What changed in this filing

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Item 1. Business

2026-03-19 compared with 2025-03-17 · 207 added, 211 removed, 531 unchanged (44% of the section changed)

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Separation from Former Parent

In January 2024, Inhibrx, Inc., or the Former Parent, announced its intent to effect 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.

On May 29, 2024, the Former Parent completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of common stock of the Company, or the Distribution.

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.

On May 30, 2024, the Former Parent completed 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.

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, 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.

Upon the closing, each Former Parent stockholder received:

(i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly listed, share of Inhibrx for every four shares of the Former Parent’s common stock held.

From and after the closing, Inhibrx continues to operate as a stand-alone, publicly traded company focused on its clinical programs, ozekibart (INBRX-109) and INBRX-106.

Transactions with Related Parties

We entered into a Separation and Distribution Agreement and various agreements relating to transition services, licenses, and certain other matters with the Former Parent, which govern our relationship with the Former Parent prior to, at, and after the Former Parent completed the Distribution.

These agreements include the allocation of employee benefits, taxes, and certain other liabilities and obligations attributable to periods prior to, at and after the Distribution.

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 and INBRX-106, both of which are clinical-stage programs.

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 consolidated financial statements included elsewhere in this Annual 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.

Current Clinical Pipeline

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:

ozekibart (INBRX-109) INBRX-106

Tetravalent DR5

agonist Hexavalent OX40

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:

ozekibart (INBRX-109)

Tetravalent DR5 agonist

Hexavalent OX40 agonist

Program Therapeutic Area Target(s)/Format STAGE OF DEVELOPMENT

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__________________

* Currently being investigated in chondrosarcoma, Ewing sarcoma, and colorectal cancer.

* Currently being investigated in chondrosarcoma, Ewing sarcoma, colorectal cancer, and certain other solid tumor types.

** Currently being investigated in patients with non-small cell lung cancer, or NSCLC, and head and neck squamous cell carcinoma, or HNSCC.

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Our board of directors is comprised of individuals with proven business and scientific accomplishments and significant operating knowledge of our company.

Our mission is to discover and develop effective biologic treatments for people with life-threatening conditions and to evolve the Company into a biopharmaceutical company with a differentiated and sustainable product portfolio by focusing on the following:

Our mission is 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.

We are a biopharmaceutical company aiming to develop a differentiated and sustainable product portfolio by focusing on the following:

Rapidly advance and optimize the clinical development of our lead programs.

Both of our clinical stage programs have key data or milestone events expected in 2025.

Since entering the clinic, we have made great strides in our trials for both programs.

Apply our protein engineering platforms to create differentiated, next-generation therapeutics in focused disease areas with particular emphasis on oncology.

Since entering the clinic, we have made great strides in our clinical programs, with the successful completion of two registration-enabling trials.

In May 2024, we completed a successful Merger and Separation with Sanofi for the

purchase of our INBRX-101 program for alpha-1 antitrypsin deficiency disorder.

Positive data from that registrational program read out in October 2025.

In October 2025, we announced positive data from our ozekibart (INBRX-109) registration-enabling trial in advanced or metastatic, unresectable chondrosarcoma.

Both ozekibart and INBRX-106 have key data or milestone events expected in 2026.

Apply our protein engineering platforms to create differentiated, next-generation therapeutics in focused disease areas with a high unmet medical need.

We continue to focus our internal clinical development where we believe we can create effective and flexible solutions to address the challenges of validated targets in areas with a high unmet medical need.

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ozekibart (INBRX-109)

Ozekibart was originally known as INBRX-109, but was granted the “ozekibart” generic name in 2023 by both International Nonproprietary Names, or INN, and United States Adopted Names, or USAN.

Ozekibart (INBRX-109) is a precisely engineered tetravalent therapeutic candidate targeting death-receptor 5, or DR5, a TNFRSF member, also known as tumor necrosis factor-related apoptosis-inducing ligand, or TRAIL, receptor 2.

Ozekibart is a precisely engineered tetravalent therapeutic candidate targeting death-receptor 5, or DR5, a TNFRSF member, also known as tumor necrosis factor-related apoptosis-inducing ligand, or TRAIL, receptor 2.

DR5 activation induces cancer-specific programmed cell death.

The valency of ozekibart (INBRX-109) was selected to maximize the therapeutic index.

The valency of ozekibart was selected to maximize the therapeutic index.

Background on DR5

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Unmet Medical Need

We are currently investigating ozekibart (INBRX-109) in chondrosarcoma, Ewing sarcoma, and colorectal cancer.

These are some of the most aggressive diseases, some of which are also orphan oncology indications that have

shown signs of activity in preclinical studies.

These indications and many of these cancer subtypes do not respond well to currently approved therapies and represent a significant unmet need.

We are currently investigating ozekibart in chondrosarcoma, Ewing sarcoma, and colorectal cancer.

These are some of the most aggressive diseases, some of which are also orphan oncology indications that have shown signs of activity in preclinical studies.

These indications, particularly in advanced or refractory settings, often do not respond well to currently approved therapies and represent a significant unmet need.

Chondrosarcoma is a rare malignant bone tumor composed of cartilage matrix-producing cells.

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Colorectal adenocarcinoma, or CRC, is the third most frequent cancer globally and the second leading cause of cancer-related death.

According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths.

According to the World Health Organization, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths.

Effective therapies beyond the second-line setting are limited.

In the U.S., the five-year relative survival rate in patients with metastatic CRC is 15.7%, underscoring the need for better treatments.

Our Solution — ozekibart (INBRX-109)

Ozekibart (INBRX-109) is a tetravalent agonist of DR5 that we designed with our proprietary single domain antibody, or sdAb, platform to drive cancer-selective programmed cell death and to maximize potency while minimizing on-target liver toxicity arising from hepatocyte apoptosis.

We believe ozekibart (INBRX-109) has the potential to overcome the limitations of previous DR5 agonists.

As shown in the diagram below, ozekibart (INBRX-109) is comprised of four DR5 targeted sdAbs fused to an Fc region that has been modified to prevent Fc receptor interactions.

In preclinical studies, we have observed that ozekibart (INBRX-109) has the ability to potently agonize DR5 through efficient receptor clustering, causing cancer cell death.

Our Solution — ozekibart

Ozekibart is a tetravalent agonist of DR5 that we designed with our proprietary single domain antibody, or sdAb, platform to drive cancer-selective programmed cell death and to maximize potency while minimizing on-target liver toxicity arising from hepatocyte apoptosis.

We believe ozekibart has the potential to overcome the limitations of previous DR5 agonists.

As shown in the diagram below, ozekibart is comprised of four DR5 targeted sdAbs fused to an Fc region that has been modified to prevent Fc receptor interactions.

In preclinical studies, we have observed that ozekibart has the ability to potently agonize DR5 through efficient receptor clustering, causing cancer cell death.

Based upon experience with earlier generation DR5 agonists, hepatocytes appear to be a non-cancerous cell type particularly sensitive to DR5 agonism.

We have engineered ozekibart (INBRX-109) with our proprietary sdAb modifications to reduce recognition by pre-existing anti-drug antibodies in humans, which can lessen the potential for hyper-clustering and thereby reduce potential hepatotoxicity.

ozekibart (INBRX-109):

We have engineered ozekibart with our proprietary sdAb modifications to reduce recognition by pre-existing anti-drug antibodies in humans, which can lessen the potential for hyper-clustering and thereby reduce potential hepatotoxicity.

Tetravalent DR5 Agonistic Antibody

Phase 1 Clinical Trial of ozekibart (INBRX-109)

Phase 1/2 Clinical Trial of ozekibart

We initiated a Phase 1 clinical trial in the United States in November 2018.

This Phase 1 clinical trial is designed as an open-label, three-part trial in patients with locally advanced or metastatic solid tumors.

Primary objectives of the Phase 1 trial are safety, tolerability, and determination of the maximum tolerated dose, or MTD, and recommended Phase 2 dose.

For some of the expansion cohorts in part 2 and part 3, clinical anti-tumor efficacy, such as response rate, was also included as one of the primary objectives.

Secondary objectives are serum exposure and immunogenicity, as measured by frequency of anti-drug antibodies.

Exploratory objectives include clinical anti-tumor efficacy, based on response rate, duration of response, disease control rate, progression-free survival and overall survival, as well as evaluation of potential predictive diagnostic and pharmacodynamic biomarkers.

Part 1 of the trial utilized a traditional 3+3 dose escalation design escalating ozekibart (INBRX-109) as a single agent from 0.3 mg/kg to 30 mg/kg.

Twenty patients were enrolled in this portion of the trial, which was completed in August 2019.

Ozekibart (INBRX-109) was observed to be well-tolerated without significant toxicities observed at doses up to and including the maximum administered dose of 30 mg/kg.

This Phase 1 clinical trial was designed as an open-label, three-part trial in patients with locally advanced or metastatic solid tumors.

Part 1 of the trial completed in August 2019 and enrolled 20 patients, utilizing a traditional 3+3 dose escalation design escalating ozekibart as a single agent from 0.3 mg/kg to 30 mg/kg.

Ozekibart was observed to be well-tolerated without significant toxicities observed at doses up to and including the maximum administered dose of 30 mg/kg.

No MTD was reached.

In September 2019, we commenced single agent dose expansion cohorts.

Part 2 is now complete and enrolled 116 patients in single agent dose cohorts in the following tumor types:

In September 2019, we commenced Part 2, single agent dose expansion cohorts, which enrolled 121 patients in single agent dose cohorts in the following tumor types:

colorectal and gastric adenocarcinomas, malignant pleural mesothelioma, chondrosarcoma, synovial sarcoma, and solid tumors.

In February 2021, we initiated chemotherapy combination cohorts in Part 3 of this trial.

We are currently investigating ozekibart (INBRX-109) in Ewing sarcoma, colorectal adenocarcinoma, and chondrosarcoma in Part 3 of this trial.

Interim Results from the Phase 1 cohort in Ewing Sarcoma

In November 2023, we announced interim efficacy and safety data from the cohort of the Phase 1 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.

Among the 13 patients evaluable as of the data cut of September 8, 2023, the observed disease control rate was 76.9%, or 10 out of 13 patients as measured by

RECISTv1.1, with seven patients achieving partial responses (53.8%) and three patients achieving stable disease (23.1%).

Overall, ozekibart (INBRX-109) in combination with IRI/TMZ was well-tolerated from a safety perspective.

We have expanded recruitment of this cohort by 50 patients as a result of these preliminary findings and expect to have interim data during the second half of 2025.

Interim Results from the Phase 1 cohort in Colorectal Adenocarcinoma

In January 2025, we announced interim efficacy and safety data from the cohort of the Phase 1 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 who received at least one dose of ozekibart, based on RECIST v1.1 criteria.

Interim results as of the cutoff date of December 2, 2024 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 progression-free survival of 7.85 months.

In February 2021, we initiated chemotherapy combination cohorts in Part 3 of this trial, of which we are still investigating in Ewing sarcoma and colorectal adenocarcinoma.

Primary objectives of the Phase 1 trial were safety, tolerability, and determination of the maximum tolerated dose, or MTD, and recommended Phase 2 dose.

For some of the expansion cohorts in Part 2 and Part 3, clinical anti-tumor efficacy, such as response rate, was also included as one of the primary objectives.

Secondary objectives were serum exposure and immunogenicity, as measured by frequency of anti-drug antibodies.

Exploratory objectives included clinical anti-tumor efficacy, based on response rate, duration of response, disease control rate, progression-free survival and overall survival, as well as evaluation of potential predictive diagnostic and pharmacodynamic biomarkers.

Colorectal Adenocarcinoma

In January 2025, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma, or CRC.

Efficacy was assessed in 10 of the 13 evaluable patients 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 progression-free survival, or PFS, of 7.85 months.

All patients had received at least one prior line of systemic therapy (median:

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.

Ozekibart-related treatment-emergent adverse events, or TEAEs, were reported in 84.6% of patients, with most being grade 1 or 2 in severity.

Grade ≥3 TEAEs were observed in 30.8% of patients.

The most common ozekibart-related TEAEs included nausea, increased alanine aminotransferase, diarrhea, and fatigue, with the majority being low-grade.

ORR, n (%) 4 (30.8)

PR, n (%) 3 (23.1)

SD, n (%) 6 (46.2)

DCR, n (%) 10 (76.9)

We have expanded recruitment of this cohort by 50 patients as a result of these preliminary findings in order to validate these findings in a more uniform patient population.

The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in the third quarter of 2025.

Interim Results from the Phase 1 cohort in Chondrosarcoma

In January 2021, the FDA granted Fast Track designation to ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma.

In November 2021, the FDA granted orphan drug designation for ozekibart (INBRX-109) for the treatment of chondrosarcoma.

In August 2022, the European Commission granted orphan designation for ozekibart (INBRX-109) for the treatment of chondrosarcoma.

In November 2024, we announced interim efficacy and safety data from the ongoing Phase 1 expansion cohort evaluating ozekibart (INBRX-109) for the treatment of chondrosarcoma.

Among the 31 patients evaluable as of

August 9, 2024, the observed disease control rate was 77.8%, or 42 out of 54 patients as measured by RECISTv1.1, with two patients achieving partial responses (3.7%) and 40 patients achieving stable disease (74.1%).

Based on the interim data observed 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.

Efficacy was assessed in 26 evaluable patients who had at least one post-baseline scan as of the cutoff date of October 15, 2025.

Based on RECIST v1.1 criteria, a 23% overall response rate, or ORR, was observed and an overall disease control rate of 92% was observed.

In general, 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.

We plan to provide an update on the expansion cohort during the second quarter of 2026 when the PFS data is mature.

If the current response and duration trends observed continue, we plan to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication.

Ewing Sarcoma

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.

Among the 13 patients evaluable as of the data cut of September 8, 2023, the observed disease control rate was 76.9%, or 10 out of 13 patients as measured by RECISTv1.1, with seven patients achieving partial responses (53.8%) and three patients achieving stable disease (23.1%).

Four of the 13 evaluable patients at that time had prior IRI exposure, including two out of the four responses.

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.

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.

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 an accelerated approval pathway for this indication.

Chondrosarcoma

Phase 1 ozekibart in Chondrosarcoma

In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with unresectable or metastatic conventional chondrosarcoma.

In November 2021, the FDA granted orphan drug designation for ozekibart for the treatment of chondrosarcoma.

In August 2022, the European Commission granted orphan designation for ozekibart for the treatment of chondrosarcoma.

In November 2024, we announced efficacy and safety data from the Phase 1 expansion cohort evaluating ozekibart for the treatment of chondrosarcoma.

Among the 54 patients evaluable, the observed disease control rate was 77.8%, or 42 out of 54 patients as measured by RECISTv1.1, with two patients achieving partial responses (3.7%) and 40 patients achieving stable disease (74.1%).

Disease control was observed in patients with and without IDH1/IDH2 mutations.

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23 of 42 patients (54.8%) who achieved disease control maintained control for longer than 6 months, and the longest duration of stable disease observed was 27 months.

At the time of evaluation, the median progression-free survival, or PFS, was 7.42 months, and one patient remained on study.

August 9, 2024;

presented at the CTOS Annual Meeting, November 13-16, 2024, San Diego, CA

Patient continued receiving ozekibart beyond progression.

Patient received priming dose of ozekibart 0.3 mg/kg in cycle 1;

in all subsequent cycles, the patient received 3 mg/kg.

Patient received ozekibart at a dose of 10 mg/kg.

Phase 2 ozekibart (INBRX-109) in Chondrosarcoma

In June 2021, we initiated a Phase 2 trial in patients with metastatic conventional chondrosarcoma, which will enroll approximately 200 patients in total at 50 different sites worldwide.

Primary objectives of the ongoing Phase 2 trial are to evaluate the efficacy of ozekibart (INBRX-109) as measured by median PFS, assessed by central real-time independent radiology review.

Secondary objectives are to evaluate the overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart (INBRX-109).

Phase 2 Trial Design

Ongoing Registration-Enabling Trial in Unresectable or Metastatic Conventional Chondrosarcoma

• FDA Fast Track designation and orphan-drug designation

• European orphan designation

Key eligibility criteria:

• Conventional chondrosarcoma

• Grades 2 and 3

• Unresectable or metastatic

Randomization 2:1

Randomization stratified by line of therapy, grade and IDH1/2 mutation status

Primary Endpoint:

progression free survival

Secondary Endpoints:

overall survival, quality of life, overall response rate, duration of response, disease control rate, safety, etc.

DSMB reviewed interim analyses in April 2024 and made the recommendation for trial continuation

ozekibart (INBRX-109)

3 mg/kg every three weeks

In early 2023, the Phase 2 trial was placed on partial clinical hold by the FDA, and we paused patient enrollment in the trial following the occurrence of a fatal (grade 5) serious adverse event of hepatotoxicity (or hepatic failure) event triggering the predefined stopping rules built into the protocol.

The additional insight gained on patients at risk of significant hepatotoxicity led us to believe that elderly patients with fatty liver disease are the at higher-risk population.

We implemented the Hepatic Steatosis Index, or HSI, into the protocol and excluded those higher-risk elderly patients with an HSI score of 36 or higher, which has helped to mitigate the risk of severe hepatotoxicity.

The FDA lifted the hold in April 2023 after we amended the trial protocol.

The safety and integrity of the Phase 2 trial is overseen by an independent group of qualified experts, known as a data safety monitoring board, or DSMB, committee.

This group provides the recommendation of whether a trial may move forward at designated check points based on access that only the group maintains to available data from the trial.

Suspension or termination of development occurs if it is determined that the participants or patients are being exposed to an unacceptable health risk.

In April 2024, the DSMB committee reviewed the interim analyses for the Phase 2 trial and made the recommendation that we continue forward with the current trial.

We expect to announce data from this trial around the third quarter of 2025.

Safety Data for ozekibart (INBRX-109)

Of the 238 patients studied and evaluable in our Phase 1 trial as of the cutoff date of January 3, 2025, the treatment-related serious adverse events observed were (i) abnormal laboratory findings of increased alanine aminotransferase (6 or 2.5%), increased aspartate aminotransferase (6 or 2.5%), transaminases increased, an increased on hepatic enzyme (1 or 0.4%), increased liver function test (1 or 0.4%) and decreased platelet count (1 or 0.4%), (ii) gastrointestinal disorders, which consisted of diarrhea (4 or 1.7%), enterocolitis, an inflammation of the small intestine and colon (1 or 0.4%), colitis (1 or 0.4%), nausea (1 or 0.4%) and vomiting (1 or 0.4%), (iii) blood and lymphatic system disorders, which consisted of anemia (3 or 1.3%), febrile neutropenia, a condition where the body has a reduced number of a certain type of white blood cells in conjunction with a fever (2 or 0.8%) and thrombocytopenia, a condition where the number of platelets in the blood is abnormally low (1 or 0.4%), (iv) hepatobiliary (liver, bile duct or gallbladder) disorders which consisted of acute hepatic failure (3 or 1.3%), hepatic

failure (1 or 0.4%), drug-induced liver injury (1 or 0.4%), (v) general disorders and administration site conditions, which consisted of asthenia, or physical weakness or general lack of energy (1 or 0.4%) and influenza-like illness (1 or 0.4%), (vi) infections, which consisted of neutropenic sepsis, a significant inflammatory response to a presumed infection in a person with or without fever (1 or 0.4%) and sepsis, an overreactive and extreme inflammatory response to infection (1 or 0.4%), (vii) metabolism and nutrition disorders, which consisted of dehydration (1 or 0.4%), failure to thrive (1 or 0.4%) and hyponatremia, a condition where the sodium levels in blood are lower than normal (1 or 0.4%), (viii) tachycardia (1 or 0.4%), and (ix) posterior reversible encephalopathy syndrome, a condition marked by headaches, vision problems, mental changes, seizures, and swelling in the brain (1 or 0.4%).

Of 161 patients studied and evaluable in our Phase 2 trial as of the cutoff date of January 3, 2025, the serious adverse events related to study drug (ozekibart (INBRX-109) or placebo) were (i) abnormal laboratory findings of increased alanine aminotransferase (5 or 3.1%) and increased aspartate aminotransferase (5 or 3.1%), (ii) hepatobiliary disorders, which consisted of hypertransaminasemia (2 or 1.2%) and hepatic failure (2 or 1.2%), (iii) infections which consisted of infectious enterocolitis (1 or 0.6%), (iv) muscular weakness (1 or 0.6%), (v) cardiac disorders which consisted of angina pectoris (1 or 0.6%) and (vi) renal and urinary disorders, which consisted of hemorrhagic Cystitis, a condition in which the bladder becomes inflamed and starts to bleed (1 or 0.6%).

The median progression-free survival, or PFS, was 7.42 months.

ChonDRAgon Trial

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.

The primary objective of the trial was the evaluation of the efficacy of ozekibart as measured by median PFS, assessed by central real-time independent radiology review per RECIST 1.1.

Secondary objectives were the evaluation of overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart.

Key enrollment criteria in order for patients to qualify for inclusion in the trial were grade 2 or 3 unresectable or metastatic conventional chondrosarcoma.

Patients received either ozekibart or placebo every three weeks at a randomization of 2:1, stratified by the line of therapy, grade and IDH1/2 mutation status.

Patients randomized to the placebo arm were allowed to crossover to receive ozekibart upon confirmation of progression as reported by central independent radiology review.

In October 2025, we announced ChonDRAgon 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;

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.

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.

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.

Following recent regulatory interactions, we plan to submit a biologics license application, or BLA, early in the second quarter of 2026.

Safety Data for ozekibart

Of th e 273 patients studied and evaluable in our Phase 1 trial as of the cutoff date of August 2, 2025, the treatment -related serious adverse events observed in more than one patient were (i) abnormal laboratory findings of increased alanine aminotransferase (8 or 2.9%), increased aspartate aminotransferase (8 or 2.9%), (ii) gastrointestinal disorders, which included diarrhea (4 or 1.5%), (iii) blood and lymphatic system disorders, which included anemia (3 or 1.1%), febrile neutropenia, a condition where the body has a reduced number of a certain type of white blood cells in conjunction with a fever (2 or 0.7%), (iv) hepatobiliary (liver, bile duct or gallbladder) disorders which included acute hepatic failure (3 or 1.1%).

Of the 180 patients studied and evaluable in the ChonDRAgon study as of the primary endpoint cutoff date of September 30, 2025, the se rious adverse events related to study drug (ozekibart during the double blind or crossover period) that occurred in more than one patient were (i) abnormal laboratory findings of increased alanine aminotransferase (6 or 3.3%), increased aspartate aminotransferase (5 or 2.8%), (ii) hepatobiliary disorders, which included hepatic failure (2 or 1.1%).

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.

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We initiated a Phase 1/2 clinical trial in December 2019 for INBRX-106.

This trial is designed as an open-label, four-part trial in patients with locally advanced or metastatic solid tumors.

Primary objectives of the trial are safety and tolerability, and the determination of the MTD and recommended Phase 2 dose of INBRX-106 as a single agent and in combination with Keytruda.

This trial was designed as an open-label, four-part trial in patients with locally advanced or metastatic solid tumors.

Primary objectives of the trial were safety and tolerability, and the determination of the MTD and recommended Phase 2 dose of INBRX-106 as a single agent and in combination with KEYTRUDA ® .

For some of the expansion cohorts in part 4, clinical anti-tumor efficacy, such as response rate, was also included as one of the primary objectives.

Secondary objectives are serum exposure, immunogenicity, as measured by the frequency of anti-drug antibodies, and clinical anti-tumor efficacy per RECIST (version 1.1) and immune RECIST based on response rate, duration of response, disease control rate, progression-free survival and overall survival.

Exploratory objectives will include evaluation of potential predictive diagnostic and pharmacodynamic biomarkers.

Secondary objectives were serum exposure, immunogenicity, as measured by the frequency of anti-drug antibodies, and clinical anti-tumor efficacy per RECIST (version 1.1) and immune RECIST based on response rate, duration of response, disease control rate, progression-free survival and overall survival.

Exploratory objectives included evaluation of potential predictive diagnostic and pharmacodynamic biomarkers.

Part 1 of the trial utilized a traditional 3+3 algorithm for single agent dose escalation from 0.0003 mg/kg to 3 mg/kg in twenty patients.

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NSCLC, melanoma, HNSCC, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma.

In Parts 3 and 4 of this trial, INBRX-106 is being evaluated in combination with Keytruda.

In the all-comer Part 3 of the trial, INBRX-106 was escalated in combination with Keytruda and enrolled patients with locally advanced or

metastatic solid tumors.

In Parts 3 and 4 of this trial, INBRX-106 was evaluated in combination with KEYTRUDA ® .

In the all-comer Part 3 of the trial, INBRX-106 was escalated in combination with KEYTRUDA ® and enrolled patients with locally

advanced or metastatic solid tumors.

It was observed to be well tolerated, with predominantly mild or moderate non-serious immune-related toxicities noted.

We observed durable responses across multiple tumor types.

In Part 4, INBRX-106 combination expansion cohorts, we continue to enroll patients with NSCLC and HNSCC, both in combination with Keytruda.

The patients must be positive for PD-L1 expression, as determined by immunohistochemistry, and possess adequate hematologic and organ function, to qualify for enrollment.

As of the January 3, 2025 cutoff date, it has been observed to be well tolerated, with predominantly mild or moderate non-serious immune-related toxicities noted.

The initial data observed from 24 NSCLC patients who all had previous checkpoint inhibitor exposure was tumor reduction or stabilization of target lesions in more than half the patients.

In Part 4, INBRX-106 combination expansion cohorts, we enrolled patients with NSCLC and HNSCC, both in combination with KEYTRUDA ® .

The patients had to be positive for PD-L1 expression, as determined by immunohistochemistry, and possess adequate hematologic and organ function, to qualify for enrollment.

The initial data with a cutoff date of August 2024 was observed from 24 NSCLC patients who all had previous checkpoint inhibitor exposure was tumor reduction or stabilization of target lesions in more than half the patients.

Of those patients, one complete response and four partial responses were observed.

The initial data observed from 14 HNSCC patients, seven of which were checkpoint failures and seven of which were checkpoint naive, was tumor reduction of target lesions in half the patients.

The initial data with a cutoff date of August 2024 was observed from 14 HNSCC patients, seven of which were checkpoint failures and seven of which were checkpoint naive, was tumor reduction of target lesions in half the patients.

Of those patients, two complete responses and five partial responses were observed.

These cohorts have been expanded to recruit additional patients, and a new cohort was added in NSCLC patients with any PD-L1 status to evaluate the safety of chemotherapy when used in conjunction with the INBRX-106 and KEYTRUDA ® combination.

All of these cohorts are currently recruiting, and we expect to have a more mature dataset in the fourth quarter of 2025 and plan to provide an update at that time.

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 locally advanced recurrent or metastatic head and neck cancer, or HNSCC.

This trial will recruit patients who have not received prior checkpoint inhibitors and whose tumors express a PDL-1 combined positive score, or CPS, equal to or greater than 20.

We plan to enroll approximately 60 patients in the Phase 2 portion with a primary endpoint of overall response rate, or ORR, supported by secondary endpoints of duration of response, PFS, and safety.

The Phase 3 portion, pending receipt of the Phase 2 data, will be approximately 350 patients randomized to INBRX-106 or placebo in combination with Keytruda.

The primary endpoint for the Phase 3 portion of the study will be PFS and overall survival.

We expect to announce data from the Phase 2 portion of this trial in the fourth quarter of 2025.

Early evaluation of the data indicate INBRX-106 in combination with pembrolizumab can be safely combined with chemotherapy, which supports further evaluation of this combination in indications where checkpoint inhibitors are used in conjunction with chemotherapy.

In November 2025, we 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, or ORR, disease control rate, duration of response, or DOR, and safety.

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 locally advanced recurrent or metastatic HNSCC.

This trial recruited patients who had not received prior checkpoint inhibitors and whose tumors expressed a PDL-1 combined positive score, or CPS, equal to or greater than 20.

During the first quarter of 2026, we completed enrollment of 68 patients in the Phase 2 portion with a primary endpoint of ORR, supported by secondary endpoints of DOR, PFS, and safety.

We plan to provide initial results from the Phase 2 trial in the second quarter of 2026.

We plan to announce PFS data from this trial in the fourth quarter of 2026 at the European Society for Medical Oncology 2026 Congress.

If positive, we anticipate this data may 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 are expected to be PFS and overall survival.

Safety Data for INBRX-106

Of the 213 patients studied and evaluable in our Phase 1/2 clinical trial for INBRX-106 as of the cutoff date of January 3, 2025, the treatment-related serious adverse events observed were (i) general disorders and administration site conditions, which consisted of pyrexia, or fever (4 or 1.9%), systemic inflammatory response syndrome (1 or 0.5%), and influenza-like illness (1 or 0.5%), (ii) metabolism and nutrition disorders, which consisted of failure to thrive (1 or 0.5%), hyponatremia, a condition when the sodium levels in blood are lower than normal (1 or 0.5%), and hypercalcemia, a condition when the calcium levels in blood are higher than normal (1 or 0.5%), (iii) gastrointestinal disorders, which consisted of diarrhea (3 or 1.4%), gastritis (1 or 0.5%), colitis (1 or 0.5%), immune-mediated enterocolitis (1 or 0.5%), and vomiting (1 or 0.5%), (iv) blood and lymphatic system disorders, which consisted of anemia (1 or 0.5%) and pancytopenia, a condition in which there is lower-than-normal number of red and white blood cells and platelets in the blood (1 or 0.5%), (v) cardiac disorders, which consisted of acute myocardial infarction (1 or 0.5%), immune-mediated myocarditis (1 or 0.5%), myocarditis (1 or 0.5%), and tachycardia (1 or 0.5%), (vi) cytokine release syndrome (3 or 1.4%), (vii) infusion-related reactions (2 or 0.9%), (viii) primary adrenal insufficiency (1 or 0.5%), (ix) increased blood bilirubin (1 or 0.5%), (x) myositis, or inflamed muscles (1 or 0.5%), (xi) toxic encephalopathy, or brain dysfunction caused by toxic exposure (1 or 0.5%), (xii) acute kidney injury (1 or 0.5%), (xiii) delirium (1 or 0.5%), (xiv) dyspnea (1 or 0.5%), (xv) drug eruption, a skin rash caused by medication (1 or 0.5%), and (xvi) pneumonia (2 or 0.9%).

Of the 272 patients studied and evaluable in our Phase 1/2 clinical trial for INBRX-106 as of the cutoff date of June 13, 2025, the treatment-related serious adverse events observed in more than one patient were (i) pyrexia, or fever (4 or 1.5%), (ii) diarrhea (3 or 1.1%), (iii) cytokine release syndrome (3 or 1.1%), (iv) infusion-related reactions (3 or 1.1%), (v) pneumonia (2 or 0.7%), and rash (2 or 0.7%).

Intellectual Property

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As of December 31, 2025, our patent estate contains 31 patent families that we solely own, 2 patent families that we co-own with Regeneron Pharmaceuticals, Inc.

(formerly 2Seventy Bio, Inc.) and 2 patent families that we co-own with Phylaxis BioScience, LLC.

(formerly 2Seventy Bio, Inc.) and 2 patent families that we co-own with Poplar Therapeutics, Inc., formerly Phylaxis BioScience, LLC.

The patent estate is comprised of 32 issued U.S.

patents, 164 issued foreign patents in various countries around the world, including Australia, Canada, China, Europe (validated in France, Germany, Italy, Spain, the United Kingdom and other European countries), Russia, India, Israel, Japan, Mexico, New Zealand, Singapore, South Korea, South Africa and other countries as further described below, 28 pending U.S.

patent applications, 3 pending Patent Cooperation Treaty, or PCT, applications and 420 pending patent applications in various jurisdictions outside of the U.S., as further described below.

patent applications, 3 pending Patent Cooperation Treaty, or PCT, applications, 1

pending US provisional application, and 348 pending patent applications in various jurisdictions outside of the U.S., as further described below.

With regard to INBRX-106, as of December 31, 2025, we solely own 3 patent families relating to the composition of matter of INBRX-106, its methods of use for the treatment of cancer and/or its alternative dosing regimens for the treatment of cancer.

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3 issued U.S.

patents, 10 issued patents in various countries around the world, including Australia, Indonesia, Israel, Japan, Mexico, Russia and Singapore, 2 pending U.S.

patent applications, 1 pending PCT application and 42 pending patent applications in various countries around the world, including Argentina, Australia, Brazil, Canada, China, Europe, Gulf Cooperation Council, India, Indonesia, Israel, Japan, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, South Korea, Taiwan, Thailand and Vietnam.

patents, 11 issued patents in various countries around the world, including Australia, Chile, Indonesia, Israel, Japan, Mexico, New Zealand, Russia and Vietnam, 1 pending U.S.

patent application, 2 pending PCT applications and 31 pending patent applications in various countries around the world, including Argentina, Australia, Brazil, Canada, China, Europe, Gulf Cooperation Council, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, New Zealand, Philippines, Singapore, South Africa, South Korea, Taiwan, and Thailand.

These patents and patents issuing from these applications, if any, are expected to expire between 2037 and 2044, absent any patent term adjustments or extensions or terminal disclaimers.

With regard to ozekibart (INBRX-109), as of December 31, 2024, we solely own 4 patent families relating to the composition of matter of INBRX-109, its methods of use for the treatment of cancer, its formulations, and/or its use in combination with select compounds.

ozekibart (INBRX-109)

With regard to ozekibart, as of December 31, 2025, we solely own 4 patent families relating to the composition of matter of ozekibart, its methods of use for the treatment of cancer, its formulations, and/or its use in combination with select compounds.

These patent families are comprised of:

3 issued U.S.

patents, 49 issued patents in various countries around the world, including Australia, China, Europe (validated in France, Germany, Italy, Spain, the United Kingdom and other European countries), India, Indonesia, Israel, Japan, Mexico, Russia, Singapore and South Africa, 4 pending U.S.

patent applications and 63 pending patent applications in various countries around the world, including Australia, Brazil, Canada, China, Eurasia, Europe, Indonesia, India, Israel, Japan, Mexico, New Zealand, Russia, Singapore, South Africa, South Korea, Taiwan and Thailand.

patents, 53 issued patents in various countries around the world, including Australia, Brazil, China, Europe (validated in France, Germany, Italy, Spain, the United Kingdom and other European countries), Hong Kong, India, Indonesia, Israel, Japan, Mexico, New Zealand, Russia, Singapore, South Korea, and South Africa, 4 pending U.S.

patent applications and 61 pending patent applications in various countries around the world, including Australia, Brazil, Canada, China, Eurasia, Europe, Hong Kong, Indonesia, India, Israel, Japan, Mexico, New Zealand, Russia, Singapore, South Africa, South Korea, Taiwan and Thailand.

These patents and patents issuing from these applications, if any, are expected to expire between 2036 and 2043, absent any patent term adjustments or extensions or terminal disclaimers.

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4 issued U.S.

patents, 12 issued patents in Australia, Canada, India, Japan, Malaysia, Mexico, New Zealand, Russia and South Korea, 7 pending U.S.

patent applications and 90 pending patent applications in various countries around the world, including Argentina, Australia, Brazil, Canada, China, Europe, Gulf Cooperation Council, India, Israel, Japan, Malaysia, Mexico, New Zealand, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea and Taiwan.

patents, 26 issued patents in Australia, Canada, China, Hong Kong, Indonesia, India, Israel, Japan, Malaysia, Mexico, New Zealand, Russia, Singapore, South Korea, and Taiwan, 6 pending U.S.

patent applications and 83 pending patent applications in various countries around the world, including Argentina, Australia, Brazil, Canada, Chile, China, Europe, Gulf Cooperation Council, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea and Taiwan.

These patents and patents issuing from these applications, if any, are expected to expire between 2036 and 2041, absent any patent term adjustments or extensions or terminal disclaimers.

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However, the term of United States patents may be extended for delays incurred due to compliance with the FDA requirements or by delays encountered during prosecution that are caused by the USPTO.

For example, the Hatch-Waxman Act permits a patent term extension for FDA-approved drugs of up to five years beyond the expiration of

For example, the Hatch-Waxman Act permits a patent term extension for FDA-approved drugs of up to five years beyond the expiration of the patent.

The length of the patent term extension is related to the length of time the drug is under regulatory review.

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Similar provisions are available in Europe and other jurisdictions to extend the term of a patent that covers an approved drug.

In the future, if and when our therapeutic candidates receive FDA approval, we expect to apply for patent term extensions on patents covering those therapeutic candidates.

In the future, if and when our therapeutic candidates receive FDA approval, we expect to apply for patent term extensions on

patents covering those therapeutic candidates.

We intend to seek patent term extensions in any jurisdiction where these are available and where we also have a patent that may be eligible;

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Our primary competitors fall into the following groups:

• Companies developing novel therapeutics based on sdAb or alternative scaffold product candidates, including Alligator Bioscience AB, Crescendo Biologics Ltd., GlaxoSmithKline plc, Lava Therapeutics N.V., Molecular Partners AG, Precirix NV, and Sanofi;

• Companies developing novel therapeutics based on sdAb or alternative scaffold product candidates, including Crescendo Biologics Ltd., Molecular Partners AG, Precirix NV, Affibody Medical AB, Numab Therapeutics AG, GT Biopharma, Inc., and Sanofi;

• Antibody drug discovery companies that may compete with us in the search for novel therapeutic antibody targets, including Regeneron Pharmaceuticals, Inc., Adimab LLC, Genmab A/S, Macrogenics, Inc., Merus N.V., Numab Therapeutics AG, Amgen, Inc., Xencor, Inc., and Zymeworks Inc.;

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The availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of our therapeutic candidates.

Our competitors also may obtain FDA or other marketing approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Our competitors also may obtain FDA or other marketing

approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Many of the companies against which we may compete 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 we do.

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Governmental authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of product candidates such as those we are developing.

Our therapeutic candidates must be approved by the FDA through the Biologics License Application, or BLA, process before they may be legally marketed in the United States and will be subject to similar requirements in other countries prior to marketing in those countries.

Our therapeutic candidates must be approved by the FDA through the BLA process before they may be legally marketed in the United States and will be subject to similar requirements in other countries prior to marketing in those countries.

The process of obtaining marketing approvals in the U.S.

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• satisfactory completion of an FDA advisory committee review, if applicable;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current Good Manufacturing Practice requirements, or cGMPs, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current Good Manufacturing Practice requirements, or cGMPs, to assure that the facilities, commercial manufacturing process, testing methods and controls are adequate to ensure manufacturing robustness and to preserve the drug’s identity, strength, quality and purity;

• satisfactory completion of potential inspection of selected clinical investigation sites to assess compliance with GCPs;

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An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an IND.

An IND is a request for allowance from the FDA to administer an

investigational drug or biological product to humans.

An IND is a request for allowance from the FDA to administer an investigational drug or biological product to humans.

An IND will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the trial includes an efficacy evaluation.

Some preclinical testing may continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA,

within the 30-day time period, places the clinical trial on a clinical hold.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

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Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval.

These trials are used to gain additional experience from the treatment of patients in the approved therapeutic

These trials are used to gain additional experience from the treatment of patients in the approved therapeutic indication.

In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of a BLA.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMPs.

manufacturing the product in commercial quantities in accordance with cGMPs.

The manufacturing process must be capable of consistently producing quality batches of the therapeutic candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug.

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Under the PREA, BLAs and certain supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver.

The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective.

The required assessment must evaluate the safety and effectiveness of the product in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective.

The sponsor or FDA may request a deferral of pediatric clinical trials for some or all of the pediatric subpopulations.

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After the FDA evaluates a BLA and conducts any required inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter, or CRL.

An approval letter authorizes commercial marketing of the drug with

prescribing information for specific indications.

An approval letter authorizes commercial marketing of the drug with prescribing information for specific indications.

A CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form.

A CRL usually describes the specific deficiencies in the BLA identified by the FDA and may require additional clinical data, including additional clinical trials, or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.

If a CRL is issued, the sponsor must resubmit the BLA addressing all of the deficiencies identified in the letter or withdraw the application.

If a CRL is issued, the sponsor must resubmit the BLA addressing all of the deficiencies identified in

the letter or withdraw the application.

Even if such data and information are submitted, the FDA may decide that the resubmitted application does not satisfy the criteria for approval.

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The sponsor of a Fast Track therapeutic candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the application may be eligible for priority review.

With regard to a Fast Track candidate, the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a

schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

With regard to a Fast Track candidate, the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A therapeutic candidate intended to treat a serious or life-threatening disease or condition may also be eligible for Breakthrough Therapy designation to expedite its development and review.

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The FDA may withdraw or limit approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing

processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;

imposition of requirements for post-market studies or clinical studies to assess new safety risks;

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Pediatric exclusivity, if granted, adds six months to existing exclusivity periods for all formulations, dosage forms, and indications of the active ingredient and to patent terms.

This six-month exclusivity, which runs from the end of an existing period of non-patent regulatory exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study, provided that at the time pediatric exclusivity is granted there is not less than nine months of exclusivity or patent term remaining.

This six-month exclusivity, which runs from the end of an existing period of non-patent regulatory exclusivity protection or patent term, may be granted based on the voluntary completion of a

pediatric study in accordance with an FDA-issued “Written Request” for such a study, provided that at the time pediatric exclusivity is granted there is not less than nine months of exclusivity or patent term remaining.

Pediatric exclusivity does not require the sponsor to obtain approval for the applicable product in the studied pediatric indication.

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Device manufacturers must also establish registration and device listings with the FDA.

production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices.

A medical device manufacturer’s manufacturing processes and those of its suppliers are required to comply with the applicable portions of the QSR, which currently covers the methods and documentation of the design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices.

Manufacturing sites for devices also remain subject to periodic unscheduled inspections by the FDA.

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The overall ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications, which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

However, there is

no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical or biological entity, and products may not qualify for data exclusivity.

However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical or biological entity, and products may not qualify for data exclusivity.

Orphan Medicinal Products

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On January 31, 2020, the United Kingdom formally withdrew from the EU, also known as Brexit.

The United Kingdom and the EU entered into a trade agreement known as the Trade and Cooperation Agreement, which went into effect on January 1, 2021.

The United Kingdom and the EU entered into a trade agreement known as the Trade and Cooperation Agreement, which went

into effect on January 1, 2021.

As of January 1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, is the United Kingdom’s standalone medicines regulatory body.

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government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic and biosimilar products.

For example, the U.S.

Department of Health and Human Services, or HHS, imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.

Products subject to the

Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.

If third-party payors do not consider our

products to be cost-effective compared to other therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.

If third-party payors do not consider our products to be cost-effective compared to other therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.

In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products.

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Moreover, among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

For example, the Affordable Care Act, or ACA, was enacted in March 2010 and has had a significant impact on the health care industry in the United States.

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, was enacted in March 2010 and has had a significant impact on the health care industry in the United States.

It also included the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

Among the provisions of the ACA of importance to our potential drug candidates are the implementation of a new methodology for calculating rebates owed by manufacturers under the Medicaid Drug Rebate Program for drugs that are inhaled, infused, instilled, implanted or injected;

an increase of the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program;

expanding manufacturer Medicaid rebate liability to include utilization under Medicaid managed care organizations;

and establishing annual fees on manufacturers of certain branded prescription drugs.

Since its enactment, certain provisions of the ACA have been subject to judicial, executive, and legislative challenges.

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Thus, the ACA will remain in effect in its current form.

As another example, the American Rescue Plan Act of 2021 included a provision that eliminated the statutory cap on manufacturer Medicaid rebates.

Beginning in January 2024, Medicaid rebates are no longer capped at 100 percent of the drug’s average manufacturer price.

Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship

between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

Most significantly, in August 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law.

This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010.

Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap;

imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

redesigns the Medicare Part D benefit (beginning in 2024);

and replaces the Part D coverage gap discount program with a new manufacturer discount program (beginning in 2025).

CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and has published the list of the subsequent 15 drugs that will be subject to negotiation.

The IRA permits the Secretary of the Department of Health and Human Services, or HHS, to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

HHS has and will continue to issue and update guidance as these programs are implemented, although the Medicare drug price negotiation program is currently subject to legal challenges.

While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

For example, on July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

We expect that additional U.S.

federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S.

federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, the U.S.

Centers for Medicare & Medicaid Services, or CMS, and related agencies.

These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct-to-consumer platform, or TrumpRx, U.S.

patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.

Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;

(2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives;

(3) imposing tariffs on imported pharmaceutical products;

and (4) as part of the Make America Healthy Again Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.

Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things.

These actions and policies may significantly reduce U.S.

drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

In June 2024, the U.S.

Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure, drug price reporting and other transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states.

We expect that further legislative changes or additions to the ACA, the IRA, the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the health care industry in the United States.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

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Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which also imposes certain obligations with respect to safeguarding the privacy and security of individually identifiable health information of covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers, as well as their business associates, independent contractors of a covered entity that perform certain services involving the use or disclosure of individually identifiable health information on their behalf and their covered subcontractors;

• The Physician Payments Sunshine Act, enacted as part of the ACA, among other things, imposes reporting requirements on manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), teaching hospitals and certain advanced non-physician healthcare practitioners, as well as ownership and investment interests held by physicians and their immediate family members.

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state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug and therapeutic biologics manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures and pricing information;

and state and local laws which require the registration of pharmaceutical sales representatives.

Ensuring that our current and future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs.

It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any such requirements, we may be subject to significant civil, criminal and administrative penalties, including monetary damages, fines, disgorgement, imprisonment, loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, reputational harm, diminished profits and future earnings, additional reporting requirements if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and the curtailment or restructuring of our operations.

and state and local laws which require certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives.

and European Data Privacy and Security Laws

Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners.

In the United States, numerous federal and state laws and

regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information.

In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.

In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information.

In addition, certain foreign laws govern the privacy and security of personal data, including

health-related data.

For example, the European Union General Data Protection Regulation, or the EU GDPR, and the United Kingdom General Data Protection Regulation and Data Protection Act 2018, or collectively, the UK GDPR (the EU GDPR and UK GDPR together referred to as the “GDPR”), impose comprehensive data privacy compliance obligations in relation to the collection and use of data relating to an identifiable living individual or “personal data”, including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training and audit, as well as regulating cross-border transfers of personal data out of the European Economic Area, or the EEA, and the UK.

Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

Additionally, the U.S.

Department of Justice issued a rule entitled the Preventing Access to U.S.

Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restriction on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons (i.e., individuals and entities who are designated as such by the U.S.

Attorney General or considered “foreign persons” and are majority owned by, organized under the laws of, a primary resident in, or a contractor of, a covered person or country of concern, as applicable) that may impact certain business activities such as vendor engagements, sale or sharing of data, employment of certain individuals, and investor agreements.

Violations of the rule could lead to significant civil and criminal fines and penalties.

The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which presents particular challenges for companies like ours and may impact our ability to engage in certain transactions or agreements with certain third parties in the future.

Other Laws and Regulations

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Employee Conduct & Ethics

We adopted corporate policies, including a Code of Conduct and Ethics and Whistleblower Policy, which apply to all of our employees.

All employees complete a mandatory public company training session and are required to abide by, review and confirm compliance to the Company’s Corporate Code of Conduct and Ethics and Whistleblower Policy, as well as our Insider Trading Policy governing trading by Company personnel in the Company’s securities.

We have adopted corporate policies, including a Corporate Code of Conduct and Ethics and Whistleblower Policy, or Code of Conduct, which apply to all of our employees.

All employees complete a mandatory public company

training session and are required to abide by, review and confirm compliance with our Code of Conduct, as well as our Insider Trading Policy governing trading by our personnel in our securities.

We have established a whistleblower reporting hotline to enable our employees to anonymously report any suspected violations of these policies.

In addition, the Company requires employees to complete Anti-Harassment Training, with employees who work in a management capacity required to complete additional trainings in Harassment Prevention.

In addition, we require employees to complete Anti-Harassment Training, with employees who work in a management capacity required to complete additional trainings in Harassment Prevention.

Employee Compensation and Benefits

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We provide internship opportunities for students interested in biotechnology and science within our research and development departments.

Many of our interns have continued on to join the Company in a full-time position after graduation.

Many of our interns have continued on to join us in a full-time position after graduation.

Our hiring process is transparent and we are an equal opportunity employer and prohibits all forms of unlawful discrimination in accordance with applicable law.

Many of our employees hold advanced degrees, as well as professional licenses and certifications;

however, the Company equally commits resources to advancing all of our employees with a range of educational backgrounds.

however, we equally commit resources to advancing all of our employees with a range of educational backgrounds.

We offer tuition reimbursement aimed at growth and career development, as well as the opportunity for employees to attend relevant conferences and symposiums.

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Corporate Information

The Company was incorporated as Ibex SpinCo, Inc.

Our company was incorporated as Ibex SpinCo, Inc.

on January 8, 2024 under the laws of the State of Delaware as a direct, wholly-owned subsidiary of the Former Parent.

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Legal Proceedings

Except as disclosed below, we are not currently a party to any material legal proceedings.

We are not currently a party to any material legal proceedings.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business.

Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

In November 2024, the Company was successful in the trade secrets case brought against it by I-Mab Biopharma in the United States District Court for the District of Delaware, with the jury rejecting all allegations of misappropriation before it.

In January 2025, the parties reached a settlement as to all asserted claims of misappropriation, including those claims not tried to the jury.

Pursuant to that agreement, the Court dismissed the action with prejudice.

Emerging Growth Company and Smaller Reporting Company Status

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business