AN2 Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights
11 Mai 2023 - 10:10PM
Business Wire
- Nearly 80 clinical sites active in pivotal Phase 2/3 trial of
epetraborole in treatment-refractory Mycobacterium avium complex
(MAC) lung disease
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
https://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 EndedMarch 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 (in thousands)
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
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version on businesswire.com: https://www.businesswire.com/news/home/20230510006124/en/
Company Contacts: Lucy O. Day Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge Investor Relations
abowdidge@an2therapeutics.com
AN2 Therapeutics (NASDAQ:ANTX)
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