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STOK on Nasdaq

Stoke Therapeutics, Inc.

In its 2026 annual report the company says: “We are a late-stage clinical company dedicated to addressing the underlying causes of severe diseases by upregulating protein expression with RNA-based medicines. Our first investigational, new medicine in development, zorevunersen (STK-001), is a potential disease modifying medicine that is in late-stage clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy.”4 It is headquartered in Bedford, United States.2 Its shares trade on Nasdaq under the symbol STOK.2

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Last updated Oct 21, 2026.

Overview

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  • TickerSTOK on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersBedford, United States2
  • Incorporated inDE3
  • Business address45 Wiggins Avenue, Bedford, Ma 017303
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300RD25SS2DIJHJ672
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O INCORPORATING SERVICES, LTD., 19901 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 55513682

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We are a late-stage clinical company dedicated to addressing the underlying causes of severe diseases by upregulating protein expression with RNA-based medicines. Using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, we are developing antisense oligonucleotides (“ASOs”) to selectively restore protein levels.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

-11.2%Operating margin5
-3.7%Net margin5
404.5%Revenue growth, 20255
-2.0%Return on equity5
$44.9MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development67¢$137.9M
  • Selling, general and admin33¢$67.1M
  • Interest0¢$9.0K

Out of $184.4M in revenue.5 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending1¢$670.0K
  • Kept or used elsewhere99¢$44.9M

Out of $45.6M of cash from operations.5

Financial statements

Revenue675$184.4M in 2025+1387% since 2022
0$50.0M$100.0M$150.0M$200.0M2022: $12.4M$12.4M20222023: $8.8M$8.8M2023−29%2024: $36.6M$36.6M2024+316%2025: $184.4M$184.4M2025+405%
Operating income8910675-$20.6M in 2025−42% since 2019
-$150.0M-$100.0M-$50.0M02019: -$35.7M-$35.7M20192020: -$53.0M-$53.0M2020+49%2021: -$86.1M-$86.1M2021+62%2022: -$104.4M-$104.4M2022+21%2023: -$114.8M-$114.8M2023+10%2024: -$101.4M-$101.4M2024−12%2025: -$20.6M-$20.6M2025−80%
Net income8910675-$6.9M in 2025−79% since 2019
-$150.0M-$100.0M-$50.0M02019: -$32.3M-$32.3M20192020: -$52.2M-$52.2M2020+62%2021: -$85.8M-$85.8M2021+64%2022: -$101.1M-$101.1M2022+18%2023: -$104.7M-$104.7M2023+4%2024: -$89.0M-$89.0M2024−15%2025: -$6.9M-$6.9M2025−92%

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

Period ending2025-12-312024-12-31
Revenue$184.4M$36.6M
Research and development$137.9M$89.1M
Sales, general and administrative$67.1M$48.8M
Total operating expenses$205.0M$137.9M
Loss from operations-$20.6M-$101.4M
Interest income (expense), net$13.8M$12.6M
Other income (expense), net-$51.0K-$247.0K
Total other income (expense)$13.7M$12.4M
Net loss-$6.9M-$89.0M
Net loss per share, basic-$0.12-$1.65
Net loss per share, diluted-$0.12-$1.65
Weighted-average common shares outstanding, basic59.2M shares54.0M shares
Weighted-average common shares outstanding, diluted59.2M shares54.0M shares
Unrealized gain (loss) on marketable securities$694.0K-$127.0K
Total other comprehensive gain (loss)$694.0K-$127.0K
Comprehensive loss-$6.2M-$89.1M

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Corporate structure

Stoke Therapeutics, Inc. 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 Stoke Therapeutics, Inc.

  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G on Stoke Therapeutics, Inc., latest Sep 30, 2026
  • Lynx1 Capital Management LP Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Aug 14, 2026 (6 filings since Nov 6, 2023)
  • Toronto-Dominion Bank Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Aug 12, 2026 (3 filings since Nov 14, 2025)
  • FMR LLC Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Aug 6, 2026 (8 filings since Feb 9, 2022)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest May 15, 2026 (5 filings since Feb 14, 2022)
  • Redmile Group, LLC Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest May 15, 2026 (6 filings since Feb 14, 2022)
  • Wellington Management Company Filed SCHEDULE 13G on Stoke Therapeutics, Inc., latest May 15, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Mar 27, 2026 (5 filings since Feb 10, 2022)
  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Feb 17, 2026 (2 filings since Nov 14, 2024)
  • Cowen Financial Products LLC Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Nov 14, 2025 (6 filings since Jan 24, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Stoke Therapeutics, Inc., latest Oct 17, 2025 (3 filings since Jul 8, 2024)
  • Skorpios Trust Filed SCHEDULE 13D/A on Stoke Therapeutics, Inc., latest Aug 26, 2025 (6 filings since Apr 18, 2024)
  • Stoke Therapeutics, Inc. Bedford, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Stoke Therapeutics, Inc. 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$13.3M5 Dec 31, 2025$12.8M5 Dec 31, 2024+4.2%
Accumulated depreciation$10.1M5 Dec 31, 2025$8.8M5 Dec 31, 2024+14.7%
Property and equipment, net$3.1M5 Dec 31, 2025$3.9M5 Dec 31, 2024−19.5%
Operating-lease assets (leased space)$3.1M5 Dec 31, 2025$4.3M5 Dec 31, 2024−28.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$84.2M5 Dec 31, 2025$128.0M5 Dec 31, 2024−34.2%
Marketable securities, current$200.4M5 Dec 31, 2025$88.9M5 Dec 31, 2024+125.4%
Marketable securities, non-current$106.3M5 Dec 31, 2025$29.8M5 Dec 31, 2024+256.3%
Debt securities available for sale$306.7M5 Dec 31, 2025$118.7M5 Dec 31, 2024+158.3%

Properties, in its own words

We currently occupy approximately 38,000 square feet of office and laboratory space in Bedford, Massachusetts, under a lease that expires on December 31, 2026. We believe this facility is suitable and adequate for our current operations. In addition, we have access to expanded office and laboratory space to support our anticipated growth. See “Note 14—Subsequent Events” for more information regarding our expanded space.

Item 2 of the 10-K filed Mar 16, 2026.4

Leadership

Who has led Stoke Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Edward M. Kaye Md.2019–2025
  2. Ian F. Smith2025–now

Chair

  1. Arthur Tzianabos2025–now

Chief financial officer

  1. Stephen J. Tulipano2019–2024
  2. Thomas Leggett2024–now

Chief operating officer

  1. Huw M. Nash2019–2024
20202025
Board members and other officers (18)

Former names

  • ASOthera Pharmaceuticals, Inc.Nov 24, 2014 to Nov 24, 20143

Timeline

  1. Sep 25, 20268-K Executive or director change36
  2. Aug 3, 20268-K Results of operations37
  3. Aug 3, 20268-K Other events38
  4. Jun 30, 20268-K Regulation FD disclosure; Other events39
  5. Jun 4, 20268-K Shareholder vote40
  6. May 7, 20268-K Results of operations41
  7. Apr 7, 20268-K Executive or director change; Regulation FD disclosure42
  8. Mar 27, 20268-K Change of auditor43
  9. Mar 3, 20268-K Executive or director change44
  10. Jan 26, 20268-K Entered a material agreement; New debt or obligation45
  11. Jan 12, 20268-K Results of operations; Regulation FD disclosure; Other events46
  12. Dec 5, 20258-K Regulation FD disclosure; Other events47
  13. Mar 20, 2025New chief executive Ian F. Smith becomes CEO13
  14. Jun 18, 2019New chief executive Edward M. Kaye Md. becomes CEO14

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.65) a share, on Nov 4, 2025.48

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results37
  2. May 7, 2026Reported quarterly or annual results41
  3. Jan 12, 2026Reported quarterly or annual results46
  4. Nov 4, 2025Reported quarterly or annual results49
  5. Aug 12, 2025Reported quarterly or annual results50
  6. May 13, 2025Reported quarterly or annual results51
  7. Mar 18, 2025Reported quarterly or annual results52
  8. Nov 5, 2024Reported quarterly or annual results53

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

Filings

439 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 202 insider forms, 57 large holders, 99 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 2026144 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Sep 30, 2026SCHEDULE 13G EDGAR
  5. Sep 25, 20264 EDGAR
  6. Sep 25, 20263 EDGAR
  7. Sep 25, 20268-K EDGAR
  8. Sep 3, 20264 EDGAR
  9. Aug 18, 20264 EDGAR
  10. Aug 18, 20264 EDGAR
  11. Aug 18, 20264 EDGAR
  12. Aug 14, 2026SCHEDULE 13G/A EDGAR
  13. Aug 12, 2026SCHEDULE 13G/A EDGAR
  14. Aug 6, 2026SCHEDULE 13G/A EDGAR
  15. Aug 5, 20264 EDGAR
  16. Aug 3, 2026144 EDGAR
  17. Aug 3, 20268-K EDGAR
  18. Aug 3, 2026424B5 EDGAR
  19. Aug 3, 2026S-8 EDGAR
  20. Aug 3, 202610-Q EDGAR

The 439 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

118 open-market trades by officers, directors and large owners since October 2021: 0 buys and 118 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Ticho BarryCHIEF MEDICAL OFFICERSale5,545$30.67$170.1KForm 4
Aug 18, 2026Allan JonathanGENERAL COUNSEL & CORP SECSale2,861$32.03$91.6KForm 4
Aug 18, 2026Ticho BarryCHIEF MEDICAL OFFICERSale4,767$32.03$152.7KForm 4
Aug 18, 2026Kaye Edward M. MDDirectorSale12,567$32.03$402.6KForm 4
Aug 3, 2026Ticho BarryCHIEF MEDICAL OFFICERSale7,176$29.04$208.4KForm 4
Jul 1, 2026Ticho BarryCHIEF MEDICAL OFFICERSale7,228$32.66$236.1KForm 4
Jun 16, 2026Allan JonathanGENERAL COUNSEL & CORP SECSale1,457$29.95$43.6KForm 4
Jun 1, 2026Ticho BarryCHIEF MEDICAL OFFICERSale1,795$30.58$54.9KForm 4
May 1, 2026Ticho BarryCHIEF MEDICAL OFFICERSale2,243$32.79$73.5KForm 4
Apr 1, 2026Ticho BarryCHIEF MEDICAL OFFICERSale1,838$32.66$60.0KForm 4
Mar 20, 2026Allan JonathanGENERAL COUNSEL & CORP SECSale9,293$33.69$313.1KForm 4
Mar 19, 2026Ticho BarryCHIEF MEDICAL OFFICERSale1,461$29.99$43.8KForm 4
Mar 18, 2026Allan JonathanGENERAL COUNSEL & CORP SECSale4,628$31.34$145.0KForm 4
Mar 18, 2026Ticho BarryCHIEF MEDICAL OFFICERSale6,686$31.34$209.5KForm 4
Mar 18, 2026Leggett ThomasChief Financial OfficerSale2,382$31.34$74.7KForm 4
Mar 18, 2026Hoitt JasonChief Patient OfficerSale1,931$31.34$60.5KForm 4
Mar 17, 2026Allan JonathanGENERAL COUNSEL & CORP SECSale4,267$33.01$140.8KForm 4
Mar 17, 2026Ticho BarryCHIEF MEDICAL OFFICERSale6,164$33.01$203.5KForm 4
Mar 17, 2026Leggett ThomasChief Financial OfficerSale2,196$33.01$72.5KForm 4
Mar 17, 2026Hoitt JasonChief Patient OfficerSale1,781$33.01$58.8KForm 4

All 118 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.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Ian F. SmithChief Executive Officer60$170.6K$27.0M68
2025Edward M. Kaye, M.D.Former Chief Executive Officer76$148.7K$3.2M68
2025Jason HoittChief Patient Officer48$494.4K$2.3M68
2025Thomas LeggettChief Financial Officer49$496.4K$1.8M68
2024Edward M. Kaye, M.D.Former Chief Executive Officer76$650.9K$5.6M68
2024Thomas LeggettChief Financial Officer49$309.5K$4.5M68

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.5,877,357$192.3M0.0%+491,643
Rtw Investments, LP5,623,525$184.0M1.6%No change
Fmr LLC5,313,100$173.8M0.0%−70,566
Lynx1 Capital Management LP4,038,404$132.1M15.3%−725,269
Redmile Group, LLC3,945,920$129.1M8.7%−218,200
Wellington Management Group Llp3,519,301$115.2M0.0%+423,601
Morgan Stanley3,452,795$113.0M0.0%+29,515
Baker Bros. Advisors LP3,336,697$109.2M0.5%No change
Toronto Dominion Bank3,173,258$103.8M0.2%No change
State Street Corp2,852,240$93.3M0.0%+575,728
Vanguard Capital Management LLC2,586,937$84.6M0.0%+231,334
Bvf Inc/il2,547,557$83.4M2.1%No change
Assenagon Asset Management S.A.2,256,776$73.8M0.0%+1,349,761
Siren, L.L.C.1,995,347$65.3M1.3%No change
Deerfield Management Company, L.P.1,823,500$59.7M0.7%No change
Jupiter Topco LLC1,814,408$59.4M0.0%New
Geode Capital Management, LLC1,524,309$49.9M0.0%+202,049
Dimensional Fund Advisors LP1,013,911$33.2M0.0%+23,975
Polar Capital Holdings Plc833,716$27.3M0.1%−298,795
EcoR1 Capital, LLC735,000$24.0M1.2%+635,000
Mpm Bioimpact LLC723,314$23.7M1.4%−43,724
Opaleye Management Inc.700,000$22.9M2.1%No change
Goldman Sachs Group Inc575,344$18.8M0.0%−255,358
Vanguard Portfolio Management LLC566,993$18.6M0.0%+104,311
Baillie Gifford & Co517,275$16.9M0.0%−57,907

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Stoke Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARStoke Therapeutics, Inc.1
  • CIK0001623526
  • Employer ID (EIN)47-11445824
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address45 Wiggins Avenue, Bedford, MA 017301
  • Phone781-430-82001
  • Shares outstanding64,526,242 as of Jul 30, 202612
  • Public float$592.0M as of Jun 30, 20254
  • AuditorKPMG LLP, Boston, MA USA PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceNov 24, 20141
  • Filings627 in all: 4 (275), 8-K (84), 144 (47), 3 (25), SC 13G/A (23), 10-Q (22), SCHEDULE 13G/A (21), SC 13G (12)1
    All 42 form types

    CORRESP (11), S-8 (11), UPLOAD (9), DEF 14A (8), DEFA14A (8), 10-K (7), 424B5 (5), EFFECT (5), SCHEDULE 13G (5), ARS (4), S-3 (4), SC 13D/A (4), SCHEDULE 13D/A (4), 4/A (3), SC TO-I/A (3), D (2), DRS (2), DRSLTR (2), PRE 14A (2), S-1/A (2), S-3ASR (2), SC 13D (2), SEC STAFF LETTER (2), 10-Q/A (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS/A (1), FWP (1), S-1 (1), S-1MEF (1), SC TO-I (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 3, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Sep 25, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareSTOKNasdaq Global Select Market

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Stoke Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 66 risks under these headings, as written.4

  • Risks Related to Product Development and Regulatory Approval
  • If we or our collaborators are unable to develop, obtain regulatory approval for and commercialize zorevunersen (STK-001), STK-002 and our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
  • Success in early preclinical studies or clinical trials may not be indicative of results obtained in later preclinical studies and clinical trials, including in our Dravet syndrome program or our ADOA program.
  • If clinical trials of zorevunersen, STK-002 or any other product candidate that we develop fail to demonstrate safety and efficacy to the satisfaction of FDA or foreign regulatory authorities or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately may be unable to complete, the development and commercialization of such product candidate.
  • Even if we complete the necessary preclinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product candidate and the approval may be for a narrower indication than we seek.
  • Certain of the diseases we seek to treat have low prevalence, and it may be difficult to identify patients with these diseases, which may lead to delays in enrollment for our trials or slower commercial revenue growth if zorevunersen, STK-002 or our future product candidates are approved.
  • We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products.
  • Any product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
  • Our failure or the failure of our collaborators to obtain regulatory approval in international jurisdictions would prevent us or our collaborators from marketing our product candidates outside the United States.
  • Zorevunersen, STK-002 or our future product candidates may cause undesirable and unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences.
  • A Rare Pediatric Disease designation by the FDA does not guarantee that the NDA for the product will qualify for a priority review voucher upon approval, and it does not lead to a faster development or regulatory review process, or increase the likelihood that zorevunersen, STK-002 or our future product candidates will receive marketing approval.
  • A Fast Track Designation by the FDA or any use of the accelerated approval pathway, may not lead to a faster development or regulatory review or approval process, and would not increase the likelihood that zorevunersen, STK-002 or our future product candidates will receive marketing approval.
The other 55 risks
  • A Breakthrough Therapy Designation by the FDA may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that zorevunersen, STK-002 or any of our future product candidates will receive marketing approval.
  • Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • We may be unsuccessful in obtaining Orphan Drug Designation or transfer of designations obtained by others for future product candidates. And, even if we obtain such designation, we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, for zorevunersen, STK-002 or our future product candidates.
  • Disruptions at FDA may slow the time necessary for new products to be reviewed and/or approved, which would adversely affect our business. In addition, there is substantial uncertainty regarding new initiatives under the current administration and how these might impact FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed toward other government agencies. These initiatives could prevent, limit or delay development and regulatory approval of our product candidates, which would adversely affect our business.
  • Our operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Risks Related to Commercialization and Manufacturing
  • The commercial success of our product candidates, including zorevunersen and STK-002, will depend upon their degree of market acceptance by providers, patients, patient advocacy groups, third-party payors and the general medical community.
  • The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • If third parties on which we depend to conduct our planned preclinical studies, any future clinical trials, or manufacturing of our product candidates do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with adverse effects on our business, financial condition, results of operations and prospects.
  • We face significant competition in an environment of rapid technological change and it is possible that our competitors may achieve regulatory approval before us or develop therapies that are more advanced or effective than ours, which may harm our business, financial condition and our ability to successfully market or commercialize zorevunersen, STK-002 and our future product candidates.
  • The manufacture of drugs is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide supply of zorevunersen, STK-002 or our future product candidates for clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients, if approved, could be delayed or stopped.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell zorevunersen, STK-002 and our future product candidates, we may be unable to generate any revenues.
  • 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 have entered into collaborations with Acadia Pharmaceuticals and Biogen and may, in the future, seek to enter into collaborations with other third parties for the discovery, development and commercialization of our product candidates. If our collaborators cease development efforts under our collaboration agreements, or if any of those agreements are terminated, these collaborations may fail to lead to commercial products and we may never receive milestone payments or future royalties under these agreements.
  • We may not be successful in finding strategic collaborators for continuing development of certain of our future product candidates or successfully commercializing or competing in the market for certain indications.
  • Risks Related to our Financial Position
  • We have a history of operating losses, and we may not achieve or sustain profitability. We anticipate that we will continue to incur losses for the foreseeable future. If we fail to obtain additional funding to conduct our planned research and development effort, we could be forced to delay, reduce or eliminate our product development programs or commercial development efforts.
  • We expect that we will need to raise additional funding before we can expect to become profitable from any potential future sales of zorevunersen, STK-002 or our future product candidates. This additional financing may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Our ability to utilize our net operating loss carryforwards may be subject to limitations.
  • U.S. federal income tax reform and changes in other tax laws could adversely affect us.
  • Risks Related to our Intellectual Property
  • Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We depend on intellectual property licensed from third parties, and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated, or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
  • We depend on intellectual property licensed to third parties, and our licensees may not always act in our best interest. If these third parties fail to comply with their obligations under their respective licenses with us, if these licenses are terminated, or if disputes regarding these licenses arise, we could lose significant revenue or rights that are important to our business.
  • Our owned and in-licensed patents and patent applications may not provide sufficient protection of our TANGO platform, our zorevunersen and STK-002 product candidates, and our future product candidates or result in any competitive advantage.
  • Our strategy of obtaining rights to key technologies through in-licenses may not be successful.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • We may be involved in lawsuits to protect or enforce our 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.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Our use of open source software could impose limitations on our ability to commercialize our product candidates.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Obtaining and maintaining our 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.
  • 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 product candidates.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.
  • We are subject to a variety of privacy and data security laws, and our failure to comply with them could harm our business.
  • Risks Related to Employee Matters, Managing Growth and Other Risks Related to our Business
  • We expect to expand our development and regulatory capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We must attract and retain highly skilled employees to succeed.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our internal computer and information systems, or those used by our CROs, CMOs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our development programs.
  • A breakdown or breach of our technology systems could subject us to liability or interrupt the operation of our business.
  • Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
  • Risks Related to Ownership of our Common Stock
  • The market price of our stock may be volatile, and you could lose all or part of your investment.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • The exclusive forum provision in our restated certificate of incorporation may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, or other employees, which may discourage lawsuits with respect to such claims.
  • We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.
  • If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • We may be subject to securities litigation, which is expensive and could divert management attention.

Legal proceedings

From time to time we may be subject to various claims, complaints and legal actions that arise in the normal course of business. We are not presently party to any legal proceedings that, in the opinion of management, the outcome of which could have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputation harm, and other factors. There can be no assurance that future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on our business, financial condition, or results of operations.

The opening of Item 3, Legal Proceedings.4

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