Inhibrx Biosciences, Inc.

Inhibrx Biosciences, Inc. is a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates, developed using its proprietary modular protein engineering platforms. The company leverages its innovative protein engineering technologies and deep understanding of target biology to create therapeutic candidates with attributes and mechanisms it believes to be superior to current approaches and applicable to a range of challenging, validated targets with high potential. The company's current pipeline is focused on oncology.

The biopharmaceutical industry is characterized by rapid evolution of technologies, fierce competition and strong defense of intellectual property. Primary competitors fall into groups including companies developing novel therapeutics based on sdAb or alternative scaffold product candidates such as Crescendo Biologics Ltd., Molecular Partners AG, Precirix NV, Affibody Medical AB, Numab Therapeutics AG, GT Biopharma, Inc., and Sanofi; antibody drug discovery companies including Regeneron Pharmaceuticals, Inc., Adimab LLC, Genmab A/S, Macrogenics, Inc., Merus N.V., Numab Therapeutics AG, Amgen, Inc., Xencor, Inc., and Zymeworks Inc.; and companies developing therapeutics for the treatment of autoimmune diseases including Sanofi, Amgen Inc., AstraZeneca plc, F. Hoffmann-La Roche AG, Pfizer Inc., Merck & Co., Inc., Novartis AG, Candid Therapeutics, Inc., Hinge Bio, Inc., and Apogee Therapeutics, Inc. Many competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and marketing approved products than Inhibrx does.

As of the date of the filing, all of the company's revenue has been derived from licenses with collaboration partners and grant awards. The company has not generated any revenue from the commercial sale of approved therapeutic products to date. The company's in-house capabilities span the disciplines of discovery, protein engineering, cell biology, translational research, chemistry, manufacturing and controls, clinical development, and commercialization.

The company's current clinical pipeline includes ozekibart (INBRX-109), a precisely engineered tetravalent therapeutic candidate targeting death-receptor 5 (DR5), a TNFRSF member also known as TRAIL receptor 2, which is currently being investigated in chondrosarcoma, Ewing sarcoma, colorectal cancer, and certain other solid tumor types. Ozekibart is comprised of four DR5 targeted sdAbs fused to an Fc region that has been modified to prevent Fc receptor interactions. The company also has INBRX-106, a hexavalent OX40 agonist currently being investigated in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). INBRX-106 is composed of six OX40 targeting sdAbs and a functional Fc domain.

In October 2025, the company announced the ChonDRAgon 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. Following recent regulatory interactions, the company plans to submit a biologics license application early in the second quarter of 2026. In November 2025, the company completed enrollment of the Phase 1/2 trial evaluating 34 patients in checkpoint inhibitor refractory or relapsed NSCLC in combination with KEYTRUDA. During the first quarter of 2026, the company completed enrollment of 68 patients in the Phase 2 portion of a seamless Phase 2/3 clinical trial for INBRX-106 in combination with KEYTRUDA as a first-line treatment for patients with locally advanced recurrent or metastatic HNSCC.

On May 29, 2024, Inhibrx, Inc. (the Former Parent) effected the spin-off of INBRX-101, 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 the company's common stock. On May 30, 2024, the Former Parent completed the Merger of Art Acquisition Sub, Inc., a wholly-owned subsidiary of Aventis Inc. (the Acquirer), a wholly-owned subsidiary of Sanofi S.A., with and into the Former Parent. Pursuant to the Merger, all assets and liabilities primarily related to INBRX-101 were transferred to the Acquirer, and by way of the Separation, the company 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. In January 2025, the company borrowed a total of $100.0 million from Oxford under a loan and security agreement. In March 2026, the company amended the 2025 Loan Agreement and borrowed an additional $75.0 million, for a total of $175.0 million.

During the year ended December 31, 2025, the company's net loss was $140.1 million. As of December 31, 2025, the company had an accumulated deficit of $246.2 million and cash and cash equivalents of $124.2 million. Total revenue for the year ended December 31, 2025 was $1.3 million, compared to $0.2 million for the year ended December 31, 2024. Research and development expense decreased by $90.7 million from $203.7 million during the year ended December 31, 2024 to $113.0 million during the year ended December 31, 2025. General and administrative expense decreased by $104.6 million from $127.9 million during the year ended December 31, 2024 to $23.3 million during the year ended December 31, 2025.

The company plans to submit a biologics license application (BLA) to the FDA for the approval of ozekibart in patients with metastatic or unresectable chondrosarcoma early in the second quarter of 2026. The company expects 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, the company plans to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication. The company also plans to provide an update on the expansion cohort for ozekibart in combination with FOLFIRI for CRC during the second quarter of 2026 when the PFS data is mature, and if trends continue, plans to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication.

For INBRX-106, the company plans to provide initial results from the Phase 2 trial in the second quarter of 2026. The company plans to announce PFS data from this trial in the fourth quarter of 2026 at the European Society for Medical Oncology 2026 Congress. If positive, the company anticipates this data may ungate the Phase 3 portion, where 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 are expected to be PFS and overall survival.

The company expects research and development expense to continue to increase over the next several years as it continues development of its therapeutic candidates currently in clinical stage development and supports its preclinical programs. The company expects certain of its general and administrative expenses will continue to increase in the future to support its continued research and development activities, including costs related to pre-commercialization and business development activities.

The company does not own or operate manufacturing facilities for the production of any of its therapeutic candidates, nor does it have plans to develop its own manufacturing operations in the foreseeable future. The company presently has relationships with suppliers for the manufacture of supplies for all of its required raw materials, antibodies, and other biologics for its preclinical research, clinical trials, and if and when applicable, commercialization. The company currently employs internal resources to manage its manufacturing relationships.

The company expects its expenses to increase in future years as it executes its plan to continue its discovery, research and development activities, including the ongoing and planned preclinical and clinical development and commercialization of its therapeutic candidates. The company believes that its existing cash and cash equivalents will be sufficient to fund its planned operations through at least the 12-month period following the date of the Annual Report. As of December 31, 2025, the company had $124.2 million in cash and cash equivalents. In January 2025, the company entered into the 2025 Loan Agreement with Oxford, upon which it received gross proceeds of $100 million. On March 18, 2026, the company entered into the First Amendment to Loan and Service Agreement with Oxford, which provides for an additional tranche in an aggregate principal amount of $75.0 million, upsized from $50.0 million originally available, $75.0 million of which was funded on the date of the amendment.

The company expects to finance its cash needs through equity offerings, debt financings or other capital sources, including strategic licensing and collaborations, strategic transactions, or other similar arrangements and transactions. The company does not have any committed external source of funds. The company's ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which it may have no or limited control.

Inflation has the potential to adversely affect the company's liquidity, business, financial condition and results of operations by increasing its overall cost structure. The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates and capital costs, shipping costs, supply shortages, increased costs of labor, weakening exchange rates and other similar effects. The company may experience increases in the prices of labor and other costs of doing business.

The company is subject to risks and uncertainties relating to the laws and regulations of China and the changes in relations between the United States and China due to its partnerships in China. The company's partnerships in China subject it to risks and uncertainties relating to the laws and regulations of China and the changes in relations between the United States and China. The company is also subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations.

The company depends heavily on the success of its therapeutic candidates ozekibart and INBRX-106, which are currently in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. As of December 31, 2025, the company had $124.2 million ¹ in cash and cash equivalents and an accumulated deficit of $246.2 million ², and expects to need substantial additional funds to advance development, with no guarantee that additional funding will be available on acceptable terms. The company has a significant amount of debt, having borrowed $100.0 million ³ in January 2025 and an additional $75.0 million ⁴ in March 2026, for a total of $175.0 million ⁵, secured by substantially all of its assets, and failure to comply with the loan covenants could materially and adversely affect the business. The company faces significant competition from major pharmaceutical and biotechnology companies with greater financial resources, and if competitors develop and market products that are more effective, safer or less expensive, the company's commercial opportunities will be negatively impacted. The company may be unable to obtain marketing approval for any product it may develop, and the marketing approval processes of the FDA and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable.

Management's message emphasizes the company's mission to discover and develop effective biologic treatments applicable to a range of challenging, validated targets with high potential to help people with life-threatening conditions. The strategic priorities emphasized for the period ahead include rapidly advancing and optimizing the clinical development of lead programs, applying protein engineering platforms to create differentiated next-generation therapeutics in focused disease areas with high unmet medical need, maintaining a culture of innovation, execution and efficiency, and maximizing the potential of the therapeutic pipeline through disciplined strategy and potential strategic partnerships. Key forward-looking statements include the plan to submit a BLA to the FDA for ozekibart in chondrosarcoma early in the second quarter of 2026, the expectation to complete enrollment in the Ewing sarcoma trial in the second half of 2026, and plans to meet with the FDA in the second half of 2026 to discuss accelerated approval pathways for both the Ewing sarcoma and CRC indications if current trends continue.