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Earnings documents stored for ANTX.
Investor releaseQuarter not tagged2026-08-11AN2 Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business and Scientific Highlights
Expanding Phase 2 study start-up activities to support global trial of oral epetraborole in polycythemia vera Enrollment ongoing in Phase 2 investigator-initiated trial of epetraborole for M. abscessus lung disease Positive non-human primate efficacy and favorable Phase 1 clinical pharmacokinetics and safety profile support planned Phase 2 initiation of AN2-502998 in chronic Chagas disease by year-end Plan to advance second boron-based compound into development in 2026 MENLO PARK, Calif., August 11, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the second quarter ended June 30, 2026. "AN2 will have three Phase 2 programs underway by the end of this year, all of which have the potential to address major unmet needs. Our near-term focus is advancing start-up activities for the Phase 2 EBO-PV-201 study in polycythemia vera. We recently held a pre-IND meeting with the FDA and are expanding the Phase 2 study to include sites in the U.S. and Australia," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Enrollment is ongoing in an investigator-initiated Phase 2 study in M. abscessus lung disease. In our chronic Chagas program, compelling non-human primate efficacy data and a favorable clinical PK and safety profile from our Phase 1 study support planned initiation of a Phase 2 trial by year-end. We are also expanding our pipeline, having declared our first development candidate for solid tumors earlier this year and expecting to advance a second development candidate by the end of 2026. Collectively, these achievements underscore the potential of our boron chemistry platform to deliver differentiated therapies across multiple disease areas." Second Quarter & Recent Business Updates: Polycythemia vera Advancing start-up activities for the global Phase 2 trial of oral epetraborole in polycythemia vera In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a slowly progressing blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction inc…Read full documentShow less
Expanding Phase 2 study start-up activities to support global trial of oral epetraborole in polycythemia vera Enrollment ongoing in Phase 2 investigator-initiated trial of epetraborole for M. abscessus lung disease Positive non-human primate efficacy and favorable Phase 1 clinical pharmacokinetics and safety profile support planned Phase 2 initiation of AN2-502998 in chronic Chagas disease by year-end Plan to advance second boron-based compound into development in 2026 MENLO PARK, Calif., August 11, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the second quarter ended June 30, 2026. "AN2 will have three Phase 2 programs underway by the end of this year, all of which have the potential to address major unmet needs. Our near-term focus is advancing start-up activities for the Phase 2 EBO-PV-201 study in polycythemia vera. We recently held a pre-IND meeting with the FDA and are expanding the Phase 2 study to include sites in the U.S. and Australia," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Enrollment is ongoing in an investigator-initiated Phase 2 study in M. abscessus lung disease. In our chronic Chagas program, compelling non-human primate efficacy data and a favorable clinical PK and safety profile from our Phase 1 study support planned initiation of a Phase 2 trial by year-end. We are also expanding our pipeline, having declared our first development candidate for solid tumors earlier this year and expecting to advance a second development candidate by the end of 2026. Collectively, these achievements underscore the potential of our boron chemistry platform to deliver differentiated therapies across multiple disease areas." Second Quarter & Recent Business Updates: Polycythemia vera Advancing start-up activities for the global Phase 2 trial of oral epetraborole in polycythemia vera In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a slowly progressing blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burdensome periodic therapeutic phlebotomies, many patients experience uncontrolled hematocrit levels and persistent symptoms, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S. The Company recently held a pre-IND meeting with the FDA and now plans to expand the Phase 2 study (EBO-PV-201) to add sites in the U.S. and Australia, with an IND filing expected in the third quarter of 2026. As a result of this expansion, Phase 2 enrollment is anticipated to commence in the fourth quarter of 2026, beginning with an open-label sentinel cohort at a sub-therapeutic dose aimed at assessing pharmacokinetics and safety in PV patients. Following successful conclusion of the sentinel group, the safety monitoring committee will advise on dose selections for Part 1, an open-label, single arm, 28-week evaluation of epetraborole’s ability to maintain hematocrit control and reduce the frequency of phlebotomy in phlebotomy-dependent PV patients. The Company anticipates releasing Part 1 data periodically throughout 2027. M. abscessus complex lung disease Enrollment ongoing in Phase 2 investigator-initiated clinical trial of epetraborole in patients with M. abscessus lung disease Building on the microbiological and safety data from AN2’s prior non-tuberculous mycobacterial (NTM) study in treatment-refractory MAC, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult-to-treat NTM infections for which no FDA-approved therapy exists. M. abscessus lung disease is a serious NTM infection requiring prolonged therapy, initially often with IV-only antibiotics. People affected by this illness face limited, burdensome treatment options, and high rates of morbidity and mortality. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of whom 10-15% have infection caused by M. abscessus. The Company is supporting an investigator-initiated trial and anticipates that data from this study, if positive, could provide clinical proof-of-concept in M. abscessus lung disease and thereby inform the design of a subsequent pivotal trial. Patient enrollment is ongoing. The 84-patient multicenter, randomized, double-blind, placebo-controlled, prospective clinical study is being led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at the Oregon Health and Sciences University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. The Company anticipates reporting topline results in late 2027, subject to enrollment progress. Chagas disease Announced positive enabling data from two studies of oral AN2-502998, under development for chronic Chagas disease, which support advancement to Phase 2 proof-of-concept study anticipated to start in 2026 The Company is studying AN2-502998, an oral, boron-based small molecule CPSF3 inhibitor for the treatment of chronic Chagas disease, also known as American trypanosomiasis. Chagas disease is caused by the parasite Trypanosoma cruzi (T. cruzi). Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with ~20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease. In June 2026, the Company announced positive results from two studies that it believes support the planned initiation later this year of a Phase 2 trial of AN2-502998 in chronic Chagas disease. In the non-human primate (NHP) efficacy study, 28 days of treatment with AN2-502998 resulted in 100% parasitic elimination at target exposures attainable in humans, in NHP’s with naturally acquired, chronic T. cruzi infection. In the Phase 1 first-in-human study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in NHPs with long-term, naturally acquired chronic infections caused by diverse T. cruzi genetic types. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease. The Company expects to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease in late 2026. Boron chemistry pipeline Advancing ENPP1 candidate for the potential treatment of solid tumors The Company is prioritizing targets in oncology and bone disorders where it believes boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds that demonstrate sub-nanomolar activity, high selectivity and excellent oral pharmacokinetic properties. Earlier this year, the Company declared a development candidate (ENPP1) for the treatment of solid tumors and expects to advance a second development candidate by the end of 2026. Selected Second Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $6.0 million, compared to $3.2 million for the same period during 2025 due to increased chemistry manufacturing and controls (CMC) expenses, other miscellaneous expenses, consulting and outside services, preclinical and research studies expenses, and clinical trial expenses. These increases were partially offset by a decrease in personnel-related expenses. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $2.9 million, compared to $4.0 million for the same period in 2025 due to decreased professional and outside services expenses and personnel-related expenses. Interest Income: Interest income for the second quarter of 2026 was $0.7 million, compared to $0.8 million for the same period during 2025 due to lower average cash, cash equivalents, and investment balances and lower interest rates in 2026 as compared to 2025. Net Loss: Net loss for the second quarter of 2026 was $8.2 million, compared to $6.5 million for the same period during 2025. Cash Position: The Company had cash, cash equivalents and investments of $79.9 million at June 30, 2026. The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to be active in 2026, two preclinical candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "believe," "estimate," "predict," "potential" or "continue," or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential of the Company’s boron chemistry platform and advancement of the Company’s development programs; support for the Company’s polycythemia vera program; expectations regarding the Company’s preclinical studies and clinical trials, including initiation, enrollment, conduct, sites, leadership, and investigators, the timing of data and related announcements, and regulatory clearance to proceed with trials; market size ; the predictivity of data; cash runway; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260811123250/en/ Contacts Company Contact: Lucy O. DayChief Financial [email protected] Investor and Media Contact: Anne [email protected]
Investor releaseQuarter not tagged2026-05-12AN2 Therapeutics Reports First Quarter 2026 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports First Quarter 2026 Financial Results and Recent Business and Scientific Highlights
Oral epetraborole program in polycythemia vera advancing toward Phase 2 Phase 2 investigator-initiated trial with epetraborole for M. abscessus lung disease underway Data expected in 2Q/2026 from two studies of oral AN2-502998, under development for chronic Chagas disease: a Phase 1 first-in-human clinical trial and a non-human primate efficacy study Declared ENPP1 candidate for solid tumors advancing from early research into development MENLO PARK, Calif., May 11, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the first quarter ended March 31, 2026. "This was an important quarter for AN2 as we announced an exciting new program in polycythemia vera that is planned to enter Phase 2 development in the third quarter of 2026. This program is supported by what we believe is a robust package of epetraborole preclinical and clinical enabling data. We commenced an investigator-initiated Phase 2 study in M. abscessus lung disease, completed dosing in a Phase 1 study for our Chagas disease program, and declared our ENPP1 candidate for the treatment of solid tumors, as well as strengthened our balance sheet," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Looking ahead, we expect to advance three programs into Phase 2 development this year and report multiple data readouts within our cash runway into 2029. I couldn’t be more excited about our progress and the potential to substantially improve the lives of patients across our diverse portfolio that is enabled by our boron chemistry pipeline." First Quarter & Recent Business Updates: Polycythemia vera Advancing oral epetraborole into a Phase 2 trial for polycythemia vera In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burd…Read full documentShow less
Oral epetraborole program in polycythemia vera advancing toward Phase 2 Phase 2 investigator-initiated trial with epetraborole for M. abscessus lung disease underway Data expected in 2Q/2026 from two studies of oral AN2-502998, under development for chronic Chagas disease: a Phase 1 first-in-human clinical trial and a non-human primate efficacy study Declared ENPP1 candidate for solid tumors advancing from early research into development MENLO PARK, Calif., May 11, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the first quarter ended March 31, 2026. "This was an important quarter for AN2 as we announced an exciting new program in polycythemia vera that is planned to enter Phase 2 development in the third quarter of 2026. This program is supported by what we believe is a robust package of epetraborole preclinical and clinical enabling data. We commenced an investigator-initiated Phase 2 study in M. abscessus lung disease, completed dosing in a Phase 1 study for our Chagas disease program, and declared our ENPP1 candidate for the treatment of solid tumors, as well as strengthened our balance sheet," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Looking ahead, we expect to advance three programs into Phase 2 development this year and report multiple data readouts within our cash runway into 2029. I couldn’t be more excited about our progress and the potential to substantially improve the lives of patients across our diverse portfolio that is enabled by our boron chemistry pipeline." First Quarter & Recent Business Updates: Polycythemia vera Advancing oral epetraborole into a Phase 2 trial for polycythemia vera In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burdensome periodic therapeutic phlebotomies, many patients experience uncontrolled hematocrit levels and persistent symptoms, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S. The Company is proceeding through the regulatory process and plans to initiate the Phase 2 clinical trial in the third quarter of 2026. Subject to regulatory clearance and enrollment progress, the Company expects to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027. M. abscessus complex lung disease Commenced Phase 2 investigator-initiated clinical trial of epetraborole in patients with M. abscessus lung disease Building on the microbiological and safety data from AN2’s prior non-tuberculous mycobacterial (NTM) study, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult-to-treat NTM infections and one for which no FDA-approved therapy exists. M. abscessus lung disease is a serious NTM infection requiring prolonged therapy, initially often with IV-only antibiotics. People affected by this illness face limited, burdensome treatment options and high rates of morbidity and 5-year mortality. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of which 10-15% are caused by M. abscessus. The Company is supporting an investigator-initiated trial and anticipates that data from this study, if positive, could provide clinical proof-of-concept in M. abscessus lung disease and thereby inform the design of a subsequent pivotal trial. Patient screening commenced in March 2026. The multicenter, randomized, double-blind, placebo-controlled, prospective clinical study is being led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at the Oregon Health and Sciences University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. The Company anticipates reporting topline results in late 2027, subject to regulatory clearance and enrollment progress. Chagas disease Oral AN2-502998: Phase 1 first-in-human clinical trial and non-human primate data expected 2Q/2026; Phase 2 proof-of-concept study planned to initiate in 2026 pending results of Phase 1 study In March 2026, the Company completed dosing all cohorts in the Phase 1 first-in-human trial of oral AN2-502998, an investigational, boron-based small molecule in development for the treatment of chronic Chagas disease, or American trypanosomiasis. In the second quarter of 2026, the Company anticipates reporting Phase 1 data from this study, as well as results from a non-human primate (NHP) study that tested the curative potential of AN2-502998 with a 28-day dosing duration. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in NHPs with long-term, naturally acquired, chronic infections caused by diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, these efficacy data may be more predictive of efficacy in human clinical trials than other animal models. The Company expects to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease later in 2026, pending results of the Phase 1 study. Boron chemistry pipeline Declared ENPP1 candidate for the potential treatment of solid tumors The Company is prioritizing targets in oncology and bone disorders for which boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties, and intellectual property, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and characterized by excellent oral pharmacokinetics. The Company recently declared its ENPP1 candidate for the treatment of solid tumors, marking an important step in transitioning the program from early research into development. Selected First Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $6.7 million, compared to $7.7 million for the same period during 2025 due to decreased chemistry manufacturing and controls (CMC) expenses, primarily due to decreased expenses related to completion of CMC activities in certain programs, and license fees. These decreases were partially offset by increases in personnel-related expenses, clinical trial expenses, consulting and outside services, and facilities and other expenses. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 and the same period during 2025 were $3.8 million. Interest Income: Interest income for the first quarter of 2026 was $0.5 million, compared to $0.9 million for the same period during 2025 due to lower average cash, cash equivalents and investment balances and lower interest rates in 2026 as compared to 2025. Net Loss: Net loss for the first quarter of 2026 was $10.0 million, compared to $10.6 million for the same period during 2025. Cash Position: The Company had cash, cash equivalents and investments of $85.3 million at March 31, 2026. In March 2026, AN2 raised gross proceeds of $40.0 million through a private placement, before deducting placement agent fees and other expenses. The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to be active in 2026, two preclinical candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "believe," "estimate," "predict," "potential" or "continue," or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential of the Company’s boron chemistry platform and advancement of the Company’s development programs; support for the Company’s polycythemia vera program; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct, sites, leadership and investigators, the timing of data and related announcements, and regulatory proceedings; market size and sales potential; the predictivity of data; cash runway; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511281560/en/ Contacts Company Contact: Lucy O. Day Chief Financial Officer [email protected] Investor and Media Contact: Anne Bowdidge [email protected]
Investor releaseQuarter not tagged2026-03-18AN2 Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business and Scientific Highlights
Phase 2 study of oral epetraborole in polycythemia vera (PV) expected to begin 3Q26 with potential for data readouts as early as 4Q26 and throughout 2027 Advancing Phase 2 investigator-initiated trial of epetraborole in M. abscessus complex lung disease; Enrollment expected to begin in 1Q26 with topline results anticipated in late 2027 Chagas disease program progresses as Phase 1 first-in-human trial of oral AN2-502998 nears completion with initial clinical data expected in 1Q26; Initiation of Phase 2 proof-of-concept study in patients with chronic Chagas disease planned for 2026 pending results On track to advance two boron-based oncology compounds into development in 2026 March 2026 private placement extends runway into 2029 MENLO PARK, Calif., March 17, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the fourth quarter and year ended December 31, 2025. "Our recent decision to advance oral epetraborole into a Phase 2 study for polycythemia vera highlights the growing opportunity across AN2’s boron chemistry pipeline and our commitment to addressing serious, underserved diseases. It also represents one of three proof-of-concept catalysts we believe we are well positioned to achieve in the next two years, including the Phase 2 investigator-initiated trial in M. abscessus complex lung disease and a Phase 2 proof-of-concept study in chronic Chagas disease planned for later this year, pending the outcome of our Phase 1 study," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. "Looking ahead, we remain on track to bring two boron-based oncology candidates into development in 2026, further demonstrating the versatility of our platform. I’m proud of the momentum we’re carrying into the year and the continued execution from our team as we work to deliver impactful therapies to patients with urgent unmet needs." Fourth Quarter & Recent Business Updates: Polycythemia Vera Expanding development of oral epetraborole into Phase 2 trial for PV In March 2026, the Company announced its plan to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia ve…Read full documentShow less
Phase 2 study of oral epetraborole in polycythemia vera (PV) expected to begin 3Q26 with potential for data readouts as early as 4Q26 and throughout 2027 Advancing Phase 2 investigator-initiated trial of epetraborole in M. abscessus complex lung disease; Enrollment expected to begin in 1Q26 with topline results anticipated in late 2027 Chagas disease program progresses as Phase 1 first-in-human trial of oral AN2-502998 nears completion with initial clinical data expected in 1Q26; Initiation of Phase 2 proof-of-concept study in patients with chronic Chagas disease planned for 2026 pending results On track to advance two boron-based oncology compounds into development in 2026 March 2026 private placement extends runway into 2029 MENLO PARK, Calif., March 17, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the fourth quarter and year ended December 31, 2025. "Our recent decision to advance oral epetraborole into a Phase 2 study for polycythemia vera highlights the growing opportunity across AN2’s boron chemistry pipeline and our commitment to addressing serious, underserved diseases. It also represents one of three proof-of-concept catalysts we believe we are well positioned to achieve in the next two years, including the Phase 2 investigator-initiated trial in M. abscessus complex lung disease and a Phase 2 proof-of-concept study in chronic Chagas disease planned for later this year, pending the outcome of our Phase 1 study," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. "Looking ahead, we remain on track to bring two boron-based oncology candidates into development in 2026, further demonstrating the versatility of our platform. I’m proud of the momentum we’re carrying into the year and the continued execution from our team as we work to deliver impactful therapies to patients with urgent unmet needs." Fourth Quarter & Recent Business Updates: Polycythemia Vera Expanding development of oral epetraborole into Phase 2 trial for PV In March 2026, the Company announced its plan to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, many patients experience uncontrolled hematocrit levels and persistent symptom burden, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S. AN2 is proceeding through the regulatory process and anticipates initiating the Phase 2 trial in India in the third quarter of 2026. The Company expects to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027, subject to regulatory clearance and enrollment progress. M. abscessus Complex Lung Disease Preparing to initiate enrollment for Phase 2 study of epetraborole in patients with M. abscessus complex lung disease In December 2025, the U.S. Food and Drug Administration (FDA) cleared an investigational New Drug Application to proceed with a Phase 2 investigator-initiated study in collaboration with Oregon Health & Science University (OHSU) evaluating epetraborole for the treatment of M. abscessus lung disease. This multicenter, randomized, double-blind, placebo-controlled, prospective clinical study will be led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at OHSU, in conjunction with other investigators across an estimated 10-15 sites in the U.S. M. abscessus lung disease is a serious and difficult-to-treat non-tuberculous mycobacterial infection requiring prolonged therapy including with IV-only antibiotics, and characterized by limited treatment options and high rates of morbidity, and 5-year mortality. No FDA-approved drug currently exists for its treatment. The Company expects to initiate enrollment in the first quarter of 2026 and report topline results in late 2027. Chagas Disease Phase 1 first-in-human clinical trial of oral AN2-502998 approaching completion; Phase 2 proof-of-concept study planned for 2026 pending results of Phase 1 study In August 2025, as part of AN2’s Chagas disease clinical development program, the Company commenced its Phase 1 first-in-human trial of oral AN2-502998 in healthy volunteers. Chagas disease (American trypanosomiasis) is an infectious disease caused by Trypanosoma cruzi, which affects an estimated 6-10 million people worldwide, including approximately 300,000 people in the U.S. and over 100,000 in Europe. Chagas disease can remain asymptomatic for years before progressing to chronic disease. In approximately 20-30% of infected individuals, chronic infection leads to serious cardiac and gastrointestinal complications, including cardiomyopathy, heart failure, arrhythmias, stroke, and megacolon or megaesophagus, which can result in significant morbidity and premature death. AN2-502998 is the only compound of which the Company is aware, to have demonstrated curative activity in preclinical studies across multiple species, including in nonhuman primates (NHPs) with long-term, naturally acquired chronic infections caused by diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, these efficacy data may be more predictive of efficacy in human clinical trials than other animal models. There are no FDA-approved treatments for adults with Chagas disease. The Company’s Phase 1 first-in-human trial with oral AN2-502998 is nearing completion, with initial clinical data expected in the first quarter of 2026 and initiation of the proof-of-concept Phase 2 trial in patients with chronic Chagas disease in 2026, depending on the outcome and timing of completion of the Phase 1 study. FDA approval of a treatment for Chagas disease, which is designated as a tropical disease under Section 524 of the Federal Food, Drug, and Cosmetic Act (FDCA), would qualify the Company to receive a priority review voucher intended to incentivize the development of therapies for neglected infectious diseases. Boron Chemistry Pipeline Advancing research programs in oncology The Company is pursuing a number of oncology targets for which boron chemistry may offer a competitive advantage in terms of binding site differentiation, pharmacodynamics, drug-like properties, and intellectual property. AN2’s lead programs include PI3Kα and ENPP1. The Company plans to advance two oncology candidates into development in 2026 targeting PI3Kα and ENPP1. Global Health Research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting tuberculosis (TB); AN2 awarded third year funding from Gates Foundation In November 2025, the Company announced a collaboration agreement with the global biopharma company GSK to develop new therapies for TB. As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually. The Company’s global health programs also include melioidosis, a severe bacterial infection associated with high death rates in endemic regions. Selected Fourth Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the full year 2025 were $24.8 million, compared to $40.5 million in the prior year. R&D expenses for the fourth quarter of 2025 were $6.9 million, compared to $5.4 million for the same period during 2024 due to increased personnel-related expenses, preclinical and research studies expenses, chemistry manufacturing and controls expenses, and allocated facilities expenses. These increases were partially offset by decreased clinical trial expenses due to termination of the EBO-301 study, partially offset by initiation of the Phase 1 trial in Chagas disease. General and Administrative (G&A) Expenses: G&A expenses for the full year 2025 were $13.3 million, compared to $14.1 million in the prior year. G&A expenses for the fourth quarter of 2025 were $2.4 million, compared to $3.2 million for the same period during 2024 due to decreased professional and outside services expenses and personnel-related expenses. Restructuring Charges: There were no restructuring charges in the full year or the fourth quarter of 2025. Restructuring charges for the full year and the fourth quarter of 2024 were $2.2 million and $0.9 million, respectively, due to severance payments and other employee termination-related expenses. Interest Income: Interest income for the full year 2025 was $2.9 million, compared to $5.5 million for the same period in 2024. Interest income for the fourth quarter of 2025 was $0.6 million, compared to $1.1 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net Loss: Net loss for the full year 2025 was $35.2 million, compared to $51.3 million for the same period in 2024. Net loss for the fourth quarter of 2025 was $8.7 million, compared to $7.5 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $60.0 million at December 31, 2025. On March 9, 2026, the Company announced that it had entered into a securities purchase agreement for a private placement with gross proceeds of approximately $40 million, before deducting placement agent fees and other expenses. The private placement included participation from Coastlands Capital, Commodore Capital, Vivo Capital and other new and existing institutional investors. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2029 under the current operating plan. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to initiate in 2026, two preclinical candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "believe," "estimate," "predict," "potential," or "continue," or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential, growing opportunity, and competitive advantage of the Company’s boron chemistry platform; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct, sites, leadership, the timing of data and related announcements, and regulatory proceedings; market size and sales potential; the predictivity of efficacy data; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs and the availability of funding; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions, and statutory, regulatory, and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued government funding of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260317440715/en/ Contacts Company Contact: Lucy O. Day Chief Financial Officer [email protected] Investor and Media Contact: Anne Bowdidge [email protected]
Investor releaseQuarter not tagged2025-11-13AN2 Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Advancing Phase 1 program in Chagas Disease; Phase 2 planning underway Clinical-stage M. abscessus program advancing through investigator-initiated trial (IIT) First of two boron-based oncology targets to enter development in early 2026 Announced research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting tuberculosis (TB) AN2 awarded third year of funding from Gates Foundation MENLO PARK, Calif., November 12, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the third quarter ended September 30, 2025. "This quarter, we continued to execute across a diverse pipeline spanning multiple, potentially high impact projects in infectious diseases and oncology, leveraging our boron chemistry platform to address areas of high unmet need. These programs reflect our commitment to delivering transformative therapies, each having potential to meaningfully add shareholder value within our cash runway," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Our program studying oral AN2-502998 for Chagas disease is progressing through a Phase 1 first-in-human clinical trial, and planning for a subsequent Phase 2 proof-of-concept study is underway with our collaborators at Drugs for Neglected Diseases initiative (DNDi). In oncology, we expect our two lead programs to enter development in 2026, each with the potential to meaningfully impact solid-tumor cancers. We’ve also entered into a collaboration with GSK focused on TB, where our work is supported by a third year of funding from the Gates Foundation. This initiative reflects our commitment to applying boron chemistry to a disease that continues to impact a quarter of the world’s population." Third Quarter & Recent Business Updates: Chagas Disease Advancing Phase 1 first-in-human clinical trial of oral AN2-502998 The Company is progressing through a Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including…Read full documentShow less
Advancing Phase 1 program in Chagas Disease; Phase 2 planning underway Clinical-stage M. abscessus program advancing through investigator-initiated trial (IIT) First of two boron-based oncology targets to enter development in early 2026 Announced research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting tuberculosis (TB) AN2 awarded third year of funding from Gates Foundation MENLO PARK, Calif., November 12, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the third quarter ended September 30, 2025. "This quarter, we continued to execute across a diverse pipeline spanning multiple, potentially high impact projects in infectious diseases and oncology, leveraging our boron chemistry platform to address areas of high unmet need. These programs reflect our commitment to delivering transformative therapies, each having potential to meaningfully add shareholder value within our cash runway," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Our program studying oral AN2-502998 for Chagas disease is progressing through a Phase 1 first-in-human clinical trial, and planning for a subsequent Phase 2 proof-of-concept study is underway with our collaborators at Drugs for Neglected Diseases initiative (DNDi). In oncology, we expect our two lead programs to enter development in 2026, each with the potential to meaningfully impact solid-tumor cancers. We’ve also entered into a collaboration with GSK focused on TB, where our work is supported by a third year of funding from the Gates Foundation. This initiative reflects our commitment to applying boron chemistry to a disease that continues to impact a quarter of the world’s population." Third Quarter & Recent Business Updates: Chagas Disease Advancing Phase 1 first-in-human clinical trial of oral AN2-502998 The Company is progressing through a Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. and over 100,000 in Europe. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in nonhuman primates (NHP) with long-term, naturally acquired chronic infections of diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, this efficacy data may be more predictive of efficacy in human clinical trials than other animal models. The Company anticipates Phase 1 data in the first quarter of 2026 and initiation of a Phase 2 proof-of-concept study in patients with chronic Chagas disease in 2026, depending upon the outcome and timing of completion of the Phase 1 study. Through the Company’s collaboration with DNDi, the company will leverage DNDi’s extensive clinical trial network and expertise in Chagas disease to rapidly advance the clinical development of AN2-502998. There are no FDA approved treatments for adults with chronic Chagas disease. Boron Chemistry Pipeline Continuing to advance boron chemistry compounds in oncology The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and with strong oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development in early 2026 with potential clinical proof-of-concept data within the Company’s current cash runway. The Company expects to advance its second oncology compound into development in mid-2026. Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus M. abscessus program advancing through investigator-initiated trial (IIT) Building on the microbiological and safety data from the Company’s prior NTM study, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult to treat NTM infections for which no FDA-approved therapies exist. The Company is supporting the design of an IIT expected to begin enrollment in early 2026, pending finalization of the trial protocol and regulatory allowance to proceed. The Company anticipates that data from this potential study, if positive, could provide the clinical evidence of human proof of concept in M. abscessus and inform the design of a subsequent pivotal trial. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of which 10–15% are caused by M. abscessus. Melioidosis Preparing for epetraborole's next phase of development in acute melioidosis, a highly lethal bacterial infection and recognized biothreat AN2 is developing epetraborole for the treatment of acute melioidosis, a highly lethal bacterial infection and recognized biothreat. The Company completed enrollment in a 200-patient observational trial (non-epetraborole treatment) in October 2024, and in June 2025 announced key insights from the trial, which reinforce the high mortality of the disease, despite standard of care. This study provided critical data which will allow the Company to optimize the design of upcoming clinical studies. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. Melioidosis has a 90-day mortality rate approaching 40%, despite standard of care (SOC) drugs, including 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. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Global Health Research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting TB; AN2 awarded third year funding from Gates Foundation In November 2025, the Company announced a collaboration with the global biopharma company GSK to develop new therapies for TB. As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually. Selected Third Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $7.0 million, compared to $8.3 million for the same period during 2024 due to decreased clinical trial expenses, personnel-related expenses, chemistry manufacturing and controls expenses, and consulting and outside services, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024. These decreases were partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease and facility and other expenses. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $3.0 million, compared to $3.5 million for the same period during 2024 due to decreased personnel-related expenses, professional and outside services expenses, and other expenses. Restructuring Charges: There were no restructuring charges in the third quarter of 2025. Restructuring charges for the third quarter of 2024 were $2.2 million due to severance payments and other employee termination-related expenses. Interest Income: Interest income for the third quarter of 2025 was $0.7 million, compared to $1.3 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net Loss: Net loss for the third quarter of 2025 was $9.4 million, compared to $12.7 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $65.1 million at September 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan. About AN2 Therapeutics, Inc. 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 and melioidosis, 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company’s boron chemistry platform; high-impact nature of the Company’s clinical programs; the potential for an IIT in M. abscessus disease to proceed and whether data from such a trial could provide human proof of concept in that condition; the Company’s approach to capital allocation and the availability of and plans to use non-dilutive funding, including the possibility that the U.S. government will not fund the Phase 2 and other future melioidosis trials; expectations regarding the Company’s clinical trials and IIT trials, including initiation, enrollment, conduct and the timing of data and related announcements; whether and to what extent NHP models de-risk translation to human efficacy in Chagas disease; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and IITs; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued government funding of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251112188096/en/ Contacts Company Contact: Lucy O. Day Chief Financial Officer [email protected] Investor and Media Contact: Anne Bowdidge [email protected]
Investor releaseQuarter not tagged2025-08-13AN2 Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Cash, cash equivalents, and investments of $71.2 million at June 30,2025 and cash runway anticipated to fund operations into 2028 MENLO PARK, Calif., August 12, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the second quarter ended June 30, 2025. "We saw continued momentum this quarter across our boron chemistry pipeline as we look to develop high-impact drugs that address serious and overlooked conditions. In our Chagas disease program, we recently dosed the first Phase 1 cohort and announced a collaboration with the Drugs for Neglected Diseases initiative that will rapidly advance preparations for our Phase 2 study and allow us to maintain critical investments in our other programs. In melioidosis, observational data shared this quarter underscore the acute lethality of this potential biothreat, emphasizing its potential danger to homeland security and to U.S. troops serving abroad. And in NTM, we presented preclinical data highlighting the therapeutic potential of epetraborole as a once daily oral treatment against M. abscessus, a disease with an 8-year all-cause mortality rate of 45% and burdensome IV treatments that are not FDA approved for the disease. We are actively exploring plans to initiate a proof-of-concept trial in M. abscessus and will provide an update in the coming months," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. Easom continued: "We are also excited about recent progress in our two oncology programs generated from our boron chemistry platform, where we expect to have two development candidates within the next 12 months—a 3rd generation wild-type sparing, pan mutant-inhibitor of PI3Kα and an ENPP1 inhibitor. We see ENPP1 as an emerging immuno-oncology target with significant market potential due to its ability to enable the host immune system by turning ‘cold’ tumors ‘hot’ and halt tumor metastasis. We believe boron chemistry may offer potential competitive advantages against these targets." Second Quarter & Recent Business Updates: Chagas Disease Commenced dosing in Phase 1 FIH clinical trial of oral AN2-502998 In August, the Company announced that it has completed dosing the first single ascending dose cohort…Read full documentShow less
Cash, cash equivalents, and investments of $71.2 million at June 30,2025 and cash runway anticipated to fund operations into 2028 MENLO PARK, Calif., August 12, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the second quarter ended June 30, 2025. "We saw continued momentum this quarter across our boron chemistry pipeline as we look to develop high-impact drugs that address serious and overlooked conditions. In our Chagas disease program, we recently dosed the first Phase 1 cohort and announced a collaboration with the Drugs for Neglected Diseases initiative that will rapidly advance preparations for our Phase 2 study and allow us to maintain critical investments in our other programs. In melioidosis, observational data shared this quarter underscore the acute lethality of this potential biothreat, emphasizing its potential danger to homeland security and to U.S. troops serving abroad. And in NTM, we presented preclinical data highlighting the therapeutic potential of epetraborole as a once daily oral treatment against M. abscessus, a disease with an 8-year all-cause mortality rate of 45% and burdensome IV treatments that are not FDA approved for the disease. We are actively exploring plans to initiate a proof-of-concept trial in M. abscessus and will provide an update in the coming months," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. Easom continued: "We are also excited about recent progress in our two oncology programs generated from our boron chemistry platform, where we expect to have two development candidates within the next 12 months—a 3rd generation wild-type sparing, pan mutant-inhibitor of PI3Kα and an ENPP1 inhibitor. We see ENPP1 as an emerging immuno-oncology target with significant market potential due to its ability to enable the host immune system by turning ‘cold’ tumors ‘hot’ and halt tumor metastasis. We believe boron chemistry may offer potential competitive advantages against these targets." Second Quarter & Recent Business Updates: Chagas Disease Commenced dosing in Phase 1 FIH clinical trial of oral AN2-502998 In August, the Company announced that it has completed dosing the first single ascending dose cohort in a Phase 1 first in human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. and over 100,000 in Europe. Parallel planning for a Phase 2 proof-of-concept study in patients with chronic Chagas disease is underway, and the Company expects to initiate this Phase 2 study in 2026. There are no FDA approved treatments for adults with chronic Chagas disease. The Company estimates peak annual sales potential of $1 billion, and priority review voucher eligibility if approved. Collaboration with DNDi for AN2-502998 clinical development in chronic Chagas disease In July 2025, the Company announced a collaboration with the Drugs for Neglected Diseases initiative (DNDi) to advance the clinical development of AN2’s oral drug candidate AN2-502998. The collaboration provides AN2 with access to DNDi’s extensive clinical trial network and expertise in Chagas disease to rapidly advance Phase 2 planning. The operational efficiencies generated from this collaboration will allow the Company to conduct a cost-efficient Phase 2 trial and preserve capital for other critical pipeline programs. Melioidosis Reported key findings from 200-patient observational study Melioidosis is a highly lethal bacterial infection caused by Burkholderia pseudomallei and is recognized by the Centers for Disease Control and Prevention (CDC) as a bioterrorism agent, underscoring its potential use as a biological weapon and its ability to cause severe disease in civilian and military populations. It is endemic in warm tropical regions of the world including areas of the Mississippi Gulf Coast, Puerto Rico and the U.S. Virgin Islands and is a Nationally Notifiable Disease, designated by the CDC for monitoring, controlling and preventing serious U.S. public health disease. In June, the Company announced key insights from its 200-patient observational study in acute melioidosis. Data from the study will inform and help optimize the design of a Phase 2 trial. The study, conducted in acute hospital settings, evaluated patients receiving standard of care antibiotics, IV meropenem or ceftazidime, tracking patients while in hospital and at 28 and 90 days. A death rate of nearly 40% (by day 90) was observed among confirmed melioidosis cases. Principal investigators observed that approximately 25% of screened patients died in the short period (~3-4 days) before a definitive diagnosis of infection was confirmed and enrollment completed. These deaths were not included in the topline mortality rate. These mortality findings highlight the serious impact of melioidosis - even with current standard of care treatment - the threat it poses as a potential bioterrorism agent, and the critical need for better treatment options. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher (through the medical countermeasure pathway) and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus Presented data demonstrating epetraborole’s potent in vitro and in vivo activity in M. abscessus at the Nontuberculous Mycobacteria Conference at Colorado State University In May 2025, the Company presented a poster at the Nontuberculous Mycobacteria Conference at the Colorado State University highlighting epetraborole’s potent in vivo activity against M. abscessus. The compound demonstrated an MIC90 that is 256-fold more potent than what was observed in the Phase 2/3 treatment-refractory NTM MAC study, reinforcing its potential as a candidate for this high-mortality condition. M. abscessus has an estimated all-cause 8-year mortality of 45% and current treatments involve burdensome IV therapies that lack FDA approval for the condition. The Company is evaluating the potential for a proof-of-concept study in M. abscessus and will provide an update on further development in the coming months. Boron Chemistry Pipeline Continuing to advance boron chemistry compounds in oncology The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole) as well as other important FDA-approved molecules including Velcade for oncology and multiple recent beta lactamase inhibitors to address multi-drug resistant bacteria. The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and have excellent oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development later this year with potential clinical proof of concept data within the Company’s current cash runway. The Company expects to advance its second oncology compound into development in the first half of 2026. Global Health Through non-dilutive funding, the Company continues its efforts to tackle global health diseases, including tuberculosis and malaria, with projects that are currently funded by a grant from the Gates Foundation. Selected Second Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $3.2 million, compared to $12.1 million for the same period during 2024 due to decreased clinical trial expenses, chemistry manufacturing and controls expenses, personnel-related expenses, consulting and outside services and other expenses, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024, partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were $4.0 million, compared to $3.7 million for the same period during 2024 due to increased professional and outside services expenses. Interest Income: Interest income for the second quarter of 2025 was $0.8 million, compared to $1.4 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net loss: Net loss for the second quarter of 2025 was $6.5 million, compared to $14.4 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $71.2 million at June 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan. About AN2 Therapeutics, Inc. 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, melioidosis, and NTM lung disease caused by M. abscessus, along with programs focused on targets in oncology and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at www.an2therapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company’s boron chemistry platform; high-impact nature of the Company’s clinical programs; the Company’s approach to capital allocation and the availability of and plans to use non-dilutive funding, including the possibility that the U.S. government will not fund the Phase 2 and other future melioidosis trials; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; the ability of non-human primate models to de-risk translation to human efficacy; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued government funding of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250812515889/en/ Contacts Company Contact: Lucy O. Day Chief Financial Officer [email protected] Investor and Media Contact: Anne Bowdidge [email protected]
Investor releaseQuarter not tagged2025-05-14AN2 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business and Scientific Highlights
Cash, cash equivalents, and investments of $78.5 million at March 31, 2025 and cash runway anticipated to fund operations into 2028 MENLO PARK, Calif., May 13, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the first quarter ended March 31, 2025. "As we look ahead to the remainder of 2025, we are poised to advance our pipeline leveraging our boron chemistry platform, which has the potential to address serious unmet needs of patients. We have high-impact clinical programs for Chagas disease and melioidosis, enabling data for potential development of epetraborole in NTM lung disease caused by M. abscessus, and an emerging portfolio of oncology programs that includes ENPP1 and PI3Kα for solid tumor indications, where our boron chemistry platform has potential for best-in-class molecules," said Eric Easom, Co-founder, Chairman, President and CEO. "We remain committed to maintaining a disciplined approach to capital allocation, including using non-dilutive funding to leverage our infrastructure and capabilities for generating near and long-term growth for our shareholders with multiple pathways to success." First Quarter & Recent Business Updates: Chagas Disease The Company has initiated start up activities for a Phase 1 first in human clinical study of its product candidate, AN2-502998, which has curative potential for chronic Chagas disease, and expects to complete this trial in the second half of 2025. Chagas is an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. Left untreated, chronic Chagas disease can result in a lifelong infection that silently damages the heart and digestive system, potentially resulting in heart failure, stroke, or sudden death. AN2-502998 is a boron-based small molecule therapeutic candidate with the same mechanism of action (CPSF3) as acoziborole, a related benzoxaborole that demonstrated ~95% cure rate in a Phase 2/3 trial (DNDi/Sanofi) after a single oral dose for human African trypanosomiasis (sleeping sickness), a related disease caused by trypanosome parasites. AN2-502998 is the only compound, of which the Company is…Read full documentShow less
Cash, cash equivalents, and investments of $78.5 million at March 31, 2025 and cash runway anticipated to fund operations into 2028 MENLO PARK, Calif., May 13, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the first quarter ended March 31, 2025. "As we look ahead to the remainder of 2025, we are poised to advance our pipeline leveraging our boron chemistry platform, which has the potential to address serious unmet needs of patients. We have high-impact clinical programs for Chagas disease and melioidosis, enabling data for potential development of epetraborole in NTM lung disease caused by M. abscessus, and an emerging portfolio of oncology programs that includes ENPP1 and PI3Kα for solid tumor indications, where our boron chemistry platform has potential for best-in-class molecules," said Eric Easom, Co-founder, Chairman, President and CEO. "We remain committed to maintaining a disciplined approach to capital allocation, including using non-dilutive funding to leverage our infrastructure and capabilities for generating near and long-term growth for our shareholders with multiple pathways to success." First Quarter & Recent Business Updates: Chagas Disease The Company has initiated start up activities for a Phase 1 first in human clinical study of its product candidate, AN2-502998, which has curative potential for chronic Chagas disease, and expects to complete this trial in the second half of 2025. Chagas is an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. Left untreated, chronic Chagas disease can result in a lifelong infection that silently damages the heart and digestive system, potentially resulting in heart failure, stroke, or sudden death. AN2-502998 is a boron-based small molecule therapeutic candidate with the same mechanism of action (CPSF3) as acoziborole, a related benzoxaborole that demonstrated ~95% cure rate in a Phase 2/3 trial (DNDi/Sanofi) after a single oral dose for human African trypanosomiasis (sleeping sickness), a related disease caused by trypanosome parasites. AN2-502998 is the only compound, of which the Company is aware, to have demonstrated curative activity in non-human primates (NHPs) with long-term, naturally acquired, chronic infection of diverse T. cruzi genetic types. NHPs naturally acquire T. cruzi infection and develop chronic disease comparable to chronic Chagas disease in humans, which the Company believes offers a unique opportunity for de-risking translation to human efficacy versus other experimental infection models. There are no FDA approved treatments for chronic Chagas disease in adults. The Company estimates peak annual sales potential of $1 billion and priority review voucher eligibility, if approved. Melioidosis The Company plans to initiate a Phase 2 study with epetraborole in melioidosis, a potentially lethal bacterial infection caused by Burkholderia pseudomallei and a U.S. national security threat, with a goal of significantly reducing the 3-month mortality rate of ~40% observed in an open-label standard-of-care observational trial expected to report out in the second quarter of 2025. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Non-Tuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus Given the extensive Phase 2/3 efficacy data from the EBO-301 study, the Company plans to use non-dilutive funding to help advance epetraborole development for the treatment of NTM lung disease caused by M. abscessus, where there is a high unmet need for oral drugs vs. the current burdensome intravenous regimens. Epetraborole’s oral profile, first-in-class novel mechanism of action (LeuRS), and enabling in vitro and in vivo data, as well as a 256-fold in vitro potency advantage over Mycobacterium avium complex (MAC) in the recent treatment-refractory MAC Phase 3 trial, suggest that epetraborole has the potential to address this high unmet need. There are over 50,000 patients in the U.S., Japan and Europe who could benefit from a novel oral treatment. Boron Chemistry Pipeline The Company is pursuing a number of oncology targets where boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and intellectual property. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including a proteasome inhibitor (Velcade), CPSF3 (AN2-502998 and acoziborole), and LeuRS (epetraborole, GSK656/AN10070 and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and have excellent oral pharmacokinetics. AN2 anticipates advancing the first oncology compound(s) into development later this year with potential clinical proof of concept within the Company’s current cash runway. Global Health The Company will continue its efforts to tackle global health disease through non-dilutive funding, including tuberculosis and malaria, currently being funded by the Gates Foundation. Selected First Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $7.7 million, compared to $14.7 million for the same period during 2024 due to decreased clinical trial expenses, personnel-related expenses, consulting and outside services and other costs, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities, partially offset by increases in preclinical and research study expenses and chemistry manufacturing and controls expenses. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $3.8 million, compared to $3.6 million for the same period during 2024 due to increased professional services expenses, partially offset by decreased consulting and outside services and personnel-related expenses. Interest Income: Interest income for the first quarter of 2025 was $0.9 million, compared to $1.7 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net loss: Net loss for the first quarter of 2025 was $10.6 million, compared to $16.6 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $78.5 million at March 31, 2025. The Company projects that existing cash and cash equivalents under our current plan will sustain operations into 2028, extending from our previous guidance through 2027. About AN2 Therapeutics, Inc. 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, melioidosis, and NTM lung disease caused by M. abscessus, along with early-stage programs focused on targets in infectious diseases and oncology. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at www.an2therapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company’s boron chemistry platform; high-impact nature of the Company’s clinical programs; the Company’s approach to capital allocation and the availability of and plans to use non-dilutive funding; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; the ability of non-human primate models to de-risk translation to human efficacy; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued funding by the National Institute of Allergy and Infectious Disease (NIAID) of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250513429697/en/ Contacts Company Contact: Lucy O. DayChief Financial [email protected] Investor and Media Contact: Anne [email protected]
Investor releaseQuarter not tagged2025-03-26AN2 Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business and Scientific Highlights
Business Wire
AN2 Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business and Scientific Highlights
Phase 3 topline data expected 2Q25 for epetraborole in patients with treatment-refractory MAC lung disease (TR MAC) Phase 1 first in human study of AN2-502998, under development for Chagas disease, to start mid-2025 in healthy volunteers Topline data for melioidosis observational trial expected in 2Q25; Phase 2 epetraborole study planned for 2H25 First oncology candidate(s) from boron chemistry platform on track to advance into development in 2H25 Cash, cash equivalents, and investments of $88.6 million at December 31, 2024 anticipated to fund operations through 2027 under current strategic plan MENLO PARK, Calif., March 25, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the fourth quarter and year ended December 31, 2024. "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 Compan…Read full documentShow less
Phase 3 topline data expected 2Q25 for epetraborole in patients with treatment-refractory MAC lung disease (TR MAC) Phase 1 first in human study of AN2-502998, under development for Chagas disease, to start mid-2025 in healthy volunteers Topline data for melioidosis observational trial expected in 2Q25; Phase 2 epetraborole study planned for 2H25 First oncology candidate(s) from boron chemistry platform on track to advance into development in 2H25 Cash, cash equivalents, and investments of $88.6 million at December 31, 2024 anticipated to fund operations through 2027 under current strategic plan MENLO PARK, Calif., March 25, 2025--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today reported financial results for the fourth quarter and year ended December 31, 2024. "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. About AN2 Therapeutics, Inc. 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, and melioidosis, along with early-stage programs focused on targets in infectious diseases and oncology. For more information, please visit our website at www.an2therapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; changes to the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial, alignment with FDA Guidance for Industry and the Company’s plans to unblind and release topline results from the Phase 3 data in the second quarter of 2025; regulatory meetings and registrational pathways; the potential of the Company’s boron chemistry platform, including the timing of development compounds, and pipeline programs; cash runway; funding for the Company’s global health programs; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: future trials of epetraborole in NTM-MAC and the ability to show clinical efficacy consistent with PRO-based data observed in prospective and post-hoc analyses to date; potential disruptions related to AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s existing and future clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its existing and future clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued funding by the National Institute of Allergy and Infectious Disease (NIAID) of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading "Risk Factors" in AN2’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and AN2’s other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250325285268/en/ Contacts Company Contact: Lucy O. DayChief Financial [email protected] Investor and Media Contact: Anne [email protected]

