UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2023, AN2 Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2023. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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AN2 Therapeutics, Inc. |
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Date: |
May 11, 2023 |
By: |
/s/ Eric Easom |
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Eric Easom |
Exhibit 99.1
AN2 Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights
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
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.
Company Contacts:
Lucy O. Day
Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge
Investor Relations
abowdidge@an2therapeutics.com
AN2 THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
11,985 |
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$ |
5,633 |
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General and administrative |
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4,054 |
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2,050 |
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Total operating expenses |
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16,039 |
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7,683 |
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Loss from operations |
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(16,039 |
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(7,683 |
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Other income, net |
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716 |
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28 |
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Net loss |
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(15,323 |
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(7,655 |
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Accretion to redemption value and cumulative dividends on preferred stock |
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— |
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(1,820 |
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Net loss attributable to common stockholders |
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$ |
(15,323 |
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$ |
(9,475 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.79 |
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$ |
(2.98 |
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Weighted-average number of shares used in computing net loss per |
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19,385,646 |
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3,180,717 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments |
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199 |
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(131 |
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Comprehensive loss |
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$ |
(15,124 |
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$ |
(7,786 |
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AN2 THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
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March 31, |
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December 31, |
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Assets |
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Cash and cash equivalents |
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$ |
26,709 |
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$ |
27,219 |
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Short-term investments |
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61,806 |
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68,840 |
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Prepaid expenses and other current assets |
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1,801 |
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2,562 |
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Deferred offering costs |
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48 |
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— |
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Long-term investments |
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— |
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3,219 |
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Other assets, long-term |
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720 |
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720 |
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Total assets |
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$ |
91,084 |
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$ |
102,560 |
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Liabilities and stockholders’ equity |
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Accounts payable |
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$ |
3,545 |
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$ |
2,122 |
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Other current liabilities |
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5,021 |
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5,064 |
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Other liabilities, long-term |
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1 |
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2 |
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Total liabilities |
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8,567 |
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7,188 |
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Stockholders’ equity |
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82,517 |
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95,372 |
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Total liabilities and stockholders’ equity |
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$ |
91,084 |
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$ |
102,560 |
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