Dyne Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 12, 2024.
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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, 2024 · Filed Aug 12, 2024
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 2024-03-31; filed 2024-05-02.
0000950170-24-052066
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-12.
0000950170-24-095527
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 124 previous paragraphs and 129 current paragraphs.
93 unchanged; 21 reworded; 6 added; 10 removed; 0 previous and 9 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 (6)
Current report
We plan to continue to engage with global regulators this year on ACHIEVE, and we anticipate providing an update on the path to registration for DYNE-101 by the end of 2024. ACHIEVE is designed to be registrational, and we are pursuing expedited approval pathways for DYNE-101. Based on dialogue with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration, or FDA, we continue to pursue an accelerated approval pathway for DYNE-101, including leveraging splicing as a potential surrogate biomarker.
Current report
We plan to continue to engage with global regulators this year on DELIVER, and we anticipate providing an update on the path to registration for DYNE-251 by the end of 2024. DELIVER is designed to be registrational, and we are pursuing expedited approval pathways for DYNE-251. We have confirmed that the FDA precedent for using dystrophin as a surrogate biomarker for accelerated approval remains available.
Current report
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 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 report
Comparison of the six months ended June 30, 2024 and 2023
Current report
Other (expense) income, net
Current report
In addition, based on the market value of our common stock held by non-affiliates as of June 30, 2024, we will no longer be able to take advantage of the various reporting and other exemptions available to “smaller reporting companies” as defined in Rule 12b-2 under the Exchange Act, beginning with our Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2025. Until such time, however, we are permitted and will continue to rely on various exemptions from certain disclosure requirements as an emerging growth company and smaller reporting company.
Removed paragraphs (10)
Previous report
Enrollment is complete through the 6.8 mg/kg Q8W cohort of the ACHIEVE trial (56 patients enrolled). These initial clinical data position us to optimize dose and dose regimen for DYNE-101 with the goal of initiating registrational cohorts in the trial by the end of 2024. We anticipate reporting data from multiple, higher dose cohorts of the ACHIEVE trial in the second half of 2024.
Previous report
Enrollment is complete through the 40 mg/kg Q8W cohort of the DELIVER trial (48 patients enrolled). These initial clinical data position us to optimize dose and dose regimen for DYNE-251 with the goal of initiating registrational cohorts by the end of 2024. We anticipate reporting data from multiple, higher dose cohorts of the DELIVER trial in the second half of 2024.
Previous report
In September 2022, we announced that we were prioritizing our focus and resources on our clinical programs, DYNE-101 for DM1 and DYNE-251 for DMD. As a result, we announced the deferral of the IND application submission for DYNE-301 for FSHD that we had originally targeted for the second half of 2022. We continue to evaluate the optimal approach to target DUX4 and translate our preclinical work to a tractable clinical development pathway, and we plan to provide an update on the FSHD program in 2024.
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Interest income
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Interest income
Previous report
We are also a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million as of the last business day of our most recently completed second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million as of the last business day of our most recently completed second fiscal quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.
Reworded paragraphs (21)
Previous wording
Our product candidate DYNE-101 is being evaluated in ACHIEVE, an ongoing Phase 1/2 global clinical trial in patients with DM1, consisting of a 24-week multiple ascending dose, or MAD, randomized, placebo-controlled period, a 24-week open-label extension, or OLE, and a 96-week long-term extension. ACHIEVE, which is designed to be registrational, is enrolling adult patients with DM1 who are 18 to 49 years of age. The primary endpoints are safety and tolerability; with secondary endpoints of pharmacokinetics and pharmacodynamics, including change from baseline in splicing, as well as measures of muscle strength and function. In the MAD portion of the ACHIEVE trial, patients are randomized to receive DYNE-101 or placebo intravenously every four weeks or every eight weeks for 24 weeks, depending on cohort. Patient cohorts will be dosed from 1.8 mg/kg to 10.2 mg/kg (approximate antisense oligonucleotide, or ASO, dose). Following the 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 ACHIEVE, an ongoing Phase 1/2 global clinical trial in patients with DM1, consisting of a 24-week multiple ascending dose, or MAD, randomized, placebo-controlled period, a 24-week open-label extension, or OLE, and a 96-week long-term extension. ACHIEVE, which is designed to be registrational, is enrolling adult patients with DM1 who are 18 to 49 years of age. The primary endpoints are safety and tolerability. Additional endpoints include pharmacokinetics, change from baseline in splicing, multiple measures of muscle strength and function as well as patient-reported outcomes, including the Myotonic Dystrophy Type 1 Activity and Participation Scale (DM1-ACTIVc) and the Myotonic Dystrophy Health Index (MDHI). In the MAD portion of the ACHIEVE trial, patients are randomized to receive DYNE-101 or placebo intravenously every four weeks or every eight weeks for 24 weeks, depending on cohort. Patient cohorts will be dosed from 1.8 mg/kg to 10.2 mg/kg (approximate antisense oligonucleotide, or ASO, dose). Following the placebo-controlled period, patients transition to DYNE-101 treatment in the OLE portion of the trial and in the long-term extension.
Previous wording
In January 2024, we announced positive initial clinical data from the ACHIEVE trial which we believe validates the promise of the FORCE platform. The initial efficacy assessment of the DYNE-101 ACHIEVE trial reported in January 2024 was based on data from 32 adult DM1 patients enrolled in the randomized, placebo-controlled MAD portion of the trial, including 6-month data from the 1.8 mg/kg (approximate ASO dose) cohort (n=16) and 3-month data from the 3.4 mg/kg Q4W cohort (n=16). In each of these cohorts, participants were randomized to receive either DYNE-101 (n=6) or placebo (n=4) once every four weeks or participants in the recovery arm (n=6) received two doses of DYNE-101 followed by placebo for the remainder of the MAD portion of the trial.
Current wording
In May 2024, we announced positive clinical data from the ACHIEVE trial. The efficacy assessment of the DYNE-101 ACHIEVE trial reported in May 2024 was based on data from 40 adult DM1 patients enrolled in the trial, including 12-month data from the 1.8 mg/kg Q4W (approximate ASO dose) cohort (n=16), 6-month data from the 3.4 mg/kg Q4W cohort (n=16) and 3-month data from the 5.4 mg/kg Q8W cohort (n=8). In the 1.8 mg/kg Q4W and 3.4 mg/kg Q4W cohorts, participants were randomized to receive either DYNE-101 (n=6) or placebo (n=4) once every four weeks or participants in the recovery arm (n=6) received two doses of DYNE-101 followed by placebo for the remainder of the MAD portion of the trial. In the 5.4 mg/kg Q8W cohort, participants were randomized to receive either DYNE-101 (n=6) or placebo (n=2) once every four weeks for the first three months followed by once every eight weeks for the remainder of the MAD portion of the trial. In these data from the ACHIEVE trial, DYNE-101 demonstrated robust muscle delivery and dose-dependent and consistent splicing correction while also showing improvement in multiple functional endpoints and patient reported outcomes.
Previous wording
Safety and tolerability data in this initial assessment of the ACHIEVE trial were based on 45 patients enrolled through the 5.4 mg/kg Q8W cohort. As of the data cutoff date of December 6, 2023, 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 treatment-emergent 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 approximately 18% of participants, with no impact on liver function. Interpretation is complicated by underlying liver disease and elevated baseline values up to approximately 2.5 times greater than the upper limit of normal.
Current wording
Safety and tolerability data from the assessment of the ACHIEVE trial reported in May 2024 were based on 56 patients enrolled through the 6.8 mg/kg Q8W cohort of the MAD portion of the ACHIEVE trial. As of the safety data cut-off date of May 8, 2024, DYNE-101 demonstrated a favorable safety profile and the majority of treatment emergent adverse events were mild or moderate and no related serious treatment emergent adverse events were identified.
Previous wording
Our product candidate DYNE-251 is being evaluated in DELIVER, an ongoing Phase 1/2 global clinical trial in patients with DMD who have mutations amenable to exon 51 skipping, consisting of a 24-week MAD randomized, placebo-controlled period, a 24-week OLE and a 96-week long-term extension. DELIVER, which is designed to be registrational, is enrolling ambulant and non-ambulant males with DMD who are ages 4 to 16 and have mutations amenable to exon 51 skipping. The primary endpoints are safety, tolerability and change from baseline in dystrophin levels as measured by Western blot. Secondary endpoints include measures of muscle function, exon skipping and pharmacokinetics.
Current wording
Our product candidate DYNE-251 is being evaluated in DELIVER, an ongoing Phase 1/2 global clinical trial in patients with DMD who have mutations amenable to exon 51 skipping, consisting of a 24-week MAD randomized, placebo-controlled period, a 24-week OLE and a 96-week long-term extension. DELIVER, which is designed to be registrational, is enrolling ambulant and non-ambulant males with DMD who are ages 4 to 16 and have mutations amenable to exon 51 skipping. The primary endpoints are safety, tolerability and change from baseline in dystrophin levels as measured by Western blot. Additional endpoints include pharmacokinetics and change from baseline in exon 51 skipping levels, muscle tissue percent dystrophin positive fibers (PDPF), multiple assessments of muscle function, including North Star Ambulatory Assessment (NSAA) score, Stride Velocity 95th Centile and certain timed functional tests.
Previous wording
In the MAD portion of the DELIVER trial, patients are randomized to receive DYNE-251 or placebo every four or eight weeks intravenously for 24 weeks, depending on cohort. Patients cohorts will be dosed from 0.7 mg/kg to 40 mg/kg (approximate phosphorodiamidate morpholino oligomer, or 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 are randomized to receive DYNE-251 or placebo every four or eight weeks intravenously for 24 weeks, depending on cohort. Patients have been dosed in cohorts from 0.7 mg/kg to 40 mg/kg (approximate phosphorodiamidate morpholino oligomer, or 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.
Previous wording
In January 2024, we announced positive initial clinical data from the DELIVER trial which we believe validates the promise of the FORCE platform. The initial efficacy assessment of the DYNE-251 DELIVER trial reported in January 2024 was based on 6-month data from six male patients with DMD amenable to exon 51 skipping enrolled in the 5 mg/kg (approximate PMO dose) cohort of the randomized, placebo-controlled MAD portion of the trial. Patients were randomized to receive either DYNE-251 (n=4) or placebo (n=2) once every four weeks. Once every 4-week administration of DYNE-251 in the DELIVER trial reached levels of dystrophin expression, exon skipping and percent dystrophin positive fibers that exceeded levels reported in a third-party clinical trial for the current weekly standard of care for DMD exon 51, eteplirsen, at 6 months with a 24-fold lower total PMO dose.
Current wording
In May 2024, we announced positive clinical data from the DELIVER trial. The efficacy assessment of the DYNE-251 DELIVER trial reported in May 2024 was based on 6-month data from eight male patients with DMD amenable to exon 51 skipping enrolled in the 10 mg/kg (approximate PMO dose) cohort of the randomized, placebo-controlled MAD portion of the trial. Patients were randomized to receive either DYNE-251 (n=6) or placebo (n=2) once every four weeks for 6 months. In the 10 mg/kg dose cohort, DYNE-251 Q4W demonstrated dose-dependent exon skipping and dystrophin expression. In these data, DYNE-251 reached levels of dystrophin expression that exceeded levels reported in a third-party clinical trial for the current weekly standard of care for DMD exon 51, eteplirsen, at 6 months with a 12-fold lower PMO dose. In these data, DYNE-251 also demonstrated encouraging trends in multiple functional endpoints.
Previous wording
Safety and tolerability data in the DELIVER trial were based on 37 patients enrolled through the 20 mg/kg cohort of the MAD portion. As of the data cutoff date of December 6, 2023, DYNE-251 demonstrated a favorable safety profile. Additionally, the majority of treatment-emergent adverse events were mild or moderate, and no related serious adverse events were identified. In addition, no participants demonstrated treatment-emergent anemia, and no clinically meaningful changes were observed in kidney parameters or electrolytes, including magnesium.
Current wording
Safety and tolerability data from the assessment of the DELIVER trial reported in May 2024 were based on 48 patients enrolled through the 40 mg/kg Q8W cohort of the MAD portion of the DELIVER trial. As of the safety data cut-off date of April 30, 2024, DYNE-251 demonstrated a favorable safety profile and the majority of treatment emergent adverse events were mild or moderate and no related serious treatment emergent adverse events were identified.
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, 2024 and 2023, we reported net losses of $65.6 million and $44.2 million, respectively. As of March 31, 2024, we had an accumulated deficit of $698.2 million.
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, 2024 and 2023, we reported net losses of $130.8 million and $109.1 million, respectively. As of June 30, 2024, we had an accumulated deficit of $763.3 million.
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 through 2025. 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 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.
Previous wording
Expenses related to DYNE-101 remained consistent in the first quarter of 2024 compared to the first quarter of 2023. Expenses related to DYNE-251 increased in the first quarter of 2024 compared to the first quarter of 2023. This was attributable to higher manufacturing activity in the first quarter of 2024 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 decreased in the second quarter of 2024 compared to the second quarter of 2023. This was attributable to higher manufacturing activity in the second quarter of 2023. Expenses related to DYNE-251 increased in the second quarter of 2024 compared to the second quarter of 2023. This was attributable to an increase in clinical trial activity for the DELIVER trial.
Previous wording
The increase in platform and external research and development expenses in the first quarter of 2024 compared to the first quarter of 2023 was primarily due to increased external research activity associated with our preclinical programs. The increase in personnel-related expenses and stock-based compensation expense was primarily due to increased headcount in our research and development function. The increase in facility-related and other expenses in the first quarter of 2024 compared to the first quarter of 2023 was primarily due to the increased costs of supporting a larger number of research and development personnel.
Current wording
The increase in platform and external research and development expenses in the second quarter of 2024 compared to the second quarter of 2023 was primarily due to increased external research activity associated with our preclinical programs. The increase in personnel-related expenses and stock-based compensation expense 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.
Previous wording
Interest income for the three months ended March 31, 2024 and 2023 was $3.0 million and $1.5 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 on which we are earning interest due to the sale of common stock in the first quarter of 2024.
Current wording
Interest income for the three months ended June 30, 2024 and 2023 was $7.1 million and $2.2 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 on which we are earning interest due to the sale of common stock in the first and second quarters of 2024.
Previous wording
The increase in personnel-related expenses in the first quarter of 2024 compared to the first quarter of 2023 was due to increased headcount in our general and administrative function. The increase in stock-based compensation expense 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. The increase in professional and consulting fees in the first quarter of 2024 was primarily due to higher intellectual property related legal costs associated with our patent portfolio and other professional fees. Facility-related and other expenses decreased primarily due to decreased general business expenses, including the cost of corporate insurance policies.
Current wording
The increase in personnel-related expenses in the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was due to increased headcount in our general and administrative function. The increase in stock-based compensation expense 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. The increase in professional and consulting fees was primarily due to higher intellectual property related legal costs associated with our patent portfolio and other professional fees. Facility-related and other expenses decreased primarily due to decreased general business expenses, including the cost of corporate insurance policies.
Previous wording
Other income for the three months ended March 31, 2024 was $0.5 million due to foreign currency gains. Other expense for the three months ended March 31, 2023 was $0.2 million due to realized losses on the sale of marketable securities and net foreign currency losses.
Current wording
Other income for the six months ended June 30, 2024 was $0.3 million due to foreign currency gains. Other expense for the six months ended June 30, 2023 was $0.6 million due to realized losses on the sale of marketable securities and net foreign currency losses.
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 several years, if at all. To date, we have funded our operations primarily with proceeds from sales of equity securities. As of March 31, 2024 we had cash, cash equivalents and marketable securities of $453.5 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 for several years, if at all. To date, we have funded our operations primarily with proceeds from sales of equity securities. As of June 30, 2024 we had cash, cash equivalents and marketable securities of $778.8 million.
Previous wording
During the three months ended March 31, 2024, we issued and sold an aggregate of 3,800,465 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of $97.9 million, after deducting sales agent commissions and offering expenses payable by us. We sold such shares at a weighted average price of $26.86 per share. In addition, on March 27, 2024, we sold 925,925 shares of common stock pursuant to the Sales Agreement. However, the sale of such shares was not settled until April 2024, the shares were not issued until April 2024 and we did not receive the proceeds until April 2024. We sold such shares at a weighted average price of $27.00 and received net proceeds of $24.3 million, after deducting sales agent commissions and offering expenses payable by us. The $24.3 million in net proceeds related to these sales is recorded in other receivables as of March 31, 2024.
Current wording
During the six months ended June 30, 2024, we issued and sold an aggregate of 3,800,465 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of $97.9 million, after deducting sales agent commissions and offering expenses payable by us. We sold such shares at a weighted average price of $26.86 per share.
Previous wording
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 consisted of a $28.8 million decrease in accounts payable and other liabilities and a $4.1 million increase in prepaid expenses. During the three months ended March 31, 2023, operating activities used $46.9 million of cash, due to our net loss of $44.2 million and net cash used by changes in our operating assets and liabilities of $7.9 million, partially offset by non-cash charges of $5.2 million. Net cash used by changes in our operating assets and liabilities consisted of a $1.4 million increase in prepaid expenses and other current assets and a $6.5 million decrease in accounts payable and other liabilities. 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, 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 consisted of a $21.4 million decrease in accounts payable and other liabilities and a $7.2 million increase in prepaid expenses. During the six months ended June 30, 2023, operating activities used $102.6 million of cash, due to our net loss of $109.1 million and net cash used by changes in our operating assets and liabilities of $3.7 million, partially offset by non-cash charges of $10.3 million. Net cash used by changes in our operating assets and liabilities consisted of a $7.9 million decrease in accounts payable and other liabilities, partially offset by a $4.2 million decrease in prepaid expenses. 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, 2024, net cash used in investing activities was $179.8 million due to purchases of marketable securities of $181.4 and purchases of property and equipment of $0.2 million, partially offset by maturities of marketable securities of $1.7 million. During the three months ended March 31, 2023, net cash provided by investing activities was $27.1 million due to maturities of marketable securities of $42.2 million and sales of marketable securities of $1.8 million, partially offset by purchases of marketable securities of $16.7 million and purchases of property and equipment of $0.2 million.
Current wording
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 and purchases of property and equipment of $1.0 million, partially offset by maturities of marketable securities of $40.1 million. During the six months ended June 30, 2023, net cash provided by investing activities was $44.3 million due to maturities of marketable securities of $77.6 million and sales of marketable securities of $1.8 million, partially offset by purchases of marketable securities of $34.7 million and purchases of property and equipment of $0.5 million.
Previous wording
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 of common stock in our January 2024 offering, $73.6 million in aggregate net proceeds from sales of common stock under our at-the-market offering program and $10.9 million in proceeds received from stock option exercises. During the three months ended March 31, 2023, net cash provided by financing activities was $28.8 million, consisting of $28.2 million in aggregate net proceeds from sales of common stock under our at-the-market offering program and $0.6 million in net proceeds received from stock option exercises.
Current wording
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 of common stock in our January 2024 and May 2024 offerings, $97.9 million in aggregate net proceeds from sales of common stock under our at-the-market offering program and $15.2 million in proceeds received from stock option exercises. During the six months ended June 30, 2023, net cash provided by financing activities was $53.7 million, consisting of $52.4 million in aggregate net proceeds from sales of common stock under our at-the-market offering program and $1.4 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 through 2025. 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 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.
Previous wording
We are currently an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an “emerging growth company.” Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions until December 31, 2025 or until such earlier time that we are no longer an “emerging growth company.”
Current wording
Based on the market value of our common stock held by non-affiliates as of June 30, 2024, we will cease to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, effective as of December 31, 2024, and as of such date, we will no longer be allowed to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are emerging growth companies, including the extended transition period for complying with new or revised accounting standards.
Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
The increase in stock-based compensation expense was due to increased headcount in our general and administrative function. The increase in professional and consulting fees was primarily due to higher intellectual property related legal costs associated with our patent portfolio and other professional fees. Personnel-related expenses and facility-related and other expenses remained generally consistent in the second quarter of 2024 compared to the second quarter of 2023.
Current report — wording carried from elsewhere
Other expense for the three months ended June 30, 2024 and 2023 was $0.2 million and $0.4 million, respectively, due to realized foreign currency losses.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:
Current report — wording carried from elsewhere
Expenses related to DYNE-101 decreased in the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This was attributable to higher manufacturing activity in the six months ended June 30, 2023. Expenses related to DYNE-251 increased in the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This was attributable to an increase in clinical trial activity for the DELIVER trial and higher manufacturing activity in the six months ended June 30, 2024.
Current report — wording carried from elsewhere
The increase in platform and external research and development expenses in the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily due to increased external research activity associated with our preclinical programs. The increase in personnel-related expenses and stock-based compensation expense 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, 2024 and 2023:
Current report — wording carried from elsewhere
Interest income for the six months ended June 30, 2024 and 2023 was $10.1 million and $3.7 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 on which we are earning interest due to the sale of common stock in the first and second quarters of 2024.
Current report — wording carried from elsewhere
In May 2024, we completed a follow-on public offering, which we refer to as the May 2024 offering, pursuant to which we issued and sold 12,075,000 shares of our common stock. We received net proceeds of $351.3 million, after deducting underwriting discounts and commissions and offering expenses payable by us.