4D Molecular Therapeutics Inc

Previous wording

We have built a deep portfolio of genetic medicine product candidates, with three novel, highly targeted next generation AAV vectors currently in the clinic. This portfolio includes six product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (“wet AMD”) and diabetic macular edema (“DME”), 4D-175 for geographic atrophy (“GA”), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (“XLRP”) and 4D-110 for the treatment of choroideremia. In addition, we have one product candidate in preclinical development: 4D-725 for alpha-1 antitrypsin deficiency lung disease.

Current wording

In January 2025, we implemented a strategic pipeline prioritization designed to prioritize the development of 4D-150 and 4D-710. Further, we will be seeking strategic alternatives, including potential partnering, for our other clinical stage product candidates: 4D-175 for the treatment of geographic atrophy, 4D-725 for the treatment of alpha-1 antitrypsin deficiency, and 4D-310 for the treatment of Fabry disease cardiomyopathy. In addition, we terminated the development of 4D-110 for the treatment of choroideremia and 4D-125 for the treatment of X-linked retinitis pigmentosa.

Previous wording

Our net losses were $43.8 million and $10.3 million for the three months ended September 30, 2024 and 2023, respectively, and $111.2 million and $68.6 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $526.5 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 $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.

Previous wording

We will require substantial additional funding to support our continuing operations and further the development of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaborations, strategic partnerships, or other strategic arrangements, for the foreseeable future. Adequate funding may not be available when needed or on terms acceptable to us, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from conflicts in the Middle East, the lingering impact of the COVID-19 pandemic, the war in Ukraine, rising interest rates, inflation and otherwise. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

Current wording

We will require substantial additional funding to support our continuing operations and further the development of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaborations, strategic partnerships, or other strategic arrangements, for the foreseeable future. Adequate funding may not be available when needed or on terms acceptable to us, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from conflicts in the Middle East, the lingering impact of the COVID-19 pandemic, the war in Ukraine, rising interest rates, tariffs, inflation and otherwise. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot assure you that we will ever be profitable or generate positive cash flow from operating 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 ophthalmology senior leadership team and announced formation of 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. 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.

Previous wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Current wording

Comparison of the Three Months Ended March 31, 2025 and 2024

Previous wording

Research and development expenses increased by $13.4 million, or 54%, from the three months ended September 30, 2023 to the three months ended September 30, 2024. The increase was primarily due to the following:

Current 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:

Previous wording

a $5.9 million increase in payroll and personnel expenses, including a $1.3 million increase in employee stock-based compensation, due to increased headcount of research and development personnel; and

Current 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;

Previous wording

a $6.3 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;

Current 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

Previous wording

a $1.2 million increase in facilities and other research and development expenses mainly due to higher consulting services, rent and software expenses.

Current 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.

Previous wording

a $1.6 million increase in payroll and personnel expenses due to increased headcount of general and administrative personnel;

Current wording

a $0.4 million increase in payroll and personnel expenses due to increased headcount of general and administrative personnel.

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 Offering 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 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.

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”). 1,684,550 shares of the Company’s common stock have been sold pursuant to the Sales Agreement for net proceeds to the Company of $34.4 million, after deducting issuance costs. On May 31, 2024, we terminated the Sales Agreement and the 2022 ATM Offering Program pursuant to the terms of the Sales Agreement.

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 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.

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 (the “2024 ATM Offering Program”). For the three and nine months ended September 30, 2024, no shares had been 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 three months ended March 31, 2025, no shares were sold pursuant to the Leerink Sales Agreement.

Previous wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $550.7 million.

Current wording

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $458.4 million.

Previous wording

We have experienced recurring net losses and had an accumulated deficit of $526.5 million as of September 30, 2024. 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 $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.

Previous wording

We believe that our existing cash and cash equivalents will allow us to fund our planned operations for at least one year from the date of the issuance of this report.

Current wording

We believe that our existing cash, cash equivalents and marketable securities will allow us to fund our planned operations for at least one year from the date of the issuance of the financial statements included in this report.

Previous wording

We do not have any committed external sources of funds. Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources to complete the clinical development for the product candidates for treatment of wet AMD, DME, GA, cystic fibrosis lung disease, alpha-1 antitrypsin deficiency lung disease, Fabry disease cardiomyopathy, XLRP, choroideremia or any other indication we may pursue. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter would result in fixed payment obligations and may involve agreements that include grants of security interests on our assets and restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, granting liens over our assets, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. Any debt financing or additional equity that we raise may contain terms that could adversely affect our common stockholders. Further, additional funds may not be available when we need them, on terms that are acceptable to us, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the war in Ukraine, conflicts in the Middle East, any expansion of these conflicts, rising interest rates and inflation, natural disasters and pandemics.

Current wording

We do not have any committed external sources of funds. Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources to complete the clinical development for the product candidates for treatment of wet AMD, DME, GA, cystic fibrosis lung disease, alpha-1 antitrypsin deficiency lung disease, Fabry disease cardiomyopathy or any other indication we may pursue. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter would result in fixed payment obligations and may involve agreements that include grants of security interests on our assets and restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, granting liens over our assets, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. Any debt financing or additional equity that we raise may contain terms that could adversely affect our common stockholders. Further, additional funds may not be available when we need them, on terms that are acceptable to us, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the war in Ukraine, conflicts in the Middle East, any expansion of these conflicts, rising interest rates and inflation, natural disasters and pandemics.

Previous wording

Net cash used in operating activities was $88.7 million for the nine months ended September 30, 2024. This was primarily due to the net loss of $111.2 million, adjusted for noncash charges of $18.2 million and net changes in operating assets and liabilities of $4.3 million. Noncash charges included $18.5 million of stock-based compensation expense, $3.6 million of depreciation and amortization and $1.4 million for the amortization of operating lease right-of-use assets, offset by $5.3 million net accretion of discount on marketable securities. Net changes in operating assets and liabilities included an increase of $8.9 million in accrued and other liabilities which were offset by decreases of $1.4 million in operating lease liabilities and $0.6 million in accounts payable and increases of $2.2 million in other assets and $0.5 million in prepaid expenses and other current assets.

Current 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.

Previous wording

Net cash used in operating activities was $51.1 million for the nine months ended September 30, 2023. This was primarily due to the net loss of $68.6 million, adjusted for noncash charges of $17.4 million and net changes in operating assets and liabilities of $0.1 million. Noncash charges included $13.8 million of stock-based compensation expense, $3.1 million of depreciation and amortization, $1.1 million for the amortization of operating lease right-of-use assets and $0.2 million change in fair value of derivative liability, offset by $0.8 million net accretion of discount on marketable securities. Net changes in operating assets and liabilities included a $1.0 million decrease in operating lease liabilities, $0.7 million decrease in deferred revenue and a $1.6 million increase in prepaid expenses and other current assets which were offset by a $2.0 million increase in accounts payable and $1.4 million increase in accrued and other liabilities.

Current 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.

Previous wording

Net cash provided by investing activities was $122.4 million for the nine months ended September 30, 2023. This was due to $144.8 million in maturities of marketable securities, offset by purchases of marketable securities of $20.2 million and purchases of property and equipment of $2.2 million.

Current 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.

Previous wording

Net cash used in investing activities was $309.5 million for the nine months ended September 30, 2024. This was due to purchases of marketable securities of $409.9 million and purchases of property and equipment of $2.8 million, offset by $103.2 million in maturities of marketable securities.

Current 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.

Previous wording

Net cash provided by financing activities was $152.1 million for the nine months ended September 30, 2023. This was primarily due to proceeds from the issuance of common stock upon public offering of $129.2 million, proceeds from the issuance of common stock from the ATM offering program of $19.1 million, proceeds from the issuance of common stock from the exercise of stock options of $3.1 million, and proceeds from the issuance of common stock from purchases from the ESPP of $0.7 million.

Current 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.

Previous wording

During the three and nine months ended September 30, 2024, 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, 2023.

Current 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.