4D Molecular Therapeutics Stock FDMT
4D Molecular Therapeutics is a clinical-stage biotechnology company developing in vivo gene therapies using its proprietary ARCUS genome-editing platform, which is designed to enable precise, single-administration treatments. 4D Molecular Therapeutics stock (FDMT): Quarterly and annual results since 2023 from Quarterly Report and SEC filings: revenue, earnings, balance sheet, cash flow and management guidance, every figure with its source. As of 08/2026, quarterly reporting. Stock analysis by NadirAlpha. 4D Molecular Therapeutics stock (FDMT): listed on Nasdaq. NadirAlpha has evaluated 39 original documents, cross-checked every figure automatically and linked each to its source; sources as of 08/2026. Latest reading: Strategic pivot, Partnership.
AI-generated report · not investment advice · figures extracted automatically; please verify against the linked original more
4D Molecular Therapeutics Current Status
The current state of 4D Molecular Therapeutics at a glance, figures as of Q2 2026, with core figures and the key management statements from the latest filing. NadirAlpha methodology
Assessment by NadirAlpha, as of Q2 2026.
“The second quarter of 2026 reflected continued strong execution across 4DMT, including completion of enrollment for 4FRONT-2, presenting positive long-term PRISM data and strengthening our financial flexibility through securing a strategic credit facility with Hercules. With topline data from both 4FRONT-1 and 4FRONT-2 in wet AMD expected in 2027, our DME Phase 3 expected to initiate in the third quarter and our Investor Day planned in October, we are well positioned to advance 4D-150 as a potential paradigm-changing backbone therapy for patients with wet AMD and DME.”
4D Molecular Therapeutics Stock: Key Figures ($ million)
NadirAlpha shows fiscal years, half-years and quarters of 4D Molecular Therapeutics one below the other, most recently Q2 2026; every figure is clickable and leads to raw value, location and source. NadirAlpha extracts all values automatically from the filings; errors are possible; please verify decision-relevant figures yourself by clicking through to the linked original. NadirAlpha methodology
All figures serve only to support your own investment decision and are not a recommendation; the company's original reports are authoritative.
Fiscal years
| Period | Revenue | Op. income | Net income | EPS ($) | OCF | Source |
|---|---|---|---|---|---|---|
| FY2025 | 85.2 | -159.5 | -140.1 | -2.42 | -109.1 | 26 |
| FY2024 | 0 | -187.8 | -160.9 | -2.98 | -134.6 | 18 |
| FY2023 | 20.7 | -112.9 | -100.8 | -2.58 | -75.8 | 9 |
Quarters
| Period | Published | Revenue | Op. income | Net income | EPS ($) | FCF | Cash | Net Debt | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2026-Q2* | 2026-08-13 | 3.8 | -77 | -72.9 | -1.04 | – | 70.4 | -50.8 | 30 |
| 2026-Q1* | 2026-05-07 | 3 | -73.6 | -68.8 | -1.01 | – | 72.5 | – | 28 |
| 2025-Q4* | 2026-03-18 | 85.1 | 14.7 | 19.4 | 0.34*≈ | – | 60.2 | -60.2 | 26 |
| 2025-Q3* | 2025-11-10 | 0.1 | -61.2 | -56.9 | -1.01 | – | 48.6 | – | 24 |
| 2025-Q2* | 2025-08-11 | 0 | -59.5 | -54.7 | -0.98 | -43.4 | 77.2 | – | 22 |
| 2025-Q1* | 2025-05-08 | 0 | -53.6 | -48 | -0.86 | -48.4 | 133.5 | – | 20 |
| 2024-Q4* | 2025-01-10 | 0 | -56.1 | -49.7 | -0.92*≈ | -46.8 | 149.3 | – | 17 |
| 2024-Q3* | 2024-11-13 | 0 | -51.1 | -43.8 | -0.79 | -31.2 | 187.5 | – | 15 |
| 2024-Q2* | 2024-08-08 | 0 | -42.5 | -35 | -0.63 | -30.6 | 189.1 | – | 13 |
| 2024-Q1* | 2024-05-09 | 0 | -38.1 | -32.4 | -0.66 | -29.8 | 275.6 | – | 11 |
| 2023-Q4* | 2024-02-29 | – | -36.7 | -32.3 | -0.83*≈ | -25.2 | 249.1 | – | 9 |
| 2023-Q3* | 2023-11-09 | 20.2 | -14 | -10.3 | -0.24 | -1.6 | 275.7 | – | 7 |
| 2023-Q2* | 2023-08-09 | 0.2 | -32.1 | -29.6 | -0.77 | -22.9 | 236.3 | – | 5 |
| 2023-Q1* | 2023-05-11 | 0.3 | -30.1 | -28.7 | -0.88 | -28.9 | 78.6 | – | 3 |
4D Molecular Therapeutics Balance Sheet & Cash Flow ($ million)
Balance sheet and cash flow of 4D Molecular Therapeutics up to Q2 2026 in $ million: net debt = financial debt minus cash, free cash flow = operating cash flow minus capex, every input sourced. NadirAlpha extracts all values automatically from the filings; errors are possible; please verify decision-relevant figures yourself by clicking through to the linked original. NadirAlpha methodology
Fiscal years
| Period | Published | Cash | Debt | Net Debt | D&A | OCF | Capex | FCF | Source |
|---|---|---|---|---|---|---|---|---|---|
| FY2025 | 2026-03-18 | 60.2 | 0 | -60.2 | 4.7 | -109.1 | 0.5 | -109.6 | 26 |
| FY2024 | 2025-02-28 | 149.3 | – | – | 4.7 | -134.6 | 3.8 | -138.4 | 18 |
| FY2023 | 2024-02-29 | 249.1 | – | – | 4.2 | -75.8 | 2.8 | -78.6 | 9 |
Quarters
| Period | Published | Cash | Debt | Net Debt | D&A | OCF | Capex | FCF | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2026-Q2 | 2026-08-13 | 70.4 | 19.6 | -50.8 | 1.3 | -70 | – | – | 30 |
| 2026-Q1 | 2026-05-07 | 72.5 | – | – | 1.3 | -68.1 | – | – | 28 |
| 2025-Q4 | 2026-03-18 | 60.2 | 0 | -60.2 | 1.2 | 28.6 | – | – | 26 |
| 2025-Q3 | 2025-11-10 | 48.6 | – | – | 1.3 | -46.5 | – | – | 24 |
| 2025-Q2 | 2025-08-11 | 77.2 | – | – | 1.2 | -43.4 | 0.1 | -43.4 | 22 |
| 2025-Q1 | 2025-05-08 | 133.5 | – | – | 1.1 | -47.8 | 0.6 | -48.4 | 20 |
| 2024-Q4 | 2025-02-28 | 149.3 | – | – | 1.1 | -45.9 | 0.9 | -46.8 | 18 |
| 2024-Q3 | 2024-11-13 | 187.5 | – | – | 1.2 | -29.4 | 1.8 | -31.2 | 15 |
| 2024-Q2 | 2024-08-08 | 189.1 | – | – | 1.2 | -30.2 | 0.3 | -30.6 | 13 |
| 2024-Q1 | 2024-05-09 | 275.6 | – | – | 1.2 | -29.1 | 0.7 | -29.8 | 11 |
| 2023-Q4 | 2024-02-29 | 249.1 | – | – | 1.1 | -24.6 | 0.5 | -25.2 | 9 |
| 2023-Q3 | 2023-11-09 | 275.7 | – | – | 1 | -1.2 | 0.4 | -1.6 | 7 |
| 2023-Q2 | 2023-08-09 | 236.3 | – | – | 1.1 | -22.1 | 0.8 | -22.9 | 5 |
| 2023-Q1 | 2023-05-11 | 78.6 | – | – | 1 | -27.9 | 1 | -28.9 | 3 |
4D Molecular Therapeutics Guidance Tracking (latest per metric/period · 7/12)
What 4D Molecular Therapeutics guided for Q2 2026 and beyond and whether the targets were met; ranges count as met when the actual lies within. NadirAlpha methodology
Direction: confirmedinitiated Verdict: pending
| For period | Guided on | Metric | Guided | Verdict | Direction | Source |
|---|---|---|---|---|---|---|
| 2027-H1 | 2024-08-08 | Cash and cash equivalents funding runway | 578 | 14 | ||
| 2026-H1 | 2023-08-09 | Cash runway | 310 | 6 | ||
| 2025-Q1 | 2024-05-09 | 4D-150 Phase 3 initiation | 1 | – | 12 | |
| 2025-Q1 | 2024-02-29 | 4D-150 Phase 3 initiation for Wet AMD | 1 | – | 10 | |
| 2025-H2 | 2024-05-09 | 4D-710 Phase 3 pivotal trial initiation | 2 | 12 | ||
| 2024-H2 | 2024-02-29 | 4D-175 Phase 1 initiation | 2 | 12 | ||
| 2024-H2 | 2024-02-29 | 4D-150 DME SPECTRA initial interim 24-week landmark data | 2 | 10 | ||
| 2024-Q3 | 2024-02-29 | 4D-150 PRISM Population Extension initial interim 24-week landmark analysis | 3 | – | 10 | |
| 2024-Q3 | 2024-02-29 | 4D-150 Phase 3 regulatory interactions update | 3 | – | 10 | |
| 2024-Q2 | 2024-02-29 | 4D-175 IND filing | 2 | – | 12 | |
| 2024-Q2 | 2024-02-29 | 4D-310 FDA submission of preclinical NHP safety data | 2 | – | 10 | |
| 2024-Q1 | 2024-02-29 | 4D-710 CF FDA feedback update | 1 | – | 10 |
4D Molecular Therapeutics Stock: Price & Chart
Price history of 4D Molecular Therapeutics stock (FDMT) as a TradingView chart, loaded only after a click, alongside the trend of the key figures from the tables. NadirAlpha methodology
Daily candles with news and earnings markers. Loads only on click.
4D Molecular Therapeutics Event Timeline
What happened at 4D Molecular Therapeutics since 2023: events from the filings, grouped by quarter, with the source date and a clickable source number. NadirAlpha methodology
2026 · 9 events
Entered credit facility with Hercules Capital for up to $200 million; initial $20 million draw at closing in June 2026 30 31
Positive 2-year 4D-150 PRISM Phase 2b data presented at ASRS, demonstrating long-term treatment effect and favorable safety profile 31
“We started 2026 with strong execution, completing enrollment in 4FRONT-1 ahead of schedule reflecting strong investigator and patient enthusiasm for 4D-150. For the remainder of the year, we look forward to completing 4FRONT-2 enrollment, initiating our global Phase 3 clinical trial in DME, and sharing 2-year data from PRISM and SPECTRA.”
Net loss widened to 68.8 million from $48.0 million in Q1 2025, reflecting higher Phase 3 R&D costs 29
Collaboration revenue rose to 3 million from $0.014 million in Q1 2025, driven by Otsuka clinical trial cost-sharing 29
4FRONT-1 Phase 3 enrollment completed ahead of schedule; 523 patients randomized in March 2026, topline data expected H1 2027 29
Net loss decreased to $140.1 million in FY2025 from $160.9 million in FY2024; Q4 net income was $19.4 million, reflecting Otsuka upfront revenue recognition offsetting ongoing R&D spend 26 27
2025 · 12 events
Operating income turned positive for the first time after 23 negative periods (-61.2 to +USD 14.7 million). 26
Net income turned positive for the first time after 23 negative periods (-56.9 to +USD 19.4 million). 26
EBITDA turned positive for the first time after 23 negative periods (-59.9 to +USD 15.9 million). 26
“In the third quarter, we made meaningful progress building upon and validating our business strategy focusing on 4D-150 and 4D-710. Our recently announced partnership with Otsuka, new data on 4D-150 in wet age-related macular degeneration, equity investment from the Cystic Fibrosis Foundation for advancement of 4D-710 and strengthened balance sheet position us well, with cash runway into 2H 2028, beyond primary readout for our two ongoing 4D-150 4FRONT Phase 3 trials in wet AMD, and provides for indication expansion in diabetic macular edema.”
Entered collaboration and license agreement with Otsuka Pharmaceutical for exclusive rights to develop and commercialize 4D-150 in APAC region, receiving $85 million upfront with up to $336 million in potential regulatory and commercial milestones 25
Cystic Fibrosis Foundation committed up to $11 million equity investment to accelerate 4D-710 into Phase 2; 4FRONT-1 exceeded 200 patients randomized and remained on track to complete enrollment in Q1 2026 25
“During the past quarter, we advanced our 4D-150 program and streamlined operations to focus on late-stage execution. Rapid enrollment in 4FRONT-1 has enabled us to accelerate the topline data expectation to the first half of 2027, and we initiated 4FRONT-2 ahead of schedule. These updates reflect strong team execution and continued enthusiasm from investigators and patients for 4D-150 as a potential genetic medicine backbone therapy in wet AMD. We also aligned our organization around key priorities for 4D-150 in wet AMD: completing Phase 3, filing a BLA, and preparing for potential commercialization. In parallel, we reported positive 60-week data from the SPECTRA trial in DME, which continues to support favorable tolerability, sustained durability, and meaningful treatment burden reduction. We are pleased to now be aligned with both FDA and European Medicines Agency (EMA) that a single successful Phase 3 study could support approval in the U.S. and Europe.”
4FRONT-2 Phase 3 wet AMD trial initiated in June 2025 ahead of schedule; 4FRONT-1 topline data readout accelerated to H1 2027 due to enrollment pace exceeding projections 23
Workforce reduction of approximately 25% announced, primarily affecting early-stage research and support functions, to concentrate resources on late-stage execution 23
“We look forward to sharing data and programmatic updates in H2 2025 for both our 4D-150 program in wet AMD and DME and our 4D-710 program in cystic fibrosis lung disease.”
“2024 was a landmark year for 4DMT, driven by groundbreaking clinical advancements toward Phase 3 trials that position us for even greater success in 2025 and beyond. The data from the PRISM and SPECTRA clinical trials have highlighted 4D-150's potential to become the first backbone therapy for retinal vascular diseases by providing patients and physicians with long-lasting and continuous disease control, plus freedom from frequent bolus injections. 4D-150's target product profile is designed to allow for seamless adoption into retina clinic practices and for pricing flexibility augmented by our low cost of goods. With the imminent start of our Phase 3 studies for 4D-150 in wet AMD, our team, investigators and clinical sites are energized to rapidly recruit patients to deliver topline results in the second half of 2027. We believe rapid enrollment in 4D-150 Phase 3 studies that mirror enrollment rates seen in our Phase 1/2 studies would validate the potential for future widespread adoption of 4D-150 in retina clinics, strengthening our path toward transforming the retinal vascular disease treatment paradigm.”
Pipeline refocused on 4D-150 and 4D-710: 4D-110 and 4D-125 terminated, 4D-175, 4D-725, and 4D-310 paused; first patients enrolled in 4FRONT-1 Phase 3 wet AMD trial across over 50 sites 21
FDA granted RMAT designation for 4D-150 in DME, adding to existing RMAT designation for wet AMD and EMA PRIME designation for wet AMD 21
FY2024 net loss $160.9M vs. $100.8M in 2023; R&D expenses up 46% to $141.3M on expanded 4D-150 clinical trial activity; accumulated deficit reached $576.2M (18, 19)
4FRONT Phase 3 program announced: two multicenter, randomized, double-masked studies; 4FRONT-1 initiation March 2025, 4FRONT-2 in Q3 2025; 52-week topline data expected H2 2027 (18, 19)
January 2025 pipeline prioritization: development focused on 4D-150 and 4D-710; investment paused in 4D-175, 4D-725, and 4D-310; 4D-110 and 4D-125 terminated (19)
2024 · 11 events
FDA alignment achieved: single Phase 3 trial acceptable as BLA submission basis for 4D-150 in DME, based on interim SPECTRA and PRISM data review (17)
4D-150 SPECTRA 3E10 vg/eye dose: sustained BCVA gain of +8.4 letters and CST reduction of -194 µm at 32 weeks in DME; 86% injection burden reduction vs. projected on-label aflibercept 2mg Q8W; selected as Phase 3 dose (17)
“Throughout 2024, 4DMT has generated compelling Phase 1/2 data and executed on Phase 3 preparations for 4D-150 in wet AMD in support of our mission to bring transformative genetic medicines to patients globally. We have built an experienced clinical and commercial team to execute this mission, including with the upcoming initiation of the 4FRONT Phase 3 program expected in Q1 2025. In September, we hosted our 4D-150 Wet AMD Development Day, where we presented positive interim data demonstrating the impressive tolerability and clinical activity of 4D-150 and showcased its potential across multiple populations, from the most severe to recently diagnosed patients. The strong data and enthusiastic feedback from our advisors, clinical trial investigators, the retina physician community and the FDA support pivotal development of 4D-150 in the treatment naïve wet AMD population. We believe that these clinical data and this trial design will enable rapid enrollment and achieve positive topline data in the 4FRONT Phase 3 studies.”
Net loss widened to $43.8M from $10.3M in Q3 2023; R&D expenses up 54% to $38.5M driven by 4D-150 clinical trial activity and higher headcount (15, 16)
Collaboration and license revenue fell from $20.2M in Q3 2023 to $3 thousand in Q3 2024; decline driven entirely by prior-year AGT $20.0M upfront fee base effect recognized in 2023, not by operational change (15)
Positive 52-week interim 4D-150 PRISM data: 83% injection burden reduction in severe wet AMD population; IOI profile numerically similar to approved agents; 4FRONT Phase 3 initiation expected Q1 2025 (16)
“4DMT continues to drive strong progress and execution toward our goal of becoming a leading late-stage genetic medicines company. We are excited to bolster our senior leadership team with clinical and commercial experts and honored to welcome world-renowned retinal disease experts to our Ophthalmology Advisory Board, which will support our strategy to be a leader in large market ophthalmology indications. At our inaugural 4D-150 Development Day in September 2024, we plan to report on the durability of 4D-150 by presenting the longest available follow-up data from the Phase 2 PRISM study in wet AMD patients who have been followed through up to 2.5 years and discuss the final wet AMD Phase 3 clinical trial design.”
Positive interim PRISM Phase 2 Population Extension results for 4D-150 in wet AMD: 89% annualized injection rate reduction in 30 patients at planned Phase 3 dose, 77% injection-free (14)
FDA removed clinical hold on Phase 1/2 INGLAXA trial for 4D-310 in Fabry disease cardiomyopathy; enrollment expected to resume in H2 2024 (13)
4D-175 received FDA clearance of IND application for Geographic Atrophy indication (14)
“The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases. With robust clinical activity from 4D-150 demonstrated in our initial interim 24-week results from the Phase 2 PRISM Dose Expansion cohort in the severe disease activity wet AMD patient population, we set the stage for additional important data readouts in 2024, including 24-week results from the Phase 2 PRISM Population Extension cohort in the broader wet AMD patient population expected to be announced at ASRS in July and 24-week results from the Phase 2 SPECTRA Dose Confirmation cohort in DME expected to be announced in the fourth quarter. We believe the emerging profile of 4D-150 shows its potential to be the best-in-class, long-acting genetic medicine for broad market use in VEGF-driven retinal diseases, and we look forward to completing alignment with the FDA and EMA to rapidly advance 4D-150 into its first pivotal trial for global development. Building on the success of intravitreal R100, we are also encouraged by the preclinical results from 4D-175 that we shared today at the 2024 Association for Research in Vision and Ophthalmology (ARVO) Annual Scientific Meeting and are looking forward to bringing the program into the clinic for treatment of geographic atrophy in the second half of the year, demonstrating the power of our modular vectors and product engine. In addition, we continue to advance towards important milestones for 4D-710 for cystic fibrosis, 4D-725 for A1AT deficiency and 4D-310 for Fabry disease cardiomyopathy. Our successful financing puts us in a strong position to execute on all our corporate objectives, with expected cash runway into the first half of 2027.”
Net loss deepened to $32.4M from $28.7M in Q1 2023; R&D expenses up 24% to $27.9M driven by 4D-150 clinical trial costs and increased headcount (12)
February 2024 public offering completed: approximately $316M net proceeds raised; cash expected to fund operations into H1 2027 (12)
Positive interim PRISM Phase 2 Dose Expansion data for 4D-150 in wet AMD enabled Phase 3 advancement planned by Q1 2025; 89% injection burden reduction and 63% injection-free at 24 weeks in high-dose cohort (12)
2023 · 11 events
“2023 was a transformative year for 4DMT with incredible progress across our product pipeline and platform in multiple therapeutic areas, especially for our lead program 4D-150 in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Robust enrollment ahead of schedule across multiple cohorts in the PRISM clinical trial of patients with wet AMD and the SPECTRA clinical trial of patients with DME have set the stage for multiple important data readouts in 2024, starting with our recent positive interim data at Angiogenesis, Exudation, and Degeneration 2024 Conference in the hardest-to-treat wet AMD patients. As of the most recent data update, 110 patients have been dosed with 4D-150 with no clinically significant inflammation, which continues to build on the emerging profile of 4D-150 as a potentially best-in-class long-acting genetic medicine with the opportunity for broad market adoption. We look forward to further updates in the broad wet AMD population and DME patients in the second half of 2024, setting the stage for our first Phase 3 clinical trial in wet AMD currently expected to initiate in the first quarter of 2025. We also look forward to providing updates on other key programs beyond 4D-150 in 2024, including 4D-175 for geographic atrophy, 4D-710 for cystic fibrosis and 4D-310 for Fabry disease cardiomyopathy. Our recent financing and resulting cash position allows us to execute on our vision of becoming a fully integrated, next-generation genetic medicines company.”
Co-development and co-commercialization agreement with Arbor Biotechnologies executed December 2023 for up to six CNS-targeting AAV-delivered CRISPR/Cas product candidates on a 50-50 cost-and-profit-sharing basis (9)
Phase 2 PRISM randomized Dose Expansion interim data for 4D-150 in wet AMD with severe disease activity supported Phase 3 pivotal development expected Q1 2025; RMAT designation received enabling increased FDA collaboration on regulatory planning (10)
“The third quarter of 2023 was another period of tremendous progress across our large market product candidate portfolio. In our ophthalmology portfolio, the European Medicines Agency has awarded PRIME designation to intravitreal 4D-150 which validates the promising clinical data to date in wet AMD patients. We also enrolled the first patient in the Population Extension cohort to the PRISM clinical trial to include the broader wet AMD patient population with lower anti-VEGF need. In our pulmonology portfolio, we presented positive interim clinical and lung biopsy biomarker data for 4D-710 in the Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease, and we selected a dose to move forward into Phase 2. We remain highly focused in executing our corporate objectives and look forward to sharing multiple key clinical and regulatory milestones over the next few months.”
Collaboration and license revenue increased to $20.2M in Q3 2023 from $0.5M in Q3 2022, driven by the one-time $20.0M Astellas upfront payment (8)
Licensing agreement with Astellas Gene Therapies for intravitreal R100 vector: $20.0M upfront payment and potential future milestone payments up to $942.5M (7)
EMA granted PRIME designation for 4D-150 in wet AMD; FDA alignment reached on plan to address clinical hold on 4D-310 for Fabry disease cardiomyopathy via protocol amendments and immunosuppressive regimen (8)
“We are excited by the significant progress we have made across our large market product candidate portfolio in the second quarter. In ophthalmology, we presented positive interim clinical data from the Dose Exploration stage of our Phase 1/2 PRISM clinical trial of 4D-150, which demonstrated excellent tolerability, clinical activity and initial long term durability in high anti-VEGF need patients that we believe support an emerging best-in-class profile. In pulmonology, we presented positive interim clinical data from cohort 1 from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease, demonstrating widespread and high-level CFTR transgene expression and initial clinical activity in a population who otherwise have no disease-modifying treatment options. Lastly, we continue to execute on business development, including the collaboration with Astellas in July, demonstrating the value of our clinically de-risked customized and evolved vectors for delivery of genetic medicine payloads. Our focus remains on relentlessly executing on our corporate objectives and look forward to sharing multiple key clinical and regulatory milestones over the next 12 months. Our strong cash position and capital-efficient operations continue to provide the foundation for long-term value creation.”
May 2023 public offering closed: 8,625,000 shares at $16.00 per share, net proceeds approximately $129M; cash and marketable securities increased to $310M at June 30, 2023 (5, 6)
Acquired worldwide rights to short-form complement factor H (sCFH) from Aevitas Therapeutics in April 2023, designated as payload for 4D-175 geographic atrophy candidate (6)
Positive Phase 1/2 AEROW interim data for 4D-710 in cystic fibrosis lung disease: widespread CFTR transgene protein expression demonstrated in lung biopsy biomarkers, no post-dosing adverse events (5)
“We are pleased with the progress of our large market ophthalmology portfolio this year. In April at ARVO, we released positive interim clinical data on all three dose cohorts in the Dose Exploration stage of our Phase 1/2 PRISM clinical trial of 4D-150 for the treatment of wet AMD. We observed excellent tolerability and clinical activity in these high anti-VEGF need patients that we believe support a differentiated profile. We are excited to see faster than expected enrollment of the Phase 2 Dose Expansion stage of the PRISM trial and believe this highlights the belief by investigators that 4D-150 has potential to be a transformative treatment for patients with wet AMD. We also announced the acquisition of the rights and know-how for sCFH from Aevitas for use in our preclinical product candidate 4D-175 for treatment of GA. We believe we have the opportunity to build a franchise in large market ophthalmology with 4D-150 for the treatment of wet AMD and diabetic macular edema (DME) and 4D-175 in for GA, each using our retinotropic vector R100. Our capital-efficient operations and strong cash position are expected to support operations into the first half of 2026.”
Net loss widened to $28.7M from $26.3M in Q1 2022 as R&D expenses rose 16% to $22.4M on higher headcount and clinical trial costs (3)
Positive Phase 1/2 PRISM interim data for 4D-150 in wet AMD: all three dose cohorts well-tolerated; 100% of Phase 2 BCVA-eligible patients at highest dose injection-free at 36 weeks (4)
4D Molecular Therapeutics Business Model
How 4D Molecular Therapeutics (FDMT) makes its money, summarised from the filings up to Q2 2026, neutral and without forecast. NadirAlpha methodology
4D Molecular Therapeutics is a clinical-stage biotechnology company developing in vivo gene therapies using its proprietary ARCUS genome-editing platform, which is designed to enable precise, single-administration treatments. Its lead program, 4D-150, is an investigational gene therapy for wet age-related macular degeneration and diabetic macular edema currently advancing through Phase 3 clinical trials; additional pipeline programs address other ocular and pulmonary conditions. 4D Molecular Therapeutics has no products approved for commercial sale and generates revenue solely from collaboration and license agreements, primarily cost-sharing and reimbursement arrangements with its partner Otsuka, while funding operations through equity and, as of June 2026, debt financing via a Hercules Capital credit facility providing up to $200 million in term loans.
4D Molecular Therapeutics Stock: Share-Price Drivers
The drivers of 4D Molecular Therapeutics stock from the company's perspective: demand, prices, costs and capacity as the investor relations reports describe them. NadirAlpha methodology
4D-150 is the company's most advanced asset, now running the 4FRONT-1 and 4FRONT-2 Phase 3 pivotal trials with 52-week primary-endpoint topline data guided for H2 2027; as a pre-commercial clinical-stage company (Q2 2026 revenue of only 3.8 million against an operating loss of 77 million), the share price is driven by these clinical read-outs rather than product sales 26 31
4FRONT-1 Phase 3 initiated around Q1 2025 and 4FRONT-2 Phase 3 subsequently initiated, with 52-week topline data guided for H2 2027; this is the lead value driver 26 19 31
Strategic partnership around Q4 2025 provides external validation and funding for 4D-150; reported revenue was materially higher at 85.1 million in Q4 2025 before falling back toward 3.8 million in Q2 2026 27
AEROW interim data and program update guided as a pipeline catalyst; traction depends on the clinical read-out 16 23
Several earlier-stage programs continue with periodic program updates, diversifying the pipeline beyond 4D-150 16 19
Cash declined to 70.4 million at Q2 2026 from 133.5 million a year earlier amid a quarterly operating cash outflow of 70 million; the company has repeatedly raised equity (2021 and 2023 offerings, ATM program), so financing/dilution remains a factor 3
Sector trend: In ophthalmology gene therapy the central demand driver is longer-acting, lower-burden alternatives to frequent anti-VEGF injections for wet AMD and DME, where durability and reduced treatment frequency are the key KPIs; 4DMT is positioning 4D-150 toward this trend through its Phase 3 program, while all programs remain pre-revenue and loss-making 26 31
4D Molecular Therapeutics Products & announcements (42/111 active+recent)
What 4D Molecular Therapeutics launched, had approved or announced, from the filings up to Q2 2026, each row with the date of first mention. NadirAlpha methodology
Status: PlannedLaunchedDiscontinuedStable
| Product/Line | Since | Status | Source |
|---|---|---|---|
| 2027 | |||
| Primary endpoint 52-week topline data from 4FRONT-2 (2x) | 2027-12 | 19 | |
| 4FRONT-2 Phase 3 topline data (4x) | 2027-12 | 31 | |
| 2026 | |||
| SPECTRA DME trial 2-year data (2x) | 2026-12 | 29 | |
| Investor Day | 2026-10 | 31 | |
| PRISM Phase 2b 2-year data presentation | 2026-09 | 29 | |
| 4D-150 Phase 3 DME trial initiation | 2026-09 | 26 | |
| 4D-150 Global Phase 3 trial in DME initiation | 2026-09 | 29 | |
| 4D-150 DME Phase 3 initiation | 2026-09 | 31 | |
| 4FRONT-1 Phase 3 enrollment (4x) | 2026-02 | 29 | |
| 2025 | |||
| PRISM 2-year and 18-month data | 2025-12 | 23 | |
| Equity offering completed | 2025-12 | 25 | |
| 4D-710 for CF Lung Disease Phase 3 initiation | 2025-12 | 14 | |
| 4D-710 Phase 3 pivotal trial initiation | 2025-12 | 12 | |
| 2-year data from Phase 1/2a PRISM cohorts (2x) | 2025-12 | 19 | |
| CFF investment in common stock | 2025-10 | 26 | |
| 52-week interim data update from SPECTRA Part 1 | 2025-09 | 19 | |
| 4FRONT-2 Phase 3 trial (4D-150 in wet AMD) initiation | 2025-09 | 21 | |
| 4FRONT-2 Phase 3 clinical trial initiation | 2025-09 | 19 | |
| 4D-150 in diabetic macular edema Phase 3 clinical trial | 2025-09 | 25 | |
| 4FRONT-2 Phase 3 trial of 4D-150 in wet AMD | 2025-06 | 26 | |
| 4FRONT-1 Phase 3 trial (4D-150 in wet AMD) | 2025-03 | 26 | |
| 4FRONT-1 Phase 3 clinical trial initiation | 2025-03 | 19 | |
| 4D-150 for wet AMD Phase 3 clinical trial initiation | 2025-03 | 14 | |
| 4D-150 RMAT designation for wet AMD and DME | 2025-03 | 20 | |
| 4D-150 Phase 3 pivotal trial for wet AMD | 2025-03 | 10 | |
| 4D-150 Phase 3 clinical trial initiation | 2025-03 | 12 | |
| 52-week interim data from Phase 2b cohort of PRISM clinical trial for 4D-150 wet AMD | 2025-02 | 16 | |
| Wet AMD Phase 3 studies | 2025 | 30 | |
| Second Phase 3 study for 4D-150 | 2025 | 22 | |
| SPECTRA 52-week interim data presentation at scientific conference | 2025 | 17 | |
| Phase 3 study of 4D-150 3E10 vg/eye versus aflibercept | 2025 | 22 | |
| Phase 3 studies for 4D-150 3E10 vs aflibercept | 2025 | 18 | |
| Equity investment from Cystic Fibrosis Foundation (up to $11 million in two tranches) | 2025 | 25 | |
| 4D-710 for cystic fibrosis Phase 1 redosing and Phase 2 cohort in AEROW trial | 2025 | 25 | |
| 4D-710 Phase 2 program update (8x) | 2025 | 16 | |
| 4D-150 wet AMD Phase 3 studies | 2025 | 26 | |
| 4D-150 Phase 3 trial design for DME | 2025 | 27 | |
| 4D-150 DME global Phase 3 trial initiation | 2025 | 27 | |
| 2023 | |||
| 4D-725 for alpha-1 antitrypsin deficiency (5x) | 2023-09 | 16 | |
| 4D-125 for X-linked retinitis pigmentosa (4x) | 2023-09 | (2025-03) | 16 |
| 4D-110 (3x) | 2023-06 | (2025-03) | 16 |
| 2022 | |||
| 4D-150 (wet AMD and DME) | 2022-01 | 24 | |
| 2025 | |||
| 4D-150 PRIME designation in EU for wet AMD | 2025-03 | 20 | |
| 2024 | |||
| 4D-175 Phase 1 initiation | 2024-12 | 12 | |
| 4D-150 planned global Phase 3 program for wet AMD | 2024-12 | 17 | |
| 4D-150 for DME SPECTRA Phase 2 Part 1 interim data | 2024-12 | 14 | |
| 4D-150 Phase 3 clinical trial initiation in DME | 2024-12 | 17 | |
| PRISM Phase 1/2 interim data presentation | 2024-09 | 14 | |
| 4D-725 | 2024-09 | 15 | |
| 4D-710 | 2024-09 | 15 | |
| 4D-310 | 2024-09 | 15 | |
| 4D-175 | 2024-09 | 15 | |
| 4D-150 Development Day virtual webcast | 2024-09 | 14 | |
| 4D-150 (2x) | 2024-09 | 18 | |
| 4D-125 | 2024-09 | 15 | |
| Phase 1/2 INGLAXA clinical trial for 4D-310 | 2024-07 | 15 | |
| 4D-310 clinical hold removal | 2024-07 | 13 | |
| 4D-310 interim clinical data with 12-month minimum follow-up | 2024-06 | 6 | |
| 4D-310 FDA submission of preclinical non-human primate data | 2024-06 | 8 | |
| 4D-150 wet AMD Phase 2 interim data release | 2024-06 | 4 | |
| 4D-150 Phase 2 dose exploration interim data presentation | 2024-06 | 5 | |
| 4D-150 Phase 2 Dose Expansion interim data | 2024-06 | 6 | |
| 4D-150 DME Phase 2 interim data release | 2024-06 | 4 | |
| FDA feedback on 4D-150 Phase 3 pivotal trial plans for wet AMD | 2024-03 | 8 | |
| 4D-710 FDA feedback on development plan for cystic fibrosis monotherapy and CF modulator combination regimens | 2024-03 | 8 | |
| 4D-310 interim data update with 12-18 months follow-up for all 6 dosed patients and additional biopsy data for Fabry disease cardiomyopathy | 2024-03 | 8 | |
| 4D-150 Phase 3 pivotal trial plans update | 2024-03 | 6 | |
| Public follow-on offering | 2024-02 | 12 | |
| 4D-310 INGLAXA interim data presented at WORLD Symposium | 2024-02 | 9 | |
| 4D-150 SPECTRA Phase 2 for DME Dose Confirmation enrollment completed | 2024-02 | 9 | |
| 4D-150 Phase 2 Dose Expansion positive interim data | 2024-02 | 9 | |
| RMAT designation for 4D-150 (wet AMD) | 2024 | 18 | |
| 4D-725 program update for AATLD | 2024 | 8 | |
| 4D-710 Phase 1 interim data update for cystic fibrosis | 2024 | 8 | |
| 4D-150 for DME Phase 2 initial interim data | 2024 | 6 | |
| 4D-150 SPECTRA Phase 2 Dose Confirmation stage initial interim data for DME | 2024 | 8 | |
| 4D-150 Population Extension cohort interim data update for wet AMD | 2024 | 8 | |
| 4D-150 Phase 3 clinical trial | 2024 | 13 | |
| 4D-150 Phase 2 Dose Expansion interim data update for wet AMD | 2024 | 8 | |
| 2023 | |||
| 4D-710 Phase 2 dose expansion initiation (2x) | 2023-12 | 6 | |
| 4D-710 FDA discussion on pivotal endpoints (2x) | 2023-12 | 6 | |
| 4D-175 GA program update | 2023-12 | 6 | |
| 4D-710 Phase 1/2 Dose Exploration interim data (cohorts 1 & 2) | 2023-11 | 6 | |
| 4D-710 Phase 1 dose exploration interim data presentation | 2023-11 | 5 | |
| 4D-710 AEROW positive interim clinical data presented | 2023-11 | 9 | |
| First patient enrolled in 4D-150 Phase 2 SPECTRA clinical trial for DME | 2023-09 | 6 | |
| 4D-175 IND filing (6x) | 2023-09 | 10 | |
| 4D-150 in wet age-related macular degeneration (4FRONT-2 Phase 3) (4x) | 2023-09 | 18 | |
| 4D-150 SPECTRA Phase 2 clinical trial first patient enrollment | 2023-09 | 5 | |
| 4D-150 Phase 2 Dose Expansion enrollment completion | 2023-09 | 4 | |
| 4D-150 DME Phase 2 SPECTRA trial enrollment start | 2023-09 | 4 | |
| 4D-150 Phase 2 PRISM dose expansion | 2023-07 | 5 | |
| Manufacturing facility expansion (17,000 sq ft Emeryville, California) | 2023-06 | 5 | |
| Catalent manufacturing and cooperation agreement | 2023-06 | 5 | |
| 4D-710 Phase 1/2 AEROW trial interim data presentation | 2023-06 | 4 | |
| 4D-125 for inherited retinal dystrophies (RPGR/XLRP) (2x) | 2023-06 | 9 | |
| Public offering of common stock (2x) | 2023-05 | 19 | |
| 4D-150 Phase 1/2 PRISM clinical trial positive interim data presentation | 2023-04 | 4 | |
| 4D-150 Phase 1 Dose Exploration positive interim data | 2023-04 | 9 | |
| 4D-310 INGLAXA enrollment paused due to acute atypical hemolytic uremic syndrome | 2023-01 | 9 | |
| 4D-310 FDA Clinical Hold notification received | 2023-01 | 9 | |
| 4D-150 Phase 2 Dose Expansion enrollment initiated | 2023-01 | 9 | |
| 4D-710 modulator combination development plan update | 2023 | 6 | |
| 4D-310 program update (11x) | 2023 | 6 | |
| 4D-310 INGLAXA-1 and INGLAXA-2 Phase 1/2 trials initiated | 2023 | 9 | |
| 4D-310 INGLAXA protocol amended with immunosuppressive regimen | 2023 | 9 | |
| 4D-150 for neovascular (wet) AMD | 2023 | 9 | |
| 2022 | |||
| 4D-125 Dose Expansion portion enrollment completed (2x) | 2022-06 | 9 | |
| 4D-710 AEROW Phase 1/2 trial first patient dosed | 2022-04 | 9 | |
| 2021 | |||
| 4D-710 IND clearance from FDA received | 2021-10 | 9 | |
| 4D-125 EXCEL Phase 1/2 clinical trial initial data reported (2x) | 2021-10 | 9 | |
4D Molecular Therapeutics Transactions & Events (19)
19 transactions and events of 4D Molecular Therapeutics from the original reports, financing measures and management changes are not listed here, cancelled items in grey. NadirAlpha methodology
Acquisitions by 4D Molecular Therapeutics
| Transaction / stake | Date | Type | Source |
|---|---|---|---|
| 2024 | |||
| Underwriter option exercise for additional shares | 2024-03 | Completed | 11 |
| March 2024 underwriter option exercise | 2024-03 | Completed | 13 |
| 2023 | |||
| 4D-710 (cystic fibrosis) (6x) | 2023-09 | Completed | 18 |
| Cystic Fibrosis Foundation grant amendment | 2023-08 | Completed | 18 |
| Acquisition of sCFH rights from Aevitas Therapeutics for 4D-175 | 2023-05 | Completed | 4 |
| 2023 Offering (4x) | 2023-05 | Completed | 3 |
| 2022 | |||
| 2022 ATM Offering Program | 2022-03 | Completed | 3 |
| 2021 | |||
| 2021 Offering | 2021-11 | Completed | 3 |
Divestitures and exits by 4D Molecular Therapeutics
| Transaction / stake | Date | Type | Source |
|---|---|---|---|
| 2025 | |||
| Terminated development of 4D-110 for choroideremia | 2025-01 | Divested | 19 |
Partnerships and contracts of 4D Molecular Therapeutics
| Transaction / stake | Date | Type | Source |
|---|---|---|---|
| 2025 | |||
| Otsuka Pharmaceutical strategic partnership for 4D-150 in Asia-Pacific | 2025-12 | Agreement | 27 |
| Otsuka Collaboration and License Agreement (2×) | 2025-10 | Agreement | 26 |
| Strategic partnership with Otsuka Pharmaceutical for 4D-150 development and commercialization in APAC region | 2025 | Agreement | 25 |
| 2023 | |||
| Arbor Biotechnologies partnership for AAV-delivered CRISPR/Cas CNS therapeutics | 2023-12 | Agreement | 10 |
| Arbor Biotechnologies co-development and co-commercialization agreement for CNS programs | 2023-12 | Agreement | 9 |
| License Agreement with Astellas Gene Therapy (AGT) | 2023-07 | Agreement | 18 |
| Astellas Pharma license agreement for R100 vector (4×) | 2023-07 | Agreement | 10 |
| AGT License Agreement | 2023-07 | Agreement | 15 |
| Astellas License Agreement upfront payment | 2023 | Agreement | 8 |
| 2019 | |||
| uniQure collaboration agreement amendment | 2019-08 | Agreement | 3 |
4D Molecular Therapeutics Risks (304 since the annual report of 2026-03-18, 730 tracked in total)
Which risks 4D Molecular Therapeutics has named since the annual report, company-specific first, generic standard risks in the expandable part; first mention refers to the document base from 2023. NadirAlpha methodology
Category: RegulatoryLegalFinancialCustomersSupply chainTechnologyCompetitionCyberMacroMarketStrategyGeopoliticsPeopleESG
| Risk | Category | Last reported |
|---|---|---|
| 4D Molecular Therapeutics: first mention in 8-K-EX99.1 earnings release of 2026-08-13 (2026-Q2), source 31 | ||
| Multiple Phase 3 trials ongoing; topline data timing dependent on enrollment and regulatory processes. | = | |
| Company product candidates in clinical/preclinical development not yet FDA approved. | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2026-08-13 (2026-Q2), source 30 | ||
| Loan agreement with Hercules contains financial and operating covenants including minimum cash requirements that could restrict operations. | = | |
| Interest payments on Hercules term loans will require substantial cash; debt service reduces funds available for operations. | = | |
| Hercules Capital Loan Agreement may preclude dividend payments without lender consent | = | |
| Manufacturing gene therapies is complex; production problems could delay development or limit supply. | = | |
| No prior experience marketing/selling pharma; significant risks in hiring, training, managing sales force | = | |
| Reliance on third-party CROs/CDMOs; termination or failure delays trials; FDA compliance responsibility remains with company | = | |
| Performance failures by manufacturers/distributors delay development/approval/commercialization | = | |
| Collaborators (e.g., Otsuka Pharmaceutical) may not maintain or defend our IP; collaborator misconduct could expose us to litigation. | = | |
| Complex license agreements susceptible to multiple interpretations; adverse resolution could narrow scope of rights or increase obligations. | = | |
| Rely on exclusive licenses from U.C. Berkeley (AAV variants, 4D-710, 4D-725) and University of Pennsylvania (sCFH, 4D-175); licenses may not cover all fields or territories. | = | |
| May be subject to third-party patent infringement claims; substantial litigation could delay commercialization and increase costs. | = | |
| Physician Payments Sunshine Act reporting requirements; state anti-kickback laws; compliance costs substantial | = | |
| Although no claims asserted to date, third parties may hold patents preventing our product candidates from being marketed. | = | |
| FDA may require costly post-marketing studies; failure to comply risks approval withdrawal or restrictions | = | |
| Off-label promotion prohibited; advertising subject to strict labeling consistency; violations risk sanctions | = | |
| RMAT/PRIME designation does not guarantee approval speed or success; FDA may rescind designations | = | |
| First-to-file system; third-party prior art submissions; post-grant proceedings (IPR/reexamination) risk patent invalidation | = | |
| Patents cannot be enforced until issued; no assurance applications will result in patents; issued patents may be invalidated | = | |
| Competitors may design around claims; interference proceedings possible; patent protection may be insufficient | = | |
| Hatch-Waxman extension eligibility not guaranteed; may not meet deadlines or requirements; extension may be less than requested | = | |
| European Unified Patent Court allows centralized revocation; opted out currently but future patents at risk if opt-out formalities fail | = | |
| Limited control over collaborators' resources/timelines; collaborators may abandon programs; IP ownership disputes possible | = | |
| Termination of collaboration restricts access to technology/IP; delays development; replacement difficult | = | |
| No specific mention; generic boilerplate risk category. | = | |
| Future equity offerings would result in stockholder dilution; debt financing may impose restrictive covenants. | = | |
| Countries impose price ceilings; reimbursement review delays commercialization; pricing subject to negotiation/approval | = | |
| Sales or perception of sales of substantial shares could reduce market price; stock option exercises and future awards will dilute ownership. | = | |
| Competitors may develop similar products not covered by our patents; others may independently develop alternative technologies without infringing our IP. | = | |
| Delaware Court of Chancery exclusive forum for certain disputes; may limit stockholders' ability to obtain favorable judicial forum. | = | |
| Interference or derivation proceedings may be necessary to determine priority of inventions; unfavorable outcomes could prevent technology use. | = | |
| Material weakness in internal controls could delay error detection and cause financial statement misstatement. | = | |
| Foreign legal systems may not favor patent enforcement; compulsory licensing laws and limited enforceability against government agencies in some countries. | = | |
| May be unable to acquire or license necessary third-party IP rights; more established companies have competitive advantage in licensing negotiations. | = | |
| Regulatory framework for AI technologies rapidly evolving; future laws may limit our ability to use AI or require costly compliance measures. | = | |
| Adverse public perception or regulatory scrutiny of genetic medicine technology may impede commercialization. | = | |
| US ACA, IRA, state price controls, reimbursement pressure; Medicare negotiation caps; tariffs on pharma imports | = | |
| American Rescue Plan eliminated rebate cap; rebates now unlimited (100%+ of average manufacturer price) | = | |
| Acquisitions and strategic partnerships may increase capital requirements, dilute stockholders, cause debt assumption, and divert management attention. | = | |
| IT systems vulnerable to cyberattacks, malware, and data breaches; loss of clinical trial data could delay regulatory approval. | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2026-05-07 (2026-Q1), source 28 | ||
| Anti-Kickback Statute, False Claims Act, HIPAA, FCPA exposure; violations risk criminal/civil penalties, exclusion from Medicare/Medicaid | 2026-Q2 2026-08-13 30 | |
| 2024 Data Security Program rule effective April 8, 2025, fully enforceable July 9, 2025, restricts data transfers to countries of concern; non-compliance carries significant penalties. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2026-03-18 (FY2025), source 26 | ||
| Patent litigation time-consuming and costly; defense expenses substantial; risk of negative publicity and stock price impact. | 2026-Q2 2026-08-13 30 | |
| Trump administration tariffs (Section 232) on non-compliant manufacturers; most-favored-nation pricing threats | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-11-10 (2025-Q3), source 24 | ||
| Currently no marketing or sales team; building capabilities expensive/time-consuming; reliance on third-party distributors risky | 2026-Q2 2026-08-13 30 | |
| Uninsured or underinsured product liability claims could result in unanticipated costs | 2026-Q2 2026-08-13 30 | |
| Foreign patent laws less favorable than US; cannot afford worldwide protection; competitors may export infringing products | 2026-Q2 2026-08-13 30 | |
| Patent filing/prosecution expensive and time-consuming; may fail to timely protect innovations | 2026-Q2 2026-08-13 30 | |
| Future equity offerings would dilute existing shareholders; debt would increase fixed payment obligations; 16.9M pre-funded warrants outstanding as of June 30, 2026. | 2026-Q2 2026-08-13 30 | |
| Commercialization would increase exposure and compliance costs under healthcare fraud laws | 2026-Q2 2026-08-13 30 | |
| Cyberattacks may escalate as part of ongoing international conflicts | 2026-Q2 2026-08-13 30 | |
| Healthcare budgets constrained globally; pricing/reimbursement restrictions; government cost-control measures | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-08-11 (2025-Q2), source 22 | ||
| Clinical trials may fail to demonstrate safety and efficacy; failure can occur at any stage. | 2026-Q2 2026-08-13 30 | |
| Potential restrictions on trade or tariffs could limit access to necessary raw materials. | 2026-Q2 2026-08-13 30 | |
| Need to grow organization; may experience difficulties managing growth; reliance on outside contractors and consultants. | 2026-Q2 2026-08-13 30 | |
| Future required licenses may not be available or available only on unfavorable commercial terms. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-05-08 (2025-Q1), source 20 | ||
| BIOSECURE Act (Dec 2025) restricts contracts with Chinese CROs/CDMOs designated adversary companies; 5-year grandfathering; Medicaid/Medicare carveouts with limits | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2025-02-28 (FY2024), source 18 | ||
| Licenses impose royalty payments and milestones; non-compliance may trigger termination; future royalty obligations unknown and may be significant. | 2026-Q2 2026-08-13 30 | |
| Limited control over patent prosecution and enforcement for licensed technology; licensor may withhold enforcement consent; licensors may not maintain patents adequately. | 2026-Q2 2026-08-13 30 | |
| Approval in one country does not ensure approval in others; separate marketing approvals required per jurisdiction | 2026-Q2 2026-08-13 30 | |
| Third-party collaborators, CROs, and contractors face heightened cybersecurity risks; breaches could harm our business. | 2026-Q2 2026-08-13 30 | |
| Choice of forum provisions may limit stockholders' ability to litigate claims in preferred venues | 2026-Q2 2026-08-13 30 | |
| SEC requires annual cybersecurity disclosures and material incident reporting on Form 8-K. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2024-11-13 (2024-Q3), source 15 | ||
| Changes to FDA regulations or guidance could lengthen approval timelines or require additional studies. | 2026-Q2 2026-08-13 30 | |
| Charter and bylaw provisions may discourage or delay change in control; staggered board, advance notice requirements, 66 2/3% amendment threshold limit stockholder power. | 2026-Q2 2026-08-13 30 | |
| May face claims that employees or consultants wrongfully used former employers' trade secrets or confidential information. | 2026-Q2 2026-08-13 30 | |
| Legal proceedings and claims could be costly and harm reputation regardless of outcome | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2024-08-08 (2024-Q2), source 13 | ||
| Six granted US patents and two pending made with government support; subject to march-in rights under 35 USC 203 | 2026-Q2 2026-08-13 30 | |
| Patents expire 20 years after filing; development time may consume patent life; commercialization may occur near/after expiration | 2026-Q2 2026-08-13 30 | |
| New or modified tax laws could adversely affect domestic and international business operations. | 2026-Q2 2026-08-13 30 | |
| Indemnification of directors and officers may reduce funds available for third-party claims. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2024-02-29 (FY2023), source 9 | ||
| Collaborator bankruptcy may halt programs; loss of access to technology/materials/IP | 2026-Q2 2026-08-13 30 | |
| May face claims challenging inventorship or ownership of patents and IP; employee/consultant assignment agreements may not be effective or self-executing. | 2026-Q2 2026-08-13 30 | |
| Directors, officers, >5% holders own ~62% of common stock as of June 30, 2026; may influence management and prevent change of control. | 2026-Q2 2026-08-13 30 | |
| Expanded sanctions or conflicts could disrupt supply arrangements and clinical operations | 2026-Q2 2026-08-13 30 | |
| Patents subject to validity challenges including lack of novelty, obviousness, non-enablement, and inequitable conduct during prosecution. | 2026-Q2 2026-08-13 30 | |
| Employee or consultant inadvertent use or disclosure of third-party trade secrets; reliance on third parties increases misappropriation risk. | 2026-Q2 2026-08-13 30 | |
| Common stock price volatile; fluctuations unrelated to operating performance; subject to securities litigation risk. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-11-09 (2023-Q3), source 7 | ||
| FDA approval of manufacturing facilities required; any non-compliance could prevent product approval. | 2026-Q2 2026-08-13 30 | |
| Other drugs may obtain approval for same orphan indication; orphan exclusivity limited to 7 years US/10 years EU | 2026-Q2 2026-08-13 30 | |
| Registered and unregistered trademarks may be challenged or determined to be infringing; inability to build brand recognition could impair competitive position. | 2026-Q2 2026-08-13 30 | |
| Environmental health and safety law violations could result in fines or operational suspension | 2026-Q2 2026-08-13 30 | |
| EU GDPR and UK GDPR impose strict requirements; fines up to €20M/£17.5M or 4% annual global revenue; data transfer mechanisms to U.S. uncertain. | 2026-Q2 2026-08-13 30 | |
| Significant costs to operate as public company; substantial time devoted to compliance; may fail to comply with Sarbanes-Oxley Section 404. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 8-K-EX99.1 earnings release of 2023-08-09 (2023-Q2), source 6 | ||
| No genetic medicine products have been approved by FDA; regulatory approval process is lengthy and unpredictable. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-08-09 (2023-Q2), source 5 | ||
| Geopolitical actions limit patent prosecution, maintenance, and enforcement in Russia; decree allows Russian companies to exploit U.S. inventions without consent. | 2026-Q2 2026-08-13 30 | |
| Confirmatory trials may fail to verify clinical benefit; FDA may withdraw accelerated approval | 2026-Q2 2026-08-13 30 | |
| Contamination from hazardous materials could exceed company resources and suspend operations | 2026-Q2 2026-08-13 30 | |
| Russia-Ukraine and Middle East conflicts may exacerbate supply chain and cyber security risks | 2026-Q2 2026-08-13 30 | |
| Highly dependent on key personnel; loss of executives or scientific staff could delay product development; competition for talent is intense. | 2026-Q2 2026-08-13 30 | |
| Subject to HIPAA, CCPA, GDPR, and other evolving data protection laws; non-compliance could result in fines and regulatory investigations. | 2026-Q2 2026-08-13 30 | |
| Misconduct by employees or vendors could violate FDA, EMA and healthcare fraud laws | 2026-Q2 2026-08-13 30 | |
| Competitors may develop technologies that render Therapeutic Vector Evolution platform technology obsolete. | 2026-Q2 2026-08-13 30 | |
| Major pharmaceutical companies with greater resources are developing competing products for retina and pulmonology indications. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 8-K-EX99.1 earnings release of 2023-05-11 (2023-Q1), source 4 | ||
| Biotech company with net losses; dependent on Otsuka collaboration payments and credit facility for funding. | 2026-Q2 2026-08-13 31 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-05-11 (2023-Q1), source 3 | ||
| AWA regulations govern animal research treatment; non-compliance risks fines, penalties, adverse publicity | 2026-Q2 2026-08-13 30 | |
| Subject to Section 382 and 383; ownership changes may limit ability to use NOLs and other tax attributes; may not achieve profitability sufficient to offset NOLs. | 2026-Q2 2026-08-13 30 | |
| Dependence on third-party suppliers for raw materials; loss of suppliers could disrupt manufacturing. | 2026-Q2 2026-08-13 30 | |
| Hazardous materials/chemicals used in research; contamination/injury risks; insurance may not cover all claims | 2026-Q2 2026-08-13 30 | |
| Difficulty recruiting and retaining experienced manufacturing, quality control, and scientific personnel. | 2026-Q2 2026-08-13 30 | |
| Non-compliance with USPTO and foreign patent office requirements could result in patent abandonment or lapse; USPTO staffing cuts may cause delays. | 2026-Q2 2026-08-13 30 | |
| FDA may deny or delay approval; uncertain clinical trial outcomes; narrow indications/restrictions possible | 2026-Q2 2026-08-13 30 | |
| Commercial success depends on market acceptance by physicians, patients, and payors; no guarantee of adoption. | 2026-Q2 2026-08-13 30 | |
| Product liability claims could result in substantial liabilities and commercialization restrictions | 2026-Q2 2026-08-13 30 | |
| cGMP compliance, facility inspections, quality control; violations risk warning letters, penalties, facility closure | 2026-Q2 2026-08-13 30 | |
| ESG reporting requirements may increase costs and not meet stakeholder or regulatory expectations | 2026-Q2 2026-08-13 30 | |
| Loss of analyst research coverage or negative evaluations could reduce stock price. | 2026-Q2 2026-08-13 30 | |
| Company does not currently intend to pay dividends; returns depend on stock price appreciation | 2026-Q2 2026-08-13 30 | |
| Unfavorable global economic conditions, recessions, or weakening U.S. dollar could increase clinical trial costs and reduce capital availability. | 2026-Q2 2026-08-13 30 | |
| Patent protection and intellectual property rights may be insufficient or challenged by competitors. | 2026-Q2 2026-08-13 30 | |
| Pending patent applications may not lead to issued patents; issued patents may be held invalid or unenforceable by competitors. | 2026-Q2 2026-08-13 30 | |
| Reliance on trade secret protection; security measures may be ineffective; unauthorized disclosure risk increases with third-party sharing. | 2026-Q2 2026-08-13 30 | |
| 4D Molecular Therapeutics: first mention in 8-K-EX99.1 earnings release of 2026-05-07 (2026-Q1), source 29 | ||
| All product candidates in clinical/preclinical development, no FDA approval | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2026-05-07 (2026-Q1), source 28 | ||
| 16,935,665 Pre-funded Warrants outstanding; exercise would dilute shareholders' voting power and EPS. | = | |
| Problems with manufacturing process including minor deviations could result in product defects, lot failures or product recalls | = | |
| Depend on third-party suppliers for raw materials; suppliers could increase prices or fail to provide adequate supply | = | |
| Collaboration arrangements with Otsuka Pharmaceutical Co., Ltd. and others subject to disputes or termination risks. | = | |
| Section 382 ownership changes limit ability to use net operating loss carryforwards and tax attributes. | = | |
| Cannot guarantee clinical trials will be initiated, conducted as planned or completed on schedule | = | |
| Product candidates may cause undesirable side effects that could halt clinical development or prevent regulatory approval | = | |
| Initiated wet AMD Phase 3 studies in 2025; delays in enrollment or other factors could result in serious harm | = | |
| Russia decree permits exploitation of US/foreign patents without consent; Ukraine conflict limits patent filing/prosecution/maintenance in Russia. | = | |
| Cyberattacks, ransomware, or data breaches could disrupt operations and compromise clinical trial data or confidential information. | = | |
| Adverse public perception or regulatory scrutiny of genetic medicine technology may negatively impact developmental progress | = | |
| No sales organization currently; building marketing/sales capabilities is expensive, time-consuming, high-risk. | = | |
| Insufficient product liability insurance could prevent product commercialization | = | |
| No specific customer concentration disclosed; risk notes reflect generic concentration vulnerabilities. | = | |
| Risk of contamination during biologics manufacturing that could materially harm ability to produce candidates on schedule | = | |
| Reliance on third-party CROs, CDMOs, and suppliers subject to earthquakes, shutdowns, or supply disruptions. | = | |
| Disruptions at FDA due to funding shortages, staffing limitations or policy changes could hinder ability to hire and deploy key personnel | = | |
| Subject to significant FDA regulatory oversight and IBC/IRB review requirements at each clinical trial institution | = | |
| Use of hazardous materials exposes company to material liability; insufficient insurance coverage possible. | = | |
| Subject to Foreign Corrupt Practices Act regarding payments to foreign officials and political parties. | = | |
| Legal proceedings and employment claims could harm reputation and increase costs | = | |
| Evolving regulatory framework for AI Technologies may require operational changes or increase compliance costs. | = | |
| Must obtain FDA regulatory approval of manufacturing process before commercial manufacture; pre-approval inspection required | = | |
| FDA established Office of Therapeutic Products within CBER and CAT committee; regulatory requirements continue to evolve | = | |
| SEC requires annual disclosures on cybersecurity risk management and material incident reporting. | = | |
| AI Technologies models could be poorly designed, trained on inadequate data, or lack sufficient oversight and governance. | = | |
| AI model performance may decay over time without human intervention; development and maintenance is expensive and complex. | = | |
| Some foreign countries have compulsory licensing laws requiring patent owners to grant licenses to third parties. | = | |
| Patents expire generally 20 years after filing; product development delays may exhaust patent life before commercialization. | = | |
| No assurance Hatch-Waxman patent term extension granted; competitors may launch after patent expiration. | = | |
| Failure to develop Therapeutic Vector Evolution platform technology could harm competitive position. | = | |
| No products approved for commercial sale; research and development inherently risky with substantial failure risk | = | |
| If licensed patents fail to provide intended exclusivity, competitors may gain freedom to market identical products. | = | |
| Competitors may independently develop similar technologies without infringing our intellectual property rights. | = | |
| Limited number of suitable replacement manufacturers; significant transition time to alternative manufacturing | = | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2026-03-18 (FY2025), source 26 | ||
| Ability to raise additional funds may be adversely impacted by global economic conditions, conflicts, rising interest rates. | = | |
| Commercial manufacturing scale-up and tech transfer to CDMOs required for potential 4D-150 launch carry execution risks and timelines. | = | |
| Section 382/383 ownership changes limit NOL/tax attribute use; prior ownership changes experienced; may not offset sufficient taxable income | = | |
| No existing marketing or sales organization; building sales capabilities expensive and time-consuming or collaboration may fail | = | |
| Future revenue depends on successful development and commercialization by collaboration partners including Otsuka and CFF. | = | |
| Supply disruptions could occur if sanctions expand or countries with operations become involved in conflicts. | = | |
| Dependence on internal GMP manufacturing capabilities and CDMO partnerships for clinical and commercial supply of proprietary AAV vectors. | = | |
| Directors/officers/5%+ holders own ~48% of outstanding stock as of Dec 31 2025; could delay change of control or affect stock price | = | |
| Pre-funded warrants outstanding to purchase 10,335,665 shares at nominal exercise price; exercise would dilute voting power/EPS | = | |
| Legal proceedings and employment claims could harm reputation and divert management resources. | = | |
| Regulatory authorities may approve fewer indications, impose restrictions, REMS, or require costly post-marketing trials | = | |
| Exposure to healthcare fraud and abuse laws with increased costs if product candidates commercialized. | = | |
| RMAT and PRIME designations do not guarantee faster review, approval, or broader approved indications | = | |
| Orphan drug exclusivity may not prevent competition from clinically superior drugs or broader approvals of same drug | = | |
| Ongoing regulatory requirements, cGMP compliance, adverse event monitoring and labeling restrictions after approval | = | |
| FDA enforcement actions including warning letters, civil/criminal penalties, approval suspension or product recall | = | |
| Third parties may have filed earlier patent applications or interference proceedings over patentable inventions | = | |
| Patent applications require compliance with procedural requirements; non-compliance can result in abandonment or lapse | = | |
| Pre-existing human antibodies to conventional AAV vectors could neutralize therapeutic effect; resistance to antibody inhibition is key differentiator for 4DMT vectors. | = | |
| U.S. BIOSECURE Act restrictions on Chinese biotechnology companies could limit CRO/CDMO services and material supply | = | |
| Large pharmaceutical companies with greater resources competing in wet AMD, DME, GA, and cystic fibrosis indications | = | |
| Cyberattacks could expand as part of ongoing conflicts, adversely affecting ability to maintain cyber security measures. | = | |
| SEC cybersecurity rule requires annual disclosures of risk management/governance and material incident reporting; compliance costs increasing | = | |
| Third-party CROs/CDMOs/collaborators may experience security breaches affecting clinical data; inadequate oversight could harm business | = | |
| Acquisitions/partnerships may require more capital, dilute equity, incur debt or contingent liabilities | = | |
| Government and third-party payors control coverage decisions, reimbursement rates and may impose discounts below costs | = | |
| Reimbursement uncertainty for genetic medicines exists as CMS and payors have not established pricing/coverage policies for this emerging therapeutic class. | = | |
| Employees/consultants may have competing IP assignment obligations to former employers; litigation necessary to defend claims | = | |
| EU Patent Package UPC provides competitors new forum to centrally revoke European patents; loss could materially harm business | = | |
| Similar healthcare laws in EU and other jurisdictions with reporting and payment restrictions to healthcare providers | = | |
| Patent protection in foreign countries less extensive than US; enforcement difficult; compulsory licensing laws limit IP rights | = | |
| Inadvertent lapses in maintenance fees/procedural requirements could cause abandonment; USPTO staffing cuts may cause delays | = | |
| Royalty obligations on licensed technology may be significant and prevent profitability | = | |
| Trademarks could be challenged, infringed or declared generic; failure to establish brand recognition harms competition | = | |
| Limited regulatory and clinical experience with AAV genetic medicine; novel technology may increase development time and cost | = | |
| AI models may experience decay over time or performance issues; training data quality/bias risks could harm products/reputation | = | |
| AI regulatory landscape rapidly evolving; new/existing laws may limit or require changes to AI Technologies use; implementation standards uncertain | = | |
| Regulatory authorities may impose clinical holds or delay approvals based on safety findings or failure to meet primary trial endpoints. | = | |
| Medicare negotiation, state price controls, reference pricing, reimbursement rate pressure on pharmaceutical pricing | = | |
| EU and other jurisdictions impose healthcare cost containment and pricing restrictions on pharmaceutical products | = | |
| States implementing prescription drug affordability boards and price limits on certain drugs | = | |
| California/other state privacy laws require specific contractual provisions with service providers; conflicting requirements challenge compliance | = | |
| Therapeutic Vector Evolution platform technology may not produce viable product candidates; competitors may develop superior platforms | = | |
| Competitors with greater resources may develop similar/better products, potentially blocking clinical trial sites or key talent | = | |
| Multiple companies pursuing AAV genetic medicines for wet AMD, DME and cystic fibrosis including AbbVie, Regeneron, Eli Lilly and Vertex Pharmaceuticals. | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-11-10 (2025-Q3), source 24 | ||
| Certificate of incorporation and bylaws contain provisions that discourage, delay or prevent change in control. | = | |
| Competitors with substantially greater resources may obtain patents preventing or limiting company's ability to make, use or sell product candidates. | = | |
| Section 203 of Delaware law prohibits business combination with interested stockholder for three years. | = | |
| Licensors may fail to prosecute, maintain, enforce or defend intellectual property rights in manner consistent with company's business interests. | = | |
| Hatch-Waxman patent term extension (max 5 years) not guaranteed; depends on timing and regulatory approval specifics. | = | |
| Russian decree (March 2022) allows exploitation of U.S. patents without consent or compensation; enforcement impossible in Russia. | = | |
| Sharing trade secrets with third parties for clinical trials, manufacturing, and distribution increases risk of competitor discovery or misappropriation. | = | |
| Intense competition for skilled personnel in biopharmaceutical industry; high turnover risk in Emeryville region. | 2026-Q1 2026-05-07 28 | |
| No identified customer concentration disclosed; generic boilerplate regarding dependence on collaborators | FY2025 2026-03-18 26 | |
| Some foreign countries require patent owners to license competitors; limits exclusivity and pricing power internationally. | = | |
| HIPAA imposes criminal and civil liability for healthcare fraud schemes; applies to data security and billing practices. | = | |
| First-to-file system; third parties may submit prior art; post-grant proceedings increase patent invalidation risks. | = | |
| Detecting patent infringement difficult; competitors may hide manufacturing methods; enforcement costly and outcome uncertain. | = | |
| EU Unified Patent Court provides centralized revocation forum; European patents automatically under UPC jurisdiction unless opted out. | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-08-11 (2025-Q2), source 22 | ||
| Risk of regulatory sanctions and litigation from alleged fraud or misconduct by employees and third parties. | = | |
| DPF/SCC uncertainty for EEA-US transfers; regulatory scrutiny increases compliance costs | = | |
| Established competitors better positioned to acquire/license attractive third-party IP rights | = | |
| Employee IP assignment agreements may be ineffective; loss of valuable IP rights possible | = | |
| Third-party patent/IP claims could delay/prevent commercialization; costly litigation required | = | |
| Loss of analyst coverage or negative evaluations could reduce visibility and depress stock price | FY2025 2026-03-18 26 | |
| Legal proceedings costly/time-consuming; harm reputation; defense disburses management resources | = | |
| Patent claims may not cover all competitive threats; issued patents may be invalid/unenforceable | = | |
| Patent protection reduced/eliminated for non-compliance with procedural/fee requirements | = | |
| Pending patent applications may not issue; newly issued patents may cover technologies unknowingly | = | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2025-05-08 (2025-Q1), source 20 | ||
| Anti-Kickback Statute, HIPAA violations could result in penalties and market exclusion | = | |
| False Claims Act violations from off-label promotion may expose to government penalties | = | |
| Non-compliance with healthcare laws could result in exclusion from government programs | = | |
| Foreign patent protection inadequate; enforcement costly and jurisdictions vary | = | |
| Patent applications may not result in issued patents or provide competitive advantage | = | |
| Future licenses may impose significant royalty payments and milestones; failure to comply may result in termination | = | |
| Limited patent lifespan may expire before or shortly after product commercialization | = | |
| Competitor patents may dominate or conflict with our patent positions | = | |
| Hatch-Waxman patent term extension may be unavailable or shorter than expected | = | |
| Insiders own ~60% of stock; could limit minority shareholder influence | = | |
| Physician Payments Sunshine Act reporting requirements create compliance burden | = | |
| Need to attract, hire and retain qualified personnel in competitive biotech industry. | FY2025 2026-03-18 26 | |
| Issued patents could be held invalid/unenforceable in litigation or USPTO proceedings; grounds include lack of novelty, obviousness, non-enablement | FY2025 2026-03-18 26 | |
| Potential litigation and enforcement actions from ESG-related matters | = | |
| Pending patent applications may not issue or issued patents may be invalid | = | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2025-02-28 (FY2024), source 18 | ||
| Net operating losses subject to annual limitation under Sections 382 and 383 if cumulative ownership changes exceed 50% in three-year period. | FY2025 2026-03-18 26 | |
| Inability to obtain adequate reimbursement coverage for product candidates could limit market access and revenue | FY2025 2026-03-18 26 | |
| Hatch-Waxman extensions may not extend beyond 14 years post-approval; failure to meet requirements could harm business | FY2025 2026-03-18 26 | |
| UK GDPR and EU GDPR restrict personal data transfers to non-EEA countries; legal uncertainty continues regarding standard contractual clauses | FY2025 2026-03-18 26 | |
| Compliance with Anti-Kickback Statute, False Claims Act, HIPAA, and other healthcare regulations required. | 2025-Q2 2025-08-11 22 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2024-11-13 (2024-Q3), source 15 | ||
| CDMO failures in manufacturing comparability or FDA non-approval could delay clinical trials and regulatory approvals | FY2025 2026-03-18 26 | |
| Reliance on CROs, CDMOs, clinical investigators; performance failures delay development and approval. | 2026-Q1 2026-05-07 28 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2024-08-08 (2024-Q2), source 13 | ||
| Will require substantial additional capital to finance operations; if unable to raise capital may delay or eliminate research programs | 2026-Q1 2026-05-07 28 | |
| Employee/contractor misconduct could violate FDA/EMA regulations and healthcare fraud laws | 2025-Q3 2025-11-10 24 | |
| Filing patents worldwide prohibitively expensive; foreign IP protection weaker; competitors exploit jurisdictions without patent protection. | 2026-Q1 2026-05-07 28 | |
| Significant legal/accounting expenses for SEC reporting, governance compliance, Section 404 SOX testing; material weakness in internal controls could harm reputation | FY2025 2026-03-18 26 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2024-05-09 (2024-Q1), source 11 | ||
| Exclusive licenses from U.C. Berkeley and University of Pennsylvania; termination could prevent product development. | 2026-Q1 2026-05-07 28 | |
| Patent enforcement proceedings are expensive and may result in patent invalidation or narrow interpretation | FY2025 2026-03-18 26 | |
| Exclusive forum provision may limit stockholders' ability to bring claims in favorable judicial forum. | 2025-Q3 2025-11-10 24 | |
| Failure to comply with obligations under license agreements could result in termination or loss of rights to develop and commercialize products. | 2025-Q3 2025-11-10 24 | |
| Operating losses continue; cash runway extends into H2 2028 based on current plan | 2026-Q1 2026-05-07 29 | |
| No assurance patents issue, afford sufficient protection, or prevent competitors from designing around; patents may be invalidated. | 2026-Q1 2026-05-07 28 | |
| AWA compliance required for research animals; contractor non-compliance results in fines, penalties, adverse publicity. | 2026-Q1 2026-05-07 28 | |
| Information systems vulnerable to cyberattacks, ransomware, phishing; loss of clinical trial data could delay regulatory approval | FY2025 2026-03-18 26 | |
| Russia-Ukraine conflict and Middle East hostilities could disrupt supply arrangements and clinical operations. | FY2025 2026-03-18 26 | |
| Recession, weak dollar, pandemic, geopolitical tensions could reduce demand, limit capital availability, strain suppliers | FY2025 2026-03-18 26 | |
| 4D Molecular Therapeutics: first mention in 10-K annual report of 2024-02-29 (FY2023), source 9 | ||
| Non-compliance with Animal Welfare Act regulations on animal research could result in fines, penalties and adverse publicity | FY2025 2026-03-18 26 | |
| Collaborator dependence on discretionary resource allocation, IP disputes, termination or change in strategic focus | FY2025 2026-03-18 26 | |
| Contamination, shortage or recall of biologically derived raw materials could disrupt manufacturing and harm commercialization | FY2025 2026-03-18 26 | |
| Violations of Anti-Kickback Statute, False Claims Act, HIPAA, Physician Payments Sunshine Act could impose significant penalties | FY2025 2026-03-18 26 | |
| Third-party CROs, CDMOs and clinical investigators may fail to meet deadlines or regulatory compliance for trials | FY2025 2026-03-18 26 | |
| Third parties may claim infringement of patents or proprietary rights, requiring costly litigation and potentially preventing commercialization. | 2025-Q3 2025-11-10 24 | |
| Potential for adverse events or durability concerns with gene therapy product 4D-150 in ongoing trials. | 2025-Q1 2025-05-08 21 | |
| RMAT/PRIME designations do not guarantee faster review, approval, or that approved indication matches designation scope. | 2026-Q1 2026-05-07 28 | |
| U.S. healthcare reform including ACA, IRA drug price negotiation, Medicaid rebate expansion affecting drug pricing | FY2025 2026-03-18 26 | |
| Competitors may adopt similar trademarks; unable to build brand recognition | 2025-Q1 2025-05-08 20 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-11-09 (2023-Q3), source 7 | ||
| Recurring net losses of $68.8M Q1 2026 with accumulated deficit of $785.1M; expects significant losses for foreseeable future | 2026-Q1 2026-05-07 28 | |
| Third-party patents or pending applications may cover materials, formulations, or methods related to product candidates. | 2026-Q1 2026-05-07 28 | |
| Limited patent lifespan may expire before or shortly after product commercialization, exposing to generic competition | FY2025 2026-03-18 26 | |
| Termination of current or future licenses would cause loss of valuable rights and prevent product development and commercialization. | 2025-Q3 2025-11-10 24 | |
| Acquisition/partnerships increase costs, dilute equity, assume liabilities, distract management | 2025-Q2 2025-08-11 22 | |
| Russia-Ukraine and Middle East conflicts may exacerbate business risks | 2026-Q1 2026-05-07 28 | |
| Public health crises such as pandemics could negatively affect clinical trial timelines and business operations | 2026-Q1 2026-05-07 28 | |
| HIPAA, CCPA, EU GDPR, and other evolving privacy laws impose compliance obligations and potential penalties. | 2026-Q1 2026-05-07 28 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-08-09 (2023-Q2), source 5 | ||
| Claims that employees/consultants wrongfully use or disclose trade secrets from former employers. | 2026-Q1 2026-05-07 28 | |
| Claims challenging inventorship or ownership of patents and intellectual property | 2025-Q1 2025-05-08 20 | |
| Government-funded patents subject to march-in rights; government may license to others | 2025-Q1 2025-05-08 20 | |
| ESG reporting efforts may not meet investor expectations and increase costs | 2026-Q1 2026-05-07 28 | |
| Operations in Emeryville, California subject to earthquakes, natural disasters, and business interruptions; insurance may not cover all losses. | 2026-Q1 2026-05-07 28 | |
| Delays possible in clinical trial initiation, enrollment, or completion affecting product development timelines | FY2025 2026-03-18 26 | |
| regulatory and legal risks from product candidate development in early stages. | 2025-Q2 2025-08-11 23 | |
| 4D Molecular Therapeutics: first mention in 8-K-EX99.1 earnings release of 2023-05-11 (2023-Q1), source 4 | ||
| Need to work with contract manufacturers to scale up manufacturing processes for product candidates. | FY2025 2026-03-18 26 | |
| Solely owned patent portfolio includes 18 granted US patents expected to expire between May 2037 and April 2042; in-licensed UC Berkeley and UPenn portfolios with earlier expiration dates. | FY2025 2026-03-18 26 | |
| Face competition from major pharmaceutical and biotech companies including Regeneron, Roche, Vertex, and others | 2026-Q1 2026-05-07 28 | |
| 4D Molecular Therapeutics: first mention in 10-Q quarterly report of 2023-05-11 (2023-Q1), source 3 | ||
| Approximately 17,000 square feet of lab/manufacturing space; may face delays producing sufficient clinical supply quantities | 2026-Q1 2026-05-07 28 | |
| Many conditions for which product candidates evaluated are rare genetic diseases with limited patient pools for enrollment | 2026-Q1 2026-05-07 28 | |
| Undesirable side effects could halt development, prevent approval, or result in liability | 2025-Q3 2025-11-10 24 | |
| Raising additional capital through equity offerings could dilute existing stockholders' ownership interests. | 2026-Q1 2026-05-07 28 | |
| Unfavorable global economic conditions could weaken demand, increase clinical trial costs, or restrict capital access. | 2026-Q1 2026-05-07 28 | |
| Rely on third-party CDMOs for certain clinical and commercial drug materials; limited control over activities | 2026-Q1 2026-05-07 28 | |
| FDA may withdraw accelerated approval if confirmatory studies fail or sponsor delays required studies. | 2026-Q1 2026-05-07 28 | |
| ACA, IRA, state pricing controls, Medicare drug price negotiations, Medicaid rebate expansions create downward pricing pressure. | 2026-Q1 2026-05-07 28 | |
| Approval in US does not ensure approval in other jurisdictions; failure to obtain international approvals limits market. | 2026-Q1 2026-05-07 28 | |
| No assurance orphan drug designation obtained, maintained, or that it prevents competition from other drugs for same indication. | 2026-Q1 2026-05-07 28 | |
| Leahy-Smith Act, EU Patent Package, UPC create uncertainty; post-grant proceedings and pan-European litigation risk for European patents. | 2026-Q1 2026-05-07 28 | |
| Mandatory rebates, price controls, and reference pricing systems reduce drug prices and market demand. | 2026-Q1 2026-05-07 28 | |
| Regulatory approval process for novel genetic medicine products can be expensive and take longer than established modalities | 2026-Q1 2026-05-07 28 | |
| No assurance reimbursement available for product candidates; coverage delays and insufficient levels limit commercialization. | 2026-Q1 2026-05-07 28 | |
| Collaborators may fail to develop/commercialize, control IP disputes, be acquired, become bankrupt, or pursue competing products. | 2026-Q1 2026-05-07 28 | |
| All product candidates based on novel AAV genetic medicine with limited regulatory and clinical experience | 2026-Q1 2026-05-07 28 | |
| Gene therapies are novel, complex and difficult to manufacture with physical/chemical properties difficult to fully characterize | 2026-Q1 2026-05-07 28 | |
| Competitors with greater resources and patent portfolios may obtain patents preventing our commercialization. | 2026-Q1 2026-05-07 28 | |
| Collaborators may infringe third-party IP; disputes may delay/terminate programs or result in costly litigation | FY2025 2026-03-18 26 | |
| Anti-Kickback Statute prohibits remuneration to induce referrals; applies to advisory boards and physician relationships. | 2025-Q3 2025-11-10 24 | |
| False Claims Act liability for off-label promotion or non-compliance with healthcare laws; whistleblower qui tam actions possible. | 2025-Q3 2025-11-10 24 | |
| Foreign Corrupt Practices Act applies to international operations; prohibits corrupt payments to foreign officials. | 2025-Q3 2025-11-10 24 | |
4D Molecular Therapeutics Reported KPIs (as disclosed) (76)
The story KPIs of 4D Molecular Therapeutics that standard databases usually miss, grouped by publication, most recent first, with source number. NadirAlpha methodology
| KPI | Value / change | Source |
|---|---|---|
| 4D Molecular Therapeutics, published 2026-08-13, period 2026-Q2 | ||
| Cash and equivalents | 430,629 | 31 |
| 4D Molecular Therapeutics, published 2026-05-07, period 2026-Q1 | ||
| Cash, cash equivalents and marketable securities | 457,631 | 29 |
| Cash and cash equivalents and marketable securities | 457.6 million | 28 |
| Accumulated deficit | 785.1 million | 28 |
| 4D Molecular Therapeutics, published 2026-03-18, period FY2025 | ||
| Leased facility square feet | 91,000 | 26 |
| Internal manufacturing square feet | 17,000 | 26 |
| Cash runway | $514 million | 27 |
| 4FRONT-1 enrollment | over 500 patients | 27 |
| 4FRONT target enrollment per trial | 480 patients | 27 |
| 4D Molecular Therapeutics, published 2025-11-10, period 2025-Q3 | ||
| Total stockholders' equity | 368,983 | 25 |
| Cash, cash equivalents and marketable securities | 372,228 | 25 |
| Accumulated deficit | (735,701) | 25 |
| 4D Molecular Therapeutics, published 2025-08-11, period 2025-Q2 | ||
| Expected annual cash compensation savings | approximately $15 million | 23 |
| Cash runway | $417 million | 23 |
| Cash, cash equivalents and marketable securities | 417.0 million | 22 |
| Accumulated deficit | 678.8 million | 22 |
| 4D Molecular Therapeutics, published 2025-05-08, period 2025-Q1 | ||
| Cash, cash equivalents and marketable securities | $458 million | 21 |
| 4D Molecular Therapeutics, published 2025-02-28, period FY2024 | ||
| Unrecognized stock-based compensation expense | $54.5 million | 18 |
| Office space leased | 91,000 | 18 |
| Intrinsic value of outstanding stock options | $0.3 million | 18 |
| Cash, cash equivalents and marketable securities | $505.5 million | 18 |
| Cash and equivalents | $505.5 million | 18 |
| Cash and equivalents | $505 million | 19 |
| Accumulated deficit | $576.2 million | 18 |
| 4D Molecular Therapeutics, published 2025-01-10, period 2024-Q4 | ||
| Treatment experienced total | 16 (73%) | 17 |
| Treatment experienced 3E10 vg/eye | 7 (78%) | 17 |
| Treatment experienced 1E10 vg/eye | 9 (75%) | 17 |
| Baseline CST total | 499 (356–671) mm | 17 |
| baseline CST 5E9 vg eye | 515 mm | 17 |
| baseline CST 3E10 vg eye | 513 (382–671) mm | 17 |
| baseline CST 1E10 vg eye | 488 (356–669) mm | 17 |
| baseline BCVA total | 63 (32–84) ETDRS letters | 17 |
| baseline BCVA 5E9 vg eye | 68 ETDRS letters | 17 |
| baseline BCVA 3E10 vg eye | 63 (41–79) ETDRS letters | 17 |
| baseline BCVA 1E10 vg eye | 62 (32–84) ETDRS letters | 17 |
| 4D Molecular Therapeutics, published 2024-11-13, period 2024-Q3 | ||
| cash and cash equivalents and marketable securities | 550.7 million | 15 |
| Accumulated deficit | 526.5 million | 15 |
| Patients completing topical steroid prophylaxis taper | 99% | 16 |
| PRISM Phase 1 2 52 week injection free rate severe population | 83% | 16 |
| PRISM Phase 1 2 52 week injection free rate recently diagnosed population | 87% | 16 |
| PRISM Phase 1 2 52 week injection free rate broad population | 70% | 16 |
| IOI rate | numerically similar to approved anti-VEGF agents | 16 |
| 4D Molecular Therapeutics, published 2024-08-08, period 2024-Q2 | ||
| Cash and equivalents | $578 million | 14 |
| cash and cash equivalents and marketable securities | 577.7 million | 13 |
| Accumulated deficit | 482.7 million | 13 |
| 4D Molecular Therapeutics, published 2024-05-09, period 2024-Q1 | ||
| cash and cash equivalents and marketable securities | 588.9 million | 11 |
| Accumulated deficit | 447.7 million | 11 |
| R&D Expenses | 27.9 million | 12 |
| Net Loss | 32.4 million | 12 |
| IPO net proceeds | 204.7 million | 11 |
| G&A Expenses | 10.3 million | 12 |
| Cash and Cash Equivalents as of March 31 | 589 million | 12 |
| AGT License Agreement upfront payment | 20.0 million | 11 |
| 2024 Offering underwriter option net proceeds | 34.9 million | 11 |
| 2024 Offering net proceeds | 281.2 million | 11 |
| 2023 Offering net proceeds | 129.2 million | 11 |
| 2022 ATM Offering shares sold | 1.1 million | 11 |
| 2022 ATM Offering net proceeds | 19.1 million | 11 |
| 2022 ATM Offering available for sale | 80.1 million | 11 |
| 2021 Offering net proceeds | 111.1 million | 11 |
| 4D Molecular Therapeutics, published 2024-02-29, period FY2023 | ||
| Unrecognized stock-based compensation expense | 55.0 million | 9 |
| patients dosed 4d 150 | 110 | 10 |
| Intrinsic value of outstanding stock options | 46.9 million | 9 |
| cash position December 31 | $299 million | 10 |
| Cash, cash equivalents and marketable securities | 299.2 million | 9 |
| Accumulated deficit | 415.3 million | 9 |
| 4D Molecular Therapeutics, published 2023-11-09, period 2023-Q3 | ||
| operational runway | first half of 2026 | 8 |
| cash and cash equivalents and marketable securities | 319.7 million | 7 |
| Accumulated deficit | 383.0 million | 7 |
| 4D Molecular Therapeutics, published 2023-08-09, period 2023-Q2 | ||
| cash and cash equivalents and marketable securities | $310.3 million | 5 |
| Accumulated deficit | $372.8 million | 5 |
| Cash and cash equivalents and marketable securities | $310 million | 6 |
| 4D Molecular Therapeutics, published 2023-05-11, period 2023-Q1 | ||
| cash and cash equivalents and marketable securities | 201.9 million | 3 |
| Accumulated deficit | 343.2 million | 3 |
| R&D Expenses | 22.4 | 4 |
| G&A Expenses | 8.0 | 4 |
4D Molecular Therapeutics Development
The business development of 4D Molecular Therapeutics period by period up to Q2 2026, each text from the original report of that period, source numbers lead to the source. NadirAlpha methodology
FY2026: 4D Molecular Therapeutics
4D Molecular Therapeutics, which has no approved products and generates no product revenue, earned collaboration and license fees of 3 million in Q1 2026 and 3.8 million in Q2 2026, primarily from clinical trial cost-sharing with Otsuka 28 29 31. 4D Molecular Therapeutics recorded net losses of 68.8 million in Q1 and 72.9 million in Q2, driven by higher R&D expenses as Phase 3 trials advanced 29 31. The company completed 4FRONT-1 enrollment ahead of schedule in Q1 2026 with 523 patients randomized, and completed 4FRONT-2 enrollment in Q2 2026, with topline data from both trials expected in 2027 29 31. 4D Molecular Therapeutics entered a credit facility with Hercules Capital for up to $200 million, with $20 million funded at closing in June 2026 30, and held $457.6 million in combined cash and marketable securities as of March 31, 2026, expected to fund operations into the second half of 2028 29.
FY2025: 4D Molecular Therapeutics
4D Molecular Therapeutics recorded FY2025 collaboration and license revenue of $85.2 million, entirely attributable to the $85 million upfront payment received in Q4 2025 from Otsuka Pharmaceutical's agreement for exclusive rights to develop and commercialize 4D-150 in Japan, China, Australia, and other APAC markets, compared to zero revenue in FY2024 26 27. 4D Molecular Therapeutics reported a net loss of $140.1 million for FY2025, reduced from $160.9 million in FY2024, while R&D expenses increased 38% to $195.7 million, primarily reflecting a $35.5 million rise in clinical trial activity for product candidates 26 27. Both Phase 3 wet AMD trials for 4D-150 were advanced during the year: 4FRONT-1 enrolled its first patients in Q1 2025 and completed enrollment of over 500 patients within approximately 11 months, while 4FRONT-2 was initiated in June 2025 ahead of schedule, with topline data from both trials expected in 2027 21 23 26. 4D Molecular Therapeutics streamlined its pipeline by terminating 4D-110 and 4D-125 and pausing three additional earlier-stage programs in Q1 2025, and completed a workforce reduction of approximately 25% in July 2025 to concentrate resources on late-stage execution 21 23. Capital resources were reinforced through the Otsuka upfront payment, approximately $93 million in net proceeds from a November 2025 equity offering, and a $7.5 million initial equity investment from the Cystic Fibrosis Foundation, extending the expected cash runway into the second half of 2028 25 26 27.
FY2024: 4D Molecular Therapeutics
4D Molecular Therapeutics generated no product revenue in FY2024, remaining a clinical-stage company; collaboration and license revenue fell to $37 thousand from $20.7 million in 2023, as the prior-year figure included a $20.0 million upfront payment from the AGT license agreement recognized in 2023 (18). Net loss widened to $160.9 million from $100.8 million, driven by a 46% increase in R&D expenses to $141.3 million reflecting expanded clinical trial activity for lead program 4D-150 (18, 19). A February 2024 public offering raised approximately $316 million in net proceeds, leaving cash, equivalents, and marketable securities at $505 million as of December 31, 2024, with runway expected into 2028 (19). The 4D-150 program generated multiple positive interim data readouts across wet AMD and DME indications and secured FDA alignment that a single Phase 3 trial is acceptable as the basis for a future BLA submission in DME when combined with 4FRONT Phase 3 wet AMD data (17, 18). In January 2025, the company announced a strategic pipeline prioritization focusing development resources on 4D-150 and 4D-710 for cystic fibrosis while pausing 4D-175, 4D-725, and 4D-310 and terminating 4D-110 and 4D-125 (19).
FY2023: 4D Molecular Therapeutics
4D Molecular Therapeutics recorded FY2023 collaboration and license revenue of $20.7 million, a 562% increase from $3.1 million in 2022, reflecting the $20.0 million upfront payment from an intravitreal vector licensing agreement with Astellas Gene Therapies executed in July 2023 (9). Net loss narrowed to $100.8 million from $107.5 million in 2022, while research and development expenses increased 21% to $97.1 million, driven by clinical trial progression and higher headcount (9). 4D Molecular Therapeutics's lead program, 4D-150 for wet AMD, completed Phase 2 Dose Expansion enrollment ahead of schedule and received EMA PRIME designation in Q3 2023, with Phase 2 randomized interim data supporting plans for Phase 3 pivotal development (8, 10). In December 2023, the company entered a co-development and co-commercialization agreement with Arbor Biotechnologies for up to six CNS-targeting AAV-delivered CRISPR/Cas candidates on a 50-50 cost-and-profit-sharing basis (9). A May 2023 public equity offering generated net proceeds of approximately $129 million, and the $20.0 million Astellas upfront payment was received in Q3 2023, supporting an operational runway into the first half of 2026 (5, 8).
Glossary
- Revenue: Revenue from contracts with customers, net of sales deductions, as the company itself reports it; not total output, gross revenue, GMV or order intake.
- Op. income: The operating line of the income statement; EBIT only as a marked fallback, never pre-tax or ordinary income.
- Net income: Net income attributable to the shareholders of the parent, after discontinued operations; not the result including minority interests, not comprehensive income.
- EPS: Diluted earnings per share attributable to the shareholders of the parent; a printed figure always beats a calculated one, calculated values are marked.
- FCF: Free cash flow = operating cash flow minus capital expenditure on property, plant and equipment; the company's own free cash flow figure is shown separately.
- OCF: Cash flow from operating activities as reported; IFRS companies may show interest paid in financing cash flow, so the figure is not always comparable.
- Cash: Cash and cash equivalents, without securities unless the company reports them as part of the position.
- Net Debt: Net debt = financial debt excluding lease liabilities minus cash at the same reporting date; the company's own net position may differ.
- *: derived, the formula is in the hover
- ≈: calculated, approximation
- ~: uncertain; the value stays visible, verdicts do not use it
- °: repaired by a targeted query against the document, or curated with documentary evidence
- EBIT: EBIT as a fallback: the income statement carries no operating line
- basic: basic earnings per share as a fallback when diluted is missing
Sources: quarterly reports, annual reports and investor relations documents
39 sources on 4D Molecular Therapeutics since 2023; the superscript numbers in the chapters refer to these rows, older documents are in the expandable part. NadirAlpha methodology
Older sources (+8)
| # | Document type | Published |
|---|---|---|
| #202 | 10-K annual report | 2021-03-25 |
| #206 | 10-K annual report | 2021-03-25 |
| #203 | 10-Q quarterly report | 2021-05-13 |
| #207 | 10-Q quarterly report | 2021-05-13 |
| #204 | 10-Q quarterly report | 2021-08-12 |
| #208 | 10-Q quarterly report | 2021-08-12 |
| #201 | 10-Q quarterly report | 2021-11-10 |
| #205 | 10-Q quarterly report | 2021-11-10 |
4D Molecular Therapeutics Stock FAQ
Where can I find the official investor relations documents of 4D Molecular Therapeutics?
NadirAlpha links all 39 original filings used (SEC filings) in the sources chapter: quarterly report, earnings release, annual report, each with type, publication date and a direct link; every figure in the report carries a source number.