Solid Biosciences Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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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.
Sep 30, 2026 · Filed Nov 4, 2026
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 2026-06-30; filed 2026-08-06.
0001193125-26-337935
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-447178
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 143 previous paragraphs and 143 current paragraphs.
108 unchanged; 32 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
Other Income, Net
Current report
General and administrative expenses were $38.3 million for the nine months ended September 30, 2026, compared to $27.6 million for the nine months ended September 30, 2025. The increase of $10.7 million was primarily related to a $6.9 million increase in personnel related costs, a $1.2 million increase in consulting and professional services, a $1.2 million increase in information technology and equipment related costs, a $1.0 million increase in costs related to commercial readiness, and a $0.3 million increase in business development and corporate costs.
Current report
On August 6, 2026, we filed a prospectus supplement under our universal shelf registration statement on Form S-3 (File No. 333‑287325) relating to the offer and sale of up to $200.0 million of shares of our common stock pursuant to the ATM Sales Agreement. As of the date of that prospectus supplement, we had sold shares for aggregate gross proceeds of approximately $85.0 million under the prior prospectus supplement, and no further sales will be made thereunder. During the three and nine months ended September 30, 2026, we sold 2,012,500 and 10,528,487 shares under the ATM Sales Agreement resulting in net proceeds of $15.7 million and $76.5 million, respectively. As of September 30, 2026, $200.0 million remained available for issuance under the August 2026 ATM Sales Agreement prospectus supplement.
Removed paragraphs (3)
Previous report
Other income, net was $2.6 million for the three months ended June 30, 2026 compared to $2.2 million for the three months ended June 30, 2025. The increase of $0.4 million was primarily related to higher interest income from our available-for-sale securities.
Previous report
General and administrative expenses were $24.3 million for the six months ended June 30, 2026, compared to $18.4 million for the six months ended June 30, 2025. The increase of $5.9 million was primarily related to a $4.1 million increase in personnel related costs, a $0.8 million increase in informational technology equipment and related costs, a $0.8 million increase in consulting services, and a $0.4 million increase in other operating expenses, partially offset by a $0.6 million decrease in legal fees.
Previous report
Other income, net was $3.2 million for the six months ended June 30, 2026 compared to $3.0 million for the six months ended June 30, 2025. The increase of $0.2 million is attributable to lower interest expense on finance leases which terminated during the fourth quarter of 2025.
Reworded paragraphs (32)
Previous wording
We are continuing to advance our pipeline of Candidates. The U.S. Food and Drug Administration (the “FDA”) has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations for SGT-003 for Duchenne, and SGT-003 has also been awarded Orphan Drug designation from the European Commission for the treatment of Duchenne, in addition to an Innovation Passport by the new UK Innovative Licensing and Access Pathway, which aims to accelerate time to market and facilitate patient access to new medicines in the United Kingdom. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-212 for the treatment of FA and SGT-501 for the treatment of CPVT.
Current wording
We are continuing to advance our pipeline of Candidates. The U.S. Food and Drug Administration (the “FDA”) has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations for SGT-003 for Duchenne, and SGT-003 has also been awarded Orphan Drug designation from the European Commission for the treatment of Duchenne, in addition to an Innovation Passport by the new UK Innovative Licensing and Access Pathway, which aims to accelerate time to market and facilitate patient access to new medicines in the United Kingdom. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-212 for the treatment of FA and SGT-501 for the treatment of CPVT, and SGT-212 has also been awarded Orphan designation from the European Commission for the treatment of FA.
Previous wording
On March 11, 2026, we announced positive new interim data from the Phase 1/2 INSPIRE DUCHENNE clinical trial as of a February 23, 2026 data cutoff date. For a full description of the initial results from the INSPIRE DUCHENNE trial, see Part I, Item I, “Business” in our Annual Report on Form 10-K filed on March 19, 2026.
Current wording
On March 11, 2026, we announced positive interim data from the Phase 1/2 INSPIRE DUCHENNE clinical trial as of a February 23, 2026 data cutoff date. For a full description of the initial results from the INSPIRE DUCHENNE trial, see Part I, Item 1, “Business” in our Annual Report on Form 10-K filed on March 19, 2026.
Previous wording
The INSPIRE DUCHENNE trial is ongoing and being conducted at clinical sites across the United States, Canada, Italy and the United Kingdom. We believe we have aligned with the FDA on SGT-003's potency assay strategy and will continue commercial-readiness CMC activities, with our process performance qualification manufacturing batches to be completed in 2026.
Current wording
The INSPIRE DUCHENNE trial is ongoing and being conducted at clinical sites across the United States, Canada, Italy and the United Kingdom. We believe we have aligned with the FDA on SGT-003's potency assay strategy and will continue our commercial‑readiness CMC activities, with our process performance qualification manufacturing batches expected to be completed by the end of 2026.
Previous wording
We plan to meet with the FDA late in the fourth quarter of 2026 to discuss the INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003; we expect to provide an update as discussions progress.
Current wording
We have scheduled a Type C meeting with the FDA late in the fourth quarter of 2026 to discuss the preliminary INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003; we expect to provide an update following the receipt of formal meeting minutes.
Previous wording
In October 2025, we activated the first clinical trial site and began screening participants for IMPACT DUCHENNE, a Phase 3 randomized, double-blind, placebo-controlled trial evaluating SGT-003. In February 2026, we announced positive feedback from a Type C meeting with the FDA where we reached alignment on the IMPACT DUCHENNE trial design, including: the patient population of ambulant participants 7 to <12 years of age, the primary endpoint of change from baseline in Time to Rise (TTR) velocity from supine position evaluated at 18 months and other key secondary endpoints. Clinical trial sites for IMPACT DUCHENNE are currently active in Australia and Canada, with additional clinical site activations expected in the second half of 2026, subject to site initiation activities and regulatory clearances. Participant screening is underway and we dosed our first participant in the IMPACT DUCHENNE trial in April 2026.
Current wording
In October 2025, we activated the first clinical trial site and began screening participants for IMPACT DUCHENNE, a Phase 3 randomized, double-blind, placebo-controlled trial evaluating SGT-003. In February 2026, we announced positive feedback from a Type C meeting with the FDA where we reached alignment on the IMPACT DUCHENNE trial design, including: the participant population of ambulant participants 7 to <12 years of age, the primary endpoint of change from baseline in Time to Rise (TTR) velocity from supine position evaluated at 18 months and other key secondary endpoints. IMPACT DUCHENNE is expected to be conducted in Canada, Australia, the United States and multiple countries in Europe. Participant screening is underway and we dosed our first participant in the IMPACT DUCHENNE trial in April 2026.
Previous wording
The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations for SGT-003 and the European Commission has granted Orphan drug designation for SGT-003 for the treatment of Duchenne. SGT-003 has been awarded an Innovation Passport by the new UK Innovative Licensing and Access Pathway, which aims to accelerate time to market and facilitate patient access to new medicines in the United Kingdom.
Current wording
The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations for SGT-003 and the European Commission has granted Orphan designation for SGT-003 for the treatment of Duchenne. SGT-003 has been awarded an Innovation Passport by the new UK Innovative Licensing and Access Pathway, which aims to accelerate time to market and facilitate patient access to new medicines in the United Kingdom.
Previous wording
Additionally, Solid has received a positive opinion from the European Medicines Agency’s Paediatric Committee on its Pediatric Investigation Plan (PIP), establishing alignment on its pediatric development framework for SGT-003 in Europe.
Current wording
Additionally, we have received a positive opinion from the European Medicines Agency’s Paediatric Committee on its Pediatric Investigation Plan (PIP), establishing alignment on its pediatric development framework for SGT-003 in Europe.
Previous wording
In January 2025, we announced that the FDA cleared our IND for SGT-212 for the treatment of FA. In October 2025, we activated the first clinical trial site and began screening participants for FALCON, an open-label, multi-center Phase 1b clinical trial of SGT-212, and in January 2026, we dosed the first participant in the trial. Two participants have been dosed in the FALCON clinical trial and SGT-212 has been well tolerated with no treatment related serious adverse events observed as of August 4, 2026.
Current wording
In January 2025, we announced that the FDA cleared our IND for SGT-212 for the treatment of FA. In October 2025, we activated the first clinical trial site and began screening participants for FALCON, an open-label, multi-center Phase 1b clinical trial of SGT-212, and in January 2026, we dosed the first participant in the trial. Five participants have been dosed in the FALCON clinical trial and SGT-212 has been well tolerated with no treatment-related serious adverse events observed as of November 3,
Previous wording
The trial is expected to enroll approximately 10 non-ambulatory and ambulatory adult participants (aged 18-40) living with FA in up to three cohorts and is designed to evaluate the safety and tolerability of contemporaneous IDN and systemic IV infusion of SGT-212, with initial data anticipated in the first quarter of 2027, subject to participant enrollment. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-212 for the treatment of FA.
Current wording
The trial is expected to enroll approximately 10 non-ambulatory and ambulatory adult participants (aged 18-40) living with FA in up to three cohorts and is designed to evaluate the safety and tolerability of contemporaneous IDN and systemic IV infusion of SGT-212, with initial data anticipated in the first quarter of 2027, subject to participant enrollment. The FDA has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to SGT-212 for the treatment of FA, and the European Commission has granted Orphan designation for SGT-212 for the treatment of FA.
Previous wording
In July 2025, we announced that the FDA cleared our IND and that Health Canada approved our clinical trial application for SGT-501 for the treatment of CPVT. In January 2026, we announced that clinical trial sites have been activated and participant screening is underway in the ARTEMIS clinical trial, an open-label, multi-center Phase 1b clinical trial evaluating SGT-501 in adult participants with CPVT. The ARTEMIS trial is designed to evaluate the safety and tolerability of a single IV infusion of SGT-501. We anticipate dosing our first participant in the second half of 2026 with initial safety data anticipated in the first half of 2027, subject to participant enrollment.
Current wording
In July 2025, we announced that the FDA cleared our IND and that Health Canada approved our clinical trial application for SGT-501 for the treatment of CPVT. In January 2026, we announced that clinical trial sites have been activated and participant screening is underway in the ARTEMIS clinical trial, an open-label, multi-center Phase 1b clinical trial evaluating SGT-501 in adult participants with CPVT. The ARTEMIS trial is designed to evaluate the safety and tolerability of a single IV infusion of SGT-501. We anticipate dosing our first participant by the end of 2026, with initial safety data anticipated in the first half of 2027, subject to participant enrollment.
Previous wording
The Company is also focused on developing innovative enabling technologies, including next-generation capsids. In March 2026, we began using the mark POLARIS-101 TMto represent our AAV-SLB101 capsid (“POLARIS-101 TM”). POLARIS‑101 TMis our rationally designed, proprietary capsid, which is used in SGT-003 for Duchenne and has been generally well tolerated as of August 4, 2026 (N=53), in the INSPIRE DUCHENNE clinical trial, and was also well tolerated in nonclinical NHP and mouse models. We aim to license POLARIS-101 TMbroadly to corporations, institutions and academic labs pursuing neuromuscular and cardiac rare disease research, with more than 50 agreements, including licenses, executed.
Current wording
In March 2026, we began using the mark POLARIS-101 TM to represent our AAV-SLB101 capsid (“POLARIS-101”). POLARIS-101 is our rationally engineered, proprietary myotropic capsid, which is used in SGT-003 for Duchenne and has been generally well tolerated as of November 3, 2026 (N=53), in the INSPIRE DUCHENNE clinical trial, and was also well tolerated in nonclinical non‑human primate and mouse models.
Previous wording
We are building additional cardiac and neuromuscular next-generation capsid and promoter libraries with capsid selection from the first library anticipated in the second half of 2026.
Current wording
POLARIS-101 is part of our broader precision genetic medicine technology platform that includes proprietary manufacturing and other enabling delivery technologies, such as additional capsids and promoters. This expanded platform has been developed to provide next-generation technologies to developers early in the research and development cycle when technology decisions can shape the long-term performance of a program. We aim to license POLARIS-101 and other delivery and manufacturing technologies broadly to corporations, institutions and academic labs, with more than 50 agreements, including licenses, executed to date. As part of our work under this platform, we are building additional cardiac and neuromuscular next-generation capsid and promoter libraries with capsid selection from the first library anticipated by the end of 2026.
Previous wording
Due to our significant research and development expenditure, licensing and patent investment, and general and administrative costs associated with our operations, we have generated substantial operating losses in each period since our inception. Our net losses were $54.8 million and $111.5 million for the three and six months ended June 30, 2026, respectively, and $39.5 million and $78.8 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1.1 billion. 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 $53.9 million and $165.5 million for the three and nine months ended September 30, 2026, respectively, and $45.8 million and $124.5 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $1.1 billion. We expect to incur significant expenses and operating losses for the foreseeable future.
Previous wording
As of June 30, 2026, we had cash, cash equivalents, and available-for-sale securities of $377.7 million, excluding restricted cash of $1.3 million. We believe that our cash, cash equivalents, and available-for-sale securities as of June 30, 2026 will enable us to fund our operating expenses and capital expenditure requirements into mid-2028. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Current wording
As of September 30, 2026, we had cash, cash equivalents, and available-for-sale securities of $348.9 million, excluding restricted cash of $1.3 million. We believe that our cash, cash equivalents, and available-for-sale securities as of September 30, 2026 will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2028. 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
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.
Current wording
Other income, net consists primarily of interest income and changes in the fair value of our derivative liabilities. Interest income consists of income earned on our cash and cash equivalents, available-for-sale securities, and restricted cash.
Previous wording
During the six months ended June 30, 2026, 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, 2025 and the notes to the unaudited condensed consolidated financial statements included in Part I, Item 1, “Financial Statements (unaudited),” of this Quarterly Report on Form 10-Q. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:
Current wording
During the nine months ended September 30, 2026, 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, 2025 and the notes to the unaudited condensed consolidated financial statements included in Part I, Item 1, “Financial Statements (unaudited),” of this Quarterly Report on Form 10-Q. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:
Previous wording
Research and development expenses for the three months ended June 30, 2026 were $44.3 million, compared to $32.4 million for the three months ended June 30, 2025. The increase of $11.9 million in research and development expenses was primarily due to a $12.2 million increase in costs for SGT-003 primarily related to manufacturing and clinical costs, a $3.2 million increase in personnel related expenses, and a $1.2 million increase in costs for SGT-212 primarily related to clinical and research costs, partially offset by a $2.2 million decrease in costs for SGT-601 related to lower manufacturing and research costs, a $1.4 million decrease in external expenses primarily related to laboratory supplies, and a $1.3 million decrease in costs for SGT-501 primarily related to lower license payments and research costs.
Current wording
Research and development expenses for the three months ended September 30, 2026 were $43.6 million, compared to $38.9 million for the three months ended September 30, 2025. The increase of $4.7 million in research and development expenses was primarily due to a $2.8 million increase in personnel related expenses, a $2.6 million increase in costs for SGT-212 primarily related to manufacturing and clinical costs, a $2.0 million increase in costs for SGT-003 primarily related to manufacturing and research costs, and a $0.6 million increase in other development programs primarily related to internal research costs, partially offset by a $1.6 million decrease in costs for SGT-601 primarily due to lower manufacturing and internal research costs, a $1.1 million decrease in external expenses primarily related to lower lab and professional service costs, and a $0.7 million decrease in costs for SGT-501 due to lower clinical and internal research costs.
Previous wording
General and administrative expenses were $13.1 million for the three months ended June 30, 2026, compared to $9.3 million for the three months ended June 30, 2025. The increase of $3.8 million was primarily related to a $2.6 million increase in personnel related costs, a $0.5 million increase in business development costs, a $0.4 million increase in equipment costs, and a $0.3 million increase in consulting services.
Current wording
General and administrative expenses were $14.1 million for the three months ended September 30, 2026, compared to $9.2 million for the three months ended September 30, 2025. The increase of $4.9 million was primarily due to a $2.8 million increase in personnel related costs, a $0.8 million increase in costs related to commercial readiness, a $0.5 million increase in consulting and professional services, a $0.4 million increase in information technology and equipment related costs, and a $0.3 million increase in finance and legal expenses.
Previous wording
Comparison of the Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of the Nine Months Ended September 30, 2026 and 2025
Previous wording
Research and development expenses for the six months ended June 30, 2026 were $90.4 million, compared to $63.3 million for the six months ended June 30, 2025. The increase of $27.1 million in research and development expenses was primarily due to a $25.8 million increase in costs for SGT-003 primarily related to manufacturing and clinical costs, a $6.5 million increase in personnel related expenses, and a $3.7 million increase in costs for SGT-212 primarily related to clinical costs and license and milestone payments, partially offset by a $4.4 million decrease in costs for SGT-501 primarily related to lower license and milestone payments and manufacturing and research costs, a $3.9 million decrease in costs for SGT-601 related to lower manufacturing and research costs, and a $1.0 million decrease in external expenses primarily related to overhead costs.
Current wording
Research and development expenses for the nine months ended September 30, 2026 were $134.0 million, compared to $102.2 million for the nine months ended September 30, 2025. The increase of $31.8 million in research and development expenses was primarily due to a $27.9 million increase in costs for SGT-003 primarily related to manufacturing and clinical costs, a $9.4 million increase in personnel related expenses, a $6.3 million increase in costs for SGT-212 primarily related to manufacturing and clinical costs, and a $0.9 million increase in other development programs primarily related to an increase in internal research costs, partially offset by a $5.5 million decrease in costs for SGT-601 related to lower manufacturing and internal research costs, a $5.1 million decrease in costs for SGT-501 primarily related to lower license and milestone payments and lower manufacturing and internal research costs, and a $2.1 million decrease in external expenses primarily related to overhead costs.
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, 2025, we sold 891,414 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $5.1 million. During the six months ended June 30, 2026, we sold 8,515,987 shares pursuant to the ATM Sales Agreement resulting in net proceeds of $60.8 million. In July 2026, the Company sold 2,012,500 shares of its common stock, pursuant to its ATM Sales Agreement for net proceeds of $15.7 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.
Previous wording
On March 9, 2026, we issued and sold 14,973,257 shares of our common stock at a price of $5.61 per share, and, to certain investors in lieu of shares of common stock, pre-funded warrants to purchase 27,807,482 shares of its common stock at a price of $5.609 per pre-funded warrant, (the “March 2026 Private Placement”). We received approximately $226.3 million of aggregate net proceeds from the March 2026 Private Placement, after deducting offering costs.
Current wording
On March 9, 2026, we issued and sold 14,973,257 shares of our common stock at a price of $5.61 per share, and, to certain investors in lieu of shares of common stock, pre-funded warrants to purchase 27,807,482 shares of our common stock at a price of $5.609 per pre-funded warrant (the “March 2026 Private Placement”). We received approximately $226.3 million of aggregate net proceeds from the March 2026 Private Placement, after deducting offering costs.
Previous wording
As of June 30, 2026, we had cash, cash equivalents, and available-for-sale securities of $377.7 million, excluding restricted cash of $1.3 million, and had no outstanding debt.
Current wording
As of September 30, 2026, we had cash, cash equivalents, and available-for-sale securities of $348.9 million, excluding restricted cash of $1.3 million, and had no outstanding debt.
Previous wording
During the six months ended June 30, 2025, operating activities used $69.3 million of cash, primarily resulting from our net loss of $78.8 million partially offset by changes in our operating assets and liabilities of $0.7 million and non-cash charges of $10.2 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2025 consisted of an increase in prepaid expenses and other assets of $2.1 million, a decrease in the operating lease liability of $0.8 million, offset by an increase in accrued expenses and other liabilities of $1.7 million, and an increase in accounts payable of $0.5 million. Non-cash activities were driven by equity-based compensation of $6.5 million, a change in the fair value of derivative liabilities of $2.6 million, non-cash lease expense of $1.2 million, and depreciation and amortization expense of $0.8 million, partially offset by amortization of available-for-sale securities of $0.8 million.
Current wording
During the nine months ended September 30, 2026, operating activities used $145.4 million of cash, primarily resulting from our net loss of $165.5 million partially offset by changes in our operating assets and liabilities of $1.2 million and non-cash charges of $18.9 million. Net cash provided by changes in our operating assets and liabilities during the nine months ended September 30, 2026 consisted of an increase in accrued expenses and other liabilities of $2.0 million and a decrease in prepaid expenses and other assets of $0.7 million, partially offset by a decrease in the operating lease liability of $1.5 million. Non-cash activities consisted of equity-based compensation of $16.9 million, a change in the fair value of derivative liabilities of $2.4 million, non-cash lease expense of $1.9 million, and depreciation and amortization expense of $1.2 million, partially offset by amortization of discount on available-for-sale securities of $3.4 million.
Previous wording
During the six months ended June 30, 2026, operating activities used $99.8 million of cash, primarily resulting from our net loss of $111.5 million and changes in our operating assets and liabilities of $1.6 million, partially offset by non-cash charges of $13.4 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2026 consisted of a decrease in accrued expenses and other liabilities of $1.4 million, a decrease in the operating lease liability of $1.0 million, and an increase in prepaid expenses and other assets of $0.3 million, offset by an increase in accounts payable of $1.1 million. Non-cash activities were driven by equity-based compensation of $10.8 million, a change in the fair value of derivative liabilities of $2.5 million, non-cash lease expense of $1.3 million, and depreciation and amortization expense of $0.8 million, partially offset by amortization of discount on available-for-sale securities of $2.0 million.
Current wording
During the nine months ended September 30, 2025, operating activities used $102.7 million of cash, primarily resulting from our net loss of $124.5 million partially offset by changes in our operating assets and liabilities of $6.4 million and non-cash charges of $15.4 million. Net cash provided by changes in our operating assets and liabilities during the nine months ended September 30, 2025 consisted of an increase in accounts payable of $4.2 million and an increase in accrued expenses and other liabilities of $3.9 million, partially offset by an increase in prepaid expenses and other assets of $0.3 million, and a decrease in the operating lease liability of $1.3 million. Non-cash activities consisted of equity-based compensation of $10.4 million, a change in the fair value of derivative liabilities of $3.4 million, non-cash lease expense of $1.8 million, and depreciation and amortization expense of $1.2 million, partially offset by amortization of discount on available-for-sale securities of $1.1 million.
Previous wording
During the six months ended June 30, 2026, investing activities used $88.8 million of cash, resulting from purchases of available-for-sale securities of $235.4 million and the purchases of property plant and equipment of $0.3 million, partially offset by the maturities of available-for-sale securities of $146.9 million.
Current wording
During the nine months ended September 30, 2026, investing activities used $92.6 million of cash, resulting from purchases of available-for-sale securities of $328.1 million and the purchases of property, plant and equipment of $0.8 million, partially offset by the maturities of available-for-sale securities of $236.3 million.
Previous wording
During the six months ended June 30, 2025, investing activities used $60.2 million of cash, resulting from the purchases of available-for-sale securities of $128.8 million and the purchases of property plant and equipment of $0.5 million, partially offset by the maturity of available-for-sale securities of $69.0 million.
Current wording
During the nine months ended September 30, 2025, investing activities used $105.5 million of cash, resulting from the purchases of available-for-sale securities of $212.0 million and the purchases of property, plant and equipment of $0.6 million, partially offset by the maturity of available-for-sale securities of $107.0 million.
Previous wording
During the six months ended June 30, 2026, financing activities provided $287.5 million of cash, primarily resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock in the March 2026 Private Placement of $226.3 million, the sale of common stock in the ATM of $60.8 million, and proceeds from the issuance of $0.3 million of shares of common stock under the Company’s Amended and Restated 2021 Employee Stock Purchase Plan ("ESPP").
Current wording
During the nine months ended September 30, 2026, financing activities provided $303.4 million of cash, primarily resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock in the March 2026 Private Placement of $226.3 million, the sale of common stock in the ATM of $76.5 million, and proceeds from the issuance of $0.3 million of shares of common stock under our Amended and Restated 2021 Employee Stock Purchase Plan ("ESPP").
Previous wording
During the six months ended June 30, 2025, financing activities provided $188.1 million of cash, resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock of $188.2 million, and proceeds from the issuance of $0.2 million of shares of common stock under the Company's ESPP.
Current wording
During the nine months ended September 30, 2025, financing activities provided $189.3 million of cash, resulting from the net proceeds from the issuance and sale of common stock and pre-funded warrants to purchase shares of common stock of $189.6 million, and proceeds from the issuance of $0.2 million of shares under our ESPP, offset by payments of the principal portion of finance lease obligations of $0.5 million.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and available-for-sale securities of $377.7 million, excluding restricted cash of $1.3 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of June 30, 2026 will be sufficient to fund our operating expenses and capital requirements into mid-2028. As a result, in order to continue to operate our business beyond that time, we will need to raise additional funds. However, there can be no assurance that we will be able to generate funds on terms acceptable to us, on a timely basis, or at all. In addition, we have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate.
Current wording
As of September 30, 2026, we had cash, cash equivalents and available-for-sale securities of $348.9 million, excluding restricted cash of $1.3 million. Based on our current operating plan, we believe that our cash, cash equivalents and available-for-sale securities as of September 30, 2026 will be sufficient to fund our operating expenses and capital requirements into the first half of 2028. 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
We are supplying, and expect to continue to supply, our ongoing and future preclinical and clinical development programs with drug product produced at a current GMP 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.
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 current good manufacturing practice 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 six months ended June 30, 2026, 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, 2025.
Current wording
During the nine months ended September 30, 2026, 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, 2025.