PepGen Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
PEPG$2.47+6.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066414
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001193125-25-174979
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 105 previous paragraphs and 118 current paragraphs.
74 unchanged; 24 reworded; 16 added; 7 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 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 (16)
Current report
Business Update
Current report
On May 28, 2025, we announced that based on the levels of dystrophin protein measured in the 10 mg/kg cohort of the CONNECT1-EDO51 study investigating our candidate, PGN-EDO51, in Duchenne muscular dystrophy, or DMD, for patients amenable to exon 51 skipping, we have decided to voluntarily discontinue development of PGN-EDO51. Additionally, we intend to wind down all DMD-related research and development activities, including our research efforts relating to exons 44, 45 and 53.
Current report
In May 2025, we reported that in the 10 mg/kg cohort (n=4) of the CONNECT1 study, PGN-EDO51 increased exon 51 skipped transcripts to 4.26% (a mean increase of 3.5%); however, total dystrophin only increased to 0.59% of normal levels (a mean increase of 0.36%). The safety profile of PGN-EDO51 continued to be generally favorable and all treatment-related adverse events were mild in nature. No serious adverse events were reported in the study. Since PGN-EDO51 did not achieve target dystrophin levels in CONNECT1 trial, we made the decision to voluntarily discontinue development of our DMD programs.
Current report
We intend to focus on advancing our development efforts on our PGN-EDODM1 program for the treatment of myotonic dystrophy type 1, or DM1, to address the underlying cause of DM1, that has a high unmet need.
Current report
PGN-EDODM1
Current report
Based on our current operating plan, we believe that our existing cash and cash equivalents as of June 30, 2025 will enable us to fund our development activities and other operations into the second quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
Current report
As of August 7, 2025, the issuance date of the interim condensed consolidated financial statements for the three- and six-months ended June 30, 2025 included elsewhere in this Form 10-Q, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, our management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that such interim condensed consolidated financial statements are issued. See “Note 1 - Nature of Business and Basis of Presentation” to our interim condensed consolidated financial statements in this, and “Liquidity and Capital Resources” below, for additional information on our assessment.
Current report
Research and development expenses decreased by $6.7 million from $25.1 million for the three months ended June 30, 2024, to $18.4 million for the three months ended June 30, 2025. This was attributable to a $6.4 million decrease in manufacturing costs related to the timing of manufacturing campaigns, and a $1.3 million decrease in preclinical costs as our two lead programs had advanced into clinical trials, prior to the discontinuation of our DMD program in late May 2025. These decreases are partially offset by a $0.7 million increase in clinical trial expense driven by charges taken during the current quarter for estimated wind-down costs for the two clinical trials for PGN-EDO51. Additionally, there was a $0.7 million non-cash charge taken during the current year associated with the impairment of unused lab equipment. Personnel-related costs remained flat.
Current report
General and administrative expenses increased by $0.2 million from $5.4 million for the three months ended June 30, 2024, to $5.6 million for the three months ended June 30, 2025. The increase was primarily driven by an increase of $0.2 million in consulting and legal expenses and an increase of $0.1 million in facility and office expenses. These increases were partially offset by a decrease in personnel-related costs of $0.1 million primarily due to a decrease in stock-based compensation expense.
Current report
Comparison of the Six Months Ended June 30, 2025 and June 30, 2024
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Income Tax Expense
Current report
Based on our current operating plan, we believe that our existing cash and cash equivalents as of June 30, 2025 will enable us to fund our development activities and other operations into the second quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
Current report
We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Current report
Critical Accounting Policies and Estimates
Removed paragraphs (7)
Previous report
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 report
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 report
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 report
Other Income (Expense), Net
Previous report
Other Income (Expense), Net
Previous report
For the three months ended March 31, 2025, there was no cash used in or provided by financing activities.
Previous report
Critical Accounting Polices and Estimates
Reworded paragraphs (24)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this 10-Q, including information with respect to our plans, strategies, objectives, expectations and intentions for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this 10-Q, our actual results could differ materially from the results described in or implied by these forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans, strategies, objectives, expectations and intentions for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Form 10-Q, our actual results could differ materially from the results described in or implied by these forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
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 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.
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, our goal is to develop a research and development pipeline of oligonucleotide therapeutic candidates that are designed to target the root cause of serious diseases.
Previous wording
The second Phase 2 study of PGN-EDO51, CONNECT2-EDO51, or CONNECT2, is a randomized, double-blind, placebo-controlled MAD study in boys and young men living with DMD amenable to exon 51 skipping In early 2024, we received authorization from the Medicines and Healthcare products Regulatory Agency, or the MHRA, to initiate CONNECT2 in the United Kingdom, or U.K. In December 2024, we received a clinical hold notice from the U.S. Food and Drug Administration, or FDA, regarding our investigational new drug, or IND, application to initiate the CONNECT2 study in the U.S. We are working with the FDA to address its questions regarding supportive data for the dosing levels planned for the patient population. In March 2025, we announced our voluntary decision to pause CONNECT2 until we can review results from the 10 mg/kg cohort in the ongoing CONNECT1 study. We believe this will allow us to gather additional safety data, assess the impact of this dose of PGN-EDO51 on dystrophin levels, and potentially improve the design of CONNECT2.
Current wording
Our clinical development program for PGN-EDO51 included a completed Phase 1 clinical trial in healthy volunteers, or HVs, and two parallel Phase 2 studies of PGN-EDO51 in DMD patients. The first study, CONNECT1-EDO51, or CONNECT1, was an open-label, multiple ascending dose, or MAD, study in boys and young men living with DMD amenable to exon 51 skipping conducted in Canada. The second Phase 2 study of PGN-EDO51, CONNECT2-EDO51, or CONNECT2, was a randomized, double-blind, placebo-controlled MAD study in boys and young men living with DMD amenable to exon 51 skipping. In early 2024, we received authorization from the Medicines and Healthcare products Regulatory Agency, or the MHRA, to initiate CONNECT2 in the United Kingdom, or U.K. In December 2024, we received a clinical hold notice from the U.S. Food and Drug Administration, or FDA, regarding our investigational new drug, or IND, application to initiate the CONNECT2 study in the U.S. In March 2025, we announced our voluntary decision to pause CONNECT2 until we could review results from the 10 mg/kg cohort in the CONNECT1 study.
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.
Current wording
We are 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
Our clinical development program for PGN-EDODM1 includes two studies, FREEDOM-DM1, or FREEDOM, a multinational, randomized, double-blind, placebo-controlled Phase 1 single ascending dose, or SAD, study, and FREEDOM2-DM1, or FREEDOM2, a multinational, randomized, double blind, placebo-controlled Phase 2 MAD study. In the FREEDOM study, we are enrolling adult participants with DM1 in multiple geographies including the U.S., U.K. and Canada, to evaluate the safety and tolerability of PGN-EDODM1, as well as oligonucleotide muscle concentrations, splicing correction and functional outcome measures at day 28 and at week 16 following a single dose of PGN-EDODM1. On February 24, 2025, we reported initial data from the 5 mg/kg and 10 mg/kg dose cohorts in this study. PGN-EDODM1 was observed to have a favorable emerging safety profile and robust splicing correction in a dose-dependent manner in the 5 and 10 mg/kg dose cohorts. The 15 mg/kg cohort is currently enrolling participants and we have begun dosing at this level. We expect to report data from the 15 mg/kg cohort of the FREEDOM study in the second half of 2025.
Current wording
Our clinical development program for PGN-EDODM1 includes two studies, FREEDOM-DM1, or FREEDOM, a multinational, randomized, double-blind, placebo-controlled Phase 1 single ascending dose, or SAD, study, and FREEDOM2-DM1, or FREEDOM2, a multinational, randomized, double blind, placebo-controlled Phase 2 MAD study. In the FREEDOM study, we are enrolling adult participants with DM1 in multiple geographies including the U.S., U.K. and Canada, to evaluate the safety and tolerability of PGN-EDODM1, as well as oligonucleotide muscle concentrations, splicing correction and functional outcome measures at day 28 and at week 16 following a single dose of PGN-EDODM1. On February 24, 2025, we reported initial data from the 5 mg/kg and 10 mg/kg dose cohorts in this study. PGN-EDODM1 was observed to have a favorable emerging safety profile and robust splicing correction in a dose-dependent manner in the 5 and 10 mg/kg dose cohorts.. Based on the positive splicing correction observed at the 5 and 10 mg/kg dose cohorts and the totality of the blinded safety data to date, we have decided to conclude dose escalation in the FREEDOM trial with the 15 mg/kg cohort. We have completed patient dosing in the 15 mg/kg cohort of the FREEDOM trial and expect to report safety, 28-day splicing and functional benefit data from the 15 mg/kg cohort in early fourth quarter of 2025.
Previous 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.
Current wording
The FDA has granted both orphan drug designation and Fast Track designation for PGN-EDODM1 for the treatment of DM1.
Previous 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.
Current wording
We have also initiated research efforts for additional indications, including neuromuscular diseases and neurologic disorders and have several programs in early research.
Previous 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.
Current wording
We have incurred operating losses in each year since our inception. Our net losses were $53.3 million and $46.4 million for the six months ended June 30, 2025 and June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $324.8 million. As of June 30, 2025, we had cash, cash equivalents, and marketable securities of $74.7 million. Notwithstanding our recent decision to cease our research and development efforts in DMD, we expect our expenses and operating losses will continue as we conduct our ongoing preclinical studies and current and planned clinical trials of PGN-EDODM1, 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
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.
Current wording
The following table (in thousands) summarizes our research and development expenses for the three and six months ended June 30, 2025 and June 30, 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 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.
Current wording
We continue to conduct our ongoing Phase 1 and Phase 2 clinical trials of our investigational drug candidate, PGN-EDODM1. On May 28, 2025, we announced that we have decided to voluntarily discontinue development of PGN-EDO51 and will be winding down all DMD-related research and development activities. Research and development expenses for our lead program 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 our remaining clinical stage product candidate or any new product candidates we develop.
Previous wording
The timelines and costs associated with research and development activities are uncertain and can vary significantly for each product candidate and development program due to the inherently unpredictable nature of preclinical and clinical development. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to preclinical and clinical results, regulatory developments, and ongoing assessments as to each program’s commercial potential. We will need to raise substantial additional capital in the future.
Current wording
The timelines and costs associated with research and development activities are uncertain and can vary significantly for our product candidate and development program due to the inherently unpredictable nature of preclinical and clinical development. We recently announced our decision to focus our development efforts on PGN-EDODM1, and to cease development of our DMD-related programs, and may make further determinations as to which programs in our research and development pipeline to pursue and how much funding to direct to each program. We will need to raise substantial additional capital in the future.
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 months ended March 31, 2025 or March 31, 2024.
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 as of June 30, 2025 or June 30, 2024.
Previous 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.
Current wording
Other income (expense), net was income of $0.8 million for the three months ended June 30, 2025 and $2.1 million for the three months ended June 30, 2024. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.
Previous 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.
Current wording
Research and development expenses increased by $4.0 million from $39.8 million for the six months ended June 30, 2024, to $43.8 million for the six months ended June 30, 2025. This was attributable to a $1.4 million increase in manufacturing costs related to the timing of manufacturing campaigns, a $2.5 million increase in personnel-related costs, including an increase of $0.5 million in stock-based compensation expense, and a $1.8 million increase in clinical trial costs associated with the advancement of clinical development programs and charges taken during the current quarter for estimated wind-down costs for the two clinical trials for PGN-EDO51. There was also a $0.7 million increase in other research and development expenses related to the non-cash charge taken during the current year associated with the impairment of unused lab equipment and a $0.4 million increase in consulting expense. These increases were partially offset by decreased preclinical costs of $2.6 million during the period as our two lead programs had both advanced into clinical trials, prior to the discontinuation of our DMD program in late May 2025. Additionally, there was a $0.2 million decrease in facility and office related expenses.
Previous 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.
Current wording
General and administrative expenses increased by $1.1 million from $10.4 million for the six months ended June 30, 2024, to $11.5 million for the six months ended June 30, 2025. The increase was primarily driven by an increase of $0.7 million in personnel-related costs, including $0.4 million in stock-based compensation expense. This increase was additionally driven by a $0.3 million increase in consulting and legal expenses.
Previous 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.
Current wording
As of June 30, 2025, we had cash, cash equivalents, and marketable securities of $74.7 million. We do not 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 Form 10-Q. 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 scope, progress, costs and results of preclinical and clinical development for our product candidates, any additional product candidates we may develop and any new indications we may pursue;
Current wording
the scope, progress, costs and results of preclinical and clinical development for PGN-EDODM1, any additional product candidates we may develop and any new indications we may pursue;
Previous wording
the scope, costs, timing and outcome of regulatory review of our product candidates, any additional product candidates we may develop and any new indications we may pursue;
Current wording
the scope, costs, timing and outcome of regulatory review of PGN-EDODM1, any additional product candidates we may develop and any new indications we may pursue;
Previous 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):
Current wording
The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2025 and June 30, 2024 (in thousands):
Previous 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.
Current wording
For the six months ended June 30, 2025, net cash used in operating activities was $46.5 million resulting from our net loss of $53.3 million and changes in our operating assets and liabilities of $1.2 million, partially offset by non-cash adjustments of $7.9 million. The net changes in our operating assets and liabilities were primarily due to a decrease in operating lease liabilities of $1.5 million. The change was further driven by a decrease in accounts payable of $0.9 million, an increase in accrued expenses of $0.5 million and a decrease in prepaids and other current assets of $0.7 million. The non-cash adjustments included $5.8 million of stock-based compensation, $0.7 million of depreciation expense, $1.2 million of amortization of discounts on our marketable securities, and $1.9 million of amortization and interest accretion on our operating lease. Additionally, there was a non-cash adjustment of $0.7 million related to the impairment of unused lab equipment.
Previous 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.
Current 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.
Previous wording
For the three months ended March 31, 2025, net cash provided by investing activities was $17.1 million resulting from $24.0 million in maturities of marketable securities partially offset by $6.7 million in purchases of marketable securities and $0.1 million in purchases of property and equipment.
Current wording
For the six months ended June 30, 2025, net cash provided by investing activities was $32.1 million resulting from $39.0 million in maturities of marketable securities partially offset by $6.7 million in purchases of marketable securities and $0.2 million in purchases of property and equipment.
Previous 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.
Current 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.
Previous 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.
Current 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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2025 and June 30, 2024 (in thousands):
Current report — wording carried from elsewhere
Other income (expense), net was income of $2.0 million for the six months ended June 30, 2025 and $3.9 million for the six months ended June 30, 2024. Interest is earned through our cash deposits and U.S. Treasury-backed money market funds.
Current report — wording carried from elsewhere
Income tax expense was nil for the six months ended June 30, 2025 and June 30, 2024.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, net cash provided by financing activities was $0.1 million of proceeds from the purchase of shares under employee equity plans.