Dyne Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Jul 28, 2025.
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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 Jul 28, 2025
DYN$18.07+4.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066386
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-28.
0000950170-25-099161
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 125 previous paragraphs and 134 current paragraphs.
95 unchanged; 21 reworded; 11 added; 9 removed; 0 previous and 7 current paragraphs rearranged.
Tables are not compared: 4 previous and 7 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 (11)
Current report
We participated in a Type C meeting with the U.S. Food and Drug Administration, or FDA, in May 2025 and discussed the path to regulatory approval, including U.S. Accelerated Approval, for DYNE-101 in DM1. As a result of the meeting, we submitted a revised protocol for review by the FDA in June 2025 for the registrational expansion cohort of the ACHIEVE trial. The primary endpoint in the revised protocol for the registrational expansion cohort is change from baseline in middle finger myotonia as measured by vHOT at 6 months compared to placebo, which is intended to serve as an intermediate clinical endpoint for U.S. Accelerated Approval. Secondary endpoints include change from baseline in splicing as measured by CASI-22, muscle strength as assessed by Quantitative Muscle Testing, or QMT, performance on both the 10-Meter Walk/Run Test, or 10MWR, and 5 Times Sit to Stand Test, or 5xSTS, and the Myotonic Dystrophy Health Index, or MDHI, patient reported outcome measure, all at 6 months compared to placebo. We intend that the data from the registrational expansion cohort and the already enrolled patients in the MAD and ongoing long-term extension portions of the ACHIEVE trial will support a potential submission for U.S. Accelerated Approval.
Current report
In June 2025, the FDA granted Breakthrough Therapy Designation to DYNE-101 for the treatment of DM1.
Current report
Additionally, in June 2025, we reported positive long-term efficacy and safety data from adult DM1 patients enrolled in the MAD portion of the ACHIEVE trial, including data from the 6.8 mg/kg Q8W cohort (n=6) at up to 12 months. At the 6.8 mg/kg Q8W dose, DYNE-101 demonstrated robust and sustained improvement in myotonia as measured by vHOT as well as sustained improvements across multiple other endpoints. We believe these data support improvement in vHOT as an early indicator of clinical benefit with DYNE-101 in DM1 and its potential as an intermediate clinical endpoint for U.S. Accelerated Approval. Treatment with DYNE-101 led to an improvement in vHOT of 3.3 seconds as compared to placebo at 6 months, and new data demonstrated that mean improvements at 6 months were sustained at 12 months for vHOT, 10MWR, 5xSTS, MDHI, and QMT, which demonstrated a 10% improvement in strength at 6 months, increasing to 20% at 12 months relative to baseline.
Current report
We believe that our existing cash, cash equivalents and marketable securities, which includes the initial term loan tranche of $100.0 million that we borrowed under our Loan Agreement with Hercules in June 2025, as well as the net proceeds from our follow-on public offering completed in July 2025, which we refer to as the July 2025 offering, will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into the third quarter of 2027. Based on our current plans and anticipated timelines and assuming positive data results from the Registrational Expansion Cohorts of our ACHIEVE and DELIVER clinical trials and assuming no additional testing is required by the FDA, we estimate that these cash resources would be sufficient to enable us to obtain data from the Registrational Expansion Cohorts of our ACHIEVE and DELIVER clinical trials, submit applications for marketing approval to the FDA for DYNE-251 in DMD and DYNE-101 in DM1 using the Accelerated Approval pathway and obtain a decision from the FDA with respect to the application for marketing approval for DYNE-251 and, if approved, commercially launch DYNE-251 in the United States.
Current report
Interest expense consists of amortization of debt issuance costs and discount and interest expense under the Loan Agreement with Hercules.
Current report
Interest expense for the three months ended June 30, 2025 was $0.1 million due to our entry into the Loan Agreement with Hercules in June 2025. No interest expense was incurred in the three months ended June 30, 2024.
Current report
Other expense for the three months ended June 30, 2025 and 2024 was $1.6 million and $0.2 million, respectively, due to realized foreign currency losses.
Current report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Interest expense for the six months ended June 30, 2025 was $0.1 million due to our entry into the Loan Agreement with Hercules in June 2025. No interest expense was incurred in the six months ended June 30, 2024.
Current report
In June 2025, we entered into the Loan Agreement with Hercules, in its capacity as administrative agent and collateral agent and as a lender, and certain other financial institutions that from time to time become parties to the Loan Agreement as lenders, which we refer to collectively as the Lenders. The Loan Agreement provides for term loans in an aggregate principal amount of up to $275.0 million under multiple tranches, available as follows: (i) an initial term loan tranche funded on the closing date of the Loan Agreement in aggregate principal amount of $100.0 million; (ii) subject to the achievement of specified clinical, regulatory and commercial milestones, three additional term loan tranches totaling up to $115.0 million; and (iii) subject to approval by the Lenders’ investment committee in their discretion, a final term loan tranche of up to $60.0 million. On June 27, 2025, we received net proceeds of $98.8 million from the initial term loan tranche, after deducting debt issuance costs payable by us. Refer to Note 7, “Long-Term Debt” in the accompanying notes to the condensed consolidated financial statements for a discussion of the Loan Agreement with Hercules.
Current report
In July 2025, we completed the July 2025 offering, pursuant to which we issued and sold 27,878,788 shares of our common stock. We estimate that the net proceeds from the offering were approximately $215.2 million, after deducting underwriting discounts and commissions and offering expenses payable by us.
Removed paragraphs (9)
Previous report
In January 2025, we reported positive efficacy and safety data from adult DM1 patients enrolled in the randomized, placebo-controlled MAD portion of the DYNE-101 ACHIEVE trial, including data from the 6.8 mg/kg Q8W cohort (n=8) at up to 6 months. At the 6.8 mg/kg Q8W dose, DYNE-101 resulted in significant splicing correction at 3 months compared to baseline, which was associated with improvement in multiple functional endpoints, beginning at 3 months and continuing at 6 months.
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Interest income
Previous report
Other income (expense), net
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Interest income
Previous report
Other income (expense), net
Reworded paragraphs (21)
Previous wording
We are a clinical-stage company focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of our FORCE platform, we are developing targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system, or CNS. Our proprietary FORCE platform therapeutics consist of a payload that we rationally design to target the genetic basis of the disease we are seeking to treat, a linker and an antigen-binding fragment, or Fab, that we attach to the payload using the linker. With our FORCE platform, we have the flexibility to deploy different classes of payloads (such as oligonucleotides and enzymes) with specific mechanisms of action that modify target functions. We leverage this modularity to focus on neuromuscular diseases with high unmet need, with etiologic targets and with clear translational potential from preclinical disease models to well-defined clinical development and regulatory pathways.
Current wording
We are a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. Leveraging the modularity of our FORCE platform, we are developing targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system, or CNS. Our proprietary FORCE platform therapeutics consist of a payload that we rationally design to target the genetic basis of the disease we are seeking to treat, a linker and an antigen-binding fragment, or Fab, that we attach to the payload using the linker. With our FORCE platform, we have the flexibility to deploy different classes of payloads (such as oligonucleotides and enzymes) with specific mechanisms of action that modify target functions. We leverage this modularity to focus on neuromuscular diseases with high unmet need, with etiologic targets and with clear translational potential from preclinical disease models to well-defined clinical development and regulatory pathways.
Previous wording
Our product candidate DYNE-101 is being evaluated in the ACHIEVE trial, a global Phase 1/2 clinical trial consisting of a 24-week multiple ascending dose, or MAD, randomized, placebo-controlled period, a 24-week open-label extension, or OLE, a 96-week long-term extension, and a registrational expansion cohort. The primary endpoints of the MAD portion of the trial were safety and tolerability; with secondary endpoints of pharmacokinetics and pharmacodynamics, including change from baseline in splicing as measured by the composite alternative splicing index, or CASI-22, as well as multiple measures of muscle strength and function and patient-reported outcomes, including the Myotonic Dystrophy Health Index. In the MAD portion of the ACHIEVE trial, patients were randomized to receive DYNE-101 or placebo intravenously every four weeks or every eight weeks for 24 weeks, depending on cohort. Patient cohorts were dosed from 1.8 mg/kg to 6.8 mg/kg (approximate ASO dose). Following the MAD placebo-controlled period, patients transition to DYNE-101 treatment in the OLE portion of the trial and in the long-term extension.
Current wording
Our product candidate DYNE-101 is being evaluated in the ACHIEVE trial, a global Phase 1/2 clinical trial consisting of a 24-week multiple ascending dose, or MAD, randomized, placebo-controlled period, a 24-week open-label extension, or OLE, a 96-week long-term extension, and a registrational expansion cohort. The primary endpoints of the MAD portion of the trial were safety and tolerability; with secondary endpoints of pharmacokinetics and pharmacodynamics, including change from baseline in splicing as measured by the composite alternative splicing index, or CASI-22, video hand opening time, or vHOT, as well as multiple other measures of muscle strength and function and patient-reported outcomes, including the Myotonic Dystrophy Health Index. In the MAD portion of the ACHIEVE trial, patients were randomized to receive DYNE-101 or placebo intravenously every four weeks or every eight weeks for 24 weeks, depending on cohort. Patient cohorts were dosed from 1.8 mg/kg to 6.8 mg/kg (approximate ASO dose). Following the MAD placebo-controlled period, patients transition to DYNE-101 treatment in the OLE portion of the trial and in the long-term extension. In January 2025, we announced the completion of the MAD portion of the trial.
Previous wording
In January 2025, we announced the completion of the MAD portion of the trial, our plans to initiate a registrational expansion cohort to support submission for U.S. Accelerated Approval, and the selection of the 6.8 mg/kg Q8W dose to be evaluated in the registrational expansion cohort. We plan to enroll up to 48 patients in the registrational expansion cohort and the primary endpoint for this cohort is mean splicing correction at 3 months as measured by CASI-22, supported by clinically meaningful measures of muscle strength and function as secondary endpoints. The registrational expansion cohort will also assess various quality of life and CNS-related endpoints (e.g., fatigue, daytime sleepiness). We intend that the data from the registrational expansion cohort and the 56 patients from the long-term extension portion of ACHIEVE will support a submission for U.S. Accelerated Approval. We participated in a Type C meeting with the U.S. Food and Drug Administration, or FDA, in May 2025 and discussed the path to regulatory approval, including U.S. Accelerated Approval. The registrational expansion cohort has been initiated and full enrollment is planned for mid-2025 with data from this cohort in the first half of 2026 and potential submission for U.S. Accelerated Approval in the first half of 2026. We continue to advance preparations for a Phase 3 trial of DYNE-101 and plan to initiate the trial in 2025. We are also pursuing expedited approval pathways globally for DYNE-101.
Current wording
The registrational expansion cohort is expected to enroll 60 patients at the 6.8 mg/kg once every eight weeks, or Q8W, dose cohort. The registrational expansion cohort has been initiated and full enrollment is planned for the fourth quarter of 2025, with data from this cohort planned for mid-2026 and potential submission for U.S. Accelerated Approval planned for late 2026. We continue to advance preparations for a Phase 3 clinical trial of DYNE-101 and plan to initiate the trial in the first quarter of 2026. We continue to pursue approval pathways for DYNE-101 outside of the U.S.
Previous wording
In January 2025, we also reported updated safety and tolerability data from the 56 patients enrolled in the MAD portion of the ACHIEVE trial. As of the data cutoff date of December 6, 2024, DYNE-101 demonstrated a favorable safety profile. Additionally, the majority of treatment-emergent adverse events were mild or moderate, and no related serious treatment-emergent adverse events were identified. In addition, no participants demonstrated persistent related anemia, and no clinically meaningful changes were observed in kidney or liver parameters. Also, no participants demonstrated kidney injury. Liver enzyme elevations were observed in a minority of participants, with no impact on liver function. Interpretation of the elevated liver enzyme levels was complicated by underlying liver disease and elevated baseline values up to approximately 2.5 times greater than the upper limit of normal.
Current wording
In June 2025, we also reported updated safety and tolerability data from the 56 patients enrolled through the 6.8 mg/kg Q8W cohort of the ACHIEVE trial. As of the data cutoff date of April 23, 2025, DYNE-101 demonstrated a favorable safety profile. Additionally, the majority of treatment-emergent adverse events were mild or moderate, and no related serious treatment-emergent adverse events were identified. In addition, no participants demonstrated persistent related anemia, and no clinically meaningful changes were observed in kidney or liver parameters. Also, no participants demonstrated kidney injury. Liver enzyme elevations were observed in a minority of participants, with no impact on liver function. Interpretation of the elevated liver enzyme levels was complicated by underlying liver disease and elevated baseline values up to approximately 2.5 times greater than the upper limit of normal.
Previous wording
In the MAD portion of the DELIVER trial, patients were randomized to receive DYNE-251 or placebo every four or eight weeks intravenously for 24 weeks, depending on cohort. Patients cohorts were dosed from 0.7 mg/kg to 20 mg/kg (approximate PMO dose). Following the placebo-controlled period, patients transition to DYNE-251 treatment in the open-label portion of the trial and in the long-term extension.
Current wording
In the MAD portion of the DELIVER trial, patients were randomized to receive DYNE-251 or placebo every four or eight weeks intravenously for 24 weeks, depending on cohort. Patients cohorts were dosed from 0.7 mg/kg to 20 mg/kg (approximate phosphorodiamidate morpholino oligomer, or PMO dose). Following the placebo-controlled period, patients transitioned to DYNE-251 treatment in the open-label portion of the trial and in the long-term extension.
Previous wording
We completed enrollment of the 20 mg/kg Q4W (approximate PMO dose) registrational expansion cohort of 32 participants as part of the DELIVER trial in the first quarter of 2025 and are planning for data from this cohort in late 2025 and potential submission for U.S. Accelerated Approval in early 2026. We continue to pursue accelerated approval in the U.S. based on dystrophin as a surrogate endpoint. We are also pursuing expedited approval pathways globally for DYNE-251.
Current wording
We completed enrollment of the 20 mg/kg Q4W (approximate PMO dose) registrational expansion cohort of 32 participants as part of the DELIVER trial in the first quarter of 2025 and are planning for data from this cohort in late 2025 and potential submission for U.S. Accelerated Approval in early 2026. We continue to pursue accelerated approval in the U.S. based on dystrophin as a surrogate endpoint. We continue to pursue approval pathways for DYNE-251 outside of the U.S.
Previous wording
In June 2024, we announced new preclinical data for DYNE-302, our product candidate for FSHD, that demonstrated robust and durable DUX4 suppression and functional benefit in a mouse model. We generated these data using an innovative hTfR1/iFLExD mouse model we developed that expresses the human transferrin 1 receptor, or TfR1, and enables tunable DUX4 induction in skeletal muscle. In hTfR1/iFLExD mice, a single intravenous dose of DYNE-302 resulted in dose-dependent and robust reduction of the DUX4 transcriptome that lasted up to three months, with benefit on muscle structure and function. DYNE-302 also demonstrated high in vitro potency in FSHD patient-derived myotubes. We are progressing DYNE-302 through IND/CTA-enabling studies.
Current wording
In June 2024 and June 2025, we announced new preclinical data for DYNE-302, our product candidate for FSHD, that demonstrated robust and durable DUX4 suppression and functional benefit in a mouse model. We generated these data using an innovative hTfR1/iFLExD mouse model we developed that expresses the human transferrin 1 receptor, or TfR1, and enables tunable DUX4 induction in skeletal muscle. In hTfR1/iFLExD mice, a single intravenous dose of DYNE-302 resulted in dose-dependent and robust reduction of the DUX4 transcriptome that lasted up to three months, with benefit on muscle structure. DYNE-302 also demonstrated prevention as well as reversal of muscle weakness. We are progressing DYNE-302 through IND/CTA-enabling studies.
Previous wording
We were incorporated and commenced operations in 2017. Since our incorporation, we have devoted substantially all of our financial resources and efforts to organizing and staffing our company, business planning, raising capital, conducting research and development activities and filing and prosecuting patent applications. We do not have any products for sale and have not generated any revenue from product sales or otherwise. To date, we have principally raised capital through sales of equity securities.
Current wording
We were incorporated and commenced operations in 2017. Since our incorporation, we have devoted substantially all of our financial resources and efforts to organizing and staffing our company, business planning, raising capital, conducting research and development activities and filing and prosecuting patent applications. We do not have any products for sale and have not generated any revenue from product sales or otherwise. To date, we have principally raised capital through sales of equity securities and our initial borrowing under our Loan and Security Agreement, or the Loan Agreement, with Hercules Capital, Inc., or Hercules.
Previous wording
Since our inception, we have incurred significant operating losses. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more product candidates. For the three months ended March 31, 2025 and 2024, we reported net losses of $115.4 million and $65.6 million, respectively. As of March 31, 2025, we had an accumulated deficit of $1.1 billion.
Current wording
Since our inception, we have incurred significant operating losses. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more product candidates. For the six months ended June 30, 2025 and 2024, we reported net losses of $226.2 million and $130.8 million, respectively. As of June 30, 2025, we had an accumulated deficit of $1.2 billion.
Previous wording
We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements at least into the second half of 2026. We have based our estimates as to how long we expect we will be able to fund our operations on assumptions that may prove to be wrong. We could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing, which may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. See “—Liquidity and capital resources” below.
Current wording
We have based our estimates as to how long we expect we will be able to fund our operations, debt service obligations and capital expenditure requirements on assumptions that may prove to be wrong. We could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing, which may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. See “—Liquidity and capital resources” below. These estimates do not give effect to any additional funding tranches we may obtain access to under our Loan Agreement with Hercules, subject to the achievement of specified clinical, regulatory and commercial milestones, and do not give effect to any revenue we may generate on commercial sales of any products for which we obtain regulatory approval.
Previous wording
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products for at least a couple of years, if at all. If our development efforts are successful and we commercialize products, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from product sales, as well as upfront, milestone and royalty payments from such collaboration or license agreements, or a combination thereof.
Current wording
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products at least until 2027, if at all. If our development efforts are successful and we commercialize products, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from product sales, as well as upfront, milestone and royalty payments from such collaboration or license agreements, or a combination thereof.
Previous wording
Expenses related to DYNE-101 increased in the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This was attributable to higher manufacturing activity in the three months ended March 31, 2025 to produce a sufficient clinical supply of drug product for the ongoing ACHIEVE trial and an increase in clinical trial activity for the ACHIEVE trial. Expenses related to DYNE-251 increased in the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This was attributable to higher manufacturing activity in the three months ended March 31, 2025 to produce a sufficient clinical supply of drug product for the ongoing DELIVER trial and an increase in clinical trial activity for the DELIVER trial.
Current wording
Expenses related to DYNE-101 increased in the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This was attributable to higher manufacturing activity in the three months ended June 30, 2025 to produce a sufficient clinical supply of drug product for the ongoing ACHIEVE trial and an increase in clinical trial activity for the registrational expansion cohort of the ACHIEVE trial. Expenses related to DYNE-251 increased in the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This was attributable to higher manufacturing activity in the three months ended June 30, 2025 to produce a sufficient clinical supply of drug product for the ongoing DELIVER trial and an increase in clinical trial activity for the registrational expansion cohort of the DELIVER trial.
Previous wording
The increase in personnel-related expenses in the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was due to increased headcount in our general and administrative function. The decrease in stock-based compensation expense in the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was attributable to entering into separation and consulting agreements with our former chief executive officer in March 2024, resulting in the acceleration of vesting and modification of previously granted equity awards in the three months ended March 31, 2024. Professional and consulting fees increased due to the higher consulting costs to support the growth of the organization in the three months ended March 31, 2025. Facility-related and other expenses increased due to higher costs of supporting a larger number of general and administrative personnel in the three months ended March 31, 2025.
Current wording
The increase in personnel-related expenses in the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due to increased headcount in our general and administrative function. The decrease in stock-based compensation expense in the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily the result of entering into separation and consulting agreements with our former chief executive officer in March 2024, resulting in the acceleration of vesting and modification of previously granted awards. Professional and consulting fees increased due to the higher consulting costs to support the growth of the organization in the six months ended June 30, 2025. Facility-related and other expenses increased due to higher costs of supporting a larger number of general and administrative personnel in the six months ended June 30, 2025.
Previous wording
Interest income for the three months ended March 31, 2025 and 2024 was $7.1 million and $3.0 million, respectively, due to interest earned on invested cash balances. The increase in interest income was due to an increased cash, cash equivalents and marketable securities balance due to the public sales of common stock in the three months ended March 31, 2025.
Current wording
Interest income for the six months ended June 30, 2025 and 2024 was $13.7 million and $10.1 million, respectively, due to interest earned on invested cash balances. The increase in interest income was due to an increased cash, cash equivalents and marketable securities balance throughout the six months ended June 30, 2025 compared to the six months ended June 30, 2024.
Previous wording
Other expense for the three months ended March 31, 2025 was $0.1 million due to net foreign currency gains and losses. Other income for the three months ended March 31, 2024 was and $0.5 million due to net foreign currency gains and losses.
Current wording
Other expense for the six months ended June 30, 2025 was $1.6 million due to net foreign currency losses. Other income for the six months ended June 30, 2024 was $0.3 million due to net foreign currency gains.
Previous wording
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we support our continued research activities and development of our product candidates and platform. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for at least a couple of years, if at all. To date, we have funded our operations primarily with proceeds from sales of equity securities. As of March 31, 2025 we had cash, cash equivalents and marketable securities of $677.5 million.
Current wording
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we support our continued research activities and development of our product candidates and platform. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates at least until 2027, if at all. To date, we have funded our operations primarily with proceeds from sales of equity securities and our initial borrowing under the Loan Agreement with Hercules. As of June 30, 2025 we had cash, cash equivalents and marketable securities of $683.9 million.
Previous wording
During the three months ended March 31, 2025, we issued and sold an aggregate of 10,660,159 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of $140.6 million, after deducting commissions and offering expenses payable by us. We sold such shares at a weighted average price of $13.60 per share.
Current wording
During the six months ended June 30, 2025, we issued and sold an aggregate of 10,660,159 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of $140.6 million, after deducting commissions and offering expenses payable by us. We sold such shares at a weighted average price of $13.60 per share.
Previous wording
During the three months ended March 31, 2025, operating activities used $105.9 million of cash, due to our net loss of $115.4 million and changes in our operating assets and liabilities of $3.6 million, partially offset by non-cash charges of $13.1 million. Net cash used in changes in our operating assets and liabilities primarily consisted of a $8.6 million decrease in accounts payable and other liabilities and a $5.0 million decrease in prepaid expenses and other assets. During the three months ended March 31, 2024, operating activities used $78.5 million of cash, due to our net loss of $65.6 million and net cash used by changes in our operating assets and liabilities of $32.8 million, partially offset by non-cash charges of $19.9 million. Net cash used by changes in our operating assets and liabilities primarily consisted of a $28.8 million decrease in accounts payable and other liabilities and a $4.1 million increase in prepaid expenses and other current assets. Changes in our operating assets and liabilities during these periods were generally due to the growth of our business, increased clinical trial activity, increased manufacturing activities, advancement of our product candidates, the timing of vendor invoices and payments and annual bonus payments.
Current wording
During the six months ended June 30, 2025, operating activities used $200.6 million of cash, due to our net loss of $226.2 million, partially offset by non-cash charges of $23.6 million and changes in our operating assets and liabilities of $2.0 million. Net cash provided by changes in our operating assets and liabilities primarily consisted of a $2.8 million decrease in prepaid expenses and other current assets, partially offset by a $0.8 million decrease in accounts payable and other liabilities. During the six months ended June 30, 2024, operating activities used $133.4 million of cash, due to our net loss of $130.8 million and net cash used by changes in our operating assets and liabilities of $28.6 million, partially offset by non-cash charges of $25.9 million. Net cash used by changes in our operating assets and liabilities primarily consisted of a $21.4 million decrease in accounts payable and other liabilities and a $7.2 million increase in prepaid expenses and other current assets. Changes in our operating assets and liabilities during these periods were generally due to the growth of our business, increased clinical trial activity, increased manufacturing activities, advancement of our product candidates, the timing of vendor invoices and payments and annual bonus payments.
Previous wording
During the three months ended March 31, 2025, net cash provided by investing activities was $1.5 million due to maturities of marketable securities of $65.4 million and sales of marketable securities of $3.0 million, partially offset by purchases of marketable securities of $66.0 and purchases of property and equipment of $1.0 million. During the three months ended March 31, 2024, net cash used in investing activities was $179.8 million due to purchases of marketable securities of $181.4 million and purchases of property and equipment of $0.2 million, partially offset by maturities of marketable securities of $1.7 million.
Current wording
During the six months ended June 30, 2025, net cash provided by investing activities was $8.2 million due to maturities of marketable securities of $107.7 million and sales of marketable securities of $8.5 million, partially offset by purchases of marketable securities of $106.9 and purchases of property and equipment of $1.0 million. During the six months ended June 30, 2024, net cash used in investing activities was $168.7 million due to purchases of marketable securities of $207.7 million and purchases of property and equipment of $1.0 million, partially offset by maturities of marketable securities of $40.1 million.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities was $141.2 million, consisting of $140.6 million in aggregate net proceeds from sales of common stock under our at-the-market offering program and $0.6 million in proceeds received from stock option exercises. During the three months ended March 31, 2024, net cash provided by financing activities was $408.4 million, consisting of $323.9 million in aggregate net proceeds from sales in our public offering in January 2024, $73.6 million in aggregate net proceeds from sales of our common stock under our at-the-market offering program and $10.9 million in net proceeds received from stock option exercises.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities was $242.0 million, consisting of $140.6 million in aggregate net proceeds from sales of common stock under our at-the-market offering program, $98.8 million in net proceeds from the initial term loan tranche under the Loan Agreement with Hercules and $2.6 million in proceeds received from stock option exercises. During the six months ended June 30, 2024, net cash provided by financing activities was $788.3 million, consisting of $675.2 million in aggregate net proceeds from sales in our public offerings in January 2024 and May 2024, $97.9 million in aggregate net proceeds from sales of our common stock under our at-the-market offering program and $15.2 million in net proceeds received from stock option exercises.
Previous wording
We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements at least into the second half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
We believe that our existing cash, cash equivalents and marketable securities, which includes the initial term loan tranche of $100.0 million that we borrowed under our Loan Agreement with Hercules in June 2025, as well as the net proceeds from the July 2025 offering, will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into the third quarter of 2027. Based on our current plans and anticipated timelines and assuming positive data results from the registrational expansion cohorts of our ACHIEVE and DELIVER clinical trials and assuming no additional testing is required by the FDA, we estimate that these cash resources would be sufficient to enable us to obtain data from the registrational expansion cohorts of our ACHIEVE and DELIVER clinical trials, submit applications for marketing approval to the FDA for DYNE-251 in DMD and DYNE-101 in DM1 using the Accelerated Approval pathway and obtain a decision from the FDA with respect to the application for marketing approval for DYNE-251 and, if approved, commercially launch DYNE-251 in the United States. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
The increase in personnel-related and stock-based compensation expenses in the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was due to increased headcount in our general and administrative function. Professional and consulting fees increased due to the higher consulting costs to support the growth of the organization in the three months ended June 30, 2025. Facility-related and other expenses increased due to higher costs of supporting a larger number of general and administrative personnel in the three months ended June 30, 2025.
Current report — wording carried from elsewhere
Interest income for the three months ended June 30, 2025 and 2024 was $6.6 million and $7.1 million, respectively, due to interest earned on invested cash balances. The decrease in interest income was due to an overall decrease in interest rates in the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Expenses related to DYNE-101 increased in the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This was attributable to higher manufacturing activity in the six months ended June 30, 2025 to produce a sufficient clinical supply of drug product for the ongoing ACHIEVE trial and an increase in clinical trial activity for the registrational expansion cohort of the ACHIEVE trial. Expenses related to DYNE-251 increased in the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This was attributable to higher manufacturing activity in the six months ended June 30, 2025 to produce a sufficient clinical supply of drug product for the ongoing DELIVER trial and an increase in clinical trial activity for the registrational expansion cohort of the DELIVER trial.
Current report — wording carried from elsewhere
The increase in platform and external research and development expenses in the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily due to increased external research activity associated with our preclinical programs and product candidates. The increase in personnel-related expenses was primarily due to increased headcount in our research and development function. The increase in facility-related and other expenses was primarily due to the increased costs of supporting a larger number of research and development personnel.
Current report — wording carried from elsewhere
The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024: