Solid Biosciences Inc.
For the period ended Jun 30, 2025. Filed Aug 12, 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 Aug 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-072560
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 138 previous paragraphs and 140 current paragraphs.
92 unchanged; 37 reworded; 9 added; 8 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 4 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 (9)
Current report
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 report
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 report
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 report
Capsids
Current report
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 report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
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 report
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 report
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.
Removed paragraphs (8)
Previous report
We have conducted preclinical studies of SGT-501, including three-and six-month good laboratory practices ("GLP") toxicology studies. IND-enabling GLP toxicology studies of SGT-501 in non-human primates, including the in-life portion of the six-month toxicology, were completed in the first quarter of 2025. We expect to submit an IND to the FDA for SGT-501 for the treatment of patients with RYR2-mediated CPVT in the first half of 2025.
Previous report
Capsid
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income, Net
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income, Net
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 orphan drug designation, Rare Pediatric Disease designation and Fast Track designation for SGT-003 for Duchenne. The FDA has granted Fast Track Designation for SGT-212 for the treatment of FA. The FDA and the European Medicines Agency (the "EMA") have granted orphan drug designation to SGT-501 for the treatment of CPVT and the FDA has granted Rare Pediatric Disease Designation for SGT-501.
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. 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.
Previous wording
Patient dosing in the Phase 1/2 INSPIRE DUCHENNE trial of SGT-003 began in the second quarter of 2024. The INSPIRE DUCHENNE trial is a Phase 1/2 first-in-human, open-label, single-dose, multicenter trial designed to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric patients with Duchenne at a dose of 1E14vg/kg. SGT-003 is administered as a one-time intravenous infusion. In September 2024, we amended the INSPIRE DUCHENNE clinical trial protocol to increase the anticipated participant enrollment size, expand the participant cohort age groups, and extend the timepoints of certain secondary objective measurements. In connection with the expanded clinical trial, we have initiated work for additional GMP batches of SGT-003.
Current wording
Participant dosing in the Phase 1/2 INSPIRE DUCHENNE trial of SGT-003 began in the second quarter of 2024. The INSPIRE DUCHENNE trial is a Phase 1/2 first-in-human, open-label, single-dose, multicenter trial designed to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric participants with Duchenne at a dose of 1E14vg/kg. SGT-003 is administered as a one-time intravenous infusion. In September 2024 and June 2025, we amended the INSPIRE DUCHENNE clinical trial protocol to increase the anticipated participant enrollment size, expand the participant cohort age groups, and extend the timepoints of certain secondary objective measurements. In connection with the expanded clinical trial, we have initiated work for additional GMP batches of SGT-003.
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.
Current 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.
Previous wording
Enrollment in the INSPIRE DUCHENNE trial is ongoing, with approximately 20 total participants anticipated to be dosed by year-end 2025.
Current 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.
Previous wording
INSPIRE DUCHENNE currently has a total of eight active clinical sites in the United States, Canada and Italy, and has an approved clinical trial application in the United Kingdom. We expect to activate additional trial sites by the end of 2025. In mid-2025, we plan to submit a meeting request to the FDA to discuss the potential for accelerated regulatory pathways for SGT-003. We anticipate that the meeting with the FDA could occur as early as the fourth quarter of 2025.
Current 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.
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 non-ambulatory and ambulatory adult patients living with FA in the second half of 2025. 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. 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.
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. We anticipate submitting an IND to the FDA for SGT-601 for the treatment of TNNT2 DCM in the second half of 2026.
Current 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.
Previous wording
Solid's proprietary capsid used in SGT-003, AAV-SLB101, was well tolerated in the first patients dosed 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 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.
Previous wording
We are focused on developing transformative treatments to improve the lives of patients with rare neuromuscular and cardiac diseases. The majority of our current programs are designed to treat these diseases with gene transfer products. Gene transfer, a type of gene therapy, is designed to address diseases caused by mutated genes through the delivery of functional versions of genes, called transgenes. The transgenes are then utilized by the body to produce desired proteins that act therapeutically to treat the condition. In addition to a transgene, our gene transfer Candidates include a viral capsid or vector (a protein shell utilized as a vehicle to deliver a transgene to cells in the body) and a promoter (a specialized DNA sequence that directs cells to produce the protein in specific tissues). The capsid is modified to no longer self-replicate yet still retain its ability to introduce new genetic material directly into patients’ cells. Adeno-associated virus ("AAV") capsids have been approved for use to deliver transgenes to patients, including via systemic delivery as well as stereotactic neurosurgical administration to the brain. The use of AAV capsids to deliver gene therapies has also been extensively studied by third parties in human clinical trials for multiple disease indications, and in certain of these trials AAV was delivered systemically to the patient.
Current wording
We are focused on developing transformative treatments to improve the lives of patients with rare neuromuscular and cardiac diseases. The majority of our current programs are designed to treat these diseases with gene transfer products. Gene transfer, a type of gene therapy, is designed to address diseases caused by mutated genes through the delivery of functional versions of genes, called transgenes. The transgenes are then utilized by the body to produce desired proteins that act therapeutically to treat the condition. In addition to a transgene, our gene transfer Candidates include a viral capsid or vector (a protein shell utilized as a vehicle to deliver a transgene to cells in the body) and a promoter (a specialized DNA sequence that directs cells to produce the protein in specific tissues). The capsid is modified to no longer self-replicate yet still retains its ability to introduce new genetic material directly into patients’ cells. Adeno-associated virus ("AAV") capsids have been approved for use to deliver transgenes to patients, including via systemic delivery as well as stereotactic neurosurgical administration to the brain. The use of AAV capsids to deliver gene therapies has also been extensively studied by third parties in human clinical trials for multiple disease indications, and in certain of these trials AAV was delivered systemically to the participant.
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 $39.3 million and $24.3 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $822.7 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 $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.
Previous wording
As we seek to develop and commercialize our Candidates, we anticipate that our expenses will increase significantly and that we will need substantial additional funding to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity financings, debt financings or other sources, which may include licensing agreements or strategic collaborations. We may be unable to raise additional funds or enter into such agreements or arrangements when needed on favorable terms, if at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development or commercialization of our Candidates.
Current wording
As we seek to develop and commercialize our Candidates, we anticipate that our expenses will increase significantly and that we will need substantial additional funding to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity financing, debt financings or other sources, which may include licensing agreements or strategic collaborations. We may be unable to raise additional funds or enter into such agreements or arrangements when needed on favorable terms, if at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development or commercialization of our Candidates.
Previous wording
As of March 31, 2025, we had cash, cash equivalents, and available-for-sale securities of $306.9 million, excluding restricted cash of $2.0 million. We believe that our cash, cash equivalents, and available-for-sale securities as of March 31, 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 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.
Previous wording
We have not generated any commercial product revenue to date and do not expect to generate any product revenue from the sale of our products for the foreseeable future, if ever. If our development efforts for our Candidates are successful and result in marketing approval, we may generate commercial product revenue in the future from product sales.
Current wording
We have not generated any commercial product revenue to date and do not expect to generate any product revenue from the sale of our products for the foreseeable future, if ever. If our development efforts for our Candidates are successful and result in marketing approval, we may generate commercial product revenue in the future.
Previous wording
expenses incurred under agreements with third parties, including contract research organizations ("CROs") that conduct research, preclinical and clinical activities on our behalf, as well as contract manufacturing organizations ("CMOs") that manufacture SGT-003, SGT-501, SGT-212, and other Candidates for use in our preclinical studies and clinical trials;
Current wording
expenses incurred under agreements with third parties, including contract research organizations ("CROs") that conduct research, preclinical and clinical activities on our behalf, as well as contract development and manufacturing organizations ("CDMOs") that manufacture SGT-003, SGT-212, SGT-501, and other Candidates for use in our preclinical studies and clinical trials;
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 trial of SGT-212, 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 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.
Previous wording
uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;
Current wording
uncertainties in clinical trial design and participant enrollment or drop out or discontinuation rates;
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 trial of SGT-212, 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 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.
Previous wording
During the three months ended March 31, 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 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:
Previous wording
Research and development expenses for the three months ended March 31, 2025 were $30.9 million, compared to $18.9 million for the three months ended March 31, 2024. The increase of $12.0 million in research and development expenses was primarily due to a $7.4 million increase in costs for SGT-003 primarily related to manufacturing, regulatory, and clinical costs, a $1.9 million increase in personnel related expenses, a $1.3 million increase in other development program expenses primarily due to manufacturing costs, a $0.8 million increase in costs for SGT-212 primarily related to regulatory and clinical costs, and a $0.7 million increase in costs for SGT-501 primarily related to research, regulatory, and clinical costs, offset by a $0.1 million decrease for SGT-001 due to our decision to deprioritize SGT-001.
Current 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.
Previous wording
General and administrative expenses were $9.1 million for the three months ended March 31, 2025, compared to $8.0 million for the three months ended March 31, 2024. The increase of $1.1 million was primarily related to a $1.7 million increase in personnel related costs, partially offset by a $0.2 million decrease in legal fees, and a $0.2 million decrease in finance costs.
Current 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.
Previous wording
Other income, net was $0.8 million for the three months ended March 31, 2025 compared to $2.6 million for the three months ended March 31, 2024. The decrease of $1.8 million was primarily related to the change in fair value of derivative liabilities.
Current 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.
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 three months ended March 31, 2025, we sold 61,542 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $0.2 million.
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 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.
Previous wording
On February 19, 2025, we issued and sold in an underwritten offering (the "February 2025 Offering"), 35,739,810 shares of our common stock at a price of $4.03 per share and, to certain investors in lieu of shares of common stock, pre-funded warrants to purchase 13,888,340 shares of common stock at a price of $4.029 per pre-funded warrant. We received approximately $188.0 million of net proceeds, after deducting underwriting discounts and commissions and offering costs.
Current wording
On February 19, 2025, we issued and sold in an underwritten offering (the "February 2025 Offering"), 35,739,810 shares of our common stock at a price of $4.03 per share and, to certain investors in lieu of shares of common stock, pre-funded warrants to purchase 13,888,340 shares of common stock at a price of $4.029 per pre-funded warrant. We received approximately $188.0 million of net proceeds from the February 2025 Offering, after deducting underwriting discounts and commissions and offering costs.
Previous wording
As of March 31, 2025, we had cash, cash equivalents, and available-for-sale securities of $306.9 million, excluding restricted cash of $2.0 million, and had no debt outstanding.
Current 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.
Previous wording
During the three months ended March 31, 2025, operating activities used $31.9 million of cash, primarily resulting from our net loss of $39.3 million partially offset by changes in our operating assets and liabilities of $1.8 million and non-cash charges of $5.6 million. Net cash used by changes in our operating assets and liabilities during the three months ended March 31, 2025 consisted of a decrease of $2.0 million in prepaid and other assets and an increase in accounts payable of $0.5 million, offset by a decrease in the operating lease liability of $0.4 million and a decrease in accrued expenses and other liabilities of $0.3 million. Non-cash activities were driven by equity-based compensation of $3.3 million, depreciation and amortization expense of $0.4 million, non-cash lease expense of $0.6 million, and a change in the fair value of derivative liabilities of $1.7 million, partially offset by amortization on available-for-sale securities of $0.3 million.
Current 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.
Previous wording
During the three months ended March 31, 2024, operating activities used $25.2 million of cash, primarily resulting from our net loss of $24.3 million and changes in our operating assets and liabilities of $2.9 million, partially offset by non-cash charges of $2.0 million. Net cash used by changes in our operating assets and liabilities during the three months ended March 31, 2024 consisted of an increase of $2.0 million in prepaid and other assets, a decrease in accounts payable of $0.6 million, and a decrease in the operating lease liability of $0.5 million, offset by an increase in accrued expenses and other liabilities of $0.2 million. Non-cash activities were driven by equity-based compensation of $1.6 million, non-cash lease expense of $0.6 million and depreciation expense of $0.3 million, partially offset by amortization on available-for-sale securities of $0.5 million and a gain on lease termination of $0.1 million.
Current 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.
Previous wording
During the three months ended March 31, 2025, investing activities used $27.5 million of cash, resulting from the purchases of available-for sale securities of $65.3 million and the purchases of property plant and equipment of $0.1 million, partially offset by the maturity of available-for sale securities of $38.0 million.
Current 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.
Previous wording
During the three months ended March 31, 2024, investing activities used $38.5 million of cash, resulting from the purchases of available-for sale securities of $83.3 million and the purchases of property plant and equipment of $0.2 million, partially offset by the maturity of available-for sale securities of $45.0 million.
Current 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.
Previous wording
During the three months ended March 31, 2024, financing activities provided $107.2 million of cash, resulting from the proceeds from the issuance of common stock and pre-funded warrants to purchase shares of common stock of $107.1 million and proceeds from the exercise of common stock options for $0.1 million.
Current 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.
Previous wording
During the three months ended March 31, 2025, financing activities provided $189.7 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 $189.9 million, offset by payments of the principal portion of finance lease obligations of $0.1 million.
Current 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.
Previous wording
continue to enroll patients in our INSPIRE DUCHENNE trial and advance clinical development of SGT-003;
Current wording
continue to enroll participants in our INSPIRE DUCHENNE trial and advance clinical development of SGT-003;
Previous wording
advance our other Candidates into clinical trials, including our planned Phase 1b clinical trial of SGT-212;
Current wording
advance our other Candidates into clinical trials, including our planned Phase 1b clinical trials of SGT-212 and SGT-501;
Previous wording
scale up our manufacturing processes and arrange manufacturing for larger quantities of our product candidates for preclinical and clinical development and potential commercialization;
Current wording
scale up our manufacturing processes and arrange manufacturing for larger quantities of our Candidates for preclinical and clinical development and potential commercialization;
Previous wording
As of March 31, 2025, we had cash, cash equivalents and available-for-sale securities of $306.9 million, excluding restricted cash of $2.0 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of March 31, 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 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.
Previous wording
the progress, costs and results of the INSPIRE DUCHENNE trial, our planned clinical trial of SGT-212, and any future clinical trials of our Candidates;
Current 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;
Previous wording
We are supplying, and expect to continue to supply, our ongoing and future pre-clinical and clinical development programs with drug product produced at a cGMP compliant facility located at one of our CMOs. We intend to establish the capability and capacity to supply Candidates at commercial scale from multiple sources.
Current wording
We are supplying, and expect to continue to supply, our ongoing and future preclinical and clinical development programs with drug product produced at a cGMP compliant facility located at one of our CDMOs. We intend to establish the capability and capacity to supply Candidates at commercial scale from multiple sources.
Previous wording
During the three months ended March 31, 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 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.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses by Candidate for the periods indicated (in thousands, except percentages):
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
SGT-003 has been well-tolerated in the first six participants dosed as of February 17, 2025. 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.