Inhibrx Biosciences, Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
View on SEC.govAbout this filing
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 14, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0002007919-25-000093
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0002007919-26-000027
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 165 previous paragraphs and 139 current paragraphs.
98 unchanged; 26 reworded; 15 added; 38 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 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 (15)
Current report
In April 2026, we announced interim data from the Phase 1/2 study evaluating ozekibart in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer, or CRC. Efficacy was assessed in 45 evaluable patients as of April 10, 2026, the cutoff date, and resulted in an ORR of 20% per RECIST v1.1 criteria. Historically, the current standard of care has yielded limited response rates (ORR of 1-6% per RECIST v1.1 criteria). Nearly half of responses were durable with a duration of response exceeding 6 months. Responses were observed irrespective of RAS/RAF mutation status. The median progression-free survival, or PFS, for the evaluable population was 5.5 months. Notably, 42% of patients remained progression-free at the 6-month landmark, with 9 patients remaining on therapy, suggesting that a significant portion of patients achieve durable disease control that extends well beyond the median PFS. The overall disease control rate (partial responses and stable disease as best response) remained robust at 87%, further supporting the potential of ozekibart to control tumor growth in a heavily pre-treated population. Ozekibart in combination with FOLFIRI continues to maintain a manageable safety profile. The most common treatment-related adverse events were diarrhea, fatigue, and nausea, which were largely Grade 1 or 2 and consistent with the known side effects of FOLFIRI. Despite the majority of the patients (68%) presenting with liver metastases at baseline, no significant liver toxicity was observed.
Current report
We plan to meet with the FDA in the second half of 2026 to discuss the potential for an accelerated regulatory pathway for ozekibart in fourth-line colorectal cancer and to discuss plans to initiate a first-line registrational trial in CRC.
Current report
We expect to complete enrollment in the Phase 1/2 trial of ozekibart in combination with IRI/TMZ for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in the second half of 2026. If the current response and duration trends observed continue, we plan to meet with the FDA in the second half of 2026 to discuss the potential for an accelerated regulatory pathway for this indication.
Current report
INBRX-106 is a hexavalent OX40 agonist currently being investigated as a single agent and in combination with KEYTRUDA® (pembrolizumab), a PD-1 blocking checkpoint inhibitor, in patients with locally advanced or metastatic solid tumors. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. INBRX-106 is currently being investigated in combination with KEYTRUDA® in patients with non-small cell lung cancer, or NSCLC, head and neck squamous cell carcinoma, or HNSCC, among others.
Current report
In May 2026, we announced positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106 in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent HNSCC. The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes. The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.
Current report
The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. We plan to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.
Current report
Based on these promising early results, we aim to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in NSCLC later this quarter. We believe OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. Outside of combination with checkpoint inhibitors, we plan to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.
Current report
Other Income (Expense)
Current report
Research and development expenses decreased by $11.7 million from $36.9 million during the three months ended March 31, 2025 to $25.2 million during the three months ended March 31, 2026. The overall decrease was primarily due to the following factors:
Current report
•contract manufacturing expense decreased by $6.5 million, primarily due to the timing and completion of certain manufacturing activities required to support our clinical trials for ozekibart (INBRX-109) and INBRX-106; and
Current report
G&A expenses were $5.7 million and $6.0 million during the three months ended March 31, 2026 and March 31, 2025, respectively. Expenses remained consistent in each period with a slight decrease in personnel expenses as a result of a decrease in headcount.
Current report
Other income (expense)
Current report
In January 2025, we entered into the 2025 Loan Agreement with Oxford Finance LLC, or Oxford, upon which we received gross proceeds of $100.0 million. On March 18, 2026, we entered into the First Amendment to Loan and Security Agreement with Oxford, or the March 2026 Amendment, or collectively with the 2025 Loan Agreement, the Amended 2025 Loan Agreement. The March 2026 Amendment provided for an additional tranche, or the Term B Loans, in an aggregate principal amount of $75.0 million, upsized from $50.0 million originally available under the 2025 Loan Agreement. Upon closing of the March 2026 Amendment, the Term B Loans were funded and we received gross proceeds of $75.0 million.
Current report
Under the 2025 Loan Agreement, as amended, we are required to make interest only payments through February 2028, with all principal payments and final fee payments beginning in March 2028 and continuing through the maturity date of January 2030. As of March 31, 2026, we have a minimum obligation of $241.7 million of long-term debt, including minimum interest and final fee payments, of which $17.0 million and $224.7 million are current and non-current, respectively. For more information regarding the Amended 2025 Loan Agreement, refer to Note 3 to the condensed consolidated financial statements.
Current report
Our consolidated financial statements and accompanying notes are prepared in accordance with United States generally accepted accounting principles, or GAAP, which requires management to make estimates and assumptions that affect the amounts reported. Management bases its estimates on historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although these estimates are based on management’s best knowledge of current events and actions that may impact us in the future, the estimation process is, by its nature, uncertain given that estimates depend on events over which we may not have control. If market and other conditions change from those that we anticipate, our consolidated financial statements may be materially affected. In addition, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material effect in our consolidated financial statements. We review our estimates, judgments, and assumptions used in our accounting practices periodically and reflect the effects of revisions in the period in which they are deemed to be necessary. We believe that these estimates are reasonable; however, our actual results may differ from these estimates.
Removed paragraphs (38)
Previous report
Separation from Former Parent
Previous report
On May 29, 2024, Inhibrx, Inc., or the Former Parent, effected the spin-off of INBRX-101, an optimized, recombinant alpha-1 antitrypsin, or AAT, augmentation therapy in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency, upon which the Former Parent completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of our common stock, or the Distribution. On May 30, 2024, the Former Parent completed a series of internal restructuring transactions, or the Separation.
Previous report
On May 30, 2024, the Former Parent completed the merger, or the Merger, of Art Acquisition Sub, Inc., a wholly-owned subsidiary of Aventis Inc., or the Acquirer, a wholly-owned subsidiary of Sanofi S.A., or Sanofi, with and into the Former Parent with the Former Parent continuing as the surviving entity. Pursuant to the Merger (i) all assets and liabilities primarily related to INBRX-101, or the 101 Business, were transferred to the Acquirer; and (ii) by way of the Separation, we acquired the assets and liabilities and corporate infrastructure associated with its ongoing programs, INBRX-106 and ozekibart (INBRX-109), and its discovery pipeline, as well as the remaining close-out obligations related to its previously terminated program, INBRX-105. From and after the closing, Inhibrx continues to operate as a stand-alone, publicly traded company focused on ozekibart (INBRX-109) and INBRX-106, both of which are clinical-stage programs.
Previous report
For periods prior to the spin-off, descriptions of historical business activities are presented as if the spin-off had already occurred, and the Former Parent’s activities related to such assets and liabilities had been performed by us. Refer to Note 1 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion of the underlying basis used to prepare the consolidated financial statements. The operating results presented in our historical financial statements prior to the Merger and in connection with the Separation and the Merger may not be indicative of our results following the Merger and Separation.
Previous report
The benefit of ozekibart was consistent across all pre-specified subgroups, including patients with isocitrate dehydrogenase, or IDH, -wild-type and IDH-mutant tumors. Other key secondary endpoints, including disease control rate (54% vs 27.5%), and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart.
Previous report
Ozekibart was generally well tolerated, with a manageable safety profile. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a known risk for this mechanism of action, occurs during the first treatment cycle and is in patients with underlying hepatic impairment. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Over the course of the ChonDRAgon study, this risk was effectively mitigated by excluding patients with severe liver impairment and by implementing close monitoring during early treatment cycles, allowing for prompt management of liver enzyme elevations. This approach resulted in a low overall incidence of treatment-related hepatic adverse events, 11.8% compared to 4.5% in the placebo arm, the majority of which were Grade 1 or 2 in severity.
Previous report
In January 2025, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma, or CRC. Efficacy was assessed in 10 of the 13 patients evaluable as of the cutoff date of December 2, 2024, who received at least one dose of ozekibart, based on RECIST v1.1 criteria. Results demonstrated one complete response, or CR, three partial responses, or PR, and six cases of stable disease, or SD. Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median PFS of 7.85 months. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). Notably, the patient achieving a CR had undergone three prior lines of therapy, and two PRs occurred in patients who had failed prior FOLFIRI-based treatments.
Previous report
Based on the initial results above, we initiated an expansion cohort enrolling 44 patients, as a fourth line of therapy for approximately 70% of patients and as a third line of therapy for approximately 30% of patients. 80% of patients had been previously treated with regimens containing irinotecan. In October 2025, we announced interim results from this expansion cohort. Efficacy, based on RECIST v1.1 criteria, was assessed in 26 evaluable patients as of the cutoff date of October 15, 2025, who had at least one post-baseline scan. The results show a 23% overall response rate, or ORR, and an overall disease control rate of 92%.
Previous report
Ozekibart, in combination with FOLFIRI, was well tolerated. The most common treatment-emergent adverse events included anemia, diarrhea, nausea, and fatigue, with the majority being low-grade and consistent with the known safety profile of FOLFIRI.
Previous report
Ozekibart in combination with IRI/TMZ was well tolerated. The most common adverse events were diarrhea, nausea, anemia, and fatigue, all consistent with the known safety profile of IRI/TMZ.
Previous report
INBRX-106 is a precisely engineered hexavalent sdAb-based therapeutic candidate targeting OX40, designed to be an optimized agonist of this co-stimulatory receptor. It is currently being investigated as a single agent and in combination with Keytruda in patients with locally advanced or metastatic solid tumors. Parts 1 and 3, dose escalation as a single agent and in combination with Keytruda, have been completed. We observed durable responses across multiple tumor types.
Previous report
In Part 4 of the Phase 1/2 trial, we continue to enroll patients with NSCLC in combination with Keytruda. Primary endpoints for this cohort is objective response rate, or ORR, disease control rate, or DCR, duration of response, or DOR, and safety. In addition, the NSCLC cohort evaluating patients dosed with chemotherapy in conjunction with the INBRX-106 and Keytruda combination is ongoing. The primary endpoint for this cohort is safety. We expect to have a more mature dataset on these cohorts during the fourth quarter of 2025 and plan to provide an update at that time.
Previous report
In June 2024, a seamless Phase 2/3 clinical trial was initiated for INBRX-106 in combination with Keytruda as a first-line treatment for patients with local advanced recurrent or metastatic head HNSCC. This trial recruits patients who have not received prior checkpoint inhibitors and whose tumors express a PDL-1 CPS equal to or greater than 20. We plan to enroll approximately 60 patients in the Phase 2 portion with a primary endpoint of ORR supported by secondary endpoints of DOR, PFS, and safety. We expect to announce initial data on Phase 2 during the fourth quarter of 2025. If positive, we anticipate this data will ungate the Phase 3 portion, where we expect approximately 350 patients will be randomized to INBRX-106 or placebo in combination with Keytruda. The co-primary endpoints for the Phase 3 portion of the study will be PFS and overall survival.
Previous report
Gain related to transaction with Acquirer. Gain related to transaction with Acquirer consists of our gain recorded in connection with the completion of the Merger during the second quarter of 2024. We do not expect future income or gains in connection with the Merger in future periods.
Previous report
Research and development expenses decreased by $10.4 million from $38.9 million during the three months ended September 30, 2024 to $28.5 million during the three months ended September 30, 2025. The overall decrease was primarily due to the following factors:
Previous report
•clinical trial expense increased by $0.2 million as a result of increased expenses related to our ongoing trials for ozekibart (INBRX-109) and INBRX-106, which were offset in part by decreased expenses following the termination of our INBRX-105 program during 2024;
Previous report
•contract manufacturing expense decreased by $8.5 million, primarily due to significant expenses incurred for Phase 2 process development and manufacturing activities performed by one of our CDMO partners for our ozekibart (INBRX-109) program during the three months ended September 30, 2024;
Previous report
•other research and development expenses decreased by $0.7 million, which was primarily attributable to a decrease in certain non-recurring sponsored research and preclinical activities, as well as a decrease in purchases of lab supplies following the decrease in headcount during the three months ended September 30, 2025.
Previous report
G&A expenses decreased by $2.6 million from $7.9 million during the three months ended September 30, 2024 to $5.3 million during the three months ended September 30, 2025. The overall decrease was primarily due to the following factors:
Previous report
•professional services-related expenses related to legal services decreased by $1.9 million, primarily attributable to the conclusion of legal proceedings; and
Previous report
•personnel-related expenses decreased by $0.5 million due to a decrease in headcount during the three months ended September 30, 2025.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024
Previous report
License Fee Revenue
Previous report
License fee revenue during the nine months ended September 30, 2025 was $1.3 million and consisted of revenue related to the Scithera License Agreement which we recognized following the completion of the transfer of all licenses, related materials, and know-how. License fee revenue during the nine months ended September 30, 2024 was $0.1 million and consisted of revenue related to the 2020 Regeneron Agreement which we recognized following the grant of a six-month extension of the option term.
Previous report
Research and Development Expense
Previous report
Research and development expenses decreased by $82.7 million from $170.4 million during the nine months ended September 30, 2024 to $87.7 million during the nine months ended September 30, 2025. The overall decrease was primarily due to the following factors:
Previous report
•contract manufacturing expense decreased by $32.6 million primarily due to a decrease in expenses in the current period following the purchase of raw materials for our drug substance manufacturing and Phase 2 process development and manufacturing activities with one of our CDMO partners for our ozekibart (INBRX-109) program during the nine months ended September 30, 2024, as well as decreased expenses following the spin-off of our INBRX-101 program, which occurred during the second quarter of 2024;
Previous report
•personnel-related expense decreased by $35.7 million, which was primarily related to $25.9 million in stock option expense recognized during the nine months ended September 30, 2024 upon the acceleration of outstanding options in connection with the close of the Merger, in addition to a decrease in headcount during the nine months ended September 30, 2025; and
Previous report
•other research and development expenses decreased by $4.7 million, which was primarily attributable to a decrease in certain non-recurring sponsored research and preclinical activities, as well as a decrease in purchases of lab supplies and travel expenses following the decrease in headcount during the nine months ended September 30, 2025.
Previous report
G&A Expense
Previous report
G&A expenses decreased by $93.5 million from $111.2 million during the nine months ended September 30, 2024 to $17.7 million during the nine months ended September 30, 2025. The overall decrease during the nine months ended September 30, 2025, was primarily due to the following factors:
Previous report
•expenses related to the Merger of $68.1 million, consisting of legal, advisory, and consulting services performed in connection to the transaction, and SEC filing fees in connection with filings related to the transaction during the nine months ended September 30, 2024;
Previous report
•personnel-related expenses decreased by $18.5 million, which was primarily related to $15.2 million in stock option expense recognized during the nine months ended September 30, 2024 upon the acceleration of outstanding options in connection with the close of the Merger, in addition to a decrease in headcount during the nine months ended September 30, 2025; and
Previous report
•professional services-related expenses related to legal services, which decreased by $3.9 million, primarily attributable to the conclusion of legal proceedings.
Previous report
Gain related to transaction with Acquirer. During the nine months ended September 30, 2024, we earned $2.0 billion of other income, consisting of gains recorded in connection with the completion of the Merger. We recorded a gain of $1.7 billion related to Merger consideration for our outstanding common stock, warrants, and stock options, in addition to $211.3 million related to the extinguishment of our Amended 2020 Loan Agreement assumed by the Acquirer. In addition to the Acquirer assuming our outstanding debt, the Acquirer assumed outstanding assets and liabilities related to INBRX-101 upon the transaction, resulting in a gain of $14.5 million. The Acquirer also reimbursed us for or paid on our behalf $68.0 million of transaction costs related to the Merger, resulting in a gain. We did not earn income or gains in connection with the Merger during the nine months ended September 30, 2025 and do not expect to in future periods.
Previous report
Interest expense. Interest expense was $9.0 million during the nine months ended September 30, 2025, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, under which we had $100.0 million in outstanding principal during the period. Interest expense was $13.5 million during the nine months ended September 30, 2024, all of which related to interest incurred and the amortization of debt discounts related to the Amended 2020 Loan Agreement, under which we had $200.0 million in outstanding principal during the period prior to its extinguishment upon the Merger.
Previous report
In January 2025, we entered into the 2025 Loan Agreement, upon which we received gross proceeds of $100.0 million. The 2025 Loan Agreement provides for up to an additional $50.0 million to be funded upon our request and at Oxford’s sole discretion.
Previous report
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Changes in estimates are reflected in reported results for the period in which they become known. Actual results could differ significantly from the estimates made by our management.
Reworded paragraphs (26)
Previous wording
Our current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize our multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function:
Current wording
Our current clinical pipeline of therapeutic candidates includes ozekibart and INBRX-106, both of which utilize our multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function:
Previous wording
Currently being investigated in chondrosarcoma, colorectal cancer, Ewing sarcoma, and certain other solid tumor types.
Current wording
Currently being investigated in chondrosarcoma, Ewing sarcoma, colorectal cancer, and certain other solid tumor types.
Previous wording
** Currently being investigated in patients with non-small cell lung cancer, or NSCLC, and head and neck squamous cell carcinoma, or HNSCC.
Current wording
** Currently being investigated in patients with non-small cell lung cancer, or NSCLC, head and neck squamous cell carcinoma, or HNSCC, among others.
Previous wording
Ozekibart (INBRX-109) is a tetravalent death receptor 5, or DR5, agonist currently being evaluated in patients diagnosed with chondrosarcoma, colorectal cancer, and Ewing sarcoma.
Current wording
Ozekibart is a precisely engineered tetravalent death receptor 5, or DR5, agonist currently being evaluated in patients diagnosed with colorectal cancer, Ewing sarcoma, chondrosarcoma, and certain other solid tumor types.
Previous wording
In November 2023, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart (INBRX-109) in combination with Irinotecan, or IRI, and Temozolomide, or TMZ, for the treatment of advanced or metastatic, unresectable Ewing sarcoma. Four of the 13 evaluable patients at that time had prior IRI exposure, including two out of the four responses. ozekibart (INBRX-109) in combination with IRI/TMZ was well tolerated from a safety perspective.
Current wording
In November 2023, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart in combination with Irinotecan, or IRI, and Temozolomide, or TMZ, for the treatment of advanced or metastatic, unresectable Ewing sarcoma. Overall, ozekibart in combination with IRI/TMZ was well tolerated from a safety perspective.
Previous wording
Based on this preliminary data, the ongoing Phase 1/2 trial in the Ewing sarcoma cohort was expanded with an expectation of enrolling up to 50 patients. In October 2025, we announced interim results from this expansion cohort. Of the 33 patients recruited to date, more than half were third or fourth line patients. Among the 25 evaluable patients based on the cutoff date of October 15, 2025, we observed a 64% ORR, and a disease control rate of 92%, with the majority of patients experiencing measurable tumor reduction.
Current wording
Based on this preliminary data, the ongoing Phase 1/2 trial in the Ewing sarcoma cohort was expanded to enroll up to an additional 50 patients. In March 2026, we provided an update at the European Society for Medical Oncology (ESMO) Sarcoma and Rare Cancers Congress. Of the 31 patients evaluable based on a cutoff date of January 15, 2026, we observed a 64.5% ORR and a disease control rate of 87.1%. At the time of the presentation, responses were ongoing in eight patients, one of which had been on treatment and progression free for more than two years.
Previous wording
In June 2021, based on the initial Phase 1 data results, we initiated a registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma for which the United States Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, granted orphan drug designation in November 2021 and August 2022, respectively. The primary endpoint for this Phase 2 trial was progression-free survival, or PFS. This trial completed full enrollment in July 2025 and in October 2025, we announced the study met its primary endpoint of a statistically significant and clinically meaningful median PFS for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo.
Current wording
In June 2021, we initiated a randomized, blinded, placebo-controlled, registrational trial in patients with metastatic, unresectable conventional chondrosarcoma, which enrolled over 200 patients in total at 68 different sites worldwide and for which the United States Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, granted orphan drug designation for the treatment of chondrosarcoma in November 2021 and August 2022, respectively. The primary endpoint for this trial is PFS.
Previous wording
Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.
Current wording
In October 2025, we announced this trial met its primary endpoint of a statistically significant and clinically meaningful median PFS for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.
Previous wording
We plan to submit to the FDA a biologics license application in the second quarter of 2026.
Current wording
We submitted a biologics license application to the FDA in April 2026 for the potential approval of ozekibart in conventional chondrosarcoma.
Previous wording
•salaries, benefits and other related costs, including non-cash stock-based compensation under the former Amended and Restated 2017 Employee, Director and Consultant Equity Incentive Plan, or the 2017 Plan, and the 2024 Omnibus Incentive Plan, or the 2024 Plan, for personnel engaged in research and development functions;
Current wording
•salaries, benefits and other related costs, including non-cash stock-based compensation under the 2024 Omnibus Incentive Plan, or the 2024 Plan, for personnel engaged in research and development functions;
Previous wording
•salaries, benefits and other related costs, including non-cash stock-based compensation under the former 2017 Plan and 2024 Plan, for personnel engaged in G&A functions;
Current wording
•salaries, benefits and other related costs, including non-cash stock-based compensation under the 2024 Plan, for personnel engaged in G&A functions;
Previous wording
Interest expense. Interest expense consists of interest on our 2025 Loan Agreement with Oxford during the three and nine months ended September 30, 2025 and on our former loans with Oxford incurred prior to the Merger in 2024, upon which the outstanding debt was assumed by the Acquirer.
Current wording
Interest expense. Interest expense consists of interest on our Amended 2025 Loan Agreement with Oxford Finance LLC and other lenders, or collectively, Oxford.
Previous wording
•clinical trial expense decreased by $10.1 million, primarily due to decreased expenses following the spin-off of our INBRX-101 program, which occurred during the second quarter of 2024, and the termination of our INBRX-105 program during 2024, in addition to decreases in expenses in our registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment ahead of our data readout. These decreases in expenses were offset in part by increases in our ongoing trials for INBRX-106, in which we opened additional sites and increased enrollment during the period;
Current wording
•clinical trial expense decreased by $4.1 million, primarily due to decreases in expenses associated with ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment;
Previous wording
•personnel-related expense decreased by $1.2 million due to a decrease in headcount during the three months ended September 30, 2025; and
Current wording
•personnel-related expense decreased by $0.8 million, which was primarily related to a decrease in headcount.
Previous wording
Interest expense. Interest expense was $3.2 million during the three months ended September 30, 2025, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, under which we had $100.0 million in outstanding principal during the period. We did not incur any interest during the three months ended September 30, 2024 following the extinguishment of our outstanding debt in connection with the Merger.
Current wording
Interest expense. Interest expense was $3.5 million and $2.7 million during the three months ended March 31, 2026 and March 31, 2025, respectively, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, as amended. $100.0 million was outstanding in principal during each period through the date of the March 2026 Amendment, upon which we received an additional $75.0 million in principal.
Previous wording
Interest income. During the three months ended September 30, 2025 and September 30, 2024, we earned $1.8 million and $2.9 million of interest income related to interest earned on our sweep and money market account balances, respectively.
Current wording
Interest income. During the three months ended March 31, 2026 and March 31, 2025, we earned $1.0 million and $2.3 million, respectively, of interest income related to interest earned on our sweep and money market account balances.
Previous wording
Since our inception, we have devoted substantially all of our efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of our therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing our intellectual property portfolio, and raising capital to support and expand these activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. Our net income or losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities, as well as the timing of other corporate transactions. During the nine months ended September 30, 2025 our net loss was $107.2 million. As of September 30, 2025, we had an accumulated deficit of $213.4 million and cash and cash equivalents of $153.1 million.
Current wording
Since our inception, we have devoted substantially all of our efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of our therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing our intellectual property portfolio, and raising capital to support and expand these activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. Our net income or losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities, as well as the timing of other corporate transactions. During the three months ended March 31, 2026 our net loss was $33.4 million. As of March 31, 2026, we had an accumulated deficit of $279.6 million and cash and cash equivalents of $161.7 million.
Previous wording
The process of conducting preclinical studies and testing therapeutic candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. We expect to continue to incur net losses for the foreseeable future until, if ever, we have an approved product and can successfully commercialize it. We expect our research and development expenses to increase as we continue our development of, and seek marketing approvals for, our therapeutic candidates (especially as we move more candidates into later stages of clinical development), and begin to commercialize any approved products, if ever. At this time, we are preparing to proceed with the commercialization of certain of our therapeutic candidates, if ever approved. As a result, we will incur significant pre-commercialization expenses in preparation for launch, the outcome of which is uncertain. Additionally, if approved and if we choose to commercialize, we would incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution.
Current wording
The process of conducting preclinical studies and testing therapeutic candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. We expect to continue to incur net losses for the foreseeable future until, if ever, we have an approved product and can successfully commercialize it. We expect our research and development expenses to increase as we continue our development of, and seek marketing approvals for, our therapeutic candidates (especially as we move more candidates into later stages of clinical development), and begin to commercialize any approved products, if ever. At this time, we are preparing to proceed with the commercialization of certain of our therapeutic candidates, if ever approved. As a result, we will incur significant pre-commercialization expenses in preparation for launch, the outcome of which is uncertain. Additionally, if approved, we will incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution.
Previous wording
Our material cash requirements from known contractual and other obligations primarily relate to our lease obligations and services provided by our third party CROs and CDMOs.
Current wording
Our material cash requirements from known contractual and other obligations primarily relate to our lease obligations, debt, and services provided by our third party CROs and CDMOs.
Previous wording
Our lease for our laboratory and office space expires in 2028, with an option to extend for an additional three years. As of September 30, 2025, we had future minimum rental payments under these leases of $8.0 million, of which $2.8 million and $5.2 million are current and non-current, respectively. For more information regarding these lease agreements, refer to Note 8 to the unaudited condensed consolidated financial statements.
Current wording
Our lease for our laboratory and office space expires in 2028, with an option to extend for an additional three years. As of March 31, 2026, we had future minimum rental payments under these leases of $6.6 million, of which $2.9 million and $3.7 million are current and non-current, respectively. For more information regarding these lease agreements, refer to Note 6 to the unaudited condensed consolidated financial statements.
Previous wording
We enter into contracts in the normal course of business with CROs related to our ongoing preclinical studies and clinical trials and with CDMOs for clinical supplies and manufacturing scale-up activities. These contracts are generally cancellable, with notice, at our option. We have recorded accrued expenses of approximately $20.4 million in our condensed consolidated balance sheets for expenditures incurred by CROs and CDMOs as of September 30, 2025.
Current wording
We enter into contracts in the normal course of business with CROs related to our ongoing preclinical studies and clinical trials and with CDMOs for clinical supplies and manufacturing scale-up activities. These contracts are generally cancellable, with notice, at our option. We have recorded accrued expenses of approximately $11.0 million in our condensed consolidated balance sheets for expenditures incurred by CROs and CDMOs as of March 31, 2026.
Previous wording
While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments. Depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from the cost of work performed to date up to twelve months of future committed manufacturing costs. As of September 30, 2025, the noncancellable portion of these contracts totaled in aggregate, excluding amounts recorded in accounts payable and accrued expenses as of this date, approximately $12.6 million. The noncancellable purchase commitments relate to future contract manufacturing of drug supply for one of our therapeutic candidates.
Current wording
While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments. Depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from the cost of work performed to date up to twelve months of future committed manufacturing costs. As of March 31, 2026, the noncancellable portion of these contracts totaled in aggregate, excluding amounts recorded in accounts payable and accrued expenses as of this date, approximately $15.8 million. The noncancellable purchase commitments relate to future contract manufacturing of drug supply for one of our therapeutic candidates.
Previous wording
Net cash used in operating activities was $150.7 million during the nine months ended September 30, 2024 and consisted primarily of a net income of $1.7 billion, adjusted for non-cash items. Non-cash adjustments primarily relate to gains recorded upon the Merger of $2.0 billion. Other non-cash adjustments include accretion on our debt discount and the non-cash portion of interest expense related to our debt of $2.1 million, stock-based compensation expense of $55.5 million, depreciation and amortization of $1.6 million and non-cash lease expense of $1.4 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, primarily related to an increase in other non-current assets of $3.5 million due to prepayments and additional deposits we made to our CRO partners during the period. Additionally, the operating lease liability decreased by $1.3 million as a result of lease payments made throughout the period. These uses of cash were offset by increases in accrued expenses and other current liabilities of $35.9 million and an increase in accounts payable of $21.0 million due to the timing of payments to our CRO and CDMO partners during the period, each of which excludes the liabilities related to INBRX-101 which were assumed by the Acquirer in the Merger.
Current wording
Net cash used in operating activities was $38.0 million during the three months ended March 31, 2026 and consisted primarily of a net loss of $33.4 million, adjusted for non-cash items, including accretion on our debt discount and the non-cash portion of interest expense related to our debt of $0.7 million, stock-based compensation expense of $2.7 million, depreciation and amortization of $0.5 million and non-cash lease expense of $0.5 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, including the decrease in operating lease liability of $0.5 million as a result of lease payments made throughout the period, and an increase in prepaid expenses and other current assets of $1.1 million and a decrease in accrued expenses of $10.2 million due to the timing of payments to our CRO and CDMO partners during the period. These uses of cash were offset in part by an increase in accounts payables of $2.8 million during the period.
Previous wording
Net cash used in operating activities was $99.7 million during the nine months ended September 30, 2025 and consisted primarily of a net loss of $107.2 million, adjusted for non-cash items, including accretion on our debt discount and the non-cash portion of interest expense related to our debt of $1.8 million, stock-based compensation expense of $8.4 million, depreciation and amortization of $1.9 million, and non-cash lease expense of $1.3 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, including the decrease in operating lease liability of $1.1 million as a result of lease payments made throughout the period, an increase in accounts receivables and other receivables of $0.4 million, and decreases in accounts payable of $2.5 million and accrued expenses of $2.9 million due to the timing of payments to our CRO and CDMO partners during the period. These uses of cash were offset in part by a decrease in prepaid expenses and other current assets of $1.0 million as a result of the timing of payments to our CRO and CDMO partners during the period.
Current wording
Net cash used in operating activities was $35.9 million during the three months ended March 31, 2025 and consisted primarily of a net loss of $43.3 million, adjusted for non-cash items, including accretion on our debt discount and the non-cash portion of interest expense related to our debt of $0.5 million, stock-based compensation expense of $2.5 million, depreciation and amortization of $0.7 million and non-cash lease expense of $0.4 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, including the decrease in operating lease liability of $0.2 million as a result of lease payments made throughout the period and the decrease in accounts payable of $0.4 million. These uses of cash were offset by a decrease in accounts receivable of $0.2 million upon the collection of balances during the period, a decrease in prepaid expenses and other current assets of $0.7 million and an increase in accrued expenses of $2.9 million due to the timing of payments to our CRO and CDMO partners during the period.
Previous wording
Net cash used in investing activities was $28,000 and $2.6 million during the nine months ended September 30, 2025 and September 30, 2024, respectively, and was related to capital purchases of software and laboratory equipment.
Current wording
Net cash used in investing activities was approximately $21,000 during the three months ended March 31, 2025, and was related to capital purchases of software and laboratory equipment. We did not use any cash in investing activities during the three months ended March 31, 2026.
Previous wording
Net cash provided by financing activities was $100.2 million during the nine months ended September 30, 2025, which consisted primarily of net proceeds of $99.8 million from the 2025 Loan Agreement which we entered into in January 2025, in addition to $0.4 million from the proceeds from the exercise of stock options. Net cash provided by financing activities was $71.7 million during the nine months ended September 30, 2024, which consisted of proceeds from the exercise of stock options.
Current wording
Net cash provided by financing activities was $75.5 million during the three months ended March 31, 2026, which consisted primarily of net proceeds from the March 2026 Amendment from which we received $75.0 million in gross proceeds during March 2026, and $0.5 million in proceeds from the exercise of stock options. Net cash provided by financing activities was $99.8 million during the three months ended March 31, 2025, which consisted of net proceeds from the 2025 Loan Agreement which we entered into in January 2025.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The following table summarizes our condensed consolidated results of operations for each of the periods indicated (in thousands, except percentages):
Previous report — wording carried elsewhere
The following table sets forth the primary external and internal research and development expenses (in thousands, except percentages):
Previous report — wording carried elsewhere
Interest income. During the nine months ended September 30, 2025 and September 30, 2024, we earned $6.2 million and $8.9 million, respectively, of interest income related to interest earned on our sweep and money market account balances.