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SGTX 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.

Company profile

SGTX stock data

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Calendar

10 Aug 21
18 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Cash on hand (at last report) 163.77M 163.77M 163.77M
Cash burn (monthly) 5.4M 6.68M (positive/no burn)
Cash used (since last report) 19.51M 24.13M n/a
Cash remaining 144.26M 139.65M n/a
Runway (months of cash) 26.7 20.9 n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
30 Sep 21 Josias Pontes Common Stock Grant Acquire A No No 0 11,500 0 13,339
1 Jul 21 Philip Ashton-Rickardt Stock Option Common Stock Grant Acquire A No No 10.61 90,000 954.9K 90,000
1 Jul 21 Robert R Ruffolo Common Stock Sell Dispose S No Yes 10.36 6,750 69.93K 0
1 Jul 21 Robert R Ruffolo Common Stock Option exercise Acquire M No Yes 0.57 6,750 3.85K 6,750
1 Jul 21 Robert R Ruffolo Stock Option Common Stock Option exercise Dispose M No Yes 0.57 6,750 3.85K 48,805
24 Jun 21 Oesterle Stephen N. Stock Option Common Stock Grant Acquire A No No 9.97 8,888 88.61K 8,888
24 Jun 21 Robert R Ruffolo Stock Option Common Stock Grant Acquire A No No 9.97 8,888 88.61K 8,888

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

97.1% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 54 54
Opened positions 11 21 -47.6%
Closed positions 11 14 -21.4%
Increased positions 16 9 +77.8%
Reduced positions 16 11 +45.5%
13F shares
Current Prev Q Change
Total value 767.94M 3.75B -79.5%
Total shares 31.13M 31.26M -0.4%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Flagship Pioneering 10.37M $111.27M 0.0%
Flagship Ventures Fund V 8.89M $426.93M 0.0%
LLY Lilly(Eli) & Co 2.74M $131.82M 0.0%
Canada Pension Plan Investment Board 1.49M $15.94M 0.0%
BLK Blackrock 1.4M $15.07M +9.3%
FMR 773K $8.29M -4.7%
Harbourvest Partners 740.74K $7.95M 0.0%
Wellington Management 620.71K $6.66M +55.6%
MS Morgan Stanley 546.94K $5.87M +26803.2%
State Of Wisconsin Investment Board 509.63K $5.47M 0.0%
Largest transactions
Shares Bought/sold Change
Avidity Partners Management 0 -850.97K EXIT
Gilder Gagnon Howe & Co 84.7K -569.51K -87.1%
MS Morgan Stanley 546.94K +544.91K +26803.2%
Monashee Investment Management 317.46K +317.46K NEW
Wellington Management 620.71K +221.68K +55.6%
American Century Companies 324.88K +132.71K +69.1%
Ubs Global Asset Management Americas 0 -123.37K EXIT
BLK Blackrock 1.4M +119.44K +9.3%
Millennium Management 0 -104.1K EXIT
Jacobs Levy Equity Management 66.09K +66.09K NEW

Financial report summary

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Risks
  • We have incurred significant losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce, or eliminate our research and product development programs or future commercialization efforts.
  • Our variable rate indebtedness subjects us to interest rate risk, which could cause our debt service obligations to increase significantly.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates we may develop.
  • Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We have never generated revenue from product sales and may never become profitable.
  • The SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use. The regulatory requirements applicable to our product candidates may change over time. The approaches we are taking to discover and develop novel therapeutics are unproven and may never lead to marketable products.
  • We may not be successful in our efforts to identify and develop product candidates. If these efforts are unsuccessful, we may never become a commercial stage company or generate any revenues.
  • We are early in our development efforts. It will be many years before we or our collaborators commercialize a product candidate, if ever. If we are unable to advance our product candidates to clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We currently have only one clinical stage product candidate, SIG-001, for which we dosed our first two patients in the fourth quarter of 2020. A failure of this product candidate in clinical development would adversely affect our business and may require us to discontinue development of other product candidates, which are all based on the same SLTx platform.
  • We only have preliminary data from the first two patients dosed with SIG-001 and no results from our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials.
  • If any of the product candidates we may develop, or the delivery modes we rely on to administer them, cause serious adverse events, undesirable side effects, or unexpected characteristics, such events, side effects or characteristics could delay or prevent regulatory approval of the product candidates, limit the commercial potential, or result in significant negative consequences following any potential marketing approval.
  • 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 experience delays or difficulties in the enrollment and dosing of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize SIG-001 or any other product candidate in the United States or any other jurisdiction, and any such approval may be for a more narrow indication than we seek.
  • Interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates may be considered combination products involving a proprietary delivery approach, which may result in additional regulatory and other risks.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent SIG-001 or any other product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our product candidates could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Even if SIG-001 or any other product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
  • If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
  • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.
  • Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Due to the novel nature of our technologies and the potential for SIG-001 or any other product candidates to offer therapeutic benefit in a single administration or limited number of administrations, we face uncertainty related to pricing and reimbursement for these product candidates.
  • If the market opportunities for SIG-001 or any other product candidates are smaller than we believe they are, our potential revenues may be adversely affected, and our business may suffer.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any medicines that we may develop.
  • If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Our technologies are novel, and any product candidates we develop may be complex and difficult to manufacture on a clinical or commercial scale. We could experience delays in satisfying regulatory authorities or production problems that result in delays in our development or commercialization programs, limit the supply of our product candidates we may develop, or otherwise harm our business.
  • We purchase some of the starting material for our product candidates from a single source or a limited number of suppliers, and the partial or complete loss of one of these suppliers could cause production delays, clinical trial delays, substantial loss of revenue and contract liability to third parties.
  • We expect to rely on third parties to conduct our clinical trials and conduct some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.
  • Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
  • We, or our third-party manufacturers, may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any.
  • We have entered and may in the future enter into collaborations with third parties for the research, development, and commercialization of SIG-002 or any other potential product candidates. If any such collaborations are not successful or our existing partners do not perform as expected, we may not be able to capitalize on the market potential of those product candidates.
  • If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • If we are unable to obtain and maintain patent and other intellectual property protection for SIG-001 or any other product candidates and for our SLTx platform, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technologies similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our SLTx platform may be adversely affected.
  • Our rights to develop and commercialize our SLTx platform technologies and product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
  • Our owned patent applications and in-licensed patents and patent applications and other intellectual property may be subject to priority disputes or to inventorship disputes and similar proceedings.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may not be successful in acquiring or in-licensing necessary rights to key technologies or any product candidates we may develop.
  • The biotechnology and pharmaceutical industries have experienced substantial litigation and other proceedings regarding intellectual property rights, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • We may become involved in lawsuits to protect or enforce our future patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful and could result in a finding that such patents are unenforceable or invalid.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in patent law in the United States and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our SLTx platform technologies and product candidates.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats.
  • Our relationships with healthcare providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
  • Healthcare and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize SIG-001 or any other product candidates and affect the prices we, or they, may obtain.
  • We have obtained orphan drug designation for SIG-001 for the treatment of Hemophilia Type A, SIG-005 for the treatment of MPS-1 and SIG-007 for the treatment of Fabry disease, and we intend to seek orphan drug designation for our product candidates, but any orphan drug designations we receive may not confer marketing exclusivity or other expected benefits.
  • Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies and contractual obligations could adversely affect our business.
  • Our future success depends on our ability to retain our Chief Executive Officer and other key executives and to attract, retain, and motivate qualified personnel.
  • We expect to expand our development, regulatory, and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our internal computer systems, or those of our third-party vendors, collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • 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.
  • The market price of our common stock may be highly volatile, which could result in substantial losses for investors.
  • A significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • Insiders have substantial influence over us, which could limit your ability to affect the outcome of key transactions, including a change of control.
  • If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
  • We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
  • We do not expect to pay any dividends for the foreseeable future.
  • Our future ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Provisions in our amended and restated certificate of incorporation, our amended and restated by-laws and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation designates the state or federal courts within the State of Delaware as the exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • U.S. federal income tax reform could adversely affect our business and financial condition.
Management Discussion
  • Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
  • We are a clinical stage biotechnology company pioneering a new class of therapeutics and seeking to develop functional cures for patients with chronic diseases by providing stable and durable levels of therapeutic molecules to patients. We have developed our Shielded Living Therapeutics, or SLTx, platform, which combines advanced cell engineering with cutting-edge innovations in biocompatible materials and enables our product candidates to produce a wide range of therapeutic molecules that may be missing or deficient, such as proteins (including therapeutic proteins and antibodies) and hormones. We are designing our product candidates to be off-the-shelf, durable, controllable and redosable, without requiring modification of the patient’s genes or immunosuppression.
  • Since our inception, we have devoted substantially all of our efforts to raising capital, obtaining financing, filing and prosecuting patent applications, organizing and staffing our company and incurring research and development costs related to advancing our biomedical platform. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from sales of common stock, convertible preferred stock, payments received under our collaboration agreement with Lilly and proceeds from borrowings under our credit facilities.
Content analysis
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