FDMT on Nasdaq

4D Molecular Therapeutics, Inc.

Logo: 4dmoleculartherapeutics.com3

Biotherapeutics company1

In its 2026 annual report the company says: “We are a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with the potential to transform treatment paradigms and provide unprecedented benefits to patients. Our products are developed with customized and evolved adeno-associated virus vectors invented from our proprietary vector discovery platform, Therapeutic Vector Evolution which was designed to generate vectors with properties that overcome the limitations of conventional AAV vectors.”6 It is headquartered in Emeryville, California.1 Its shares trade on Nasdaq under the symbol FDMT.1

Price unavailable

Last updated Oct 21, 2026.

Overview

$85.2MRevenue, fiscal 20254
-$140.1MNet income, fiscal 20254

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  • TickerFDMT on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersEmeryville, California1
  • Website4dmoleculartherapeutics.com
  • Incorporated inDE5
  • Business address5858 Horton Street #455, Emeryville, Ca 946085
  • Filer categoryNon-accelerated filer, Smaller reporting company5
4D Molecular Therapeutics, Inc. image from its website
Image: 4dmoleculartherapeutics.com3

We are a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with the potential to transform treatment paradigms and provide unprecedented benefits to patients. Our products are developed with customized and evolved adeno-associated virus (“AAV”) vectors invented from our proprietary vector discovery platform, Therapeutic Vector Evolution (“TVE”) which was designed to generate vectors with properties that overcome the limitations of conventional AAV vectors. TVE applies the principles of directed evolution in non-human primate (“NHP”) models to select vectors that target tissues of diseases with high unmet need using routine and local routes of administration. We are focused on clinical-stage product candidates in retina and lung utilizing vectors invented with TVE and believe the clinical results to date validate the platform.6 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

-187.2%Operating margin4
-164.4%Net margin4
230194.6%Revenue growth, 20254
-27.7%Return on equity4
-$109.6MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

Japan brought in 100% of the revenue 4D Molecular Therapeutics, Inc. broke down this way in fiscal 2025.

  1. Japan$85.0M4100%
  2. United States$209.0K40%up 465% from 2024
Regions by year
Regions20242025
Japan$0$85.0M
United States$37.0K$209.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Other costs100¢$85.2M

Out of $85.2M in revenue.4 The company lost money this year.

Financial statements

Revenue78910114$85.2M in 2025+1124% since 2019
0$25.0M$50.0M$75.0M$100.0M2019: $7.0M$7.0M20192020: $13.4M$13.4M2020+92%2021: $18.0M$18.0M2021+35%2022: $3.1M$3.1M2022−83%2023: $20.7M$20.7M2023+562%2024: $37.0K$37.0K2024−100%2025: $85.2M$85.2M2025+230195%
Operating income78910114-$159.5M in 2025+214% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$50.8M-$50.8M20192020: -$56.7M-$56.7M2020+12%2021: -$71.3M-$71.3M2021+26%2022: -$110.0M-$110.0M2022+54%2023: -$112.9M-$112.9M2023+3%2024: -$187.8M-$187.8M2024+66%2025: -$159.5M-$159.5M2025−15%
Net income78910114-$140.1M in 2025+184% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$49.3M-$49.3M20192020: -$56.7M-$56.7M2020+15%2021: -$71.3M-$71.3M2021+26%2022: -$107.5M-$107.5M2022+51%2023: -$100.8M-$100.8M2023−6%2024: -$160.9M-$160.9M2024+60%2025: -$140.1M-$140.1M2025−13%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Collaboration and license revenue$85.2M$37.0K
Research and development (includes $1,322 and $1,005 for the years ended December 31, 2025 and 2024, respectively, attributable to related parties)$195.7M$141.3M
General and administrative$49.1M$46.6M
Total operating expenses$244.8M$187.9M
Loss from operations-$159.5M-$187.8M
Interest income$19.5M$27.1M
Other expense, net-$37.0K-$77.0K
Total other income, net$19.4M$27.0M
Net loss-$140.1M-$160.9M
Net loss per share, basic-$2.42-$2.98
Net loss per share, diluted-$2.42-$2.98
Weighted-average shares outstanding used in computing net loss per share, basic57.9M shares53.9M shares
Weighted-average shares outstanding used in computing net loss per share, diluted57.9M shares53.9M shares
Research and development expense, related party$1.3M$1.0M

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Corporate structure

4D Molecular 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 4D Molecular Therapeutics, Inc.

  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest May 15, 2026 (7 filings since Jun 21, 2022)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest May 15, 2026 (7 filings since Jun 5, 2023)
  • State Street Corporation Filed SCHEDULE 13G on 4D Molecular Therapeutics, Inc., latest May 12, 2026
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Apr 7, 2026 (7 filings since Feb 11, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Mar 26, 2026 (3 filings since Nov 4, 2024)
  • Novo Holdings A/S Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Feb 17, 2026 (2 filings since Oct 20, 2025)
  • Goldman Sachs Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Feb 9, 2026 (3 filings since Nov 6, 2024)
  • BlackRock Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Oct 17, 2025 (8 filings since Feb 4, 2022)
  • Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest May 15, 2025 (4 filings since May 15, 2023)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on 4D Molecular Therapeutics, Inc., latest Feb 14, 2025 (6 filings since Nov 4, 2021)
  • VIKING GLOBAL INVESTORS LP Filed SC 13G/A on 4D Molecular Therapeutics, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • David Kirn Filed SC 13G/A on 4D Molecular Therapeutics, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
  • 4D Molecular Therapeutics, Inc. Emeryville, California

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

What it owns

What 4D Molecular 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$36.1M4 Dec 31, 2025$36.1M4 Dec 31, 2024+0.1%
Accumulated depreciation$21.3M4 Dec 31, 2025$16.6M4 Dec 31, 2024+28.3%
Property and equipment, net$14.9M4 Dec 31, 2025$19.5M4 Dec 31, 2024−23.9%
Operating-lease assets (leased space)$18.1M4 Dec 31, 2025$21.1M4 Dec 31, 2024−13.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$60.2M4 Dec 31, 2025$149.3M4 Dec 31, 2024−59.7%
Marketable securities, current$342.4M4 Dec 31, 2025$275.5M4 Dec 31, 2024+24.3%
Marketable securities, non-current$111.4M4 Dec 31, 2025$80.6M4 Dec 31, 2024+38.2%

Properties, in its own words

Our corporate headquarters are located in Emeryville, California, where we lease approximately 91,000 square feet of office, research and development, engineering, laboratory and warehouse space pursuant to lease agreements that expire between August 2026 and December 2030. We believe that our facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Mar 18, 2026.6

Leadership

Who has led 4D Molecular Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (20)

Former names

  • 4D Molecular Therapeutics Inc.Jul 21, 2020 to May 12, 20225
  • 4D Molecular Therapeutics IncAug 13, 2015 to Sep 30, 20195

Timeline

  1. Sep 28, 20268-K Other events39
  2. Aug 13, 20268-K Results of operations40
  3. Jul 20, 20268-K Other events41
  4. Jun 29, 20268-K Entered a material agreement; New debt or obligation42
  5. Jun 22, 20268-K Shareholder vote43
  6. May 7, 20268-K Results of operations44
  7. Mar 30, 20268-K Executive or director change45
  8. Mar 18, 20268-K Results of operations46
  9. Jan 26, 20268-K Unregistered sale of shares47
  10. Jan 7, 20268-K Results of operations; Executive or director change48
  11. Dec 10, 20258-K Other events49
  12. Nov 17, 20258-K Executive or director change50
  13. Dec 2020Went public Listed on NASDAQ1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.01) a share, on Nov 10, 2025.51

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results40
  2. May 7, 2026Reported quarterly or annual results44
  3. Mar 18, 2026Reported quarterly or annual results46
  4. Jan 7, 2026Reported quarterly or annual results48
  5. Nov 10, 2025Reported quarterly or annual results52
  6. Nov 6, 2025Reported quarterly or annual results53
  7. Aug 11, 2025Reported quarterly or annual results54
  8. May 8, 2025Reported quarterly or annual results55

Drug trials and FDA: coming up

  1. Mar 2027Phase 1/2 trial readout expected Phase 1/2 trial of 4D-150 IVT and Aflibercept IVT in Neovascular (Wet) Age-Related Macular Degeneration: primary completion expected Mar 2027 (ClinicalTrials.gov NCT05197270).56
  2. Jun 2027Phase 3 trial readout expected Phase 3 trial of 4D-150 IVT (3E10 vg/eye) and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in Macular Neovascularization Secondary to Age-Related Macular Degeneration: primary completion expected Jun 2027 (ClinicalTrials.gov NCT06864988).57
  3. Jun 2027Phase 2 trial readout expected Phase 2 trial of 4D-710 in Cystic Fibrosis Lung: primary completion expected Jun 2027 (ClinicalTrials.gov NCT05248230).58

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

358 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 59 major events, 136 insider forms, 58 large holders, 85 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Oct 5, 2026144 EDGAR
  3. Sep 28, 20268-K EDGAR
  4. Sep 22, 20264 EDGAR
  5. Sep 16, 20264 EDGAR
  6. Sep 14, 2026144 EDGAR
  7. Sep 3, 20264 EDGAR
  8. Aug 21, 20264 EDGAR
  9. Aug 19, 2026144 EDGAR
  10. Aug 17, 2026144 EDGAR
  11. Aug 17, 20264 EDGAR
  12. Aug 13, 2026144 EDGAR
  13. Aug 13, 202610-Q EDGAR
  14. Aug 13, 20268-K EDGAR
  15. Aug 5, 20264 EDGAR
  16. Aug 4, 2026144 EDGAR
  17. Aug 4, 20264 EDGAR
  18. Aug 3, 2026144 EDGAR
  19. Jul 20, 20268-K EDGAR
  20. Jul 14, 20264 EDGAR

The 358 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

62 open-market trades by officers, directors and large owners since October 2021: 1 buys and 61 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Bizily ScottChief Legal OfficerSale1,635$13.65$22.3KForm 4
Sep 14, 2026Kirn DavidSee RemarksSale58,333$13.90$810.8KForm 4
Sep 1, 2026Bizily ScottChief Legal OfficerSale584$14.00$8.2KForm 4
Aug 19, 2026Kirn DavidSee RemarksSale69,076$15.76$1.1MForm 4
Aug 17, 2026Bizily ScottChief Legal OfficerSale1,635$12.20$19.9KForm 4
Aug 13, 2026Bizily ScottChief Legal OfficerSale1,635$12.00$19.6KForm 4
Aug 4, 2026Kirn DavidSee RemarksSale26,842$10.23$274.6KForm 4
Aug 3, 2026Kirn DavidSee RemarksSale12,415$10.05$124.8KForm 4
Jul 10, 2026Kirn DavidSee RemarksSale15,725$12.03$189.2KForm 4
Jul 9, 2026Kirn DavidSee RemarksSale42,608$12.87$548.4KForm 4
Jun 30, 2026Bizily ScottChief Legal OfficerSale6,566$14.00$91.9KForm 4
Jun 23, 2026Bizily ScottChief Legal OfficerSale9,810$12.00$117.7KForm 4
Jun 22, 2026Kirn DavidSee RemarksSale114,746$10.47$1.2MForm 4
Jun 1, 2026Kirn DavidSee RemarksSale1,922$10.02$19.3KForm 4
Mar 20, 2026Gupta AshooVP, Finance and ControllerSale390$8.61$3.4KForm 4
Dec 20, 2025Gupta AshooVP, Finance and ControllerSale389$8.68$3.4KForm 4
Dec 16, 2025Bizily ScottChief Legal OfficerSale1,635$10.90$17.8KForm 4
Nov 17, 2025Bizily ScottChief Legal OfficerSale1,635$10.59$17.3KForm 4
Oct 24, 2025Bizily ScottChief Legal OfficerSale2,678$12.00$32.1KForm 4
Oct 16, 2025Bizily ScottChief Legal OfficerSale1,635$10.17$16.6KForm 4

All 62 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
2025Kristian HumerChief Financial Officer51$66.0K$4.0M74
2025David Kirn, M.D.President and Chief Executive Officer64$667.3K$2.1M74
2025Fariborz Kamal, Ph.D.Former Chief Operating Officer & President$551.7K$1.4M74
2024David Kirn, M.D.President and Chief Executive Officer64$662.8K$1.0M74
2024Fariborz Kamal, Ph.D.Former Chief Operating Officer & President$546.3K$734.6K74

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
Jupiter Topco LLC5,746,289$76.5M0.0%New
Ra Capital Management, L.P.5,049,779$67.2M0.6%No change
BlackRock, Inc.4,546,059$60.5M0.0%+400,756
Goldman Sachs Group Inc4,258,668$56.6M0.0%+53,230
Novo Holdings A/s3,249,178$43.2M2.5%−401,559
State Street Corp2,911,109$38.7M0.0%+203,234
Bvf Inc/il2,879,289$38.3M1.0%No change
Adage Capital Partners Gp, L.l.c.2,249,203$29.9M0.0%+644,047
Trails Edge Capital Partners, LP2,227,917$29.6M4.7%+925,000
Vanguard Capital Management LLC2,099,055$27.9M0.0%−96,523
Armistice Capital, LLC2,000,000$26.6M0.7%No change
Geode Capital Management, LLC1,128,466$15.0M0.0%+63,121
Bank Of America Corp /de/1,120,674$14.9M0.0%+146,501
Evergreen Quality Fund GP, Ltd.951,474$12.7M0.2%No change
Parkman Healthcare Partners LLC948,184$12.6M1.3%+425,607
Dimensional Fund Advisors LP730,857$9.7M0.0%+208,034
Deutsche Bank Ag\710,942$9.5M0.0%+2,898
Citadel Advisors LLC687,597$9.1M0.0%+423,501
Renaissance Technologies LLC614,573$8.2M0.0%+36,308
Vanguard Portfolio Management LLC579,903$7.7M0.0%+24,074
Diadema Partners LP571,107$7.6M2.9%New
Northern Trust Corp562,929$7.5M0.0%+220,895
Acuta Capital Partners, LLC507,801$6.8M4.7%New
Nuveen, LLC503,071$6.7M0.0%−58,734
Morgan Stanley503,020$6.7M0.0%+157,610

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

SEC filer profile

How 4D Molecular 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 EDGAR4D Molecular Therapeutics, Inc.2
  • CIK0001650648
  • Employer ID (EIN)47-35069946
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address5858 Horton Street #455, Emeryville, CA 946082
  • Phone51050526802
  • Shares outstanding51,051,487 Common Stock shares; 16,935,665 Pre Funded Warrants shares as of Mar 16, 20266
  • Public float$166.5M as of Jun 30, 20256
  • AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceAug 13, 20152
  • Filings438 in all: 4 (141), 8-K (66), SC 13G/A (32), 144 (30), 3 (26), SCHEDULE 13G/A (18), 10-Q (17), SC 13G (14)2
    All 37 form types

    CORRESP (10), S-8 (8), EFFECT (7), UPLOAD (7), 10-K (6), 424B5 (6), DEF 14A (6), DEFA14A (6), S-3 (4), ARS (3), D (3), DRS (3), S-1 (3), SCHEDULE 13G (3), 3/A (2), 424B4 (2), S-1/A (2), SEC STAFF LETTER (2), 144/A (1), 8-A12B (1), CERT (1), DRS/A (1), FWP (1), POS AM (1), POSASR (1), RW (1), S-1MEF (1), S-3ASR (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 28, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks 4D Molecular Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 74 risks under these headings, as written.6

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • We are in the late stages of drug development for our lead program and have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
  • We have had recurring net losses, and we expect to continue to incur significant net losses for the foreseeable future.
  • We will require substantial additional capital to finance our operations. 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.
  • Due to the significant resources required for the development of our product candidates, and depending on our ability to access capital, we must prioritize development of certain product candidates. Moreover, we may expend our limited resources on product candidates that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • Risks Related to the Research, Discovery, Development and Commercialization of Our Product Candidates
  • All of our product candidates are based on a novel AAV genetic medicine technology with which there is limited regulatory and clinical experience to date, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval. Further, the regulatory approval process for novel product candidates such as ours can be more expensive and take longer than for other, better known or extensively studied therapeutic modalities.
  • Adverse public perception or regulatory scrutiny of genetic medicine technology may negatively impact the developmental progress or commercial success of product candidates that we develop alone or with collaborators.
  • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have no products approved for commercial sale, and we have never generated any revenue from product sales, and we may never generate product revenue or be profitable.
  • We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
The other 62 risks
  • The limited number of patients who have the diseases for which many of our product candidates are being studied may make it more difficult for us to enroll or complete clinical trials or may result in findings in our clinical trials that do not reach levels of statistical significance sufficient for marketing approval.
  • Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized or if they will ever be successfully commercialized.
  • Public health crises such as pandemics or similar outbreaks have affected and could continue to seriously and adversely affect our preclinical and clinical trials, business, financial condition and results of operations.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations or policy changes 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.
  • Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, which would prevent, delay or limit the scope of regulatory approval and commercialization, which could seriously harm our business.
  • Interim, “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may not be successful in our efforts to continue to create a pipeline of product candidates or to develop commercially successful products. If we fail to successfully identify and develop additional product candidates, our commercial opportunity may be limited, which could seriously harm our business.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • 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.
  • Even if any product candidates we develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • Risks Related to Manufacturing
  • Gene therapies are novel, complex and difficult to manufacture. We could experience production problems that result in delays in our development or commercialization programs, limit the supply of our products or otherwise seriously harm our business.
  • Delays in obtaining regulatory approval of our manufacturing process or disruptions in our manufacturing process may delay or disrupt our commercialization efforts.
  • Delays in developing our manufacturing capabilities or failure to achieve operating efficiencies from it may require us to devote additional resources and management time to manufacturing operations and may delay our product development timelines.
  • We currently rely and expect to continue to rely on third parties to conduct product manufacturing for certain of our product candidates, and these third parties may not perform satisfactorily.
  • Any contamination in our manufacturing process, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our research studies, preclinical, and clinical development or marketing schedules.
  • We depend on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could seriously harm our business.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • The regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy, expensive, time consuming, and inherently unpredictable. If we are ultimately unable
  • to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • Even if we or our collaborators obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • We have received orphan drug designation for 4D-710 for cystic fibrosis, and we may seek orphan drug designation for certain future product candidates. However, we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • We have received Regenerative Medicine Advanced Therapy ("RMAT") and PRIority MEdicine ("PRIME") designation for 4D-150 for the treatment of wet AMD and RMAT designation for 4D-150 for treatment of DME. We may seek RMAT and PRIME designations for certain future product candidates, however we may not be able to obtain such designations, and there is no guarantee that 4D-150 will experience a faster regulatory review or obtain regulatory approval.
  • We have obtained a rare pediatric disease designation for 4D-710, however, there is no guarantee that FDA approval of 4D-710 will result in issuance of a priority review voucher.
  • If the product candidates that we or our collaborators may develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for such product candidates and seriously harm our business.
  • Enacted and future healthcare legislation or regulation may increase the difficulty and cost for us to obtain marketing approval of and to commercialize our product candidates and may affect the prices we may set.
  • The successful commercialization of any product candidates for which we obtain approval will depend in part on the extent to which governmental authorities, private health insurers, and other third-party payors provide coverage and adequate reimbursement. Failure to obtain or maintain
  • coverage and adequate reimbursement for our product candidates, if any and if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Even if we obtain FDA approval for any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell any products effectively, if approved, or generate product revenue.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties and seriously harm our business.
  • We use and generate materials that may expose us to material liability.
  • Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
  • Risks Related to Our Reliance on Third Parties
  • We expect to rely on third parties to conduct our clinical trials and 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.
  • We may depend on collaborations with third parties for the research, development and commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to realize the market potential of those product candidates.
  • Our reliance on Chinese biotechnology companies may subject us to additional risks.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • The lives of our patents may not be sufficient to effectively protect our product candidates and business.
  • If we do not obtain patent term extension for our product candidates, our business may be seriously harmed.
  • Changes in patent law in the United States or in other countries could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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.
  • If we are unable to protect the confidentiality of our trade secrets, our business would be seriously harmed.
  • Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our product candidates may be dependent on our licensors.
  • If our trademarks and trade names, whether registered in the future or unregistered now, 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 to our competitive advantage.
  • Our existing collaborations and any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.
  • Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may fail to comply with any of our obligations under existing or future agreements pursuant to which we license or have otherwise acquired intellectual property rights or technology, which could result in the loss of rights or technology that are material to our business.
  • Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our products.
  • 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. Further, our issued patents could be found invalid or unenforceable if challenged.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and licenses.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we, our employees or consultants have wrongfully used or disclosed alleged confidential information or trade secrets of their former or concurrent employers or former or current clients.
  • Risks Related to Our Operations
  • We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • If we engage in acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • Our information technology systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches and other disruptions.
  • Business disruptions could seriously harm our business.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • Our business may be affected by the evolving regulatory framework for AI Technologies.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may seriously harm our business.
  • Risks Related to Ownership of Our Common Stock

Legal proceedings

We are not currently a party to any material legal proceedings.

From time to time, the Company may become involved in legal proceedings arising from the ordinary course of its business. If applicable, the Company records a liability for such matters when it believes that it is both probable that a liability may have been incurred, and the amount of the liability can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.6

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