4D Molecular Therapeutics Inc

Previous wording

Our net losses were $35.0 million and $29.6 million for the three months ended June 30, 2024 and 2023, respectively, and $67.4 million and $58.3 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $482.7 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 $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.

Previous wording

In August 2019, we amended our agreement with uniQure and entered into a separate new collaboration and license agreement with uniQure. Neither party was required to pay monetary consideration in connection with the amendment or new agreement. We determined the incremental transaction price of the amendment and new agreement to be $5.1 million and recorded the amount as deferred revenue in August 2019. We began recognizing revenue related to uniQure in 2020 and recognized the remaining revenue under the agreement during the third quarter of 2023. We recognized revenue of $0.2 million and $0.5 million during the three and six months ended June 30, 2023, respectively, related to this agreement. See Note 7, Research and Collaboration Agreements, to our financial statements included elsewhere in this report for further discussion regarding the accounting treatment of this agreement.

Current wording

In August 2019, we amended our agreement with uniQure and entered into a separate new collaboration and license agreement with uniQure. Neither party was required to pay monetary consideration in connection with the amendment or new agreement. We determined the incremental transaction price of the amendment and new agreement to be $5.1 million and recorded the amount as deferred revenue in August 2019. We began recognizing revenue related to uniQure in 2020 and recognized the remaining revenue under the agreement during the third quarter of 2023. We recognized immaterial revenue during the three months ended September 30, 2023, and $0.6 million during the nine months ended September 30, 2023 related to this agreement. See Note 7, Research and Collaboration Agreements, to our condensed financial statements included elsewhere in this report for further discussion regarding the accounting treatment of this agreement.

Previous wording

Our other income (expense), net primarily consists of interest income earned on our cash equivalents and marketable securities and adjustments for the change in the fair value of our derivative liability which must be remeasured at each reporting date.

Current wording

Our other income, net primarily consists of interest income earned on our cash equivalents and marketable securities and adjustments for the change in the fair value of our derivative liability which must be remeasured at each reporting date.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

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

Previous wording

Revenue decreased by $0.2 million, or 98%, from the three months ended June 30, 2023 to the three months ended June 30, 2024, while revenue decreased by $0.5 million, or 94%, from the six months ended June 30, 2023 to the six months ended June 30, 2024. The decrease in revenue is due to revenue from uniQure that was fully earned in 2023 when the Company completed its performance obligation.

Current wording

Revenue decreased by $20.2 million, or 100%, from the three months ended September 30, 2023 to the three months ended September 30, 2024, while revenue decreased by $20.7 million, or 100%, from the nine months ended September 30, 2023 to the nine months ended September 30, 2024. The decrease in revenue is due to the upfront fees received from the License Agreement with Astellas in 2023.

Previous wording

Research and development expenses increased by $8.3 million, or 35%, from the three months ended June 30, 2023 to the three months ended June 30, 2024. The increase was primarily due to the following:

Current 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:

Previous wording

a $4.9 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;

Current wording

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

Previous wording

a $3.7 million increase in payroll and personnel expenses, including a $1.1 million increase in employee stock-based compensation, due to increased headcount of research and development personnel; and

Current 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

Previous wording

a $1.2 million increase in facilities and other research and development expenses mainly due to higher consulting services and fixed assets depreciation.

Current wording

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

Previous wording

Research and development expenses increased by $13.7 million, or 30%, from the six months ended June 30, 2023 to the six months ended June 30, 2024. The increase was primarily due to the following:

Current wording

Research and development expenses increased by $27.1 million, or 38%, from the nine months ended September 30, 2023 to the nine months ended September 30, 2024. The increase was primarily due to the following:

Previous wording

a $8.8 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;

Current wording

a $15.1 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;

Previous wording

a $2.4 million increase in payroll and personnel expenses, including a $0.5 million increase in employee stock-based compensation, due to increased headcount of research and development personnel; and

Current wording

a $9.6 million increase in payroll and personnel expenses, including a $2.4 million increase in employee stock-based compensation, due to increased headcount of research and development personnel; and

Previous wording

a $1.0 million increase in facilities and other research and development expenses mainly due to higher consulting services and fixed assets depreciation.

Current wording

a $2.4 million increase in facilities and other research and development expenses mainly due to higher consulting services, rent and software expenses.

Previous wording

a $1.2 million increase in payroll and personnel expenses due to increased headcount of general and administrative personnel;

Current wording

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

Previous wording

a $1.1 million increase in facilities and other expenses mainly due to higher non-employee stock compensation expense, consulting services, software expenses and business taxes, which was partially offset by lower business insurance; and

Current wording

a $1.0 million increase in facilities and other expenses mainly due to higher non-employee stock compensation expense, consulting services, software expenses, service fees and business taxes, which was partially offset by lower business insurance; and

Previous wording

a $2.9 million increase in payroll and personnel expenses, including a $1.2 million increase in employee stock-based compensation, due to increased headcount of general and administrative personnel;

Current wording

a $4.6 million increase in payroll and personnel expenses, including a $1.5 million increase in employee stock-based compensation, due to increased headcount of general and administrative personnel;

Previous wording

a $1.9 million increase in facilities and other expenses mainly due to higher non-employee stock compensation expense, consulting services, software expenses, audit and tax fees and business taxes, which was partially offset by lower business insurance; and

Current wording

a $3.0 million increase in facilities and other expenses mainly due to higher non-employee stock compensation expense, consulting services, software expenses, expensed property and equipment, audit and tax fees, service fees and business taxes, which was partially offset by lower business insurance; and

Previous wording

Other income, net increased by $5.0 million, or 198%, from the three months ended June 30, 2023 to the three months ended June 30, 2024. It increased by $9.3 million, or 236%, from the six months ended June 30, 2023 to the six months ended June 30, 2024. The increase is attributable to higher balances of cash equivalents and marketable securities, and higher market yields on our cash equivalents and marketable securities.

Current wording

Other income, net, increased by $3.6 million, or 96%, from the three months ended September 30, 2023 to the three months ended September 30, 2024. It increased by $12.9 million, or 168%, from the nine months ended September 30, 2023 to the nine months ended September 30, 2024. The increase is attributable to higher balances of cash equivalents and marketable securities, and higher market yields on our 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 and Follow-on 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 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.

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"). For the three and six months ended June 30, 2024, 585,938 shares of the Company's common stock had been sold pursuant to the Sales Agreement for net proceeds to the Company of $15.3 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”). 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.

Previous wording

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 six months ended June 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 (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.

Previous wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $577.7 million.

Current wording

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

Previous wording

We have experienced recurring net losses and had an accumulated deficit of $482.7 million as of June 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 $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.

Previous wording

the impact of the COVID-19 pandemic and adverse macroeconomic conditions such as, but not limited to, higher inflation and increased interest rates, each of which may exacerbate the magnitude of the factors discussed above.

Current wording

the lingering impact of the COVID-19 pandemic and adverse macroeconomic conditions such as, but not limited to, higher inflation and increased interest rates, each of which may exacerbate the magnitude of the factors discussed above.

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 ongoing COVID-19 pandemic, the war in Ukraine, rising interest rates and inflation.

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, 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.

Previous wording

Net cash used in operating activities was $50.0 million for the six months ended June 30, 2023. This was primarily due to the net loss of $58.3 million, adjusted for noncash charges of $11.4 million and net changes in operating assets and liabilities of $3.1 million. Noncash charges included $9.2 million of stock-based compensation expense, $2.1 million of depreciation and amortization and $0.7 million for the amortization of operating lease right-of-use assets, offset by $0.6 million net amortization/accretion of premium/discount on marketable securities. Net changes in operating assets and liabilities included a $2.2 million decrease in accrued and other liabilities, $0.5 million decrease in operating lease liabilities, $0.5 million decrease in deferred revenue and a $0.5 million increase in prepaid expenses and other current assets which were offset by a $0.6 million increase in accounts payable.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous wording

Net cash provided by investing activities was $92.4 million for the six months ended June 30, 2023. This was due to $114.4 million in maturities of marketable securities, offset by purchases of marketable securities of $20.2 million and purchases of property and equipment of $1.8 million.

Current 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.

Previous 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.

Current wording

Net cash provided by financing activities was $336.6 million for the nine months ended September 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 $4.5 million and proceeds from the issuance of common stock from purchases from the Company’s 2020 Employee Stock Purchase Plan (“ESPP”) of $0.7 million.

Previous wording

Net cash provided by financing activities was $141.5 million for the six months ended June 30, 2023. This was primarily due to proceeds from the issuance of common stock upon public offering of $129.7 million, proceeds from the issuance of common stock from the 2022 ATM Offering Program of $9.6 million, proceeds from the issuance of common stock from the exercise of stock options of $2.0 million, and proceeds from the issuance of common stock from ESPP purchases of $0.7 million, offset by payments of public offering costs of $0.3 million and ATM costs of $0.2 million.

Current 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.

Previous wording

As of June 30, 2024, our principal commitments consisted of obligations under our operating leases for our headquarters. Please see Note 9, Commitments and Contingencies, to our unaudited condensed financial statements included elsewhere in this report for further details.

Current wording

As of September 30, 2024, our principal commitments consisted of obligations under our operating leases for our headquarters. Please see Note 9, Commitments and Contingencies, to our condensed financial statements included elsewhere in this report for further details.

Previous wording

During the three and six months ended June 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 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.

Previous wording

See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this report for information.

Current wording

See Note 2, Summary of Significant Accounting Policies, to our condensed financial statements included elsewhere in this report for information.