4D Molecular Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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, 2024 · Filed Aug 8, 2024
FDMT$12.25+8.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0000950170-24-056933
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0000950170-24-094010
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 112 previous paragraphs and 124 current paragraphs.
86 unchanged; 24 reworded; 8 added; 1 removed; 1 previous and 6 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 (8)
Current report
In July 2024, the U.S. Food and Drug Administration removed the clinical hold on the Phase 1/2 INGLAXA clinical trial in the United States for 4D-310 for the treatment of Fabry disease cardiomyopathy.
Current report
In March 2024, the underwriters exercised their option to purchase 1,259,299 additional shares of common stock resulting in net proceeds of $34.9 million, after deducting underwriting discounts and commissions.
Current report
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 report
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 report
General and administrative expenses increased by $1.8 million, or 21%, from the three months ended June 30, 2023 to the three months ended June 30, 2024. The increase was primarily due to:
Current report
General and administrative expenses increased by $4.1 million, or 25%, from the six months ended June 30, 2023 to the six months ended June 30, 2024. The increase was primarily due to:
Current report
In March 2024, the underwriters exercised their option and purchased 1,259,299 additional shares of common stock resulting in net proceeds of $34.9 million, after deducting underwriting discounts and commissions.
Current report
On May 31, 2024, we terminated the Sales Agreement and the 2022 ATM Offering Program pursuant to the terms of the Sales Agreement. In June 2024, we entered into a Sales Agreement (the “Leerink Sales
Removed paragraphs (1)
Previous report
General and administrative expenses increased by $2.3 million, or 29%, from the three months ended March 31, 2023 to the three months ended March 31, 2024. The increase was primarily due to:
Reworded paragraphs (24)
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 five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (“wet AMD”) and diabetic macular edema (“DME”), 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 two product candidates in preclinical development: 4D-175 for geographic atrophy (“GA”) and 4D-725 for alpha-1 antitrypsin deficiency lung disease.
Current 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.
Previous wording
Our net losses were $32.4 million and $28.7 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $447.7 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 $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.
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 $0.3 million during the three months ended March 31, 2023 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 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.
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. 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 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.
Previous wording
Comparison of the Three Months Ended March 31, 2024 and 2023
Current wording
Comparison of the Three and Six Months Ended June 30, 2024 and 2023
Previous wording
Revenue decreased by $0.3 million, or 91%, from the three months ended March 31, 2023 to the three months ended March 31, 2024 mainly due to revenue from uniQure that was fully earned in 2023 when the Company completed its performance obligation.
Current 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.
Previous wording
Research and development expenses increased by $5.4 million, or 24%, from the three months ended March 31, 2023 to the three months ended March 31, 2024. The increase was primarily due to the following:
Current 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:
Previous wording
a $3.9 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;
Current wording
a $4.9 million increase in clinical trial costs mainly due to increased clinical trial activity for our product candidates, primarily 4D-150;
Previous wording
a $1.3 million increase in payroll and personnel expenses (including a $0.6 million increase in employee stock-based compensation) due to increased headcount of research and development personnel; and
Current 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
Previous wording
a $0.2 million increase in facilities and other research and development expenses mainly due to higher consulting services.
Current wording
a $1.0 million increase in facilities and other research and development expenses mainly due to higher consulting services and fixed assets depreciation.
Previous wording
a $0.3 million decrease in outside services.
Current wording
a $0.5 million decrease in outside services.
Previous wording
a $1.7 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 $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;
Previous wording
a $0.9 million increase in facilities and other expenses mainly due to higher consulting services, audit and tax fees, equipment rental and business taxes, which was partially offset by lower business insurance; and
Current 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
Previous wording
Other income, net increased by $4.3 million, or 303%, from the three months ended March 31, 2023 to the three months ended March 31, 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 $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.
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
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"). 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.
Previous wording
As of March 31, 2024, we had cash, cash equivalents and marketable securities of $588.9 million.
Current wording
As of June 30, 2024, we had cash, cash equivalents and marketable securities of $577.7 million.
Previous wording
We have experienced recurring net losses and had an accumulated deficit of $447.7 million as of March 31, 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 $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.
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 used in operating activities was $27.9 million for the three months ended March 31, 2023. This was primarily due to the net loss of $28.7 million, adjusted for noncash charges of $5.2 million and net changes in operating assets and liabilities of $4.4 million. Noncash charges included $4.2 million of stock-based compensation expense, $1.0 million of depreciation and amortization and $0.4 million for the amortization of operating lease right-of-use assets, offset by $0.4 million amortization/accretion of premium/discount on marketable securities. Net changes in operating assets and liabilities included a $3.4 million decrease in accrued and other liabilities, $0.4 million decrease in operating lease liabilities, $0.3 million decrease in accounts payable, $0.3 million decrease in deferred revenue and a $0.1 million increase in other assets which were offset by a $0.1 million decrease in prepaid expenses and other current assets.
Current 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.
Previous wording
Net 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 investing activities was $43.1 million for the three months ended March 31, 2023. This was due to $58.9 million in maturities of marketable securities, offset by purchases of marketable securities of $14.7 million and purchases of property and equipment of $1.0 million.
Current 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.
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 issuance of common stock upon public 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
Net cash provided by financing activities was $11.0 million for the three months ended March 31, 2023. This was primarily due to proceeds from the issuance of common stock from the 2022 ATM Offering program of $9.6 million and proceeds from the issuance of common stock from the exercise of stock options of $1.4 million.
Current 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.
Previous wording
During the three months ended March 31, 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 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.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
a $8.8 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
a $1.2 million increase in facilities and other research and development expenses mainly due to higher consulting services and fixed assets depreciation.
Current report — wording carried from elsewhere
a $1.2 million increase in payroll and personnel expenses due to increased headcount of general and administrative personnel;
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
a $0.7 million decrease in outside services.
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Offering Program"). As of March 31, 2024, 1.1 million shares of the Company's common stock had been sold pursuant to the Sales Agreement for net proceeds to the Company of $19.1 million, after deducting issuance costs. As of March 31, 2024, $80.1 million of common stock remained available for sale under the Sales Agreement.