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].

Financial Performance - Cash, cash equivalents, and investments totaled $104.5 million as of June 30, 2024, expected to fund operations through 2027[1] - Net loss for Q2 2024 was $14.4 million, an improvement from a net loss of $15.8 million in Q2 2023[7] - Other income for Q2 2024 was $1.4 million, up from $0.8 million in Q2 2023, attributed to increased interest income[6] - Total operating expenses for Q2 2024 were $15.9 million, slightly down from $16.6 million in Q2 2023[11] Research and Development - Research and Development (R&D) expenses for Q2 2024 were $12.1 million, a decrease of 10.3% from $13.5 million in Q2 2023[5] - The company plans to advance two development programs into clinical trials in 2025, including AN2-502998 for chronic Chagas disease and epetraborole for melioidosis[2] - The Phase 2 part of the EBO-301 study was terminated, although it met its primary objective regarding a novel patient-reported outcome tool[3] - The company published new data on epetraborole's efficacy against M. abscessus, indicating its potential as an important therapy for lung disease[4] Administrative Expenses - General and Administrative (G&A) expenses increased to $3.7 million in Q2 2024 from $3.1 million in Q2 2023, reflecting higher personnel-related expenses[5] Product Pipeline - The company has a pipeline of boron-based compounds targeting high unmet needs in infectious disease and oncology[2]

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].

Core Viewpoint - AN2 Therapeutics, Inc. (ANTX) has experienced a downtrend with a 5.5% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Stock Performance and Indicators - The stock has been under significant selling pressure, indicated by an RSI reading of 24.66, which suggests it is oversold [4]. - A stock is generally considered oversold when its RSI falls below 30, and ANTX's current RSI indicates a potential reversal in trend [2]. Group 2: Earnings Estimates and Analyst Consensus - Over the last 30 days, the consensus EPS estimate for ANTX has increased by 4.1%, reflecting a strong agreement among analysts regarding improved earnings [4]. - ANTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a favorable outlook for a turnaround [5].

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].

Financial Performance - As of March 31, 2024, the company had cash, cash equivalents, and investments totaling $118.1 million [1] - Research and Development (R&D) expenses for Q1 2024 were $14.7 million, an increase from $12.0 million in Q1 2023, attributed to higher clinical trial and personnel-related expenses [5] - General and Administrative (G&A) expenses for Q1 2024 were $3.6 million, down from $4.1 million in Q1 2023, due to reduced professional services and insurance costs [5] - The net loss for Q1 2024 was $16.6 million, compared to a net loss of $15.3 million in Q1 2023 [6] - Other income for Q1 2024 was $1.7 million, up from $0.7 million in Q1 2023, driven by increased interest and investment income [6] - The total operating expenses for Q1 2024 were $18.3 million, compared to $16.0 million in Q1 2023 [11] Clinical Trials - The company plans to report Phase 2 topline results in August 2024 from the ongoing Phase 2/3 trial (EBO-301) in treatment-refractory Mycobacterium avium Complex (TR-MAC) [1] - The Phase 2 topline data will provide the first clinical efficacy data for epetraborole in patients with treatment-refractory MAC [2] - The company has paused Phase 3 enrollment in the EBO-301 trial, with 97 patients currently enrolled, pending further data review [3] - The company is assessing the continuation of Phase 3 enrollment after reviewing unblinded Phase 2 data and discussions with the FDA [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 other jurisdiction ...

Financial Performance - Cash, cash equivalents, and investments totaled $134.5 million as of December 31, 2023[1] - Research and Development (R&D) expenses for the full year 2023 were $54.9 million, up from $29.5 million in 2022, with Q4 2023 R&D expenses at $14.9 million compared to $8.8 million in Q4 2022[6] - General and Administrative (G&A) expenses for the full year 2023 were $14.8 million, compared to $12.8 million in 2022, with Q4 2023 G&A expenses at $3.9 million versus $3.7 million in Q4 2022[6] - Net loss for the full year 2023 was $64.7 million, compared to $41.0 million in 2022, with a Q4 2023 net loss of $16.9 million compared to $11.8 million in Q4 2022[7] Clinical Trials and Research - The Phase 2 topline results for the epetraborole trial in treatment-refractory Mycobacterium avium Complex (TR-MAC) are expected in summer 2024[1] - The Phase 3 enrollment for the epetraborole trial is currently paused due to an analysis showing potentially lower than expected efficacy, with 97 patients enrolled[3] - A licensing agreement was signed with the University of Georgia Research Foundation to develop a novel therapy for chronic Chagas disease, which is in late preclinical development[2] - The company received a grant from the Bill & Melinda Gates Foundation to discover novel boron-containing small molecules for tuberculosis and malaria treatment[5] - The company plans to discuss the Phase 2/3 trial data with the FDA in the coming months[2] - The company presented new epetraborole data at the IDWeek 2023 conference, highlighting its potential in treating NTM lung disease[4]