On March 25, 2025 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, AN2 Therapeutics, MAR 25, 2025, View Source [SID1234651439]).
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"Epetraborole demonstrated potential proof-of-concept in Phase 2, achieving nominal statistical significance on two patient-reported outcome measures in patients with treatment-refractory MAC lung disease. Building on these encouraging findings, we updated our statistical analysis plan to select QOL-B as the primary efficacy endpoint for the Phase 3 part of the study, for which we plan to unblind and announce topline results in the second quarter. Should the Phase 3 data support the findings from Phase 2, we plan to engage with the FDA to explore potential registrational pathways for this highly refractory population with limited treatment options," said Eric Easom Co-Founder, Chairman, President and Chief Executive Officer. "Our robust pipeline, including upcoming clinical trials in Chagas disease and melioidosis, highlights our commitment to advancing innovative treatments. We also anticipate our first oncology development candidate later this year and are excited about the potential of our pipeline to address unmet medical needs and improve patient outcomes."
Fourth Quarter & Recent Business Updates:
Epetraborole Phase 2/3 Clinical Study in TR-MAC Lung Disease
In February 2025, the Company submitted an amended statistical analysis plan to the FDA selecting the Quality of Life – Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial. The Company believes that this approach aligns with current FDA Guidance for Industry on NTM drug development regarding the use of a symptom-focused clinical outcome measure as the sole primary endpoint and it also follows the precedent established by Insmed’s ongoing confirmatory study of Arikayce in treatment-naïve patients, where Insmed has reported the same QOL-B instrument as the primary efficacy measure.
The Company intends to announce topline Phase 3 results in the second quarter of 2025, subject to the timing of any potential FDA feedback with respect to the trial or amended statistical analysis plan. Ninety-seven subjects had completed treatment in Phase 3 when the trial was terminated in August 2024 (2:1 epetraborole+optimized background regimen (OBR) vs. placebo+OBR), the data for which remains blinded and available for analysis as a Phase 3 dataset. If the Phase 3 data align with the potential efficacy signal observed in Phase 2, the Company plans to review both Phase 2 and Phase 3 results with the FDA and discuss potential registrational pathways.
Chagas Disease
During the quarter, the Company conducted Phase 1-enabling activities for AN2-502998, a candidate for chronic Chagas disease, which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S., and can cause severe cardiac disease and death. The Company plans to initiate a Phase 1 clinical study in mid-2025.
Melioidosis
The Company completed enrollment in a 200-patient observational trial in acute melioidosis in October 2024. These data will inform a potential Phase 2 proof of concept study of epetraborole that is planned to initiate start up activities in the second half of 2025. Melioidosis is a deadly bacterial infection and global bioterrorism threat with a 90-day mortality rate of approximately 50% using standard of care drugs ceftazidime or meropenem. The aim of the program is to meaningfully lower the expected mortality rate by dosing epetraborole on top of standard of care.
Boron Chemistry Pipeline
Additional development programs are underway and focused on targets in infectious diseases and oncology with high unmet needs. The Company anticipates delivering development compound(s) in 2025, including the first oncology targets using its boron chemistry platform.
Global Health
In October 2024, the Company announced that it received a second-year continuation of a research grant from the Gates Foundation to discover novel boron containing small molecules for the treatment of tuberculosis and malaria. The Company will continue its efforts to tackle global health disease through non-dilutive funding.
Selected Fourth Quarter and Full Year 2024 Financial Results
Research and Development (R&D) Expenses: R&D expenses for the full year 2024 were $40.5 million, compared to $54.9 million in the prior year. R&D expenses for the fourth quarter of 2024 were $5.4 million, compared to $14.9 million for the same period during 2023 due to decreased clinical trial expenses, personnel-related expenses, consulting and outside services, chemistry manufacturing and controls expenses, and allocated facilities and miscellaneous expenses, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities, and a decrease in licensing fees, partially offset by an increase in preclinical and research expenses.
General and Administrative (G&A) Expenses: G&A expenses for the full year 2024 were $14.1 million, compared to $14.8 million in the prior year. G&A expenses for the fourth quarter of 2024 were $3.2 million, compared to $3.9 million for the same period during 2023 due to decreased personnel-related expenses, professional services expenses and allocated facilities and miscellaneous expenses, partially offset by increased D&O insurance expenses.
Restructuring Charges: Restructuring charges for the full year 2024 were $2.2 million due to severance payments and other employee termination expenses.
Interest Income: Interest income for the full year 2024 was $5.5 million, compared to $4.9 million in the prior year. Interest income for the fourth quarter of 2024 was $1.1 million, compared to $1.9 million for the same period in 2023 due to higher interest rates despite lower cash, cash equivalents and investment balances in 2024 as compared to 2023.
Net loss: Net loss for the full year 2024 was $51.3 million, compared to $64.7 million in the prior year. Net loss for the fourth quarter of 2024 was $7.5 million, compared to $16.9 million for the same period during 2023.
Cash Position: The Company had cash, cash equivalents and investments of $88.6 million at December 31, 2024.