Business Overview and History

Inhibrx Biosciences, Inc. (INBX) is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. The company has leveraged its innovative protein engineering technologies and deep understanding of target biology to create therapeutic candidates with attributes and mechanisms superior to current approaches, applicable to a range of challenging, validated targets with high potential.

Inhibrx Biosciences, Inc. was founded in 2017, initially operating as Inhibrx, Inc. The company's primary focus was on developing a broad pipeline of novel biologic therapeutic candidates using its proprietary modular protein engineering platforms. In its early years, Inhibrx faced several challenges as it worked to advance its preclinical programs. These challenges included securing funding for R&D efforts, establishing key partnerships, and navigating the complex regulatory landscape for bringing new biologic drugs to market.

Despite these obstacles, Inhibrx made steady progress in moving its lead therapeutic candidates, including ozekibart (INBRX-109) and INBRX-106, into clinical trials. In 2020, the company took a significant step to support its ongoing development activities by entering into a loan and security agreement with Oxford Finance LLC, securing up to $200 million in financing. This financial boost provided critical runway for Inhibrx to continue advancing its pipeline.

In 2022, Inhibrx faced a legal challenge when I-Mab Biopharma filed a lawsuit alleging misappropriation of trade secrets. However, the company successfully defended itself, with a jury finding in favor of Inhibrx and rejecting all of I-Mab's allegations in November 2024.

Prior to 2024, Inhibrx operated as a subsidiary of Inhibrx, Inc. (the "Former Parent"). A major transformation occurred in January 2024 when the Former Parent announced its intent to spin off Inhibrx's INBRX-101 program, an optimized, recombinant alpha-1 antitrypsin therapy, into a separate company. This separation was completed in May 2024, at which point Inhibrx Biosciences emerged as a standalone, publicly traded company focused on advancing its remaining programs, ozekibart (INBRX-109) and INBRX-106.

In 2020, Inhibrx entered into a strategic collaboration with Regeneron Pharmaceuticals, granting the company exclusive worldwide rights to develop binders and cell therapy products containing single-domain antibodies (sdAbs) directed to specified targets. This partnership has continued to evolve, with Regeneron exercising options to advance additional programs under the agreement.

In 2024, Inhibrx underwent a significant transformation as its former parent company, Inhibrx, Inc., announced plans to spin off the INBRX-101 program, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy, to Sanofi S.A. As part of this transaction, Inhibrx Biosciences was established as a standalone, publicly traded company, retaining the assets and liabilities associated with its ongoing programs, INBRX-106 and ozekibart INBRX-109, as well as its discovery pipeline.

The spin-off and subsequent merger of Inhibrx, Inc. with Sanofi's subsidiary allowed Inhibrx Biosciences to focus solely on the development and commercialization of its promising oncology and rare disease therapeutic candidates. The company's clinical pipeline now includes ozekibart INBRX-109, a tetravalent death receptor 5 (DR5) agonist, and INBRX-106, a precisely engineered hexavalent sdAb-based therapeutic candidate targeting OX40.

Financials

As of September 30, 2024, Inhibrx Biosciences reported cash and cash equivalents of $196.33 million, reflecting the proceeds from the Sanofi transaction and the exercise of stock options by employees. The company's net income for the nine months ended September 30, 2024, was $1.74 billion, primarily driven by the gain recognized on the Sanofi transaction.

Inhibrx's research and development expenses for the nine months ended September 30, 2024, were $170.38 million, reflecting the company's continued investment in the development of its clinical-stage programs and its discovery pipeline. General and administrative expenses for the same period were $111.24 million, including $68.10 million in expenses related to the Sanofi transaction.

For the most recent fiscal year, Inhibrx reported annual revenue of $1.63 million, an annual net loss of $155 million, annual operating cash flow of negative $129 million, and annual free cash flow of negative $133.6 million. In the most recent quarter, the company reported no revenue and a net loss of $43.86 million. The decrease in revenue and net income compared to the prior year was primarily due to the company's continued investment in research and development for its clinical programs.

Liquidity

The company's strong financial position, with no outstanding debt following the Sanofi transaction, provides Inhibrx Biosciences with the resources and flexibility to advance its clinical programs and explore new opportunities in the oncology and rare disease space. As of September 30, 2024, Inhibrx had a debt-to-equity ratio of 0.01, a current ratio of 4.70, and a quick ratio of 4.70. Prior to the merger, the company had $200 million in outstanding debt under the Amended 2020 Loan Agreement with Oxford Finance, which was assumed and repaid by the acquirer.

Clinical Pipeline and Milestones

Inhibrx's clinical pipeline is currently focused on two lead therapeutic candidates:

1. ozekibart INBRX-109: A tetravalent DR5 agonist being evaluated in patients diagnosed with difficult-to-treat cancers, such as chondrosarcoma, mesothelioma, colorectal cancer, Ewing sarcoma, and pancreatic adenocarcinoma. In June 2021, the company initiated a registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma, for which the FDA and EMA have granted orphan drug designation. The company expects to report data from this trial in the middle of 2025.

2. INBRX-106: A precisely engineered hexavalent sdAb-based therapeutic candidate targeting OX40, designed to be an optimized agonist of this co-stimulatory receptor. INBRX-106 is currently being investigated as a single agent and in combination with Keytruda in patients with locally advanced or metastatic solid tumors. The company has completed parts 1 and 3 of the Phase 1/2 trial and is continuing to enroll patients in part 4, with data expected in the second half of 2025. Additionally, a seamless Phase 2/3 clinical trial was initiated in June 2024 for INBRX-106 in combination with Keytruda as a first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Inhibrx's robust pipeline and the ongoing clinical development of its lead candidates position the company well to potentially address significant unmet medical needs in oncology and rare diseases. The company's anticipated data readouts in 2025 will be crucial milestones as it continues to advance its therapeutic candidates through the clinical stage.

Competitive Landscape and Risks

Inhibrx operates in a highly competitive biopharmaceutical industry, with numerous companies developing novel therapies for oncology and rare diseases. The company faces competition from both large pharmaceutical and biotechnology companies, as well as smaller, specialized players. The success of Inhibrx's therapeutic candidates will depend on their ability to demonstrate superior efficacy, safety, and differentiation compared to existing and emerging therapies.

One of the key risks facing Inhibrx is the inherent uncertainty and challenges associated with the drug development process. The company's ability to successfully navigate clinical trials, obtain regulatory approvals, and eventually commercialize its products will be critical to its long-term success. Additionally, Inhibrx's reliance on third-party contract manufacturers and the potential for supply chain disruptions, as well as the company's ability to attract and retain key talent, represent additional risks that the management team must actively manage.

Outlook and Conclusion

Inhibrx Biosciences has emerged as a promising player in the oncology and rare disease landscape, leveraging its innovative protein engineering platforms to develop a diverse pipeline of therapeutic candidates. The company's successful spin-off from its former parent and the subsequent merger with Sanofi have positioned Inhibrx for a renewed focus on its core programs, ozekibart INBRX-109 and INBRX-106.

With a strong financial position and an anticipated slate of key data readouts in 2025, Inhibrx is well-positioned to continue advancing its clinical-stage assets and expanding its presence in the biopharmaceutical industry. As the company navigates the competitive landscape and the inherent challenges of drug development, its ability to successfully execute on its strategic priorities will be crucial in driving long-term value for its shareholders.

The company's primary operations are in the United States, and it has successfully overcome legal challenges, as evidenced by the favorable jury verdict in the lawsuit filed by I-Mab Biopharma. This legal victory, along with the company's strategic focus on its core oncology pipeline, positions Inhibrx Biosciences for potential growth and success in the coming years.