On November 7, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biopharmaceutical company with four clinical programs in development and a strong emerging pipeline, reported financial results for the third quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, NOV 7, 2022, View Source [SID1234623336]).
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Recent Corporate Highlights
On August 15, 2022, Inhibrx announced that the European Commission, based on a positive opinion issued by the European Medicines Agency, has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
On October 4, 2022, Inhibrx announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is potential to pursue an accelerated approval in the United States for INBRX-101 in patients with emphysema due to Alpha-1 Antitrypsin Deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint. Inhibrx plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA’s Accelerated Approval Program.
On October 4, 2022, Inhibrx announced the detection of INBRX-101 in the bronchoalveolar lavage fluid samples from all AATD patients tested in the Phase 1 study.
On October 26, 2022, Inhibrx announced the draw of its final tranche under its loan and security agreement with Oxford Finance LLC and received gross proceeds of $30.0 million.
Financial Results
Cash and Cash Equivalents. As of September 30, 2022, Inhibrx had cash and cash equivalents of $146.1 million, compared to $131.3 million as of December 31, 2021. As of October 31, 2022, Inhibrx had cash and cash equivalents of $290.2 million.
R&D Expense. Research and development expenses were $24.9 million during the third quarter of 2022, compared to $18.5 million during the third quarter of 2021. During the third quarter of 2022, Inhibrx’s clinical trial expenses increased, both for its Phase 1 trials as they continue to progress, as well as its continued expenses related to the INBRX-109 potentially registration-enabling Phase 2 trial which was initiated during the second quarter of 2021. The organization also incurred increased contract manufacturing expenses due to greater production run costs at its contract development and manufacturing organization partners, including drug substance batch manufacturing in preparation for a Phase 2 trial supply and pilot batch production for one of its preclinical candidates. Personnel-related costs also increased during the period, which is attributable to an increase in headcount as Inhibrx continues to expand its clinical operations and technical operations teams.
G&A Expense. General and administrative expenses were $5.3 million during the third quarter of 2022, compared to $2.8 million during the third quarter of 2021. This overall increase was primarily driven by an increase in additional personnel-related costs due to an increase in headcount as the organization builds out its commercial strategy team. In addition, Inhibrx incurred market research and other scientific publication expenses related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $35.3 million during the third quarter of 2022, or $0.90 per share, compared to $20.6 million during the third quarter of 2021, or $0.54 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary single-domain antibody (sdAb) platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.