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AN2 Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights • Nearly 80 clinical sites active in pivotal Phase 2/3 trial of epetraborole in treatment-refractory Mycobacterium avium complex

Key Takeaway: AN2 Therapeutics reported its first quarter 2023 financial results, highlighting nearly 80 clinical sites active in a pivotal Phase 2/3 trial for epetraborole, aimed at treating treatment-refractory Mycobacterium avium complex lung disease. The company is seeing promising momentum in Asia-Pacific regions, particularly in Japan, South Korea, and Australia. Despite a significant net loss of $15.3 million for the quarter, they maintain a robust cash position of $88.5 million, expected to sustain operations through mid-2024. The company aims to complete enrollment in the Phase 2 portion of the trial by mid-2023, with the Phase 3 trial to follow immediately after.

Market Sentiment Analysis

POSITIVE FACTORS

  • AN2 Therapeutics has nearly 80 clinical sites active in its pivotal Phase 2/3 trial.
  • Epetraborole is a once-daily, oral treatment that may significantly benefit patients.
  • The company has a sufficient cash position of $88.5 million to fund operations through mid-2024.

CONCERNS & RISKS

  • Net loss for Q1 2023 was $15.3 million, increasing from $7.7 million in the previous year.
  • Research and development expenses increased significantly compared to the prior year.
  • Uncertainties exist regarding enrollment progress and potential regulatory approval for epetraborole.

Full Press Release Details

AN2 Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights
-Nearly 80 clinical sites active in pivotal Phase 2/3 trial of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease
Menlo Park, CA May 11, 2023 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 reported financial results for the quarter ended March 31, 2023.
In the first quarter we continued to advance our pivotal Phase 2/3 trial evaluating epetraborole for treatment-refractory MAC lung disease with a total of nearly 80 clinical sites active worldwide. We are pleased with the momentum we're seeing in the Asia-Pacific region, particularly at new sites in Japan, South Korea and Australia, said Eric Easom, Co-Founder, President and Chief Executive Officer. MAC lung disease, the most common form of nontuberculous mycobacteria, or NTM, lung disease, is a rare, chronic, and progressive disease which leads to irreversible lung disease and can be fatal. We believe epetraborole, as a once-daily, oral treatment with a novel mechanism of action, has the potential to provide significant benefit to patients that are in need of new treatment options.
First Quarter & Recent Business Updates:
Advanced Epetraborole Pivotal Phase 2/3 Clinical Study.
The Company is currently enrolling its Phase 2/3 pivotal trial evaluating once-daily, oral epetraborole for treatment-refractory MAC lung disease at nearly 80 clinical sites. AN2 expects to complete enrollment in the Phase 2 portion of the pivotal Phase 2/3 clinical trial in approximately mid-2023 and plans to seamlessly begin enrollment of the Phase 3 portion of the trial immediately thereafter. The Company expects to announce top-line data for each of the Phase 2 and Phase 3 portions of the trial approximately nine months after the completion of enrollment in each respective portion of the trial.
Selected First Quarter Financial Results
-Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2023, were $12.0 million, compared to $5.6 million in the prior year. R&D expenses increased when compared to the same period during 2022 due to increased personnel-related expenses, costs related to chemistry manufacturing and controls, research studies and outside services and consulting expenses, partially offset by lower clinical trials costs. Phase 2/3 clinical trial expenses increased in the first quarter of 2023, but not to the extent of the higher costs of three Phase 1 clinical trials conducted in the first quarter of 2022.
-General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2023, were $4.1 million, compared to $2.1 million in the prior year. G&A expenses increased when compared to the same period during 2022 due to increased personnel-related costs, insurance and other expenses, professional services, and consulting and outside services to support the Company's ongoing operations.
-Other Income, Net: Other income, net was $0.8 million for the three months ended March 31, 2023, compared to $0.03 million in the prior year.
-Net Loss: Net loss was $15.3 million for the three months ended March 31, 2023, compared to $7.7 million in the prior year.
-Cash Position: Cash, cash equivalents and investments totaled $88.5 million at March 31, 2023, which the company expects will be sufficient to fund its operating expenses through mid-2024.
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 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; AN2's estimated cash runway and the timing of use of its capital resources; 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: macroeconomic conditions; AN2's ability to progress enrollment in its Phase 2/3 pivotal clinical trial of epetraborole; timely enrollment of patients in its current 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; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 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.
Chief Financial Officer
AN2 THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Three Months Ended March 31,
2023 2022
Operating expenses:
Research and development $ 11,985 $ 5,633
General and administrative 4,054 2,050
Total operating expenses 16,039 7,683
Loss from operations (16,039 ) (7,683 )
Other income, net 716 28
Net loss (15,323 ) (7,655 )
Accretion to redemption value and cumulative dividends on preferred stock (1,820 )
Net loss attributable to common stockholders $ (15,323 ) $ (9,475 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.79 ) $ (2.98 )
Weighted-average number of shares used in computing net loss per share, basic and diluted 19,385,646 3,180,717
Other comprehensive loss:
Unrealized gain (loss) on investments 199 (131 )
Comprehensive loss $ (15,124 ) $ (7,786 )
AN2 THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
March 31, 2023 (unaudited) December 31, 2022
Assets
Cash and cash equivalents $ 26,709 $ 27,219
Short-term investments 61,806 68,840
Prepaid expenses and other current assets 1,801 2,562
Deferred offering costs 48
Long-term investments 3,219
Other assets, long-term 720 720
Total assets $ 91,084 $ 102,560
Liabilities and stockholders' equity
Accounts payable $ 3,545 $ 2,122
Other current liabilities 5,021 5,064
Other liabilities, long-term 1 2
Total liabilities 8,567 7,188
Stockholders' equity 82,517 95,372
Total liabilities and stockholders' equity $ 91,084 $ 102,560

Frequently Asked Questions

What is AN2 Therapeutics focusing on?

AN2 Therapeutics is focused on developing treatments for rare, chronic infectious diseases.

What trial is AN2 currently conducting?

AN2 is conducting a pivotal Phase 2/3 trial of epetraborole for MAC lung disease.

How many sites are involved in the clinical trial?

Nearly 80 clinical sites are currently active in the trial worldwide.

What were AN2's net losses in Q1 2023?

AN2 reported net losses of $15.3 million for the first quarter of 2023.

What is AN2's cash position as of March 2023?

As of March 31, 2023, AN2 has $88.5 million in cash and investments.

Last updated: May 11, 2023