Latest news with #AN2Therapeutics
Business Wire
30-06-2025
- Business
- Business Wire
AN2 Therapeutics Reports Key Insights from 200-Patient Observational Study in Acute Melioidosis, Laying Groundwork for Phase 2 Proof-of-Concept Trial of Epetraborole
MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced the completion of a 200-patient observational study in acute melioidosis, a highly lethal bacterial infection and recognized biothreat. The study, conducted under real-world conditions in acute hospital settings, evaluated patients receiving the current standard of care (SoC): IV meropenem or ceftazidime. Completed under a contract funded entirely by the National Institutes of Health, the study was completed in just 11 months across three sites in acute melioidosis-endemic regions, demonstrating efficient enrollment and strong site engagement. The study generated an important follow-up dataset for patients treated for acute melioidosis with current standard of care antibiotics, tracking patients for over 90 days. The results revealed a striking mortality rate of nearly 40% (by Day 90) among confirmed melioidosis cases. Principal Investigators observed that approximately 25% of screened patients died in the short period (~3-4 days) before a definitive diagnosis of infection with the causative pathogen (Burkholderia pseudomallei) was confirmed and were not included in the topline mortality rate. These mortality findings highlight the serious impact of melioidosis, the critical importance of early detection and the urgent need for more effective treatment options. 'The study represents a critical step in our mission to transform outcomes for patients with melioidosis,' said Eric Easom, Co-founder, Chairman, President and CEO of AN2 Therapeutics. 'It has given us a much deeper understanding of the patient population, clarified enrollment criteria, and provided the insights needed to design a Phase 2 proof-of-concept trial with the greatest chance of success. The data underscore the devastating impact of melioidosis and the limitations of current therapies, even under best-of-care conditions. We believe epetraborole has the potential to significantly reduce mortality when added to standard treatment. These findings will directly support our planned IND submission, and we look forward to initiating our Phase 2 trial later this year to address this urgent and unmet medical and biodefense need.' Easom continued,'AN2 recognizes and greatly acknowledges the invaluable contribution of all the organizations involved in the study, especially the University of Oxford, MORU (Mahidol Oxford Tropical Medicine Research Unit) and LOMWRU (Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit), together with the hospital sites and the patient participants and their families, for enabling this valuable data to be documented in the battle against this disease.' Due to its high mortality and ease of environmental acquisition, B. pseudomallei is classified as a high priority biothreat agent. If approved for the treatment of acute melioidosis, the Company would seek a priority review voucher and could generate revenue from U.S. and other government stockpiling, as well as from use as a treatment in disease endemic countries, including the U.S. About Melioidosis Melioidosis is estimated to cause over 200,000 cases globally each year; the disease-causing pathogen is mostly found in tropical climates, especially in Southeast Asia and northern Australia, where it causes widespread melioidosis. In the United States, B. pseudomallei occurs in Puerto Rico, the U.S. Virgin Islands, and the Gulf Coast area of the state of Mississippi. Funding This project was funded in whole with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93022C00059. About AN2 Therapeutics AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with early-stage programs focused on targets in infectious diseases and oncology. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: AN2's plans to transform melioidosis treatment for patients; the design, execution, and outcome of a potential Phase 2 proof of concept trial in melioidosis; epetraborole's potential to treat melioidosis; the impact of melioidosis and efficacy of current standard-of-care treatments; and the ability to obtain a priority review voucher upon potential FDA approval in melioidosis. These statements are based on AN2's current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2's ability to conduct Phase 2 and future trials in melioidosis; the continued availability of non-dilutive funding, including U.S. federal government funding, to support future development; timely enrollment of patients in AN2's clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2's ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidates; the significant uncertainty associated with AN2's product candidates ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading 'Risk Factors' in AN2's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2's website at and on the SEC's website at Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.
Yahoo
28-06-2025
- Business
- Yahoo
Positive Signs As Multiple Insiders Buy AN2 Therapeutics Stock
When a single insider purchases stock, it is typically not a major deal. However, when multiple insiders purchase stock, like in AN2 Therapeutics, Inc.'s (NASDAQ:ANTX) instance, it's good news for shareholders. While we would never suggest that investors should base their decisions solely on what the directors of a company have been doing, logic dictates you should pay some attention to whether insiders are buying or selling shares. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. The Independent Director Robin Readnour made the biggest insider purchase in the last 12 months. That single transaction was for US$213k worth of shares at a price of US$1.16 each. That means that even when the share price was higher than US$1.08 (the recent price), an insider wanted to purchase shares. While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company's future. We always take careful note of the price insiders pay when purchasing shares. As a general rule, we feel more positive about a stock if insiders have bought shares at above current prices, because that suggests they viewed the stock as good value, even at a higher price. Over the last year, we can see that insiders have bought 295.61k shares worth US$312k. On the other hand they divested 17.61k shares, for US$24k. In the last twelve months there was more buying than selling by AN2 Therapeutics insiders. The chart below shows insider transactions (by companies and individuals) over the last year. By clicking on the graph below, you can see the precise details of each insider transaction! Check out our latest analysis for AN2 Therapeutics There are always plenty of stocks that insiders are buying. If investing in lesser known companies is your style, you could take a look at this free list of companies. (Hint: insiders have been buying them). We saw some AN2 Therapeutics insider buying shares in the last three months. Insiders purchased US$21k worth of shares in that period. It's great to see that insiders are only buying, not selling. However, in this case the amount invested recently is quite small. Another way to test the alignment between the leaders of a company and other shareholders is to look at how many shares they own. We usually like to see fairly high levels of insider ownership. From our data, it seems that AN2 Therapeutics insiders own 6.7% of the company, worth about US$2.2m. We do generally prefer see higher levels of insider ownership. We note a that there has been a bit of insider buying recently (but no selling). Overall the buying isn't worth writing home about. On a brighter note, the transactions over the last year are encouraging. We'd like to see bigger individual holdings. However, we don't see anything to make us think AN2 Therapeutics insiders are doubting the company. So while it's helpful to know what insiders are doing in terms of buying or selling, it's also helpful to know the risks that a particular company is facing. Our analysis shows 3 warning signs for AN2 Therapeutics (1 can't be ignored!) and we strongly recommend you look at these before investing. Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of interesting companies. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions of direct interests only, but not derivative transactions or indirect interests. — Investing narratives with Fair Values A case for TSXV:USA to reach USD $5.00 - $9.00 (CAD $7.30–$12.29) by 2029. By Agricola – Community Contributor Fair Value Estimated: CA$12.29 · 0.9% Overvalued DLocal's Future Growth Fueled by 35% Revenue and Profit Margin Boosts By WynnLevi – Community Contributor Fair Value Estimated: $195.39 · 0.9% Overvalued Historically Cheap, but the Margin of Safety Is Still Thin By Mandelman – Community Contributor Fair Value Estimated: SEK232.58 · 0.1% Overvalued View more featured narratives — Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Business Wire
29-05-2025
- Business
- Business Wire
AN2 Therapeutics Announces Poster Presentation Highlighting M. Abscessus Data at 2025 Colorado Mycobacteria Conference
MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today announced that the company will present a poster highlighting the preclinical activity of epetraborole against M. abscessus on Thursday, May 29, 2025 at the Nontuberculous Mycobacteria Conference to be held May 27-30, 2025 at Colorado State University. It is estimated that M. abscessus affects approximately 50,000 patients in the U.S., Japan and Europe. Details of the poster presentation are as follows: Abstract title: Epetraborole, a Potential Oral Agent for Mycobacterium abscessus Lung Disease Date and Time: Poster/Abstract number: 74 Presenting Author: MRK Alley, Ph.D. A copy of the poster will be available on the AN2 Therapeutics website at the following link simultaneously with the poster session Development Pipeline | AN2 Therapeutics. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with early-stage programs focused on targets in infectious diseases and oncology. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at
Business Wire
13-05-2025
- Business
- Business Wire
AN2 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business and Scientific Highlights
MENLO PARK, Calif.--(BUSINESS WIRE)--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 first quarter ended March 31, 2025. 'As we look ahead to the remainder of 2025, we are poised to advance our pipeline leveraging our boron chemistry platform, which has the potential to address serious unmet needs of patients. We have high-impact clinical programs for Chagas disease and melioidosis, enabling data for potential development of epetraborole in NTM lung disease caused by M. abscessus, and an emerging portfolio of oncology programs that includes ENPP1 and PI3Kα for solid tumor indications, where our boron chemistry platform has potential for best-in-class molecules,' said Eric Easom, Co-founder, Chairman, President and CEO. 'We remain committed to maintaining a disciplined approach to capital allocation, including using non-dilutive funding to leverage our infrastructure and capabilities for generating near and long-term growth for our shareholders with multiple pathways to success.' First Quarter & Recent Business Updates: Chagas Disease The Company has initiated start up activities for a Phase 1 first in human clinical study of its product candidate, AN2-502998, which has curative potential for chronic Chagas disease, and expects to complete this trial in the second half of 2025. Chagas is an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. Left untreated, chronic Chagas disease can result in a lifelong infection that silently damages the heart and digestive system, potentially resulting in heart failure, stroke, or sudden death. AN2-502998 is a boron-based small molecule therapeutic candidate with the same mechanism of action (CPSF3) as acoziborole, a related benzoxaborole that demonstrated ~95% cure rate in a Phase 2/3 trial (DNDi/Sanofi) after a single oral dose for human African trypanosomiasis (sleeping sickness), a related disease caused by trypanosome parasites. AN2-502998 is the only compound, of which the Company is aware, to have demonstrated curative activity in non-human primates (NHPs) with long-term, naturally acquired, chronic infection of diverse T. cruzi genetic types. NHPs naturally acquire T. cruzi infection and develop chronic disease comparable to chronic Chagas disease in humans, which the Company believes offers a unique opportunity for de-risking translation to human efficacy versus other experimental infection models. There are no FDA approved treatments for chronic Chagas disease in adults. The Company estimates peak annual sales potential of $1 billion and priority review voucher eligibility, if approved. Melioidosis The Company plans to initiate a Phase 2 study with epetraborole in melioidosis, a potentially lethal bacterial infection caused by Burkholderia pseudomallei and a U.S. national security threat, with a goal of significantly reducing the 3-month mortality rate of ~40% observed in an open-label standard-of-care observational trial expected to report out in the second quarter of 2025. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Non-Tuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus Given the extensive Phase 2/3 efficacy data from the EBO-301 study, the Company plans to use non-dilutive funding to help advance epetraborole development for the treatment of NTM lung disease caused by M. abscessus, where there is a high unmet need for oral drugs vs. the current burdensome intravenous regimens. Epetraborole's oral profile, first-in-class novel mechanism of action (LeuRS), and enabling in vitro and in vivo data, as well as a 256-fold in vitro potency advantage over Mycobacterium avium complex (MAC) in the recent treatment-refractory MAC Phase 3 trial, suggest that epetraborole has the potential to address this high unmet need. There are over 50,000 patients in the U.S., Japan and Europe who could benefit from a novel oral treatment. Boron Chemistry Pipeline The Company is pursuing a number of oncology targets where boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and intellectual property. 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 a proteasome inhibitor (Velcade), CPSF3 (AN2-502998 and acoziborole), and LeuRS (epetraborole, GSK656/AN10070 and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and have excellent oral pharmacokinetics. AN2 anticipates advancing the first oncology compound(s) into development later this year with potential clinical proof of concept within the Company's current cash runway. Global Health The Company will continue its efforts to tackle global health disease through non-dilutive funding, including tuberculosis and malaria, currently being funded by the Gates Foundation. Selected First Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $7.7 million, compared to $14.7 million for the same period during 2024 due to decreased clinical trial expenses, personnel-related expenses, consulting and outside services and other costs, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities, partially offset by increases in preclinical and research study expenses and chemistry manufacturing and controls expenses. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $3.8 million, compared to $3.6 million for the same period during 2024 due to increased professional services expenses, partially offset by decreased consulting and outside services and personnel-related expenses. Interest Income: Interest income for the first quarter of 2025 was $0.9 million, compared to $1.7 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net loss: Net loss for the first quarter of 2025 was $10.6 million, compared to $16.6 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $78.5 million at March 31, 2025. The Company projects that existing cash and cash equivalents under our current plan will sustain operations into 2028, extending from our previous guidance through 2027. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with early-stage programs focused on targets in infectious diseases and oncology. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company's boron chemistry platform; high-impact nature of the Company's clinical programs; the Company's approach to capital allocation and the availability of and plans to use non-dilutive funding; expectations regarding the Company's clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; the ability of non-human primate models to de-risk translation to human efficacy; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2's ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2's clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2's ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidates; the significant uncertainty associated with AN2's product candidates ever receiving any regulatory approvals; continued funding by the National Institute of Allergy and Infectious Disease (NIAID) of AN2's development program for melioidosis; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading 'Risk Factors' in AN2's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2's website at and on the SEC's website at Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) March 31, 2025 (unaudited) December 31, 2024 Assets Current assets: Cash and cash equivalents $ 19,985 $ 21,351 Short-term investments 47,075 62,267 Prepaid expenses and other current assets 2,499 2,644 Long-term investments 11,480 5,021 Other assets, long-term 304 804 Total assets $ 81,343 $ 92,087 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 3,073 $ 3,317 Other current liabilities 4,941 6,921 Total liabilities 8,014 10,238 Stockholders' equity 73,329 81,849 Total liabilities and stockholders' equity $ 81,343 $ 92,087 Expand
