• Enrollment Ongoing in Phase 3 Part of 2/3 Pivotal Trial of Epetraborole in Treatment-Refractory Mycobacterium avium complex (MAC) Lung Disease

MENLO PARK, Calif. / Oct 11, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced two oral presentations and three poster presentations at the Infectious Disease Society of America (IDSA) IDWeek 2023 Conference from October 11-15, 2023 in Boston, Massachusetts. AN2 Therapeutics is currently enrolling patients in the Phase 3 part of its pivotal Phase 2/3 clinical trial evaluating once-daily, oral epetraborole for treatment-refractory Mycobacterium avium complex (MAC) lung disease.

“We are excited to showcase our latest data at IDWeek 2023. These results highlight epetraborole’s potent nonclinical activity against MAC isolates, as well as M. abscessus, another difficult-to-treat NTM pathogen. Additionally, epetraborole demonstrated favorable pharmacokinetics at the current dose in patients with various degrees of renal impairment and in Japanese subjects with different alcohol dehydrogenase genotypes, which further supports our dosing strategy in patients with treatment-refractory MAC lung disease,” said Paul Eckburg, M.D., Chief Medical Officer of AN2 Therapeutics. “These data, combined with results from our ongoing pivotal Phase 2/3 study — which is currently enrolling participants in the Phase 3 portion — are expected to provide the basis for regulatory filings for approval in the U.S. and Japan. We are enthusiastic about the progress we have achieved so far and look forward to advancing our mission to develop a novel therapy for patients with treatment-refractory MAC lung disease."

Oral presentations pertaining to epetraborole:

Title: Epetraborole: A Novel Antibiotic for NTM Lung Disease & Melioidosis
Session: New Antimicrobials in the Pipeline Part 1
Date: Thursday, October 12, 2023
Time: 8:48 AM – 9:00 AM ET
Room: 104ABC
Presentation # 32

Title: In Vitro Susceptibility of Recent Mycobacterium abscessus Isolates to Epetraborole (EBO) and Comparators by Broth Microdilution
Session: Experimental Therapeutics
Date: Saturday, October 14, 2023
Time: 10:54 AM – 11:06 AM ET
Location: 102AB
Presentation # 2064

Poster presentations pertaining to epetraborole:

Title: A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function
Session: Antimicrobial Novel Agents
Date: Saturday, October 14, 2023
Time: 12:15 PM - 1:30 PM ET
Location: Hall B&C
Presentation # 2144

Title: A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics (PK), Safety, and Tolerability of Epetraborole Tablets and the Impact of Alcohol Dehydrogenase (ADH) Genotype on the PK of Epetraborole and Metabolite M3 in Healthy Japanese Adult Subjects
Session: PK/PD Studies
Date: Saturday, October 14, 2023
Time: 12:15 PM - 1:30 PM ET
Location: Hall B&C
Presentation # 2556

Title: Epetraborole in vitro Activity Against Mycobacterium avium complex Recent Clinical Isolates from Japan
Session: Antimicrobial Novel Agents
Date: Saturday, October 14, 2023
Time: 12:15 PM - 1:30 PM ET
Location: Hall B&C
Presentation # 2135

About AN2 Therapeutics, Inc.

AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at www.an2therapeutics.com.

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 timing, progress, and anticipated results from AN2's Phase 2/3 pivotal clinical trial; AN2's anticipated progress, business plans, business strategy and planned clinical trials; the potential clinical benefits and therapeutic potential of epetraborole; 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: the continuing effects of the COVID-19 pandemic; macroeconomic conditions; AN2's ability to progress enrollment in its Phase 2/3 pivotal clinical trial of epetraborole; the ability of AN2 to effectively and timely make amendments to the Phase 2/3 pivotal trial design pursuant to additional FDA feedback; timely enrollment of patients in its current and future clinical trials; AN2's ability to procure sufficient supply of its product candidate for its existing and future 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 candidate; the significant uncertainty associated with AN2's product candidate ever receiving any regulatory approvals; 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 current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in AN2's reports to be filed with the SEC, including AN2’s Report on Form 10-Q for the quarter ended June 30, 2023. These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at www.sec.gov. 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.