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
September 30, 2022.
“Chronic lung infections, such as Mycobacterium
avium complex (MAC) lung disease, are debilitating and can be
fatal. AN2 Therapeutics is committed to developing more effective
solutions for patients and healthcare providers that are seeking
new treatment options. Over the past several months we’ve continued
to advance our epetraborole development strategy. Enrollment is
ongoing in our pivotal Phase 2/3 clinical trial in
treatment-refractory (MAC) lung disease, and we’ve taken important
steps to include Japanese patients in the pivotal trial based on
data from our recent Phase 1 trial conducted in Japanese subjects,
which supports the use of a single 500-mg daily oral dose of
epetraborole and validated data from previous studies. Also, new
data recently presented at IDWeek further validates the potential
of epetraborole,” said Eric Easom, Co-Founder, President and Chief
Executive Officer. “Finally, the recent decision by the National
Institutes of Allergy and Infectious Diseases (NIAID) to award AN2
Therapeutics a contract for the development of epetraborole in
acute systemic melioidosis, an infectious disease with unacceptably
high mortality that also poses a serious biothreat, underscores the
potential of epetraborole, which has shown significant promise
across preclinical models of infection. We will continue to explore
the utility of epetraborole in areas with urgent unmet global
health needs that will allow us to capture synergies with our
existing epetraborole program.”
Third Quarter & Recent Business
Updates:
Advanced Epetraborole Clinical
Development. Enrollment is ongoing in the Company’s
pivotal Phase 2/3 clinical trial evaluating once-daily, oral
epetraborole for treatment-refractory MAC lung disease, the most
common form of nontuberculous mycobacterial (NTM) lung disease. The
Company expects to complete enrollment in the Phase 2 part of the
pivotal Phase 2/3 clinical trial in mid-2023 and plans to
seamlessly begin enrollment of the Phase 3 portion of the trial
immediately thereafter. We expect 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.
Announced Epetraborole Data from Phase 1
Study in Japanese Subjects that Supports Use of Once-Daily 500 mg
Dose in Japanese Patients. In October, the Company
announced results from a Phase 1 study designed to evaluate the
pharmacokinetics, safety, and tolerability of oral epetraborole
administered as a single 500 mg dose to healthy Japanese volunteers
with different alcohol dehydrogenase (ADH) genotypes. Results of
the study showed that no subjects experienced treatment-emergent
adverse events and support use of AN2’s recommended dose in
Japanese patients enrolled in its ongoing pivotal Phase 2/3
clinical trial, regardless of ADH genotype.
Received Orphan Medicinal Product
Designation for Epetraborole in the European Union. In
August, the Company received the orphan medicinal product
designation for epetraborole in NTM lung disease from the European
Commission.
Presented New Epetraborole Data at
Infectious Disease Society of America (IDSA) IDWeek 2022
Conference. In October, AN2 presented nine poster
presentations and one oral presentation that advance the
understanding of epetraborole in NTM lung disease.
Awarded Contract by National Institute
of Allergy and Infectious Diseases (NIAID) to Advance Development
of Epetraborole for Acute Systemic Melioidosis. In
September, AN2 announced the award of a contract valued up to $17.8
million from the NIAID, part of the National Institutes of Health
(NIH), to advance the development of epetraborole for acute
systemic melioidosis and other biothreat pathogens.
Strengthened Senior Leadership
Team. In September, Joshua M. Eizen was appointed Chief
Legal Officer and Secretary. Mr. Eizen brings significant industry
experience to AN2, including as counsel to Jazz Pharmaceuticals, GW
Pharmaceuticals and the U.S. Food and Drug Administration.
Financial Results for Third Quarter
2022:
- Research and Development (R&D) Expenses:
R&D expenses increased for the three months ended
September 30, 2022, compared to the same period during 2021
due to a related party license fee associated with dosing of the
first patient in our pivotal Phase 2/3 clinical trial, increased
clinical trial activity, additional R&D personnel and related
expenses, and increased outside services and consultant costs.
These increases were partially offset by lower outside research and
toxicology study costs related to our development activities.
- General and Administrative (G&A) Expenses:
G&A expenses increased for the three months ended
September 30, 2022, compared to the same period during 2021
due to additional G&A personnel and related expenses, increased
insurance and other expenses, and increased outside legal and
consulting services costs as we conducted business as a public
company. These increases were partially offset by lower accounting
professional fees compared to 2021 fees related to preparation for
AN2’s Initial Public Offering.
- Cash Position: Cash, cash equivalents and
investments totaled $106.4 million on September 30, 2022. The
Company expects that current cash, cash equivalents and investments
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 lead
candidate is epetraborole, which we are studying in a pivotal Phase
2/3 clinical trial 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: AN2's anticipated progress, business plans, business
strategy and planned clinical trials; the timing of anticipated
results from AN2's pivotal Phase 2/3 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
geographies; 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 and
macro-economic conditions; AN2's ability to continue enrollment in
its pivotal Phase 2/3 clinical trial of epetraborole and the
ability to enable epetraborole development in Japan; the ability of
AN2 to effectively and timely make amendments to the pivotal Phase
2/3 clinical 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 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
September 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.
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
amounts) (unaudited)
|
|
Three Months Ended September
30, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
7,428 |
|
|
$ |
5,345 |
|
Research and development—related party |
|
|
1,000 |
|
|
|
— |
|
General and administrative |
|
|
3,342 |
|
|
|
1,587 |
|
Total operating expenses |
|
|
11,770 |
|
|
|
6,932 |
|
Loss from operations |
|
|
(11,770 |
) |
|
|
(6,932 |
) |
Interest income |
|
|
466 |
|
|
|
25 |
|
Other expense |
|
|
(35 |
) |
|
|
(36 |
) |
Net loss |
|
|
(11,339 |
) |
|
|
(6,943 |
) |
Accretion to redemption value and cumulative dividends on preferred
stock |
|
|
— |
|
|
|
(1,925 |
) |
Net loss attributable to common stockholders |
|
$ |
(11,339 |
) |
|
$ |
(8,868 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.59 |
) |
|
$ |
(3.35 |
) |
Weighted-average number of shares used in computing net loss per
share, basic and diluted |
|
|
19,347,148 |
|
|
|
2,643,879 |
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on investments |
|
|
(181 |
) |
|
|
(3 |
) |
Comprehensive loss |
|
$ |
(11,520 |
) |
|
$ |
(6,946 |
) |
AN2 THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS (in
thousands)
|
|
September 30, 2022
(unaudited) |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
28,802 |
|
|
$ |
12,097 |
|
Short-term investments |
|
|
75,580 |
|
|
|
46,458 |
|
Prepaid expenses and other current assets |
|
|
2,914 |
|
|
|
1,551 |
|
Deferred offering costs |
|
|
— |
|
|
|
1,724 |
|
Long-term investments |
|
|
1,992 |
|
|
|
3,486 |
|
Other assets, long-term |
|
|
720 |
|
|
|
— |
|
Total assets |
|
$ |
110,008 |
|
|
$ |
65,316 |
|
|
|
|
|
|
|
|
Liabilities, redeemable convertible preferred stock, and
stockholders’ equity
(deficit) |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,440 |
|
|
$ |
1,063 |
|
Other current liabilities |
|
|
2,992 |
|
|
|
2,332 |
|
Other liabilities, long-term |
|
|
3 |
|
|
|
13 |
|
Total liabilities |
|
|
4,435 |
|
|
|
3,408 |
|
Redeemable convertible preferred stock |
|
|
— |
|
|
|
109,319 |
|
Stockholders’ equity (deficit) |
|
|
105,573 |
|
|
|
(47,411 |
) |
Total liabilities, redeemable convertible preferred stock, and
stockholders’ equity (deficit) |
|
$ |
110,008 |
|
|
$ |
65,316 |
|
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