SECURITIES AND EXCHANGE COMMISSION
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): May 10, 2021
SIGILON THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
100 Binney Street
(Address of principal executive offices)
(Registrant’s telephone number, including area code): (617) 336-7540
(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)
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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:
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on which registered
Common Stock, $0.001 par value per
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 May 10, 2021, Sigilon Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 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 7.01 Regulation FD Disclosure.
On May 10, 2021 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. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time.
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 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.
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.
/s/ Rogerio Vivaldi Coelho, M.D.
Rogerio Vivaldi Coelho, M.D.
President and Chief Executive Officer
Date: May 10, 2021
Sigilon Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights
Cambridge, MA—May 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 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.|
|●||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.|
|●||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:|
|o||Sigilon expects to disclose up to 9 months of follow up data for 3-4 patients in the third quarter of 2021; and|
|o||Sigilon expects to complete enrollment of the study in the second half of 2021.|
|●||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.
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)
Accounts receivable (inclusive of $83 and $63 from a related party at March 31, 2021 and December 31, 2020, respectively)
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Liabilities, convertible preferred stock and stockholders’ equity (deficit)
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Total current liabilities
Deferred revenue from related party, net of current portion
Lease liability, net of current portion
Long-term debt, net of discount
Commitments and contingencies (Note 9)
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
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
Total stockholders’ equity
Total liabilities, convertible preferred stock and stockholders’ equity
Sigilon Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Three Months Ended March 31,
Collaboration revenue (inclusive of $2,932 and $3,466 from a related party for the three months ended March 31, 2021 and 2020, respectively)
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)
General and administrative
Total operating expenses
Loss from operations
Other income (expense), net:
Change in fair value of preferred stock warrant liability
Total other expense, net
Net loss and comprehensive loss
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Weighted average common stock outstanding—basic and diluted
Sigilon Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
Three Months Ended March 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Stock-based compensation expense
Other non-cash expenses, net
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Proceeds from issuance of convertible preferred stock, including deemed dividend, net of issuance costs
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SOURCE: Sigilon Therapeutics, Inc.
Sigilon Therapeutics, Head of Investor Relations
Advancing Potential Functional Cures for Patients With Chronic Diseases ©2021 Sigilon Therapeutics, Inc. May 2021
Disclaimer This presentation has been prepared by Sigilon Therapeutics, Inc. (“we,” “us,” “our,” “Sigilon” or the “Company”) and is made for 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. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and Sigilon makes no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources. While the Company believes its internal research is reliable, such 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 this presentation are forward- looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning: our current cash runway; the initiation, timing, progress and results of our research and development programs, preclinical studies and clinical trials, including the timing of our clinical trials for SIG-001 for the treatment of Hemophilia A and the submission of INDs or CTAs for our other product candidates; our ability to advance 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 Company explicitly disclaims any obligation to update any forward-looking statements. The Company’s business is subject to substantial risks and uncertainties. Applicable risks and uncertainties include, among others, that we have incurred significant losses since inception and our need for additional funding; 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 the testing of any of our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials; we may be unable to obtain and maintain patent protection and other intellectual property rights for SIG-001 or any other product candidates and for our SLTx platform, or the scope of the patent and other intellectual property protection obtained may not be sufficiently broad; that a pandemic, epidemic, or outbreak of an infectious disease, such the COVID-19 pandemic, may materially and adversely affect our business and our financial results and could cause a disruption to the development or supply of SIG-001 or any other product candidates; and other risks and uncertainties identified under the heading “Risk Factors” and in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and in any subsequent filings with the Securities and Exchange Commission. 1 Non-Confidential
SHIELDED LIVING THERAPEUTICS PLATFORM Company Overview Our mission is to develop functional cures for patients living with a wide range of chronic diseases • Designed to overcome significant limitations of cell and gene therapies and drawbacks of current biologic-based therapies • Potential benefits include: ✓ Safety – no interference with patient’s DNA ✓ Durability ✓ Ability to redose and retrieve ✓ Controllable dosing ✓ Broad patient eligibility ✓ No immunosuppression required ✓ Modularity – efficient development and manufacturing • $372 million in funding to date • Completed IPO in December with $144.9 million in gross proceeds (priced at $18) • Current cash runway into Q4 2022 with IPO proceeds •Dosing in FIH trial in Hem A started in 4Q ‘20 •Regulatory agencies have acknowledged the potential to leverage CMC and non-clinical data across pipeline •Pipeline with 4 IND filings expected within next 2 years STRONG FINANCIAL POSITION CLEARLY DEFINED REGULATORY PATH 2
+ + 1. The Cells Selection criteria based on: ✓ Safety ✓ Durability ✓ Scalability ✓ Engineerability Ability to switch transgene allows for plug-n-play 3 pillars of our modular platform technology Modular SLTx Product Platform From Cell Function to Potential Functional Cure 2. The Sphere 3. The Manufacturing Process Dual layer sphere optimized to: ✓ To prevent immune response ✓ To enhance cell longevity and productivity No significant changes required from product to product Standardized processes: ✓ Cell expansion ✓ Biomaterials manufacturing ✓ Proprietary methods for encapsulation Strategic advantages ✓ Scalable and flexible ✓ Potential Reduced COGS Modular platform allows for production of novel SLTx product candidates with the potential to treat broad range of chronic diseases Placement 3 Afibromer Matrix Administration via IP port
Our Company History 2018 – 2019 2016 - 2017 1980 - 2015 Sigilon created by Flagship Pioneering Foundational partnership Developed our modular platform Hemophilia A Orphan Drug Designation (FDA) Key publications in peer-reviewed journal, Nature Seminal work by Drs. Robert (Bob) Langer and Daniel Anderson at MIT led to discovery of AfibromerTM Evidence of fibrosis No fibrosis observed Series A $26M Lilly Deal $75M + With AfibromerTM Without AfibromerTM Expanded our pipeline 4
2020: A Transformational Year For Sigilon ✓ Secured Series B financing of $105M ✓ Closed an upsized IPO (Dec 8, 2020), at a public offering price of $18.00 per share and aggregate gross proceeds were $144.9 million ✓ Dosed first patients in Phase 1/2 study of SIG-001 for Hem A ✓ Received 03 Orphan Drug Designations: SIG-001 (Hem A), SIG-005 (MPS-1) & SIG-007 (Fabry – Q121) ✓ Completed one-year NHP study of empty spheres ✓ Completed GMP mfg of our final product for SIG-001 ✓ Next wave of INDs in portfolio and moving toward IND 5
Robust Preclinical Programs ✓ 4-month NHP islets ✓ 12-month rat Islet in STZ mouse model ✓ 6 & 5-month NSG mice (SIG-001 and SIG-005) ✓ 6 & 12-month NHP (empty spheres) DURABILITY OF SLTX PLATFORM ✓ Product delivery method evaluated in mice, NHP and human cadavers ✓ Hem A, MPS-1, Fabry, FVII Def & Hem B dose/response in animal models ✓ Successful redosing and retrieval in NHP ✓ 500+ mice studied in multiple safety & tox studies ✓ 50+ NHP evaluated in safety & tox studies ✓ Multiple rodent studies in Hemophilia A and MPS-1, Fabry, FVII, & Hem B provide evidence on bioavailability in plasma ✓ NHP PK study in Hem A (SIG-001) confirmed bioavailability in plasma NONCLINICAL SAFETY DOSING, CONTROL, & REDOSING BIOAVAILABILITY FROM IP → PLASMA 6
SLTx Offers Many Important Potential Advantages Versus Other Modalities 7
SLTx Offers Important Potential Advantages Versus Gene Therapy 8 Recent Gene Therapy Setbacks: ✓ Declining efficacy (including loss of all expression) ✓ Unpredictable overdosing ✓ Insertional mutagenesis risk with AAV (genotoxicity risk) ✓ Insertional mutagenesis risk with alkylating agents ✓ Serious Adverse Events: blindness/deaths
PROGRAM DISCOVERY LEAD OPTIMIZATION IND ENABLING PHASE 1/2 PHASE 3 Rare Blood Disorders SIG-001 – Hemophilia A SIG-009 – FVII Deficiency SIG-003 – Hemophilia B Lysosomal Diseases SIG-005 – MPS-1 SIG-007 – Fabry SIG-018 – MPS-2 SIG-020 – MPS-6 Endocrine & Other Chronic Diseases SIG-002 – Type 1 Diabetes SIG-015 – Immune-Mediated Diseases Addressing a Broad Range Of Chronic Diseases Platform could be foundation for multiple products to enable treatment of vast array of disorders that require chronic protein administration 9
SIG-001 for Hem A: Efficacy, Durability and Controllability Observed in Preclinical Studies * -Statistically significant reduction in bleeding time relative to HA + wt (p<0.05). Bleeding time (in sec) W T HA + wt cells HA + SIG-001 0 500 1000 1500 2000 WT Mice HA Mice + Control Spheres HA Mice + SIG-001 * 0.25 mL SIG-001 0.5 mL SIG-001 0.0 0.1 0.2 0.3 0.4 0.5 Group h F V I I I : A g ( I U / m L ) 103 days 174 days 191 days ✓ Efficacious ✓ Controllable ✓ Durable Rare Blood Disorders Hem A mice Hem A mice NSG mice 0 0.5 1 1.5 2 2.5 SIG-001 Low dose SIG-001 Mid dose SIG-001 High dose hFVIII:C (IU/mL) Normal range 30 spheres 75 spheres 140 spheres ✓ Orphan Drug Designation 10
SIG-001 Phase 1/2 Dose Escalation Study Represents Significant Milestone For SLTx Platform Rare Blood Disorders • Significant milestones for: • Product platform for our pipeline • GMP Manufacturing • Logistics of Fresh Product • Initial Safety Observations • Measurable plasma FVIII activity • Recent amendments cleared • Next steps: • Continue dose escalation SIG-001 spheres (omentum) Administration catheter 11 8 mm Insufflation & Administration Port 5 mm Camera Port
SIG-005: Phenotypic Correction in Bone after 5 Months of Treatment in Mice with MPS-1 Reduced thickness in cortical areas Sustained reduction in GAGs Female Male 0 5 10 15 20 25 T r a b e c u l a , R e l a t i v e a m o u n t o f b o n e P=0.042 P=0.008 Reduction in bone volume Female Male 0 100 200 300 M i n e r a l d e n s i t y , m g H A / c m 3 Untreated SIG-005 p=0.0285 p=0.141 Reduction in mineral density Female Male 0.8 1.0 1.2 1.4 1.6 A v e r a g e a r e a o f b o n e , C t .. A r p=0.089 p=0.012 SIG-005 Untreated 0 2000 4000 6000 n g B M 6 5 2 / m g t o t a l p r o t e i n SIG-005 Untreated 0 2000 4000 6000 p m o l 4 M U / h o u r / m g o f p r o t e i n IDUA activity in liver *microCT data is from the femur bone Lysosomal Diseases 12
Reduction of Substrate in Tissues of MPS-1 Mice 5 Months After SIG-005 Heart Kidney Liver Lung Treated Untreated Zeiss 20x; Alcian blue; Black arrow indicates substrate (Untx: G7-1; Tx: G3-1); * Glomerulus; * Bronchiole Lysosomal Diseases 13
Reduction Lyso-Gb3 Across Tissues 1 Month After SIG-007 Administration in Mice with Fabry Lysosomal Diseases Presented at the 17th Annual WORLDSymposium™ February 8th - 12th 2021, virtually. N=6/group; L:low dose; M: medium dose; H:high dose; Unt: untreated; unpaired t-test vs untreated: ****p<0.001; ***p<0.001; **p<0.01; *p<0.05; nsp>0.05 14
Sigilon and Lilly Collaborating to Develop Potential Functional Cure for Type 1 Diabetes • Sigilon is responsible for execution of the program through IND • Eli Lilly, a global leader in diabetes, will develop and commercialize program worldwide if approved • Financial Terms: • $75 million initial commitment • $415 million in milestones & tiered (from single- to-low double digit) sales-based royalties Type 1 Diabetes 15
Diabetes Program Progresses Toward IND Blood Glucose (mg/dL) Mean ± SEM 600 500 400 300 200 100 0 Time (Days) 600 500 400 300 200 100 0 330 300 270 240 210 180 150 120 90 60 30 0 Review Article by Langer R; Molecular Frontiers Journal (2017) Rat donor islets in STZ mice (12 months) Type 1 Diabetes 16 0 10 20 30 40 50 60 70 80 90 100 0 100 200 300 400 500 600 700 800 900 Encapsulated Human Islets in Diabetic Mice Time (days) B l o o d G l u c o s e ( m g / d L ) STZ Human Islets (n=5) STZ Control (n=6) Non-STZ Control (n=6) ~3,000 IEQ 0 10 20 30 40 50 60 70 80 90 100 0 100 200 300 400 500 600 700 800 900 Encapsulated Human Islets in Diabetic Mice Time (days) B l o o d G l u c o s e ( m g / d L ) STZ Human Islets (n=5) STZ Control (n=6) Non-STZ Control (n=6) Encapsulated Human Islets in Diabetic Mice Our goal: normalize glucose control with no hypoglycemia in the absence of immunosuppression
Sustained IL-10 Administration Protects Mice from Concanavalin-A Induced Liver Inflammation 17 Liver Necrosis + + - + Concanavalin A Immune Mediated Diseases ❑ Autoimmune hepatitis: ▪ Hepatocyte destruction by pro-inflammatory cytokines ▪ Incidence is 1 to 2 per 100,00O and prevalence is about 24 per 100,000. ▪ SOC: Immunosuppressive agents such as prednisolone and azathioprine ▪ Problem: Often resulting in serious adverse effects and associated morbidities. ▪ We believe this provides proof of concept for this and other immune mediated diseases
Pioneering an Innovative and Scalable Automated Encapsulation System Simpler process than other advanced therapies may lead to COGS on the order of mAbs 18
Multiple Milestones Targeted within 24 months Filing a 2nd IND/CTA submission H1 21 •IND/CTA Submission: SIG-005/MPS-1 Initiating a 2nd Clinical Program H2 21 •Up to 9-month follow-up Phase 1/2 data (3 – 4 patients): SIG-001/Hem A •Complete enrollment of dose cohorts: SIG-001/Hem A Phase 1/2 •Phase 1/2 Initiation: SIG-005/MPS-1 (pending IND/CTA approval) •IND/CTA submission: 3rd undisclosed program Potential Multiple programs into the clinic 2022 •IND/CTA submission: 4th undisclosed program •Ongoing clinical development: SIG-001/Hem A •Phase 1/2 initial follow up: SIG-005/MPS-1 (pending IND/CTA approval) 19