AN2 Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business and Scientific Updates
AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company dedicated to discovering and developing novel small-molecule therapeutics using its proprietary boron chemistry platform, today announced its financial results for the third quarter ended September 30, 2025, along with recent business and research highlights.
Management Commentary
“This quarter, AN2 Therapeutics continued to execute effectively across a diverse pipeline of potentially high-impact programs in infectious diseases and oncology,” said Eric Easom, Co-Founder, Chairman, President, and Chief Executive Officer of AN2 Therapeutics. “Leveraging the versatility of our boron chemistry platform, we are addressing significant areas of unmet medical need and advancing programs that have the potential to deliver meaningful patient benefit and long-term shareholder value within our existing cash runway.”
Easom added, “Our Phase 1 clinical trial evaluating oral AN2 Therapeutics -502998 for Chagas disease is progressing well, and planning for a subsequent Phase 2 proof-of-concept study is already underway in collaboration with the Drugs for Neglected Diseases initiative (DNDi). Meanwhile, our oncology portfolio continues to mature, and we anticipate our two lead programs will advance into development in 2026, each with strong potential to impact solid-tumor indications. Additionally, our partnership with GSK to develop boron-based therapeutics for tuberculosis (TB), supported by renewed funding from the Bill & Melinda Gates Foundation, underscores our commitment to tackling global health challenges using boron chemistry.”
Third Quarter and Recent Business Highlights
Chagas Disease Program: Advancing Phase 1 Clinical Study of Oral AN2-502998
AN2 Therapeutics is advancing a Phase 1 first-in-human trial of oral AN2-502998, designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. AN2-502998 targets chronic Chagas disease, an infectious condition caused by Trypanosoma cruzi (T. cruzi). The disease affects an estimated 6–7 million people globally, including approximately 300,000 in the U.S. and over 100,000 in Europe.
AN2-502998 is the only compound known to have demonstrated curative activity in preclinical models across multiple species, including nonhuman primates (NHPs) with long-term, naturally acquired infections from diverse T. cruzi strains. Because these NHP infections occur naturally, they are believed to better mirror the biological conditions of human disease, potentially making this efficacy data more predictive of clinical outcomes.
The company expects Phase 1 data in Q1 2026 and plans to initiate a Phase 2 proof-of-concept trial later in 2026, contingent on successful completion of the current study. Through its collaboration with DNDi, AN2 Therapeutics will leverage DNDi’s global clinical trial infrastructure and deep expertise in neglected tropical diseases to accelerate the development of AN2-502998. Notably, there are currently no FDA-approved therapies for adults with chronic Chagas disease, highlighting the potential importance of this program.
Boron Chemistry Pipeline: Expanding into Oncology
AN2 continues to explore new therapeutic frontiers using its boron chemistry platform, which enables the discovery of unique small molecules that can engage targets traditionally considered undruggable. The company is focusing initially on oncology programs directed at ENPP1 and PI3Kα, where boron’s chemical versatility offers significant advantages in binding selectivity, pharmacodynamic control, and drug-like properties.
Boron chemistry has previously produced first-in-class molecules against targets such as CPSF3 (e.g., AN2-502998 and acoziborole) and LeuRS (e.g., epetraborole, ganfeborole, and tavaborole). AN2’s preclinical oncology compounds have shown sub-nanomolar potency, high selectivity, and favorable oral pharmacokinetics in preclinical models.
The company plans to advance its first oncology candidate into development in early 2026 and expects clinical proof-of-concept data within its current cash runway. A second oncology compound is expected to follow into development by mid-2026, reflecting AN2’s goal of establishing a robust pipeline spanning infectious disease and cancer therapeutics.
Nontuberculous Mycobacteria (NTM) Lung Disease: Progress Toward Human Proof-of-Concept
Building on promising microbiological and safety data from prior NTM studies, AN2 believes that epetraborole has the potential to address a major unmet medical need in M. abscessus lung disease — one of the most difficult NTM infections to treat and for which no FDA-approved therapies currently exist.
The company is supporting the design of an investigator-initiated trial (IIT) that is expected to begin enrollment in early 2026, pending protocol finalization and regulatory approval. If successful, the study could deliver the first human proof-of-concept data for epetraborole in M. abscessus, informing the design of a future pivotal trial.
NTM lung disease is an increasing public health issue, affecting 120,000–150,000 individuals in the U.S., with 10–15% of cases attributed to M. abscessus. A successful outcome could establish a novel therapeutic pathway in a patient population with limited options.
Melioidosis: Advancing Epetraborole Toward Next Clinical Phase
AN2 is also developing epetraborole for acute melioidosis, a severe bacterial infection recognized as a global biothreat. The company recently completed a 200-patient observational study in October 2024 (non-epetraborole treatment), which provided valuable clinical insights into disease progression and mortality trends. In June 2025, AN2 released data from the study confirming the persistently high mortality rate — approximately 40% within 90 days, despite current standard-of-care treatments such as ceftazidime or meropenem.
The findings will guide the design of AN2’s upcoming Phase 2 trial, for which discussions are underway with the U.S. government regarding potential funding. The company aims to significantly improve survival outcomes by administering epetraborole alongside standard of care. If approved, AN2 expects to pursue a priority review voucher (PRV) and generate potential revenues through government stockpiling and distribution in endemic regions, including Southeast Asia and the U.S.
Global Health Initiative: Collaboration with GSK and Continued Gates Foundation Support
In November 2025, AN2 announced a strategic research collaboration with GSK to co-develop boron-based LeuRS inhibitors for the treatment of tuberculosis (TB). This collaboration represents a key milestone in expanding the application of AN2’s boron chemistry platform beyond traditional drug discovery.
As part of this partnership, the Bill & Melinda Gates Foundation awarded AN2 a third year of funding to support its TB-focused research activities. TB remains a major global health crisis, affecting over one-quarter of the world’s population and causing more than 1.25 million deaths each year. AN2’s boron-based inhibitors aim to offer a novel, highly targeted approach to combating this persistent infectious threat.
Third Quarter 2025 Financial Results
Research and Development (R&D) Expenses:
R&D expenses for the third quarter of 2025 totaled $7.0 million, compared to $8.3 million in the same period of 2024. The decrease was primarily due to reduced clinical trial and personnel costs, lower chemistry manufacturing and controls (CMC) expenses, and fewer consulting and outside service costs. These reductions followed the termination of the EBO-301 clinical study and corporate restructuring activities completed in August 2024. The decreases were partially offset by increased preclinical and research spending, as well as startup expenses for the ongoing Phase 1 Chagas disease trial.
General and Administrative (G&A) Expenses:
G&A expenses for the quarter were $3.0 million, down from $3.5 million in Q3 2024. The reduction reflects lower personnel costs, reduced professional services, and other administrative efficiencies achieved following restructuring.
Restructuring Charges:
No restructuring charges were recorded in Q3 2025. In comparison, Q3 2024 included $2.2 million in restructuring-related expenses, primarily due to severance payments and other employee termination costs.
Interest Income:
Interest income for Q3 2025 was $0.7 million, compared to $1.3 million in the prior-year period. The decline reflects lower average cash and investment balances and reduced market interest rates.
Net Loss:
The company reported a net loss of $9.4 million for the third quarter of 2025, compared to a net loss of $12.7 million for Q3 2024, representing an improvement driven by lower operating expenses.
Cash Position:
As of September 30, 2025, AN2 held $65.1 million in cash, cash equivalents, and investments. The company expects its current financial resources to support operations into 2028 under its existing operating plan.
AN2 Therapeutics, Inc. (Nasdaq: ANTX) is a clinical-stage biopharmaceutical company harnessing the power of boron chemistry to discover and develop transformative small-molecule therapeutics for infectious diseases and oncology. AN2’s proprietary platform enables the creation of highly selective, orally bioavailable compounds targeting previously intractable biological pathways. Through innovative science, strategic collaborations, and a focused development approach, AN2 aims to deliver novel therapies that address urgent global health challenges.
AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, NTM lung disease caused by M. abscessus andmelioidosis, along with programs focused on targets in oncology and other infectious diseases. We are committed to delivering high-impact drugs to patients that address critical medical needs and improve health outcomes. For more information, please visit our website at www.an2therapeutics.com.
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