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GUTS on Nasdaq

Fractyl (United States)

In its 2026 annual report the company says: “We are a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes. Our Revita ® and Rejuva ® candidates are designed to target root causes of metabolic diseases, allowing us to advance metabolic disease treatment from chronic management towards prevention and reversion of the disease.”4 It was founded in 2010.1 It is headquartered in Lexington.1 Its shares trade on Nasdaq under the symbol GUTS.1

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Last updated Oct 21, 2026.

Overview

2010Founded1

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  • TickerGUTS on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersLexington1
  • Websitewww.fractyl.com
  • Incorporated inDE3
  • Business address3 Van De Graaff Drive, Suite 200, Burlington, Ma 018033
  • Filer category, Emerging growth company3
  • Legal formCorporation

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We are a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (“T2D”). Our Revita ® and Rejuva ® candidates are designed to target root causes of metabolic diseases, allowing us to advance metabolic disease treatment from chronic management towards prevention and reversion of the disease.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-100.0%Revenue growth, 20255
-1490.3%Return on equity5
-$90.9MFree cash flow5

Financial statements

Revenue65$0 in 2025
0$50.0K$100.0K$150.0K2023: $120.0K$120.0K20232024: $93.0K$93.0K2024−22%2025: $0$02025
Gross profit65$43.0K in 2024+0% since 2023
0$20.0K$40.0K$60.0K2023: $43.0K$43.0K20232024: $43.0K$43.0K2024+0%
Operating income65-$96.8M in 2025+90% since 2023
-$100.0M-$75.0M-$50.0M-$25.0M02023: -$50.8M-$50.8M20232024: -$93.5M-$93.5M2024+84%2025: -$96.8M-$96.8M2025+4%
Net income65-$141.0M in 2025+83% since 2023
-$150.0M-$100.0M-$50.0M02023: -$77.1M-$77.1M20232024: -$68.7M-$68.7M2024−11%2025: -$141.0M-$141.0M2025+105%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenue$0$93.0K
Cost of goods sold$0$50.0K
Gross Profit$43.0K
Research and development$74.5M$70.5M
Selling, general and administrative$22.3M$23.1M
Total operating expenses$96.8M$93.6M
Loss from operations-$96.8M-$93.5M
Interest income, net$1.5M$4.1M
Change in fair value of notes payable-$4.7M$2.8M
Change in fair value of warrant liabilities-$40.9M$17.9M
Other expense, net-$53.0K-$47.0K
Total other income (expense), net-$44.1M$24.8M
Net loss and comprehensive loss-$141.0M-$68.7M
Accretion of dividends on convertible preferred stock-$1.7M
Net loss attributable to common stockholders-$141.0M-$70.4M
Net loss per share attributable to common stockholders, basic-$1.86-$1.62
Net loss per share attributable to common stockholders, diluted-$1.86-$1.62
Weighted-average number of common shares outstanding, basic75.8M shares43.5M shares
Weighted-average number of common shares outstanding, diluted75.8M shares43.5M shares

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Corporate structure

Fractyl (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Fractyl (United States)

  • Fractyl (United States) Lexington

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Fractyl (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$5.1M5 Dec 31, 2025$4.6M5 Dec 31, 2024+12.2%
Accumulated depreciation$2.7M5 Dec 31, 2025$1.6M5 Dec 31, 2024+70.8%
Property and equipment, net$2.4M5 Dec 31, 2025$3.0M5 Dec 31, 2024−19.2%
Operating-lease assets (leased space)$26.8M5 Dec 31, 2025$28.4M5 Dec 31, 2024−5.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$81.5M5 Dec 31, 2025$67.5M5 Dec 31, 2024+20.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$73.0K5 Dec 31, 2024$73.0K6 Dec 31, 20230%

Properties, in its own words

Our corporate headquarters is located at 3 Van de Graaff Drive, Suite 200, Burlington, Massachusetts, 01803, where we currently lease office and laboratory space of approximately 78,000 square feet under a lease agreement which will expire in June 2034, subject to earlier termination or extension. We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed. As of March 1, 2026, 82 of our employees are located at our corporate headquarters.

Item 2 of the 10-K filed Mar 24, 2026.4

Leadership

Who has led Fractyl (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Harith Rajagopalan2024–now

President

  1. Jay David Caplan2024–now

Chief financial officer

  1. Lisa Davidson2024–2025
  2. Weber Lara Smith2026–now
201520202025
Board members and other officers (12)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerJUAN CARLOS LOPEZ-TALAVERA named Jan 25, 202224
  • DirectorAJAY ROYAN named Jan 25, 202224
  • DirectorBRIAN DOVEY named Jan 25, 202224
  • DirectorWILLIAM BRADLEY named Jan 25, 202224

Former names

  • Fractyl Laboratories Inc.Mar 21, 2013 to Mar 19, 20203

Timeline

  1. Oct 1, 20268-K Bylaws or fiscal year changed25
  2. Sep 24, 20268-K Shareholder vote26
  3. Sep 11, 20268-K Listing notice or transfer27
  4. Aug 10, 20268-K Results of operations28
  5. Jul 15, 20268-K Regulation FD disclosure; Other events29
  6. Jun 11, 20268-K Shareholder vote30
  7. Jun 4, 20268-K Regulation FD disclosure; Other events31
  8. May 12, 20268-K Results of operations32
  9. May 11, 20268-K Regulation FD disclosure33
  10. Mar 24, 20268-K Results of operations; Regulation FD disclosure34
  11. Mar 17, 20268-K Listing notice or transfer35
  12. Feb 26, 20268-K Regulation FD disclosure36
  13. Feb 1, 2024New chief executive Harith Rajagopalan becomes CEO9
  14. 2010Founded Founded1

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($4.20) a share, on Nov 12, 2025.37

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results28
  2. May 12, 2026Reported quarterly or annual results32
  3. Mar 24, 2026Reported quarterly or annual results34
  4. Jan 5, 2026Reported quarterly or annual results38
  5. Nov 12, 2025Reported quarterly or annual results39
  6. Aug 12, 2025Reported quarterly or annual results40
  7. May 13, 2025Reported quarterly or annual results41
  8. Mar 3, 2025Reported quarterly or annual results42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

217 filings to the SEC since October 2021: 3 annual reports, 8 quarterly reports, 44 major events, 90 insider forms, 19 large holders, 1 private raises, 52 other. The latest 20:

  1. Oct 13, 2026SCHEDULE 13G EDGAR
  2. Oct 1, 20268-K EDGAR
  3. Sep 24, 20268-K EDGAR
  4. Sep 16, 20264 EDGAR
  5. Sep 11, 20268-K EDGAR
  6. Aug 24, 2026DEF 14A EDGAR
  7. Aug 14, 2026PRE 14A EDGAR
  8. Aug 10, 202610-Q EDGAR
  9. Aug 10, 20268-K EDGAR
  10. Jul 15, 20268-K EDGAR
  11. Jun 15, 20264 EDGAR
  12. Jun 11, 20268-K EDGAR
  13. Jun 11, 20264 EDGAR
  14. Jun 11, 20264 EDGAR
  15. Jun 11, 20264 EDGAR
  16. Jun 11, 20264 EDGAR
  17. Jun 11, 20264 EDGAR
  18. Jun 11, 20264 EDGAR
  19. Jun 11, 20264 EDGAR
  20. Jun 11, 20264 EDGAR

The 217 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

23 open-market trades by officers, directors and large owners since October 2021: 16 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 14, 2026BRADLEY WILLIAMDirectorBuy64,516$0.62$40.0KForm 4
Jun 12, 2026Royan AjayDirectorBuy23,000$0.85$19.6KForm 4
Jun 10, 2026BRADLEY WILLIAMDirectorBuy68,493$0.73$50.0KForm 4
Jun 10, 2026Sheffield IanDirectorBuy35,000$0.73$25.6KForm 4
Jun 10, 2026Rajagopalan HarithChief Executive OfficerBuy25,000$0.73$18.2KForm 4
Jun 8, 2026Smith Weber LaraChief Financial OfficerBuy20,000$0.69$13.8KForm 4
Dec 4, 2025Rajagopalan HarithChief Executive OfficerBuy10,416$1.92$20.0KForm 4
Mar 14, 2025Royan AjayDirectorBuy17,901$1.28$22.9KForm 4
Mar 14, 2025Barnes Kelly AnnDirectorBuy31,000$1.30$40.3KForm 4
Mar 13, 2025SCHULMAN AMY WDirectorBuy8,550$1.17$10.0KForm 4
Mar 13, 2025BRADLEY WILLIAMDirectorBuy16,129$1.26$20.3KForm 4
Mar 13, 2025Conaway SamuelDirectorBuy8,550$1.17$10.0KForm 4
Jan 31, 2025Rajagopalan HarithChief Executive OfficerSale90,972$1.82$165.6KForm 4
Jan 31, 2025Caplan Jay DavidPresident, Chief Product Off.Sale22,346$1.81$40.4KForm 4
Jan 30, 2025Rajagopalan HarithChief Executive OfficerSale20,948$1.95$40.8KForm 4
Jan 30, 2025Caplan Jay DavidPresident, Chief Product Off.Sale21,472$1.95$41.9KForm 4
Nov 11, 2024Rajagopalan HarithChief Executive OfficerSale96,517$2.47$238.4KForm 4
Nov 11, 2024Caplan Jay DavidPresident, Chief Product Off.Sale64,197$2.47$158.6KForm 4
Sep 12, 2024Caplan Jay DavidPresident, Chief Product Off.Sale65,000$2.90$188.5KForm 4
Feb 6, 2024Royan AjayDirectorBuy333,333$15.00$5.0MForm 4

All 23 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$20.1M 2022–2022
Money received by yearMoney received by year, 2022–2022: $20.1M in all. Private raises (Form D) $20.1M.$0$10M$20M$30M2022 · Private raises (Form D): $20.1M2022
Figures by year
YearPrivate raises (Form D)Total
2022$20.1M$20.1M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jan 11, 2022Raised $20.1 million in a private offering of debt24 Form D: 4 investors so far Form D

SEC filer profile

How Fractyl (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARFRACTYL HEALTH, INC.2
  • CIK0001572616
  • Employer ID (EIN)27-35534774
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address3 Van De Graaff Drive, Suite 200, Burlington, MA 018032
  • Phone781-902-88002
  • Shares outstanding159,179,848 as of Aug 4, 20268
  • Public float$49.6M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceMar 21, 20132
  • Filings225 in all: 4 (63), 8-K (44), 3 (25), 10-Q (8), SCHEDULE 13G/A (8), D (7), SCHEDULE 13G (7), UPLOAD (7)2
    All 33 form types

    DRS/A (6), CORRESP (5), DEF 14A (4), DRSLTR (4), SC 13G (4), 10-K (3), 144 (3), 424B5 (3), ARS (2), D/A (2), DEFA14A (2), EFFECT (2), PRE 14A (2), S-8 (2), SEC STAFF LETTER (2), 3/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), S-1 (1), S-1/A (1), S-3 (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Mar 24, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Aug 24, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.00001 par value per shareGUTSThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Fractyl (United States) names in Item 1A of its 10-K filed Mar 24, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have a limited operating history in developing medical devices and biopharmaceutical products, have not completed any pivotal clinical studies and have no products which have received marketing authorization for commercial sale in the United States, which may make it difficult for you to evaluate our current business and predict our future success and viability.
  • We have incurred significant net losses since inception, we expect to continue to incur significant net losses for the foreseeable future and may never achieve or sustain profitability, and we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
  • We require substantial additional capital or must implement other business strategies to execute our operating plan and continue to operate as a going concern. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • Our estimate as to how long we expect our existing cash and cash equivalents to be able to continue to fund our operating expenses and capital expenditures requirements is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
  • Our Credit Agreement contains restrictive and financial covenants that may limit our operating flexibility.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us.
  • Unfavorable global economic conditions, including any adverse macroeconomic conditions or geopolitical events, including the conflict between Ukraine and Russia, the conflict between Israel and Hamas, the conflict between Iran and the U.S. and recent bank failures affecting the financial services industry, have affected and could further adversely affect our business, financial condition, results of operations or liquidity, either directly or through adverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinical studies.
  • Our ability to utilize our net operating loss carryforwards, research and development tax credit carryforwards, and certain other tax attributes to offset taxable income or taxes may be limited.
  • Risks Related to Development, Regulatory Approval and Commercialization
  • The regulatory approval processes of the FDA, comparable foreign regulatory authorities, and notified bodies is lengthy, time-consuming, and inherently unpredictable, and even if we complete the necessary clinical studies we cannot predict when, or if, we will obtain marketing authorization for any of our product candidates, and any such authorization may be for a more narrow indication than we seek.
  • Clinical studies are expensive, time-consuming, difficult to design and implement, and have an uncertain outcome. Further, we may encounter substantial delays in our clinical studies.
The other 63 risks
  • We currently conduct and may in the future conduct clinical studies for our product candidates outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies.
  • We may not be able to submit IDEs or IDE supplements or comparable documents in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or comparable foreign regulatory authorities may not permit us to proceed.
  • We may not be able to submit INDs or IND amendments with the FDA, CTAs or comparable documents with regulatory bodies in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or other comparable foreign regulatory authorities may not permit us to proceed.
  • Delays or disruptions in regulatory, permit or governmental approval processes may impact our business.
  • Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates may cause serious adverse events or undesirable side effects or have other properties which may cause us to suspend or discontinue clinical studies, delay or prevent regulatory approval or certification, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • In previous clinical studies conducted by third parties involving viral vectors for gene therapy, some participants experienced serious adverse events, including the development of leukemia due to vector-related insertional oncogenesis. If our vectors demonstrate a similar effect, we may be required to halt or delay clinical development of our Rejuva gene therapy candidates or future gene therapy candidates.
  • Although Revita has received Breakthrough Device designation, there can be no guarantee that the designation will benefit the development and regulatory approval process.
  • If healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, if approved, such products will not likely be widely used.
  • Additional time may be required to develop and obtain regulatory approval or certification for our Rejuva gene therapy candidates because we expect them to be regulated as a combination product.
  • Obtaining and maintaining regulatory approval or certification of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval or certification of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval or certification of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • We expect our Rejuva gene therapy candidates will be, and future gene therapy candidates may be, regulated as biological products, or biological product-device combination products, and therefore may be subject to competition sooner than anticipated.
  • Disruptions at the FDA and other government agencies or notified bodies caused by policy changes, new leadership, 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, cleared or approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • A recall of our products, if approved, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
  • If we obtain approval or certification of any of our product candidates, we may be subject to enforcement action if we engage in the off-label promotion of our products.
  • Our current and potential future use of artificial intelligence technologies may not be successful and presents new risks and challenges to our business.
  • Risks Related to Our Business and Strategy
  • We are substantially dependent on the success of our lead product candidate, Revita, and our lead gene therapy product candidate, RJVA-001, in the Rejuva platform. If we are unable to obtain marketing approval or certification for and commercialize any of our current or future product candidates in a timely manner, our business will be harmed.
  • Our long-term prospects depend in part upon discovering, developing and commercializing product candidates, which may fail in development or suffer delays that adversely affect their commercial viability. We intend to identify and develop novel product candidates, which makes it difficult to predict the time, cost and potential success of our current product candidates, and other product candidates we may develop in the future.
  • We may not be able to gain the support of leading hospitals and key thought leaders, or to publish the results of our clinical studies in peer-reviewed journals, which may make it difficult to establish the Revita DMR procedure and/or our Rejuva gene therapy candidates as a standard of care, if approved, and may limit our revenue growth and ability to achieve profitability.
  • We have not yet studied the ability of Revita to be used in repeated procedures. If we are unable to demonstrate the safety and improved glycemic effects of Revita for repeat use, it could have a material adverse effect on the clinical utility and commercial adoption of the device.
  • We have never obtained marketing authorization for a product candidate in the United States and we may be unable to obtain, or may be delayed in obtaining, marketing authorization for any product candidate in the United States.
  • If we are unable to obtain a billing code from the U.S. Department of Health and Human Services so that procedures using Revita, if approved, are covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect on our business, financial condition and operating results.
  • If Revita, our Rejuva gene therapy candidates, or any of our other future product candidates is approved or certified and fail to achieve and sustain sufficient market acceptance, we will not generate expected revenue and our business may be harmed.
  • Our future growth depends on physician awareness and adoption of the Revita DMR procedure.
  • The training required for endoscopists to use Revita could reduce the market acceptance of our products.
  • We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
  • The medical device, obesity and diabetes management and biopharmaceutical markets are highly competitive. We face significant competition, including companies developing endoscopic, duodenum-targeted metabolic interventions that may compete with our product candidates, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.
  • We may not be able to develop new product candidates or enhance the capabilities of our existing product candidates to keep pace with our industry’s rapidly changing technology and customer requirements, which could have a material adverse impact on our revenue, results of operations and business.
  • If the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer.
  • If the quality of our product candidates does not meet the expectations of obesity specialists, diabetologists, gastroenterologists, interventional endoscopists, endocrinologists, PCPs or other referring physicians, or participants, then our brand and reputation could suffer and our business could be adversely impacted.
  • Our sales cycle will be lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
  • The medical community and third-party payors may choose not to use or cover the DMR procedure using Revita or they may require extensive and/or independently performed clinical studies prior to covering or maintaining coverage of the DMR procedure using Revita.
  • We depend on our information technology systems, and any failure of these systems could harm our business.
  • Negative public opinion and increased regulatory scrutiny of gene therapy may damage public perception of the safety of our Rejuva gene therapy candidates, and any of our potential future gene therapy candidates, and adversely affect our ability to conduct our business or obtain regulatory approvals for our Rejuva gene therapy candidates.
  • Risks Relating to Our Dependence on Third Parties
  • We substantially rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct certain aspects of our preclinical studies, and clinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain marketing authorization of or commercialize our product candidates and our business could be substantially harmed.
  • If we decide to establish new collaborations in the future, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may enter into collaborations in the future with third parties for the development and commercialization of product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Risks Related to Manufacturing
  • We contract with third parties for the manufacture and supply of sub-assembly components for Revita and for the materials for our Rejuva gene therapy platform for preclinical studies and our ongoing clinical studies, and expect to continue to do so for additional clinical studies and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • If we or our suppliers fail to comply with the FDA’s good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner.
  • We depend on third-party sole-source suppliers for certain sub-assembly components of Revita, and any interruption in our relationship with such third-party sole-source suppliers may materially adversely affect our business.
  • Changes in methods of our Rejuva gene therapy candidates’ manufacturing or formulation may result in additional costs or delay.
  • Any contamination or interruption in our Rejuva gene therapy candidates’ manufacturing process, shortages of raw materials or failure of our suppliers of plasmids and viruses to manufacture and deliver necessary components could result in delays in our Rejuva gene therapy candidates’ preclinical and clinical development or marketing schedules.
  • If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our product candidates and, as a result, there will be an adverse impact on our business until we are able to secure a new facility.
  • Risks Related to Legal and Regulatory Compliance Matters
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • We are subject to applicable fraud and abuse, transparency, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Healthcare reform initiatives and other administrative and legislative proposals in the United States may adversely affect our business, financial condition, results of operations and cash flows.
  • We may not be able to successfully commercialize our product candidates due to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could make it difficult for us to sell our product candidates profitably.
  • Changes in and actual or perceived failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • We are subject to U.S. and certain foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our business.
  • We are subject to complex and changing laws and regulations, which exposes us to potential liabilities, increased costs and other adverse effects on our business.
  • Damage to our reputation or brand image could adversely affect our sales and results of operations.
  • Risks Related to Our Intellectual Property
  • We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Our commercial success depends significantly on our ability to operate without infringing, misappropriating or otherwise violating the intellectual property rights of third parties.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties in order to develop or market our product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future product candidates and technologies.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may not be sufficient to effectively protect our product candidates and business for an adequate period of time.
  • 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.
  • If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position may be harmed.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.

Legal proceedings

We are not subject to any material legal proceedings. From time to time, we may become party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of business.

The opening of Item 3, Legal Proceedings.4

Sources

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