PepGen Inc.

Previous wording

PepGen Inc., also referred to as “PepGen,” “we,” “our” or “us”, is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. Our proprietary EDO platform is founded on over a decade of research and development and leverages cell-penetrating peptides, or CPPs, to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that are designed to target the root cause of serious diseases.

Current wording

PepGen Inc., also referred to as “PepGen,” “we,” “our” or “us”, is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. Our proprietary Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides, or CPPs, to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that are designed to target the root cause of serious diseases.

Previous 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.

Current 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 an exon 51-skipping approach and PGN-EDODM1 for DM1 patients, as well as a number of 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. 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.

Current wording

We completed a first-in-human Phase 1 clinical trial in healthy volunteers, or HVs, with PGN-EDO51 in the third quarter of 2022. In the Phase 1 HV clinical trial, treatment with PGN-EDO51 resulted in high levels of exon skipping in humans following a single dose. Our ongoing clinical development program for PGN-EDO51 is comprised of two parallel Phase 2 studies of PGN-EDO51 in DMD patients. The first study, CONNECT1-EDO51, or CONNECT1, is an ongoing open-label, multiple ascending dose, or MAD, study in boys and young men living with DMD amenable to exon 51 skipping being conducted in Canada. In July 2024, we reported initial clinical data from the CONNECT1 study from the 5 mg/kg starting dose cohort, which we believe demonstrate promising early exon skipping and dystrophin production. All participants from the first cohort have continued in the long-term extension, or LTE, portion of the study. We have fully enrolled the 10 mg/kg dose cohort in CONNECT1. We have received communication from Health Canada that dosing of participants in the 5 and 10 mg/kg cohorts may continue at their current dose levels. Health Canada has requested additional information from us to address its safety concerns before any further dose escalation or enrollment of any additional participants at the current dose levels. We are working with Health Canada to address its questions. 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 January 23, 2025, we believe PGN-EDO51 has a favorable emerging safety profile. We expect to report initial safety, exon skipping and dystrophin production data from the 10 mg/kg cohort by the end of the third quarter of 2025.

Previous 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.

Current wording

The FDA has granted both orphan drug designation and 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 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.

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.

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. 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.

Current wording

The safety data from the ongoing FREEDOM study has informed the design of FREEDOM2, which is currently open in Canada and U.K. We also plan to open the FREEDOM2 study other geographies, including the U.S., subject to regulatory authorizations. FREEDOM2 is a 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. This study is currently dosing participants in the 5 mg/kg dose cohort and we expect to report data from this cohort in the first quarter of 2026.

Previous wording

The FDA has granted both orphan drug designation and Fast Track designation for PGN-EDODM1 for the treatment of DM1.

Current wording

The FDA has granted both orphan drug designation and Fast Track designation for PGN-EDODM1 for the treatment of DM1.In addition to these lead clinical stage programs, we are evaluating EDO candidates for additional DMD sub-populations amenable to skipping of other exons, including exon 53, 45 and 44. We have also initiated research efforts for additional indications, including neuromuscular diseases and neurologic disorders.

Previous 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.

Current wording

We have incurred operating losses in each year since our inception. Our net losses were $30.2 million and $18.0 million for the three months ended March 31, 2025 and March 31, 2024, respectively. As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $97.8 million. As of March 31, 2025, we had an accumulated deficit of $301.7 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, current and planned clinical trials, manufacturing campaigns and our expenditures on other research and development activities.

Previous wording

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. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our currently planned operations for at least 12 months from the date of the filing of this 10-Q. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

After the Reorganization was completed, PepGen Limited began the process of transferring operations, including financial management functions, to PepGen pursuant to an intercompany services agreement, effective as of April 2021, and certain assets, including a novation of all intellectual property assets, pursuant to an asset transfer agreement, effective as of January 1, 2022. After the transfer of intellectual property and other assets from PepGen Limited to PepGen, there were limited operations through the end of 2022 at PepGen Limited.

Current wording

After the Reorganization was completed, PepGen Limited began the process of transferring certain operations, including financial management functions, to PepGen pursuant to an intercompany services agreement, effective as of April 2021, and certain assets, including a novation of all intellectual property assets, pursuant to an asset transfer agreement, effective as of January 1, 2022. After the transfer of intellectual property and other assets from PepGen Limited to PepGen, there were limited operations through the end of 2022 at PepGen Limited. PepGen Limited was dissolved on December 10, 2024.

Previous 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.

Current wording

The following table (in thousands) summarizes our research and development expenses for the three months ended March 31, 2025 and March 31, 2024. 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 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.

Current wording

We continue to conduct our CONNECT1 trial for PGN-EDO51and our ongoing Phase 1 and Phase 2 clinical trials of PGN-EDODM1. 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 status of clinical trials, animal and other preclinical studies and IND- or CTA-enabling studies;

Current wording

the status of clinical trials, the timing and costs, if any, associated with resolving a clinical hold, animal and other preclinical studies and IND- or clinical trial application, or CTA-enabling studies;

Previous wording

We anticipate that our general and administrative expenses will increase in 2024 as compared to 2023 primarily due to personnel costs, including stock-based compensation expense. Other general and administrative expenses will remain consistent to support our public company operating expenses associated with audit, legal, regulatory, and tax-related services associated with maintaining compliance with our exchange listing and SEC requirements, director and officer insurance premiums, and investor relations.

Current wording

Other general and administrative expenses will remain consistent to support our public company operating expenses associated with audit, legal, regulatory, and tax-related services associated with maintaining compliance with our exchange listing and SEC requirements, director and officer insurance premiums, and investor relations.

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 did not record any tax liability for the three and nine months ended September 30, 2024 or September 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 months ended March 31, 2025 or March 31, 2024.

Previous 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.

Current wording

Research and development expenses increased by $10.6 million from $14.7 million for the three months ended March 31, 2024, to $25.4 million for the three months ended March 31, 2025. This was attributable to a $7.8 million increase in manufacturing costs related to the timing of manufacturing campaigns, a $2.6 million increase in personnel-related costs, including an increase of $0.9 million in stock-based compensation expense, and a $1.2 million increase in clinical trial costs associated with the advancement of clinical trials for our two lead programs. There was also a $0.4 million increase in consulting expenses. These increases were partially offset by decreased preclinical costs of $1.3 million as our two lead programs are now in clinical trials.

Previous 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.

Current wording

General and administrative expenses increased by $0.9 million from $5.1 million for the three months ended March 31, 2024, to $5.9 million for the three months ended March 31, 2025. The increase was primarily driven by an increase of $0.8 million in personnel-related costs due to increased headcount, including $0.6 million in stock-based compensation expense. This increase was additionally driven by a $0.1 million increase in consulting and legal expenses.

Previous 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.

Current wording

Other income (expense), net was income of $1.1 million for the three months ended March 31, 2025 and $1.8 million for the three months ended March 31, 2024. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.

Previous 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.

Current wording

As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $97.8 million. We believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our currently planned operations for at least 12 months from the date of the filing of this 10-Q. 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 nine months ended September 30, 2024 and September 30, 2023 (in thousands):

Current wording

The following table sets forth a summary of the net cash flow activity for the three months ended March 31, 2025 and March 31, 2024 (in thousands):

Previous 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.

Current wording

For the three months ended March 31, 2025, net cash used in operating activities was $22.9 million resulting from our net loss of $30.2 million, partially offset by changes in our operating assets and liabilities of $3.2 million and by non-cash adjustments of $4.1 million. The net changes in our operating assets and liabilities were primarily due to an increase in accrued expenses of $2.7 million, as a result of the timing of manufacturing campaigns, and an increase in accounts payable of $0.9 million. The change was further driven by a decrease in operating lease liabilities of $0.8 million and a decrease in prepaids and other current assets of $0.3 million. The non-cash adjustments included $3.4 million of stock-based compensation, $0.4 million of depreciation expense, $0.7 million of amortization of discounts on our marketable securities, and $0.9 million of amortization and interest accretion on our operating lease.

Previous 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.

Current wording

For the three months ended March 31, 2024, net cash used in operating activities was $22.5 million resulting from our net loss of $18.0 million and changes in our operating assets and liabilities of $6.3 million partially offset by non-cash charges of $1.8 million. The net changes in our operating assets and liabilities were primarily due to a decrease in accrued expenses of $6.8 million, an increase in prepaids and other current assets of $0.1 million, an increase in accounts payable of $0.1 million, and a decrease in operating lease liabilities of $0.3 million. The $6.8 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 $2.0 million of stock-based compensation, $0.4 million of depreciation expense, $0.5 million of amortization of discounts on our marketable securities, and $0.1 million of amortization and interest accretion on our operating lease.

Previous 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.

Current wording

For the three months ended March 31, 2024, net cash used in investing activities was $11.3 million resulting from $29.2 million in purchases of marketable securities partially offset by $18.0 million in maturities of marketable securities.

Previous 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.

Current wording

For the three months ended March 31, 2024, net cash provided by financing activities was $87.0 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 $0.4 million from proceeds from the purchase of shares under employee equity plans, partially offset by $0.2 million in the payment of deferred offering costs.

Previous wording

There have been no material changes to our critical accounting policies and estimates from those described in our financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 2023, as amended by the Form 10K/A filed on March 29, 2024.

Current wording

There have been no material changes to our critical accounting policies and estimates from those described in our financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 2024.