AN2 Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates
12 August 2022 - 6:10AM
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, 2022.
“We’ve made significant strides with the epetraborole clinical
program, initiating the pivotal Phase 2/3 trial in
treatment-refractory MAC lung disease in the U.S., and completing
enrollment in a Phase 1 study in healthy volunteers in Japan.
Furthermore, we recently gained alignment with the PMDA on the
registrational path in Japan, including the use of a
microbiological endpoint as the basis for potential approval. As a
result, the company is planning to include Japanese patients in our
ongoing pivotal Phase 2/3 trial,” said Eric Easom, President and
Chief Executive Officer. "Initiating the pivotal study for
epetraborole in the U.S. and paving the way to add Japanese
patients to the study is an important milestone for AN2 and
patients suffering from NTM lung disease. With the highest
incidence of NTM globally, Japan is an important part of our
epetraborole strategy.”
Second Quarter & Recent Business
Updates:
Initiated Pivotal Phase 2/3 Trial for
Epetraborole in Treatment-Refractory MAC Lung Disease. In
June 2022, AN2 Therapeutics reported that it screened its first
patient in its pivotal Phase 2/3 clinical trial evaluating
once-daily, oral epetraborole for treatment-refractory
Mycobacterium avium complex (MAC) lung disease, the most common
form of nontuberculous mycobacterial (NTM) lung disease.
Expanded Company’s Board of
Directors. During the second quarter of 2022, AN2
Therapeutics announced that Maggie FitzPatrick, a corporate
affairs, communications and business operations leader, was
appointed to its Board of Directors. Ms. FitzPatrick previously
served as Global Chief Communications Officer and led public
affairs at Johnson & Johnson.
Advancing Epetraborole Clinical
Development. AN2 Therapeutics has completed enrollment in
the Phase 1 safety and pharmacokinetics (PK) study of oral
epetraborole in healthy volunteers in Japan. The
Company recently met with the Japanese Pharmaceutical and Medical
Devices Agency (PMDA) and gained alignment on the use of a
microbiological primary endpoint to support potential registration
in Japan. The Company is planning to include Japanese patients in
the EBO-301 pivotal Phase 2/3 clinical trial and expects that data
from the ongoing pivotal Phase 2/3 clinical trial of oral
epetraborole for treatment-refractory MAC lung disease, if
positive, will serve as the basis for the application for marketing
approval in Japan.
Financial Results for Second Quarter
2022:
- Research
and Development (R&D) Expenses: R&D expenses
increased for the three months ended June 30, 2022, compared
to the same period during 2021 due to higher clinical trial
activity, additional R&D personnel and related expenses,
increased outside consultant costs and research studies related to
our research and development activities. These increases were
partially offset by lower clinical manufacturing costs for our
clinical trials and lower related party license fees.
- General and
Administrative (G&A) Expenses: G&A expenses
increased for the three months ended June 30, 2022, compared
to the same period during 2021 due to additional G&A personnel
and related expenses, higher outside legal and accounting
professional service costs and increased consulting services, as we
expanded our post-initial public offering (IPO) activities.
- Cash
Position: Cash, cash equivalents and investments totaled
$115.8 million on June 30, 2022. The Company expects that
current cash, cash equivalents and investments, including net
proceeds from the underwriters’ IPO over-allotment option exercised
in April, 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. AN2 is
developing epetraborole, a once-daily oral treatment 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: AN2's anticipated progress, business plans, business
strategy and planned clinical trials; the timing of anticipated
results from AN2's recently initiated Phase 2/3 pivotal clinical
trial; the potential clinical benefits and therapeutic potential of
epetraborole; AN2's estimated cash runway and the timing of use of
its capital resources; the timing of initial data from AN2's
research and development programs; ability of AN2 to expand into
other markets and initiate clinical trials in other jurisdictions;
and other statements that are not historical fact. These statements
are based on AN2's current plans, objectives, estimates,
expectations 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 effects of the evolving COVID-19 pandemic; AN2's ability to
continue enrollment in its Phase 2/3 pivotal clinical trial of
epetraborole and the ability to enable epetraborole development in
Japan, the anticipated timing of development in Japan or at all;
the ability of AN2 to effectively and timely make amendments to the
Phase 2/3 pivotal trial design pursuant to additional FDA feedback;
initiation of planned clinical trials and enrollment of patients in
its future clinical trials; AN2's ability to procure sufficient
supply of its product candidate for its future clinical trials; the
preclinical profiles of AN2's product candidate not translating in
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
prospectus filed with the U.S. Securities and Exchange Commission
(SEC) on March 24, 2022 and in AN2's reports to be filed with the
SEC, including AN2’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022. 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.
AN2 THERAPEUTICS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except share and
per share amounts)(unaudited)
|
|
Three Months EndedJune 30, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
6,698 |
|
|
$ |
3,850 |
|
Research and development - related party |
|
|
— |
|
|
|
250 |
|
General and administrative |
|
|
3,635 |
|
|
|
898 |
|
Total operating expenses |
|
|
10,333 |
|
|
|
4,998 |
|
Loss from operations |
|
|
(10,333 |
) |
|
|
(4,998 |
) |
Interest income |
|
|
228 |
|
|
|
15 |
|
Other expense |
|
|
(15 |
) |
|
|
(24 |
) |
Net loss |
|
|
(10,120 |
) |
|
|
(5,007 |
) |
Accretion to redemption value and
cumulative dividends on preferred stock |
|
|
— |
|
|
|
(1,904 |
) |
Net loss attributable to common
stockholders |
|
$ |
(10,120 |
) |
|
$ |
(6,911 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.53 |
) |
|
$ |
(2.62 |
) |
Weighted-average number of shares
used in computing net loss per share, basic and diluted |
|
|
19,258,066 |
|
|
|
2,633,954 |
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on
investments |
|
|
(202 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(10,322 |
) |
|
$ |
(5,007 |
) |
AN2 THERAPEUTICS,
INC.CONDENSED BALANCE SHEETS(in
thousands)
|
|
June
30,2022(unaudited) |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
40,616 |
|
|
$ |
12,097 |
|
Short-term investments |
|
|
72,773 |
|
|
|
46,458 |
|
Prepaid expenses and other current assets |
|
|
3,488 |
|
|
|
1,551 |
|
Deferred offering costs |
|
|
— |
|
|
|
1,724 |
|
Long-term investments |
|
|
2,419 |
|
|
|
3,486 |
|
Other assets, long-term |
|
|
720 |
|
|
|
— |
|
Total assets |
|
$ |
120,016 |
|
|
$ |
65,316 |
|
|
|
|
|
|
|
|
Liabilities, redeemable
convertible preferred stock, and stockholders’
equity (deficit) |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,612 |
|
|
$ |
1,063 |
|
Other current liabilities |
|
|
2,537 |
|
|
|
2,332 |
|
Other liabilities, long-term |
|
|
4 |
|
|
|
13 |
|
Total liabilities |
|
|
4,153 |
|
|
|
3,408 |
|
Redeemable convertible preferred stock |
|
|
— |
|
|
|
109,319 |
|
Stockholders’ equity (deficit) |
|
|
115,863 |
|
|
|
(47,411 |
) |
Total liabilities, redeemable convertible preferred stock, and
stockholders’ equity |
|
$ |
120,016 |
|
|
$ |
65,316 |
|
Company Contacts:
Lucy O. Day
Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge
Investor Relations
abowdidge@an2therapeutics.com
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