4D Molecular Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 11, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 11, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-067040
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0000950170-25-106244
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 104 previous paragraphs and 114 current paragraphs.
75 unchanged; 26 reworded; 10 added; 3 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
In March 2025, we announced the first patients have been enrolled across multiple sites in the 4FRONT-1, our North American Phase 3 clinical trial evaluating 4D-150 for the treatment of wet AMD. In July 2025, we announced that initial enrollment and site activation for 4FRONT-1 have exceeded initial projections, reflecting continued strong engagement and enthusiasm from investigators and patients. We expect 52-week topline data in the first half of 2027, an acceleration of the timeline from the previous guidance to the second half of 2027, providing more than six months of expected cash runway beyond the expected data readout.
Current report
Additionally, our second Phase 3 trial of 4D-150 in wet AMD, 4FRONT-2, was initiated in June 2025, ahead of schedule. 4FRONT-2 is a global clinical trial and has an identical design to 4FRONT-1, except for enrolling both treatment naïve and recently diagnosed, treatment-experienced patients. We expect 52-week topline data for 4FRONT-2 in the second half of 2027, consistent with previous guidance.
Current report
In July 2025, we presented positive 60-week results from the 4D-150 SPECTRA clinical trial in DME where 4D-150 continued to be well tolerated with no intraocular inflammation observed at any timepoint or dose level. In addition, 4D-150 demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and anatomic control between 3E10 vg/eye, the selected Phase 3 dose, and lower doses. The Phase 3 dose achieved clinically meaningful 78% reduction in treatment burden vs. projected on-label aflibercept 2mg Q8W. The FDA and EMA are aligned on a proposed single Phase 3 clinical trial being acceptable for regulatory submissions for 4D-150 in DME.
Current report
We have incurred significant operating losses and expect that our operating losses will remain relatively stable as we increase expense on Phase 3 studies for 4D-150 in wet AMD offset by reduction in our expenses on early-stage research and development, and maintain, protect and enforce our intellectual property portfolio.
Current report
Workforce Reduction
Current report
On July 2, 2025, we 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. In connection with the workforce reduction, we estimate that we will pay cash expenses of approximately $3 million, including severance, benefits, and related termination costs, which will be paid primarily in the third quarter of 2025. 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 BLA preparation. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $417.0 million, which we believe is sufficient to support planned expenses to deliver 52-week topline data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials and Biologics License Application (“BLA”) preparation for 4D-150 in wet AMD, continue Phase 1/2 and pre-Phase 3 planning activities for 4D-150 in diabetic macular edema and continue ongoing Phase 1/2 development of 4D-710 in cystic fibrosis.
Current report
Research and development expenses increased by $28.9 million, or 48%, from the six months ended June 30, 2024 to the six months ended June 30, 2025. The increase was primarily due to the following:
Current report
a $9.5 million increase in payroll and personnel expenses primarily due to increased headcount from an increase in research and development personnel; and
Current report
General and administrative expenses increased by $3.6 million, or 17%, from the six months ended June 30, 2024 to the six months ended June 30, 2025. The increase was primarily due to:
Current report
Net cash provided by financing activities was $0.9 million for the six months ended June 30, 2025 which was due to proceeds from the issuance of common stock from ESPP purchases of $0.9 million.
Removed paragraphs (3)
Previous report
We have incurred significant operating losses and expect that our operating losses will increase significantly as we, among other things, continue to advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for, and, if approved, proceed to commercialization; broaden and improve our platform; acquire, discover, validate and develop additional product candidates; maintain, protect and enforce our intellectual property portfolio; and hire additional personnel.
Previous report
General and administrative expenses increased by $2.6 million, or 26%, from the three months ended March 31, 2024 to the three months ended March 31, 2025. The increase was primarily due to:
Previous report
There was no net cash provided by financing activities for the three months ended March 31, 2025.
Reworded paragraphs (26)
Previous wording
Our lead product candidate 4D-150 utilizes our proprietary R100 vector and a transgene cassette encoding aflibercept and inhibitory miRNA targeting vascular endothelial growth factor-C (“VEGF-C”). 4D-150 was designed to become the first backbone therapy for the treatment of retinal vascular diseases by providing multi-year sustained production of anti-VEGF from the retina with a single, safe, intravitreal injection, substantially reducing treatment burden and improving long-term patient outcomes. 4D-150 is initially being developed for the treatment of wet age-related macular degeneration (“wet AMD”) and diabetic macular edema (“DME”). In March 2025, we announced the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet AMD.
Current wording
Our lead product candidate 4D-150 utilizes our proprietary R100 vector and a transgene cassette encoding aflibercept and inhibitory miRNA targeting vascular endothelial growth factor-C (“VEGF-C”). 4D-150 was designed to become the first backbone therapy for the treatment of retinal vascular diseases by providing multi-year sustained production of anti-VEGF from the retina with a single, safe, intravitreal injection, substantially reducing treatment burden and improving long-term patient outcomes. 4D-150 is initially being developed for the treatment of wet age-related macular degeneration (“wet AMD”) and diabetic macular edema (“DME”).
Previous wording
Our second priority product candidate is 4D-710, which we believe is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis (CF). We believe these results will translate into durable clinical improvements in people with CF, including improved lung function and quality of life.
Current wording
Our second priority product candidate is 4D-710, which we believe is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis (CF). We believe these results will translate into durable clinical improvements in people with CF, including improved lung function and quality of life. We expect to provide an interim data update from the ongoing AEROW Phase 1 clinical trial and a program update in the fourth quarter of 2025.
Previous wording
Our net losses were $48.0 million and $32.4 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $624.2 million. We do not expect positive cash flows from operations in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Current wording
Our net losses were $54.7 million and $35.0 million for the three months ended June 30, 2025 and 2024, respectively, and $102.6 million and $67.4 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $678.8 million. We do not expect positive cash flows from operations in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Previous wording
At this time, we cannot reasonably estimate or know the nature, timing or estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. We expect our research and development expenses to increase for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, as our product candidates advance into later stages of development, as we begin to conduct larger clinical trials, as we seek regulatory approvals for any product candidates that successfully complete clinical trials, and incur expenses associated with hiring additional personnel to support our research and development efforts. We have strengthened our ophthalmology senior leadership team and announced formation of the Ophthalmology Advisory Board, ahead of first Phase 3 clinical trial initiation for 4D-150 in wet AMD. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. See the section titled “Risk Factors” for additional risks regarding regulatory development and approval.
Current wording
At this time, we cannot reasonably estimate or know the nature, timing or estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. However, we expect our overall research and development expenses to remain relatively stable in the near term as we leverage prior investments and streamline operations to offset for 4D-150 Phase 3 studies. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. See the section titled “Risk Factors” for additional risks regarding regulatory development and approval.
Previous wording
We expect our general and administrative expenses to increase as a result of increased personnel-related costs, patent costs for our product candidates, consulting, legal and accounting services associated with maintaining compliance with stock exchange listing and requirements of the SEC, investor relations costs, director and officer insurance premiums, and other costs associated with being a public company.
Current wording
We expect our general and administrative expenses to remain relatively stable or potentially decline in the near term as a result of operational streamlining while maintaining patents for our product candidates, consulting, legal and accounting services associated with maintaining compliance with stock exchange listing and requirements of the SEC, investor relations costs, director and officer insurance premiums, and other costs associated with being a public company.
Previous wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Previous wording
Revenue decreased by an immaterial amount from the three months ended March 31, 2024 to the three months ended March 31, 2025. Revenue for both periods was from CFF.
Current wording
Revenue increased by an immaterial amount from the three months ended June 30, 2024 to the three months ended June 30, 2025, and decreased by an immaterial amount from the six months ended June 30, 2024 to the six months ended June 30, 2025. Revenue for both periods was from CFF.
Previous wording
Research and development expenses increased by $12.8 million, or 46%, from the three months ended March 31, 2024 to the three months ended March 31, 2025. The increase was primarily due to the following:
Current wording
Research and development expenses increased by $16.1 million, or 51%, from the three months ended June 30, 2024 to the three months ended June 30, 2025. The increase was primarily due to the following:
Previous wording
a $4.5 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150; and
Current wording
a $9.3 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;
Previous wording
a $4.8 million increase in payroll and personnel expenses, including a $0.9 million increase in employee stock-based compensation, due to increased headcount of research and development personnel;
Current wording
a $4.7 million increase in payroll and personnel expenses primarily due to increased headcount of research and development personnel; and
Previous wording
a $3.5 million increase in facilities and other research and development expenses mainly due to higher rent, consulting services, software and information technology expenses.
Current wording
a $5.6 million increase in facilities and other research and development expenses primarily due to higher rent, consulting services, software and information technology expenses.
Previous wording
a $2.2 million increase in legal fees and consulting services related to public company compliance costs and increase in expenses related to information technology systems implementations; and
Current wording
a $2.8 million increase in legal fees and consulting services related to public company compliance costs and an increase in expenses related to information technology systems implementations; and
Previous wording
a $0.4 million increase in payroll and personnel expenses due to increased headcount of general and administrative personnel.
Current wording
an $0.8 million increase in payroll and personnel expenses primarily due to increased headcount of general and administrative personnel.
Previous wording
Other income, net, decreased by $0.1 million, or 1%, from the three months ended March 31, 2024 to the three months ended March 31, 2025. The decrease is attributable to lower balances of cash equivalents and marketable securities.
Current wording
Other income, net, decreased by $2.7 million, or 36%, from the three months ended June 30, 2024 to the three months ended June 30, 2025. It decreased by $2.8 million, or 21%, from the six months ended June 30, 2024 to the six months ended June 30, 2025. The decrease is attributable to lower balances of cash equivalents and marketable securities.
Previous wording
We have funded our operations primarily through the sale and issuance of our equity securities, including from the sale of our common stock in our IPO, Follow-on Offerings, and “at-the-market” offerings and the sale of our Series A, Series A-1, Series B and Series C redeemable preferred stock, and to a lesser extent from cash received pursuant to our collaboration and license agreements.
Current wording
We have funded our operations primarily through the sale and issuance of our equity securities, including from the sale of our common stock in our IPO, Follow-on Offerings, and “at-the-market” offerings and the sale of our redeemable preferred stock, and to a lesser extent from cash received pursuant to our collaboration and license agreements.
Previous wording
In December 2020, we completed our IPO. We issued and sold 9,660,000 shares of common stock at a price to the public of $23.00 per share. The aggregate net proceeds from our IPO were $204.7 million after deducting underwriting discounts and commissions and other offering costs.
Current wording
In December 2020, we issued and sold 9,660,000 shares of common stock in our IPO at a price to the public of $23.00 per share. The aggregate net proceeds from our IPO were $204.7 million after deducting underwriting discounts and commissions and other offering costs.
Previous wording
In March 2022, we filed a Registration Statement on Form S-3 covering the offering of up to $300.0 million of common stock, preferred stock, debt securities, warrants and units, which was declared effective by the SEC in April 2022 (the “S-3 Registration Statement”). In March 2022, we also entered into an Open Market Sales Agreement (the “Sales Agreement”) with Jefferies LLC as sales agent to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $100.0 million pursuant to the S-3 Registration Statement as an “at-the-market” offering under the Securities Act (the “2022 ATM Offering Program”). On May 31, 2024, we terminated the Sales Agreement and the 2022 ATM Offering Program pursuant to the terms of the Sales Agreement. At termination, 1,684,550 shares of the Company’s common stock had been sold pursuant to the Sales Agreement for net proceeds to the Company of $34.4 million, after deducting issuance costs.
Current wording
In March 2022, we filed a Registration Statement on Form S-3 covering the offering of up to $300.0 million of common stock, preferred stock, debt securities, warrants and units, which was declared effective by the SEC in April 2022 (the “S-3 Registration Statement”). In March 2022, we also entered into an Open Market Sales Agreement (the “Sales Agreement”) with Jefferies LLC as sales agent to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $100.0 million pursuant to the S-3 Registration Statement as an “at-the-market” offering under the Securities Act (the “2022 ATM Offering Program”). On May 31, 2024, we terminated the Sales Agreement and the 2022 ATM Offering Program pursuant to the terms of the Sales Agreement. At termination, 1,684,550 shares of our common stock had been sold pursuant to the Sales Agreement for net proceeds to us of $34.4 million, after deducting issuance costs.
Previous wording
In June 2024, we entered into a Sales Agreement (the “Leerink Sales Agreement”) with Leerink Partners LLC (“Leerink”) as sales agent to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $250.0 million pursuant to a Registration Statement on Form S-3 that we filed with the SEC in February 2024 as an “at-the-market” offering under the Securities Act. For the three months ended March 31, 2025, no shares were sold pursuant to the Leerink Sales Agreement.
Current wording
In June 2024, we entered into a Sales Agreement (the “Leerink Sales Agreement”) with Leerink Partners LLC (“Leerink”) as sales agent to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $250.0 million pursuant to a Registration Statement on Form S-3 that we filed with the SEC in February 2024 as an “at-the-market” offering under the Securities Act. For the six months ended June 30, 2025, no shares were sold pursuant to the Leerink Sales Agreement.
Previous wording
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $458.4 million.
Current wording
As of June 30, 2025, we had cash, cash equivalents and marketable securities of $417.0 million.
Previous wording
We have experienced recurring net losses and had an accumulated deficit of $624.2 million as of March 31, 2025. Our transition to profitability is dependent upon the successful development, approval and commercialization of our product candidates and those of our collaboration partners and achieving a level of revenue adequate to support our cost structure. We expect to continue to incur losses for the foreseeable future.
Current wording
We have experienced recurring net losses and had an accumulated deficit of $678.8 million as of June 30, 2025. Our transition to profitability is dependent upon the successful development, approval and commercialization of our product candidates and those of our collaboration partners and achieving a level of revenue adequate to support our cost structure. We expect to continue to incur losses for the foreseeable future.
Previous wording
Net cash used in operating activities was $47.8 million for the three months ended March 31, 2025. This was primarily due to the net loss of $48.0 million, adjusted for noncash charges of $7.4 million and net changes in operating assets and liabilities of $7.2 million. Noncash charges included $7.0 million of stock-based compensation expense, $1.1 million of depreciation and amortization and $0.7 million for the amortization of operating lease right-of-use assets, offset by $1.3 million net accretion of discount on marketable securities and $0.1 million change in fair value of derivative liability. Net changes in operating assets and liabilities included decreases of $0.8 million in operating lease liabilities, $2.3 million in accrued and other liabilities and $0.2 million in accounts payable, and increases of $2.8 million in other assets and $1.1 million in prepaid expenses and other current assets.
Current wording
Net cash used in operating activities was $91.1 million for the six months ended June 30, 2025. This was primarily due to the net loss of $102.6 million, adjusted for noncash charges of $13.1 million and net changes in operating assets and liabilities of $1.6 million. Noncash charges included $11.9 million of stock-based compensation expense, $2.2 million of depreciation and amortization and $1.4 million for the amortization of operating lease right-of-use assets, offset by $2.4 million net accretion of discount on marketable securities. Net changes in operating assets and liabilities included a $1.5 million decrease in operating lease liabilities and a $5.1 million increase in other assets, offset by a $4.3 million increase in accounts payable and a $0.7 million increase in accrued and other liabilities.
Previous wording
Net cash used in operating activities was $29.1 million for the three months ended March 31, 2024. This was primarily due to the net loss of $32.4 million, adjusted for noncash charges of $6.8 million and net changes in operating assets and liabilities of $3.5 million. Noncash charges included $6.0 million of stock-based compensation expense, $1.2 million of depreciation and amortization and $0.4 million for the amortization of operating lease right-of-use assets, offset by $0.8 million net amortization/accretion of premium/discount on marketable securities. Net changes in operating assets and liabilities included a $0.5 million decrease in operating lease liabilities, a $2.4 million decrease in accrued and other liabilities, a $1.3 million increase in prepaid expenses and other current assets and a $0.1 million increase in other assets, offset by $0.7 million increase in accounts payable and a $0.1 million increase in deferred revenue.
Current wording
Net cash used in operating activities was $59.3 million for the six months ended June 30, 2024. This was primarily due to the net loss of $67.4 million, adjusted for noncash charges of $12.2 million and net changes in operating assets and liabilities of $4.2 million. Noncash charges included $12.0 million of stock-based compensation expense, $2.4 million of depreciation and amortization and $0.9 million for the amortization of operating lease right-of-use assets, offset by $3.1 million net amortization/accretion of premium/discount on marketable securities. Net changes in operating assets and liabilities included a $1.0 million decrease in operating lease liabilities, a $0.1 million decrease in accounts payables, a $2.3 million increase in prepaid expenses and other current assets and a $1.6 million increase in other assets, offset by a $0.8 million increase in accrued and other liabilities and a $0.1 million increase in deferred revenue.
Previous wording
Net cash provided by investing activities was $31.9 million for the three months ended March 31, 2025. This was due to $166.7 million in maturities of marketable securities, offset by purchases of marketable securities of $134.1 million and purchases of property and equipment of $0.6 million.
Current wording
Net cash provided by investing activities was $18.1 million for the six months ended June 30, 2025. This was due to $268.3 million in maturities of marketable securities, offset by purchases of marketable securities of $249.5 million and purchases of property and equipment of $0.7 million.
Previous wording
Net cash used in investing activities was $263.2 million for the three months ended March 31, 2024. This was due to purchases of marketable securities of $277.3 million and purchases of property and equipment of $0.7 million, offset by $14.8 million in maturities of marketable securities.
Current wording
Net cash used in investing activities was $336.8 million for the six months ended June 30, 2024. This was due to purchases of marketable securities of $374.1 million and purchases of property and equipment of $1.0 million, offset by $38.3 million in maturities of marketable securities.
Previous wording
Net cash provided by financing activities was $318.8 million for the three months ended March 31, 2024. This was primarily due to proceeds from the 2024 Offering, net of issuance costs, of $315.7 million, and proceeds from the issuance of common stock from the exercise of stock options of $3.1 million.
Current wording
Net cash provided by financing activities was $336.1 million for the six months ended June 30, 2024. This was primarily due to proceeds from the issuance of common stock upon public offering, net of issuance costs, of $316.1 million, proceeds from the issuance of common stock from the 2022 ATM Offering Program of $15.3 million, proceeds from the issuance of common stock from the exercise of stock options and warrants of $4.0 million and proceeds from the issuance of common stock from ESPP purchases of $0.7 million.
Previous wording
During the three months ended March 31, 2025, there were no changes to our critical accounting policies and significant judgments and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
During the three and six months ended June 30, 2025, there were no changes to our critical accounting policies and significant judgments and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
a $2.1 million increase in facilities and other research and development expenses primarily due to higher rent, software and information technology expenses.
Current report — wording carried from elsewhere
a $13.8 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;
Current report — wording carried from elsewhere
General and administrative expenses increased by $0.9 million, or 9%, from the three months ended June 30, 2024 to the three months ended June 30, 2025. The increase was primarily due to an increase in legal fees and consulting services related to public company compliance costs and increase in expenses related to information technology systems implementations.