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
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
- Research and Development (R&D) Expenses: R&D
expenses increased for the three months ended June 30, 2023,
compared to the same period during 2022 due to increased clinical
trial expenses, personnel-related expenses, chemistry manufacturing
and controls costs and other expenses, partially offset by lower
preclinical and research study expenses.
- General and Administrative (G&A) Expenses: G&A
expenses decreased for the three months ended June 30, 2023,
compared to the same period during 2022 due to a decrease in
insurance costs and professional service fees.
- Other Income, Net: Other income, net was $0.8 million
for the three months ended June 30, 2023, compared to $0.2 million
in the prior year.
- Net loss: Net loss was $15.8 million for the three
months ended June 30, 2023, compared to $10.1 million in the prior
year.
- Cash Position: On June 26, 2023, the Company sold an
aggregate of 2,502,000 shares of the Company’s common stock at a
purchase price of $8.00 per share under its existing at-the-market
offering. This resulted in aggregate gross proceeds to the Company
of approximately $20 million. The Company expects that current
cash, cash equivalents and investments of $95.3 million at June 30,
2023, will be sufficient to fund its operating expenses through the
expected data readout of the Phase 2 portion of its pivotal Phase
2/3 trial in treatment-refractory MAC lung disease and through the
end of 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 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.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Operating expenses: Research and development
$
13,538
$
6,698
$
25,523
$
12,331
General and administrative
3,063
3,635
7,117
5,685
Total operating expenses
16,601
10,333
32,640
18,016
Loss from operations
(16,601
)
(10,333
)
(32,640
)
(18,016
)
Other income, net
797
213
1,513
241
Net loss
(15,804
)
(10,120
)
(31,127
)
(17,775
)
Accretion to redemption value and cumulative dividends on preferred
stock
-
-
-
(1,820
)
Net loss attributable to common stockholders
$
(15,804
)
$
(10,120
)
$
(31,127
)
$
(19,595
)
Net loss per share attributable to common stockholders, basic and
diluted
$
(0.81
)
$
(0.53
)
$
(1.60
)
$
(1.74
)
Weighted-average number of shares used in computing net loss per
share, basic and diluted
19,497,494
19,258,066
19,442,010
11,263,804
Other comprehensive loss: Unrealized gain (loss) on investments
56
(202
)
255
(333
)
Comprehensive loss
$
(15,748
)
$
(10,322
)
$
(30,872
)
$
(18,108
)
AN2 THERAPEUTICS, INC. CONDENSED BALANCE
SHEETS (in thousands)
June 30,
2023
(unaudited)
December
31,
2022
Assets Cash and cash equivalents
$
40,812
$
27,219
Short-term investments
54,446
68,840
Prepaid expenses and other current assets
2,948
2,562
Long-term investments
-
3,219
Other assets, long-term
720
720
Total assets
$
98,926
$
102,560
Liabilities and stockholders' equity Accounts payable
$
3,131
$
2,122
Other current liabilities
8,030
5,064
Other liabilities, long-term
1
2
Total liabilities
11,162
7,188
Stockholders' equity
87,764
95,372
Total liabilities and stockholders' equity
$
98,926
$
102,560
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230810314462/en/
Lucy O. Day Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge Investor Relations
abowdidge@an2therapeutics.com
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