FDMT
4D Molecular TherapeuticsFDocument history
Earnings documents stored for FDMT.
Investor releaseQuarter not tagged2026-08-134DMT Reports Second Quarter 2026 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports Second Quarter 2026 Financial Results, Operational Highlights and Expected Upcoming Milestones
Completed enrollment for 4D-150 4FRONT-2 wet AMD Phase 3; topline data expected in H2 2027 4D-150 4FRONT-1 Phase 3 topline data expected in Q2 2027 Presented positive 2-year data from 4D-150 PRISM Phase 2b at ASRS, highlighting long-term continuous treatment effect and ongoing favorable safety profile Plan to initiate a 4D-150 DME Phase 3 in Q3 2026 Company to host an Investor Day on October 21, 2026, in New York City Entered into a strategic credit facility agreement with Hercules Capital, Inc. for up to $200 million, initial draw of $20 million $431 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q2 2026 financial results, provided operational highlights and outlined expected upcoming milestones. “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,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “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.” Recent Highlights and Expected Milestones Corporate Highlights: 4D-150 for Wet Age-related Macular Degeneration (AMD): 4D-150 for Diabetic Macular Edema (DME): 4D-175 for Geographic Atrophy: 4D-710 for Cystic Fibrosis: Q2 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $430.6 million as of June 30, 2026, as compared to $514.0 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating…Read full documentShow less
Completed enrollment for 4D-150 4FRONT-2 wet AMD Phase 3; topline data expected in H2 2027 4D-150 4FRONT-1 Phase 3 topline data expected in Q2 2027 Presented positive 2-year data from 4D-150 PRISM Phase 2b at ASRS, highlighting long-term continuous treatment effect and ongoing favorable safety profile Plan to initiate a 4D-150 DME Phase 3 in Q3 2026 Company to host an Investor Day on October 21, 2026, in New York City Entered into a strategic credit facility agreement with Hercules Capital, Inc. for up to $200 million, initial draw of $20 million $431 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q2 2026 financial results, provided operational highlights and outlined expected upcoming milestones. “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,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “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.” Recent Highlights and Expected Milestones Corporate Highlights: 4D-150 for Wet Age-related Macular Degeneration (AMD): 4D-150 for Diabetic Macular Edema (DME): 4D-175 for Geographic Atrophy: 4D-710 for Cystic Fibrosis: Q2 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $430.6 million as of June 30, 2026, as compared to $514.0 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028. Collaboration and License Revenue: Collaboration and license revenue was $3.8 million for the second quarter of 2026, as compared to an insignificant amount for the second quarter of 2025. The increase in revenue was primarily due to the clinical trial cost sharing and reimbursement amounts from Otsuka. R&D Expenses: Research and development expenses were $68.3 million for the second quarter of 2026, as compared to $48.0 million for the second quarter of 2025. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD. G&A Expenses: General and administrative expenses were $12.5 million for the second quarter of 2026, as compared to $11.5 million for the second quarter of 2025. Net Loss: Net loss was $72.9 million for the second quarter of 2026, as compared to net loss of $54.7 million for the second quarter of 2025. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, Backbone 4 Retina™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for, the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company's expectations regarding financing alternatives and potential partnerships, the Company’s use of proceeds, and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian PeiHead of Investor Relations and Strategic [email protected]
Investor releaseQuarter not tagged2026-08-06Collegium Pharmaceutical (COLL) Beats Q2 Earnings and Revenue Estimates
Zacks
Collegium Pharmaceutical (COLL) Beats Q2 Earnings and Revenue Estimates
Collegium Pharmaceutical (COLL) came out with quarterly earnings of $1.92 per share, beating the Zacks Consensus Estimate of $1.68 per share. This compares to earnings of $1.68 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +14.29%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $1.42 per share when it actually produced earnings of $1.76, delivering a surprise of +23.94%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Collegium Pharmaceutical, which belongs to the Zacks Medical - Drugs industry, posted revenues of $199.88 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.20%. This compares to year-ago revenues of $188 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Collegium Pharmaceutical shares have lost about 22.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Collegium Pharmaceutical has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Collegium Pharmaceutical was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in…Read full documentShow less
Collegium Pharmaceutical (COLL) came out with quarterly earnings of $1.92 per share, beating the Zacks Consensus Estimate of $1.68 per share. This compares to earnings of $1.68 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +14.29%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $1.42 per share when it actually produced earnings of $1.76, delivering a surprise of +23.94%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Collegium Pharmaceutical, which belongs to the Zacks Medical - Drugs industry, posted revenues of $199.88 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.20%. This compares to year-ago revenues of $188 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Collegium Pharmaceutical shares have lost about 22.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Collegium Pharmaceutical has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Collegium Pharmaceutical was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.03 on $228.5 million in revenues for the coming quarter and $7.56 on $863.9 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. 4D Molecular Therapeutics, Inc. (FDMT), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $1.04 per share in its upcoming report, which represents a year-over-year change of -6.1%. The consensus EPS estimate for the quarter has been revised 1.5% lower over the last 30 days to the current level. 4D Molecular Therapeutics, Inc.'s revenues are expected to be $1.56 million, up 15500% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Collegium Pharmaceutical, Inc. (COLL) : Free Stock Analysis Report 4D Molecular Therapeutics, Inc. (FDMT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05Bioventus (BVS) Q2 Earnings Meet Estimates
Zacks
Bioventus (BVS) Q2 Earnings Meet Estimates
Bioventus (BVS) came out with quarterly earnings of $0.22 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.21 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post earnings of $0.09 per share when it actually produced earnings of $0.15, delivering a surprise of +66.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Bioventus, which belongs to the Zacks Medical - Drugs industry, posted revenues of $153.21 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 1.16%. This compares to year-ago revenues of $147.66 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Bioventus shares have added about 80.4% since the beginning of the year versus the S&P 500's gain of 13%. While Bioventus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Bioventus was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year…Read full documentShow less
Bioventus (BVS) came out with quarterly earnings of $0.22 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.21 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post earnings of $0.09 per share when it actually produced earnings of $0.15, delivering a surprise of +66.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Bioventus, which belongs to the Zacks Medical - Drugs industry, posted revenues of $153.21 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 1.16%. This compares to year-ago revenues of $147.66 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Bioventus shares have added about 80.4% since the beginning of the year versus the S&P 500's gain of 13%. While Bioventus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Bioventus was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.17 on $149.16 million in revenues for the coming quarter and $0.79 on $605.34 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, 4D Molecular Therapeutics, Inc. (FDMT), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $1.04 per share in its upcoming report, which represents a year-over-year change of -6.1%. The consensus EPS estimate for the quarter has been revised 1.5% lower over the last 30 days to the current level. 4D Molecular Therapeutics, Inc.'s revenues are expected to be $1.56 million, up 15500% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bioventus Inc. (BVS) : Free Stock Analysis Report 4D Molecular Therapeutics, Inc. (FDMT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-30Amneal Pharmaceuticals (AMRX) Q2 Earnings and Revenues Surpass Estimates
Zacks
Amneal Pharmaceuticals (AMRX) Q2 Earnings and Revenues Surpass Estimates
Amneal Pharmaceuticals (AMRX) came out with quarterly earnings of $0.3 per share, beating the Zacks Consensus Estimate of $0.24 per share. This compares to earnings of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.00%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.17 per share when it actually produced earnings of $0.27, delivering a surprise of +58.82%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Amneal, which belongs to the Zacks Medical - Drugs industry, posted revenues of $796.2 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.70%. This compares to year-ago revenues of $724.51 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amneal shares have added about 51.6% since the beginning of the year versus the S&P 500's gain of 6.9%. While Amneal has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amneal was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy)…Read full documentShow less
Amneal Pharmaceuticals (AMRX) came out with quarterly earnings of $0.3 per share, beating the Zacks Consensus Estimate of $0.24 per share. This compares to earnings of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.00%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.17 per share when it actually produced earnings of $0.27, delivering a surprise of +58.82%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Amneal, which belongs to the Zacks Medical - Drugs industry, posted revenues of $796.2 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.70%. This compares to year-ago revenues of $724.51 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amneal shares have added about 51.6% since the beginning of the year versus the S&P 500's gain of 6.9%. While Amneal has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amneal was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.27 on $820.85 million in revenues for the coming quarter and $1.00 on $3.12 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. 4D Molecular Therapeutics, Inc. (FDMT), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $1.04 per share in its upcoming report, which represents a year-over-year change of -6.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. 4D Molecular Therapeutics, Inc.'s revenues are expected to be $0.02 million, up 100% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report 4D Molecular Therapeutics, Inc. (FDMT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-114D Molecular Therapeutics, Inc. (NASDAQ:FDMT) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates
Simply Wall St.
4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates
Investors in 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) had a good week, as its shares rose 7.4% to close at US$10.14 following the release of its quarterly results. Revenues of US$3.0m crushed expectations, although expenses understandably increased with statutory losses reaching US$1.01 per share, somewhat higher than what the analysts forecast. Earnings are an important time for investors, as they can track a company's performance, look at what the analysts are forecasting for next year, and see if there's been a change in sentiment towards the company. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Taking into account the latest results, the current consensus, from the eight analysts covering 4D Molecular Therapeutics, is for revenues of US$15.0m in 2026. This implies a substantial 83% reduction in 4D Molecular Therapeutics' revenue over the past 12 months. Per-share losses are expected to explode, reaching US$3.92 per share. Before this earnings announcement, the analysts had been modelling revenues of US$9.86m and losses of US$3.59 per share in 2026. Ergo, there's been a clear change in sentiment, with the analysts lifting this year's revenue estimates, while at the same time increasing their loss per share numbers to reflect the cost of achieving this growth. View our latest analysis for 4D Molecular Therapeutics There was no major change to the consensus price target of US$28.22, with growing revenues seemingly enough to offset the concern of growing losses. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. Currently, the most bullish analyst values 4D Molecular Therapeutics at US$36.00 per share, while the most bearish prices it at US$17.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. These estimates imply that revenue is expected to slow, with a forecast annualised decli…Read full documentShow less
Investors in 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) had a good week, as its shares rose 7.4% to close at US$10.14 following the release of its quarterly results. Revenues of US$3.0m crushed expectations, although expenses understandably increased with statutory losses reaching US$1.01 per share, somewhat higher than what the analysts forecast. Earnings are an important time for investors, as they can track a company's performance, look at what the analysts are forecasting for next year, and see if there's been a change in sentiment towards the company. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Taking into account the latest results, the current consensus, from the eight analysts covering 4D Molecular Therapeutics, is for revenues of US$15.0m in 2026. This implies a substantial 83% reduction in 4D Molecular Therapeutics' revenue over the past 12 months. Per-share losses are expected to explode, reaching US$3.92 per share. Before this earnings announcement, the analysts had been modelling revenues of US$9.86m and losses of US$3.59 per share in 2026. Ergo, there's been a clear change in sentiment, with the analysts lifting this year's revenue estimates, while at the same time increasing their loss per share numbers to reflect the cost of achieving this growth. View our latest analysis for 4D Molecular Therapeutics There was no major change to the consensus price target of US$28.22, with growing revenues seemingly enough to offset the concern of growing losses. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. Currently, the most bullish analyst values 4D Molecular Therapeutics at US$36.00 per share, while the most bearish prices it at US$17.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. These estimates imply that revenue is expected to slow, with a forecast annualised decline of 91% by the end of 2026. This indicates a significant reduction from annual growth of 32% over the last five years. By contrast, our data suggests that other companies (with analyst coverage) in the same industry are forecast to see their revenue grow 22% annually for the foreseeable future. It's pretty clear that 4D Molecular Therapeutics' revenues are expected to perform substantially worse than the wider industry. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at 4D Molecular Therapeutics. They also upgraded their revenue estimates for next year, even though it is expected to grow slower than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. Following on from that line of thought, we think that the long-term prospects of the business are much more relevant than next year's earnings. We have forecasts for 4D Molecular Therapeutics going out to 2028, and you can see them free on our platform here. You still need to take note of risks, for example - 4D Molecular Therapeutics has 2 warning signs (and 1 which can't be ignored) we think you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-084DMT Reports First Quarter 2026 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports First Quarter 2026 Financial Results, Operational Highlights and Expected Upcoming Milestones
4D-150 4FRONT-1 wet AMD Phase 3 randomization complete (N=523); topline data expected in H1 2027 4FRONT-2 enrollment completion expected in H2 2026; topline data expected in H2 2027 4D-150 PRISM wet AMD Phase 2b 2-year data expected at a scientific conference in Q3 2026, and SPECTRA DME trial 2-year data expected in H2 2026 $458 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q1 2026 financial results, provided operational highlights and outlined expected upcoming milestones. “We started 2026 with strong execution, completing enrollment in 4FRONT-1 ahead of schedule reflecting strong investigator and patient enthusiasm for 4D-150,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “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.” Recent Highlights and Expected Milestones 4D-150 for Wet Age-related Macular Degeneration: 4FRONT Global Phase 3 Program: 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Enrollment completion expected in H2 2026; topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Phase 2b 2-year data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in Q3 2026 4D-150 for Diabetic Macular Edema: SPECTRA clinical trial 2-year data expected in H2 2026 Global Phase 3 trial design expected in mid-2026 and initiation expected in Q3 2026 4D-175 for Geographic Atrophy: Company maintains an active IND and continues to evaluate strategic funding alternatives to advance the program into the clinic 4D-710 for Cystic Fibrosis: AEROW Phase 1/2 clinical trial and program update expected in H2 2026 Q1 2026 Financial R…Read full documentShow less
4D-150 4FRONT-1 wet AMD Phase 3 randomization complete (N=523); topline data expected in H1 2027 4FRONT-2 enrollment completion expected in H2 2026; topline data expected in H2 2027 4D-150 PRISM wet AMD Phase 2b 2-year data expected at a scientific conference in Q3 2026, and SPECTRA DME trial 2-year data expected in H2 2026 $458 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q1 2026 financial results, provided operational highlights and outlined expected upcoming milestones. “We started 2026 with strong execution, completing enrollment in 4FRONT-1 ahead of schedule reflecting strong investigator and patient enthusiasm for 4D-150,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “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.” Recent Highlights and Expected Milestones 4D-150 for Wet Age-related Macular Degeneration: 4FRONT Global Phase 3 Program: 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Enrollment completion expected in H2 2026; topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Phase 2b 2-year data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in Q3 2026 4D-150 for Diabetic Macular Edema: SPECTRA clinical trial 2-year data expected in H2 2026 Global Phase 3 trial design expected in mid-2026 and initiation expected in Q3 2026 4D-175 for Geographic Atrophy: Company maintains an active IND and continues to evaluate strategic funding alternatives to advance the program into the clinic 4D-710 for Cystic Fibrosis: AEROW Phase 1/2 clinical trial and program update expected in H2 2026 Q1 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $458 million as of March 31, 2026, as compared to $514 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028. Collaboration and License Revenue: Collaboration and license revenue was $3.0 million for the first quarter of 2026, as compared to an insignificant amount for the first quarter of 2025. The increase in revenue was primarily due to the clinical trial cost sharing and reimbursement amounts from Otsuka. R&D Expenses: Research and development expenses were $65.0 million for the first quarter of 2026, as compared to $40.7 million for the first quarter of 2025. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD. G&A Expenses: General and administrative expenses were $11.7 million for the first quarter of 2026, as compared to $12.9 million for the first quarter of 2025. Net Loss: Net loss was $68.8 million for the first quarter of 2026, as compared to net loss of $48.0 million for the first quarter of 2025. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company's expectations regarding financing alternatives and potential partnerships, the Company’s use of proceeds, and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian Pei Head of Investor Relations and Strategic Finance [email protected]
Investor releaseQuarter not tagged2026-03-194D Molecular Therapeutics, Inc. (FDMT) Q4 Earnings and Revenues Beat Estimates
Zacks
4D Molecular Therapeutics, Inc. (FDMT) Q4 Earnings and Revenues Beat Estimates
4D Molecular Therapeutics, Inc. (FDMT) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of a loss of $0.53 per share. This compares to a loss of $0.9 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +180.75%. A quarter ago, it was expected that this company would post a loss of $1.02 per share when it actually produced a loss of $1.01, delivering a surprise of +0.98%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. 4D Molecular Therapeutics, which belongs to the Zacks Medical - Drugs industry, posted revenues of $85.09 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 147.86%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. 4D Molecular Therapeutics shares have added about 14.8% since the beginning of the year versus the S&P 500's decline of 1.9%. While 4D Molecular Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for 4D Molecular Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will b…Read full documentShow less
4D Molecular Therapeutics, Inc. (FDMT) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of a loss of $0.53 per share. This compares to a loss of $0.9 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +180.75%. A quarter ago, it was expected that this company would post a loss of $1.02 per share when it actually produced a loss of $1.01, delivering a surprise of +0.98%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. 4D Molecular Therapeutics, which belongs to the Zacks Medical - Drugs industry, posted revenues of $85.09 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 147.86%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. 4D Molecular Therapeutics shares have added about 14.8% since the beginning of the year versus the S&P 500's decline of 1.9%. While 4D Molecular Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for 4D Molecular Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$1.05 on $0.03 million in revenues for the coming quarter and -$3.40 on $25.7 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 36% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, IGC Pharma, Inc. (IGC), has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.02 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. IGC Pharma, Inc.'s revenues are expected to be $0.19 million, down 26.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report 4D Molecular Therapeutics, Inc. (FDMT) : Free Stock Analysis Report IGC Pharma, Inc. (IGC) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-03-194DMT Reports Full Year 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports Full Year 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
Completed enrollment in 4D-150 4FRONT-1 wet AMD Phase 3 trial within approximately 11 months, ahead of initial projections and reflecting strong interest from investigators and patients; topline data expected in H1 2027 PRISM wet AMD Phase 2b 2-year data expected in mid-2026 and SPECTRA DME trial 2-year data in H2 2026 4D-150 DME global Phase 3 trial initiation expected in Q3 2026 $514 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported full year 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “2025 was a transformative year for 4DMT highlighted by meaningful progress advancing 4D-150 with rapid Phase 3 trial enrollment, presenting strong 4D-150 Phase 1/2 durability data, entering a strategic partnership with Otsuka and strengthening our financial position,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “These achievements position us well for execution in 2026 and beyond as we continue toward our goal of redefining the treatment paradigm for retinal vascular disease with 4D-150, with our first pivotal data readout for wet AMD expected in the first half of 2027.” Recent Corporate Highlights Expanded Leadership to Support Late-Stage Execution and Commercial Readiness Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees Kristian Humer joined as Chief Financial Officer Julie Clark, M.D., was promoted to Chief Medical Officer Katy Barglow, Ph.D., was promoted to Chief Technical Officer Kim Maplestone was promoted to Chief Clinical Operations Officer Chris Simms’ role expanded to Chief Commercial & Business Officer Entered Strategic Partnership with Otsuka Pharmaceutical Co., Ltd. for 4D-150 in Asia-Pacific Region 4DMT received $85 million upfront cash payment in the fourth quarter of 2025 and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supp…Read full documentShow less
Completed enrollment in 4D-150 4FRONT-1 wet AMD Phase 3 trial within approximately 11 months, ahead of initial projections and reflecting strong interest from investigators and patients; topline data expected in H1 2027 PRISM wet AMD Phase 2b 2-year data expected in mid-2026 and SPECTRA DME trial 2-year data in H2 2026 4D-150 DME global Phase 3 trial initiation expected in Q3 2026 $514 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported full year 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “2025 was a transformative year for 4DMT highlighted by meaningful progress advancing 4D-150 with rapid Phase 3 trial enrollment, presenting strong 4D-150 Phase 1/2 durability data, entering a strategic partnership with Otsuka and strengthening our financial position,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “These achievements position us well for execution in 2026 and beyond as we continue toward our goal of redefining the treatment paradigm for retinal vascular disease with 4D-150, with our first pivotal data readout for wet AMD expected in the first half of 2027.” Recent Corporate Highlights Expanded Leadership to Support Late-Stage Execution and Commercial Readiness Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees Kristian Humer joined as Chief Financial Officer Julie Clark, M.D., was promoted to Chief Medical Officer Katy Barglow, Ph.D., was promoted to Chief Technical Officer Kim Maplestone was promoted to Chief Clinical Operations Officer Chris Simms’ role expanded to Chief Commercial & Business Officer Entered Strategic Partnership with Otsuka Pharmaceutical Co., Ltd. for 4D-150 in Asia-Pacific Region 4DMT received $85 million upfront cash payment in the fourth quarter of 2025 and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration The Company is eligible for up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties 4DMT retains full development and commercialization rights for 4D-150 outside the Asia-Pacific region, including in the U.S., Europe and Latin America Strengthened Balance Sheet Position with $118 Million Financing, Extending Cash Runway into H2 2028 In October 2025, secured an equity investment from the Cystic Fibrosis (CF) Foundation of up to $11 million in two tranches, with the first tranche of $7.5 million received upfront, to accelerate the development of 4D-710 for the treatment of CF lung disease In October 2025, raised gross proceeds of $10 million from sale of common stock through at-the-market offering facility In November 2025, completed an equity offering with gross proceeds of $100 million before underwriting discounts, commissions and offering expenses, resulting in net proceeds of approximately $93 million Recent Highlights and Expected Milestones for 4D-150 4D-150 for Wet Age-related Macular Degeneration: 4FRONT Global Phase 3 Program: To further the potential for global regulatory success, target enrollment for both the 4FRONT-1 and the 4FRONT-2 Phase 3 clinical trials was increased from 400 to 480 patients per trial Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Announced positive long-term interim results (data cutoff: August 22, 2025) 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026 4D-150 for Diabetic Macular Edema: 2-year SPECTRA Phase 1/2 clinical trial data expected in H2 2026 Phase 3 trial design expected mid-2026 Global Phase 3 trial initiation expected in Q3 2026 Recent Highlights and Expected Milestones in 4D-710 Program for CF Lung Disease Announced positive long-term interim results from the AEROW Phase 1/2 clinical trial (data cut-off: December 1, 2025) Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Phase 2 ongoing, fully funded by the Cystic Fibrosis Foundation, with program update expected in H2 2026 Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $514 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028. Collaboration and License Revenue: Collaboration and license revenue was $85 million for the year ended December 31, 2025, as compared to $0 million for the year ended December 31, 2024. This increase was primarily due to the $85 million upfront cash payment related to the Otsuka collaboration agreement. R&D Expenses: Research and development expenses were $196 million for 2025, as compared to $141 million for 2024. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD. G&A Expenses: General and administrative expenses were $49 million for 2025, as compared to $47 million for 2024. Net Loss: Net loss was $140 million for 2025, as compared to net loss of $161 million for 2024. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company’s use of proceeds, the potential benefits of the investment from and collaboration with the CF Foundation, the potential additional second tranche funding from the CF Foundation and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Annual Report on Form 10-K filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian Pei Head of Investor Relations and Strategic Finance [email protected]
Investor releaseQuarter not tagged2025-11-104DMT Reports Third Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports Third Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
Entered strategic partnership with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of 4D-150 in the APAC region; to receive $85 million in upfront cash and expects to receive at least $50 million from cost sharing Announced positive long-term safety and efficacy data with 1.5 to 2 years of follow-up from the Phase 1/2 PRISM clinical trial in wet AMD Completed equity offering providing net proceeds of ~$93 million Announced up to $11 million equity investment from the Cystic Fibrosis Foundation to accelerate development of 4D-710 for cystic fibrosis into Phase 2 $372 million in cash, cash equivalents and marketable securities as of September 30, 2025, combined with upfront and expected cost sharing from Otsuka partnership and ~$93 million in net proceeds from equity offering, expected to fund currently planned operations into second half of 2028 EMERYVILLE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q3 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “In the third quarter, we made meaningful progress building upon and validating our business strategy focusing on 4D-150 and 4D-710,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “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.” Recent Corporate Highlights Announced Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific Region: 4DMT to receive $85 million upfront cash payment and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration The Company is eligible for up to $336 million in potential regulatory and commercial mi…Read full documentShow less
Entered strategic partnership with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of 4D-150 in the APAC region; to receive $85 million in upfront cash and expects to receive at least $50 million from cost sharing Announced positive long-term safety and efficacy data with 1.5 to 2 years of follow-up from the Phase 1/2 PRISM clinical trial in wet AMD Completed equity offering providing net proceeds of ~$93 million Announced up to $11 million equity investment from the Cystic Fibrosis Foundation to accelerate development of 4D-710 for cystic fibrosis into Phase 2 $372 million in cash, cash equivalents and marketable securities as of September 30, 2025, combined with upfront and expected cost sharing from Otsuka partnership and ~$93 million in net proceeds from equity offering, expected to fund currently planned operations into second half of 2028 EMERYVILLE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q3 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “In the third quarter, we made meaningful progress building upon and validating our business strategy focusing on 4D-150 and 4D-710,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “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.” Recent Corporate Highlights Announced Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific Region: 4DMT to receive $85 million upfront cash payment and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration The Company is eligible for up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties 4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the U.S., Europe and Latin America Completed an Equity Offering with Approximately $93 Million of Net Proceeds: Proceeds to support planned operations into second half of 2028, which include planned 4D-150 Phase 3 clinical trial in diabetic macular edema (DME), and provide more than 12 months of expected cash runway beyond the expected 4FRONT-1 topline data Strengthened Leadership Team to Drive 4D-150 Program Execution Julie Clark, M.D., was promoted to Chief Medical Officer, bringing over 20 years of experience in retina and global clinical development, with a proven track record across 10 BLA-enabling studies, including six Phase 3 trials, with leadership roles in development and approvals of EYLEA®, JETREA®, BEOVU® and IZERVAY® Liansheng Zhu, Ph.D., joined as SVP, Biometrics and Data Quality, bringing nearly two decades of global experience in late-stage and post-approval clinical development. His expertise includes biostatistics, statistical programming, data science and Health Economics and Outcomes Research. Dr. Zhu has led or contributed to multiple pivotal clinical trials and regulatory submissions resulting in efficient and successful U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, including for LUCENTIS®, BEOVU® and IZERVAY® Created Retina Leadership Advisory Board: Glenn P. Sblendorio – Former President and CEO of Iveric Bio Cal Roberts, M.D. – Former CEO of Lighthouse Guild, Former Chief Medical Officer of Bausch + Lomb, Clinical Professor of Ophthalmology at Weill Cornell Medical Center Wiley A. Chambers, M.D. – Former Director of the Division of Ophthalmology, Center for Drug Evaluation and Research at the FDA Recent Highlights and Expected Milestones for 4D-150 4D-150 for Wet AMD: 4FRONT Global Phase 3 Program: 4FRONT-1, North American Clinical Trial: Enrollment rate exceeds initial expectations, with over 200 patients randomized to date, and is on track to complete enrollment in Q1 2026, with 52-week topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Enrollment remains on track to be completed in H2 2026, with 52-week topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Announced positive long-term interim results (data cutoff: August 22, 2025) 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 4D-150 for DME: SPECTRA Clinical Trial: Presented positive 60-week results (data cutoff: May 3, 2025) 4D-150 continues to be well tolerated across all patients and dose levels, with no intraocular inflammation observed at any time point or dose level Following the three loading doses of aflibercept, 3E10 vg/eye, the Phase 3 dose demonstrated strong signals of clinical activity, with sustained gain of BCVA of +9.7 letters and reduction of CST of -174 µm from baseline Supplemental injections: Phase 3 dose achieved 78% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W Dose response observed for the Phase 3 dose vs. lower doses (58% fewer injections) Recent Highlights and Expected Milestones in 4D-710 Program 4D-710 for Cystic Fibrosis (CF) Lung Disease: Secured an equity investment from the CF Foundation of up to $11 million in two tranches, with the first tranche of $7.5 million received in October 2025 The funding will support: Phase 1 Redosing and Phase 2 Cohort in AEROW clinical trial Phase 3 Readiness Interim safety and efficacy data from AEROW Phase 1 clinical trial expected by year-end 2025 Q3 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $372 million as of September 30, 2025, as compared to $505 million as of December 31, 2024. The net decrease in cash was primarily a result of cash used in operations. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, together with the net proceeds from the November 2025 equity offering, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028. R&D Expenses: Research and development expenses were $49.4 million for the third quarter of 2025, as compared to $38.5 million for the third quarter of 2024. This increase was primarily driven by the Phase 3 clinical trials of 4D-150 in wet AMD. G&A Expenses: General and administrative expenses were $11.8 million for the third quarter of 2025, as compared to $12.7 million for the third quarter of 2024. The decrease was primarily due to decreased headcount of general and administrative personnel. Net Loss: Net loss was $56.9 million for the third quarter of 2025, as compared to net loss of $43.8 million for the third quarter of 2024. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company’s use of proceeds, the potential benefits of the investment from and collaboration with the CF Foundation, the potential additional second tranche funding from the CF Foundation and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian Pei Head of Investor Relations and Strategic Finance [email protected]
Investor releaseQuarter not tagged2025-08-114DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
4D-150 Phase 3 program in wet AMD advancing ahead of plan, with expected 4FRONT-1 data readout accelerated to H1 2027 from H2 2027 and 4FRONT-2 initiated ahead of schedule Presented positive 60-week results from 4D-150 SPECTRA clinical trial in DME Streamlined organization to drive late-stage execution $417 million in cash, cash equivalents and marketable securities as of June 30, 2025, expected to fund planned operations into 2028 EMERYVILLE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q2 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “During the past quarter, we advanced our 4D-150 program and streamlined operations to focus on late-stage execution,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “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 the FDA and the European Medicines Agency (EMA) that a single successful Phase 3 study could support approval in the U.S. and Europe.” Recent Corporate Highlights Streamlined Organization to Drive Accelerated Phase 3 Development Announced a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in the areas supporting early-stage research and development and support functions The workforce reduction is expected to provide annual cash compensation cost savings of approximately $15 million and offsets additional expenses expected based on the accelerated timelines for the 4FRONT…Read full documentShow less
4D-150 Phase 3 program in wet AMD advancing ahead of plan, with expected 4FRONT-1 data readout accelerated to H1 2027 from H2 2027 and 4FRONT-2 initiated ahead of schedule Presented positive 60-week results from 4D-150 SPECTRA clinical trial in DME Streamlined organization to drive late-stage execution $417 million in cash, cash equivalents and marketable securities as of June 30, 2025, expected to fund planned operations into 2028 EMERYVILLE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q2 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “During the past quarter, we advanced our 4D-150 program and streamlined operations to focus on late-stage execution,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “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 the FDA and the European Medicines Agency (EMA) that a single successful Phase 3 study could support approval in the U.S. and Europe.” Recent Corporate Highlights Streamlined Organization to Drive Accelerated Phase 3 Development Announced a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in the areas supporting early-stage research and development and support functions The workforce reduction is expected to provide annual cash compensation cost savings of approximately $15 million and offsets additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and Biologics License Application (BLA) preparation, which supports the Company’s cash runway into 2028, as previously guided Recent Highlights and Expected Milestones for 4D-150 4D-150 for Wet Age-related Macular Degeneration (Wet AMD): 4FRONT Global Phase 3 Program: Initial enrollment and site activation for 4FRONT-1, the North American Phase 3 clinical trial of 4D-150 in wet AMD, have exceeded initial projections, reflecting continued strong engagement and enthusiasm from investigators and patients 52-week topline data expected in H1 2027, accelerated from previous guidance of H2 2027 The second Phase 3 trial of 4D-150 in wet AMD, 4FRONT-2, was initiated in June 2025, ahead of schedule 52-week topline data for 4FRONT-2 are expected in H2 2027 PRISM Phase 1/2 Clinical Trial: 2-year data from Phase 1/2a and 18-month data from Phase 2b cohorts expected in Q4 2025 4D-150 for Diabetic Macular Edema (DME): SPECTRA Clinical Trial: Presented positive 60-week results (data cutoff: May 3, 2025) Across all patients and dose levels treated to date, 4D-150 continues to be well tolerated, with no intraocular inflammation observed at any timepoint or dose level No subjects required modification to the topical corticosteroid regimen, and all patients are currently off corticosteroids No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions were reported Mean intraocular pressure was within normal limits Post-three loading doses of aflibercept, 3E10 vg/eye, the Phase 3 dose demonstrated strong signals of clinical activity, with sustained gain of BCVA of +9.7 letters and reduction of CST of -174 µm from baseline Supplemental injections: Utilized stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity Clear dose response observed for the Phase 3 dose vs. lower doses (58% fewer injections) Phase 3 dose achieved 78% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W Phase 3 Planning: Following U.S. Food and Drug Administration (FDA) alignment, as communicated in January 2025, EMA is also aligned that a single Phase 3 clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the two ongoing wet AMD Phase 3 clinical trials, would be acceptable as the basis for a marketing authorization application submission for 4D-150 in DME Received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 4D-150 for the treatment of DME Next steps pending final FDA and EMA alignment on Phase 3 clinical trial design and funding pathway Recent Highlights and Expected Milestones in Pulmonology Program 4D-710 for Cystic Fibrosis Lung Disease: Completed enrollment of Cohort 4 (n=6) in Phase 1 stage of AEROW clinical trial (completed total enrollment of n=16 participants) Interim data from AEROW clinical trial and program update expected in Q4 2025 Q2 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $417 million as of June 30, 2025, as compared to $505 million as of December 31, 2024. The net decrease in cash was primarily a result of cash used in operations. We currently expect cash, cash equivalents and marketable securities to be sufficient to fund planned operations into 2028. R&D Expenses: Research and development expenses were $48.0 million for the second quarter of 2025, as compared to $31.9 million for the second quarter of 2024. This increase was primarily driven by the initiation of our first Phase 3 clinical trial of 4D-150 in wet AMD, including increased personnel and professional services to support Phase 3 development. G&A Expenses: General and administrative expenses were $11.5 million for the second quarter of 2025, as compared to $10.6 million for the second quarter of 2024. This increase was primarily driven by increased use of professional services. Net Loss: Net loss was $54.7 million for the second quarter of 2025, as compared to net loss of $35.0 million for the second quarter of 2024. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates and interactions with FDA and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian Pei Head of Investor Relations and Strategic Finance [email protected]
Investor releaseQuarter not tagged2025-08-014DMT Presents Positive 60-Week Results from 4D-150 SPECTRA Clinical Trial in DME and Regulatory Update
GlobeNewswire
4DMT Presents Positive 60-Week Results from 4D-150 SPECTRA Clinical Trial in DME and Regulatory Update
4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level 4D-150 demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and anatomic control Phase 3 dose (3E10 vg/eye) achieved clinically meaningful 78% reduction in treatment burden vs. projected on-label aflibercept 2mg Q8W EMA aligned with proposed single Phase 3 clinical trial being acceptable for regulatory submission for 4D-150 in DME, consistent with previously announced alignment with FDA EMERYVILLE, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced positive results from the SPECTRA clinical trial evaluating 4D-150 in patients with diabetic macular edema (DME), and alignment with the European Medicines Agency (EMA) on a registrational pathway for 4D-150 in DME. The data, which included both the 52-week primary endpoint and 60-week analyses, were presented by David Almeida, M.D., MBA, Ph.D., Erie Retina Research in an oral presentation titled “Interim Results from the SPECTRA Phase 2a Clinical Trial Evaluating Intravitreal 4D-150 in Adults with Diabetic Macular Edema” at the 43rd Annual American Society of Retina Specialists (ASRS) Scientific Meeting. “The positive results from the SPECTRA trial demonstrate the tolerability and consistent, durable clinical activity of 4D-150 in DME, highlighting the potential for the product candidate to become a backbone therapy that can dramatically reduce treatment burden compared to the labeled regimen of standard-of-care aflibercept 2mg every eight weeks,” said David Almeida, M.D., MBA, Ph.D. “4D-150 has the potential to fundamentally transform the treatment of DME by reducing treatment burden with a product that has adherence by design, while providing meaningful, lasting vision improvement. This is especially important in DME, which frequently occurs in a working-age population.” Clinical Trial Design & Interim Data from 4D-150 SPECTRA Clinical Trial (Data Cutoff of May 2, 2025): Objectives: Evaluate safety and tolerability, and identify dose level for further evaluation Study Population: Enrolled patients with h…Read full documentShow less
4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level 4D-150 demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and anatomic control Phase 3 dose (3E10 vg/eye) achieved clinically meaningful 78% reduction in treatment burden vs. projected on-label aflibercept 2mg Q8W EMA aligned with proposed single Phase 3 clinical trial being acceptable for regulatory submission for 4D-150 in DME, consistent with previously announced alignment with FDA EMERYVILLE, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced positive results from the SPECTRA clinical trial evaluating 4D-150 in patients with diabetic macular edema (DME), and alignment with the European Medicines Agency (EMA) on a registrational pathway for 4D-150 in DME. The data, which included both the 52-week primary endpoint and 60-week analyses, were presented by David Almeida, M.D., MBA, Ph.D., Erie Retina Research in an oral presentation titled “Interim Results from the SPECTRA Phase 2a Clinical Trial Evaluating Intravitreal 4D-150 in Adults with Diabetic Macular Edema” at the 43rd Annual American Society of Retina Specialists (ASRS) Scientific Meeting. “The positive results from the SPECTRA trial demonstrate the tolerability and consistent, durable clinical activity of 4D-150 in DME, highlighting the potential for the product candidate to become a backbone therapy that can dramatically reduce treatment burden compared to the labeled regimen of standard-of-care aflibercept 2mg every eight weeks,” said David Almeida, M.D., MBA, Ph.D. “4D-150 has the potential to fundamentally transform the treatment of DME by reducing treatment burden with a product that has adherence by design, while providing meaningful, lasting vision improvement. This is especially important in DME, which frequently occurs in a working-age population.” Clinical Trial Design & Interim Data from 4D-150 SPECTRA Clinical Trial (Data Cutoff of May 2, 2025): Objectives: Evaluate safety and tolerability, and identify dose level for further evaluation Study Population: Enrolled patients with high disease activity as measured by central subfield thickness (CST) 22 patients enrolled across 3 dose levels: 3E10 vg/eye (n=9) (Phase 3 dose) Lower doses (1E10 vg/eye, n=12; 5E9 vg/eye, n=1) 2 patients dosed with 1E10 vg/eye missed >50% of study visits and were considered not evaluable for injection burden or other efficacy parameters Safety Results Through 60 Weeks (n=22): 4D-150 was well tolerated with no intraocular inflammation at any timepoint No subjects required modification to the topical corticosteroid regimen, and all patients are currently off corticosteroids No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions were reported Mean intraocular pressure was within normal limits Efficacy Results Through 60 Weeks: Utilized stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity Phase 3 Dose: Sustained gain of best corrected visual acuity (BCVA) of +9.7 letters Sustained improvement in anatomic control, with reduction of CST, as measured by optical coherence tomography (OCT), of -174 µm Supplemental Injections: Post-aflibercept loading doses (3), patients treated with Phase 3 dose required substantially fewer supplemental injections compared to patients receiving lower doses or projected on-label aflibercept 2mg Q8W (expected Phase 3 comparator): Mean supplemental injections per patient: Phase 3 dose: 1.6 Lower doses: 3.7 Projected on-label aflibercept 2mg Q8W: 7.0 Dose response observed for Phase 3 dose vs. lower doses (58% fewer injections) Phase 3 dose demonstrated a reduction of 78% vs. projected on-label aflibercept 2mg Q8W 0-1 injections: 5 of 9 overall (Phase 3 dose) vs. 2 of 11 (lower doses) Injection-free: 4 of 9 overall (Phase 3 dose) vs. 1 of 11 overall (lower doses) 4D-150 DME Phase 3 Regulatory Update Following U.S. Food and Drug Administration (FDA) alignment, as communicated in January 2025, EMA is also aligned that a single Phase 3 clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the two planned Phase 3 clinical trials in the 4FRONT wet age-related macular degeneration (wet AMD) program, would be acceptable as the basis for a marketing authorization application (MAA) submission for 4D-150 in DME “The consistency of dose response, safety and efficacy data we’ve seen with 4D-150 across all patients evaluated in both DME and wet AMD reinforces our belief that 4D-150 has the potential to become a true backbone therapy, and may significantly improve the lives of millions of patients living with retinal vascular disease,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With alignment from both FDA and EMA for a single Phase 3 DME trial to complement the 4FRONT wet AMD program, we believe we have a clear streamlined path to bring 4D-150 to patients with high unmet need in two of the most prevalent blinding retinal vascular diseases.” About 4D-150 4D-150 is an investigational agent with the potential to become a backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes the Company’s customized and evolved intravitreal vector, R100, which was invented at 4DMT through the Company’s proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and DME, which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision. About DME DME, or diabetic macular edema, is a complication of diabetic retinopathy and is a highly prevalent disease with significant unmet medical need and poor treatment adherence. It is estimated that there are approximately one million individuals with DME in the U.S. according to published data. DME is characterized by inflammation swelling in the macula due to leakage from blood vessels, which can lead to vision loss. DME is typically treated with intravitreal anti-VEGF agents administered approximately every 4-12 weeks, although patient compliance with therapy is poor and results in high unmet medical need. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical development plans for 4D-150 and interactions with FDA and EMA. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on May 8, 2025 as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' current views and should not be relied upon as representing its views as of any subsequent time. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian Pei Head of Investor Relations and Strategic Finance [email protected]
Investor releaseQuarter not tagged2025-05-094DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
GlobeNewswire
4DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
Enrolled first patients in first 4D-150 Phase 3 clinical trial (4FRONT-1) in wet AMD, with over 50 clinical trial sites open to date Initiation of second 4D-150 Phase 3 clinical trial (4FRONT-2) expected in Q3 2025, with topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027 RMAT designation received from FDA for 4D-150 in DME, adding to previous regulatory designations of RMAT and PRIME (EMA) for 4D-150 in wet AMD $458 million in cash, cash equivalents, and marketable securities as of March 31, 2025, expected to fund planned operations into 2028 EMERYVILLE, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q1 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “The first quarter of 2025 marked a pivotal moment for 4DMT as we focused our pipeline on our highest value programs, 4D-150 and 4D-710, reported compelling 4D-150 Phase 2 results in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and initiated our first 4D-150 Phase 3 clinical trial 4FRONT-1 in wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With strong Phase 1/2 data, optimized Phase 3 trial design, and a world-class leadership team, we are well positioned to execute on our mission to dramatically improve lives and outcomes for patients living with retinal vascular diseases with 4D-150, a backbone therapy designed to provide long-lasting relief from frequent and burdensome injections. Our strong balance sheet provides us an expected operational runway into 2028, enabling us to deliver topline results from both wet AMD Phase 3 clinical trials in H2 2027 without raising additional capital. 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.” Recent Corporate Highlights Focused Pipeline and Extended Cash Runway Identified core programs: 4D-150 for wet AMD and DME and 4D-710 for cystic fibrosis (CF) lung disease Paused significant additional capital allocation and investment, pending additional fina…Read full documentShow less
Enrolled first patients in first 4D-150 Phase 3 clinical trial (4FRONT-1) in wet AMD, with over 50 clinical trial sites open to date Initiation of second 4D-150 Phase 3 clinical trial (4FRONT-2) expected in Q3 2025, with topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027 RMAT designation received from FDA for 4D-150 in DME, adding to previous regulatory designations of RMAT and PRIME (EMA) for 4D-150 in wet AMD $458 million in cash, cash equivalents, and marketable securities as of March 31, 2025, expected to fund planned operations into 2028 EMERYVILLE, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q1 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “The first quarter of 2025 marked a pivotal moment for 4DMT as we focused our pipeline on our highest value programs, 4D-150 and 4D-710, reported compelling 4D-150 Phase 2 results in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and initiated our first 4D-150 Phase 3 clinical trial 4FRONT-1 in wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With strong Phase 1/2 data, optimized Phase 3 trial design, and a world-class leadership team, we are well positioned to execute on our mission to dramatically improve lives and outcomes for patients living with retinal vascular diseases with 4D-150, a backbone therapy designed to provide long-lasting relief from frequent and burdensome injections. Our strong balance sheet provides us an expected operational runway into 2028, enabling us to deliver topline results from both wet AMD Phase 3 clinical trials in H2 2027 without raising additional capital. 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.” Recent Corporate Highlights Focused Pipeline and Extended Cash Runway Identified core programs: 4D-150 for wet AMD and DME and 4D-710 for cystic fibrosis (CF) lung disease Paused significant additional capital allocation and investment, pending additional financing or partnerships, for 4D-175 for geographic atrophy, 4D-725 for alpha-1 antitrypsin deficiency lung disease, and 4D-310 for Fabry disease cardiomyopathy Terminated development of 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa Paused investment into new preclinical product candidates As a result, cash runway was extended into 2028 and includes full execution and topline 52-week data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials in wet AMD, as well as ongoing Phase 1 & 2 clinical development of 4D-150 in DME and 4D-710 in CF Recent Highlights and Expected Milestones in Large Market Ophthalmology Portfolio 4D-150 for wet AMD: 4FRONT Global Phase 3 Program: Enrolled first patients in North American clinical trial, 4FRONT-1 Global clinical trial, 4FRONT-2, expected to initiate in Q3 2025 Primary endpoint 52-week topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Presented positive 52-week results from 3E10 vg/eye (Phase 3 dose) arm of Phase 2b Population Extension cohort (best available data as of January 15, 2025): In the broad population (n=30), 3E10 vg/eye demonstrated 83% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W; 70% of patients required 0-1 supplemental injection and 57% were injection-free In the recently diagnosed subgroup (n=15), which most resembles the Phase 3 4FRONT-1 and 4FRONT-2 patient populations, 3E10 vg/eye demonstrated 94% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W; 87% of patients required 0-1 supplemental injection and 80% were injection-free Improved and maintained best corrected visual acuity (BCVA) and central subfield thickness (CST) with fewer fluctuations 4D-150 continues to be well tolerated during up to three years of follow-up in all patients (n=71) treated with 3E10 vg/eye dose, with the highest 4D-150-related intraocular inflammation (SUN/NEI scales) observed as mild (1+) vitreous cells at a single timepoint in 2.8% (2 of 71) of patients Presented biomarker data from patients treated with 3E10 vg/eye in Phase 1/2a and 2b cohorts supporting ongoing multi-year durability with stable aqueous humor aflibercept concentrations consistently within projected therapeutic range with up to two years of follow-up (best available data as of November 20, 2024) 2-year data from Phase 1/2a and 18-month data from Phase 2b cohorts expected in Q4 2025 4D-150 for DME: SPECTRA Part 1 Clinical Trial: Presented positive interim 32-week data (data cutoff: December 13, 2024) Across all patients dosed to date, 4D-150 continues to be well-tolerated, with no intraocular inflammation observed at any timepoint or dose level Post-3 loading doses of aflibercept, 3E10 vg/eye demonstrated strong signals of clinical activity, with sustained gain of BCVA of +8.4 letters and reduction of CST of -194 µm from baseline 3E10 vg/eye achieved an 86% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W and dose response, with 61% reduction vs. the lower-dose cohort at 1E10 vg/eye, with 0.6 mean supplemental injections per patient, with stringent supplemental injection criteria 52-week interim data update expected at a scientific conference in Q3 2025 Phase 3 Planning: Announced alignment with U.S. Food and Drug Administration (FDA) on registrational path FDA aligned with proposed single Phase 3 clinical trial being acceptable for the basis of a BLA submission for 4D-150 in DME, based on review of data from SPECTRA and PRISM (wet AMD) clinical trials to date and planned global Phase 3 clinical development program for wet AMD Per FDA feedback, the Company may proceed to Phase 3 (SPECTRA Part 2 no longer needed), and the FDA is aligned with key design elements of a Phase 3 clinical trial with approximately 300-400 patients total with a primary endpoint of BCVA noninferiority vs. on-label aflibercept 2 mg (5 loading doses and Q8W) and revised supplemental injection criteria Received Regenerative Medicine Advanced Therapy (RMAT) designation from FDA, validating 4D-150’s potential to address the significant unmet medical needs in treating DME Next steps pending final FDA and EMA alignment on Phase 3 clinical trial design and funding pathway Recent Highlights and Expected Milestones in Pulmonology Program 4D-710 for CF Lung Disease: Ongoing enrollment extension of three additional participants in Cohort 4 (target enrollment of n=6) of Phase 1 stage of AEROW clinical trial (target total enrollment of n=16 participants) Interim data from AEROW clinical trial and program update expected at a scientific conference in H2 2025 Q1 2025 Financial Results Cash position: Cash, cash equivalents, and marketable securities were $458 million as of March 31, 2025, as compared to $505 million as of December 31, 2024. The net decrease in cash was primarily a result of cash used in operations. We currently expect cash, cash equivalents, and marketable securities to be sufficient to fund planned operations into 2028. R&D Expenses: Research and development expenses were $40.7 million for the first quarter of 2025, as compared to $27.9 million for the first quarter of 2024. This increase was primarily driven by the initiation of our first Phase 3 clinical trial of 4D-150 in wet AMD, including increased personnel and professional services to support Phase 3 development. G&A Expenses: General and administrative expenses were $12.9 million for the first quarter of 2025, as compared to $10.3 million for the first quarter of 2024. This increase was primarily driven by professional services. Net Loss: Net loss was $48.0 million for the first quarter of 2025, as compared to net loss of $32.4 million for the first quarter of 2024. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. Our lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. Our lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. Our second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of our product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of our product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates and interactions with FDA and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna Communications [email protected] Investors: Julian PeiHead of Investor Relations and Corporate [email protected]

