PRECISION BIOSCIENCES INC
For the period ended Mar 31, 2026. Filed May 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 5, 2026
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 2025-09-30; filed 2025-11-03.
0001628280-25-047919
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001628280-26-030124
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 135 previous paragraphs and 126 current paragraphs.
65 unchanged; 31 reworded; 29 added; 35 removed; 4 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (29)
Current report
Wholly-Owned Portfolio
Current report
PBGENE-HBV is our wholly ownedin vivo gene editing program under investigation in a global first-in-human clinical trial, ELIMINATE-B, which is designed to be a potentially curative treatment for chronic hepatitis B infection. In patients with chronic hepatitis B, cccDNA acts as the template to make new infectious viral particles. PBGENE-HBV is the only clinical stage program that targets the elimination of covalently closed circular DNA (“cccDNA”), the sole source of viral replication, leading to sustained loss of hepatitis B virus (“HBV”) DNA and other downstream viral markers. PBGENE-HBV is the firstin vivo gene editing approach to prospectively employ repeat administrations of lipid nanoparticle (“LNP”).
Current report
As part of the ongoing assessment of the safety and efficacy profile of PBGENE-HBV after repeat doses in Part 1 dose finding, we have treated 16 patients with 38 administrations of PBGENE-HBV across five cohorts evaluating the impact of escalating dose levels as well as 8-week and 4-week dosing intervals. The goal during Part 1 of the study is to select the dose and schedule that achieves the desired therapeutic index to move to the expansion phase of the ELIMINATE-B trial.
Current report
Looking ahead, we expect to share further clinical data from the PBGENE-HBV program at hepatitis-focused medical conferences throughout 2026, starting with the European Association for the Study of the Liver (“EASL”).
Current report
In April 2026, we announced that a late-breaking poster for PBGENE-HBV was accepted for presentation at the EASL Congress 2026. The poster titled, “First evidence of elimination and inactivation of cccDNA in liver biopsies collected from patients with chronic hepatitis B treated with PBGENE-HBV” will be presented by investigator, Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at The University of Hong Kong.
Current report
Also in April 2026, we announced that we received Clinical Trial Application (“CTA”) approval to expand ELIMINATE-B into France and Romania, broadening the study’s footprint in Europe. Site initiation activities are underway and initial patient screening in those countries is expected in the second quarter of 2026.
Current report
Following investigational new drug (“IND”) clearance from the U.S. Food and Drug Administration (“FDA”) in early 2026, we advanced Institutional Review Board (“IRB”) activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial for PBGENE-DMD. In April 2026, we activated Arkansas Children’s Hospital as the first clinical trial site and are actively enrolling patients.
Current report
In March 2026, PBGENE-DMD received FDA Fast Track designation; we hosted a DMD investor event, and we presented preclinical PBGENE-DMD data highlighting durable dystrophin expression and functional benefit at the Muscular Dystrophy Association Clinical & Scientific Conference 2026.
Current report
In partnership with iECURE, ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial, OTC-HOPE, evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (“OTC”) deficiency. iECURE previously announced alignment with the FDA on key study elements could support a potential Biologics License Application (“BLA”). The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain.
Current report
iECURE expects to present clinical data from the ongoing OTC-HOPE clinical trial at the American Society of Gene & Cell Therapy (“ASGCT”) Annual Meeting in May 2026. The oral presentation at ASGCT will include preliminary data from study participants in the first three dose cohorts (n=7) of the ongoing OTC-HOPE study, including a decreased rate of hyperammonemic crises following ECUR-506 administration. In addition, iECURE plans to present a poster at the Society for Inherited Metabolic Disorders Annual Meeting in May 2026 featuring one-year post-treatment data from the first infant dosed in the study who achieved a complete clinical response as defined by study protocol, including sustained discontinuation of standard-of-care therapies.
Current report
Non-Core Ex Vivo Programs
Current report
Imugene continues development of azer-cel in diffuse large B-cell lymphoma and has received written guidance from the FDA regarding the registrational pathway for azer-cel. The guidance provided clear alignment with the FDA across key elements required to support advancement into a pivotal study, including dosing regimen, patient population, endpoints, and manufacturing readiness. Azer-cel has been selected for oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting being held in May 2026.
Current report
Separately, azer-cel is being evaluated by TG Therapeutics (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. In March 2026, we announced the achievement of a clinical milestone under its license agreement with TG Therapeutics. As a result, we have earned a cash payment of $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of our common stock by TG Therapeutics at $11.17 per share. Anticipated 2026 events include presentation of preliminary Phase 1 azer-cel data in progressive multiple sclerosis in the second half of 2026 and commencement of additional exploratory studies in autoimmune diseases outside of multiple sclerosis.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Changes in fair value on our equity method investment represents changes in the investment value of our equity method investee, Elo Life Systems, Inc. (“Elo”). As of March 31, 2026, Elo is no longer classified as an equity method investment. Any subsequent changes to the investment’s fair value will be recorded through the other fair value adjustments line item.
Current report
The change in fair value of warrant liability represents the mark-to-market fair value adjustments to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering. Refer to Note 11, Warrants, in the accompanying notes to the financial statements for more information on the fair value assumptions.
Current report
Interest Expense
Current report
Gain (loss) on Disposal of Assets
Current report
Revenue for the three months ended March 31, 2026 was $10.8 million, compared to less than $0.1 million for the three months ended March 31, 2025. The increase in revenue was the result of revenue recognized under the TG License Agreement and a legacy ARCUS agriculture gene editing agreement during the three months ended March 31, 2026.
Current report
Research and Development Expenses
Current report
Due to the pause in development of PBGENE-3243 to prioritize our two lead programs, PBGENE-HBV and PBGENE-DMD, expenses for PBGENE-3243 have been recast for the periods presented below. The amounts previously reporting under “PBGENE-3243 external development costs” are now reported within the “Platform development and early-stage research expense” line item.
Current report
The decrease in platform development and early-stage research expenses of $2.3 million was primarily the result of paused development of the PBGENE-3243 program as well as a reduction in employee-related costs, partially offset by an increase in licensing fees and other research and development costs. Direct expenses in PBGENE-DMD increased by $1.6 million as we initiated IRB activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial.
Current report
General and Administrative Expenses
Current report
Gain from Equity Method Investment
Current report
For the three months ended March 31, 2025, the $1.3 million gain from equity investment was the result of a $2.3 million gain recorded 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 loss. As of March 31, 2026, Elo is no longer classified as an equity method investment. There were no changes to the investment value for the three months ended March 31, 2026 and any subsequent changes in the investment’s fair value will be recorded through other fair value adjustments.
Current report
Interest Expense
Current report
Gain (loss) on Disposal of Assets
Current report
The change in cash used in operating assets and liabilities is primarily driven by the net changes of accounts receivable as a result of an outstanding receivable from a legacy ARCUS agriculture gene editing collaboration agreement during the three months ended March 31, 2026 as well as the net changes in prepaid expenses year over year, partially offset by the net changes in other liabilities and other current liabilities year over year.
Removed paragraphs (35)
Previous report
We are leveraging our proprietary ARCUS genome editing platform to advancein vivo gene editing programs that go beyond gene knockouts in the liver and carry out more sophisticated edits such as gene insertions, gene excision, and gene elimination, unlocking a broader potential for ARCUSin vivo gene editing in human therapeutics.
Previous 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.
Previous 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.
Previous report
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 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.
Previous report
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 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.
Previous report
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 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.
Previous 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).
Previous 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.
Previous report
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 report
As part of the consideration received in connection to the development and license agreement with iECURE, we entered into an equity issuance agreement with iECURE (the “iECURE Equity Agreement”), pursuant which iECURE issued us common stock in iECURE.
Previous report
The change in fair value of warrant liability represents the mark-to-market fair value adjustments to the outstanding warrants issued in connection with an underwriting agreement in March 2024 relating to a public offering of (i) 2,500,000 shares of our common stock, par value $0.000005 per share, and (ii) warrants to purchase up to an aggregate of 2,500,000 shares of our common stock (the “March 2024 Public Offering”).
Previous report
Gain on Disposal of Assets
Previous report
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 report
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 report
Loss from Equity Method Investment
Previous report
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 report
Gain on Disposal of Assets
Previous report
Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024
Previous report
Revenue
Previous report
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 report
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 report
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 report
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 report
Gain (Loss) from Equity Method Investment
Previous report
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 report
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 report
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 report
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 report
Loss on Disposal of Assets
Previous report
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 report
Our sources of funding to finance our cash needs include proceeds from third parties through a combination of financings including our initial public offering (“IPO”), preferred stock and convertible note financings, underwritten offerings of our common stock and warrants, at-the-market (“ATM”) offerings of our common stock as part of our shelf registration statement, upfront and milestone payments from partners, borrowings under bank facilities and funding from other strategic alliances and grants.
Previous report
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.
Reworded paragraphs (31)
Previous 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.
Current wording
PBGENE-DMD is our wholly-owned development program for the treatment of Duchenne muscular dystrophy, or DMD. PBGENE-DMD is designed to potentially improve function for approximately 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 microdystrophin approaches with minimal functional benefit.
Previous wording
PBGENE-3243 is a potential treatment for m.3243 associated mitochondrial disease that is designed to specifically target and eliminate mutant m.3243G mitochondrial DNA (“mtDNA”), thereby eliminating the root cause of the disease. We have paused development of PBGENE-3243 to prioritize our two lead programs, PBGENE-HBV and PBGENE-DMD.
Current wording
PBGENE-3243 is a potential treatment for m.3243 associated mitochondrial disease that is designed to specifically target and eliminate mutant m.3243G mitochondrial DNA, thereby eliminating the root cause of the disease. We have paused development of PBGENE-3243 to prioritize our two lead programs, PBGENE-HBV and PBGENE-DMD.
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.
Current wording
Partnered In Vivo Gene Editing Program
Previous wording
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales in the foreseeable future. We record revenue from collaboration and license agreements, including amounts related to upfront payments, milestone payments, fees for licenses of our intellectual property, and research and development funding.
Current wording
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales in the foreseeable future. We record revenue from collaboration agreements, including amounts related to upfront payments, milestone payments, fees for licenses of our intellectual property and research and development funding.
Previous wording
Research and development activities are central to our business model. While we expect our costs to decrease in the short-term for 2026 and 2027 as a result of our cost reduction initiatives, we expect that our research and development expenses will increase over the long term and will comprise a larger percentage of our total expenses as we progress development of our product candidates.
Current wording
Research and development activities are central to our business model. We expect that our research and development expenses will increase over the long term and will comprise a larger percentage of our total expenses as we progress development of our product candidates.
Previous wording
The change in other fair value adjustments represents the assessed changes in fair value of assets and liabilities carried at fair value.
Current wording
The change in fair value represents the assessed changes in assets and liabilities carried at fair value.
Previous wording
We adjust the carrying value of the iECURE investment under the iECURE Equity Agreement to its fair value each reporting period with any changes in fair value recorded to other (expense) income.
Current wording
We adjust the carrying value of the ordinary shares issued from Imugene to its fair value each reporting period with any changes in fair value recorded to other income (expense). We adjust the carrying value of the iECURE investment under the iECURE Equity Agreement to its fair value each reporting period with any changes in fair value recorded to other (expense) income.
Previous wording
Interest income consists of interest income earned on our cash and cash equivalents and note receivable from Elo.
Current wording
Interest income consists of interest income earned on our cash and cash equivalents.
Previous 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.
Current wording
Gain (loss) 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
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.
Current wording
Research and development expenses for the three months ended March 31, 2026 were $13.1 million, compared to $13.6 million for the three months ended March 31, 2025. The decrease of $0.5 million was primarily due to a $2.3 million decrease in platform development and early-stage research expenses, partially offset by a $1.8 million increase in our direct expenses in PBGENE-DMD and PBGENE-HBV.
Previous wording
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 wording
General and administrative expenses were $6.8 million for the three months ended March 31, 2026, compared to $8.6 million for the three months ended March 31, 2025. The decrease of approximately $1.8 million was primarily due to a $1.6 million decrease in employee-related costs.
Previous 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.
Current wording
Loss on changes in other fair value adjustments was $3.0 million for the three months ended March 31, 2026, which is attributable to the decrease in fair value on the ordinary shares held for Imugene Limited. Gain on changes in other fair value adjustments was less than $0.1 million for the three months ended March 31, 2025, which was primarily attributable to the increase in fair value on the ordinary shares held for Imugene Limited.
Previous wording
(Loss) Gain on Change in Fair Value of Warrant Liability
Current wording
Loss on Change in Fair Value of Warrant Liability
Previous 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.
Current wording
The non-cash loss from change in fair value of the warrant liability was $7.1 million for the three months ended March 31, 2026 compared to a non-cash loss of $0.8 million for the three months ended March 31, 2025, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering.
Previous 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.
Current wording
Interest expense was $0.3 million for the three months ended March 31, 2026 compared to $0.4 million for the three months ended March 31, 2025 primarily driven by declining interest rates on the 2024 Term Loan over the comparison period.
Previous 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.
Current wording
Interest income was $1.0 million during the three months ended March 31, 2026 compared to $1.3 million during the three months ended March 31, 2025. The decrease of approximately $0.3 million was primarily driven by the Elo note receivable interest accrued for in the prior year as well as declining interest rates which was partially offset by a higher cash balance for the current period.
Previous 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.
Current wording
Gain on disposal of assets was less than $0.1 million during the three months ended March 31, 2026 compared to the loss on disposal of assets of less than $0.1 million during the three months ended March 31, 2025.
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 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.
Current wording
We have incurred significant operating losses since our inception 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 March 31, 2026, we had an accumulated deficit of $546.6 million.
Previous 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.
Current wording
As of March 31, 2026, we had cash and cash equivalents of $99.4 million and $26.5 million in restricted cash under the 2024 Term Loan and compensatory arrangements with certain of our officers, respectively. Refer to Note 4, Commitments and Contingencies, in the accompanying notes to the financial statements for more information on these compensatory arrangements. Pursuant to our July 31, 2024 amended and restated loan and security agreement with Banc of California (the “2024 Loan and Security Agreement”), 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
We believe that, as of the date of this Quarterly Report on Form 10-Q, existing cash and cash equivalents, expected operational receipts, including potential near-term consideration to be received from licensees, operational efficiencies gained from divestment of our historical CAR T operations, and availability of our ATM facility will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2027. We expect our cash runway to be sufficient to enable potential commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal study for PBGENE-DMD pending supportive Phase 1 data readouts. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of current global macroeconomic conditions. If we are unable to obtain sufficient financing on a timely basis or on favorable terms, we may be required to significantly delay, alter reduce or eliminate one or more of our research or product development programs and/or commercialization efforts, or to grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. We may also be otherwise unable to execute our business plan or growth strategy, or capitalize on business opportunities as desired. Any of these events could materially adversely affect our financial condition and business prospects. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
Current wording
As described in Part II. Item 1A. “Risk Factors,” we believe that, as of the date of this Quarterly Report on Form 10-Q, existing cash and cash equivalents, continued fiscal and operating discipline, and availability of our at-the-market (“ATM”) facility will be sufficient to fund our operating expenses and capital expenditure requirements through 2028. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of current global macroeconomic conditions. If we are unable to obtain sufficient financing on a timely basis or on favorable terms, we may be required to significantly delay, alter reduce or eliminate one or more of our research or product development programs and/or commercialization efforts, or to grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. We may also be otherwise unable to execute our business plan or growth strategy, or capitalize on business opportunities as desired. Any of these events could materially adversely affect our financial condition and business prospects.
Previous 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.
Current wording
Our cash, cash equivalents, and restricted cash totaled $125.8 million and $99.8 million as of March 31, 2026 and March 31, 2025, respectively.
Previous 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.
Current wording
Cash used in operating activities during the three months ended March 31, 2026 was $11.9 million compared to $19.1 million during the three months ended March 31, 2025. The $7.1 million decrease in cash used in operating activities was primarily driven by a $2.1 million decrease in net loss and an increase of $9.6 million in non-cash adjustments, partially offset by $4.6 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 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.
Current wording
The increase in non-cash adjustments was primarily driven by the net change in fair value of warrants during the three months ended March 31, 2026 compared to during the three months ended March 31, 2025. Also contributing to the increase in non-cash adjustments was the change in fair value of the Imugene ordinary shares during the three months ended March 31, 2026.
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 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.
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 three months ended March 31, 2026 was $0.1 million, compared to $0.3 million used in investing activities in the three months ended March 31, 2025. The decrease in cash used in investing activities was primarily the result of a $0.2 million decrease in intangible asset purchases during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.
Previous 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.
Current wording
Net cash provided by financing activities during the three months ended March 31, 2026 was $0.7 million, compared to $10.7 million during the three months ended March 31, 2025. The $9.9 million decrease in cash provided by financing activities during the three months ended March 31, 2026 was primarily due to $9.5 million in net proceeds from the issuance of common stock through the Company's ATM facility during the three months ended March 31, 2025, whereas there were no proceeds from the issuance of common stock through the Company's ATM facility during the three months ended March 31, 2026.
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 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%.
Current wording
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 March 31, 2026, the outstanding principal balance on the 2024 Term Loan was $22.5 million, the stated interest rate was 5.25% and the effective interest rate was 5.62%.
Previous wording
Under the terms of the 2024 Loan and Security Agreement, we granted Banc of California a security interest in a cash security account at Banc of California (the “Cash Security Account”), and Banc of California agreed to terminate all other security interests it had in our assets. We are required to maintain an aggregate unencumbered balance in the Cash Security Account at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Current wording
Under the terms of the 2024 Loan and Security Agreement, we granted Banc of California a security interest in a cash security account at Banc of California (the “Cash Security Account”). We are required to maintain an aggregate unencumbered balance in the Cash Security Account at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Previous wording
•the progress, costs and results of our additional research and preclinical development programs including ourin vivo pipeline and our planned IND or CTA submissions and potential biologics license application (“BLA”) submissions;
Current wording
•the progress, costs and results of our additional research and preclinical development programs including ourin vivo pipeline and our planned IND or CTA submissions and potential BLA submissions;
Previous wording
In March 2024, we entered into an underwriting agreement relating to the offering, issuance and sale of an aggregate of 2,500,000 shares of our common stock and warrants to purchase up to an aggregate of 2,500,000 shares of our common stock at a combined offering price of $16.00 per share. Each warrant has an exercise price per share of $20.00, is immediately exercisable and will expire on March 5, 2029. The offering was made pursuant to a registration statement on Form S-3.
Current wording
In November 2025, we entered into an underwriting agreement relating to the offering, issuance and sale of an aggregate of 10,815,000 shares of our common stock and accompanying one-half warrants to purchase up to an aggregate of 5,407,500 shares of our common stock at a combined offering price of $6.14 per share. Additionally, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 1,400,000 shares of common stock and accompanying one-half warrants to purchase up to 700,000 shares of common stock at a combined offering price of $6.139995. Each whole warrant has a five year term and an exercise price of $7.25 per share. The offering was made pursuant to a registration statement on Form S-3. Gross proceeds from the transaction were $75.0 million before deducting underwriting discounts and commissions and offering expenses of approximately $5.0 million. We intend to use the net proceeds of the offering to fund ongoing and planned research and development, and for working capital and other general corporate purposes.
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. 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.
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, the 2024 Term Loan, 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. 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, 2025.
Previous wording
Our critical accounting policies and estimates are described in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K. We have reviewed those critical accounting policies and estimates for the nine months ended September 30, 2025. There have been no significant changes in our critical accounting policies and estimates from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Current wording
Our critical accounting policies and estimates are described in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K. We have reviewed those critical accounting policies and estimates for the three months ended March 31, 2026. There have been no significant changes in our critical accounting policies and estimates from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
We believe that, as of the date of this Quarterly Report on Form 10-Q, existing cash and cash equivalents, continued fiscal and operating discipline, and availability of our ATM facility will be sufficient to fund our operating expenses, including our PBGENE-HBV and PBGENE-DMD data milestones, and capital expenditure requirements through 2028. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
(Loss) Gain on Changes in Other Fair Value Adjustments
Previous report — wording carried elsewhere
(Loss) Gain on Change in Fair Value of Warrant Liability
Previous report — wording carried elsewhere
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.