Financial Performance - The company reported a net loss of $51.3 million for the year ended December 31, 2024, compared to a net loss of $64.7 million for 2023, resulting in an accumulated deficit of $205.8 million[134]. - The company expects to incur significant expenses and operating losses over the next several years as it continues its research and development efforts[134]. - The company anticipates substantial additional funding will be required to meet its financial needs and pursue business objectives[149]. - As of December 31, 2024, the company had federal net operating loss carryforwards of approximately $81.3 million and state net operating loss carryforwards of approximately $166.3 million[322]. - The company does not expect to pay any cash dividends on its common stock in the foreseeable future, relying instead on capital appreciation for returns[321]. - The company is incurring significantly increased costs due to compliance with U.S. public company regulations, which may affect financial performance[327]. - The company has broad discretion in the use of its cash, which could lead to financial losses if not applied effectively[319]. - The company’s ability to utilize net operating loss carryforwards may be limited by ownership changes, affecting future tax liabilities[322]. Research and Development - The Phase 2 part of the EBO-301 study demonstrated a PRO-based clinical response rate of 39.5% for epetraborole + optimized background regimen (OBR) compared to 25.0% for placebo + OBR, with a treatment difference of 13.9%[133]. - The company plans to transition from a research and development focus to supporting commercial activities, which may pose challenges[142]. - The company may defer or discontinue development of epetraborole based on further FDA feedback or data review[164]. - The success of product candidates depends on timely completion of clinical trials and obtaining regulatory approvals[157]. - There is a high failure rate for product candidates in clinical trials, with significant setbacks possible even after promising results in earlier stages[162]. - The company is developing product candidates to treat bacterial infections, but the potential for bacteria to develop resistance could impact revenue potential[169]. - Patient enrollment in clinical trials is critical, and challenges in recruiting eligible patients could lead to significant delays and increased development costs[180]. - The company may face difficulties in enrolling patients for trials targeting rare diseases, which could hinder clinical development[181]. - The company is focusing on discovering and commercializing a portfolio of product candidates targeting diseases with high unmet needs, utilizing a targeted-design drug discovery platform[176]. Regulatory and Compliance Risks - The company may face delays in obtaining regulatory approvals, which would materially impair its ability to generate revenue[135]. - Regulatory authorities may impose additional requirements or restrictions on approved product candidates, affecting market acceptance and commercialization[174]. - The lengthy and unpredictable nature of the regulatory approval process may significantly harm the company's business and growth prospects[266]. - The FDA must approve any proprietary names for product candidates, and objections could require significant resources to resolve[250]. - The company must comply with extensive FDA requirements, including cGMP and GCP, to avoid sanctions and ensure product safety[281]. - The company is exposed to risks related to employee misconduct and non-compliance with regulatory standards, which could lead to significant penalties[287]. - The company may seek accelerated approval for certain product candidates, but there is no assurance that such applications will be accepted or lead to timely approvals[276]. - Disruptions at regulatory agencies, such as the FDA, due to funding shortages or global health concerns, could negatively impact the company's ability to obtain timely approvals[269]. Market and Competitive Landscape - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may result in competitors obtaining regulatory approvals more rapidly[205]. - The company lacks a sales and marketing infrastructure, which is essential for the successful commercialization of its product candidates[209]. - Market acceptance of the company's product candidates will depend on factors such as safety, efficacy, and reimbursement availability[203]. - The company faces risks related to the inability to establish its own sales, marketing, and distribution capabilities, which could lead to lower revenues and profitability compared to self-distribution[211]. - The company may face challenges in international marketing due to differing regulatory requirements and potential economic instability in foreign markets[218]. Intellectual Property and Legal Risks - The company relies on licenses for critical intellectual property, including a key agreement with Anacor for epetraborole[234]. - Compliance with license agreements is essential; failure to do so could result in loss of rights to important technologies[236]. - The patent application process is expensive and time-consuming, with uncertain outcomes regarding the issuance and enforceability of patents[230]. - The patent position is highly uncertain, with potential changes in laws affecting the value and enforceability of patents[233]. - The company may face expensive and time-consuming lawsuits to protect its intellectual property rights, which could divert management's attention and resources[241]. - There is a risk that third parties may infringe on the company's patents, potentially leading to costly litigation and adverse effects on stock price[242]. - The company may face claims from third parties asserting ownership of its intellectual property, which could lead to litigation and distract management[246]. Workforce and Management - A workforce reduction was implemented in August 2024, resulting in recognized severance and other charges of $2.2 million[146]. - The company has reduced its workforce by approximately 50% as part of a restructuring effort, which may affect its ability to manage future growth effectively[226]. - The company is highly dependent on key executives and may face challenges in retaining them, which could impede its business strategy[219]. - The company may encounter difficulties in recruiting and retaining qualified personnel, impacting its research, development, and commercialization objectives[220]. Economic and Market Conditions - The company faces macroeconomic uncertainties that could adversely affect its business, including inflation rates and volatility in financial markets[221]. - The Inflation Reduction Act of 2022 (IRA) is expected to significantly impact the pharmaceutical industry, including provisions for price negotiations on certain high-expenditure drugs starting in fiscal year 2023[293]. - State-level legislation is increasingly controlling pharmaceutical pricing, potentially imposing price limits on certain drugs[294]. - Government downsizing initiatives may negatively impact the FDA's ability to review and approve new drug applications, leading to delays[295].

Financial Performance - Cash, cash equivalents, and investments totaled $88.6 million as of December 31, 2024, expected to fund operations through 2027[1] - Net loss for the full year 2024 was $51.3 million, compared to a net loss of $64.7 million in 2023, representing a 20.5% improvement[9] - Interest income for the full year 2024 was $5.5 million, an increase from $4.9 million in 2023[9] - General and Administrative (G&A) expenses for the full year 2024 were $14.1 million, slightly down from $14.8 million in 2023[9] - Research and Development (R&D) expenses for the full year 2024 were $40.5 million, a decrease of 26.2% from $54.9 million in 2023[9] - Restructuring charges for the full year 2024 amounted to $2.2 million due to severance payments and other employee termination expenses[9] Clinical Development - The company plans to announce topline Phase 3 results for epetraborole in the second quarter of 2025[4] - A Phase 1 clinical study for AN2-502998, targeting Chagas disease, is expected to start in mid-2025[1] - Enrollment in a 200-patient observational trial for melioidosis was completed in October 2024, with a Phase 2 study planned for the second half of 2025[6] - The company aims to advance its first oncology candidate from its boron chemistry platform into development in the second half of 2025[1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-41331 AN2 Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-0606654 (State or ...

Clinical Trial Results - Epetraborole-treated patients showed a statistically significant improvement in the QOL-B respiratory domain with a least squares mean change of 7.20 compared to 0.30 for the placebo group, resulting in a mean difference of 6.90 (p-value: 0.0365) from baseline to month 6[4] - The MACrO2 post-hoc analysis indicated a mean change of -12.91 for the epetraborole group versus -7.10 for the placebo group, with a mean difference of -5.81 (p-value: 0.0433) from baseline to month 6[6] - The company completed enrollment in a 200-patient observational trial for epetraborole in acute melioidosis in October 2024, with plans for a Phase 2 proof of concept study in the second half of 2025[12] - The company anticipates releasing top-line Phase 3 data from 97 patients in mid-2025, pending discussions with the FDA[10] - The company plans to initiate Phase 1 clinical development for AN2-502998 targeting chronic Chagas disease in mid-2025[11] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $8.3 million, a decrease from $14.4 million in Q3 2023, attributed to reduced clinical trial costs and other operational efficiencies[15] - General and Administrative (G&A) expenses for Q3 2024 were $3.5 million, down from $3.8 million in the same period last year, reflecting a decrease in professional services[15] - The net loss for Q3 2024 was $12.7 million, an improvement from a net loss of $16.7 million in Q3 2023[15] Cash and Investments - The company had cash, cash equivalents, and investments totaling $93.4 million as of September 30, 2024, which is expected to fund operations through 2027[16] - Cash and cash equivalents increased significantly from $15,647,000 to $33,504,000, showing a growth of about 113.5%[20] - Short-term investments decreased from $91,648,000 to $59,922,000, a reduction of approximately 34.5%[20] Assets and Liabilities - Total assets decreased from $138,744,000 in December 31, 2023 to $97,689,000 as of September 30, 2024, representing a decline of approximately 29.6%[20] - Total liabilities reduced from $14,043,000 to $10,017,000, indicating a decrease of around 28.5%[20] - Stockholders' equity declined from $124,701,000 to $87,672,000, reflecting a decrease of about 29.7%[20] - Accounts payable decreased from $2,676,000 to $1,711,000, a decline of approximately 36.1%[20] - Other current liabilities reduced from $11,367,000 to $8,306,000, showing a decrease of about 27.0%[20] - Long-term investments were eliminated, dropping from $27,194,000 to $0[20] - Other long-term assets decreased from $1,043,000 to $0, indicating a complete reduction[20] Operational Efficiency - The company achieved a 50% reduction in expenditures through strategic realignment of operations[16]

Company Overview - AN2 Therapeutics (ANTX) is a clinical-stage company focused on developing small molecule therapeutics using its boron chemistry platform to address infectious diseases and cancer [1] - The lead candidate, epetraborole, is being evaluated for nontuberculous mycobacteria (NTM) lung disease and acute melioidosis in early-stage studies [1] Recent Developments - Shares of AN2 Therapeutics fell 66.3% in the past month after the company discontinued a mid to late-stage study on epetraborole for treatment-refractory mycobacterium avium complex (MAC) lung disease due to unsatisfactory efficacy results [1] - Year-to-date, ANTX shares have plummeted 95.2%, contrasting with a 1.7% decline in the industry [1] Study Results - The phase II portion of the EBO-301 study showed a higher patient-reported outcome (PRO) clinical response rate of 39.5% in the epetraborole arm compared to 25% in the placebo arm [2] - However, the study did not demonstrate a statistically significant superior sputum culture conversion at month six, a key secondary endpoint [2] Strategic Actions - Following the setback, the company plans to evaluate EBO-301 study results for future development of epetraborole for NTM lung disease in other patient populations [4] - AN2 Therapeutics will undergo strategic restructuring, including a workforce reduction of approximately 50% by the end of 2024, with anticipated charges of $2-$3 million [4] Future Plans - The company is preparing to initiate a phase I clinical study of its second product candidate, AN2-502998, aimed at curing chronic Chagas disease [5] - Additionally, a mid-stage study of epetraborole for the melioidosis indication is also planned [5]

Financial Performance - For the six months ended June 30, 2024, the net loss was $31.1 million, consistent with the net loss of $31.1 million for the same period in 2023, resulting in an accumulated deficit of $185.5 million as of June 30, 2024[118]. - The company reported net losses of $31.1 million for both the six months ended June 30, 2024, and 2023, with an accumulated deficit of $185.5 million as of June 30, 2024[141]. Operating Expenses - Total operating expenses for the three months ended June 30, 2024, were $15.9 million, a decrease of 4% from $16.6 million in the same period of 2023[128]. - Total operating expenses for the six months ended June 30, 2024, were $34.2 million, an increase of 5% from $32.6 million in the same period of 2023[135]. - General and administrative expenses increased by 22% to $3.7 million for the three months ended June 30, 2024, compared to $3.0 million in the same period of 2023[132]. - General and administrative expenses were $7.4 million for the six months ended June 30, 2024, compared to $7.1 million in 2023, marking a 4% increase[139]. - Research and development expenses decreased by 10% to $12.1 million for the three months ended June 30, 2024, compared to $13.5 million for the same period in 2023[129]. - Research and development expenses increased to $26.8 million for the six months ended June 30, 2024, up from $25.5 million in the same period of 2023, representing a 5% increase[136]. - Clinical trial expenses rose by $3.3 million to $10.4 million, a 46% increase compared to $7.1 million in 2023[138]. - Personnel-related expenses increased by $1.3 million to $9.3 million, reflecting a 17% rise from $8.0 million in 2023[138]. Income and Cash Flow - Other income, net increased by 81% to $1.4 million for the three months ended June 30, 2024, compared to $0.8 million for the same period in 2023, driven by higher interest rates and cash balances[133]. - Other income, net increased to $3.1 million for the six months ended June 30, 2024, up from $1.5 million in 2023, a 107% increase[140]. - Cash used in operating activities was $32.0 million for the six months ended June 30, 2024, compared to $24.4 million in 2023[152][153]. - Net cash provided by investing activities was $42.8 million for the six months ended June 30, 2024, compared to $18.8 million in 2023[154]. - The company generated approximately $65.5 million from an Underwritten Offering in August 2023, after deducting commissions and offering expenses[142]. Funding and Future Outlook - The company has raised a total of $182.4 million through various funding rounds since its inception, including $70.0 million from an underwritten offering in August 2023[118]. - Future funding requirements are expected to be substantial, as the company does not have any products approved for sale and anticipates continued operating losses[143][144]. - As of June 30, 2024, the company had cash, cash equivalents, and investments totaling $104.5 million, expected to fund operations for at least the next twelve months[120]. - The company had cash, cash equivalents, and investments totaling $104.5 million as of June 30, 2024, primarily in money market funds and marketable securities[162]. Regulatory and Compliance - The company intends to rely on exemptions provided by the JOBS Act, including not complying with auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act[161]. - The company will remain an emerging growth company (EGC) until total annual revenues exceed $1.235 billion or it qualifies as a large accelerated filer with at least $700 million in equity securities held by non-affiliates[161]. Economic Factors - A hypothetical 10% relative change in interest rates would not have had a material impact on the company's financial statements[163]. - The company was not exposed to material foreign currency risk during the quarter ended June 30, 2024[164]. - Inflation has generally increased the company's labor and operating costs, but it has not had a material effect on the unaudited interim condensed financial statements[165].

Exhibit 99.1 AN2 Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business and Scientific Highlights Cash, cash equivalents, and investments of $104.5 million at June 30, 2024; cash runway anticipated to fund operations through 2027 Menlo Park, CA – August 13, 2024 – AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform today reported financial results for the q ...

Core Insights - AN2 Therapeutics' stock is experiencing a significant decline following an update on its EBO-301 Phase 2/3 study, with a drop of 34.8% as of Friday morning [2]. Group 1: Study Update - The Phase 2 study of epetraborole met its primary endpoint but failed to meet a key secondary endpoint [1]. - The company ceased accepting new patients for the Phase 3 part of the study in February due to potentially lower-than-expected efficacy from blinded aggregate data [1]. - AN2 Therapeutics has decided to terminate both the Phase 2 and Phase 3 parts of the study [1]. Group 2: Future Plans - The co-founder and CEO of AN2 Therapeutics stated that the company will evaluate the EBO-301 study results and consider future development of epetraborole for NTM lung disease in other patient populations [2]. - In the near term, the company plans to accelerate R&D efforts on its boron chemistry platform, focusing on promising programs in infectious diseases and oncology [2]. Group 3: Financial Strategy - AN2 Therapeutics will undergo a strategic restructuring to extend its cash runway into 2027 [1].

A downtrend has been apparent in AN2 Therapeutics, Inc. (ANTX) lately with too much selling pressure. The stock has declined 5.5% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicato ...

Financial Performance - For the three months ended March 31, 2024, the net loss was $16.6 million, compared to a net loss of $15.3 million for the same period in 2023, representing an 8% increase in losses [116]. - The company has incurred an accumulated deficit of $171.1 million as of March 31, 2024 [116]. - Net losses for Q1 2024 were $16.6 million, compared to $15.3 million in Q1 2023, with an accumulated deficit of $171.1 million as of March 31, 2024 [132]. - Cash used in operating activities was $17.6 million in Q1 2024, compared to $11.6 million in Q1 2023 [144]. - Other income increased to $1.7 million in Q1 2024, compared to $0.7 million in Q1 2023, driven by higher interest rates and cash balances [131]. Expenses - Research and development expenses increased to $14.7 million for the three months ended March 31, 2024, up from $12.0 million in the same period of 2023, marking a 22% increase [125]. - Total operating expenses for the first quarter of 2024 were $18.3 million, a 14% increase from $16.0 million in the first quarter of 2023 [125]. - Clinical trial expenses increased by $3.7 million in 2024 due to higher enrollment and related activities [127]. - Clinical trials expenses increased to $5.8 million in Q1 2024, up 175% from $2.1 million in Q1 2023 [129]. - General and administrative expenses decreased to $3.6 million in Q1 2024 from $4.1 million in Q1 2023, a decrease of 10% [125]. - General and administrative expenses decreased to $3.6 million in Q1 2024, down from $4.1 million in Q1 2023, primarily due to reduced professional services costs [130]. Funding and Cash Position - The company had cash, cash equivalents, and investments totaling $118.1 million as of March 31, 2024, which is expected to fund operations for at least the next twelve months [117]. - The company raised gross proceeds of $70.0 million from an underwritten offering in August 2023, with net proceeds of $65.5 million after expenses [116]. - The company expects to require substantial additional funding to support ongoing operations and product development [134]. - Future funding may be sought through public or private equity offerings or debt financings, which could result in dilution for existing shareholders [135]. - The company had cash, cash equivalents, and investments totaling $118.1 million as of March 31, 2024, primarily in money market funds and investment-grade securities [154]. Regulatory and Operational Plans - The Phase 2 portion of the clinical trial for epetraborole has completed enrollment, with topline data expected in August 2024 [115]. - The company plans to hire a specialty sales force if regulatory approval for epetraborole is obtained, which will increase operating costs [118]. - The company has not generated any revenue from contracts with customers and does not expect to do so until regulatory approval is obtained for its product candidates [134]. Market and Economic Conditions - A hypothetical 10% relative change in interest rates would not have had a material impact on the company's financial statements [155]. - The company was not exposed to material foreign currency risk during the quarter ended March 31, 2024 [156]. - Inflation has not had a material effect on the company's unaudited condensed financial statements [157]. - The company intends to remain an Emerging Growth Company (EGC) until it exceeds $1.235 billion in total annual revenues or meets other specified criteria [153].