Solid Biosciences Inc
For the period ended Jun 30, 2024. Filed Aug 13, 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 13, 2024
SLDB$6.59+6.6%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 2024-05-15.
0000950170-24-060034
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0000950170-24-096130
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 125 previous paragraphs and 127 current paragraphs.
76 unchanged; 37 reworded; 12 added; 12 removed; 0 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 (12)
Current report
We are continuing to advance our pipeline of Candidates. The FDA has granted orphan drug designation to SGT-003 for the treatment of Duchenne and the FDA and EMA have granted orphan drug designation to SGT-501 for the treatment of CPVT. We expect to file an IND for CPVT in the first half of 2025. The FDA has also granted Rare Pediatric Disease and fast track designation for SGT-003.
Current report
Patient dosing in the Phase 1/2 INSPIRE Duchenne trial of SGT-003 began in the second quarter of 2024, and at the time of filing, SGT-003 has been well tolerated and no Significant Adverse Events (SAEs) were observed in the patients dosed. Initial safety, expression and certain functional endpoint data is expected in Q4 2024. A Clinical Trial Application (CTA) for INSPIRE Duchenne has been approved in Canada We plan to expand clinical development in the US and Globally and . Subject to clearance, we expect additional sites to become active by Q2 2025 to support current and potential future trials. In anticipation of an expanded clinical trial, we have initiated work for additional GMP batches of SGT-003.
Current report
Our proprietary capsid used in SGT-003 (AAV-SLB101) has now been observed as well tolerated in human, non-human primate (NHP), and mouse studies. Ten different academic labs and one corporation have begun utilizing AAV-SLB101, with additional entities currently in negotiation.
Current report
The following table summarizes our research and development expenses by Candidate for the respective periods (in thousands):
Current report
The following table summarizes our research and development expenses by Candidates for the respective periods (in thousands, except percentages) :
Current report
Comparison of the six months ended June 30, 2024 and 2023
Current report
The following table summarizes our research and development expenses by Candidate for the respective periods (in thousands, except percentages) :
Current report
Research and development expenses for the six months ended June 30, 2024 were $38.3 million, compared to $44.4 million for the six months ended June 30, 2023. The decrease of $6.1 million in research and development expenses was primarily due to a $10.6 million decrease for SGT-003 primarily related to manufacturing and research costs, a $2.6 million decrease in costs for SGT-001 due to our decision to deprioritize SGT-001, a $1.0 million decrease in personnel related expenses, offset by a $5.6 million increase in costs for SGT-501 primarily related to manufacturing and research, a $2.0 million increase in other Candidates primarily related to BAG3, and a $0.5 million increase in external expenses.
Current report
General and administrative expenses were $16.3 million for the six months ended June 30, 2024, compared to $14.5 million for the six months ended June 30, 2023. The increase of $1.8 million was primarily related to a $1.4 million increase in legal fees and a $0.2 million increase in software costs, and a $0.2 million increase in audit and tax fees.
Current report
During the six months ended June 30, 2023, financing activities provided $2.6 million of cash, resulting from the proceeds from the issuance of common stock of $2.5 million and purchases of shares under our ESPP.
Current report
A summary of significant recent accounting pronouncements that we have adopted or expect to adopt is included in
Current report
Note 1 – Nature of the Business and Basis of Presentation to our condensed consolidated financial statements (See Part I, Item 1 – Financial Statements, of this Quarterly Report on Form 10-Q).
Removed paragraphs (12)
Previous report
Research and development expenses
Previous report
The following table summarizes our research and development expenses by product candidates for the respective periods:
Previous report
General and administrative expenses
Previous report
Other income, net
Previous report
Income taxes
Previous report
We account for income taxes using an asset and liability approach, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements but have not been reflected in taxable income. A valuation allowance is established to reduce deferred tax assets to their estimated realizable value.
Previous report
We account for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Other income, net
Previous report
During the three months ended March 31, 2023, there was no cash from financing activities.
Previous report
See Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Reworded paragraphs (37)
Previous wording
We are a life sciences company focused on advancing a portfolio of current and future gene therapy candidates, which we refer to collectively as our Candidates, including SGT-003 for the treatment of Duchenne muscular dystrophy, or Duchenne, SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia, or CPVT, and additional assets for the treatment of cardiac and other diseases, at different stages of development, with varying levels of investment. We are advancing our diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management and care. Patient-focused and founded by those directly impacted by Duchenne, our mission is to improve the daily lives of patients living with these devastating diseases.
Current wording
Solid Biosciences Inc. (we, us, our, the Company, or Solid) is a life sciences company focused on advancing a portfolio of current and future gene therapy candidates, which we refer to collectively as our Candidates, including SGT-003 for the treatment of Duchenne muscular dystrophy, or Duchenne, SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia, or CPVT, and additional assets for the treatment of cardiac and other diseases, at different stages of development, with varying levels of investment. We are advancing our diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management and care. Patient-focused and founded by those directly impacted by Duchenne, our mission is to improve the daily lives of patients living with these devastating diseases.
Previous wording
On December 2, 2022, we completed our acquisition of AavantiBio, Inc., or AavantiBio, a privately held gene therapy company focused on transforming the lives of patients with Friedreich’s ataxia, or FA, and rare cardiomyopathies, or the Acquisition. Upon the consummation of the Acquisition, we acquired AavantiBio’s gene therapy programs, AVB-202-TT for the treatment of FA and AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy ("DCM"), additional assets for the treatment of cardiac diseases, platform technologies and know-how related thereto.
Current wording
On December 2, 2022, we completed our acquisition of AavantiBio, Inc., or AavantiBio, a privately held gene therapy company focused on transforming the lives of patients with Friedreich’s ataxia, or FA, and rare cardiomyopathies, or the Acquisition. Upon the consummation of the Acquisition, we acquired AavantiBio’s gene therapy programs, AVB-202-TT for the treatment of FA and AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy, or BAG3, additional assets for the treatment of cardiac diseases, platform technologies and know-how related thereto.
Previous wording
In January 2024, we sold to investors in a private placement, or the January 2024 Private Placement, an aggregate of 16,973,103 shares of our common stock at a price of $5.53 per share, and, to one investor in lieu of shares, pre-funded warrants to purchase 2,712,478 shares of our common stock, at a price of $5.529 per pre-funded warrant. We received $103.7 million of aggregate net proceeds, after deducting offering costs.
Current wording
In January 2024, we sold to investors in a private placement, or the January 2024 Private Placement, an aggregate of 16,973,103 shares of our common stock at a price of $5.53 per share, and, to one investor in lieu of shares, pre-funded warrants to purchase
Previous wording
Due to our significant research and development expenditure, licensing and patent investment, and general administrative costs associated with our operations, we have generated substantial operating losses in each period since our inception. Our net losses were $24.3 million and $30.1 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $683.1 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 administrative costs associated with our operations, we have generated substantial operating losses in each period since our inception. Our net losses were $25.1 million and $49.4 million for the three and six months ended June 30, 2024 and $24.6 million and $54.7 million for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $708.1 million. We expect to incur significant expenses and operating losses for the foreseeable future.
Previous wording
As of March 31, 2024, we had cash, cash equivalents, and available-for-sale securities of $206.1 million, excluding restricted cash of $1.8 million. We believe that our cash, cash equivalents, and available-for-sale securities as of March 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements into 2026. 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, 2024, we had cash, cash equivalents, and available-for-sale securities of $190.3 million, excluding restricted cash of $1.9 million. We believe that our cash, cash equivalents, and available-for-sale securities as of June 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into 2026. 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 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 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 from product sales.
Previous wording
We classify our operating expenses into two categories: research and development, and general and administrative expenses. Personnel costs, including salaries, benefits, bonuses and equity-based compensation expense, comprise a significant component of each of these expense categories. We allocate expenses associated with personnel costs based on the nature of work associated with these resources.
Current wording
We classify our operating expenses into two categories: research and development and general and administrative expenses. Personnel costs, including salaries, benefits, bonuses, and equity-based compensation expense comprise a significant component of both expense categories. We allocate expenses associated with personnel costs based on the nature of work associated with these resources.
Previous wording
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of SGT-003 and other Candidates and include:
Current wording
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and clinical and preclinical development activities for our Candidates and include:
Previous wording
expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct research and preclinical activities on our behalf, as well as contract manufacturing organizations, or CMOs, that manufacture SGT-003 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, or CROs, that conduct research, preclinical and clinical activities on our behalf, as well as contract manufacturing organizations, or CMOs, that manufacture SGT-003, SGT-501, and other Candidates for use in our preclinical studies and clinical trials;
Previous wording
costs incurred in seeking regulatory approval of SGT-003 and other Candidates;
Current wording
costs incurred in seeking regulatory approval of our Candidates;
Previous wording
Research and development activities are central to our business model. We are still in the early stages of development of our Candidates. Product 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 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, and continue to identify and develop additional Candidates.
Previous wording
We typically use our employee and infrastructure resources across our product candidates. We track outsourced development costs and milestone payments made under our licensing arrangements by product candidates, but we do not allocate personnel costs, license payments made under our licensing arrangements or other internal costs to product candidates on a program-specific basis. These costs are included in unallocated research and development expenses in the table below.
Current wording
We typically use our employee and infrastructure resources across our Candidates. We track outsourced development costs and milestone payments made under our licensing arrangements by Candidate, but we do not allocate personnel costs, license payments made under our licensing arrangements or other internal costs to Candidates on a program-specific basis. These costs are included in unallocated research and development expenses in the table below.
Previous wording
We cannot determine with certainty the duration, costs and timing of clinical trials of SGT-003 or other Candidates, or if, when or to what extent we will generate revenue from the commercialization and sale of any of our product candidates for which we obtain marketing approval or our other research and development expenses. We may never succeed in obtaining marketing approval for any of our product candidates. The duration, costs and timing of clinical trials and development of our candidates will depend on a variety of factors, including:
Current wording
We cannot determine with certainty the duration, costs, and timing of clinical trials of SGT-003, SGT-501, or our other Candidates, or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our Candidates for which we obtain marketing approval or our other research and development expenses. We may never succeed in obtaining marketing approval for any of our Candidates. The duration, costs, and timing of clinical trials and development of our Candidates will depend on a variety of factors, including:
Previous wording
Other income, net consists of interest income earned on our cash, cash equivalents, available-for-sale securities, amortization of investment premium or accretion of investment discount, net of financing leases interest expense, and sub-lease income.
Current wording
Other income, net consists primarily of interest income. Interest income consists of income earned on our cash and cash equivalents, available-for-sale securities, and restricted cash equivalents.
Previous wording
Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.
Current wording
Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, costs. and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ materially from these estimates.
Previous wording
During the three months ended March 31, 2024, 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, 2023 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, 2024, there were no material changes to our critical accounting policies, except as noted in Note 1 – Nature of the Business and Basis of Presentation. 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, 2023 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, 2024 were $18.9 million, compared to $24.6 million for the three months ended March 31, 2023. The decrease of $5.8 million in research and development expenses was due to a $7.2 million decrease in costs for SGT-003 primarily related to lower manufacturing and non-clinical study costs as we prepare to dose patients, a $2.3 million decrease in costs for SGT-001 primarily related to lower manufacturing and non-clinical study costs due to our decision to prioritize SGT-003 and SGT-501, a $1.2 million decrease in personnel costs, offset by a $3.8 million increase in costs for SGT-501 primarily related to manufacturing and research, a $0.9 million increase in unallocated external expenses, and a $0.2 million increase in other development programs.
Current wording
Research and development expenses for the three months ended June 30, 2024 were $19.5 million, compared to $19.8 million for the three months ended June 30, 2023. The decrease of $0.3 million in research and development expenses was due to a $3.3 million decrease in costs for SGT-003 primarily related to lower manufacturing and research costs, a $0.3 million decrease in costs for SGT-001 primarily related to lower clinical and research costs due to our decision to deprioritize SGT-001, a $0.4 million decrease in external expenses, offset by a $1.7 million increase in costs for SGT-501 primarily related to manufacturing and research, a $1.7 million increase in other Candidate costs primarily related to BAG3, and a $0.2 million increase in personnel related costs.
Previous wording
General and administrative expenses were $8.0 million and $7.4 million for the three months ended March 31, 2024 and 2023, respectively. The increase of $0.6 million was primarily related to a $0.4 million increase in legal fees, and a $0.2 million increase in corporate and business development costs.
Current wording
General and administrative expenses were $8.3 million for the three months ended June 30, 2024, compared to $7.1 million for the three months ended June 30, 2023. The increase of $1.2 million was primarily related to a $0.9 million increase in legal fees and a $0.3 million increase in recruiting and license fees.
Previous wording
Other income, net was $2.6 million for the three months ended March 31, 2024, compared to $2.0 million for the three months ended March 31, 2023. The activity was primarily related to the increase in interest income on available-for-sale securities included within our portfolio due to higher investment balances from proceeds of our ATM Sales Agreement and private placement.
Current wording
Other income, net was $5.3 million for the six months ended June 30, 2024 compared to other expense of $4.2 million for the six months ended June 30, 2023. The activity was primarily related to the increase in interest income on available-for-sale securities included within our portfolio due to higher investment balances from proceeds of ATM Sales Agreement and January 2024 Private Placement.
Previous wording
To date, we have financed our operations primarily through the sale of redeemable preferred units and member units, the sale of common stock and pre-funded warrants to purchase shares of our common stock in private placements and the sale of common stock in our initial public offering and a follow-on public offering and sales of common stock under our amended and restated “at-the market offering” sales agreement, dated March 13, 2024, by and between us and Jefferies LLC, or Jefferies, or the ATM Sales Agreement. Through March 31, 2024, 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 $650.7 million of net proceeds from the sale of our common stock through public offerings, including our IPO and a follow-on public offering, private placements, the ATM Sales Agreement, and pursuant to the stock purchase agreement with Ultragenyx, as detailed in the following paragraphs.
Current wording
To date, we have financed our operations primarily through the sale of redeemable preferred units and member units, the sale of common stock and pre-funded warrants to purchase shares of our common stock in private placements and the sale of common stock in our initial public offering and a follow-on public offering and sales of common stock under our ATM Sales Agreement. Through June 30, 2024, 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 $656.0 million of net proceeds from the sale of our common stock through public offerings, including our IPO and a follow-on public offering, private placements, the ATM Sales Agreement, and pursuant to the stock purchase agreement with Ultragenyx, as detailed in the following paragraphs.
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, 2023, we sold 602,030 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $3.0 million. During the three months ended March 31, 2024, we sold 350,664 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $3.1 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, 2023, we sold 602,030 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $3.0 million. During the three and six months ended June 30, 2024, we sold 526,953 and 877,617 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $5.4 million and $8.4 million, respectively.
Previous wording
As of March 31, 2024, we had cash, cash equivalents and available-for-sale securities of $206.1 million, excluding restricted cash of $1.8 million, and had no debt outstanding.
Current wording
As of June 30, 2024, we had cash, cash equivalents and available-for-sale securities of $190.3 million, excluding restricted cash of $1.9 million, and had no debt outstanding.
Previous wording
The following table summarizes our sources and uses of cash for each of the periods presented:
Current wording
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
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 $2.2 million, partially offset by non-cash charges of $1.3 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 $1.3 million in prepaid and other assets, a decrease in accounts payable of $0.6 million, and a decrease in accrued expenses and other liabilities of $0.3 million. Non-cash activities were driven by equity-based compensation of $1.6 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 on 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, 2023, operating activities used $28.0 million of cash, primarily resulting from our net loss of $30.1 million and changes in our operating assets and liabilities of $0.9 million, partially offset by non-cash charges of $3.0 million. Net cash used by changes in our operating assets and liabilities during the three months ended March 31, 2023 consisted of a decrease in accrued expenses and other current and non-current liabilities of $4.9 million, partially offset by an increase in accounts payable of $2.7 million and a decrease in prepaid and other assets of $1.3 million. Non-cash activities were driven by equity-based compensation of $2.1 million and depreciation and amortization expense of $1.1 million, partially offset by amortization on available-for-sale securities of $0.2 million.
Current wording
During the six months ended June 30, 2023, operating activities used $55.5 million of cash, primarily resulting from our net loss of $54.7 million and changes in our operating assets and liabilities of $7.6 million, partially offset by non-cash charges of $6.8 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2023 consisted of a decrease in accrued expenses and other current and non-current liabilities of $6.2 million, a decrease in the operating lease liability of $0.8 million, an increase of $0.6 million in prepaid and other assets. Non-cash activities were driven by equity-based compensation of $4.1 million and depreciation and impairment expense of $1.8 million, and non-cash lease expense of $1.2 million, partially offset by amortization on available-for-sale securities of $0.3 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, 2023, investing activities provided $37.3 million of cash, resulting from the proceeds of the maturity of available-for-sale securities of $37.8 million, partially offset by the purchase of property and equipment of $0.5 million.
Current wording
During the six months ended June 30, 2023, investing activities used $11.0 million of cash, resulting from the purchases of available-for sale securities of $68.6 million and the purchases of property plant and equipment of $1.0 million, partially offset by the maturity of available-for sale securities of $58.6 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, 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 Company's 2021 Employee Stock Purchase Plan, or ESPP, offset by payments of the principal portion of finance lease obligations of $0.2 million.
Previous wording
enroll patients in our INSPIRE Duchenne trial and advance clinical development of SGT-003;
Current wording
continue to enroll patients in our INSPIRE Duchenne trial and advance clinical development of SGT-003;
Previous wording
engage in regulatory interactions with the FDA and other regulatory authorities;
Current wording
engage in regulatory interactions with the United States Food and Drug Administration, or FDA, and other regulatory authorities;
Previous wording
arrange manufacturing for larger quantities of our product candidates for preclinical and clinical development and potential commercialization;
Current wording
arrange manufacturing for larger quantities of our Candidates for preclinical and clinical development and potential commercialization;
Previous wording
As of March 31, 2024, we had cash, cash equivalents and available-for-sale securities of $206.1 million, excluding restricted cash of $1.8 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of March 31, 2024 will be sufficient to fund our operating expenses and capital requirements into 2026. 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, 2024, we had cash, cash equivalents and available-for-sale securities of $190.3 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, 2024 will be sufficient to fund our operating expenses and capital requirements into 2026. 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
Because of the numerous risks and uncertainties associated with the development of our Candidates and because the extent to which we may enter collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our future capital requirements will depend on many factors, including:
Current wording
Because of the numerous risks and uncertainties associated with the development of our Candidates and because the extent to which we may enter collaborations with third parties for development of our Candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our Candidates. Our future capital requirements will depend on many factors, including:
Previous wording
We are supplying, and expect to continue to supply, our ongoing and future clinical development programs with drug 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 clinical development programs with drug produced at a facility compliant with the current Good Manufacturing Practice regulations enforced by the FDA, or cGMPs, located at one of our CMOs. We intend to establish the capability and capacity to supply Candidates at commercial scale from multiple sources.
Previous wording
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any products for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Current wording
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any Candidates or generate revenue from the sale of any products for which we may obtain marketing approval. In addition, our Candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Previous wording
If we raise additional funds through licensing agreements and strategic collaborations with third parties, we may have to relinquish valuable rights to our technology, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds, we may be required to delay, limit, reduce and/or terminate development of our product candidates or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. .
Current wording
If we raise additional funds through licensing agreements and strategic collaborations with third parties, we may have to relinquish valuable rights to our technology, future revenue streams, research programs, or Candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds, we may be required to delay, limit, reduce and/or terminate development of our Candidates or any future commercialization efforts or grant rights to develop and market Candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
During the three months ended March 31, 2024, 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, 2023.
Current wording
During the six months ended June 30, 2024, 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, 2023.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
2,712,478 shares of our common stock, at a price of $5.529 per pre-funded warrant. We received $103.7 million of aggregate net proceeds, after deducting offering costs.
Current report — wording carried from elsewhere
Other income, net was $2.7 million for the three months ended June 30, 2024, compared to $2.2 million for the three months ended June 30, 2023. The activity was primarily related to the increase in interest income on available-for-sale securities included within our portfolio due to higher investment balances from proceeds of our amended and restated at-the market offering sales agreement, dated March 13, 2024, by and between us and Jefferies LLC, or Jefferies, or the ATM Sales Agreement, and January 2024 Private Placement.