An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Start Date08 Oct 2018

Sponsor / Collaborator

Inhibrx Biosciences, Inc.

100 Clinical Results associated with Ozekibart

100 Translational Medicine associated with Ozekibart

100 Patents (Medical) associated with Ozekibart

Literatures (Medical) associated with Ozekibart

01 Apr 2025·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Recent Advances in Succinate Dehydrogenase Deficient Gastrointestinal Stromal Tumor Systemic Therapies

Review

Author: Van Galen, Joseph ; Dedousis, Demitrios ; Gadra, Elyse ; von Mehren, Margaret

OPINION STATEMENT:

Gastrointestinal stromal tumors (GIST) are the most common gastrointestinal soft tissue sarcomas, with an incidence of about 15 cases per million person-years. Approximately 15% of GIST develop due to succinate dehydrogenase deficiency (SDH-Def), and such tumors do not respond well to the tyrosine kinase inhibitors (TKIs) used to treat other GIST. Due to its indolent nature SDH-Def GIST can often be surveilled if asymptomatic. In our current practice we typically treat advanced symptomatic SDH-Def GIST with the anti-angiogenic TKIs, sequentially treating with sunitinib, regorafenib and pazopanib. This practice is based on limited data. This systematic review provides an update on new data (12/21/2021 to 9/26/2024) for systemic treatment of SDH-Def GIST, both with agents generally used to treat other GIST subtypes and with agents approved in other malignancies. Olverembatinib and rogaratinib have shown promising activity in pre-clinical models and small SDH-Def GIST cohorts. Other agents whose benefits are explored here include the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab and temozolomide, whether as monotherapy or in combination with INBRX-109 (a pro-apoptotic antibody) or olaparib. Additional research into TKI agents with anti-vascular endothelial growth factor receptor (VEGFR) and anti-fibroblast growth factor receptor (FGFR) activity in this clinical setting is needed. Patients with SDH-Def will benefit more broadly from ongoing explorations of treatments with alternative mechanisms of action, especially those that exploit cellular pathways involved in SDH-Def GIST tumorigenesis.

01 Mar 2025·Oncology and Therapy

Advancing Systemic Therapy in Chondrosarcoma: New Horizons

Article

Author: Duffaud, Florence ; Jones, Robin L ; Li, Ka Hou C ; Gulia, Ashish

The systemic treatment landscape for advanced and metastatic chondrosarcoma, a malignancy with limited responsiveness to conventional therapies, has always been notoriously challenging. While standard chemotherapy offers minimal benefits, certain subtypes, such as mesenchymal and dedifferentiated chondrosarcomas, have shown some response to systemic therapies initially developed for other sarcomas. Investigational strategies are focusing on molecular targets, including mutations in the isocitrate dehydrogenase gene (IDH), signaling pathways, such as hedgehog and death receptor 5 (DR5) and immune modulation. IDH mutations, notably found in conventional and dedifferentiated chondrosarcomas, have prompted the evaluation of IDH inhibitors, which have demonstrated promising efficacy in preclinical and early clinical trials, despite limited data in chondrosarcoma. Additionally, the hedgehog pathway, implicated in chondrosarcoma progression, has been targeted with inhibitors, although clinical translation has shown mixed results. Immunotherapy, including programmed cell death 1 (PD-1) checkpoint inhibitors and chimeric antigen receptor-T (CAR-T) cells, is also being investigated but faces challenges due to the immunosuppressive tumour microenvironment. Among new approaches, DR5 agonists such as INBRX-109 have shown single-agent efficacy, with minimal toxicity, opening possibilities for use in combination therapies to improve outcomes. Given the heterogenous and treatment-resistant nature of chondrosarcoma, we highlight the need for multi-omics and genetic profiling to guide personalized, combination therapies that target multiple carcinogenic pathways. The integration of multi-targeted approaches could enhance efficacy, address tumour heterogeneity, and overcome resistance, presenting a hopeful direction for systemic therapy in this challenging cancer. The investigation of combination regimens with IDH inhibitors, immunotherapy and DR5 agonists hold promise for transforming the management of advanced chondrosarcoma.

Frontiers in Molecular Biosciences

Targeting Death Receptor 5 (DR5) for imaging and treatment of primary bone and soft tissue tumors: an update of the literature

Review

Author: Gerrand, Craig ; Rankin, Kenneth Samora ; Gamie, Zakareya ; Krippner-Heidenreich, Anja

Background:

Death Receptor 5 (DR5) is expressed on the surface of primary bone and soft tissue sarcoma cells, and its activation induces cell death primarily through apoptosis. The combination of DR5 agonists and commonly used chemotherapeutic agents, such as doxorubicin, can promote cell death. Currently, clinical trials are investigating the effectiveness of DR5 activation using new biological agents, such as bi-specific or tetravalent antibodies, in improving the survival of patients with relapsed or refractory cancers. Furthermore, investigations continue into the use of novel combination therapies to enhance DR5 response, for example, with inhibitor of apoptosis protein (IAP) antagonist agents [such as the second mitochondria-derived activator of caspase (SMAC) mimetics] and with immune checkpoint inhibitor anti-programmed death-ligand 1 (anti-PD-L1) or anti-programmed cell death-1 (anti-PD-1) antibodies. Other therapies include nanoparticle-mediated delivery of TRAIL plasmid DNA or TRAIL mRNA and stem cells as a vehicle for the targeted delivery of anti-cancer agents, such as TRAIL, to the tumor.

Methods:

scoping review of the literature from November 2017 to March 2024, utilizing PubMed and Google Scholar.

Results:

New agents under investigation include nanoTRAIL, anti-Kv10.1, multimeric IgM, and humanized tetravalent antibodies. Developments have been made to test novel agents, and imaging has been used to detect DR5 in preclinical models and patients. The models include 3D spheroids, genetically modified mouse models, a novel jaw osteosarcoma model, and patient-derived xenograft (PDX) animal models. There are currently two ongoing clinical trials focusing on the activation of DR5, namely, IGM-8444 and INBRX-109, which have progressed to phase 2. Further modifications of TRAIL delivery with fusion to single-chain variable fragments (scFv-TRAIL), directed against tumor-associated antigens (TAAs), and in the use of stem cells focus on targeted TRAIL delivery to cancer cells using bi-functional strategies.

Conclusion:

In vitro, in vivo, and clinical trials, as well as advances in imaging and theranostics, indicate that targeting DR5 remains a valid strategy in the treatment of some relapsed and refractory cancers.

News (Medical) associated with Ozekibart

19 Mar 2026

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Inhibrx Reports Fourth Quarter and Fiscal Year 2025 Financial Results

SAN DIEGO, March 19, 2026 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the fourth quarter and fiscal year 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. (the "Acquirer") and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials. Upcoming Milestones ozekibart (INBRX-109) We expect to submit the Biologics License Application ("BLA") for ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma to the U.S. Food and Drug Administration ("FDA") early in the second quarter of 2026; We plan to announce progression-free survival ("PFS") data for the Phase 1/2 colorectal cancer expansion cohort in the second quarter of 2026; and We plan to meet with the FDA to discuss accelerated approval for Ewing Sarcoma and fourth line colorectal cancer in the second half of 2026. INBRX-106 We plan to announce interim objective response rate ("ORR") data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma ("HNSCC") in combination with KEYTRUDA® (pembrolizumab) in the second quarter of 2026; and We plan to announce PFS data from the randomized Phase 2/3 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026 at the European Society for Medical Oncology ("ESMO") 2026 Congress. Financial Results Cash and Cash Equivalents. As of December 31, 2025, Inhibrx had cash and cash equivalents of $124.2 million. On March 18, 2026, the Company entered into the First Amendment to the Loan and Security Agreement with Oxford Finance, LLC and received gross proceeds of $75.0 million. R&D Expense Research and development expenses were $25.3 million during the fourth quarter of 2025 as compared to $33.4 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to a decrease in expense related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment ahead of our data readout in October 2025, as well as a decrease in contract manufacturing expenses; Research and development expenses were $113.0 million during the fiscal year 2025 as compared to $203.7 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors: a decrease in clinical trial expense primarily related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as discussed above; a decrease in contract manufacturing expense primarily attributable to decreased expenses incurred at our contract development and manufacturing organizations for our ozekibart program and INBRX-106 program, as well as decreased expenses following the 101 Transaction; and increased personnel-related expense during the fiscal year 2024 related to the recognition of $25.9 million upon the acceleration of outstanding options in connection with the closing of the 101 Transaction. G&A Expense General and administrative expenses were $5.6 million during the fourth quarter of 2025, compared to $16.7 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to an increase in legal services incurred in the prior period in connection with legal proceedings, which have since concluded, finding the Company not liable for damages. General and administrative expenses were $23.3 million during the fiscal year 2025, compared to $127.9 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors: one-time expenses incurred during the fiscal year 2024 related to the 101 Transaction, including $68.1 million of legal, advisory, and consulting services, and the recognition of $15.2 million in stock option expense upon the acceleration of outstanding options in connection with the closing of the 101 Transaction; and increased expense during the fiscal year 2024 related to legal services incurred in connection with the Company's legal proceedings as discussed above. Other Income (Expense) Other expense was $1.9 million during the fourth quarter of 2025, compared to other income of $2.1 million during the fourth quarter of 2024. Other expense in the current period consisted of $3.2 million of interest expense on the Company's $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest income earned on the Company's sweep and money market account balances. During the fourth quarter of 2024, the Company did not incur any interest expense following the extinguishment of all outstanding debt in connection with the 101 Transaction. Other expense was $5.0 million during the fiscal year 2025, compared to other income of $2.0 billion during the fiscal year 2024. Other expense in the current period consisted of $12.2 million of interest expense on the Company's $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest earned on the Company's sweep and money market account balances. During the fiscal year ended 2024, as noted above, other income also included the gain recorded in connection with the completion of the 101 Transaction. This gain consisted of (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company's outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the Inhibrx 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer. Net Income (Loss) Net loss was $32.8 million during the fourth quarter of 2025, or $2.11 per share, basic and diluted, compared to a net loss of $47.9 million during the fourth quarter of 2024, or $3.09 per share, basic and diluted. Net loss was $140.1 million during the fiscal year 2025, or $9.04 per share, basic and diluted, compared to a net income of $1.7 billion during the fiscal year 2024, or earnings per share $114.01 basic and $112.62 diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what Inhibrx believes to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding statements regarding the safety and efficacy of its therapeutic candidate, ozekibart, based on topline and interim results; the potential for ozekibart to be used for the treatment of chondrosarcoma, colorectal cancer and Ewing sarcoma; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials; and Inhibrx's plans to submit to the FDA a BLA early in the second quarter of 2026, to announce data regarding its ozekibart Phase 1/2 colorectal cancer expansion cohort and meet with the FDA to discuss accelerated approval for Ewing sarcoma and fourth-line colorectal cancer in the second quarter of 2026, to announce ORR data regarding its INBRX-106 Phase 2/3 trial in HNSCC in combination with pembrolizumab in the second quarter of 2026 and to announce data regarding its INBRX-106 Phase 2/3 trial in HNSCC in combination with pembrolizumab at the ESMO 2026 Congress. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of topline, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; regulatory review and approval of the Company's therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

Financial StatementLicense out/inAcquisitionAccelerated Approval

16 Dec 2025

·www.prnewswire.com

Inhibrx Biosciences Provides Progress Updates on the INBRX-106 Program and the Expansion Cohorts of the ozekibart (INBRX-109) Program

SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology today announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda® (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and the Phase 1/2 trial evaluating patients with checkpoint inhibitor refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda. The Company also provided a brief progress update on the expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma. INBRX-106 Inhibrx has recruited 46 of the 60 patients in the randomized Phase 2 portion of the Phase 2/3 clinical trial evaluating INBRX-106 in combination with Keytruda versus Keytruda as a first-line treatment for patients with unresectable or metastatic HNSCC. Inhibrx expects to complete enrollment in the Phase 2 portion of the trial during the first quarter of 2026. This trial is recruiting patients who have not received prior systemic therapy for unresectable or metastatic HNSCC and have tumor PD-L1 CPS expression equal to or greater than 20. Patients are randomized one to one to either INBRX-106 in combination with Keytruda or Keytruda. The primary endpoint of the Phase 2 portion of this trial is overall response rate, supported by secondary endpoints of duration of response, progression free survival and safety. In November 2025, Inhibrx completed enrollment of the Phase 1/2 trial evaluating 34 patients in checkpoint inhibitor refractory or relapsed NSCLC in combination with Keytruda. Primary endpoints for this cohort are objective response rate, disease control rate, duration of response and safety. The current datasets for both HNSCC and NSCLC lack sufficient maturity to support an interpretation and conclusion on the viability of this program. Inhibrx expects that in the second half of 2026, the data should be mature enough to inform whether INBRX-106, in combination with Keytruda, demonstrates superior efficacy and sustained clinical benefit relative to the current standard of care. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp. Ozekibart (INBRX-109) In late October 2025, Inhibrx completed enrollment of 44 patients in the expansion cohort of the Phase 1/2 trial evaluating ozekibart in combination with FOLFIRI in heavily pretreated (third and fourth line) advanced or metastatic, unresectable colorectal cancer. As previously reported, ozekibart in combination with FOLFIRI was well tolerated, with durable responses and a high rate of disease control. The progression free survival data should be mature in the second quarter of 2026, and we plan to provide an update at that time. Inhibrx expects to complete enrollment in the Phase 1/2 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in the second quarter of 2026. If the current response and duration trends observed continue, Inhibrx plans to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication. About INBRX-106 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 in combination with Keytruda in patients with locally advanced or metastatic solid tumors, specifically HNSCC and NSCLC. About ozekibart (INBRX-109) Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. Inhibrx read out a successful single agent registration study in chondrosarcoma and a BLA filing is expected in early Q2 of 2026. Additionally, Inhibrx is evaluating ozekibart in patients diagnosed with colorectal cancer and Ewing sarcoma. About Inhibrx Biosciences, Inc. Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart and INBRX-106, both of which utilize 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. For more information, please visit . Forward-Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline; statements regarding the safety and efficacy of its therapeutic candidatesbased on topline and interim results; the potential for its therapeutic candidates to be used for certain indications; the clinical development of its therapeutic candidates, including expected enrollment, data readouts, regulatory submissions and interactions, and the timing thereof; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of topline, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; results from preclinical studies or early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of its therapeutic candidates that may limit their development, regulatory approval and/or commercialization; the potential for its programs and prospects to be negatively impacted by developments relating to its competitors, including the results of studies or regulatory determinations relating to its competitors; the timing or likelihood of regulatory filings and approvals and regulatory developments in the U.S. and foreign countries; the successful commercialization of its therapeutic candidates, if approved; an accelerated development or approval pathway may not be available for its therapeutic candidates and any such pathway may not lead to a faster development process; it may not realize the benefits associated with orphan drug designation, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the pricing, coverage and reimbursement of its therapeutic candidates, if approved; its ability to utilize its technology platform to generate and advance additional therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly Deck, CFO [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

Orphan DrugAcquisitionPhase 1

14 Nov 2025

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Inhibrx Reports Third Quarter 2025 Financial Results

SAN DIEGO, Nov. 14, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the third quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials. Recent Corporate Highlights On October 23, 2025, Inhibrx announced positive topline results from its registrational trial of ozekibart (INBRX-109) in chondrosarcoma and provided an update on its colorectal cancer and Ewing sarcoma expansion cohorts. Ozekibart met its primary endpoint in chondrosarcoma, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival compared to placebo. Key secondary endpoints reinforce the primary benefit, demonstrating meaningful improvements in disease control and patient quality of life. Inhibrx plans to submit to the U.S. Food and Drug Administration a biologics license application in the second quarter of 2026. Interim data from expansion cohorts in patients with colorectal cancer and Ewing sarcoma demonstrate high response and disease control rates in difficult-to-treat, heavily pretreated patients. Financial Results Cash and Cash Equivalents . As of September 30, 2025, Inhibrx had cash and cash equivalents of $153.1 million, as compared to $186.6 million as of June 30, 2025. R&D Expense . Research and development expenses were $28.5 million for the third quarter of 2025, as compared to $38.9 million for the third quarter of 2024. The decrease was primarily related to a decrease in process development and manufacturing activities performed by our CDMO partners during the prior year in connection with the Company's clinical trial for ozekibart (INBRX-109). In addition, personnel-related expenses decreased as a result of a decrease in headcount in the current period. G&A Expense . General and administrative expenses were $5.3 million during the third quarter of 2025, compared to $7.9 million during the third quarter of 2024. The decrease was primarily related to decreased legal expenses following the conclusion of legal proceedings as well as decreased personnel-related expenses as a result of a decrease in headcount in the current period. Other Expense. Other expense was $1.4 million during the third quarter of 2025, as compared to other income of $2.9 million during the third quarter of 2024. Other expense in the current period consisted of $3.2 million of interest expense on the Company's $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest income earned on the Company's sweep and money market account balances. During the third quarter of 2024, the Company did not incur any interest expense following the extinguishment of all outstanding debt in connection with the 101 Transaction. Net Loss. Net loss was $35.3 million during the third quarter of 2025, or $2.28 per share, basic and diluted, as compared to a net loss of $43.9 million during the third quarter of 2024, or $2.84 per share, basic and diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what Inhibrx believes to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding statements regarding the safety and efficacy of its therapeutic candidate, ozekibart, based on topline and interim results; the potential for ozekibart to be used for the treatment of chondrosarcoma, colorectal cancer and Ewing sarcoma; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials; and Inhibrx's plans to submit it to the U.S. Food and Drug Administration a biologics license application in the second quarter of 2026. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of topline, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; regulatory review and approval of the Company's therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the SEC, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

Financial StatementClinical ResultPhase 1

100 Deals associated with Ozekibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chondrosarcoma	Phase 2	United States	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Australia	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	France	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Germany	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Ireland	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Italy	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Netherlands	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	Spain	Inhibrx Biosciences, Inc.	23 Sep 2021
Chondrosarcoma	Phase 2	United Kingdom	Inhibrx Biosciences, Inc.	23 Sep 2021
Adenocarcinoma of large intestine	Phase 1	United States	Inhibrx Biosciences, Inc.	08 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03715933 (PRNewswire) Manual	Phase 1/2	Colorectal Cancer \| Ewing Sarcoma Last line \| Third line	51	Ozekibart + FOLFIRI (Colorectal Cancer)	xntrqtkncn(ihorxuctwq) = Group1: The most common TEAEs included anemia, diarrhea, nausea, and fatigue, with the majority being low-grade. Group2: The most common adverse events were diarrhea, nausea, anemia, and fatigue. iagpjwurpz (rstepxbboo )	Positive	23 Oct 2025
NCT03715933 (PRNewswire) Manual	Phase 1/2	Colorectal Cancer \| Ewing Sarcoma Last line \| Third line	51	Ozekibart + Irinotecan + Temozolomide (Ewing Sarcoma)		Positive	23 Oct 2025
NCT04950075 (ChonDRAgon, PRNewswire) Manual	Phase 2/3	Chondrosarcoma	206	Ozekibart	vqwlnbfryv(gawbgvqaed) = ispiyctias oqihuykrig (opdruvrxnn ) Met View more	Positive	23 Oct 2025
NCT04950075 (ChonDRAgon, PRNewswire) Manual	Phase 2/3	Chondrosarcoma	206	Placebo	vqwlnbfryv(gawbgvqaed) = fnoinganpl oqihuykrig (opdruvrxnn ) Met View more	Positive	23 Oct 2025
NCT03715933 (ASCO_GI2025)	Phase 1	Adenocarcinoma of large intestine Second line	13	Ozekibart 1 mg/kg + FOLFIRI	nweubxqdix(fxdaeypbom) = Ozekibart-related adverse events (AEs) were reported in 85% of pts (grade ≥3, 31%) and led to ozekibart interruption in 3 pts and discontinuation in 1 pt ojvobsbcqq (ymccjttosp ) View more	Positive	23 Jan 2025
NCT03715933 (PRNewswire) Manual	Phase 1	Ewing Sarcoma	13	INBRX-109+Irinotecan+Temozolomide	slcutwmkve(jkohqebmbn) = bgqffxqbas nmmwbsqiop (eeujbmfseg ) View more	Positive	02 Nov 2023
NCT03715933 (Pubmed \| Clin Cancer Res)	Phase 1	Chondrosarcoma IDH1/IDH2-mutant	-	INBRX-109 3 mg/kg	ihpwmxozdd(cdnkuqslso) = <4 months snwyeggghw (jiwmsxgciy ) View more	-	15 Aug 2023
NCT03715933 (Corporate Publications) Manual	Phase 1	Chondrosarcoma	33	INBRX-109	mhbssnykfg(arifajxgms) = increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. egudcwsvla (mzuypcfnmr )	Positive	16 Nov 2022
NCT04950075 (ASCO2022)	Phase 2	Chondrosarcoma	201	INBRX-109	hrpfupsbav(ckqqashupt) = vyjndvbrhd iswejcppxq (qorrxsewgm )	-	02 Jun 2022
NCT04950075 (ASCO2022)	Phase 2	Chondrosarcoma	201	Placebo	hrpfupsbav(ckqqashupt) = mpqeizyswd iswejcppxq (qorrxsewgm )	-	02 Jun 2022

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