AN2 Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Highlights
AN2 Therapeutics, Inc. (Nasdaq: ANTX) recently reported its financial results for 2022, marking a transformative year as the company transitioned to public status. The pivotal Phase 2/3 trial for epetraborole, targeting treatment-refractory Mycobacterium avium complex (MAC) lung disease, is currently progressing with nearly 60 clinical sites globally, including newly opened sites in Japan, South Korea, and Australia. The company received significant funding of up to $17.8M for developing epetraborole against melioidosis. In 2022, R&D expenses increased to $29.5M, while the net loss reached $41M. AN2's cash reserves are projected to last through mid-2024, supporting ongoing clinical efforts.
- Received up to $17.8M in non-dilutive funding for melioidosis development.
- Phase 2/3 trial for epetraborole is nearing completion with global site expansion.
- Regulatory designations from FDA and EU enhance market access prospects.
- R&D expenses increased significantly to $29.5 million from $16.9 million.
- Net loss of $41 million for the year raises concerns about financial sustainability.
- Approaching 60 clinical sites participating in pivotal Phase 2/3 trial of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease to date
-
Opened up sites in three additional countries --
Japan ,South Korea , andAustralia in addition to theU.S. ;Japan has some of the highest rates of MAC lung disease in the world - Activities underway to advance development of epetraborole for acute systemic melioidosis using non-dilutive funding
“2022 was a transformative year for AN2 as we transitioned from a private company into a public company and initiated a single pivotal Phase 2/3 clinical trial, EBO-301, for epetraborole in treatment-refractory MAC lung disease. We continued to generate data that support the potential of epetraborole to meet an ideal target product profile for NTM lung disease caused by MAC. Importantly, based on discussions with FDA and the
Highlighting the company’s commitment to global health using non-dilutive funding, AN2 was awarded a contract in the third quarter of 2022 valued up to
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. We expect to complete enrollment in the Phase 2 portion of the pivotal Phase 2/3 clinical trial in mid-2023 and plan 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.
In 2022, the FDA granted epetraborole Fast Track designation for treatment-refractory MAC lung disease, Qualified Infectious Disease Product designation for treatment-refractory MAC lung disease, and orphan-drug designation for the treatment of infections caused by NTM.
Announced Epetraborole Data from Phase 1 Study in Japanese Subjects that Supports Use of
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. The study showed that epetraborole was well tolerated at this dosage and supports use in Japanese patients enrolled in the ongoing Phase 2/3 pivotal trial.
Presented New Epetraborole Data at the
In October, the Company presented one oral presentation and nine data poster presentations at the
Granted Orphan Medicinal Product Designation in NTM Lung Disease in
In October, the Company announced that it received the orphan medicinal product designation for epetraborole in NTM lung disease from the
Selected Fourth Quarter and Full Year 2022 Financial Results
-
Research and Development (R&D) Expenses: R&D expenses for the full year 2022 were
, compared to$29.5 million in the prior year. R&D expenses for the fourth quarter of 2022 were$16.9 million , compared to$8.7 million for the same period last year.$5.8 million -
General and Administrative (G&A) Expenses: G&A expenses for the full year 2022 were
, compared to$12.8 million in the prior year. General and administrative expenses for the fourth quarter of 2022 were$4.7 million , compared to$3.7 million for the same period last year. Most of the increase is attributable to being a publicly-traded company.$1.8 million -
Interest and Other Income: Interest and other income, net for the full year 2022 was
, compared to$1.3 million in the prior year. Interest and other income, net for the fourth quarter of 2022 was$0.03 million , compared to$0.6 million for the fourth quarter of 2021.$0.05 million -
Net loss: For the three months and full year ended
December 31, 2022 net loss was and$11.8 million , respectively.$41.0 million -
Cash Position: Cash, cash equivalents and investments totaled
at$99.3 million December 31, 2022 , which the company expects will be sufficient to fund its operating expenses through mid-2024.
About
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; 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; macro-economic 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
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended
|
|
Year Ended
|
||||||||||||||
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
||
Operating expenses: | ||||||||||||||||
Research and development | $ |
8,752 |
|
$ |
5,312 |
|
$ |
28,511 |
|
$ |
16,156 |
|
||||
Research and development - related party |
|
- |
|
|
500 |
|
|
1,000 |
|
|
750 |
|
||||
General and administrative |
|
3,724 |
|
|
1,782 |
|
|
12,751 |
|
|
4,668 |
|
||||
Total operating expenses |
|
12,476 |
|
|
7,594 |
|
|
42,262 |
|
|
21,574 |
|
||||
Loss from operations |
|
(12,476 |
) |
|
(7,594 |
) |
|
(42,262 |
) |
|
(21,574 |
) |
||||
Interest income |
|
630 |
|
|
27 |
|
|
1,351 |
|
|
69 |
|
||||
Other income (expense) |
|
4 |
|
|
22 |
|
|
(45 |
) |
|
(38 |
) |
||||
Net loss |
|
(11,842 |
) |
|
(7,545 |
) |
|
(40,956 |
) |
|
(21,543 |
) |
||||
Accretion to redemption value and cumulative dividends on preferred stock |
|
- |
|
|
(1,925 |
) |
|
(1,820 |
) |
|
(6,515 |
) |
||||
Net loss attributable to common stockholders | $ |
(11,842 |
) |
$ |
(9,470 |
) |
$ |
(42,776 |
) |
$ |
(28,058 |
) |
||||
Net loss per share attributable to common stockholders, basic and diluted | $ |
(0.61 |
) |
$ |
(3.57 |
) |
$ |
(2.79 |
) |
$ |
(10.64 |
) |
||||
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
19,352,854 |
|
|
2,653,858 |
|
|
15,340,134 |
|
|
2,638,197 |
|
||||
Other comprehensive loss: | ||||||||||||||||
Unrealized (gain) loss on investments |
|
167 |
|
|
(24 |
) |
|
(347 |
) |
|
(27 |
) |
||||
Comprehensive loss | $ |
(11,675 |
) |
$ |
(7,569 |
) |
$ |
(41,303 |
) |
$ |
(21,570 |
) |
CONDENSED BALANCE SHEETS | |||||||||||
(in thousands) | |||||||||||
(unaudited) | |||||||||||
|
|
|
|||||||||
Assets | |||||||||||
Cash and cash equivalents | $ |
27,219 |
$ |
12,097 |
|
||||||
Short-term investments |
|
68,840 |
|
46,458 |
|
||||||
Prepaid expenses and other current assets |
|
2,562 |
|
1,551 |
|
||||||
Deferred offering costs |
|
- |
|
1,724 |
|
||||||
Long-term investments |
|
3,219 |
|
3,486 |
|
||||||
Other assets, long-term |
|
720 |
|
- |
|
||||||
Total assets | $ |
102,560 |
$ |
65,316 |
|
||||||
Liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) | |||||||||||
Accounts payable | $ |
2,122 |
$ |
1,063 |
|
||||||
Other current liabilities |
|
5,064 |
|
2,332 |
|
||||||
Other liabilities, long-term |
|
2 |
|
13 |
|
||||||
Total liabilities |
|
7,188 |
|
3,408 |
|
||||||
Redeemable convertible preferred stock |
|
- |
|
109,319 |
|
||||||
Stockholders' equity (deficit) |
|
95,372 |
|
(47,411 |
) |
||||||
Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) | $ |
102,560 |
$ |
65,316 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230328005954/en/
Chief Financial Officer
l.day@an2therapeutics.com
Investor Relations
abowdidge@an2therapeutics.com
Source:
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