ANTX 10-K & 10-Q changes, risk factors and insider trading
AN2 Therapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1880438 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Evaluation of our product candidates in investigator-initiated clinical trials (“IITs”) may expose us to additional risks that could impair the development of our product candidates.”
Removed heading “We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.”
Removed heading “Government Downsizing Initiatives Could Adversely Impact FDA Operations, Leading to Potential Delays in Regulatory Review and Approval”
Removed heading “Disruptions at the FDA and other government agencies caused by funding shortages, staff reductions or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.”
Largest changes
“We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.”see in full comparison
general economic, political, market, andsee in full comparisonmarketindustryconditionsconditions, including economic slowdowns, recessions, inflationary pressures, rising interest rates, tariffs, trade wars, and reduced credit availability, and overall fluctuations in the financial markets in theUnited StatesU.S. or other countries where we conduct critical business;
“The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for any product candidate that we commercialize. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. …”see in full comparison
“Disruptions at the FDA and other government agencies caused by funding shortages, staff reductions or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.”see in full comparison
“In August 2024, we announced a business restructuring plan and implemented a workforce reduction. The objective of these initiatives was to focus the organization and our resources on product candidates and development compounds to treat Chagas diseases, NTM, melioidosis, other infectious diseases, and oncology while we continue to evaluate the TR-MAC program.”see in full comparison
“We may also incur other charges, costs, future cash expenditures or impairments not currently contemplated due to events that may occur as a result of, or in connection with, the revised business strategy and workforce reduction. In addition, we may be unsuccessful in distributing the duties and obligations of departed employees among our remaining employees.”see in full comparison
Full comparison: every changed paragraph (108)
We have a pipeline that is primarily composed of early-stage and mid-stage programs, and clinical proof of concept has not yet been established for any of our product candidates. Our ability to advance these molecules into clinical development, and successfully progress them through preclinical, clinical, and regulatory milestones, is highly uncertain. The inherent risks of early-stage drug discovery and development, including challenges in translation from preclinical data to human studies, may prevent us from achieving meaningful clinical results, obtaining regulatory approval, or realizing the value of our pipeline assets.
We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.
We face substantial competition, which may result in others discovering, developing,developing or commercializing products before or more successfully than we do.
We operate with a small team and our future success depends on our ability to retain key executives and to attract, retain,retain and motivate qualified personnel.
We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs or other difficulties.
OnFor example, in August 8, 2024, we announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of optimized background regimen (“OBR”) in treatment-refractory MAC lung disease. The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). SputumHowever, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). EpetraboroleIn May 2025, we announced that the truncated Phase 3 portion of the EBO-301 study did not meet its primary endpoint of demonstrating an improvement on the QOL-B respiratory domain PRO instrument (change from baseline to month 6), though epetraborole was generally well tolerated in the trial. Based on these results, we decided to suspend further development of epetraborole for treatment-refractory MAC lung disease.
Our net loss was $51.3$35.2 million and $64.7$51.3 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $205.8$241.0 million. We have funded our operations to date primarily with proceeds from our underwritten offering (the "“Underwritten Offering”), our “at-the-market” equity offering program (“ATM Offering”), our IPO, and the sale of our redeemable convertible preferred stock. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical and nonclinical studies, manufacturing, clinical trials, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year.
We commenced active operations in November 2019, and our operations to date have been largely focused on raising capital, developing epetraborole,epetraborole and other product candidates, broadening our expertise in the development of epetraborole, and other product candidates, undertaking preclinical and nonclinical studies, manufacturing clinical trial material, preparing for and initiating clinical trials, and general and administrative operations. As a company, we have not yet demonstrated an ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a commercial product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
We have and may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. For example, in May 2025, we decided to discontinue our development of epetraborole for treatment-refractory MAC lung disease following the failure of the truncated Phase 3 portion of the EBO-301 study to meet its primary endpoint.
We have and may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. For example, in August 2024, we announced topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating our initial product candidate, epetraborole, in patients with treatment-refractory MAC lung disease. Although the Phase 2 part of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). Given these results, we decided to close out the trial and are in the process of planning to unblind the Phase 3 part of the study and meet with the FDA to determine next steps.
We may not realize the expected benefits from our business restructuring and workforce reduction and we may incur additional costs implementing it or other difficulties.
In August 2024, we announced a business restructuring plan and implemented a workforce reduction. The objective of these initiatives was to focus the organization and our resources on product candidates and development compounds to treat Chagas diseases, NTM, melioidosis, other infectious diseases, and oncology while we continue to evaluate the TR-MAC program.
However, the changes to our business strategy and the reduction in workforce may yield unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond our intended workforce reduction, a reduction in morale among our remaining employees, and the risk that we may not achieve the anticipated benefits, all of which may have an adverse effect on our development activities, ability to progress our product candidate development, and results of operations or financial condition. As a result of the workforce reduction, we have recognized severance and other charges of $2.2 million as of December 31, 2024, primarily consisting of severance payments and other employee termination-related expenses.
We may also incur other charges, costs, future cash expenditures or impairments not currently contemplated due to events that may occur as a result of, or in connection with, the revised business strategy and workforce reduction. In addition, we may be unsuccessful in distributing the duties and obligations of departed employees among our remaining employees.
We may also discover that the workforce reduction and cost cutting measures will make it difficult for us to pursue new opportunities and initiatives and require us to hire qualified replacement personnel, which may require us to incur additional and unanticipated costs and expenses. Moreover, there is no assurance we will be successful in our pursuit of any of our new goals. Our failure to successfully accomplish any of the above activities and goals may have a negative impact on our business, financial condition, results of operations and growth prospects.
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. However, in addition to the $40.0 million financing completed in March 2026, we will need to obtain substantial additional funding in connection with our continuing operations and planned activities. Our future capital requirements will depend on many factors, including:
We currently have no products approved for sale and have historically invested a significant portion of our efforts and financial resources on the development of our initial product candidate, epetraborole, as a treatment for treatment-refractory MAC lung disease. Although we have discontinued our development efforts with respect to epetraborole in the treatment-refractory MAC population studied in the EBO-301 trial until completion of discussions with the FDA to align on potential next steps,population, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of our product candidates. We cannot be certain that any product candidate will advance through each of the various stages of drug development and receive regulatory approval or will be successfully commercialized even if it receives regulatory approval. The research, development, manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain, subject to comprehensive regulation by the FDA and other comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of any product candidates, we must demonstrate through preclinical and nonclinical studies and clinical trials that the product candidate is safe and effective for use in each target indication. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage during our nonclinical studies, clinical trials or drug product manufacturing process. These delays or failures could be caused by a variety of factors, including but not limited to, toxicity, safety, tolerability, efficacy, problems with clinical trial enrollment, drug product availability, stability, and impurity issues related to drug product manufacturing. For example, in AugustMay 2024,2025, we announceddecided toplineto datadiscontinue fromour the Phase 2 portiondevelopment of EBO-301, our Phase 2/3 clinical trial evaluating epetraborole in patients withfor treatment-refractory MAC lung disease.disease Althoughfollowing the Phase 2 partfailure of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (“PRO”) tool and a non-significant, but numerically higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). Given these topline results, we decided to close out thetruncated Phase 3 portion of the trialEBO-301 and commence a review of datastudy to helpmeet informits furtherprimary development. Although we believe that to date our ongoing data review supports the continued development of epetraborole in patients with treatment-refractory MAC lung disease, it is possible that we will determine to defer or discontinue development of epetraborole in NTM, whether due to further FDA feedback or otherwise.endpoint.
Failure to obtain regulatory approval for our product candidates in the United StatesU.S. or other territories will prevent us from commercializing and marketing such product candidates. The success of our product candidates will depend on several additional factors, including:
maintaining a continued acceptable safety and tolerability profile of our drugs following approval; and allowance to proceed with clinical trials under future investigational new drug applications ("INDs"),INDs, or under comparable applications submitted outside the United States.U.S.
A key element of our strategy is to develop our AN2 drug discovery platform, build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of PV, M. abscessus lung disease, Chagas disease, NTM,melioidosis, melioidosis,tuberculosis, other infectious diseases, and in oncology. Our pipeline is primarily composed of early-stage and mid-stage programs, and clinical proof of concept has not yet been established for any of our product candidates. We may not be able to develop product candidates that are safe and effective for any proposed use. Even if we are successful in continuing to build our pipeline, the potential product candidates that we identify may not be suitable for clinical development, as a result of significant safety, tolerability and other negative characteristics or limitations that may prevent successful regulatory approval or limit market acceptance or reimbursements from third-party payors. If we do not successfully develop and commercialize any of our product candidates, we will not be able to obtain product revenue in future periods, which could significantly harm our financial position and adversely affect the trading price of our common stock.
Prior to marketing any product candidate in the United States,U.S., we must demonstrate that such product candidate is safe and provide substantial evidence of effectiveness for its intended uses. The FDA has generally interpreted the “substantial evidence” requirements as requiring sponsors to conduct two adequate and well-controlled Phase 3 clinical trials. However, in some circumstances, the FDA may conclude that substantial evidence of efficacy has been demonstrated through the conduct of one adequate and well-controlled clinical trial, plus confirmatory evidence (whether obtained prior to or after such trial). Regardless of the clinical development plans we decide to pursue with respect to our product candidates, there can be no assurance that the FDA will not require additional clinical trials for approval of such product candidates beyond the trials that we currently plan to conduct, including in other geographies, even if we successfully complete the trial and believe the results are sufficiently positive.
As a company, we have limited experience designing and conducting clinical trials in the United StatesU.S. or other geographies and may be unable to design and execute a clinical trial to support regulatory approval. In addition, the design and results of our clinical trials may not be sufficient to support approval, since factors such as an inappropriate dosage or flaws in the design of a clinical trial may not become apparent until the clinical trial is in progress or data are available.
There is a high failure rate for product candidates proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. For example, in AugustMay 2024,2025, we announced topline data fromthat the truncated Phase 23 portion of our Phase 2/3 clinical trial evaluating epetraborole in patients with treatment-refractory MAC lung disease. Although we believe the Phase 2 part of theEBO-301 study metdid not meet its primary objectiveendpoint inof demonstrating an improvement on the potentialQOL-B validationrespiratory ofdomain aPRO novel patient-reported outcomeinstrument (PROchange from baseline to month 6), toolthough andepetraborole awas highergenerally PRO-basedwell clinical response ratetolerated in the epetraboroletrial. +Based OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). Givenon these results, we decided to closesuspend thefurther Phase 3 portiondevelopment of theepetraborole trialfor andtreatment-refractory MAC lung disease. There is no guarantee that we will not experience similar setbacks with respect to commenceour aother reviewproduct of data to help inform further development.candidates.
Although we believe that our ongoing data review to date supports the continued development of epetraborole in patients with treatment-refractory MAC lung disease, it is possible that we will defer or discontinue development of epetraborole in NTM, whether due to further FDA feedback or otherwise. For example, based on the results from the Phase 2 portion of the EBO-301 trial, we submitted an amended statistical analysis plan for the EBO-301 trial selecting the Quality of Life – Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the revised primary efficacy endpoint. However, the FDA may not consider the data from the Phase 3 portion of the trial to be clinically meaningful or otherwise supportive for regulatory decision-making purposes, even if the Phase 3 data show a statistically significant outcome with respect to QOL-B.
Although a substantial amount of our effort will focus on potential clinical testing and potential regulatory approval of our current and future product candidates, including the development of AN2-502998, a boron-based small molecule therapeutic candidate for the treatment of Chagas disease, epetraborole for NTM or melioidosis, and other development compounds, an element of our strategy is to discover, develop and commercialize a portfolio of product candidates to treat diseases with high unmet need. We are seeking to do so by utilizing our targeted-design AN2 drug discovery platform, which uses bacterial genomics and state-of-the-art molecular and dynamic models to design active new compounds that target known mechanisms. We focus our clinical development on pathogens, drug targets, and patients with high, unmet medical needs to leverage the development and regulatory paths available for first-in-class or best-in-class therapeutics. Research efforts to identify and develop product candidates require substantial technical, financial, and human resources, whether or not any product candidates are ultimately identified. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including the following:
a product candidate may on further study be shown to havereveal harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
In particular, we may face delays and difficulties in enrollment in our planned trials of certain of our product candidates because PV, M. abscessus, Chagas disease and certain other conditions we may target include rare diseases (i.e., the size of the targeted patient population is small). Because of this, we may experience difficulties in recruiting sufficient patients into certain of our planned clinical trials.
We may conduct clinical trials for our product candidates outside of the United States,U.S., and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
We conduct and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the UnitedU.S. States.For instance, we will be initiating a PV Phase 2 study in India. The acceptance of study data from clinical trials conducted outside the United StatesU.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States,U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the relevant jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, we and our CROs are required to comply with regulations and comply with good laboratory practice requirements for the conduct of certain preclinical studies and GCP requirements for clinical trials, which are regulations and guidelines enforced by the FDA, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Similar regulatory requirements apply outside the United States,U.S., including the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. Failure to comply with these requirements by us or by third parties can result in FDA refusal to approve applications based on the clinical data, enforcement actions, adverse publicity and civil and criminal sanctions.
Evaluation of our product candidates in investigator-initiated clinical trials (“IITs”) may expose us to additional risks that could impair the development of our product candidates.
We are currently supporting an IIT evaluating epetraborole in patients with M. abscessus lung disease, and may in the future support other IITs for our product candidates that are designed and managed by independent investigators or institutions. While we believe these clinical trials have the potential to provide supportive data that may further the development of our product candidates, we do not directly control the clinical development process, including, but not limited to, the initiation, enrollment, safety reporting, or conduct of these trials. As a result, investigator-sponsored trials may be subject to significant delays. fail to comply with GCP or other regulatory requirements. be terminated prematurely by the investigator or applicable IRBs or ethics committees, or produce data that is not useful for, or acceptable to, regulatory authorities for purposes of obtaining regulatory approval. IITs may also identify safety or tolerability concerns that could adversely affect the development of our product candidates, including through the imposition of clinical holds, or otherwise subject us to liability. Moreover, if the data from IITs differ from the data we have observed in our sponsored clinical studies, such differences could potentially require us to conduct additional clinical trials or otherwise delay or prevent regulatory approval from the FDA or other regulatory authorities. Any of these factors could adversely impact our reputation, delay our development timelines, or negatively affect our ability to obtain regulatory approval.
Even if any of our product candidates receivesreceive regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
the convenience and ease of once-a-day oral administration compared to alternative treatments (e.g., inhaled drug through nebulizer);
Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical and nonclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do as an organization. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. In addition, following the August 2024 announcement of topline data from the Phase 2 portion of our Phase 2/3 clinical trial evaluating epetraborole, we effected a restructuring resulting in the elimination of a significant portion of the workforce and could result in additional unplanned loss of personnel. Continued disruption caused by the transition or by the loss of ongoing services of any qualified scientific and management personnel could delay or prevent the successful development of our current and future product candidates.
We do not have a sales or marketing infrastructure and have limited experience in the sale, marketing, or distribution of pharmaceutical products. To achieve commercial success for any product candidate for which we may obtain regulatory approval, we will need to establish a sales and marketing organization or enter into collaboration, distribution and other marketing arrangements with one or more third parties to commercialize such product candidate. In the United StatesU.S. and other key markets, we intend to build a commercial organization to target areas with the greatest incidence of conditions for which we may at some point obtain regulatory approval and recruit experienced sales, marketing and distribution professionals. The development of sales, marketing and distribution capabilities will require substantial resources, will be time-consuming and could delay any product launch. We may decide to work with regional specialty pharmacies, distributors, and/or multi-national pharmaceutical companies to leverage their commercialization capabilities to commercialize any product candidate for which we may obtain regulatory approval outside of the United States.U.S.
If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and distribution capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization costs. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. In addition, we may not be able to hire a sales force in the United StatesU.S. that is sufficient in size or has adequate expertise to target the areas that we intend to target. If we are unable to establish a sales force and marketing and distribution capabilities, our operating results may be adversely affected.
If we are unable to establish our own sales, marketing and distribution capabilities in the United StatesU.S. and other jurisdictions in which any of our product candidates are approved and, instead, enter into arrangements with third parties to perform these services, our revenues and profitability, if any, are likely to be lower than if we were to sell, market and distribute any product candidates that we develop ourselves. We may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us. We likely will have limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing any product candidates.
We may seek regulatory approval for our product candidates outside of the United StatesU.S. and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
workforce uncertainty in countries where labor unrest is more common than in the United StatesU.S.;
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United StatesU.S.;
We are highly dependent on the management, research and development, financial and business development expertise of Eric Easom, our co-founder,key president, and chief executive officer, Sanjay Chanda, Ph.D., our chief development officer, Lucy Day, our chief financial officer, Josh Eizen, J.D., our chief legal and operating officer, Michael R.K. (Dickon) Alley, Ph.D., our co-founder and SVP research fellow and head of biology, Stephen Prior, Ph.D., our chief strategy officer, and Vincent Hernandez, our senior vice president research and head of chemistry,executives, as well as the other members of our research, development, and business teams. Each may terminate employment with us at any time. We do not maintain “key person” insurance for any of our executives or employees.
The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability. Higher interest rates, coupled with reduced government spending and volatility in financial markets may increase economic uncertainty and affect consumer spending. Similarly, volatility and disruptions in global markets and supply chains, tariffs, and global conflicts may adversely affect our business or the third parties on whom we rely. If the equity and credit markets deteriorate, including as a result of political unrest or war, or new tariffs,tariffs and any retaliatory trade protection measures or trade wars that ensue, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive. Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. To the extent that macroeconomic uncertainties continue to harm our business, financial condition, results of operations and growth prospects, many of the other risks described in this “Risk Factors” section will be exacerbated.
Although we effected a 2024 restructuring to reduce our workforce by approximately 50%, if the development of our product candidates progresses, we may experience growth in the scope of our operations, particularly in the areas of research, drug development, regulatory affairs and, if any of our product candidates receives regulatory approval, sales, marketing and distribution. To manage any such growth, we will need to implement and improve our managerial, operational, and financial systems, expand our facilities and recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such growth, we may not be able to effectively manage such an expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may also lead to significant costs and may divert our management and research and development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Our success depends in large part on our ability to obtain and maintain patent protection in the United StatesU.S. and other countries with respect to our product candidates. We seek to protect our proprietary position by developing and in-licensing intellectual property relating to our product candidates including patent applications in the United StatesU.S. and abroad related to our technology and product candidates that are important to our business. If we or our licensors do not adequately protect the intellectual property we in-license or own, competitors may be able to use our technologies and erode or negate any competitive advantage that we may have, which could harm our business and ability to achieve profitability. To protect our proprietary positions, we and our licensors file patent applications in the United StatesU.S. and abroad related to our novel technologies and product candidates that are important to our business. The patent application and prosecution process is expensive and time-consuming. We and our current licensors and licensees, or any future licensors and licensees, may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. We or our current licensors and licensees, or any future licensors or licensees may also fail to identify patentable aspects of our research and development before it is too late to obtain patent protection, or fail to continue to prosecute patents relating to our product candidates. Therefore, these and any of our in-licensed patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. It is possible that defects of form in the preparation or filing of our licensors’ patents or our patent applications may exist, or may arise in the future, such as with respect to proper priority claims, inventorship, claim scope or patent term adjustments. If our current licensors and licensees, or any future licensors or licensees, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised and we might not be able to prevent third parties from making, using, and selling competing products. We cannot predict whether the patent applications we and our licensors or licensees are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors. If there are material defects in the form or preparation of our or our licensors’ patents or patent applications, such patents or applications may be invalid and unenforceable. Moreover, our competitors may independently develop equivalent knowledge, methods, and know-how, and we may not be able to prevent such competitors from commercializing such equivalent knowledge, methods, and know-how. Any of these outcomes could impair our ability to prevent competition from third parties and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain and has been the subject of much litigation in recent years. Changes in either the patent laws or interpretation of the patent laws in the United StatesU.S. and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.U.S. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United StatesU.S. or in many foreign jurisdictions. In addition, the determination of patent rights with respect to pharmaceutical compounds and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Furthermore, recent changes in patent laws in the United States,U.S., including the America Invents Act of 2011, and future changes in patent laws in or outside the United StatesU.S. may affect the scope, strength and enforceability of our patent rights or the nature of proceedings that may be brought by us related to our patent rights.
We may not be aware of all third-party intellectual property rights potentially relating to our product candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United StatesU.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in patents or pending patent applications that we in-license or own, or that we or our licensors were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted with any certainty. Moreover, we or our licensors may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office (“USPTO”), or become involved in opposition, derivation, reexamination, inter partes review, or interference proceedings, in the United StatesU.S. or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates, and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize product candidates without infringing third-party patent rights.
The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our in-licensed patents or patents we may own in the future may be challenged in the courts or patent offices in the United StatesU.S. and abroad. Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of our technology and product candidates. In addition, given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Any impairment of our intellectual property rights, or our failure to protect our intellectual property rights adequately, could give third parties access to our technology and product candidates and could materially and adversely impact our business, financial condition, results of operations and growth prospects.
Anacor has relied upon, our other licensors may have relied upon, and any future licensors may rely upon, third-party companies, consultants or collaborators, or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-licensed. We have sublicensed certain patents from Anacor that are owned, maintained and prosecuted by GSK.GlaxoSmithKline plc (“GSK”). If third-party companies such as GSK fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize our product candidates that are the subject of such licensed rights could be adversely affected. Further, we rely upon Anacor’s compliance with its license agreement with GSK to maintain our sublicense to such patents owned by GSK, and any termination of Anacor’s license agreement with GSK could result in us losing our license to epetraborole. Further development and commercialization of our product candidates may require us to enter into additional license or collaboration agreements. Our future licenses may not provide us with exclusive rights to use the licensed patent rights and other intellectual property, or may not provide us with exclusive rights to use such patent rights and intellectual property in all relevant fields of use and in all territories in which we wish to develop or commercialize our product candidates in the future.
Competitors or other third parties may infringe, misappropriate or otherwise violate our in-licensed issued patents or other intellectual property rights we may own. To counter such infringement, misappropriation, violation or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against third parties could provoke these parties to assert counterclaims against us alleging that we infringe, misappropriate or otherwise violate their patents, trademarks, copyrights or other intellectual property rights. In addition, our in-licensed patents may become involved in inventorship or priority disputes. Third parties may raise challenges to the validity of certain of our in-licensed patent claims and may in the future raise similar claims before administrative bodies in the United StatesU.S. or abroad, even outside the context of litigation. For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in derivation, revocation, reexamination, post-grant review (“PGR”), inter partes review (“IPR”), interference proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings challenging any patents that we may own or in-license. Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of our owned or licensed pending patent applications. A third party may also claim that our potential future owned patents or licensed patent rights are invalid or unenforceable in a litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, invalidate, or render unenforceable, our potential future owned patents or licensed patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights In a patent infringement proceeding, there is a risk that a court will decide that a patent we own or in-license is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents are upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our owned or in-licensed patents do not cover the invention. An adverse outcome in a litigation or proceeding involving our owned or in-licensed patents could limit our ability to assert our owned or in-licensed patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Similarly, in the future, we expect to rely on trademarks to distinguish our product candidates that are approved for marketing, if any, and if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the third party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.
Third parties may initiate legal proceedings alleging that we are infringing, misappropriatingmisappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could significantly harm our business.
There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigationlitigation, or other adversarial proceedings regarding intellectual property rights with respect to our technology or product candidates, including interference proceedings before the USPTO. Third parties may assert claims against us based on existing or future intellectual property rights. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance.
We expect to rely on trademarks as one means to distinguish any of our product candidates that are approved for marketing from the products of our competitors. We have not yet selected trademarks for our product candidates and have not yet begun the process of applying to register trademarks for our product candidates. Once we select trademarks and apply to register them, our trademark applications may not be approved. Third parties who have prior rights to our trademarks or third parties who have prior rights to similar trademarks may oppose our trademark applicationsapplications, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our product candidates, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. At times, competitors may adopt trade names or trademarks similar to ours, thereby diluting or impeding our ability to build brand identity and possibly leading to market confusion. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks and may not be able to prevent such third parties from using and marketing any such trademarks.
In addition, any proprietary name we propose to use with any product candidate in the United StatesU.S. must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. If we are unable to establish name recognition based on our trademarks, we may not be able to compete effectively and our business, financial condition, results of operations and growth prospects may be adversely affected.
In addition to seeking patent protection for our product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. However, these agreements may be inadequate to protect our proprietary and intellectual property rights. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets. In addition, we may not be able to obtain adequate remedies for any such breaches. Although we use reasonable efforts to protect this proprietary information and technology, we also cannot guarantee that we have entered into such agreements with each party that may have or have had access to our confidential information, know-how, trade secrets or other proprietary information or each individual who has developed intellectual property on our behalf. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property rights will be effective. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, distracting to management, and time-consuming, and the outcome is unpredictable and varied depending on the jurisdiction. In addition, some courts inside and outside the United States,U.S., in countries in which we operate or intend to operate, are less willing, or unwilling, to protect trade secrets, know-how and other proprietary information. Any claims or litigation could cause us to incur significant expenses. Some third parties may be able to sustain the costs of complex litigation more effectively than we can because they have substantially greater resources.
Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and patent applications will be due to be paid to the USPTO and various government patent agencies outside of the United StatesU.S. over the lifetime of our owned or in-licensed patents and patent applications. In certain circumstances, we rely on our licensing partners to pay these fees due to U.S. and non-U.S. patent agencies. The USPTO and various non-U.S. government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. We are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual property. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United StatesU.S. could be less extensive than those in the United States.U.S. In some cases, we or our licensors may not be able to obtain patent protection for certain licensed technology outside the United States.U.S. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States,U.S., even in jurisdictions where we or our licensors do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our in-licensed inventions in all countries outside the United States,U.S., even in jurisdictions where our licensors do pursue patent protection or from selling or importing products made using our inventions in and into the United StatesU.S. or other jurisdictions.
In addition, geo-political actions in the United StatesU.S. and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors. For example, the United StatesU.S. and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United StatesU.S. without consent or compensation. Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.
Competitors may use our technologies in jurisdictions where we or our licensors have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States.U.S. These products may compete with our product candidates and our preclinical programs. Our in-licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, record-keeping, labeling, storage, approval, advertising, promotion, sale, import, export and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United StatesU.S. and by comparable foreign regulatory authorities, with regulations differing from country to country. Failure to obtain regulatory approval for a product candidate will prevent us from commercializing the product candidate. We currently do not have any products approved for sale in any jurisdiction. For example, we are not permitted to market any product candidate in the United StatesU.S. until we receive regulatory approval of an NDA from the FDA. We as a company only have limited experience in filing and supporting the applications necessary to gain regulatory approvals and may rely on third-party contract research organizations to assist us in this process.
Management's Discussion & Analysis (MD&A)
New heading “Epetraborole - Polycythemia vera”
New heading “Epetraborole – M. abscessus”
New heading “AN2-502998 - Chagas disease”
New heading “Our research and development initiatives - Oncology”
New heading “Recent developments”
New heading “Future funding requirements”
New heading “Financial Operations Overview”
Removed heading “Stock-Based Compensation”
Largest changes
“In December 2025, the U.S. Food and Drug Administration (“FDA”) cleared an Investigational New Drug Application (“IND”) to proceed with a Phase 2 investigator-initiated study (“IIT”) in collaboration with Oregon Health and Sciences 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. …”see in full comparison
Research and developmentsee in full comparisonexpenses, including related-party research and development expenses,expenses were $24.8 million for the year ended December 31, 2025 compared to $40.5 million for the year ended December 31,2024 compared to $54.9 million for the year ended December 31, 2023.2024. The decrease of$14.4$15.7 million was primarily due to decreases in clinical trialcosts,expenses, personnel-related expenses, consulting and outside services expenses, chemistry manufacturing and controls (“CMC”) expenses,personnel-related expenses, allocatedand facilities and miscellaneous expenses,licensingpartiallyfees,offset by increased preclinical andconsultingresearch study expenses andoutsideotherservices,expenses. Clinical trial expenses decreased by $12.8 million primarily due to the termination of the EBO-301 trial in August 2024, partially offset byantheincreaseinitiation of the Phase 1 trial inpreclinicalChagasanddisease.research expenses. Clinical trialsPersonnel-related expenses decreased by$5.6$4.3 million primarily due todecreased costs associated with the termination ofourPhaserestructuring2/3 clinical trialactivities intreatment2024.refractory NTM lung disease in August 2024Consulting andcompletionoutsideofservicesour Phase 1 clinical trials in 2023. Costs related to CMC activitiesexpenses decreased by$4.4$2.3 million primarily due tocompletion of certainreduced activities related to the clinical development of epetraborole in treatment-refractory NTM, completion of the melioidosis observational study, and the timing of non-dilutivefunding expensecontract offsets.Personnel-relatedCMCcostsexpenses decreased by$3.3$1.3 million due to decreases in expenses related to epetraborole development in treatment-refractory NTM and the timing of when receipt of research contract offsets became reasonably assured, partially offset by increased CMC activities for ourrestructuringChagasactivities.program. Allocated facilities and miscellaneous expensesdecreased by $0.9 million due to recognition of our qualified small business payroll tax credit and our non-dilutive funding expense offset. Licensing fees decreased by $0.2 million and consulting and outside servicesdecreased by $0.1 million. These decreases were partially offset by$0.1increased preclinical and research study expenses of $5.0 millionincreaseresultingdue tofrom the prioritization and increased activities of certain researchprograms.programs and increased other expenses of $0.1 million. During the years ended December 31,20242025 and2023, a total2024, reimbursement of$3.7$5.2 million and$2.5$3.7 million, respectively, of operating expenseswerewas recognized related to our funding arrangements.
“We use a fair value-based method to account for all stock-based compensation arrangements with employees and non-employees, which include stock options. The fair value of the option granted is recognized on a straight-line basis over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period, which usually is the vesting period. We account for forfeitures as they occur. …”see in full comparison
Full comparison: every changed paragraph (50)
We are a clinical stage biopharmaceutical company focused on discoveringthe discovery and developingdevelopment of novel small molecule therapeutics derived from our boron chemistry platform. AN2Our has adevelopment pipeline ofspans boron-basedhematologic compoundsdiseases, infectious diseases, and oncology with three Phase 2 studies expected to initiate in development for Chagas disease, non-tuberculous mycobacterial (“NTM”)2026 and melioidosis,two alongpreclinical withcandidates, early-stageas well as advanced research programs focused on targets in infectiousoncology, diseasesbone disorders, and oncology.infectious diseases. We are committed to delivering high-impact drugs to patients that address critical medical needs and improve health outcomes.
Epetraborole - Polycythemia vera
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 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.
We are proceeding through the regulatory process and anticipate initiating a Phase 2 trial in India in the third quarter of 2026. We expect to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027, subject to regulatory clearance and enrollment progress.
Epetraborole – M. abscessus
Building on the microbiological and safety data from our prior NTM study, 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 therapies exist. The Company is supporting the design of an investigator-initiated trial (“IIT”) and 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.
In December 2025, the U.S. Food and Drug Administration (“FDA”) cleared an Investigational New Drug Application (“IND”) to proceed with a Phase 2 investigator-initiated study (“IIT”) in collaboration with Oregon Health and Sciences 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 drugs currently exist for its treatment. We expect to initiate enrollment in the first quarter of 2026 and to report topline results in late 2027.
AN2-502998 - Chagas disease
Our lead candidate is epetraborole, which we are studying as a potential once-daily, oral treatment with a novel mechanism of action for patients with non-tuberculous mycobacterial (“NTM”) lung disease, a rare, chronic and progressive infectious disease caused by bacteria known as mycobacteria, which leads to irreversible lung damage and can be fatal. Epetraborole is designed to produce broad-spectrum antimycobacterial activity through inhibition of an essential and universal step in bacterial protein synthesis. Its novel mechanism of action is enabled by boron chemistry, our core technology approach. We in-licensed the exclusive worldwide development and commercialization rights for epetraborole from Pfizer Inc. in 2019.
Our lead development target in NTM is treatment-refractory MAC lung disease, a condition with high unmet need where the mycobacterial infection persists despite standard front-line therapies. These patients represent complex cases for treatment, often presenting with structural lung damage, high levels of resistance to background therapies, and persistent symptoms that can significantly degrade quality of life. In 2023, the FDA issued a Guidance for Industry recommending that new potential therapies demonstrate evidence of symptom improvement, measured with patient-reported outcome tools, as the primary endpoint for approval. To date, no drugs have been approved by the FDA based on symptom improvement in a treatment refractory population. The only approved therapy for treatment-refractory MAC lung disease received accelerated approval based on the surrogate endpoint of sputum culture conversion without demonstrating symptom improvement.
On August 8, 2024, we announced topline results from the Phase 2 part of EBO-301, a Phase 2/3 study evaluating epetraborole on top of optimized background regimen (“OBR”) in treatment-refractory MAC lung disease, and terminated the Phase 3 portion of the trial with 97 patients enrolled. The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). Epetraborole was generally well tolerated in the trial.
Consistent with the FDA’s 2023 Guidance, the primary purpose of the Phase 2 part of the EBO-301 study was to test the validity of multiple patient-reported outcome tools in a treatment refractory population, with the goal of identifying a PRO-based primary endpoint for the Phase 3 portion of the trial. To that end, we recently 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. We anticipate releasing top-line Phase 3 data from the 97 Phase 3 patients in the second quarter of 2025. If these Phase 3 data confirm the Phase 2 findings, we plan to meet with the FDA to discuss potential registrational pathways in TR-MAC.
We are also studying epetraborole for the treatment of acute melioidosis. We completed enrollment in a 200-patient observational trial (non-epetraborole treatment) in October 2024 and expect to announce topline data in the second half of 2025. These data will inform a Phase 2 proof of concept study 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 (SOC) drugs ceftazidime or meropenem. The aim of the program is to meaningfully lower the expected mortality rate by dosing epetraborole on top of SOC.
BeyondIn epetraborole,August 2025, as part of our Chagas disease clinical development program, we arecommenced conductingour Phase-1-enablingPhase studies1 withfirst-in-human trial of oral AN2-502998 (formerly known as AN15368), an investigational, boron-based small molecule in development for the treatment of chronic Chagas disease,disease and havewe severalanticipate researchPhase programs1 targetingdata in the developmentfirst quarter of novel2026 compoundsand initiation of a Phase 2 proof-of-concept study in oncologypatients with chronic Chagas disease in 2026, depending on the outcome and infectioustiming diseaseof basedcompletion onof ourthe boronPhase chemistry1 platform.study. The Phase 1 study is evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 for chronic Chagas disease, in healthy volunteers. In October 2023, we announced an exclusive license agreement with the University of Georgia Research Foundation to advance the development of AN2-502998, originally discovered by researchers at Anacor, in close collaboration with the University of Georgia. AN2-502998 is the only compound of which we are aware to have demonstrated curative activity in preclinical studies across multiple species, including in non-human primates with long-term, naturally acquired chronic infections ofcaused by diverse T. cruzi genetic types. WeBecause anticipateNHP initiatinginfections 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 chronic Chagas disease. In July 2025, we announced a Phasecollaboration 1with studythe non-profit medical research organization Drugs for Neglected Diseases initiative (“DNDi”) to advance clinical development of AN2-502998. Through the collaboration, AN2 will leverage DNDi's extensive clinical trial network and expertise in 2025.Chagas We also anticipate 1disease to 2rapidly newadvance the clinical development candidatesof in oncology in 2025.AN2-502998.
Our research and development initiatives - Oncology
We are 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 have excellent oral pharmacokinetics. We plan to advance two oncology candidates into development in 2026 targeting PI3Kα and ENPP1.
Melioidosis
We are also studying epetraborole for the treatment of acute melioidosis, a highly lethal bacterial infection and recognized biothreat. We 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 (SOC). 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 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 SOC. If approved for the treatment of melioidosis, we plan to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from the use of treatment in disease-endemic countries.
Recent developments
In August 2024, we also announced a reduction of approximately 50% of our workforce, which was approved by the Board in connection with our restructuring following discontinuation of the EBO-301 Phase 2/3 study of epetraborole in treatment refractory MAC lung disease and to further extend our operating capital. In connection with the workforce reduction, we recognized severance and other charges of $2.2 million, primarily consisting of severance payments and other employee termination-related expenses.
Future funding requirements
We do not have any products approved for sale and have not generated any revenue since inception. Our net losses were $51.3$35.2 million and $64.7$51.3 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $205.8$241.0 million. We have funded our operations from the sale and issuance of redeemable convertible preferred stock,stock and proceeds from our initial public offering (“IPO”), “at-the-market” equity offering program (“ATM Offering”) and an underwritten offering (the “Underwritten Offering”). 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 Offering 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 entered into a Securities Purchase Agreement with certain investors to sell through a private placement 8,245,611 shares of common stock at a price of $2.85 per share and pre-funded warrants to purchase up to 5,789,473 shares of common stock at a purchase price of $2.84999 per pre-funded warrant, resulting in aggregate gross proceeds of $40.0 million before deducting the placement agent’s fees and other offering expenses and excluding any proceeds we may receive upon exercise of the pre-funded warrants (the “Private Placement”).
Financial Operations Overview
As of December 31, 2024,2025, we had cash, cash equivalents and investments of $88.6$60.0 million. We believe that our available cash will be sufficient to fund our planned operations through at least twelve months following the date of this Form 10-K.10‑K.
Substantially all of our research and development expenses consist of expenses incurred in connection with the development of our initial product candidate, epetraborole, and other product candidates. These expenses include fees incurred under arrangements with third parties, including CROs, CMOs, preclinical and nonclinical testing organizations, and academic and non-profit institutions. Research and development expenses also include consulting fees, license fees, payroll and personnel-related expenses, including salaries and bonuses, payroll taxes, employee benefit costs and non-cash stock-based compensation for our research and development employees. We expense both internal and external research and development expenses as they are incurred.
Research and development expenses, including related-party research and development expenses,expenses were $24.8 million for the year ended December 31, 2025 compared to $40.5 million for the year ended December 31, 2024 compared to $54.9 million for the year ended December 31, 2023.2024. The decrease of $14.4$15.7 million was primarily due to decreases in clinical trial costs,expenses, personnel-related expenses, consulting and outside services expenses, chemistry manufacturing and controls (“CMC”) expenses, personnel-related expenses, allocatedand facilities and miscellaneous expenses, licensingpartially fees,offset by increased preclinical and consultingresearch study expenses and outsideother services,expenses. Clinical trial expenses decreased by $12.8 million primarily due to the termination of the EBO-301 trial in August 2024, partially offset by anthe increaseinitiation of the Phase 1 trial in preclinicalChagas anddisease. research expenses. Clinical trialsPersonnel-related expenses decreased by $5.6$4.3 million primarily due to decreased costs associated with the termination of our Phaserestructuring 2/3 clinical trialactivities in treatment2024. refractory NTM lung disease in August 2024Consulting and completionoutside ofservices our Phase 1 clinical trials in 2023. Costs related to CMC activitiesexpenses decreased by $4.4$2.3 million primarily due to completion of certainreduced activities related to the clinical development of epetraborole in treatment-refractory NTM, completion of the melioidosis observational study, and the timing of non-dilutive funding expensecontract offsets. Personnel-relatedCMC costsexpenses decreased by $3.3$1.3 million due to decreases in expenses related to epetraborole development in treatment-refractory NTM and the timing of when receipt of research contract offsets became reasonably assured, partially offset by increased CMC activities for our restructuringChagas activities.program. Allocated facilities and miscellaneous expenses decreased by $0.9 million due to recognition of our qualified small business payroll tax credit and our non-dilutive funding expense offset. Licensing fees decreased by $0.2 million and consulting and outside services decreased by $0.1 million. These decreases were partially offset by $0.1increased preclinical and research study expenses of $5.0 million increaseresulting due tofrom the prioritization and increased activities of certain research programs.programs and increased other expenses of $0.1 million. During the years ended December 31, 20242025 and 2023, a total2024, reimbursement of $3.7$5.2 million and $2.5$3.7 million, respectively, of operating expenses werewas recognized related to our funding arrangements.
General and administrative expenses were $13.3 million for the year ended December 31, 2025 compared to $14.1 million for the year ended December 31, 2024. The decrease of $0.8 million was primarily attributable to $0.6 million decrease in personnel-related expenses, primarily related to stock-based compensation expense, and a $0.3 million decrease in professional services expenses. These decreases were partially offset by a $0.1 million increase in facilities and miscellaneous expenses.
General and administrative expenses were $14.1 million for the year ended December 31, 2024 compared to $14.8 million for the year ended December 31, 2023. The decrease of $0.7 million was primarily attributable to $0.4 million decrease in professional services expenses, $0.4 million decrease in facilities and miscellaneous expenses and $0.2 million decrease in D&O insurance expenses. These decreases were partially offset by $0.3 million increase in personnel related expenses, primarily related to stock-based compensation expense.
There were no restructuring charges for the year ended December 31, 2025. Restructuring charges were $2.2 million for the year ended December 31, 20242024, consisting of severance payments and other employee termination-related expenses. We had no restructuring charges for the year ended December 31, 2023.
Interest Income was $2.9 million for the year ended December 31, 2025 compared to $5.5 million for the year ended December 31, 2024 compared to $4.9 million for the year ended December 31, 2023.2024. The increasedecrease of $0.6$2.6 million was due to higher interest rates despite lower cash, cash equivalents and short and long-term investment balances and lower interest rates in 20242025 as compared to 2023.2024.
To date, we have funded our operations primarily through our Underwritten Offering, ATM Offering, IPO and private placements of our then existing redeemable convertible preferred stock. In March 2026, we generated aggregate gross proceeds from the Private Placement of $40.0 million before deducting the placement agent’s 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 Offering, 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.
Net cash used in operating activities was $29.8 million for the year ended December 31, 2025, which consisted of a net loss of $35.2 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $0.2 million in our net operating assets and liabilities, partially offset by a net increase of $5.2 million in non-cash charges. The non-cash charges consisted of stock-based compensation expense of $6.2 million, partially offset by net accretion of discounts on investments of $1.0 million. The net decrease in our operating assets and liabilities was primarily due to a decrease of $1.5 million in prepaid expenses and other current assets and increases of $0.7 million in accrued compensation, $0.4 million in other current liabilities, and $0.2 million in other non-current liabilities, partially offset by increases of $2.4 million in accrued liabilities and $0.3 million in accounts payable.
Net cash used in operating activities was $53.3 million for the year ended December 31, 2023, which consisted of a net loss of $64.7 million, due to the use of funds to develop our initial drug product candidate offset by a net increase of $5.8 million in our net operating assets and liabilities and $5.6 million in non-cash charges. The net increase in our operating assets and liabilities was primarily due to an increase of $6.2 million in accounts payable, accrued compensation and accrued liabilities due to an increase in accrued research and development expenses, and an increase of $0.7 million in other current liabilities, partially offset by a decrease of $1.0 million in prepaid expenses and other current assets and a decrease of $0.1 million in operating lease liabilities. The non-cash charges consisted of stock-based compensation expense of $8.4 million and non-cash operating lease expense of $0.1 million, partially offset by net accretion of discounts on investments of $2.9 million.
Cash UsedProvided inby Investing Activities
Net cash provided by investing activities was $28.3 million for the year ended December 31, 2025, which primarily consisted of $74.5 million in proceeds from maturities of investments, partially offset by $46.2 million in purchases of investments.
Net cash used in investing activities was $43.3 million for the year ended December 31, 2023, which primarily consisted of $132.2 million in purchases of investments, partially offset by $88.9 million in proceeds from maturities of investments.
Net cash provided by financing activities was $0.1 million for the year ended December 31, 2025, which primarily consisted of net proceeds from the issuance of common stock under the ESPP and from the exercises of stock options.
Net cash provided by financing activities was $85.0 million for the year ended December 31, 2023, which primarily consisted of net proceeds from the issuance of common stock in our Underwritten Offering and ATM Offering.
Critical Accounting Policies, Significant Judgements,Judgments, and Use of Estimates
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgementsjudgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgementsjudgments and estimates. While our significant accounting policies are described in more detail in Part I, Note 2—Basis of Presentation and Summary of Significant Accounting Policies to our financial statements appearing elsewhere in this Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
We have entered into various agreements with CMOs and CROs. We record research and development expenses to operations as incurred. Research and development expenses represent costs incurred by us for the discovery and development of our product candidates and the development of our technology and include: internal research and development expense, including employee-related expenses (such as salaries, bonus, benefits, travelbenefits and non-cash stock-based compensation expense); external research and development expenses incurred under arrangements with third parties, such as CROs, preclinical testing organizations, CMOs, academic and non-profit institutions and consultants; related-party milestone payments; license fees; and other expenses. Costs to develop our technologies are recorded as research and development expense as incurred.
Stock-Based Compensation
We use a fair value-based method to account for all stock-based compensation arrangements with employees and non-employees, which include stock options. The fair value of the option granted is recognized on a straight-line basis over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period, which usually is the vesting period. We account for forfeitures as they occur. In determining fair value of the stock options granted, we use the Black–Scholes option pricing model, which requires the input of subjective assumptions. These assumptions include: the estimated length of time employees will retain their vested stock options before exercising them (expected term), the estimated volatility of our common stock price over the expected term (expected volatility), risk-free interest rate, and expected dividends. See Note 9—Equity Incentive Plan and Stock-Based Compensation to our audited financial statements included elsewhere in this Form 10-K for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in the years ended December 31, 2024 and 2023. Changes in the following assumptions can materially affect the estimate of fair value and ultimately how much stock-based compensation expense is recognized; and the resulting change in fair value, if any, is recognized in our statement of operations and comprehensive loss during the period the related services are rendered. These inputs are subjective and generally require significant analysis and judgment to develop.
Fair Value of Common Stock—See the subsection titled “Common Stock Valuations” below.
Expected Term—The expected term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term.
Expected Volatility—We use an average historical stock price volatility of a peer group of comparable publicly traded companies in biotechnology and pharmaceutical-related industries to be representative of our expected future stock price volatility, as we have limited trading history for our common stock. For purposes of identifying these peer companies, we consider the industry, therapeutic area, stage of development, size and financial leverage of potential comparable companies. For each grant, we measure historical volatility over a period equivalent to the expected term.
Risk-Free Interest Rate—The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equivalent to the expected term of the stock award.
Expected Dividend Rate—We have not paid and do not anticipate paying any dividends in the near future. Accordingly, we estimate the dividend yield to be zero.
For the years ended December 31, 2024 and 2023, there was $0.2 million and an insignificant amount of cash received upon exercise of stock options, respectively.
We will remain an EGC until the earliest to occur of: (1) the last day of our first fiscal year in which we have total annual revenues of more than $1.235 billion; (2) the date we qualify as a “large accelerated filer,” with at least $700.0 million of equity securities held by non-affiliates; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three- yearthree-year period; and (4) the last day of the fiscal year ending after the fifth anniversary of our IPO.
What changed in the latest 10-Q
Risk Factors
Largest changes
Our net loss was $35.2 million for the year ended December 31, 2025 andsee in full comparison$10.0$18.2 million and$10.6$17.1 million for thethreesix months endedMarchJune31,30, 2026 and 2025, respectively. As ofMarchJune31,30, 2026, we had an accumulated deficit of$251.0$259.2 million. We have funded our operations to date primarily with proceeds from our ATM Offerings, 2026 PrivatePlacementPlacement,(the “2026 Private Placement”), underwritten offering (the “UnderwrittenOffering”), our “at-the-market” equity offering program (“ATM Offering”),Offering, our IPO, and the sale of our redeemable convertible preferred stock. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical and nonclinical studies, manufacturing, clinical trials, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year.
We conduct and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the U.S. For instance, we will be initiating a global PV Phase 2 study insee in full comparisonIndia.the U.S., Australia and India and a Chagas Phase 2 study in Bolivia. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the relevant jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. However,see in full comparisonin addition to the $40.0 million financing completed in March 2026,we will need to obtain substantial additional funding in connection with our continuing operations and planned activities. Our future capital requirements will depend on many factors, including:
Full comparison: every changed paragraph (20)
We are conducting clinical trials for our product candidates outside of the U.S., including our planned PV Phase 2 trial in India, and the planned Phase 2 trial in Bolivia, and the FDA may not accept data from such trials, in which case our development plans may be delayed.
For example, in August 2024, we announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of OBR in treatment-refractory MAC lung disease. The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel PRO tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). In May 2025, we announced that the truncated Phase 3 portion of the EBO-301 study did not meet its primary endpoint of demonstrating an improvement on the QOL-B respiratory domain PRO instrument (change from baseline to month 6), though epetraborole was generally well tolerated in the trial. Based on these results, we decided to suspenddiscontinue further development of epetraborole for treatment-refractory MAC lung disease.
Our net loss was $35.2 million for the year ended December 31, 2025 and $10.0$18.2 million and $10.6$17.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $251.0$259.2 million. We have funded our operations to date primarily with proceeds from our ATM Offerings, 2026 Private PlacementPlacement, (the “2026 Private Placement”), underwritten offering (the “Underwritten Offering”), our “at-the-market” equity offering program (“ATM Offering”),Offering, our IPO, and the sale of our redeemable convertible preferred stock. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical and nonclinical studies, manufacturing, clinical trials, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year.
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. However, in addition to the $40.0 million financing completed in March 2026, we will need to obtain substantial additional funding in connection with our continuing operations and planned activities. Our future capital requirements will depend on many factors, including:
There is a high failure rate for product candidates proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. For example, in May 2025, we announced that the truncated Phase 3 portion of the EBO-301 study did not meet its primary endpoint of demonstrating an improvement on the QOL-B respiratory domain PRO instrument (change from baseline to month 6), though epetraborole was generally well tolerated in the trial. Based on these results, we decided to suspenddiscontinue further development of epetraborole for treatment-refractory MAC lung disease. There is no guarantee that we will not experience similar setbacks with respect to our other product candidates.
Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates, whether used alone onor in combination with other therapies, could cause us or regulatory authorities to interrupt, delay or halt clinical trials or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities, or, if such product candidates are approved, result in a more restrictive label and other post-approval requirements. Any treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial, or could result in potential product liability claims. Any of these occurrences may harm our business, financial condition, results of operations and growth prospects significantly.
efforts to facilityfacilitate timely enrollment in clinical trials;
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, financial condition, operating results, and growth prospects.
We are currently conducting and may continue to conduct clinical trials for our product candidates outside of the U.S., and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
We conduct and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the U.S. For instance, we will be initiating a global PV Phase 2 study in India.the U.S., Australia and India and a Chagas Phase 2 study in Bolivia. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the relevant jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
Prior to the completion of the IPO, we had been a private company with limited accounting personnel to adequately execute our accounting processes and other supervisory resources with which to address our internal control over financial reporting. In connection with the preparation of our financial statements, we identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. The following material weaknesses continue to exist as of MarchJune 31,30, 2026:
Competitors or other third parties may infringe, misappropriate or otherwise violate our in-licensed issued patents or other intellectual property rights we may own. To counter such infringement, misappropriation, violation or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against third parties could provoke these parties to assert counterclaims against us alleging that we infringe, misappropriate or otherwise violate their patents, trademarks, copyrights or other intellectual property rights. In addition, our in-licensed patents may become involved in inventorship or priority disputes. Third parties may raise challenges to the validity of certain of our in-licensed patent claims and may in the future raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in derivation, revocation, reexamination, post-grant review (“PGR”), inter partes review (“IPR”), interference proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings challenging any patents that we may own or in-license. Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of our owned or licensed pending patent applications. A third party may also claim that our potential future owned patents or licensed patent rights are invalid or unenforceable in a litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, invalidate, or render unenforceable, our potential future owned patents or licensed patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rightsrights. In a patent infringement proceeding, there is a risk that a court will decide that a patent we own or in-license is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents are upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our owned or in-licensed patents do not cover the invention. An adverse outcome in a litigation or proceeding involving our owned or in-licensed patents could limit our ability to assert our owned or in-licensed patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Similarly, in the future, we expect to rely on trademarks to distinguish our product candidates that are approved for marketing, if any, and if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the third party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.
Our employees, consultants, and other parties may unintentionally or willfully disclose our information or technology to competitors and there can be no assurance that the legal protections and precautionprecautions taken by us will be adequate to prevent misappropriation of our technology or that competitors will not independently develop technologies equivalent or superior to ours. Trade secrets and know-how can be difficult to protect. Our competitors or other third parties may independently develop knowledge, methods and know-how equivalent to our trade secrets. Additionally, competitors could purchase our product candidates and replicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents we license or may own in the future protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our product candidates. Depending upon the timing, duration, and specifics of any FDA approval of any of our product candidates, one or more of our in-licensed U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration ActionAct of 1984 (the “Hatch-Waxman Amendments”). The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such patent term extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and growth prospects could be materially harmed.
Further, on June 1, 2023, the European Union Patent Package (“EU Patent Package”) regulations were implemented with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (“UPC”) for litigation involving European patents. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical industries. Our European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patent applications and patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain a pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates and, resultantly, on our business, financial condition, results of operations and growth prospects.
The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional confirmatory studies to verityverify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit or are not completed in a timely manner, the FDA may withdraw its approval of the drug on an expedited basis. In addition, the Food and Drug Omnibus Reform Act of 2022, provided the FDA additional statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval. Under these provisions, the FDA may require a sponsor of a product seeking accelerated approval to, among other things, have a confirmatory trial underway prior to such approval being granted.
The FDA and other regulatory authorities strictly regulatesregulate marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, and promotional activities involving the internet and off-label promotion. For example, any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by the FDA. While physicians in the U.S. may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote any products will be narrowly limited to those indications that are specifically approved by the FDA.
If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of any product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business, financial condition, results of operations and growth prospects.
the federal Physician Payments Sunshine Act, which requires manufacturers of certain drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to payments and “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other healthcare providers (such as nurse practitioners and physiciansphysician assistants) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and local laws requiring the licensure of pharmaceutical sales representatives.
As a public company in the U.S., we are incurring significant legal, accounting, and other expenses. These expenses will likely be even more significant after we no longer qualify as an emerging growth company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies in the U.S., including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our senior management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations hashave increased our legal and financial compliance costs and has made some activities more time-consuming and costly. We cannot predict or estimate the amount of additional costs we will incur or the timing of such costs.
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “General and Administrative Expenses”
New heading “Interest Income”
Removed heading “Research and Development Expenses”
Removed heading “Research and Development Expenses”
Largest changes
“In March 2026, we completed dosing all cohorts in our Phase 1 first-in-human trial of oral AN2-502998 (formerly known as AN15368), an investigational, boron-based small molecule in development for the treatment of chronic Chagas disease, or American trypanosomia. In the second quarter of 2026, we anticipate 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. …”see in full comparison
Full comparison: every changed paragraph (43)
The following discussion and analysis of our financial condition as of MarchJune 31,30, 2026 and results of operations for the three and six months ended MarchJune 31,30, 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 “AN2AN2,” “the Company,” “we,” “us” and “our” refer to AN2 Therapeutics, Inc.
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.
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.
We are proceeding through the regulatory process and anticipate initiating the Phase 2 trial in the third quarter of 2026. We expect to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027, subject to regulatory clearance and enrollment progress.
Epetraborole – M. abscessus complex lung disease
Building on the microbiological and safety data from our prior non-tuberculous mycobacterial (“NTM”) study,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 an estimated 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 whichwhom 10–15% are caused by M. abscessus.
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 screeningenrollment commencedis in March 2026.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 SciencesScience 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 regulatory clearance and enrollment progress.
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.
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.
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.
We expect to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease in late 2026.
In October 2023, we announced an exclusive license agreement with the University of Georgia Research Foundation to advance the development of AN2-502998, originally discovered by researchers at Anacor, in close collaboration with the University of Georgia. Upon achievement of certain development and sales milestones, we are required to make payments of up to approximately $0.9 million and a low single digit royalty.
In March 2026, we completed dosing all cohorts in our Phase 1 first-in-human trial of oral AN2-502998 (formerly known as AN15368), an investigational, boron-based small molecule in development for the treatment of chronic Chagas disease, or American trypanosomia. In the second quarter of 2026, we anticipate 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. In October 2023, we announced an exclusive license agreement with the University of Georgia Research Foundation to advance the development of AN2-502998, originally discovered by researchers at Anacor, in close collaboration with the University of Georgia. Upon achievement of certain development and sales milestones, we are required to make payments of up to approximately $0.9 million and a low single digit royalty. 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. 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. We expect 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.
Our boron chemistry research and development initiatives - Oncology
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 with profiles that aredemonstrate sub-nanomolar,sub-nanomolar highlyactivity, selectivehigh selectivity and characterized by excellent oral pharmacokinetics.pharmacokinetic Weproperties. haveEarlier this year, the Company declared ana ENPP1development candidate (ENPP1) for the treatment of solid tumors markingand anexpects importantto stepadvance ina transitioningsecond development candidate by the programend fromof early research into development.2026.
We do not have any products approved for sale and have not generated any revenue since inception. Our net losses were $10.0$18.2 million and $10.6$17.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $251.0$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 programprograms (“ATM OfferingOfferings”), 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 OfferingOfferings 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 $37.3$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.
As of MarchJune 31,30, 2026, we had cash, cash equivalents, and investments of $85.3$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.
Research and Development Expenses
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
Research and Development Expenses
Research and development expenses were $6.7$6.0 million for the three months ended MarchJune 31,30, 2026 compared to $7.7$3.2 million for the three months ended MarchJune 31,30, 2025. The decreaseincrease of $1.0$2.8 million was primarily due to decreasesincreases in chemistry manufacturing and controls (“CMC”) expenses, other miscellaneous expenses, consulting and outside services, preclinical and research study expenses and licenseclinical fees,trial expenses, partially offset by increasesa decrease in personnel-related expenses,expenses. clinicalIn trial2025, 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, facilities andother miscellaneous expenses, and consulting and outside services.services when comparing the second quarter of 2026 to the same period in 2025. CMC expenses decreasedincreased by $1.5 million due to melioidosis program expense offsets, partially offset by decreased CMC activity inrelated to our melioidosis and Chagas programs.program. LicenseOther fees decreased $0.2 million. Personnel-relatedmiscellaneous expenses increased by $0.2$0.6 million primarilydue an increase related to melioidosis program overhead offsets. Consulting and outside services increased by $0.6 million due to compensation-relatedan paymentsincrease offsetin melioidosis program expense offsets and the prioritization of earlier stage research and clinical programs. Preclinical and research study expenses increased by decreased$0.5 stock-basedmillion compensationdue expense.to increased activity in earlier stage research and preclinical programs. Clinical trial expenses increased by $0.2$0.3 million primarily due to initiationincreased ofactivity in our Phase 1 trialtrials in Chagas disease and ourdisease, M. abscessus Phaseand 2 clinical trial,PV, partially offset by decreased expenses due to the termination of the EBO-301 trial. Allocated facilities and miscellaneousPersonnel-related expenses increaseddecreased by $0.2$0.7 million primarily due to thedecreased recognitionstock-based ofcompensation our qualified small business payroll tax credit in 2025. Consulting and outside services increased by $0.1 million.expense. During the three months ended MarchJune 31,30, 2026 and 2025, reimbursement of $0.7$0.4 million and $0.4$3.7 million, respectively, of operating expenses was recognized related to our funding arrangements.
General and administrative expenses were $3.8$2.9 million for the three months ended MarchJune 31,30, 2026 and March$4.0 31,million 2025. Forfor the three months ended MarchJune 31,30, 2026,2025. personnel-relatedThe expensesdecrease decreasedof by$1.1 $0.3million million,is offsetprimarily bydue to a $0.2$0.6 million increasedecrease in professional and outside services expenses and a $0.1$0.5 million increasedecrease in allocatedpersonnel-related facilitiesexpenses anddue miscellaneousto expenses.a decrease in stock-based compensation.
Interest income was $0.5$0.7 million for the three months ended MarchJune 31,30, 2026 compared to $0.9$0.8 million for the three months ended MarchJune 31,30, 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.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table sets forth the significant components of our results of operations:
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.
The following table shows our research and development expenses by type of activity:
General and Administrative Expenses
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.
Interest Income
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.
We have incurred net losses since our inception. For the threesix months ended MarchJune 31,30, 2026 and 2025, we had net losses of $10.0$18.2 million and $10.6$17.1 million, respectively, and we expect to incur substantial additional losses in future periods. As of MarchJune 31,30, 2026, we had an accumulated deficit of $251.0$259.2 million. As of MarchJune 31,30, 2026, we had cash, cash equivalents, short-term and long-term investments of $85.3$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.
To date, we have funded our operations primarily through our 2026 Private Placement, Underwritten Offering, ATM Offering,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 $37.3$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 Offering,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.
In April 2026, we entered into an open market sale agreement with Jefferies, as sales agent, pursuant to which we may offer and sell, from time to time, up to an aggregate of $80.0 million in shares of our common stock in an at-the-market offering. As of the date hereof, we have not sold any shares of our common stock under the open market sale agreement.
Net cash used in operating activities was $12.1$19.1 million for the threesix months ended MarchJune 31,30, 2026, which consisted of a net loss of $10.0$18.2 million, primarily due to the use of funds to develop our product candidates, and a net decrease of $3.4$3.1 million in our net operating assets and liabilities, partially offset by $1.4$2.2 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $3.1$3.6 million in accrued liabilities, accounts payable, accrued compensation, and other current liabilitiesliabilities, andpartially anoffset increaseby a decrease of $0.3$0.5 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $1.5$2.4 million, partially offset by net accretion of discounts on investments of $0.1$0.2 million.
Net cash used in operating activities was $10.6$18.2 million for the threesix months ended MarchJune 31,30, 2025, which consisted of a net loss of $10.6$17.1 million, primarily due to the use of funds to develop our initial drug product candidate,candidates, and a net decrease of $1.6$4.4 million in our net operating assets and liabilities, partially offset by $1.6$3.3 million in non-cash charges. The net decrease in our operating assets and liabilities was primarily due to a decrease of $2.2$3.2 million in accrued liabilities, accounts payable, accrued compensation, accounts payable, and other current liabilities partiallyand offsetan by a decreaseincrease of $0.6$1.2 million in prepaid expenses and other assets. The non-cash charges consisted of stock-based compensation expense of $2.0$4.0 million, partially offset by net accretion of discounts on investments of $0.4$0.7 million.
Net cash provided by investing activities was $8.3$4.6 million for the threesix months ended MarchJune 31,30, 2026, which primarily consisted of $11.0$21.0 million in proceeds from the maturity of investments, partially offset by $2.7$16.4 million in purchases of investments.
Net cash provided by investing activities was $9.2$15.0 million for the threesix months ended MarchJune 31,30, 2025, which primarily consisted of $31.5$49.0 million in proceeds from the maturity of investments, partially offset by $22.3$34.0 million in purchases of investments.
Net cash provided by financing activities was $37.3$38.8 million for the threesix months ended MarchJune 31,30, 2026, which consisted of $37.3$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 planplan. andThese $0.02increases were partially offset by $0.2 million fromin payment of deferred offering costs related to the exerciseATM of stock options.Offerings.
Net cash provided by financing activities was $0.1 million for the threesix months ended MarchJune 31,30, 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.
See the section “Recently Adopted Accounting Pronouncements” in “Note 2—Basis of Presentation and Summary of Significant Accounting Policies” to the Notes to Financial Statements in Part I, Item 1 of this Quarterly Report on 10-Q.Form 10‑Q.
The preparation of financial statements and related disclosures in conformity with GAAP requires us to make judgments, assumptions, and estimates that affect the amounts reported in the condensed financial statements and accompanying notes. “Note 2—Summary of Significant Accounting Policies” to the financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025 describes the significant accounting policies and methods used in the preparation of the financial statements. Our critical accounting estimates, identified in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Part II, Item 7 of our Annual Report on Form 10-K include for the year ended December 31, 2025, but are not limited to, the discussion of estimates used for research and development and stock-based compensation. Such accounting policies and estimates require significant judgments and assumptions to be used in the preparation of the condensed financial statements, and actual results could differ materially from the amounts reported. There have been no material changes to these critical accounting policies and estimates through MarchJune 31,30, 2026 from those discussed in our Annual Report on Form 10-K.
We will remain an EGC until the earliest to occur of: (1) the last day of our first fiscal year in which we have total annual revenues of more than $1.235 billion; (2) the date we qualify as a “large accelerated filer,” with at least $700.0 million of equity securities held by non-affiliates; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three- year period; and (4) theDecember last31, day of the fiscal year ending after the fifth anniversary of our IPO.2027.
ANTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 2,098 shares, about $11.6K) and open-market sales in 6 filings (3 insiders, 7 trade dates, 59,111 shares, about $344.2K; 3 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -57,013 (purchases minus sales); net value about -$332.6K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-15 | Trenor Cameron C. Iii |
Grant/award | 116,667 | — | — |
| 2026-09-09 | Readnour Robin Shane |
Open-market sale |
585 | $6.02 | $3.5K |
| 2026-09-09 | Readnour Robin Shane |
Open-market sale |
523 | $6.02 | $3.1K |
| 2026-09-08 | Readnour Robin Shane |
Open-market sale |
4,725 | $6.02 | $28.4K |
| 2026-09-08 | Readnour Robin Shane |
Open-market sale |
5,294 | $6.02 | $31.9K |
| 2026-09-03 | Readnour Robin Shane |
Open-market sale |
2,877 | $6.07 | $17.5K |
| 2026-09-03 | Readnour Robin Shane |
Open-market sale |
3,223 | $6.07 | $19.6K |
| 2026-09-01 | Williams Sarah Joanne |
Open-market sale | 272 | $5.53 | $1.5K |
| 2026-09-01 | Fitzpatrick Margaret M |
Open-market purchase | 2,098 | $5.53 | $11.6K |
| 2026-08-17 | Readnour Robin Shane |
Open-market sale |
16,696 | $6.01 | $100.3K |
| 2026-08-17 | Readnour Robin Shane |
Open-market sale |
18,706 | $6.01 | $112.4K |
| 2026-08-14 | Zakrzewski Joseph S |
Gift | 405,880 | — | — |
| 2026-07-10 | Aziz Kabeer |
Grant/award | 2,852 | — | — |
| 2026-07-10 | Marks Gilbert Lynn |
Grant/award | 2,789 | — | — |
| 2026-07-10 | Martin Patricia A. |
Grant/award | 766 | — | — |
| 2026-07-08 | Eizen Joshua M |
Open-market sale | 5,945 | $4.17 | $24.8K |
| 2026-05-29 | Williams Sarah Joanne |
Open-market sale | 265 | $4.43 | $1.2K |
Well-known investors holding ANTX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 2,318,692 | $11.2M | 0.01% | Added 4% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 951,997 | $4.6M | 0.0% | Added 513% |
| Renaissance Technologies | 2026-06-30 | 129,700 | $627.7K | 0.0% | Reduced 35% |
| Two Sigma Investments | 2026-06-30 | 15,913 | $77.0K | 0.0% | New position |