII activity was observed at the lowest dose ( 50 mL) for approximately 20 weeks after administration • During retrieval procedure, mature localized pericapsular fibrotic overgrowth (PFO) was observed • No organ or tissue fibrosis Hem A Phase 1/2 Safety And Dose Ranging Study Update • In July 2021, SAE reported • In November 2021, retrieval and PFO finding • In December 2021, reprioritized programs to focus on Diabetes, MPS - 1 and platform optimization • In Q3 2022, submitted Clinical Hold Response to FDA • IND/CTA withdrawal and close out activities for Hem A planned for Q4 22 • First time ever patients w/ Hem A dosed with an allogeneic cell therapy • Three patients dosed (300 million to more than a billion cells) with an allogeneic cell therapy for hemophilia A • The product was implantable and retrievable Safety & Factor VIII Investigation Timeline 7 Non - Confidential

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Sigilon Encapsulated Drug Product Discovery Process Therapeutic concept Protein/Cell engineering Cell Encapsulation Optimization Lead Drug Product Optimization PFO/Efficacy Assessment Tox/PK - PD Assessment First in human • Sequence optimization • Cell line selection • Cell Engineering • Differentiation protocol optimization • Format • Viability • Productivity • Potency • Efficacy • PK/PD • Biomarker discovery • In vitro macrophage attachment • In vivo PFO ( huBLT ) • NHP/rodent Tox • PK/PD • Biomarker discovery Non - Confidential Prediction Models 8

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9 PFO is a Complex Immunological Process Non - Confidential

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10 Building Optimized Cell Therapies: Steps to mitigate PFO risk and optimize Sigilon’s SLTx platform + + Manufacturing Placement Cells Sphere OPTIMIZATION: ❖ iPSC derived cells are less immunogenic than epithelial cells ❖ Exploring lower cell density through higher potency expression ❖ Exploring ImmunoQuiet cells to mitigate antigen response OPTIMIZATION: ❖ Cryopreserved drug substance expected to significantly decrease manufacturing lead times OPTIMIZATION: ❖ Minimally invasive, interventional radiology guided sphere delivery with local anesthesia OPTIMIZATION: ❖ Strengthened sphere integrity and stability with the addition of dXL (ionic + covalent crosslinking = dXL) Non - Confidential

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Developed Allogeneic PFO Prediction Methods Non - Confidential Macrophage Attachment Assay GO NO - GO huBLT mouse model PFO/Clumping Non - Human Primates Durable PK EXAMPLE 1 day 5 weeks 8 weeks 5 weeks 8 weeks 1 day 5 weeks 8 weeks 11

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1) External surface of sphere • Macrophage attachment 2) Secretome • Inflammatory stimulation 3) Antigens • Adaptive Immunity to specific antigen activation Potential PFO Triggers Non - Confidential 12

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Dual Crosslinking ( dXL ) Alginate Stabilized Afibromer a nd Spheres In Vivo in Preclinical Studies D0 D28 D56 D84 0 50 100 Afibromer Stability with dXL 7 % Afibromer relative to D0 • Stabilizes spheres • Minimizes Ba 2+ content • Supports cell viability and productivity • Maintains potency • Improves PFO mitigation Benefits of dXL 13 Non - Confidential

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1) External surface of sphere • Macrophage attachment 2) Secretome • Inflammatory stimulation 3) Antigens • Adaptive Immunity to specific antigen activation Potential PFO Triggers Non - Confidential 14

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No Evidence of PFO for SIG - 002 in Allogeneic hu - BLT Mice SIG-000 iXL SG1 SIG-005 25M iXL SG1 SIG-005 25M dXL SG1 SIG-002 dXL SG1 Polystyrene Beads 0 100 200 300 400 500 1000 1500 PFO Response at Day 35 (huBLT model) Total Weight of Clumped Spheres (mg) Clumps No Clumps We expect that SIG - 002 will be a low PFO clinical product • SIG - 002 has no PFO (same as negative control, empty spheres) • Positive control, polystyrene beads, shows higher level of PFO than SIG - 005 • SIG - 005 25 M/ml dXL has less PFO than SIG - 005 25 M/ml iXL Polystyrene Beads SIG - 005 dXL SG1 SIG - 005 iXL SG1 SIG - 002 dXL SG1 SIG - 000 iXL SG1 Non - Confidential 15

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1) External surface of sphere • Macrophage attachment 2) Secretome • Inflammatory stimulation 3) Antigens • Adaptive Immunity to specific antigen activation Potential PFO Triggers Non - Confidential 16

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• SIG - 005 non - toxic and well tolerated in NHP study • Edmonton protocol reduced antibodies to encapsulated cells & improved pharmacokinetic profile of SIG - 005, even in iXL spheres • Results corroborate current dosing assumptions Inhibition of Adaptive Immunity Improves PK of SIG - 005 Edmonton treated group had significantly higher IDUA activity levels measured in liver & spleen Group 1 SIG-005 - Edmonton Group 2 SIG-005 + Edmonton 0 2 4 6 8 Kidney ng IDUA/mg protein ✱✱✱ Non - Confidential 17

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SLTx Encapsulation May Have Significant Advantages Over Naked Cell Therapies SLTx PLATFORM – POTENTIAL ADVANTAGES • No antibody - m ediated c ytotoxicity • Known b iology and IP landscape • Minimal gene edits to reduce risk of off - target effects • Designed to block antibody and immune cell infiltration, including pre - existing T1D autoantibody response NAKED ISLET THERAPY – CHALLENGES • Prone to antibody m ediated c ytotoxicity • Uncertain biology and FTO • Multi - gene edits increase risk of off - target effects • Protection from autoantibody induced islet rejection of T1D is uncertain Non - Confidential Prevent allo - antigen induced immune response Spheres prevent direct or indirect immune rejection Afibromer inhibits macrophage attachment Spheres block antibody effector mechanisms 18

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PROGRAM CELL PRODUCT/TYPE DISCOVERY LEAD OPTIMIZATION IND ENABLING PHASE 1/2 Prioritized Programs SIG - 002 – Type 1 Diabetes Insulin & others SIG - 105/205 – CNS MPS - 1 BBB - Human IDUA Lysosomal Diseases SIG - 207 – CNS Fabry BBB - Human GLA SIG - 218 – CNS MPS - 2 BBB - Human IDS SIG - 220 – MPS - 6 Human ARSB Liver Diseases SIG - XXX – Acute Liver Failure ApoL - IL10 SIG - XXX – Acute Liver Failure Human Hepatocyte SIG - XXX – Anemia Human Hepatocyte/EPO Target Validation Other Monogenic CNS Other IMD ImmunoOncology Q E I Q E Q E Q E I I Prioritized Pipeline Q E Q E Q E Q E + Covalent Dual Cross Linking ( dXL ) SIG - 002 iPSC derived Islets Target IND Submission H2 2024 Diabetes Program Constitutive Sense & Response I iPSC derived Q ImmunoQuiet E Epithelial Cell Target IND Submission H2 2024 Non - Confidential 19 SIG - 105 Expanded MPS - 1 Program SIG - 105 ARPE - 19 - LSD 2.0 (CNS targeting) + Covalent Dual Cross Linking ( dXL ) ImmunoQuiet * ARPE - 19 LSD 2.0 SIG - 205 + Covalent Dual Cross Linking ( dXL ) ImmunoQuiet (CNS targeting)

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Diabetes Program 20 + Covalent Dual Cross Linking ( dXL ) SIG - 002 iPSC derived Islets Target IND Submission H2 2024 Non - Confidential Our Strategic Partner Partnership Overview Lilly’s Financial Commitment • Discover, develop and commercialize encapsulated cell therapy for T1D • Sigilon will create proprietary products and develop through IND • Eli Lilly responsible for clinical development and commercialization • $75 million up front • $415 million in milestones • Tiered single - to - low double - digit sales - based royalties

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21 Differentiation Protocol Optimization Produces SC - islets with Improved Cell Profiles and Potency iPSC Mesendoderm Stage 1 Definitive Endoderm Stage 1 Primitive Gut Tube Stage 2 Foregut Endoderm Stage 3 Pancreatic Progenitors Stage 4 Pancreatic Endocrine Precursors Stage 5 Islets Immature Beta Cells Stage 6 Islets Maturing Beta Cells Stage 7 61% NKX6.1 C - Peptide Current Optimized SC - islets in vitro • Increased Beta Cells: Avg = 61 % (STD* 5%) • Increased Insulin Content: Avg = 325 nU /cell (STD 92) • Increased “glucose - stimulated” Insulin Secretion : Avg = 75 pU /cell/ min (STD 41) Non - Confidential *STD= Standard deviation

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22 SIG - 002: Efficacious in Immune - Deficient Diabetic Mice 10 weeks after implantation Non - Confidential 0 30 60 90 120 0 200 400 600 800 SG-VIVO7966-1 D70 Oral Glucose Tolerance Test Time (min) Blood Glucose (mg/dL)

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Expanded MPS - 1 Program 23 SIG - 105 SIG - 105 ARPE - 19 - LSD 2.0 (CNS targeting) + Covalent Dual Cross Linking ( dXL ) ImmunoQuiet * ARPE - 19 LSD 2.0 SIG - 205 + Covalent Dual Cross Linking ( dXL ) ImmunoQuiet (CNS targeting) Non - Confidential • SOC (enzyme replacement therapy) requires life - long weekly administration and can be hampered by a short enzyme half - life • Preclinically, we have demonstrated enzyme transported to target tissues, even the hard - to - reach tissues like bone, heart and lungs Therapeutic efficacy Sub - therapeutic efficacy No therapeutic efficacy 0 50 100 150 200 Plasma Enzyme Level Time (hours) Traditional Therapies Pulsatile protein delivery (ERT) SLTx product • In Q4 2022, pivoting from SIG - 005 to an expanded MPS - 1 product candidate, SIG - 105 or SIG - 205 • Targeting new IND Submission in H2 2024 • Expect to withdraw the Clinical Trial Applications for SIG - 005 in Q4 2022 Our SLTx platform offers the potential for sustained substrate reduction (vs. peaks and troughs)

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SIG - 005: Reduction of Substrate in Tissues After 6 Months of Treatment in Mice With MPS - 1 24 Untreated MPSI - H SIG - 005 * * * * * * * * * * * * 10x 10x 10x 10x 10x 10x 10x 10x 40x 40x 40x 40x 40x 40x 40x 40x MPS - 1: mucopolysaccharidosis type I; Images taken by NanoZoomer S60 with 20x Representative images taken from single untreated male mouse & single SIG - 005 treated male mouse Heart Lung Liver Kidney Zeiss 20x; Alcian blue; Black arrow indicates substrate ( Untx : G7 - 1; Tx: G3 - 1); * Glomerulus; * Bronchiole Non - Confidential

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25 SIG - 005: Phenotypic Correction in Bone After 6 Months of Treatment in Mice With MPS - 1 Distal Femur – Sagittal View of Trabecular Areas Untreated MPS - 1H SIG - 005 Treated M F M F Untreated MPS - 1H SIG - 005 - treated Laronidase - treated F M F M F M Laronidase Treated M F Zygomatic Arch – Total Bone Volume Non - Confidential

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Expanded MPS - 1 Program Will Enable Blood Brain Barrier Penetration BBB - penetrant Camelid HCAb BBB V H H Cargo Protein Half - life V H H Half - life extending Camelid HCAb VH + - 32% Technology Details Good systemic tissue penetration and functional activity towards target substrate Total Heparan sulfate reduction in systemic tissues 26 Liver Spleen Kidney Lung Heart 0 50 100 150 200 Total Heparan sulfate reduction in systemic tissues Percent of Untreated BBB-hIDUA Untreated ✱✱ ✱✱✱✱ ✱✱✱✱ ✱✱✱✱ ✱✱✱ Brain Heparan Sulfate Reduction BBB-hIDUA Untreated 0 50 100 Brain heparan sulfate reduction Percent of Untreated ✱✱✱✱ Liver Spleen Kidney Lung Heart 0 50 100 150 200 Total Heparan sulfate reduction in systemic tissues Percent of Untreated BBB-hIDUA Untreated ✱✱ ✱✱✱✱ ✱✱✱✱ ✱✱✱✱ ✱✱✱ Non - Confidential

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27 Manufacturing Strategy – Long - Term Improvements to Enable Off - the - Shelf Allogeneic Products Non - Confidential • Scale up drug substance manufacturing • Automate and scale up drug product manufacturing • Develop cryopreserved drug product

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• Acute • Chronic • CNS • Immune mediated Diseases (IMD) • Liver Diseases • Immuno - oncology Multiple Cell Lines Existing Technologies & Capabilities Allowing for the exploration of a broad range of indications, including: *Future Cells Source Future Expansion Strategy Non - Confidential Vision to become cell therapy powerhouse, leveraging encapsulation platform and manufacturing capabilities across multiple cell types to deliver groundbreaking and durable therapeutics 28 Epithelial cells (+ CNS) iPSC cells (undisclosed)* Process & Analytical Dev/MFG/Quality/Clinical Dev Cell encapsulation Translational models/humanized mice/ NHP/PFO assays Gene Editing/Blood Brain Barrier Transport/Protein Engineering iPSC islet derived cells

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29 Upcoming Milestones • H2 2023: initiate IND - enabling studies for Type 1 Diabetes program with optimized spheres • H2 2023: initiate IND - enabling studies for Expanded MPS - 1 Program • Continued pipeline expansion • IND for Type 1 Diabetes • IND for Expanded MPS - 1 Program • IND enabling studies for 3 - 4 new targets 2023 2024 Non - Confidential