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AN2 Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 9, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 9, 2026

ANTX$4.000.0%Stored close · as of Nov 9, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-11.

0001193125-26-344569

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001193125-26-452664

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 96 previous paragraphs and 98 current paragraphs.

66 unchanged; 26 reworded; 6 added; 3 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (6)

Current report

We have selected AN2-504661, an oral, boron-based inhibitor of ectonucleotide pyrophosphatase/phosphodiesterase 1 (“ENPP1”), as our development candidate for the treatment of HPP. HPP is a rare, inherited metabolic bone disease caused by loss-of-function mutations in the ALPL gene, which encodes tissue-nonspecific alkaline phosphatase (“TNAP”). TNAP deficiency allows inorganic pyrophosphate (“PPi”), a potent inhibitor of bone mineralization, to accumulate. HPP encompasses a spectrum of disease ranging from life-threatening perinatal and infantile forms to adult-onset disease characterized by fractures, chronic pain, muscle weakness, impaired mobility, and other serious complications throughout life. Because ENPP1 is the principal enzyme that generates extracellular PPi, we believe that inhibiting ENPP1 may reduce PPi production at its source, normalize PPi levels, and improve bone mineralization. The only U.S.-approved therapy for HPP, asfotase alfa (“Strensiq®”), is an enzyme replacement therapy indicated for patients with perinatal/infantile or juvenile-onset HPP. It requires subcutaneous injections three to six times per week on an ongoing basis and is commonly associated with injection-site reactions. In addition, AstraZeneca has recently submitted a Biologics License Application for efzimfotase alfa, a biweekly subcutaneous enzyme replacement therapy for HPP in patients aged two years and older. We believe there is a significant unmet need for an oral therapy, including for pediatric patients with juvenile-onset disease and adult-onset patients. There is currently no approved therapy for adult-onset HPP in the U.S. We believe adult patients, many of whom are underdiagnosed and may have milder disease, represent a largely underserved patient population for whom an oral treatment option could address an important unmet need. Oral ENPP1 inhibitors have the potential to address the underlying bone manifestations of the disease and provide a more patient-friendly oral treatment option.

Current report

We believe ENPP1 is a target well suited to our boron chemistry platform. Under physiological conditions, boron can convert from a neutral, trigonal planar form to a negatively charged, tetrahedral form. This allows our compounds to bind the bimetallic zinc center of the ENPP1 active site as a phosphate mimic, without requiring the permanently charged groups that have limited the oral bioavailability of other ENPP1 inhibitor chemotypes. AN2-504661 was selected following extensive lead optimization and preclinical evaluation demonstrating the potential for a differentiated profile characterized by potent and selective ENPP1 inhibition, favorable pharmacokinetic properties and oral bioavailability, efficacy in animal models, and an encouraging nonclinical safety profile with low potential for hERG-related cardiac events and other safety liabilities, supporting its potential to be best-in-class. We plan to initiate a Phase 1 clinical study for AN2-504661 in the second half of 2027.

Current report

Research and development expenses were $5.7 million for the three months ended September 30, 2026 compared to $7.0 million for the three months ended September 30, 2025, resulting in a decrease of $1.3 million in expenses. Preclinical and research study expenses decreased by $1.0 million due to certain compounds completing the preclinical research stage and progressing into nonclinical development. Other miscellaneous expenses decreased by $0.5 million due to updated estimates of provisional indirect cost rates under the NIAID contract in 2025. Clinical trial expenses decreased by $0.3 million due to the completion of our Chagas Phase 1 study, partially offset by start-up and other costs related to initiation of Phase 2 trials in M. abscessus, PV and Chagas disease. Personnel-related expenses increased by $0.4 million primarily due to stock-based compensation expense. CMC expenses increased by $0.1 million due to clinical trial material production for our Chagas Phase 2 study and scale-up of research material for our HPP program, partially offset by completion of the Chagas Phase 1 clinical trial material production. During the three months ended September 30, 2026 and 2025, reimbursement of $0.7 million and $0.3 million, respectively, of operating expenses was recognized related to our funding arrangements.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025
Removed paragraphs (3)

Previous report

Research and development expenses were $12.8 million for the six months ended June 30, 2026 compared to $10.9 million for the six months ended June 30, 2025. The increase of $1.9 million was primarily due to increases in consulting and outside services, other miscellaneous expenses, preclinical and research study expenses, and clinical trial expenses, partially offset by decreases in personnel-related expenses and CMC expenses. In 2025, we completed manufacturing of the melioidosis drug product and due to the timing of when receipt of research contract offsets became reasonably assured, increases are seen in consulting and outside services, other miscellaneous expenses, and CMC expenses when comparing the six months ended June 30, 2026 to the same period in 2025. Consulting and outside services increased by $0.7 million due to melioidosis program expense offsets and the prioritization of earlier stage research and clinical programs. Other miscellaneous expenses increased by $0.9 million primarily due an increase related to melioidosis program overhead offsets and recognition of our qualified small business payroll tax credit in 2025, partially offset by a $0.2 million decrease in license fees. Preclinical and research study expenses increased by $0.5 million due to increased activity in earlier stage research and preclinical programs. Clinical trial expenses increased by $0.5 million primarily due to increased activity in our trials in Chagas disease, M. abscessus and PV, partially offset by decreased expenses due to the termination of the EBO-301 trial. These increases are partially offset by a decrease of $0.5 million in personnel-related expenses primarily due to decreased stock-based compensation expense, partially offset by compensation-related payments. CMC expenses decreased by $0.1 million due to decreased CMC activity related to our Chagas program, partially offset by an increase in CMC activity related to melioidosis program expense offsets. During the six months ended June 30, 2026 and 2025, reimbursement of $1.0 million and $4.1 million, respectively, of operating expenses was recognized related to our funding arrangements.
Reworded paragraphs (26)

Previous wording

The following discussion and analysis of our financial condition as of June 30, 2026 and results of operations for the three and six months ended June 30, 2026 and 2025 should be read in conjunction with our condensed financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q (“Form 10-Q”) and our audited financial statements and the related notes thereto included as a part of our Annual Report on Form 10-K for the year ended December 31, 2025. Except as otherwise indicated herein or as the context otherwise requires, references in this Form 10-Q to “AN2,” “the Company,” “we,” “us” and “our” refer to AN2 Therapeutics, Inc.

Current wording

The following discussion and analysis of our financial condition as of September 30, 2026 and results of operations for the three and nine months ended September 30, 2026 and 2025 should be read in conjunction with our condensed financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q (“Form 10-Q”) and our audited financial statements and the related notes thereto included as a part of our Annual Report on Form 10-K for the year ended December 31, 2025. Except as otherwise indicated herein or as the context otherwise requires, references in this Form 10-Q to “AN2,” “the Company,” “we,” “us” and “our” refer to AN2 Therapeutics, Inc.

Previous wording

We are 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 and 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 medical needs and improve health outcomes.

Current wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. We are committed to delivering high-impact drugs to patients that address critical medical needs and improve health outcomes.

Previous wording

In March 2026, we announced our 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 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.

Current wording

Polycythemia vera (“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.

Previous wording

In July, the Company 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.

Current wording

Study startup activities are underway for a global Phase 2 study (EBO-PV-201) to evaluate the efficacy and safety of oral epetraborole in adults with phlebotomy-dependent PV. We have received regulatory clearance to proceed in all planned jurisdictions, including U.S. FDA clearance of our IND and regulatory clearances in Australia and India. We anticipate commencing enrollment by the end of 2026, beginning with an open-label sentinel cohort receiving a predicted subtherapeutic dose to assess pharmacokinetics and safety in PV patients. Following completion of the sentinel group, the safety monitoring committee will advise on dose selection for Part 1, an open-label, single-arm, dose escalation, 28-week evaluation of epetraborole to maintain hematocrit control and reduce the frequency of phlebotomy in patients with phlebotomy-dependent PV. We anticipate releasing Part 1 data periodically throughout 2027.

Previous wording

Building on the microbiological and safety data from our prior non-tuberculous mycobacterial (“NTM”) study in treatment-refractory MAC, we believe 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% are caused by M. abscessus.

Current wording

Building on the microbiological and safety data from our prior non-tuberculous mycobacterial (“NTM”) study in treatment-refractory Mycobacterium avium complex (“MAC”), we believe 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, often initially 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, with M. abscessus accounting for approximately 10–15% of the cases.

Previous wording

The Company is supporting an investigator-initiated trial (“IIT”) 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 Science University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. We anticipate reporting topline results in late 2027, subject to enrollment progress.

Current wording

We are supporting an investigator-initiated trial (“IIT”) of oral epetraborole in M. abscessus lung disease and anticipate 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 Science University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. We anticipate reporting topline results in late 2027, subject to enrollment progress.

Previous wording

We are studying AN2-502998 (formerly known as AN15368), 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.

Current wording

We are studying AN2-502998 (formerly known as AN15368), 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 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.

Previous wording

In June 2026, we announced positive results from two studies that we believe 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.

Current wording

In June 2026, we announced positive results from two studies that we believe support the initiation of a Phase 2 trial of AN2-502998 in chronic Chagas disease. In the nonhuman primate (“NHP”) efficacy study, 28 days of treatment with AN2-502998 resulted in 100% parasitic elimination at target exposures attainable in humans, in NHPs with naturally acquired, chronic T. cruzi infection. In our Phase 1 first-in-human study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds.

Previous wording

AN2-502998 is the only compound of which we are 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. We believe that efficacy in naturally infected NHP’s is the most clinically relevant predictor of efficacy for human chronic Chagas disease.

Current wording

AN2-502998 is the only compound of which we are 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. We believe that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease. Startup activities are underway for a Phase 2 proof-of-concept study in adults with chronic T. cruzi infection.

Previous wording

We are prioritizing targets in oncology and bone disorders where we believe 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.

Current wording

We are prioritizing targets where we believe boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including ENPP1 and PI3Kα for oncology indications. 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). We have discovered preclinical compounds that demonstrate sub-nanomolar activity, high selectivity and excellent oral pharmacokinetic properties. In the fourth quarter of 2026, we selected AN2-504661 as a development candidate for HPP (see above).

Previous wording

We do not have any products approved for sale and have not generated any revenue since inception. Our net losses were $18.2 million and $17.1 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $259.2 million. We have funded our operations from the sale and issuance of redeemable convertible preferred stock and proceeds from our initial public offering (“IPO”), “at-the-market” equity offering programs (“ATM Offerings”), an underwritten offering (the “Underwritten Offering”), and the 2026 Private Placement (the “2026 Private Placement”). From November 2019 through October 2020, we raised an aggregate of $12.0 million from the sale of Series A redeemable convertible preferred stock. In March 2021, we raised an aggregate of $80.0 million from the sale of Series B redeemable convertible preferred stock. In March and April 2022, we completed our IPO, with gross proceeds of $79.4 million and net proceeds of $70.4 million, net of underwriting discounts, commissions and offering expenses. In June 2023, we raised gross proceeds of $20.0 million from the ATM Offerings and net proceeds of $19.1 million, after deducting commissions and offering expenses. In August 2023, we raised gross proceeds of $70.0 million from the Underwritten Offering and net proceeds of $65.5 million, after deducting commissions and offering expenses. In March 2026, we raised gross proceeds of $40.0 million from the 2026 Private Placement and net proceeds of $37.2 million, after deducting placement agent fees and other offering expenses. In the six months ended June 30, 2026, we raised net proceeds of $1.4 million from the ATM Offerings, after deducting commissions and offering expenses.

Current wording

We do not have any products approved for sale and have not generated any revenue since inception. Our net losses were $26.2 million and $26.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $267.1 million. We have funded our operations from the sale and issuance of redeemable convertible preferred stock and proceeds from our initial public offering (“IPO”), “at-the-market” equity offering programs (“ATM Offerings”), an underwritten offering (the “Underwritten Offering”), and the 2026 private placement (the “2026 Private Placement”). From November 2019 through August 2023, we raised gross proceeds of an aggregate of $261.4 million from the sale of Series A and Series B redeemable convertible preferred stock and the sale of common stock under our IPO, ATM Offerings and the Underwritten Offering, resulting in $247.0 million proceeds net of underwriting discounts, commissions, and offering expenses. In March 2026, we raised gross proceeds of $40.0 million from the 2026 Private Placement resulting in net proceeds of $37.2 million, after deducting placement agent fees and other offering expenses. In the nine months ended September 30, 2026, we raised net proceeds of $8.0 million from the ATM Offerings, after deducting commissions and offering expenses.

Previous wording

As of June 30, 2026, we had cash, cash equivalents, and investments of $79.9 million. We believe that our available cash will be sufficient to fund our planned operations under our current operating plan through at least twelve months following the date of this Form 10-Q.

Current wording

As of September 30, 2026, we had cash, cash equivalents, and investments of $80.2 million. We believe that our available cash will be sufficient to fund our planned operations under our current operating plan through at least twelve months following the date of this Form 10-Q.

Previous wording

General and administrative expenses were $2.9 million for the three months ended June 30, 2026 and $4.0 million for the three months ended June 30, 2025. The decrease of $1.1 million is primarily due to a $0.6 million decrease in professional and outside services expenses and a $0.5 million decrease in personnel-related expenses due to a decrease in stock-based compensation.

Current wording

General and administrative expenses were $2.9 million for the three months ended September 30, 2026 and $3.0 million for the three months ended September 30, 2025. The decrease of $0.1 million was due to a $0.4 million decrease in personnel-related expenses, primarily due to stock-based compensation expense, partially offset by a $0.2 million increase in professional and outside services expenses and a $0.1 million increase in other miscellaneous expenses.

Previous wording

Interest income was $0.7 million for the three months ended June 30, 2026 compared to $0.8 million for the three months ended June 30, 2025.

Current wording

Interest income was $0.7 million for both the three months ended September 30, 2026 and 2025.

Previous wording

Research and development expenses were $6.0 million for the three months ended June 30, 2026 compared to $3.2 million for the three months ended June 30, 2025. The increase of $2.8 million was primarily due to increases in chemistry manufacturing and controls (“CMC”) expenses, other miscellaneous expenses, consulting and outside services, preclinical and research study expenses and clinical trial expenses, partially offset by a decrease in personnel-related expenses. In 2025, we completed manufacturing of the melioidosis drug product and due to the timing of when receipt of research contract offsets became reasonably assured, increases are seen in CMC expenses, other miscellaneous expenses, and consulting and outside services when comparing the second quarter of 2026 to the same period in 2025. CMC expenses increased by $1.5 million due to melioidosis program expense offsets, partially offset by decreased CMC activity related to our Chagas program. Other miscellaneous expenses increased by $0.6 million due an increase related to melioidosis program overhead offsets. Consulting and outside services increased by $0.6 million due to an increase in melioidosis program expense offsets and the prioritization of earlier stage research and clinical programs. Preclinical and research study expenses increased by $0.5 million due to increased activity in earlier stage research and preclinical programs. Clinical trial expenses increased by $0.3 million primarily due to increased activity in our trials in Chagas disease, M. abscessus and PV, partially offset by decreased expenses due to the termination of the EBO-301 trial. Personnel-related expenses decreased by $0.7 million primarily due to decreased stock-based compensation expense. During the three months ended June 30, 2026 and 2025, reimbursement of $0.4 million and $3.7 million, respectively, of operating expenses was recognized related to our funding arrangements.

Current wording

Research and development expenses were $18.5 million for the nine months ended September 30, 2026 compared to $17.9 million for the nine months ended September 30, 2025, resulting in an increase of $0.6 million in expenses. Consulting and outside services increased by $0.7 million to support our M. abscessus, PV and Chagas clinical programs, partially offset by decreased expenses related to our terminated NTM treatment refractory program. Other miscellaneous expenses increased by $0.2 million due to increased expenses related to melioidosis program overhead offsets and recognition of a qualified small business payroll tax credit in 2025, partially offset by a decrease in non-recurring license fees. Clinical trial expenses increased $0.1 million due to start-up and other costs related to initiation of Phase 2 trials in M. abscessus, PV and Chagas disease, offset by termination of the EBO-301 study and completion of the Chagas Phase 1 study. Preclinical and research study expenses decreased by $0.4 million due to completion of a long-term nonclinical study in 2025, partially offset by increased spending on certain preclinical research programs. During the nine months ended September 30, 2026 and 2025, reimbursement of $1.8 million and $4.5 million, respectively, of operating expenses was recognized related to our funding arrangements.

Previous wording

General and administrative expenses were $6.7 million for the six months ended June 30, 2026 and $7.9 million for the six months ended June 30, 2025. The decrease of $1.2 million is primarily due to a decrease of $0.9 million in personnel-related expenses due to a decrease in stock-based compensation and a decrease of $0.5 million in professional and outside services expenses, partially offset by a $0.2 million increase in other miscellaneous expenses.

Current wording

General and administrative expenses were $9.6 million for the nine months ended September 30, 2026 and $10.9 million for the nine months ended September 30, 2025. The decrease of $1.3 million was due to a decrease of $1.2 million in personnel-related expenses, primarily due to stock-based compensation expense, and a $0.3 million decrease in professional and outside services expenses, partially offset by a $0.2 million increase in other miscellaneous expenses.

Previous wording

Interest income was $1.2 million for the six months ended June 30, 2026 compared to $1.6 million for the six months ended June 30, 2025. The decrease of $0.4 million was due to lower average cash, cash equivalents, and investment balances and lower interest rates in 2026 as compared to 2025.

Current wording

Interest income was $2.0 million for the nine months ended September 30, 2026 compared to $2.3 million for the nine months ended September 30, 2025. The decrease of $0.3 million was due to lower interest rates in 2026 as compared to 2025.

Previous wording

We have incurred net losses since our inception. For the six months ended June 30, 2026 and 2025, we had net losses of $18.2 million and $17.1 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2026, we had an accumulated deficit of $259.2 million. As of June 30, 2026, we had cash, cash equivalents, short-term and long-term investments of $79.9 million. Based on our current plan, we believe that our available cash will be sufficient to fund our operations for at least 12 months following the date of this Form 10-Q.

Current wording

We have incurred net losses since our inception. For the nine months ended September 30, 2026 and 2025, we had net losses of $26.2 million and $26.5 million, respectively, and we expect to incur substantial additional losses in future periods. As of September 30, 2026, we had an accumulated deficit of $267.1 million. As of September 30, 2026, we had cash, cash equivalents, short-term and long-term investments of $80.2 million. Based on our current plan, we believe that our available cash will be sufficient to fund our operations for at least 12 months following the date of this Form 10-Q.

Previous wording

To date, we have funded our operations primarily through our 2026 Private Placement, Underwritten Offering, ATM Offerings, IPO and issuances of our then existing redeemable convertible preferred stock. In the six months ended June 30, 2026, we issued and sold 286,498 shares of common stock under the ATM Offerings, resulting in net proceeds of $1.4 million, after deducting commissions and offering expenses. In March 2026, we generated approximately $37.2 million from the 2026 Private Placement, after deducting placement agent fees and other offering expenses. In August 2023, we generated approximately $65.5 million from the Underwritten Offering, after deducting commissions and offering expenses. In June 2023, we generated approximately $19.1 million in net proceeds from the ATM Offerings, after deducting commissions and offering expenses. In March and April 2022, we generated aggregate net proceeds of approximately $70.4 million from our IPO, after deducting underwriting discounts and commissions and offering expenses. Prior to our IPO, we raised $91.6 million from the issuance of our redeemable convertible preferred stock. Upon the closing of our IPO, all outstanding shares of our then existing redeemable convertible preferred stock were converted into shares of our common stock.

Current wording

To date, we have funded our operations primarily through our 2026 Private Placement, Underwritten Offering, ATM Offerings, IPO and issuances of our then existing redeemable convertible preferred stock. In the nine months ended September 30, 2026, we issued and sold 1,692,768 shares of common stock under the ATM Offerings, resulting in net proceeds of $8.0 million, after deducting commissions and offering expenses. In March 2026, we generated approximately $37.2 million from the 2026 Private Placement, after deducting placement agent fees and other offering expenses. From November 2019 through August 2023, we raised aggregate gross proceeds of $261.4 million from the sale of Series A and Series B redeemable convertible preferred stock and the sale of common stock under our IPO, ATM Offerings and the Underwritten Offering, resulting in $247.0 million proceeds, net of underwriting discounts, commissions, and offering expenses.

Previous wording

We do not have any products approved for sale, and we have never generated any revenue from contracts with customers. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval for and commercialize any of our current and future product candidates and we do not know when, or if, those events will occur. Historically, we have incurred operating losses and negative cash flows as a result of ongoing efforts to develop our product candidates, including conducting ongoing preclinical and nonclinical studies, clinical trials, API and drug product materials manufacturing, and providing general and administrative support for these operations. We expect our negative cash flows to increase significantly over the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization, and continue our research and development efforts. We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. Moreover, we expect to continue to incur costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations, as we do not expect positive cash flows from operations in the foreseeable future.

Current wording

We do not have any products approved for sale, and we have never generated any revenue from contracts with customers. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval for and commercialize any of our current and future product candidates and we do not know when, or if, those events will occur. Historically, we have incurred operating losses and negative cash flows as a result of ongoing efforts to develop our product candidates, including conducting ongoing preclinical and nonclinical studies, clinical trials, API and drug product materials manufacturing, and providing general and administrative support for these operations. We expect our negative cash flows to increase significantly over the next several years as we advance our product candidates through nonclinical and clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization, and continue our research and development efforts. We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. Moreover, we expect to continue to incur costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations, as we do not expect positive cash flows from operations in the foreseeable future.

Previous wording

Net cash used in operating activities was $19.1 million for the six months ended June 30, 2026, which consisted of a net loss of $18.2 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $3.1 million in our net operating assets and liabilities, partially offset by $2.2 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $3.6 million in accrued liabilities, accounts payable, accrued compensation, and other current liabilities, partially offset by a decrease of $0.5 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $2.4 million, partially offset by net accretion of discounts on investments of $0.2 million.

Current wording

Net cash used in operating activities was $25.2 million for the nine months ended September 30, 2026, which consisted of a net loss of $26.2 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $2.0 million in our net operating assets and liabilities, partially offset by $3.0 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $2.5 million in accrued liabilities, accounts payable, accrued compensation, and other current liabilities, partially offset by a decrease of $0.5 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $3.4 million, partially offset by net accretion of discounts on investments of $0.4 million.

Previous wording

Net cash used in operating activities was $18.2 million for the six months ended June 30, 2025, which consisted of a net loss of $17.1 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $4.4 million in our net operating assets and liabilities, partially offset by $3.3 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $3.2 million in accrued liabilities, accounts payable, accrued compensation, and other current liabilities and an increase of $1.2 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $4.0 million, partially offset by net accretion of discounts on investments of $0.7 million.

Current wording

Net cash used in operating activities was $24.6 million for the nine months ended September 30, 2025, which consisted of a net loss of $26.5 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $2.0 million in our net operating assets and liabilities, partially offset by $3.9 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $3.4 million in accrued liabilities, accounts payable, accrued compensation, and other current liabilities, partially offset by a decrease of $1.4 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $4.8 million, partially offset by net accretion of discounts on investments of $0.9 million.

Previous wording

Net cash provided by investing activities was $15.0 million for the six months ended June 30, 2025, which primarily consisted of $49.0 million in proceeds from the maturity of investments, partially offset by $34.0 million in purchases of investments.

Current wording

Net cash used in investing activities was $19.8 million for the nine months ended September 30, 2026, which primarily consisted of $49.8 million in purchases of investments, partially offset by $30.0 million in proceeds from the maturity of investments.

Previous wording

Net cash provided by investing activities was $4.6 million for the six months ended June 30, 2026, which primarily consisted of $21.0 million in proceeds from the maturity of investments, partially offset by $16.4 million in purchases of investments.

Current wording

Net cash provided by investing activities was $21.1 million for the nine months ended September 30, 2025, which primarily consisted of $59.0 million in proceeds from the maturity of investments, partially offset by $37.9 million in purchases of investments.

Previous wording

Net cash provided by financing activities was $38.8 million for the six months ended June 30, 2026, which consisted of $37.5 million in net proceeds from the issuance of common stock and pre-funded warrants from the 2026 Private Placement, $1.4 million in net proceeds from the issuance of common stock from the ATM Offerings, $0.08 million from the exercise of stock options, and $0.04 million in proceeds from the issuance of common stock under the employee stock purchase plan. These increases were partially offset by $0.2 million in payment of deferred offering costs related to the ATM Offerings.

Current wording

Net cash provided by financing activities was $45.3 million for the nine months ended September 30, 2026, which consisted of $37.2 million in net proceeds from the issuance of common stock and pre-funded warrants from the 2026 Private Placement, $8.0 million in net proceeds from the issuance of common stock from the ATM Offerings, $0.2 million from the exercise of stock options, and $0.1 million in proceeds from the issuance of common stock under the employee stock purchase plan. These increases were partially offset by $0.3 million in payment of deferred offering costs related to the ATM Offerings.

Previous wording

Net cash provided by financing activities was $0.1 million for the six months ended June 30, 2025, which consisted of $0.05 million in proceeds from the issuance of common stock under the employee stock purchase plan and $0.05 million from the exercise of stock options.

Current wording

Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2025, which consisted of $0.08 million in proceeds from the issuance of common stock under the employee stock purchase plan and $0.02 million from the exercise of stock options.
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Previous report — wording carried elsewhere

We expect to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease in late 2026.