PRECISION BIOSCIENCES INC
For the period ended Sep 30, 2025. Filed Nov 3, 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.
Sep 30, 2025 · Filed Nov 3, 2025
DTIL$10.60+7.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001628280-25-038594
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-03.
0001628280-25-047919
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 131 previous paragraphs and 135 current paragraphs.
75 unchanged; 42 reworded; 17 added; 13 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 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 (17)
Current report
In August 2025, we announced Phase 1 safety and efficacy data for Cohort 1 (0.2 mg/kg) and initial safety data from Cohort 2 (0.4 mg/kg) in the ELIMINATE-B study and subsequently presented the data in September 2025 at the 6th International Coalition to Eliminate HBV Cure Symposium. Following multiple administrations across two dose levels in Cohort 1 and Cohort 2, PBGENE-HBV has continued to be well-tolerated and active. We commenced dosing patients in Cohort 3 in the third quarter of 2025 with additional data readouts planned in early 2026.
Current report
We have been selected to deliver a late-breaking oral presentation at the upcoming Liver Meeting 2025 during the 75th American Association for the Study of Liver Diseases on November 10, 2025. The oral presentation will feature new data from the first two cohorts of the ongoing Phase 1 ELIMINATE-B Trial.
Current report
On October 10, 2025, we presented a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society meeting, highlighting durable improvements in muscle function over time through increased dystrophin expression and dystrophin-positive cells for PBGENE-DMD. The data from a DMD mouse model demonstrated that dystrophin protein was detected in all muscles evaluated following the administration of PBGENE-DMD at doses up to 1x1014 vg/kg, with increased expression observed at 9 months versus prior timepoints in the quadriceps, gastrocnemius, heart, and diaphragm, resulting in substantial and sustained functional muscle improvement. An increase in dystrophin-positive muscle cells were observed in all muscles. The maximum force output was significantly improved over untreated DMD mice at 3-, 6- and 9-months post-treatment, highlighting expected durability of PBGENE-DMD outcomes.
Current report
In partnership with iECURE, Inc. (“iECURE”), an ARCUS-mediated targeted gene insertion approach is being pursued as a potential treatment option for neonatal onset ornithine transcarbamylase (“OTC”) deficiency. iECURE presented at several recent medical conferences with updated ECUR-506 clinical data including the 6th International Symposium on Urea Cycle Disorders and the 15th International Congress of Inborn Errors of Metabolism, both held in early September 2025 in Kyoto, Japan. In October 2025, medical conferences included the European Society of Gene & Cell Therapy Annual Congress held in Sevilla, Spain, and the American Society of Human Genetics Annual Meeting in Boston, Massachusetts.
Current report
Imugene Limited, our clinical stage partner developing azer-cel for oncology indications, announced in September 2025, additional efficacy data from its Phase 1b clinical trial evaluating azer-cel and IL-2 in patients with relapsed/refractory diffuse large B-cell lymphoma. The updated data showcased an overall response rate of 81% in patients treated with azer-cel and IL-2 with seven complete responses and six partial responses in patients treated with azer-cel including several patients remaining in durable remission beyond one year.
Current report
On October 28, 2025, Imugene announced the first efficacy results from the CAR T-naïve cohort of its ongoing Phase 1b trial of azer-cel. Of six evaluable CAR T-naïve patients, five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending. A total of ten patients have been treated in this CAR T-naïve cohort thus far, with additional results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably Waldenström Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL), and Primary Central Nervous System Lymphoma (PCNSL).
Current report
Imugene is actively enrolling patients in the Phase 1b azer-cel trial at ten U.S. sites and five sites in Australia. Imugene has scheduled a Type C meeting with the FDA to discuss potential pivotal study design options for azer-cel. On October 31, 2025, the Company received an $8.0 million milestone payment from Imugene, including $3.0 million in cash and $5.0 million in Imugene stock.
Current report
Change in Equity Method Investment
Current report
Changes in Other Fair Value Adjustments
Current report
Gain on Disposal of Assets
Current report
General and administrative expenses were $7.3 million for the three months ended September 30, 2025, compared to $8.8 million for the three months ended September 30, 2024. The decrease of approximately $1.4 million was primarily due to a $1.1 million decrease in employee-related costs and a $0.2 million decrease in consulting and professional services expenses.
Current report
(Loss) Gain on Changes in Other Fair Value Adjustments
Current report
Gain on Disposal of Assets
Current report
Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024
Current report
Gain (Loss) from Equity Method Investment
Current report
(Loss) Gain on Changes in Other Fair Value Adjustments
Current report
Loss on Disposal of Assets
Removed paragraphs (13)
Previous report
In May 2025, we presented initial safety data for PBGENE-HBV at the European Association for the Study of the Liver Congress as well as safety data for the sentinel patient in cohort 2 during the American Society of Gene and Cell Therapy (“ASGCT”) annual meeting.
Previous report
On August 6, 2025, we announced Phase 1 safety and efficacy data for Cohort 1, the lowest dose level in the ELIMINATE-B trial. Cohort 1 consisted of three patients each of whom received three planned administrations of 0.2 mg/kg of PBGENE-HBV dosed approximately eight weeks apart. The primary objective is to characterize the safety of PBGENE-HBV. PBGENE-HBV was well-tolerated in all three patients in Cohort 1. Across Cohort 1, no patient experienced above a Grade 2 treatment-related adverse event, a serious adverse event, or dose-limiting toxicity. No clinically significant lab abnormalities were observed, including liver enzymes and platelets.
Previous report
PBGENE-HBV demonstrated a substantial HBsAg reduction in all three patients in Cohort 1 with best response reductions of 56%, 69% and 47% compared to baseline HBsAg levels (ranging between 562-11,813 IU/mL) in patients one, two and three, respectively. One of three patients (33%) in Cohort 1 achieved a durable HBsAg reduction of approximately 50% from baseline that was maintained as of the data cutoff-date (July 28, 2025), which was seven months after initial dosing. This data provides evidence of the ability of PBGENE-HBV to drive a durable antiviral response by editing the viral DNA at the source of chronic Hepatitis B infection. There was no association between baseline HBsAg and efficacy in Cohort 1.
Previous report
We also announced initial safety data from Cohort 2 (0.4 mg/kg) in the ELIMINATE-B study. As of the data cutoff, one patient received three dose administrations with two weeks of follow-up, and two patients received one dose administration with four weeks of follow-up. In these patients, no adverse events above Grade 2 were observed. No serious adverse events or dose limiting toxicities were observed, and no cumulative adverse effects were observed. There were no clinically significant elevations of liver transaminases. One additional patient did not complete their dose due to a transient infusion-related serious adverse event that resolved within minutes. The Data Monitoring Committee determined that this transient reaction was not dose-related or dose-limiting. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recently recommended initiation of Cohort 3.
Previous report
We are on track to complete dosing of all three patients across all dose administrations in Cohort 2 and commence dosing Cohort 3. We expect to provide a data update later in 2025.
Previous report
In July 2025, we announced new preclinical data building upon previous data shared at ASGCT in May 2025. These data demonstrated the ability of PBGENE-DMD to target the key muscle types involved in the progression of DMD as well as significant, durable functional improvement in a humanized DMD mouse model. PBGENE-DMD showed a three-fold increase in dystrophin-positive muscle cells between three and nine months in the quadricep, gastrocnemius (calf), heart, and diaphragm. In the gastrocnemius specifically, up to 85% of cells were dystrophin-positive. This broad increase in dystrophin-positive cells, combined with the increased dystrophin protein detected in tissues, further validates the improved muscle function that was observed over time and may be attributable to edited satellite cells.
Previous report
As we advance the ELIMINATE-B clinical trial and prepare to file an IND and/or CTA for the PBGENE-DMD program, we are closely managing our operating costs. We have also extended our expected cash runway to the second half of 2027 to enable meaningful clinical data readouts for both programs. In July 2025, we initiated an operating efficiency program, including reductions in early research, manufacturing, and general and administrative operating expenses, which are aimed at reducing our annual operating expenses.
Previous report
Imugene, our clinical stage partner developing azer-cel for oncology indications, announced updated clinical data in July 2025. In the updated data in patients diagnosed with relapsed/refractory diffuse large B-cell lymphoma (“DLBCL”), two additional patients achieved a Complete Response and three additional patients achieved a Partial Response. Imugene reported that, as a result of the new data, the best overall response rate for azer-cel in DLBCL reached 75%, and the Complete Response rate reached 55%. Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL, Imugene expects to request an end of Phase 1 meeting with the FDA in the fourth quarter of 2025 to present the data and discuss designs for a pivotal/registrational trial for azer-cel.
Previous report
(Loss) Gain from Equity Method Investment
Previous report
Gain (Loss) on Change in Fair Value of Warrant Liability
Previous report
General and administrative expenses were $9.1 million for the three months ended June 30, 2025, compared to $8.5 million for the three months ended June 30, 2024. The increase of $0.6 million was primarily due to a $0.6 million increase in employee-related costs, partially offset by decreases in other general and administrative expenses.
Previous report
Comparison of the Six Months Ended June 30, 2025 and June 30, 2024
Previous report
Gain from Equity Method Investment
Reworded paragraphs (42)
Previous wording
PBGENE-HBV is our wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA, the root cause chronic Hepatitis B. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. The ELIMINATE-B trial is recruiting patients in the U.S., Moldova, Hong Kong, New Zealand and the U.K. and six patients have been treated to date.
Current wording
PBGENE-HBV is our wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA, the root cause chronic Hepatitis B. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. The ELIMINATE-B trial is recruiting patients in the U.S., Moldova, Hong Kong, New Zealand and the U.K.
Previous wording
DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the United States alone. There are currently no approved therapies with curative intent that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit.
Current wording
Duchenne muscular dystrophy, or DMD, is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the United States alone. There are currently no approved therapies with curative intent that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit.
Previous wording
The FDA granted PBGENE-DMD Rare Pediatric Disease designation in June 2025 for the treatment of DMD followed by Orphan Drug Designation in July 2025, highlighting the significant unmet need for new therapeutic options for those living with DMD.
Current wording
The U.S. Food and Drug Adminstration (“FDA”) granted PBGENE-DMD Rare Pediatric Disease designation in June 2025 for the treatment of DMD followed by Orphan Drug Designation in July 2025, highlighting the significant unmet need for new therapeutic options for those living with DMD.
Previous wording
We are advancing the final U.S. investigational new drug (“IND”)-enabling toxicology studies with an anticipated IND and/or clinical trial application (“CTA”) filing targeted by the end of 2025 with initial clinical data expected in 2026.
Current wording
We have completed final toxicology studies and are manufacturing clinical supplies with an anticipated U.S. investigational new drug (“IND”) filing by the end of 2025. Pending IND clearance, Phase 1 initiation in DMD patients is anticipated in the first half of 2026 with initial clinical data expected in the second half of 2026.
Previous wording
In partnership with iECURE, Inc. (“iECURE”), an ARCUS-mediated gene insertion approach is being pursued as a potential treatment option for neonatal onset ornithine transcarbamylase (“OTC”) deficiency. In January 2025, iECURE reported clinical efficacy and safety data in the first patient dosed showing a complete clinical response from three months post-exposure to the end of study at six months, as defined by the study protocol. The patient is now more than one year of age and is eating appropriate levels of protein for a child of his age. iECURE has reported that a second infant with severe OTC deficiency was dosed in the first half of 2025. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain, and iECURE expects to complete enrollment in 2025 and anticipates complete data from the trial in the first half of 2026.
Current wording
These data presentations build upon previously reported clinical results demonstrating complete clinical response in the first participant at the lowest dose level (1.3x1013 GC/kg) of ECUR-506, as defined by the study protocol. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain with data from the trial expected in the first half of 2026.
Previous wording
Gain from equity method investment represents a gain from dilution from our proportionate share of our equity method investee, Elo Life Systems, Inc. (“Elo”), resulting from its Series A-2 financing offset by our proportionate share of net loss of Elo.
Current wording
Changes in fair value on our equity method investment represents changes in the investment value as a result of dilution from our proportionate share of our equity method investee, Elo Life Systems, Inc. (“Elo”), resulting from its Series A-2 financing offset by our proportionate share of net loss of Elo. Changes in the investment value also occur as a result of our proportionate share of Elo’s profit and loss activity in a reporting period.
Previous wording
The change in fair value represents the assessed changes in fair value of assets and liabilities carried at fair value.
Current wording
The change in other fair value adjustments represents the assessed changes in fair value of assets and liabilities carried at fair value.
Previous wording
Loss on disposal of assets represents the remaining net book value of disposed assets at the time of their disposal and impairment recognized on assets held for sale.
Current wording
Gain on disposal of assets represents the difference between the sale price and remaining net book value of sold assets at the time of their sale.
Previous wording
Revenue for the three months ended June 30, 2025 was less than $0.1 million, compared to $49.9 million for the three months ended June 30, 2024. The decrease of $49.9 million in revenue during the three months ended June 30, 2025 was primarily the result of $48.2 million of revenue recognized in the prior period which represented all remaining deferred revenue related to the Prevail Therapeutics Agreement at its conclusion in April 2024. Additionally contributing to the decrease in revenue was a $0.9 million decrease in revenue recognized under the TG License Agreement during the three months ended June 30, 2024, and a $0.8 million decrease in revenue recognized under the Novartis Agreement as we near the completion of our preclinical work plan during the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Current wording
Revenue for the three months ended September 30, 2025 was less than $0.1 million, compared to $0.6 million for the three months ended September 30, 2024. The decrease in revenue during the three months ended September 30, 2025 was the result of less billable effort under our collaboration and license agreement (the “Novartis Agreement”) with Novartis Pharma AG (“Novartis”) as we neared the completion of our preclinical work plan during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Previous wording
Research and development expenses for the three months ended June 30, 2025 were $12.8 million, compared to $17.2 million for the three months ended June 30, 2024. The decrease of $4.5 million was primarily due to a $7.3 million decrease in our direct expenses in PBGENE-HBV and PBGENE-3243 programs, partially offset by a $4.0 million increase in our direct expenses in PBGENE-DMD. Additionally contributing to the decrease was a reduction in platform development and early-stage research expenses of $1.2 million.
Current wording
Research and development expenses for the three months ended September 30, 2025 were $13.4 million, compared to $13.1 million for the three months ended September 30, 2024. The increase of $0.3 million was primarily due to a $3.4 million increase in our direct expenses in PBGENE-DMD which was partially offset by a $2.8 million decrease in our direct expenses in the PBGENE-HBV and PBGENE-3243 programs. Additionally offsetting the increase was a $0.4 million reduction in platform development and early-stage research expenses.
Previous wording
The direct expense decrease of $6.3 million for PBGENE-HBV was due to lower manufacturing and toxicology expenses as the program transitioned to the clinic in the fall of 2024. The increase in expense of $4.0 million for PBGENE-DMD was a result of the program's acceleration in the second quarter of 2025. PBGENE-3243 had a $1.0 million decrease in expense as we have paused development. Platform development and early-stage research expenses decreased over the comparison period as a result of a $0.6 million decrease in employee-related costs and a $0.5 million decrease in depreciation and amortization.
Current wording
The increase in expense of $3.4 million for PBGENE-DMD was a result of the program’s acceleration in 2025. The direct expense decrease of $0.9 million for PBGENE-HBV was due to lower manufacturing and toxicology expenses as the program transitioned to the clinic at the end of 2024. PBGENE-3243 also had an expense decrease of $1.9 million as we have paused development. Platform development and early-stage research expenses decreased over the comparison period as a result of a $0.3 million decrease in depreciation and amortization and a $0.2 million decrease in laboratory supplies and services expenses.
Previous wording
Loss from equity method investment was $0.7 million during the three months ended June 30, 2025 compared to $1.0 million during the three months ended June 30, 2024, which represented our proportionate share of Elo's net loss in each period.
Current wording
Loss from equity method investment was $0.6 million during the three months ended September 30, 2025 compared to $0.9 million during the three months ended September 30, 2024, which represented our proportionate share of Elo’s net loss in each period.
Previous wording
Loss on changes in fair value was $2.5 million for the three months ended June 30, 2025 resulting from the change in fair value of the iECURE investment in the current period. Gain on changes in fair value was $0.7 million for the three months ended June 30, 2024, which was primarily attributable to the increase in fair value of the Imugene Convertible Note for that period.
Current wording
Loss on changes in other fair value adjustments was less than $0.1 million for the three months ended September 30, 2025, which is attributable to the change in fair value on the final payment fee associated with the term loan. Gain on changes in other fair value adjustments was $0.6 million for the three months ended September 30, 2024, which was primarily attributable to the increase in fair value of the Imugene Convertible Note for that period.
Previous wording
Gain from change in fair value of the warrant liability was $0.8 million for the three months ended June 30, 2025 compared to a gain of $7.8 million for the three months ended June 30, 2024, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering.
Current wording
Loss from change in fair value of the warrant liability was $1.2 million for the three months ended September 30, 2025 compared to a gain of $3.6 million for the three months ended September 30, 2024, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering.
Previous wording
Interest expense was $0.4 million for the three months ended June 30, 2025 compared to $0.6 million for the three months ended June 30, 2024. The decrease of $0.2 million of interest expense was primarily driven by lower interest rates during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024.
Current wording
Interest expense was $0.4 million for the three months ended September 30, 2025 compared to $0.3 million for the three months ended September 30, 2024. During the three months ended September 30, 2024, the final payment fee from our previous line of credit debt instrument was waived, which was offset against interest expense during the period.
Previous wording
Interest income was $1.1 million during the three months ended June 30, 2025 compared to $1.8 million during the three months ended June 30, 2024. The $0.7 million decrease in interest income was the result of lower interest rates and a lower cash balance during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024.
Current wording
Interest income was $1.0 million during the three months ended September 30, 2025 compared to $1.8 million during the three months ended September 30, 2024. The decrease of approximately $0.7 million in interest income was the result of lower interest rates and a lower cash balance during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024.
Previous wording
Loss on disposal of assets was less than $0.1 million during the three months ended June 30, 2025 compared to $0.2 million during the three months ended June 30, 2024.
Current wording
Gain on disposal of assets was less than $0.1 million during the three months ended September 30, 2025. There was no gain or loss on disposal of assets during the three months ended September 30, 2024.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and June 30, 2024, together with the changes in those items:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and September 30, 2024, together with the changes in those items:
Previous wording
Revenue for the six months ended June 30, 2025 was less than $0.1 million, compared to $67.5 million for the six months ended June 30, 2024. The decrease of $67.4 million in revenue during the six months ended June 30, 2025 was primarily the result of $52.7 million of revenue recognized in the prior period which represented all remaining deferred revenue related to the Prevail Therapeutics Agreement at its conclusion in April 2024. Additionally contributing to the decrease in revenue was a $9.5 million decrease as a result of revenue recognized under the TG License Agreement and a license agreement with Caribou Biosciences, Inc. during the six months ended June 30, 2024 and a $5.3 million decrease in revenue recognized under the Novartis Agreement as we near the completion of our preclinical work plan.
Current wording
Revenue for the nine months ended September 30, 2025 was less than $0.1 million, compared to $68.1 million for the nine months ended September 30, 2024. The decrease of $68.0 million in revenue during the nine months ended September 30, 2025 was primarily the result of $52.7 million of revenue recognized in the prior period related to the conclusion of the Prevail Therapeutics Agreement, which represented all remaining deferred revenue under that agreement. Additionally contributing to the decrease in revenue were $9.5 million of revenue recognized under the TG License Agreement and Caribou Biosciences, Inc. license agreement during the nine months ended September 30, 2024, and a $5.9 million decrease in revenue recognized under the Novartis Agreement as we neared the completion of our preclinical work plan.
Previous wording
Research and development expenses for the six months ended June 30, 2025 were $26.4 million, compared to $30.6 million for the six months ended June 30, 2024. The decrease of $4.2 million was primarily due to a $7.8 million decrease in our direct expenses in PBGENE-HBV and a $2.7 million decrease in platform development and early-stage research expenses. These expense decreases were partially offset by a $6.3 million increase in our direct expenses in PBGENE-DMD.
Current wording
Research and development expenses for the nine months ended September 30, 2025 were $39.7 million, compared to $43.7 million for the nine months ended September 30, 2024. The decrease of approximately $3.9 million was primarily due to a $10.5 million decrease in our direct expenses within the PBGENE-HBV and PBGENE-3243 programs along with a $3.1 million decrease in platform development and early-stage research expenses. These expense decreases were partially offset by a $9.7 million increase in our direct expenses in PBGENE-DMD.
Previous wording
The direct expense decrease of $7.8 million for PBGENE-HBV was due to lower manufacturing and toxicology expenses as the program transitioned to the clinic in the fall of 2024. These decreases were partially offset by the $6.3 million increase in PBGENE-DMD development due to the program's acceleration in the second quarter of 2025. Platform development and early-stage research expenses also decreased by $2.7 million in expense over the comparison period. The primary factors for the decrease were a $1.1 million decrease in depreciation and amortization, a $0.7 million decrease in employee-related costs, and a $0.5 million decrease in license fees and other research and development costs.
Current wording
The direct expense decrease of $8.6 million for PBGENE-HBV was due to lower manufacturing and toxicology expenses as the program transitioned to the clinic at the end of 2024. PBGENE-3243 also had an expense decrease of $1.9 million as we have paused development. These decreases were offset by the $9.7 million increase in PBGENE-DMD development due to the program's acceleration in 2025. Platform development and early-stage research expenses also decreased by $3.1 million in expense over the comparison period. The primary factors for the decrease were a $1.3 million decrease in depreciation and amortization, a $0.6 million decrease in laboratory supplies and services expenses, and a $0.5 million decrease in licensing fees and other research and development costs.
Previous wording
General and administrative expenses were $17.7 million for the six months ended June 30, 2025, compared to $17.0 million for the six months ended June 30, 2024. The increase of $0.7 million was primarily due to a $1.1 million increase in employee-related costs, partially offset by decreases in depreciation and amortization and other operating expenses, specifically subscription software.
Current wording
General and administrative expenses were $25.0 million for the nine months ended September 30, 2025, compared to $25.7 million for the nine months ended September 30, 2024. The decrease of $0.7 million was primarily due to decreases in other operating expenses.
Previous wording
Gain from equity method investment was $0.7 million during the six months ended June 30, 2025 which was primarily driven by a $2.3 million gain on dilution from our proportionate share of Elo’s proceeds from a Series A-2 financing in such period, partially offset by our proportionate share of Elo’s net loss of $1.6 million during the period. Gain from equity method investment was $0.8 million during the six months ended June 30, 2024 which was primarily driven by a $2.7 million gain on dilution from our proportionate share of Elo’s proceeds from a Series A-2 financing in such period, partially offset by our proportionate share of Elo’s net loss of $1.9 million during the period.
Current wording
Gain from equity method investment was $0.1 million during the nine months ended September 30, 2025 which was primarily driven by a $2.3 million gain on dilution from our proportionate share of Elo’s proceeds from an additional tranche of the Series A-2 financing in such period, partially offset by our proportionate share of Elo’s net loss of $2.2 million during the period. Loss from equity method investment was $0.1 million during the nine months ended September 30, 2024 which was primarily driven by a $2.7 million gain on dilution from our proportionate share of Elo's proceeds from the Series A-2 financing in such period, offset by our proportionate share of Elo’s net loss of $2.8 million during the period.
Previous wording
Loss on changes in fair value was $2.4 million for the six months ended June 30, 2025 due to the change in fair value of the iECURE investment in the current period. Gain on changes in fair value was $0.3 million for the six months ended June 30, 2024, which was primarily attributable to a increase during such period in the fair value of the Imugene Convertible Note.
Current wording
Loss on changes in other fair value adjustments was $2.4 million for the nine months ended September 30, 2025 due to the change in fair value of the iECURE investment in the current period. Gain on changes in other fair value adjustments was $0.9 million for the nine months ended September 30, 2024, which was primarily attributable to an increase during such period in the fair value of the Imugene Convertible Note.
Previous wording
Gain on Change in Fair Value of Warrant Liability
Current wording
(Loss) Gain on Change in Fair Value of Warrant Liability
Previous wording
Loss from change in fair value of the warrant liability was less than $0.1 million for the six months ended June 30, 2025 compared to a gain of $18.2 million for the six months ended June 30, 2024, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering.
Current wording
Loss from change in fair value of the warrant liability was $1.2 million for the nine months ended September 30, 2025 compared to a gain of $21.8 million for the nine months ended September 30, 2024, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering.
Previous wording
Interest expense was $0.7 million for the six months ended June 30, 2025 compared to $1.1 million for the six months ended June 30, 2024. The decrease of $0.4 million of interest expense was primarily driven by lower interest rates during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.
Current wording
Interest expense was $1.1 million for the nine months ended September 30, 2025 compared to $1.4 million for the nine months ended September 30, 2024. The decrease of $0.3 million of interest expense was primarily driven by lower interest rates during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.
Previous wording
Interest income was $2.4 million during the six months ended June 30, 2025 compared to $3.5 million during the six months ended June 30, 2024. The $1.1 million decrease in interest income was the result of lower interest rates and a lower cash balance during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.
Current wording
Interest income was $3.5 million during the nine months ended September 30, 2025 compared to $5.3 million during the nine months ended September 30, 2024. The $1.8 million decrease in interest income was the result of lower interest rates and a lower cash balance during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.
Previous wording
Loss on disposal of assets was less than $0.1 million during the six months ended June 30, 2025 and $0.3 million during the six months ended June 30, 2024.
Current wording
Loss on disposal of assets was less than $0.1 million during the nine months ended September 30, 2025 and $0.3 million during the nine months ended September 30, 2024.
Previous wording
We have historically incurred significant operating losses and have not generated any revenue from the sale of products. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates or the product candidates of our collaborators or other licensees for which we may receive milestone payments or royalties. As of June 30, 2025, we had an accumulated deficit of $526.5 million.
Current wording
We have historically incurred significant operating losses and have not generated any revenue from the sale of products. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates or the product candidates of our collaborators or other licensees for which we may receive milestone payments or royalties. As of September 30, 2025, we had an accumulated deficit of $548.3 million and a cash, cash equivalents and restricted cash balance of $71.2 million.
Previous wording
As of June 30, 2025, we had a total cash, cash equivalents and restricted cash balance of $84.8 million. Pursuant to our July 31, 2024 amended and restated loan and security agreement with Banc of California (the “2024 Loan and Security Agreement”) pursuant to which Banc of California provided us with a term loan with a principal amount of $22.5 million (the “2024 Term Loan”), we are not entitled to borrow any additional amounts under the 2024 Term Loan and are required to maintain an aggregate balance in a cash security account with Banc of California (the “Cash Security Account”) at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Current wording
Pursuant to our July 31, 2024 amended and restated loan and security agreement with Banc of California (the “2024 Loan and Security Agreement”) pursuant to which Banc of California provided us with a term loan with a principal amount of $22.5 million (the “2024 Term Loan”), we are not entitled to borrow any additional amounts under the 2024 Term Loan and are required to maintain an aggregate balance in a cash security account with Banc of California (the “Cash Security Account”) at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Previous wording
Because of the numerous risks and uncertainties associated with the development of therapeutic products, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be required to raise additional capital, potentially on terms that are unfavorable to us, or we may be unable to continue our operations at planned levels and be forced to reduce or terminate operations.
Current wording
Because of the numerous risks and uncertainties associated with the development of therapeutic products, we are unable to predict the timing or amount of our future expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be required to raise additional capital, potentially on terms that are unfavorable to us, or we may be unable to continue our operations at planned levels and be forced to reduce or terminate operations.
Previous wording
Our cash, cash equivalents, and restricted cash totaled $84.8 million and $123.6 million as of June 30, 2025 and June 30, 2024, respectively.
Current wording
Our cash, cash equivalents, and restricted cash totaled $71.2 million and $121.3 million as of September 30, 2025 and September 30, 2024, respectively.
Previous wording
Cash used in operating activities during the six months ended June 30, 2025 was $39.3 million compared to $33.9 million during the six months ended June 30, 2024. The $5.5 million increase in cash used in operating activities was primarily driven by an $85.4 million decrease in net income offset by increases of $19.1 million in non-cash adjustments and $60.9 million in changes in operating assets and liabilities.
Current wording
Cash used in operating activities during the nine months ended September 30, 2025 was $54.6 million compared to $39.8 million during the nine months ended September 30, 2024. The $14.8 million increase in cash used in operating activities was primarily driven by an $90.8 million decrease in net income offset by increases of $23.1 million in non-cash adjustments and $52.9 million in changes in operating assets and liabilities.
Previous wording
The increase in non-cash adjustments year over year was primarily driven by the net change in fair value of warrants during the six months ended June 30, 2024 due to the decrease in the warrant liability which resulted in a negative balance within non-cash adjustments for the period. For the six months ended June 30, 2025, the net change in fair value of warrants was slightly positive within non-cash adjustments given the incremental increase in the warrant liability for the current period. Also contributing to the increase in non-cash adjustments year over year was the change in fair value of the iECURE investment in the current period.
Current wording
The increase in non-cash adjustments year over year was primarily driven by the net change in fair value of warrants during the nine months ended September 30, 2024 due to the decrease in the warrant liability which resulted in a negative balance within non-cash adjustments for the period. For the nine months ended September 30, 2025, the net change in fair value of warrants was positive within non-cash adjustments given the incremental increase in the warrant liability for the current period. Also contributing to the increase in non-cash adjustments year over year was the change in fair value of the iECURE investment in the current period.
Previous wording
The change in cash used in operating assets and liabilities is primarily driven by the net changes of deferred revenue as a result of the conclusion of the Prevail collaboration and a decrease in revenue recognized under the Novartis collaboration for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. Additionally driving the change in cash used in operating assets and liabilities is the net change of the contract asset as a result of the TG Therapeutics deferred share payment in January 2025 as well as the and net change in accounts payable across the comparison period.
Current wording
The change in cash used in operating assets and liabilities is primarily driven by the net changes of deferred revenue as a result of the conclusion of the Prevail collaboration and a decrease in revenue recognized under the Novartis collaboration for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. Additionally driving the change in cash used in operating assets and liabilities is the net change of the contract asset as a result of the TG Therapeutics deferred share payment in January 2025 as well as the net changes in prepaid expenses and accounts payable across the comparison period.
Previous wording
Cash used in investing activities primarily relates to cash expenditures to acquire leasehold additions, equipment, software and intangible assets. Net cash used in investing activities during the six months ended June 30, 2025 was $0.3 million, compared to an amount less than $0.1 million used in investing activities in the six months ended June 30, 2024. The increase in cash used in investing activities was primarily the result of a $0.3 million increase in intangible asset purchases during the six months ended June 30, 2025.
Current wording
Cash used in investing activities primarily relates to cash expenditures to acquire leasehold additions, equipment, software and intangible assets. Net cash used in investing activities during the nine months ended September 30, 2025 was $0.3 million, compared to $0.1 million used in investing activities in the nine months ended September 30, 2024. The increase in cash used in investing activities was primarily the result of a $0.2 million increase in intangible asset purchases during the nine months ended September 30, 2025.
Previous wording
Net cash provided by financing activities during the six months ended June 30, 2025 was $16.0 million, compared to $40.8 million during the six months ended June 30, 2024. The $24.8 million decrease in cash provided by financing activities during the six months ended June 30, 2025 was primarily due to the Company receiving $37.5 million in net proceeds from an underwritten offering of common stock and warrants in the six months ended June 30, 2024, whereas the Company did not receive any net proceeds from underwritten offerings during the six months ended June 30, 2025. The decrease was partially offset by a $12.1 million increase in net proceeds from the issuance of common stock through the ATM facility between the comparison periods.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2025 was $17.6 million, compared to $44.5 million during the nine months ended September 30, 2024. The $26.9 million decrease in cash provided by financing activities during the nine months ended September 30, 2025 was primarily due to the Company receiving $37.0 million in net proceeds from an underwritten offering of common stock and warrants in the nine months ended September 30, 2024, whereas the Company did not receive any net proceeds from underwritten offerings during the nine months ended September 30, 2025. The decrease was partially offset by a $10.0 million increase in net proceeds from the issuance of common stock through the ATM facility between the comparison periods.
Previous wording
On July 31, 2024, we replaced our revolving line of credit with Banc of California with the 2024 Term Loan with an aggregate principal amount of $22.5 million. The stated interest rate under the 2024 Term Loan is equal to the greater of 1.50% below the Prime Rate or 4.5%. As of June 30, 2025, the outstanding principal balance on the 2024 Term Loan was $22.5 million, the stated interest rate was 6.00% and the effective interest rate was 6.43%.
Current wording
On July 31, 2024, we replaced our revolving line of credit with Banc of California with the 2024 Term Loan with an aggregate principal amount of $22.5 million. The stated interest rate under the 2024 Term Loan is equal to the greater of 1.50% below the Prime Rate or 4.5%. As of September 30, 2025, the outstanding principal balance on the 2024 Term Loan was $22.5 million, the stated interest rate was 5.75% and the effective interest rate was 6.17%.
Previous wording
In addition to the contractual obligations and commitments as described elsewhere in this Quarterly Report on Form 10-Q with respect to leases, outstanding indebtedness, and intellectual property licenses, we also enter into contracts in the normal course of business with CMOs, universities, and other third parties for preclinical research studies, testing, manufacturing services, and other services and products for operating purposes. These contracts are generally cancellable upon written notice. There have been no material changes to our contractual obligations from those described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Current wording
In addition to the contractual obligations and commitments as described elsewhere in this Quarterly Report on Form 10-Q with respect to leases, outstanding indebtedness and intellectual property licenses, we also enter into contracts in the normal course of business with CMOs, universities, and other third parties for preclinical research studies, testing, manufacturing services, and other services and products for operating purposes. These contracts are generally cancellable upon written notice. Except for the compensatory arrangements described in Note 4, Commitments and Contingencies, there have been no material changes to our contractual obligations from those described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Showing the first 40 of 42 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Change in Fair Value of Warrant Liability
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
As of the filing of this Quarterly Report on Form 10-Q, we are subject to the Baby Shelf Rule, as defined and described in “Risk Factors – We will need substantial additional funding, and if we are unable to raise a sufficient amount of capital when needed on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.” in Part II, Item 1A. of this Quarterly Report on Form 10-Q. As a result of the Baby Shelf Rule, we will be limited in the amount of proceeds we are able to raise by selling shares of our common stock using our Form S-3, including under our ATM facility, until such time as our public float exceeds $75 million.