“Our recent decision to advance oral epetraborole into a Phase 2 study for polycythemia vera highlights the growing opportunity across AN2’s boron chemistry pipeline and our commitment to addressing serious, underserved diseases. It also represents one of three proof-of-concept catalysts we believe we are well positioned to achieve in the next two years, including the Phase 2 investigator-initiated trial in M. abscessus complex lung disease and a Phase 2 proof-of-concept study in chronic Chagas disease planned for later this year, pending the outcome of our Phase 1 study,” said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. “Looking ahead, we remain on track to bring two boron-based oncology candidates into development in 2026, further demonstrating the versatility of our platform. I’m proud of the momentum we’re carrying into the year and the continued execution from our team as we work to deliver impactful therapies to patients with urgent unmet needs.”
Fourth Quarter & Recent Business Updates:
Polycythemia Vera
M. abscessus Complex Lung Disease
Chagas Disease
Boron Chemistry Pipeline
Global Health
Selected Fourth Quarter Financial Results
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to initiate in 2026, two preclinical candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential, growing opportunity, and competitive advantage of the Company’s boron chemistry platform; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct, sites, leadership, the timing of data and related announcements, and regulatory proceedings; market size and sales potential; the predictivity of efficacy data; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs and the availability of funding; 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 and investigator-initiated 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 government funding 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 www.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.
| AN2 THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
|
|
| Three Months Ended |
| Year Ended | ||||||||||||
|
|
|
| 2025 |
|
|
| 2024 |
|
|
| 2025 |
|
|
| 2024 |
|
| Operating expenses: |
|
|
|
|
|
|
|
| ||||||||
| Research and development |
| 6,879 |
|
| 5,397 |
|
| 24,769 |
|
| 40,488 |
| ||||
| General and administrative |
|
| 2,437 |
|
|
| 3,210 |
|
|
| 13,340 |
|
|
| 14,066 |
|
| Restructuring charge |
|
| — |
|
|
| (9 |
|
| — |
|
|
| 2,234 |
| |
| Total operating expenses |
|
| 9,316 |
|
|
| 8,598 |
|
|
| 38,109 |
|
|
| 56,788 |
|
| Loss from operations |
|
| (9,316 |
|
| (8,598 |
|
| (38,109 |
|
| (56,788 | ||||
| Interest income |
|
| 605 |
|
|
| 1,076 |
|
|
| 2,934 |
|
|
| 5,466 |
|
| Other income |
|
| 1 |
|
|
| — |
|
|
| 1 |
|
|
| 1 |
|
| Net loss attributable to common stockholders |
| (8,710 |
| (7,522 |
| (35,174 |
| (51,321 | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted |
| (0.29 |
| (0.25 |
| (1.16 |
| (1.72 | ||||||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
| 30,356,776 |
|
|
| 29,882,993 |
|
|
| 30,215,747 |
|
|
| 29,828,227 |
|
| Other comprehensive loss: |
|
|
|
|
|
|
|
| ||||||||
| Unrealized (loss) gain on investments |
|
| (7 |
|
| (81 |
|
| 26 |
|
|
| (244 | |||
| Comprehensive loss |
| (8,717 |
| (7,603 |
| (35,148 |
| (51,565 | ||||||||
| AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) | ||||||
|
|
| December 31, |
| December 31, | ||
| Assets |
|
|
|
| ||
| Current assets: |
|
|
|
| ||
| Cash and cash equivalents |
| 19,941 |
| 21,351 | ||
| Short-term investments |
|
| 38,060 |
|
| 62,267 |
| Prepaid expenses and other current assets |
|
| 1,936 |
|
| 2,644 |
| Long-term investments |
|
| 2,013 |
|
| 5,021 |
| Other assets, long-term |
|
| — |
|
| 804 |
| Total assets |
| 61,950 |
| 92,087 | ||
|
|
|
|
|
| ||
| Liabilities and stockholders’ equity |
|
|
|
| ||
| Current liabilities: |
|
|
|
| ||
| Accounts payable |
| 3,021 |
| 3,317 | ||
| Other current liabilities |
|
| 5,699 |
|
| 6,921 |
| Total current liabilities |
|
| 8,720 |
|
| 10,238 |
| Other non-current liabilities |
|
| 170 |
|
| — |
| Total liabilities |
|
| 8,890 |
|
| 10,238 |
| Stockholders’ equity |
|
| 53,060 |
|
| 81,849 |
| Total liabilities and stockholders’ equity |
| 61,950 |
| 92,087 | ||
View source version on businesswire.com: https://www.businesswire.com/news/home/20260317440715/en/
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