On March 6, 2023 Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a biopharmaceutical company with four clinical programs in development and a strong emerging pipeline, reported financial results for the fourth quarter and fiscal year 2022 (Press release, Inhibrx, MAR 6, 2023, View Source [SID1234628188]).
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Key Highlights
•INBRX-101: Timing for the potentially registration-enabling trial for Alpha-1 Antitrypsin Deficiency, or AATD, is on track with sites expected to activate and initiate enrollment in April 2023. Initial trial data is anticipated in early 2025. We expect to initiate clinical trial(s) in Graft-versus-host-disease, or GvHD, during the second half of 2023.
•INBRX-105: To date, we have observed a therapeutic window for our targeted 4-1BB agonist in the checkpoint refractory population, with responses both as a single agent and in combination with Keytruda. We expect to announce clinical data from these cohorts during the second half of 2023.
•INBRX-109: We believe we can now more precisely identify the at-risk population for severe liver toxicity in our DR5 agonist trials as elderly individuals with fatty liver disease. Enrollment is paused while we implement the Hepatic Steatosis Index, or HSI, into our screening criteria protocol. We expect enrollment to resume by the middle of the year and do not anticipate this to impact the timeline for completion of the potentially registration-enabling trial in chondrosarcoma during the second half of 2024.
Financial Results
•Cash and Cash Equivalents. As of December 31, 2022, Inhibrx had cash and cash equivalents of $273.9 million, compared to $131.3 million as of December 31, 2021.
•R&D Expense. Research and development expenses were $30.5 million during the fourth quarter of 2022, compared to $18.6 million during the fourth quarter of 2021. Research and development expenses were $110.2 million during the fiscal year 2022, compared to $71.4 million during the fiscal year 2021. Clinical trial expenses increased related to the progression of the Company’s four Phase 1 trials and its potentially registration-enabling Phase 2 trial, which was initiated during the second quarter of 2021. The Company 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 both periods, partially attributable to an increase in headcount as the Company continues to expand its clinical operations and technical operations teams as well as increased salaries and the expansion of our bonus eligibility pool in the current year.
•G&A Expense. General and administrative expenses were $5.3 million during the fourth quarter of 2022, compared to $3.6 million during the fourth quarter of 2021. General and
Exhibit 99.1
administrative expenses were $21.1 million during the fiscal year 2022, compared to $12.4 million during the fiscal year 2021. This overall increase in both periods was primarily driven by an increase in personnel-related costs, in part due to the expansion of the Company’s commercial strategy team as well as an increase in salaries and the expansion of our bonus eligibility pool in the current year. In addition, market research and other scientific publication expenses were incurred related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109. The Company also incurred increased accounting and legal fees as a result of the establishment of its ATM facility and the continued expansion of its intellectual property portfolio.
•Net Loss. Net loss was $40.9 million during the fourth quarter of 2022, or $0.95 per share, compared to $21.2 million during the fourth quarter of 2021, or $0.55 per share. Net loss was $145.2 million during the fiscal year 2022, or $3.62 per share, compared to $81.8 million during the fiscal year 2021, or $2.15 per share.