What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-08-16 compared with 2021-05-14 · 102 added, 66 removed, 251 unchanged (40% of the section changed)

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In April 2021, an eighth patient, also in the 2E14 vg/kg cohort, was treated with SGT-001.

The patient experienced an inflammatory response which was classified as a serious adverse event and considered by the investigator to be drug related.

The patient experienced a systemic inflammatory response which has since fully resolved.

The event was classified as a serious adverse event and considered by the investigator to be drug related.

This type of event is described in our Investigators Brochure and is not considered unexpected.

As of the patient’s 30-day follow-up visit, laboratory values had either returned to normal or continue to trend towards normal.

As part of our clinical mitigation strategy, the status of both patients dosed under the amended protocol have been shared with the Data Safety Monitoring Board, or DSMB, as well as the Food and Drug Administration, or FDA.

We are carefully examining the full details of the clinical course of these patients and are continuing our discussions with the DSMB and FDA.

No new drug-related

safety findings have been identified in p atients 1-6 , who have post dosing period s of 1.5 years to more than 3 years following treatment.

In May 2021, we reported long-term biopsy data collected from patients 4-6, who were dosed at the 2E14 vg/kg dose level.

Analyses of the biopsies, taken 2 years, 1.5 years and 1 year post-dosing, respectively, demonstrate durable and widespread expression of the microdystrophin protein.

Following dosing of these two patients with our second-generation manufacturing process and clinical strategy, we conducted an extensive review of all clinical data, resulting in a strengthened risk mitigation plan, which has also been submitted to the FDA.

Activities are underway to advance IGNITE DMD with the next patient dosing anticipated in the fourth quarter of 2021.

No new drug-related safety findings have been identified in patients 1 through 8 in post-dosing periods of 90 days to more than 3 years.

We continue to follow dosed patients and collect data to support the potential benefit from dosing with SGT-001.

In May 2021, we reported long-term biopsy data collected from patients four through six, who were dosed at the 2E14 vg/kg dose level.

Analyses of the biopsies, taken 2 years, 1.5 years and 1 year post-dosing, respectively, demonstrated durable and widespread expression of the microdystrophin protein.

The long-term results are consistent with the day 90, interim data reported in March 2021 and continue to demonstrate the functionality of the SGT-001 microdystrophin, as highlighted by the recruitment of key dystrophin associated proteins:

beta-sarcoglycan and neuronal Nitric Oxide Synthase (nNOS).

The long-term muscle biopsy results were analyzed by two methods, Western Blot and Immunofluorescence (IF).

As reflected in the table below, the Western Blot data indicate that expression was maintained in Patient 4 and increased compared to the Day 90 biopsies in Patient 5 and 6.

IF data show microdystrophin function via continued localization to the muscle membrane, with the percent positive fibers remaining comparable to the Day 90 biopsies in all three patients.

beta-sarcoglycan and neuronal Nitric Oxide Synthase or nNOS.

The long-term muscle biopsy results were analyzed by two methods, western blot and immunofluorescence.

As reflected in the table below, the Western Blot data indicate that expression was maintained in patient 4 and increased compared to the day 90 biopsies in patients 5 and 6.

Immunofluorescence data show microdystrophin function via continued localization to the muscle membrane, with the percent positive fibers remaining comparable to the day 90 biopsies in all three patients.

Last Timepoint Post-Dosing

Immunofluorescence (% Positive Fibers)

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*Below the limit of quantification

Further morphological analysis of the muscle biopsies conducted by Solid indicate that sustained microdystrophin protein expression and function resulted in membrane stabilization, evidenced by minimal progression of muscle deterioration since the Day 90 timepoint.

Further morphological analysis of the muscle biopsies conducted by us indicate that sustained microdystrophin protein expression and function resulted in membrane stabilization, evidenced by minimal progression of muscle deterioration since the day 90 timepoint.

These long-term pathophysiological improvements support the recently reported positive trends in the clinical biomarker and functional data.

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SGT-003 is a preclinical candidate that combines a novel and rationally-designed capsid candidate from this library with Solid’s proprietary nNOS containing microdystrophin construct.

We are currently targeting an IND submission for SGT-003 in early-2023.

Since our inception, we have devoted substantial resources to identifying and developing SGT-001 SGT-003 and our other product candidates, developing our manufacturing processes, organizing and staffing our company and providing general and administrative support for these operations.

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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 $88.3 million and $117.2 million for the years ended December 31, 2020 and 2019, respectively.

Our net losses were $16.9 million for the three months ended March 31, 2021 and $26.7 million for the three months ended March 31, 2020.

As of March 31, 2021, we had an accumulated deficit of $421.5 million.

Our net losses were $35.6 million for the six months ended June 30, 2021 and $45.7 million for the six months ended June 30, 2020.

As of June 30, 2021, we had an accumulated deficit of $440.2 million.

We expect to incur significant expenses and operating losses for the foreseeable future.

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In December 2020, we completed a private placement of shares of common stock resulting in net proceeds to us of $86.2 million, after deducting offering costs.

In March 2021, we issued and sold in a public offering 25,000,000 shares of our common stock at a price per share to the public of $5.75, including the full exercise by the underwriters of an option to purchase additional shares of common stock, or (March 2021 Offering).

We received net proceeds of approximately $134.9 million after deducting underwriter discounts and commissions and offering expenses.

As of March 31, 2021, we had cash and cash equivalents of $268.5 million.

We believe that our cash and cash equivalents as of March 31, 2021 will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2022.

As of June 30, 2021, we had cash, cash equivalents, and available-for-sale securities of $249.0 million.

We believe that our cash, cash equivalents, and available-for-sale securities as of June 30, 2021 will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2022.

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.

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Centers for Disease Control and Prevention as well as federal, state, and local governments regarding working-from-home practices for non-essential employees.

As a result, we have modified our business practices, including implementing a work from home policy for all employees who are able to perform their duties remotely and restricting all nonessential travel, and we expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees, and other business partners in light of COVID-19.

As a result, we have modified our business practices, including implementing a work from home policy for all employees who are able to perform their duties remotely.

We expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees, and other business partners in light of COVID-19.

The full extent of the impact of COVID-19 on our business, results of operations and financial condition will depend on future developments that are highly uncertain, including the length and severity of this pandemic, the actions taken to contain it or treat its impact and the impact on our clinical development, employees, vendors and suppliers, all of which are uncertain and cannot be predicted.

We will continue to monitor the situation closely.

Corporate conversion

We operated as a Delaware limited liability company under the name Solid Biosciences, LLC until immediately prior to the effectiveness of our registration statement on Form S-1 on January 25, 2018, at which time we converted into a Delaware corporation pursuant to a statutory conversion and changed our name to Solid Biosciences Inc.

In addition, immediately following the statutory conversion, entities formed solely for the purpose of holding membership interests in our limited liability company were merged with and into us.

We refer to the corporate conversion and the mergers, collectively as the Corporate Conversion.

As a result of the

Corporate Conversion, the holders of the Series 1 and 2 Senior Preferred and Junior Preferred Units and Series A, B, C and D Common Units of Solid Biosciences, LLC became holders of common stock of Solid Biosciences Inc.

The consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are those of Solid Biosciences Inc.

and its subsidiaries.

Financial operations overview

Collaboration revenue

Collaboration revenue was $3.3 million for the three months ended March 31, 2021.

Collaboration revenue was $3.6 million and $6.9 million for the three and six months ended June 30, 2021, respectively .

We recognized this revenue related to research services and cost reimbursement from the Ultragenyx Collaboration Agreement.

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Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of SGT-001, SGT-003 and our other product candidates and include:

expenses incurred under agreements with third parties, including contract research organizations (“CROs”), that conduct research and preclinical activities on our behalf, as well as contract manufacturing organizations (“CMOs”), that manufacture SGT-001, SGT-003 and our other product candidates for use in our preclinical studies and clinical trials;

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-001, SGT-003 and our other product candidates for use in our preclinical studies and clinical trials;

salaries, benefits and other related costs, including equity-based compensation expense, for personnel engaged in research and development functions;

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Three Months Ended

Six Months Ended

(In thousands)

Other product candidates

SGT-003 and other product candidates

Unallocated research and development expenses

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Our actual results may differ from these estimates.

During the three months ended March 31, 2021, there were no material changes to our critical accounting policies.

During the six months ended June 30, 2021, 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, 2020 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.

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Results of operations

Comparison of the three months ended March 31, 2021 and 2020

The following table summarizes our results of operations for the three months ended March 31, 2021 and 2020:

Comparison of the three months ended June 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended June 30, 2021 and 2020:

Three Months Ended

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Collaboration revenue

Collaboration revenue for the three months ended March 31, 2021 was $3.3 million, compared to no collaboration revenue for the three months ended March 31, 2020.

The increase in collaboration revenue was related to research services and cost reimbursement received under the Collaboration Agreement with Ultragenyx.

Collaboration revenue for the three months ended June 30, 2021 was $3.6 million, compared to no collaboration revenue for the three months ended June 30, 2020.

The increase in collaboration revenue was related to research services and cost reimbursement received under the Collaboration Agreement with Ultragenyx, which we entered into in the fourth quarter of 2020.

Research and development expenses

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(in thousands)

Other product candidates

SGT-003 and other product candidates

Unallocated research and development expenses

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Total research and development expenses

Research and development expenses for the three months ended March 31, 2021 were $14.2 million, compared to $19.7 million for the three months ended March 31, 2020.

The decrease of $5.5 million in research and development expenses was primarily due to a $4.0 million decrease in costs related to our lead product candidate SGT-001, driven by a reduction in manufacturing costs of $3.8 million and in clinical costs of $0.2 million, and a decrease in unallocated research and development costs of $1.4 million, primarily due to a reduction in personnel related expenses of $0.4 million and a decrease in other R&D expenses of $0.9 million.

The reduction in research and development was also driven by a $0.1 million decrease in costs related to other product candidates as we focus on advancing SGT-001.

Research and development expenses for the three months ended June 30, 2021 were $15.5 million, compared to $13.4 million for the three months ended June 30, 2020.

The increase of $2.1 million in research and development expenses was primarily due to a $1.1 million increase in costs related to our lead product candidate SGT-001, driven by an increase in manufacturing costs of $1.0 million and in clinical costs of $0.1 million, and an increase in unallocated research and development costs of $0.7 million, primarily due to an increase in personnel related expenses of $0.4 million and an increase in other R&D expenses of $0.3 million as we focus on advancing SGT-001.

The increase in research and development was also driven by a $0.2 million increase in costs related to SGT-003 and other product candidates.

General and administrative expenses

General and administrative expenses were $6.0 million for the three months ended March 31, 2021, compared to $5.3 million for the three months ended March 31, 2020.

The increase of $0.7 million was due to an increase in corporate expenses of $0.6 million and an increase in personnel related expenses of $0.1 million.

General and administrative expenses were $6.8 million for the three months ended June 30, 2021, compared to $5.5 million for the three months ended June 30, 2020.

The increase of $1.2 million was due to an increase in personnel related expenses of $0.7 million and an increase in corporate expenses of $0.5 million.

Interest (expense) income

Interest expense was less than $0.1 million for the three months ended March 31, 2021, compared to interest income of $0.2 million for the three months ended March 31, 2020.

The decrease was primarily related to a reduction of available-for-sale securities included within our portfolio.

We had no other income for the three months ended March 31, 2021 compared to $0.1 million of other income for the three months ended March 31, 2020.

Interest expense was less than $0.1 million for each of the three months ended June 30, 2021 and 2020.

The activity was primarily related to the increase in available-for-sale securities included within our portfolio.

Other income was less than $0.1 million for the three months ended June 30, 2021 compared to no other income for the three months ended June 30, 2020.

Other income relates to contributions from charitable organizations.

We do not expect these contributions to be significant in future periods.

Comparison of the six months ended June 30, 2021 and 2020

The following table summarizes our results of operations for the six months ended June 30, 2021 and 2020:

Six Months Ended June 30,

(in thousands)

Collaboration revenue - related party

Operating expenses:

Research and development

General and administrative

Restructuring charges

Total operating expenses

Loss from operations

Other income (expense):

Interest income

Total other income (expense)

Collaboration revenue

Collaboration revenue for the six months ended June 30, 2021 was $6.9 million, compared to no collaboration revenue for the six months ended June 30, 2020.

Research and development expenses

Six Months Ended June 30,

(in thousands)

SGT-003 and other product candidates

Unallocated research and development expenses

Personnel related expenses

External expenses

Total unallocated research and development expenses

Total research and development expenses

Research and development expenses for six months ended June 30, 2021 were $29.7 million, compared to $33.1 million for the six months ended June 30, 2020.

The decrease of $3.4 million in research and development expenses was primarily due to a $2.9 million decrease in costs related to our lead product candidate SGT-001, driven by lower manufacturing costs of $3.0 million offset by an increase in clinical costs of $0.1 million, and a decrease in unallocated research and development costs of $0.6 million, primarily due to a reduction in personnel related expenses of $0.1 million and a decrease in other R&D expenses of $0.5 million.

The decrease in research and development was offset by a $0.1 million increase in costs related to SGT-003 and other product candidates.

General and administrative expenses

General and administrative expenses were $12.8 million for the six months ended June 30, 2021, compared to $10.8 million for the six months ended June 30, 2020.

The increase of $2.0 million was due to an increase in personnel related expenses of $1.6 million and an increase in corporate expenses of $0.4 million.

Interest (expense) income

Interest expense was less than $0.1 million for the six months ended June 30, 2021, compared to interest income of $0.2 million for the six months ended June 30, 2020.

The decrease was primarily related to less interest income earned on the available-for-sale securities in our portfolio.

Other income was less than $0.1 million for the six months ended June 30, 2021 compared to less than $0.1 million of other income for the six months ended June 30, 2020.

Other income relates to contributions from charitable organizations.

We do not expect these contributions to be significant in future periods.

Liquidity and capital resources

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To date, we have financed our operations primarily through the sale of redeemable preferred units and member units, the sale of common stock and prefunded 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.

Through March 31, 2021, 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 $471.3 million of net proceeds from the sale of our common stock through public offerings, including our IPO, private placements, our ATM Sales Agreement and pursuant to the stock purchase agreement with Ultragenyx, as detailed in the following paragraphs.

Through June 30, 2021, 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 $471.3 million of net proceeds from the sale of our common stock through public offerings, including our IPO, private placements, our ATM Sales Agreement and pursuant to the stock purchase agreement with Ultragenyx, as detailed in the following paragraphs.

We completed our initial public offering on January 30, 2018, in which we sold 8,984,375 shares of common stock, including the underwriters’ over-allotment option, at a public offering price of $16.00 per share, resulting in net proceeds of $129.1 million.

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We received $57.9 million of net proceeds from the private placement after deducting offering costs .

In October 2020, we entered into the Collaboration Agreement with Ultragenyx.

On October 2, 2020, 137,460 of these pre-funded warrants were exercised.

On October 22, 2020, we entered into the Collaboration Agreement with Ultragenyx.

In connection with the execution of the Collaboration Agreement, we also entered into a stock purchase agreement with Ultragenyx, pursuant to which we issued and sold 7,825,797 shares of our common stock to Ultragenyx for an aggregate purchase price of approximately $40 million.

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We received $86.2 million of net proceeds from the private placement after deducting offering costs.

In March 2019, we entered into the ATM Sales Agreement under which we may offer and sell, from time to time, shares of our common stock having aggregate gross proceeds of up to $50.0 million through Jefferies as sales agent.

On March 13, 2019, we entered into the ATM Sales Agreement under which we may offer and sell, from time to time, shares of our common stock having aggregate gross proceeds of up to $50.0 million 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 three months ended March 31, 2021, we did not sell any shares pursuant to the ATM Sales Agreement.

During the six months ended June 30, 2021 , we did not sell any shares pursuant to the ATM Sales Agreement.

During the year ended December 31, 2020, we sold 6,309,632 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $23.2 million.

In March 2021, we issued and sold in a public offering 25,000,000 shares of our common stock at a price per share of $5.75, including the full exercise by the underwriters of an option to purchase additional shares of common stock, or the March 2021 Offering.

On March 23, 2021, we issued and sold in a public offering 25,000,000 shares of our common stock at a price per share of $5.75, including the full exercise by the underwriters of an option to purchase additional shares of common stock, or the March 2021 Offering.

We received net proceeds of approximately $134.9 million after deducting underwriter discounts and commissions and offering expenses.

As of March 31, 2021, we had cash and cash equivalents of $268.5 million and had no debt outstanding.

As of June 30, 2021, we had cash, cash equivalents and available-for-sale securities of $249.0 million and had no debt outstanding.

The following table summarizes our sources and uses of cash for each of the periods presented:

Three Months Ended

Six Months Ended

(in thousands)

Cash used in operating activities

Cash provided by investing activities

Cash (used in) provided by investing activities

Cash provided by financing activities

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Operating activities

During the three months ended March 31, 2021, operating activities used $21.4 million of cash, primarily resulting from our net loss of $16.9 million and cash used in changes in our operating assets and liabilities of $8.1 million offset by non-cash charges of $3.6 million due to equity-based compensation of $2.9 million and depreciation expense of $0.7 million.

Net cash used in changes in our operating assets and liabilities during the three months ended March 31, 2021 consisted primarily of a reduction in accrued expenses and other liabilities of $3.9 million, a decrease in deferred revenue of $3.1 million, a net increase in prepaid expenses and other assets of $0.8 million and an increase in accounts receivable of $0.3 million.

During the three months ended March 31, 2020, operating activities used $29.3 million of cash, primarily resulting from our net loss of $26.7 million and cash used in changes in our operating assets and liabilities of $6.7 million offset by non-cash charges of $4.1 million due to equity-based compensation of $3.1 million and depreciation expense of $1.0 million.

Net cash used in changes in our operating assets and liabilities during the three months ended March 31, 2020 consisted primarily of a reduction in accrued expenses and other liabilities of $1.2 million and a decrease in accounts payable of $4.3 million as well as an increase in prepaid expenses and other assets of $1.2 million.

During the six months ended June 30, 2021, operating activities used $38.5 million of cash, primarily resulting from our net loss of $35.6 million and cash used in changes in our operating assets and liabilities of $10.9 million offset by non-cash charges of $8.0 million due to equity-based compensation of $6.5 million and depreciation expense of $1.5 million.

Net cash used in changes in our operating assets and liabilities during the six months ended June 30, 2021 consisted primarily of a reduction in accrued expenses and other liabilities of $4.8 million, a decrease in deferred revenue of $6.4 million, and an increase in accounts receivable of $0.3 million, offset by a net decrease in prepaid expenses and other assets of $0.6 million.

During the six months ended June 30, 2020, operating activities used $42.3 million of cash, primarily resulting from our net loss of $45.7 million and cash used in changes in our operating assets and liabilities of $5.3 million offset by non-cash charges of $8.7 million due primarily to equity-based compensation of $6.3 million and depreciation expense of $2.4 million.

Net cash used in changes in our operating assets and liabilities during the six months ended June 30, 2020 consisted primarily of a reduction in accrued expenses and other liabilities of $1.8 million and a decrease in accounts payable of $3.9 million, partially offset by a net decrease in prepaid expenses and other assets of $0.4 million.

These changes were primarily due to the timing of payments.

Investing activities

During the three months ended March 31, 2021, investing activities used $0.1 million of cash, resulting from purchases of property and equipment.

During the three months ended March 31, 2020, investing activities generated $6.4 million of cash, consisting primarily of proceeds from maturities of available-for-sale securities partially offset by purchases of property and equipment, and available-for-sale securities.

During the six months ended June 30, 2021, investing activities used $48.8 million of cash, resulting from purchases of available-for-sale securities and property and equipment.

During the six months ended June 30, 2020, investing activities provided $6.7 million of cash, consisting primarily of proceeds from maturities of available-for-sale securities partially offset by purchases of property and equipment, and available-for-sale securities.

Financing activities

During the three months ended March 31, 2021, financing activities generated $135.1 million of cash resulting from the March 2021 Offering.

During the three months ended March 31, 2020, we received no cash from financing activities.

During the six months ended June 30, 2021, financing activities provided $134.9 million of cash resulting from the March 2021 Offering.

During the six months ended June 30, 2020, we received no cash from financing activities.

Funding requirements

We expect our expenses to increase substantially in connection with our ongoing development activities related to SGT-001.

We expect our expenses to increase substantially in connection with our ongoing development activities related to SGT-001, SGT-003 and our other product candidates.

In addition, we expect to incur additional costs associated with operating as a public company.

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add operational, financial and management information systems and personnel.

As of March 31, 2021, we had cash and cash equivalents of $268.5 million.

We believe that our cash and cash equivalents as of March 31, 2021 will be sufficient to fund our operating expenses and capital requirements into the fourth quarter of 2022.

As of June 30, 2021, we had cash, cash equivalents and available-for-sale securities of $249.0 million.

We believe that our cash, cash equivalents and available-for-sale securities as of June 30, 2021 will be sufficient to fund our operating expenses and capital requirements into the fourth quarter of 2022.

As a result, in order to continue to operate our business beyond that time, we will need to raise additional funds.

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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.

Because of the numerous risks and uncertainties associated with the development of SGT-001, SGT-003 and other product candidates and programs 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.

Because of the numerous risks and uncertainties associated with the development of SGT-001, SGT-003 and our other product candidates and programs 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:

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We are exposed to market risk related changes in interest rates.

As of March 31, 2021, our cash equivalents consisted of money market accounts that have contractual maturities of less than 90 days from the date of acquisition.

As of June 30, 2021, our cash equivalents consisted of money market accounts that have contractual maturities of less than 90 days from the date of acquisition.

As of June 30, 2021, our investments consisted of corporate bond securities that have contractual maturities of less than one year.

Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis