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:
Securities registered pursuant to Section 12(b) of the Act:
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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 August 10, 2023, AN2 Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 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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Press Release of AN2 Therapeutics Inc. dated August 10, 2023 |
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: |
August 10, 2023 |
By: |
/s/ Eric Easom |
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Eric Easom |
Exhibit 99.1
AN2 Therapeutics Reports Second Quarter 2023 Financial Results and Recent Highlights
Sufficient patients in screening expected to complete enrollment in Phase 2 portion of pivotal Phase 2/3 study of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease
Expected initiation of Phase 3 portion of pivotal Phase 2/3 study in September
Menlo Park, CA – August 10, 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 June 30, 2023.
“We’re pleased with the accelerated pace of enrollment in our pivotal Phase 2/3 study evaluating epetraborole for treatment-refractory MAC lung disease and believe we currently have sufficient patients in screening to initiate Phase 3 next month, immediately after we complete enrollment in the Phase 2 portion of the study. Continued momentum in the Asia-Pacific region coupled with the modifications we made to our clinical trial protocol had a positive impact on study enrollment,” said Eric Easom, Co- Founder, President and Chief Executive Officer. “With over $95 million in cash and cash equivalents, including proceeds from the at-the-market transaction closed during the quarter, we believe we are capitalized through the expected data readout of the Phase 2 portion of our pivotal trial and through the end of 2024. We remain committed to our vision of developing therapeutics to treat rare chronic and serious infectious diseases in areas of high unmet medical need.”
Second 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 over 90 active clinical sites across the U.S., Japan, South Korea, and Australia. AN2 expects to complete enrollment in the Phase 2 portion of the study and to begin Phase 3 in September. The Company expects to announce top-line data from the Phase 2 portion of the study in summer 2024.
Selected Second 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 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; anticipated timing of enrollment in Phase 2 and Phase 3 portions of the Phase 2/3 pivotal trial of epetraborole in treatment-refractory MAC lung disease; anticipated timing of the data readout of the Phase 2 portion of AN2’s pivotal Phase 2/3 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 planned usage and the timing of use of its capital resources; ability of AN2 to expand into other geographies; 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.
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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Six Months Ended |
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2023 |
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2022 |
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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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$ |
13,538 |
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$ |
6,698 |
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$ |
25,523 |
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$ |
12,331 |
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General and administrative |
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3,063 |
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3,635 |
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7,117 |
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5,685 |
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Total operating expenses |
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16,601 |
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10,333 |
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32,640 |
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18,016 |
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Loss from operations |
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(16,601 |
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(10,333 |
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(32,640 |
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(18,016 |
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Other income, net |
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797 |
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213 |
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1,513 |
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241 |
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Net loss |
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(15,804 |
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(10,120 |
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(31,127 |
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(17,775 |
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Accretion to redemption value and cumulative dividends on preferred stock |
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— |
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— |
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— |
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(1,820 |
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Net loss attributable to common stockholders |
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$ |
(15,804 |
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$ |
(10,120 |
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$ |
(31,127 |
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$ |
(19,595 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.81 |
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$ |
(0.53 |
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$ |
(1.60 |
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$ |
(1.74 |
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Weighted-average number of shares used in computing net loss per |
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19,497,494 |
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19,258,066 |
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19,442,010 |
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11,263,804 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments |
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56 |
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(202 |
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255 |
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(333 |
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Comprehensive loss |
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$ |
(15,748 |
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$ |
(10,322 |
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$ |
(30,872 |
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$ |
(18,108 |
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AN2 THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
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June 30, |
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December 31, |
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Assets |
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Cash and cash equivalents |
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$ |
40,812 |
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$ |
27,219 |
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Short-term investments |
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54,446 |
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68,840 |
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Prepaid expenses and other current assets |
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2,948 |
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2,562 |
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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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$ |
98,926 |
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$ |
102,560 |
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Liabilities and stockholders’ equity |
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Accounts payable |
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$ |
3,131 |
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$ |
2,122 |
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Other current liabilities |
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8,030 |
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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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11,162 |
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7,188 |
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Stockholders’ equity |
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87,764 |
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95,372 |
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Total liabilities and stockholders’ equity |
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$ |
98,926 |
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$ |
102,560 |
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