Tavaborole

Parasite elimination achieved with 28-day treatment in 100% of nonhuman primates (NHPs) naturally infected with Trypanosoma cruzi (T. cruzi) at target exposures planned in humans Phase 1 First-In-Human (FIH) study showed favorable safety and tolerability profile; no dose-limiting toxicities Significant U.S. commercial opportunity, including Priority Review Voucher eligibility upon approval MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX) a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced positive results from two studies evaluating the Company’s oral CPSF3 inhibitor, AN2-502998, for the treatment of chronic Chagas disease (American trypanosomiasis) caused by infection with the parasite T. cruzi. Key findings from the two studies: In NHPs with naturally acquired, chronic T. cruzi parasite infection, 28 days of AN2-502998 treatment resulted in 100% parasitic elimination at target exposures attainable in humans, through four months following the end of treatment. In the Phase 1 FIH study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds, with no dose-limiting toxicities. “Results from these studies converge on the picture we were hoping to see: efficacy in NHPs at an exposure level achievable in humans, with an excellent safety pro shown in the FIH study. Notably, parasites were eliminated after one month of treatment in NHPs with the same naturally acquired, chronic infection that we see in humans,” said Eric Easom, Co-founder, Chairman, President and CEO of AN2 Therapeutics. “Together, these data support our goal of making AN2-502998 the first FDA-approved therapy for chronic Chagas disease in adults.” Easom continued, “We believe an oral therapy capable of delivering high rates of parasitic cure after just one month of treatment could enable large-scale test-and-treat campaigns against this often lethal disease, which affects over 300,000 people in the U.S. and approximately 10 million globally. We look forward to initiating a Phase 2 proof-of-concept study late this year.” "Chagas disease is hiding in plain sight. We have simple, inexpensive serologic tests, and we know exactly which populations are at risk, no different from where we were with hepatitis C or HIV before systematic screening became standard of care,” said Dr. David Hamer, Professor of Global Health and Medicine, Boston University Schools of Public Health and Medicine. “The patients are there; it's a matter of clinical awareness and systematic screening. What has been missing is an effective, well-tolerated treatment that physicians and patients can rely on for adults with chronic Chagas disease, who represent the vast majority of patients. It is genuinely encouraging to see serious drug development in this space - chronic Chagas disease represents one of the highest unmet needs in infectious disease, and these data suggest we may finally be moving toward a meaningful therapeutic option for patients who have had too few for too long." Overview of Chagas Disease Chagas disease (also known as American trypanosomiasis) is caused by the parasite 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. Chagas Disease Opportunity The Company believes that Chagas disease represents a potential multi-billion-dollar global market opportunity globally, given its large and readily treatable patient population. Well-established risk profiles including country of birth, travel history, and exposure to triatomine vectors enable targeted, cost-effective screening, and low-cost diagnostics are widely available. The commercial pro Chagas disease therapeutics shares key structural characteristics with that of other large infectious disease markets, most notably hepatitis C, for which accessible diagnostics, defined risk populations, high urgency to treat, and broad insurance coverage transformed a historically underdiagnosed condition into a substantial market. In parallel, through its work with the Drugs for Neglected Diseases initiative (DNDi), the Company is committed to ensuring global access to AN2-502998, should it eventually be approved, in Chagas-endemic developing regions. AN2-502998, if approved, would also be eligible for an FDA Tropical Disease Priority Review Voucher. Key Findings: 28-Day Nonhuman Primate (NHP) Study The NHP efficacy study evaluated AN2-502998 administered for 28 days in macaques with naturally-acquired, chronic T. cruzi infection, contracted via triatomine (kissing bug) vectors in their natural habitats, the same vector that transmits the parasite to humans. The Chagas disease vector is increasingly prevalent across the southern half of the U.S. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease. 100% of treated animals achieved parasite elimination at target exposures attainable in humans. Elimination of parasitemia in treated animals was durable and maintained through four months following the end of treatment. Parasitemia was evaluated using an enhanced PCR method with improved sensitivity and robustness. AN2-502998 was well tolerated with no drug-related adverse events. AN2-502998 is the only compound to have demonstrated curative activity in NHPs with long-term, naturally acquired T. cruzi infection. Key Findings: Phase 1 First-in-Human Study The Phase 1 FIH study (NCT07024589) evaluated single ascending oral doses of AN2-502998 and then multiple ascending doses administered over 10 days in healthy adult volunteers: AN2-502998 was generally well tolerated with no dose-limiting toxicities. Human PK was well characterized; plasma exposures at or above NHP efficacy thresholds were achieved. About AN2-502998 AN2-502998 is a boron-based small molecule therapeutic candidate from the benzoxaborole class, which has a broad therapeutic pro includes two FDA-approved drugs (crisaborole and tavaborole). AN2-502998 is an orally active inhibitor of CPSF3 in T. cruzi . CPSF3 is an essential enzyme involved in messenger RNA processing, is clinically validated, and the same target as acoziborole that was recently approved by the EMA for the treatment of human African trypanosomiasis (HAT), caused by a related trypanosome parasite. AN2 Therapeutics is advancing AN2-502998 into Phase 2 clinical study in collaboration with DNDi, a non-profit research and development organization whose medical expertise, established presence in Chagas-endemic regions, and commitment to delivering accessible treatments for neglected diseases provides a critical foundation for both the timely execution of clinical development and ensuring broad global access upon approval. The program also benefits from ongoing collaboration with the University of Georgia Research Foundation and the laboratory of Prof. Rick Tarleton, whose pioneering work in T. cruzi biology has been instrumental in advancing the scientific understanding of Chagas disease. About AN2 Therapeutics 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 oncology 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; NHP study data as a predictor of efficacy outcomes in human trials; market size and sales potential; the commercial pro Chagas disease therapeutics; advancement of AN2-502998 into Phase 2 in collaboration with DNDi and other ongoing collaborations; expectations regarding the Company’s clinical trials; the predictivity of data; 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 and on the SEC’s website at 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. Contacts COMPANY CONTACT: Lucy O. Day Chief Financial Officer l.day@an2therapeutics.com INVESTOR AND MEDIA CONTACT: Anne Bowdidge ir@an2therapeutics.com

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.--(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 and on the SEC’s website at . 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. AN2 THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ 6,743 $ 7,690 General and administrative 3,808 3,847 Total operating expenses 10,551 11,537 Loss from operations (10,551 ) (11,537 ) Interest income 523 888 Net loss $ (10,028 ) $ (10,649 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.29 ) $ (0.35 ) Weighted-average number of shares used in computing net loss per share, basic and diluted 34,059,876 30,053,659 Other comprehensive loss: Unrealized (loss) gain on investments (62 ) 17 Comprehensive loss $ (10,090 ) $ (10,632 ) AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) March 31, 2026 (unaudited) December 31, 2025 Assets Current assets: Cash and cash equivalents $ 53,487 $ 19,941 Short-term investments 31,801 38,060 Prepaid expenses and other current assets 2,203 1,936 Long-term investments — 2,013 Total assets $ 87,491 $ 61,950 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 2,615 $ 3,021 Other current liabilities 2,947 5,699 Total current liabilities 5,562 8,720 Other non-current liabilities 170 170 Total liabilities 5,732 8,890 Stockholders’ equity 81,759 53,060 Total liabilities and stockholders’ equity $ 87,491 $ 61,950 Contacts Company Contact: Lucy O. Day Chief Financial Officer l.day@an2therapeutics.com Investor and Media Contact: Anne Bowdidge ir@an2therapeutics.com