PepGen Inc

Previous wording

We are initially focused on addressing the underlying cause of Duchenne muscular dystrophy, or DMD, and myotonic dystrophy type 1, or DM1, that have high unmet need. Our current pipeline consists of two clinical stage programs, PGN-EDO51 for DMD patients who are amenable to exon 51 skipping and PGN-EDODM1 for DM1 patients, along with three additional preclinical stage programs. We anticipate expanding this pipeline over time to include other neuromuscular targets as well as potential opportunities in neurologic diseases.

Current wording

We are focused on addressing the underlying cause of Duchenne muscular dystrophy, or DMD, and myotonic dystrophy type 1, or DM1, that have high unmet need. Our current pipeline consists of two clinical stage programs, PGN-EDO51 for DMD patients who are amenable to exon 51 skipping and PGN-EDODM1 for DM1 patients, along with several additional preclinical stage programs. We anticipate expanding this pipeline over time to include other neuromuscular targets as well as potential opportunities in neurologic diseases.

Previous wording

Our clinical development program for PGN-EDO51 comprises two parallel Phase 2 studies of PGN-EDO51 in DMD patients whose mutations are amenable to an exon 51-skipping approach. The first study, CONNECT1-EDO51, or CONNECT1, is an ongoing open-label, multiple ascending dose, or MAD, Phase 2 study in boys and young men living with DMD being conducted in Canada. The CONNECT1 study was designed to provide proof-of-concept for our EDO platform and PGN-EDO51, as well as inform the design and conduct of our CONNECT2-EDO51, or CONNECT2, study. In July 2024, we reported initial clinical data from the CONNECT1 study from the 5 mg/kg starting dose cohort (n=3). PGN-EDO51 produced mean exon skipping in biceps tissue of 2.15% at week 13 compared to baseline, measured by RT-PCR. In addition, PGN-EDO51 achieved a mean muscle-adjusted dystrophin level of 1.49% of normal (0.70% increase from baseline) and a mean absolute dystrophin level (by Western blot analysis) of 0.61% of normal (0.26% increase from baseline), in each case after four doses, measured at week 13. The 5 mg/kg dose of PGN-EDO51 was well tolerated by all study cohort participants through week 13. There were no discontinuations, dose interruptions or dose reductions. The one related treatment-emergent adverse event was mild and resolved. There was no sustained elevation in kidney biomarkers. There were no cases of hypomagnesemia or hypokalemia. There were also no changes in electrolytes or hepatic function and no cases of anemia or thrombocytopenia. As of July 29, 2024, all three patients in this cohort were continuing to be dosed with PGN-EDO51 at 5 mg/kg in the long-term extension, or LTE, phase of the clinical trial and PGN-EDO51 was well tolerated during the LTE as of such date. As of July 29, 2024, two participants had received a total of four doses at 10 mg/kg in the ongoing CONNECT1 study, and as of such date, PGN-EDO51 had been generally well tolerated at this dose level. We expect to report initial results from the 10 mg/kg cohort in early 2025.

Current wording

Our clinical development program for PGN-EDO51 comprises two parallel Phase 2 studies of PGN-EDO51 in DMD patients whose mutations are amenable to an exon 51-skipping approach. The first study, CONNECT1-EDO51, or CONNECT1, is an ongoing open-label, multiple ascending dose, or MAD, Phase 2 study in boys and young men living with DMD being conducted in Canada. The CONNECT1 study was designed to provide proof-of-concept for our EDO platform and PGN-EDO51, as well as inform the design and conduct of our CONNECT2-EDO51, or CONNECT2, study. In July 2024, we reported initial clinical data from the CONNECT1 study from the 5 mg/kg starting dose cohort (n=3). PGN-EDO51 produced mean exon skipping in biceps tissue of 2.15% at week 13 compared to baseline, measured by RT-PCR. In addition, PGN-EDO51 achieved a mean muscle-adjusted dystrophin level of 1.49% of normal (0.70% increase from baseline) and a mean absolute dystrophin level (by Western blot analysis) of 0.61% of normal (0.26% increase from baseline), in each case after four doses, measured at week 13. As of October 31, 2024, all three participants in this cohort were continuing to be dosed with PGN-EDO51 at 5 mg/kg in the long-term extension, or LTE, phase of the clinical trial. As of October 31, 2024, a total of 10 doses had been administered at 10 mg/kg in the ongoing CONNECT1 study. Based on the totality of data in both the 5 mg/kg cohort and the ongoing 10 mg/kg cohort in the CONNECT1 trial as of October 31, 2024, we believe PGN-EDO51 has a favorable emerging safety profile. There have been no treatment-related serious adverse events, or SAEs, and all treatment-related adverse events have been mild or moderate. There was no sustained elevation in kidney biomarkers. There were also no changes in hepatic function and no cases of hypokalemia, anemia or thrombocytopenia. Asymptomatic hypomagnesemia has been observed in two participants in the 10 mg/kg cohort and treated with oral magnesium supplementation. As of October 31, 2024, all participants continue in the study as planned, with no discontinuations, dose modifications or dose interruptions.

Previous wording

The second Phase 2 study of PGN-EDO51, CONNECT2, is a multinational, randomized, double-blind, placebo-controlled MAD study. The CONNECT2 study will evaluate multiple dose cohorts and trial participants will be administered PGN-EDO51 once every four weeks for six months. We will assess safety, tolerability, exon skipping, dystrophin expression and functional outcomes in this study. Based on the data from CONNECT1, including PGN-EDO51’s emerging safety profile to date, we are working to optimize the design of the CONNECT2 trial. The CONNECT2 study, together with data from the CONNECT1 study, is intended to support a potential accelerated approval pathway for PGN-EDO51, subject to regulatory authority feedback.

Current wording

The second Phase 2 study of PGN-EDO51, CONNECT2, is a multinational, randomized, double-blind, placebo-controlled MAD study. The CONNECT2 study will evaluate multiple dose cohorts and trial participants will be administered PGN-EDO51 once every four weeks for six months. We will assess safety, tolerability, exon skipping, dystrophin expression and functional outcomes in this study. Based on the data from CONNECT1, including PGN-EDO51’s favorable emerging safety profile to date, we are also working to optimize the design of the CONNECT2 trial. The CONNECT2 study, together with data from the CONNECT1 study, is intended to support a potential accelerated approval pathway for PGN-EDO51, subject to regulatory authority feedback.

Previous wording

In February 2024, we received clearance from the Medicines and Healthcare products Regulatory Agency, or MHRA, to initiate CONNECT2 in the United Kingdom, or U.K. We plan to continue to engage with regulators in the European Union, or EU, regarding the CONNECT2 study and expect to file an investigational new drug, or IND, application and open the clinical trial in the United States by year-end, subject to regulatory clearance.

Current wording

In February 2024, we received clearance from the Medicines and Healthcare products Regulatory Agency, or the MHRA, to initiate CONNECT2 in the United Kingdom, or U.K. We plan to continue to engage with regulators in the European Union, or the EU, regarding the CONNECT2 study and expect to file an investigational new drug, or IND, application and open the clinical trial in the U.S. by year-end, subject to regulatory clearance.

Previous wording

The U.S. Food and Drug Administration, or FDA has granted both orphan drug designation and rare pediatric disease designation, or RPDD, for PGN-EDO51 for the treatment of DMD patients who are amenable to exon 51 skipping.

Current wording

The U.S. Food and Drug Administration, or the FDA has granted both orphan drug designation and rare pediatric disease designation, or RPDD, for PGN-EDO51 for the treatment of DMD patients who are amenable to exon 51 skipping.

Previous wording

We are also developing PGN-EDODM1 for the treatment of DM1 and are utilizing what we believe to be a unique mechanism of action and a different delivery approach compared to other approaches in more advanced stages of clinical development. We have conducted extensive preclinical studies of our product candidate, and these preclinical data form the basis of our clinical development plan for PGN-EDODM1. In May 2023, we announced that we received a clinical hold notice from the FDA, regarding our investigational new drug, or IND, application to initiate our first-in-human Phase 1 FREEDOM-DM1, or FREEDOM, study. In September 2023, we announced that Health Canada had cleared our Clinical Trial Application, or CTA, for the FREEDOM study in Canada. In October 2023, we announced that the FDA lifted the clinical hold on the FREEDOM study, allowing this study to proceed in the U.S. In December 2023, we announced that the MHRA had cleared our CTA for the FREEDOM study in the U.K. and we began dosing patients in this study. FREEDOM is a multinational, randomized, double-blind, placebo-controlled, single ascending dose, or SAD, study designed to assess PGN-EDODM1’s safety and tolerability, splicing correction and functional outcome measures in DM1 patients. We expect to report preliminary data from this study in the fourth quarter of 2024.

Current wording

We are also developing PGN-EDODM1 for the treatment of DM1 and are utilizing what we believe to be a unique mechanism of action and a different delivery approach compared to other approaches in more advanced stages of clinical development. We have conducted extensive preclinical studies of our product candidate, and these preclinical data form the basis of our clinical development plan for PGN-EDODM1. In May 2023, we announced that we received a clinical hold notice from the FDA, regarding our investigational new drug, or IND, application to initiate our first-in-human Phase 1 FREEDOM-DM1, or FREEDOM, study. In September 2023, we announced that Health Canada had cleared our Clinical Trial Application, or CTA, for the FREEDOM study in Canada. In October 2023, we announced that the FDA lifted the clinical hold on the FREEDOM study, allowing this study to proceed in the U.S. In December 2023, we announced that the MHRA had cleared our CTA for the FREEDOM study in the U.K. and we began dosing patients in this study. FREEDOM is a multinational, randomized, double-blind, placebo-controlled, single ascending dose, or SAD, study designed to assess PGN-EDODM1’s safety and tolerability, splicing correction and functional outcome measures in DM1 patients. We expect to report data from both the 5 mg/kg and 10 mg/kg dose cohorts in this study by the end of the first quarter of 2025.

Previous wording

The safety data from the ongoing FREEDOM study has informed the design of the FREEDOM2-DM1, or FREEDOM2, Phase 2 randomized, double-blind, placebo-controlled MAD study of PGN-EDODM1 in DM1 patients. FREEDOM2 is designed to assess PGN-EDODM1’s safety and tolerability, splicing correction and functional outcome measures in DM1 patients. We recently announced that both Health Canada and the MHRA have cleared our CTA filings for the FREEDOM2 study, and we expect to initiate patient dosing in the second half of 2024.

Current wording

The safety data from the ongoing FREEDOM study has informed the design of the FREEDOM2-DM1, or FREEDOM2, Phase 2 randomized, double-blind, placebo-controlled MAD study of PGN-EDODM1 in DM1 patients. FREEDOM2 is designed to assess PGN-EDODM1’s safety and tolerability, splicing correction and functional outcome measures in DM1 patients. Both Health Canada and the MHRA have cleared our CTA filings for the FREEDOM2 study, and we expect to initiate patient dosing in the fourth quarter of 2024. We also plan to open the FREEDOM2 study in the U.S., subject to regulatory clearance.

Previous wording

In addition to these lead candidates, we are developing EDO candidates for additional DMD sub-populations amenable to skipping of other exons, including exon 53, 45 and 44. We have previously reported robust exon 53-skipping levels following either a single dose or multiple doses in non-human primates, or NHPs, for our PGN-EDO53 program. We continue to advance PGN-EDO53 in CTA and/or IND-enabling preclinical studies.

Current wording

In addition to these lead candidates, we are developing EDO candidates for additional DMD sub-populations amenable to skipping of other exons, including exon 53, 45 and 44. We have previously reported robust exon 53-skipping levels following either a single dose or multiple doses in non-human primates, or NHPs, for our PGN-EDO53 program. We continue to evaluate PGN-EDO53 in CTA and/or IND-enabling preclinical studies.

Previous wording

We have incurred operating losses in each year since our inception. Our net losses were $46.4 million and $35.8 million for the six months ended June 30, 2024 and June 30, 2023, respectively. As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $161.3 million. As of June 30, 2024, we had an accumulated deficit of $227.8 million. We expect our expenses and operating losses will continue as we conduct our ongoing preclinical studies and current and planned clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel, protect our intellectual property and incur additional costs associated with being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with an exchange listing and SEC, requirements, director and officer insurance premiums, and investor relations costs. In addition, we have several development, regulatory and commercial milestone payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and current and planned clinical trials and our expenditures on other research and development activities.

Current wording

We have incurred operating losses in each year since our inception. Our net losses were $67.7 million and $59.1 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $138.9 million. As of September 30, 2024, we had an accumulated deficit of $249.2 million. We expect our expenses and operating losses will continue as we conduct our ongoing preclinical studies and current and planned clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel, protect our intellectual property and incur additional costs associated with being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with an exchange listing and SEC requirements, director and officer insurance premiums, and investor relations costs. In addition, we have several development, regulatory and commercial milestone payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and current and planned clinical trials and our expenditures on other research and development activities.

Previous wording

The following table (in thousands) summarizes our research and development expenses for the three and six months ended June 30, 2024 and June 30, 2023. The direct external development program expenses reflect external costs attributable to our clinical development candidates and preclinical candidates selected for further development. Our internal resources, personnel and infrastructure are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs. As such, we do not track internal expenses on a program-specific basis.

Current wording

The following table (in thousands) summarizes our research and development expenses for the three and nine months ended September 30, 2024 and September 30, 2023. The direct external development program expenses reflect external costs attributable to our clinical development candidates and preclinical candidates selected for further development. Our internal resources, personnel and infrastructure are not directly tied to any one research or drug discovery program and are deployed across multiple programs. As such, we do not track internal expenses on a program-specific basis.

Previous wording

We expect to increase our research and development expenses in the remainder of 2024 as we conduct our ongoing Phase 2 clinical trials for PGN-EDO51 and our ongoing Phase 1 clinical trial of PGN-EDODM1, and potentially initiate dosing in our FREEDOM2 Phase 2 clinical trial for PGN-EDODM1, and increase our headcount to support these programs. Additionally, we continue to conduct our ongoing research and development activities, and advance our preclinical research programs toward clinical development, including conducting IND- and CTA-enabling studies for PGN-EDO53. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for any of our product candidates.

Current wording

We expect to increase our research and development expenses in the remainder of 2024, as compared to the same period in 2023, as we conduct our ongoing Phase 2 clinical trials for PGN-EDO51 and our ongoing Phase 1 clinical trial of PGN-EDODM1, and potentially initiate dosing in our FREEDOM2 Phase 2 clinical trial for PGN-EDODM1. We also continue to increase our research and development headcount to support these programs. Research and development expenses for our lead programs can be variable quarter-over-quarter due to the timing of manufacturing campaigns, which are accounted for under the percentage of completion method. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for any of our product candidates.

Previous wording

the cost and timing of manufacturing our product candidates;

Current wording

the cost and timing of manufacturing our product candidates and the cost and timing of our manufacturing campaigns;

Previous wording

We have not recorded a U.S. provision for federal or state income taxes as we have no revenue and have incurred losses since inception. We had no tax liability for the three and six months ended June 30, 2024 or June 30, 2023.

Current wording

We have not recorded a U.S. provision for federal or state income taxes as we have no revenue and have incurred losses since inception. We did not record any tax liability for the three and nine months ended September 30, 2024 or September 30, 2023.

Previous wording

Research and development expenses increased by $8.5 million from $31.3 million for the six months ended June 30, 2023, to $39.8 million for the six months ended June 30, 2024. This increase was attributable to expenses related to the advancement of clinical trials for our two lead programs, including a $6.1 million increase in clinical trial costs, a $4.8 million increase in manufacturing costs, and a $3.4 million increase in personnel-related costs, including an increase of $0.6 million in stock-based compensation expense. These increases were partially offset by a $5.9 million decrease in preclinical costs as our two lead programs are now in clinical trials.

Current wording

Research and development expenses decreased by $2.8 million from $20.5 million for the three months ended September 30, 2023, to $17.7 million for the three months ended September 30, 2024. This was attributable to a $3.8 million decrease in manufacturing costs related to the timing of manufacturing campaigns, and a $2.7 million decrease in preclinical costs as our two lead programs are now in clinical trials. These decreases were partially offset by increased costs associated with the advancement of clinical trials for our two lead programs, including a $1.0 million increase in clinical trial costs, and a $1.7 million increase in personnel-related costs, including an increase of $0.6 million in stock-based compensation expense. There was also a $0.6 million increase in consulting expenses and a $0.2 million increase in facility and other office related expenses.

Previous wording

General and administrative expenses increased by $1.1 million from $4.2 million for the three months ended June 30, 2023, to $5.3 million for the three months ended June 30, 2024. The increase was primarily driven by an increase of $1.1 million in personnel-related costs due to increased headcount, including $0.5 million in stock-based compensation expense.

Current wording

General and administrative expenses increased by $1.2 million from $4.2 million for the three months ended September 30, 2023, to $5.4 million for the three months ended September 30, 2024. The increase was primarily driven by an increase of $1.1 million in personnel-related costs due to increased headcount, including $0.7 million in stock-based compensation expense.

Previous wording

Other income (expense), net was income of $2.1 million for the three months ended June 30, 2024 and $1.7 million for the three months ended June 30, 2023. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.

Current wording

Other income (expense), net was income of $1.8 million for the three months ended September 30, 2024 and $1.5 million for the three months ended September 30, 2023. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2024 and June 30, 2023 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2024 and September 30, 2023 (in thousands):

Previous wording

Research and development expenses increased by $8.1 million from $16.9 million for the three months ended June 30, 2023, to $25.1 million for the three months ended June 30, 2024. This increase was attributable to expenses related to the advancement of clinical trials for our two lead programs, including a $4.0 million increase in clinical trial costs, a $5.3 million increase in manufacturing costs, and a $2.1 million increase in personnel-related costs, including an increase of $0.5 million in stock-based compensation expense. These increases were partially offset by a $3.1 million decrease in preclinical costs as our two lead programs are now in clinical trials, and a $0.2 million decrease in facility and other office related expenses.

Current wording

Research and development expenses increased by $5.7 million from $51.8 million for the nine months ended September 30, 2023, to $57.5 million for the nine months ended September 30, 2024. This increase was attributable to expenses related to the advancement of clinical trials for our two lead programs, including a $7.2 million increase in clinical trial costs, a $1.0 million increase in manufacturing costs, and a $5.1 million increase in personnel-related costs, including an increase of $1.3 million in stock-based compensation expense. Additionally, there was an increase of $0.4 million in facility and other office related expenses, including depreciation, and a $0.2 million increase in consulting expense. These increases were partially offset by a $8.6 million decrease in preclinical costs as our two lead programs are now in clinical trials.

Previous wording

General and administrative expenses increased by $2.5 million from $7.9 million for the six months ended June 30, 2023, to $10.4 million for the six months ended June 30, 2024. The increase was driven primarily by an increase of $2.2 million in personnel-related costs due to increased headcount, including $1.1 million in stock-based compensation expense, and an increase of $0.2 million in facility and office related expenses related to rent expense for our operating lease and depreciation on office furniture.

Current wording

General and administrative expenses increased by $3.7 million from $12.1 million for the nine months ended September 30, 2023, to $15.9 million for the nine months ended September 30, 2024. The increase was driven primarily by an increase of $3.3 million in personnel-related costs due to increased headcount, including $1.7 million in stock-based compensation expense, and an increase of $0.6 million in facility and office related expenses related to rent expense for our operating lease and depreciation on office furniture. These increases were partially offset by a $0.2 million decrease in insurance expense.

Previous wording

Other income (expense), net was income of $3.9 million for the six months ended June 30, 2024 and $3.5 million for the six months ended June 30, 2023. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.

Current wording

Other income (expense), net was income of $5.7 million for the nine months ended September 30, 2024 and $4.8 million for the nine months ended September 30, 2023. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.

Previous wording

Income tax expense was nil for the six months ended June 30, 2024 and June 30, 2023.

Current wording

Income tax expense was nil for the nine months ended September 30, 2024 and September 30, 2023.

Previous wording

As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $161.3 million. Based on our currently planned operations, we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations into 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Current wording

As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $138.9 million. Based on our currently planned operations, we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations into 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Previous wording

The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2024 and June 30, 2023 (in thousands):

Current wording

The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2024 and September 30, 2023 (in thousands):

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities was $38.9 million resulting from our net loss of $46.4 million, partially offset by changes in our operating assets and liabilities of $1.6 million and by non-cash charges of $5.8 million. The net changes in our operating assets and liabilities were primarily due to an increase in accounts payable of $6.6 million related to manufacturing commitments. The change was further driven by a decrease in accrued expenses of $2.3 million, an increase in prepaids and other current assets of $1.2 million, and a decrease in operating lease liabilities of $1.5 million. The $2.3 million decrease in accrued expenses was primarily due to lower research and development accruals as a result of manufacturing timing, and the payment of our annual employee incentive bonus. The non-cash charges included $4.9 million of stock-based compensation, $0.7 million of depreciation expense, $1.7 million of amortization of discounts on our marketable securities, and $1.9 million of amortization and interest accretion on our operating lease.

Current wording

For the nine months ended September 30, 2024, net cash used in operating activities was $62.9 million resulting from our net loss of $67.7 million, and changes in our operating assets and liabilities of $4.3 million, partially offset by non-cash adjustments of $9.2 million. The net changes in our operating assets and liabilities were primarily due to an increase in accounts payable of $4.9 million related to manufacturing commitments. The change was further driven by a decrease in accrued expenses of $5.8 million, an increase in prepaids and other current assets of $1.2 million, and a decrease in operating lease liabilities of $2.2 million. The $5.8 million decrease in accrued expenses was primarily due to lower research and development accruals as a result of the timing of manufacturing campaigns. The non-cash adjustments included $8.1 million of stock-based compensation, $1.1 million of depreciation expense, $2.9 million of amortization of discounts on our marketable securities, and $2.8 million of amortization and interest accretion on our operating lease.

Previous wording

For the six months ended June 30, 2023, net cash used in operating activities was $33.1 million resulting from our net loss of $35.8 million, and changes in our operating assets and liabilities of $0.8 million partially offset by non-cash charges of $3.5 million. The net changes in our operating assets and liabilities were primarily due to an increase in prepaids and other assets of $0.6 million, and a decrease in operating lease liabilities of $1.3 million. The non-cash charges included $3.2 million of stock-based compensation, $0.5 million of depreciation expense, and an immaterial amount of amortization and interest accretion on our operating lease.

Current wording

For the nine months ended September 30, 2023, net cash used in operating activities was $49.6 million resulting from our net loss of $59.1 million partially offset by non-cash adjustments of $5.7 million and changes in our operating assets and liabilities of $3.7 million. The net changes in our operating assets and liabilities were primarily due to an increase in accounts payable of $2.6 million, accrued expenses of $2.0 million, and prepaids and other assets of $0.7 million, and a decrease in operating lease liabilities of $1.5 million. The non-cash adjustments included $5.1 million of stock-based compensation, $0.8 million of depreciation expense, and $0.2 million of amortization and interest accretion on our operating lease.

Previous wording

For the six months ended June 30, 2024, net cash used in investing activities was $64.0 million resulting from $94.0 million in purchases of marketable securities partially offset by $30.0 million in maturities and sales of marketable securities.

Current wording

For the nine months ended September 30, 2024, net cash used in investing activities was $64.2 million resulting from $123.9 million in purchases of marketable securities partially offset by $60.0 million in maturities and sales of marketable securities.

Previous wording

For the six months ended June 30, 2023, net cash used in investing activities was $2.2 million related to the purchase of property and equipment, primarily associated with building lab space at our new Boston headquarters.

Current wording

For the nine months ended September 30, 2023, net cash used in investing activities was $2.4 million related to the purchase of property and equipment, primarily associated with building lab space at our new Boston headquarters.

Previous wording

For the six months ended June 30, 2024, net cash provided by financing activities was $88.3 million resulting from $76.9 million in proceeds from the Follow-on Offering, $9.9 million in proceeds from sales under the Sales Agreement, and $1.9 million from proceeds from the purchase of shares under employee equity plans, partially offset by $0.4 million in the payment of deferred offering costs.

Current wording

For the nine months ended September 30, 2024, net cash provided by financing activities was $88.6 million resulting from $76.9 million in proceeds from the Follow-on Offering, $9.9 million in proceeds from sales under the Sales Agreement, and $2.4 million from proceeds from the purchase of shares under employee equity plans, partially offset by $0.5 million in the payment of deferred offering costs.

Previous wording

Net cash provided by financing activities was $0.3 million during the six months ended June 30, 2023 related to proceeds from the purchase of shares under employee equity plans.

Current wording

Net cash provided by financing activities was $0.2 million during the nine months ended September 30, 2023 related to the payment of deferred offering costs related to the 2023 registration statement on Form S-3 partially offset by proceeds from the purchase of shares under employee equity plans.