AN2 Therapeutics — Third Quarter 2026 Earnings Summary
Financial Performance:
- Net loss for the quarter ended September 30, 2026, was $8.0 million (reported as $7.957 million in financial statements), compared to $9.4 million ($9.353 million) in the same period of 2025.
- Research and Development (R&D) expenses were $5.7 million ($5.724 million) for the quarter, down from $7.0 million ($7.000 million) in Q3 2025, driven by decreased preclinical, research, and clinical trial expenses, partially offset by increases in personnel and CMC costs.
- General and Administrative (G&A) expenses were $2.9 million ($2.946 million) for the quarter, down from $3.0 million ($3.040 million) in Q3 2025, due to decreased personnel expenses, partially offset by increased professional services and miscellaneous expenses.
- Interest income was $0.7 million ($713,000) for the quarter, consistent with $0.7 million ($687,000) in Q3 2025.
- Cash, cash equivalents, and investments totaled $80.2 million as of September 30, 2026, comprising $20.2 million in cash and cash equivalents, $44.2 million in short-term investments, and $15.8 million in long-term investments.
- Total operating expenses were $8.7 million ($8.670 million) for the quarter, compared to $10.0 million ($10.040 million) in Q3 2025.
- Net loss per share (basic and diluted) was $0.17 for the quarter, compared to $0.31 in Q3 2025.
- Weighted-average shares outstanding were 46.1 million for the quarter, compared to 30.3 million in Q3 2025.
- Total assets were $82.0 million ($81.955 million) as of September 30, 2026, compared to $62.0 million ($61.950 million) as of December 31, 2025.
- Total liabilities were $6.4 million ($6.445 million) as of September 30, 2026, compared to $8.9 million ($8.890 million) as of December 31, 2025.
- Stockholders' equity was $75.5 million ($75.510 million) as of September 30, 2026, compared to $53.1 million ($53.060 million) as of December 31, 2025.
Guidance and Future Outlook:
- The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan.
- Enrollment for the global Phase 2 study of epetraborole in polycythemia vera (PV) is expected to initiate by the end of 2026.
- Part 1 data for the PV Phase 2 study is anticipated to be released periodically throughout 2027.
- Topline results for the Phase 2 investigator-initiated trial of epetraborole in M. abscessus lung disease are anticipated in late 2027, subject to enrollment progress.
- A Phase 1 clinical study for the development candidate AN2-504661 in hypophosphatasia (HPP) is planned to initiate in the second half of 2027.
Business Segments and Product Lines:
- Polycythemia Vera (PV): Received regulatory clearance (including FDA IND) to proceed with a global Phase 2 study of oral epetraborole in all planned jurisdictions (U.S., Australia, India). The study will begin with an open-label sentinel cohort to assess pharmacokinetics and safety, followed by a 28-week open-label, single-arm dose escalation to maintain hematocrit control.
- M. abscessus Lung Disease: Enrollment is ongoing in an 84-patient, multicenter, randomized, double-blind, placebo-controlled Phase 2 investigator-initiated trial led by Oregon Health and Science University. The study aims to provide clinical proof-of-concept to inform a subsequent pivotal trial.
- Chagas Disease: Advancing startup activities for a Phase 2 proof-of-concept study of AN2-502998 (formerly AN15368), an oral CPSF3 inhibitor, in adults with chronic T. cruzi infection. The compound demonstrated curative activity in preclinical studies across multiple species, including nonhuman primates.
- Hypophosphatasia (HPP): Selected AN2-504661 as the oral development candidate. It is an ENPP1 inhibitor selected for its potent and selective inhibition, favorable pharmacokinetic properties, and encouraging nonclinical safety profile.
- Tuberculosis: The Gates Foundation awarded an extension of funding to support the Company's tuberculosis research collaboration with GSK.
- Corporate Leadership: Appointed Cameron Trenor, M.D., as Chief Medical Officer in August 2026.
Market and Competitive Landscape:
- PV: The Phase 2 study aims to reduce the frequency of phlebotomy in patients with phlebotomy-dependent PV.
- M. abscessus: No FDA-approved therapy currently exists for this difficult-to-treat NTM infection.
- Chagas Disease: There are no FDA-approved treatments for adults with chronic Chagas disease; over 10 million people are infected worldwide.
- HPP: AN2-504661 is positioned to be a best-in-class therapy for this rare inherited metabolic bone disease.
Risks and Challenges:
- Risks include the ability to implement plans for the boron chemistry platform and pipeline programs, timely patient enrollment in clinical trials, and reliance on third-party collaborators and investigators.
- Potential for clinical trial results to differ from preclinical or expected results, including significant adverse events or toxicities.
- Uncertainty regarding regulatory approvals and the ability to obtain, maintain, or protect intellectual property rights.
- Sufficiency of capital resources and the need for additional capital to achieve goals.
- Global macroeconomic conditions and conflicts.
Management Commentary and Tone:
- CEO Eric Easom stated the quarter was marked by continued execution across the clinical pipeline and progress in expanding the boron chemistry platform.
- Management highlighted the FDA IND clearance for epetraborole in PV as a key milestone enabling the global Phase 2 study.
- The selection of AN2-504661 for HPP was cited as further evidence of the productivity of the research organization and the platform's potential to generate differentiated therapies.
- Management expressed confidence in being well-positioned to build value across a diverse pipeline of boron-based therapies.
Other Key Points:
- The Company presented four abstracts at the SOHO 2026 Annual Meeting in August 2026 and a poster at the 18th International Congress on Myeloproliferative Neoplasms in October 2026.
- The Phase 2 PV study design was presented at the MPN Congress.
- AN2-502998 is the only compound the Company is aware of to demonstrate curative activity in preclinical studies for chronic Chagas disease across multiple species.
- The Company has no revenue reported in the financial statements, consistent with its clinical-stage status.
- Comprehensive loss for the quarter was $8.1 million ($8.141 million), including an unrealized loss on investments of $0.2 million ($184,000).
- Company
- AN2 THERAPEUTICS INC
- Sector
- Healthcare
- Industry
- Biotechnology