Solid Biosciences Inc.
For the period ended Sep 30, 2025. Filed Nov 3, 2025.
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.
Sep 30, 2025 · Filed Nov 3, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-107279
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-03.
0001193125-25-262818
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 140 previous paragraphs and 143 current paragraphs.
102 unchanged; 37 reworded; 3 added; 1 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 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 (3)
Current report
For a more detailed description of the interim results from the INSPIRE DUCHENNE trial, see our Form 8-K filed November 3, 2025.
Current report
The FDA has granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations for SGT-003 for the treatment of Duchenne. SGT-003 has been awarded an Innovation Passport by the new UK Innovative Licensing and Access Pathway, which aims to accelerate time to market and facilitate patient access to new medicines in the United Kingdom.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Removed paragraphs (1)
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Reworded paragraphs (37)
Previous wording
We are continuing to advance our pipeline of Candidates. The U.S. Food and Drug Administration (the "FDA") has granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations for SGT-003 for Duchenne. The FDA has granted Fast Track designation for SGT-212 for the treatment of FA. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-501 for the treatment of CPVT.
Current wording
We are continuing to advance our pipeline of Candidates. The U.S. Food and Drug Administration (the "FDA") has granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations for SGT-003 for Duchenne and SGT-003 has also been awarded an Innovation Passport by the new UK Innovative Licensing and Access Pathway. The FDA has granted Fast Track and Rare Pediatric Disease designations for SGT-212 for the treatment of FA. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-501 for the treatment of CPVT.
Previous wording
On February 18, 2025, we announced positive initial data from the Phase 1/2 INSPIRE DUCHENNE trial as of the data cutoff date of February 11, 2025. Interim biopsy data reported in the first three participants showed an average microdystrophin expression of 110%, as measured by western blot, and improvements in multiple biomarkers that are indicators of muscle integrity, health and resilience. For a full description of the initial results from the INSPIRE DUCHENNE trial, see Part I, Item I, “Business” appearing in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
On November 3, 2025, we announced positive interim data from the Phase 1/2 INSPIRE DUCHENNE trial as of the data cutoff date of September 29, 2025. Interim biopsy data reported from 10 participants treated with SGT-003 showed a mean microdystrophin expression of 58%, as measured by both western blot and mass spectrometry, and mean microdystrophin positive fibers of 51%, as measured by immunofluorescence. Interim data also demonstrated early signals of cardiac function normalization and improvements in multiple biomarkers that are indicators of muscle integrity, health and resilience. These interim data include favorable reductions across a range of biomarkers of muscle injury and breakdown, including serum creatine kinase (CK), serum alanine transaminase (ALT), serum aspartate aminotransferase (AST), serum lactate dehydrogenase (LDH) and serum titin, through both Day 90 and Day 360 after treatment with SGT-003. Additionally, following treatment with SGT-003, we observed restoration of key components of the dystrophin associated protein complex (DAPC), including beta-sarcoglycan and neuronal nitric oxide synthase (nNOS), and early signals of a potential for cardiac benefit through reduction in troponin I (cTnI) and increased systolic function as measured by LVEF by echocardiography.
Previous wording
As of August 12, 2025, 15 participants have been dosed in the INSPIRE DUCHENNE trial and SGT-003 has been well tolerated as of such date.
Current wording
As of October 31, 2025, 23 participants have been dosed in the INSPIRE DUCHENNE trial and SGT-003 has been generally well tolerated as of such date. There has been one treatment-related serious adverse event reported in the INSPIRE DUCHENNE trial. This serious adverse event was identified as a Grade 3 immune-mediated myositis which, importantly, was not associated with muscle pain or weakness, and occurred in a participant who had a large deletion in a region coded for by SGT-003's microdystrophin. The study participant promptly responded to steroid treatment with all clinical symptoms noted at presentation resolving and with muscle biomarkers, including CK, declining well below baseline levels. This SAE was reviewed by the data and safety monitoring board (DSMB) with the recommendation to continue dosing without interruption.
Previous wording
Enrollment and dosing in the INSPIRE DUCHENNE trial is ongoing, with at least 20 total participants anticipated to be dosed by year-end 2025.
Current wording
Enrollment and dosing in the INSPIRE DUCHENNE trial is ongoing, with 30 total participants anticipated to be dosed by early 2026.
Previous wording
The INSPIRE DUCHENNE trial currently has 10 active sites across the U.S., Canada, Italy and the United Kingdom, with additional sites expected to be activated by the end of 2025. A meeting with the FDA to discuss potential regulatory pathways for SGT-003 is anticipated to occur in the fourth quarter of 2025.
Current wording
The INSPIRE DUCHENNE trial currently has 15 active sites across the U.S., Canada, Italy and the United Kingdom, with an additional site expected to be activated by the end of 2025. A meeting with the FDA to discuss potential regulatory pathways, including accelerated approval pathways, for SGT-003 is anticipated to occur in the first half of 2026.
Previous wording
Additionally, we intend to initiate a separate randomized, double-blind, placebo-controlled trial evaluating SGT-003 outside of the United States, also expected in the fourth quarter of 2025, with the aim of supporting potential global regulatory authorizations.
Current wording
Additionally, in October 2025, we activated the first clinical trial site and began screening participants for IMPACT DUCHENNE, a Phase 3 randomized, double-blind, placebo-controlled trial evaluating SGT-003 outside of the United States. IMPACT DUCHENNE has been designed with the aim of supporting potential ex-U.S. regulatory authorizations. We have received regulatory approvals to conduct IMPACT DUCHENNE in both Canada and Australia, and we plan to expand the trial into additional countries, subject to receipt of regulatory approval.
Previous wording
In January 2025, we announced that the FDA cleared our investigational new drug ("IND") for SGT-212 for the treatment of FA. We anticipate initiating an open-label, multi-center Phase 1b clinical trial of SGT-212 in the fourth quarter of 2025. The trial is expected to enroll non-ambulatory and ambulatory adult participants living with FA in up to three cohorts and is designed to evaluate the safety and tolerability of systemic and bilateral IDN administration of SGT-212. The FDA has granted Fast Track designation to SGT-212 for the treatment of FA.
Current wording
In January 2025, we announced that the FDA cleared our investigational new drug ("IND") for SGT-212 for the treatment of FA. In October 2025, we activated the first clinical trial site and began screening participants for FALCON, an open-label, multi-center Phase 1b clinical trial of SGT-212. The trial is expected to enroll non-ambulatory and ambulatory adult participants living with FA in up to three cohorts and is designed to evaluate the safety and tolerability of systemic and bilateral intradentate nucleus administration of SGT-212. The FDA has granted Fast Track and Rare Pediatric Disease designations to SGT-212 for the treatment of FA.
Previous wording
In July 2025, we announced that the FDA cleared our IND and that Health Canada approved our clinical trial application ("CTA") for SGT-501 for the treatment of CPVT. We anticipate initiating an open-label, multi-center Phase 1b clinical trial of SGT-501 in adult participants with CPVT in the fourth quarter of 2025. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-501 for the treatment of CPVT.
Current wording
In July 2025, we announced that the FDA cleared our IND and that Health Canada approved our clinical trial application ("CTA") for SGT-501 for the treatment of CPVT. We anticipate activating the first clinical trial site for ARTEMIS, an open-label, multi-center Phase 1b clinical trial of SGT-501 in adult participants with CPVT in the fourth quarter of 2025. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-501 for the treatment of CPVT.
Previous wording
We are currently developing a preclinical stage product candidate, SGT-601, for the treatment of TNNT2 DCM. Efficacy studies in mice suggest that SGT-601 treatment resulted in a restoration of ejection fraction function and a stabilization in cardiac function over time.
Current wording
We are currently developing a preclinical product candidate, SGT-601, for the treatment of TNNT2 DCM. Efficacy studies in mice suggest that SGT-601 treatment resulted in a restoration of ejection fraction function and a stabilization in cardiac function over time.
Previous wording
AAV-SLB101, Solid's proprietary, rationally designed capsid used in SGT-003, has been well tolerated as of August 12, 2025 (N=15), in the INSPIRE DUCHENNE trial as well as in non-human primates ("NHP") and mouse studies.
Current wording
AAV-SLB101, Solid's proprietary, rationally designed capsid used in SGT-003, has been generally well tolerated as of October 31, 2025 (N=23), in the INSPIRE DUCHENNE trial as well as in non-human primates ("NHP") and mouse studies.
Previous wording
We are building multiple cardiac and neuromuscular next-generation capsid and promoter libraries with final capsid selection from the first cardiac capsid library anticipated in the fourth quarter of 2025.
Current wording
We are building multiple cardiac and neuromuscular next-generation capsid and promoter libraries with final capsid selection from the first cardiac capsid library anticipated in the first half of 2026.
Previous wording
Due to our significant research and development expenditure, licensing and patent investment, and general and administrative costs associated with our operations, we have generated substantial operating losses in each period since our inception. Our net losses were $39.5 million and $78.8 million for the three and six months ended June 30, 2025, respectively, and $25.1 million and $49.4 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $862.2 million. We expect to incur significant expenses and operating losses for the foreseeable future.
Current wording
Due to our significant research and development expenditure, licensing and patent investment, and general and administrative costs associated with our operations, we have generated substantial operating losses in each period since our inception. Our net losses were $45.8 million and $124.5 million for the three and nine months ended September 30, 2025, respectively, and $32.7 million and $82.1 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $908.0 million. We expect to incur significant expenses and operating losses for the foreseeable future.
Previous wording
As of June 30, 2025, we had cash, cash equivalents, and available-for-sale securities of $268.1 million, excluding restricted cash of $1.9 million. We believe that our cash, cash equivalents, and available-for-sale securities as of June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Current wording
As of September 30, 2025, we had cash, cash equivalents, and available-for-sale securities of $236.1 million, excluding restricted cash of $1.9 million. We believe that our cash, cash equivalents, and available-for-sale securities as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Previous wording
Research and development activities are central to our business model. We are still in the early stages of development of our Candidates. Candidates in later stages of clinical development generally have higher development costs than those in preclinical development or in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will continue to increase for the foreseeable future if and as we conduct clinical trials for SGT-003, initiate clinical trials for our other Candidates, including our planned Phase 1b clinical trials of SGT-212 and SGT-501, and continue to identify and develop additional Candidates.
Current wording
Research and development activities are central to our business model. We are still in the early stages of development of our Candidates. Candidates in later stages of clinical development generally have higher development costs than those in preclinical development or in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will continue to increase for the foreseeable future if and as we continue to conduct clinical trials for SGT-003 and SGT-212, initiate clinical trials for our other Candidates, including our planned ARTEMIS trial of SGT-501, and continue to identify and develop additional Candidates.
Previous wording
We expect that our general and administrative expenses will increase in the future as we support our research and development activities and activities related to our INSPIRE DUCHENNE trial, our planned Phase 1b clinical trials of SGT-212 and SGT-501, and any other planned or future clinical trials for and potential commercialization of our Candidates.
Current wording
We expect that our general and administrative expenses will increase in the future as we support our research and development activities and activities related to our INSPIRE DUCHENNE trial, our IMPACT DUCHENNE trial, our FALCON trial, our planned ARTEMIS trial of SGT-501, and any other planned or future clinical trials for and potential commercialization of our Candidates.
Previous wording
During the six months ended June 30, 2025, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2024 and the notes to the unaudited condensed consolidated financial statements included in Part I, Item 1, “Financial Statements (unaudited),” of this Quarterly Report on Form 10-Q. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:
Current wording
During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2024 and the notes to the unaudited condensed consolidated financial statements included in Part I, Item 1, “Financial Statements (unaudited),” of this Quarterly Report on Form 10-Q. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:
Previous wording
Research and development expenses for the three months ended June 30, 2025 were $ 32.4 million, compared to $19.5 million for the three months ended June 30, 2024. The increase of $13.0 million in research and development expenses was primarily due to a $9.9 million increase in costs for SGT-003 primarily related to manufacturing, regulatory, and clinical costs, a $2.3 million increase in personnel related expenses, a $2.1 million increase in costs for SGT-601 primarily related to manufacturing costs, a $1.0 million increase in costs for SGT-212 primarily related to clinical and research costs, partially offset by a $1.5 million decrease in costs for other development programs primarily related to lower research costs, and a $1.2 million decrease in in costs for SGT-501 primarily related to lower research and manufacturing costs.
Current wording
Research and development expenses for the three months ended September 30, 2025 were $38.9 million, compared to $27.3 million for the three months ended September 30, 2024. The increase of $11.5 million in research and development expenses was primarily due to a $12.8 million increase in costs for SGT-003 primarily related to manufacturing, regulatory, and clinical costs, a $2.7 million increase in personnel related expenses, and a $0.9 million increase in costs for SGT-601 primarily related to manufacturing and research costs, partially offset by a $3.3 million decrease in costs for SGT-212 primarily related to lower license and milestone related costs partially offset by an increase in clinical costs, and a $1.8 million decrease in in costs for SGT‑501 primarily related to lower research and manufacturing costs.
Previous wording
General and administrative expenses were $18.4 million for the six months ended June 30, 2025, compared to $16.3 million for the six months ended June 30, 2024. The increase of $2.1 million was primarily related to a $3.0 million increase in personnel related costs, partially offset by a $0.7 million decrease in legal and consulting fees.
Current wording
General and administrative expenses were $9.2 million for the three months ended September 30, 2025, compared to $7.9 million for the three months ended September 30, 2024. The increase of $1.3 million was primarily related to a $0.9 million increase in personnel related costs and a $0.4 million increase in legal and consulting fees.
Previous wording
Other income, net was $2.2 million for the three months ended June 30, 2025 compared to $2.7 million for the three months ended June 30, 2024. The decrease of $0.5 million was primarily related to the change in fair value of derivative liabilities.
Current wording
Other income, net was $2.3 million for the three months ended September 30, 2025 compared to $2.5 million for the three months ended September 30, 2024. The decrease of $0.2 million was primarily related to the change in fair value of derivative liabilities.
Previous wording
Research and development expenses for the six months ended June 30, 2025 were $63.3 million, compared to $38.3 million for the six months ended June 30, 2024. The increase of $25.0 million in research and development expenses was primarily due to a $17.3 million increase in costs for SGT-003 primarily related to manufacturing and clinical costs, a $4.2 million increase in personnel related expenses, a $4.0 million increase in costs for SGT-601 primarily related to manufacturing and research costs, a $1.8 million increase in costs for SGT-212 primarily related to clinical and research costs, offset by a $2.1 million decrease in other development programs primarily related to lower research and manufacturing costs, and a $0.5 million decrease in costs for SGT-501 primarily related to lower manufacturing and study costs partially offset by an increase in clinical, regulatory and licensing fees.
Current wording
Research and development expenses for the nine months ended September 30, 2025 were $102.2 million, compared to $65.7 million for the nine months ended September 30, 2024. The increase of $36.5 million in research and development expenses was primarily due to a $30.1 million increase in costs for SGT-003 primarily related to manufacturing and clinical costs, a $7.0 million increase in personnel related expenses, a $4.9 million increase in costs for SGT-601 primarily related to manufacturing and research costs, partially offset by a $2.3 million decrease in costs for SGT-501 primarily related to lower manufacturing and study costs partially offset by an increase in clinical, regulatory and licensing fees, a $2.1 million decrease in other development programs primarily related to lower research and manufacturing costs, and a $1.5 million decrease in costs for SGT-212 primarily related to lower license and milestone payments partially offset by an increase in clinical, regulatory, and research costs.
Previous wording
General and administrative expenses were $9.3 million for the three months ended June 30, 2025, compared to $8.3 million for the three months ended June 30, 2024. The increase of $1.0 million was primarily related to a $1.2 million increase in personnel related costs, partially offset by a $0.3 million decrease in consulting fees.
Current wording
General and administrative expenses were $27.6 million for the nine months ended September 30, 2025, compared to $24.2 million for the nine months ended September 30, 2024. The increase of $3.4 million was primarily related to a $3.7 million increase in personnel related costs and a $0.3 million increase in equipment costs, partially offset by a $0.3 million decrease in recruiting fees.
Previous wording
Other income, net was $3.0 million for the six months ended June 30, 2025 compared to $5.3 million for the six months ended June 30, 2024. The decrease of $2.3 million was primarily related to the change in fair value of derivative liabilities.
Current wording
Other income, net was $5.3 million for the nine months ended September 30, 2025 compared to $7.7 million for the nine months ended September 30, 2024. The decrease of $2.5 million was primarily related to the change in fair value of derivative liabilities.
Previous wording
To date, we have financed our operations primarily through the sale of redeemable preferred units and member units, the sale of securities in private placements and follow-on offerings, the sale of common stock in our initial public offering, and sales of common stock under our "at-the-market offering" sales agreement with Jefferies LLC ("Jefferies") (the "ATM Sales Agreement"). Through June 30, 2025, we raised an aggregate of $144.6 million of gross proceeds from our sales of preferred units prior to the completion of our initial public offering, and an aggregate of $857.1 million of net proceeds from the sale of our common stock through public offerings, including our IPO and follow-on public offerings, private placements, the ATM Sales Agreement, and pursuant to the stock purchase agreements.
Current wording
To date, we have financed our operations primarily through the sale of redeemable preferred units and member units, the sale of securities in private placements and follow-on offerings, the sale of common stock in our initial public offering, and sales of common stock under our "at-the-market offering" sales agreement with Jefferies LLC ("Jefferies") (the "ATM Sales Agreement"). Through September 30, 2025, we raised an aggregate of $144.6 million of gross proceeds from our sales of preferred units prior to the completion of our initial public offering, and an aggregate of $858.5 million of net proceeds from the sale of our common stock through public offerings, including our IPO and follow-on public offerings, private placements, the ATM Sales Agreement, and pursuant to the stock purchase agreements.
Previous wording
On March 13, 2019, we entered into the ATM Sales Agreement, which was amended and restated in March 2024, under which we may offer and sell, from time to time, shares of our common stock through Jefferies as sales agent. Any such sales being made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act. We will pay Jefferies a commission of up to 3% of the gross proceeds of any sales of common stock pursuant to the ATM Sales Agreement. During the year ended December 31, 2024, we sold 2,212,937 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $18.4 million. During the six months ended June 30, 2025, we sold 61,542 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $0.2 million. We sold no shares pursuant to the ATM Sales Agreement during the three months ended June 30, 2025.
Current wording
On March 13, 2019, we entered into the ATM Sales Agreement, which was amended and restated in March 2024, under which we may offer and sell, from time to time, shares of our common stock through Jefferies as sales agent. Any such sales being made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act. We will pay Jefferies a commission of up to 3% of the gross proceeds of any sales of common stock pursuant to the ATM Sales Agreement. During the year ended December 31, 2024, we sold 2,212,937 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $18.4 million. During three and nine months ended September 30, 2025, we sold 236,616 and 298,158 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $1.4 million and $1.7 million, respectively.
Previous wording
As of June 30, 2025, we had cash, cash equivalents, and available-for-sale securities of $268.1 million, excluding restricted cash of $1.9 million, and had no debt outstanding.
Current wording
As of September 30, 2025, we had cash, cash equivalents, and available-for-sale securities of $236.1 million, excluding restricted cash of $1.9 million, and had no debt outstanding.
Previous wording
During the six months ended June 30, 2025, operating activities used $69.3 million of cash, primarily resulting from our net loss of $78.8 million partially offset by changes in our operating assets and liabilities of $0.7 million and non-cash charges of $10.2 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2025 consisted of an increase in prepaid expenses and other assets of $2.1 million, a decrease in the operating lease liability of $0.8 million, offset by an increase in accrued expenses and other liabilities of $1.7 million, and an increase in accounts payable of $0.5 million. Non-cash activities were driven by equity-based compensation of $6.5 million, a change in the fair value of derivative liabilities of $2.6 million, non-cash lease expense of $1.2 million, depreciation and amortization expense of $0.8 million, partially offset by amortization of available-for-sale securities of $0.8 million.
Current wording
During the nine months ended September 30, 2025, operating activities used $102.7 million of cash, primarily resulting from our net loss of $124.5 million partially offset by changes in our operating assets and liabilities of $6.4 million and non-cash charges of $15.4 million. Net cash used by changes in our operating assets and liabilities during the nine months ended September 30, 2025 consisted of an increase in prepaid expenses and other assets of $0.3 million, and a decrease in the operating lease liability of $1.3 million, offset by an increase in accounts payable of $4.2 million, and an increase in accrued expenses and other liabilities of $3.9 million. Non-cash activities were driven by equity-based compensation of $10.4 million, a change in the fair value of derivative liabilities of $3.4 million, non-cash lease expense of $1.8 million, depreciation and amortization expense of $1.2 million, partially offset by amortization of available-for-sale securities of $1.1 million.
Previous wording
During the six months ended June 30, 2024, operating activities used $46.7 million of cash, primarily resulting from our net loss of $49.4 million and changes in our operating assets and liabilities of $2.1 million, partially offset by non-cash charges of $4.8 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2024 consisted of an increase of $1.6 million in prepaid and other assets, a decrease in the operating lease liability of $0.9 million, a decrease in accrued expenses and other liabilities of $0.2 million, offset by an increase in accounts payable of $0.5 million. Non-cash activities were driven by equity-based compensation of $3.7 million, depreciation and amortization expense of $1.6 million, and non-cash lease expense of $1.2 million, partially offset by amortization of available-for-sale securities of $1.6 million and a gain on lease termination of $0.1 million.
Current wording
During the nine months ended September 30, 2024, operating activities used $70.4 million of cash, primarily resulting from our net loss of $82.1 million partially offset by changes in our operating assets and liabilities of $0.7 million and non-cash charges of $11.0 million. Net cash used by changes in our operating assets and liabilities during the nine months ended September 30, 2024 consisted of an increase of $2.5 million in prepaid and other assets, and a decrease in the operating lease liability of $1.3 million, offset by an increase in accrued expenses and other liabilities of $3.1 million, and an increase in accounts payable of $1.4 million. Non-cash activities were driven by equity-based compensation of $6.7 million, depreciation and amortization expense of $2.0 million, non-cash lease expense of $1.8 million, and a change in the fair value of derivative liabilities of $3.4 million, partially offset by amortization of available-for-sale securities of $2.8 million.
Previous wording
During the six months ended June 30, 2024, investing activities used $43.7 million of cash, resulting from the purchases of available-for sale securities of $103.6 million and the purchases of property plant and equipment of $0.4 million, partially offset by the maturity of available-for sale securities of $60.3 million.
Current wording
During the nine months ended September 30, 2025, investing activities used $105.5 million of cash, resulting from the purchases of available-for sale securities of $212.0 million and the purchases of property plant and equipment of $0.6 million, partially offset by the maturity of available-for sale securities of $107.0 million.
Previous wording
During the six months ended June 30, 2025, investing activities used $60.2 million of cash, resulting from the purchases of available-for sale securities of $128.8 million and the purchases of property plant and equipment of $0.5 million, partially offset by the maturity of available-for sale securities of $69.0 million.
Current wording
During the nine months ended September 30, 2024, investing activities used $54.7 million of cash, resulting from the purchases of available-for sale securities of $189.0 million and the purchases of property plant and equipment of $0.5 million, partially offset by the maturity of available-for sale securities of $134.8 million.
Previous wording
During the six months ended June 30, 2025, financing activities provided $188.1 million of cash, resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock of $188.2 million, and proceeds from the issuance of shares of $0.2 million under the Company's Amended and Restated 2021 Employee Stock Purchase Plan, or ESPP, offset by payments of the principal portion of finance lease obligations of $0.3 million.
Current wording
During the nine months ended September 30, 2025, financing activities provided $189.3 million of cash, resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock of $189.6 million, and proceeds from the issuance of shares of $0.2 million under our Amended and Restated 2021 Employee Stock Purchase Plan, or ESPP, offset by payments of the principal portion of finance lease obligations of $0.5 million.
Previous wording
During the six months ended June 30, 2024, financing activities provided $112.2 million of cash, resulting from the net proceeds from the issuance of common stock and pre-funded warrants to purchase shares of common stock of $112.2 million, proceeds from the exercise of common stock options for $0.2 million, and proceeds from the issuance of shares of $0.1 million under the ESPP offset by payments of the principal portion of finance lease obligations of $0.2 million.
Current wording
During the nine months ended September 30, 2024, financing activities provided $115.5 million of cash, resulting from the net proceeds from the issuance of common stock and pre-funded warrants to purchase shares of common stock of $115.3 million, proceeds from the exercise of common stock options for $0.4 million, and proceeds from the issuance of shares of $0.1 million under the ESPP, offset by payments of the principal portion of finance lease obligations of $0.3 million.
Previous wording
continue to enroll participants in our INSPIRE DUCHENNE trial and advance clinical development of SGT-003;
Current wording
enroll participants in our INSPIRE DUCHENNE, IMPACT DUCHENNE and FALCON trials and advance clinical development of SGT-003 and SGT-212;
Previous wording
advance our other Candidates into clinical trials, including our planned Phase 1b clinical trials of SGT-212 and SGT-501;
Current wording
advance our other Candidates into clinical trials, including our planned ARTEMIS trial of SGT-501;
Previous wording
As of June 30, 2025, we had cash, cash equivalents and available-for-sale securities of $268.1 million, excluding restricted cash of $1.9 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of June 30, 2025 will be sufficient to fund our operating expenses and capital requirements into the first half of 2027. As a result, in order to continue to operate our business beyond that time, we will need to raise additional funds. However, there can be no assurance that we will be able to generate funds on terms acceptable to us, on a timely basis, or at all. In addition, we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Current wording
As of September 30, 2025, we had cash, cash equivalents and available-for-sale securities of $236.1 million, excluding restricted cash of $1.9 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of September 30, 2025 will be sufficient to fund our operating expenses and capital requirements into the first half of 2027. As a result, in order to continue to operate our business beyond that time, we will need to raise additional funds. However, there can be no assurance that we will be able to generate funds on terms acceptable to us, on a timely basis, or at all. In addition, we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Previous wording
the progress, costs and results of the INSPIRE DUCHENNE trial, our planned clinical trials of SGT-212 and SGT-501, and any future clinical trials of our Candidates;
Current wording
the progress, costs and results of the INSPIRE DUCHENNE, IMPACT DUCHENNE and FALCON trials, our planned ARTEMIS trial of SGT-501, and any future clinical trials of our Candidates;
Previous wording
Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity securities, our existing stockholders’ ownership interest may be diluted. Any debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute existing stockholders’ ownership interests.
Current wording
ownership interest may be diluted. Any debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute existing stockholders’ ownership interests.
Previous wording
During the six months ended June 30, 2025, there were no material changes to our contractual obligations and commitments from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Current wording
During the nine months ended September 30, 2025, there were no material changes to our contractual obligations and commitments from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity securities, our existing stockholders’