AN2 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business and Scientific Highlights
- Enrollment well underway in Phase 3 part of pivotal Phase 2/3 study of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease
- On track to announce Phase 2 clinical data summer 2024
-
Cash and investments of
$150.2 million atSeptember 30, 2023 ; cash runway anticipated to fund operations through summer 2025
“We are incredibly proud of the significant milestones achieved recently and over the past quarter. In September, we initiated enrollment in the Phase 3 part of our pivotal Phase 2/3 clinical trial for epetraborole in treatment-refractory MAC lung disease after fully enrolling the Phase 2 part of the trial. At IDWeek in
Initiated Phase 3 Part of Pivotal Phase 2/3 Clinical Trial for Epetraborole. In September, the Company announced that it had commenced the Phase 3 part of the Phase 2/3 clinical trial after fully enrolling 80 patients in the Phase 2 part of the trial evaluating once-daily, oral epetraborole for treatment-refractory MAC lung disease. The trial is being conducted at over 100 clinical sites across the
Presented New Epetraborole Data at
Executed License from
Received Grant from
Selected Third Quarter Financial Results
-
Research and Development (R&D) Expenses: R&D expenses increased for the three months ended
September 30, 2023 , compared to the same period during 2022 due to increased clinical trial expenses, personnel-related expenses, consulting and outside services and preclinical and research study expenses, partially offset by lower chemistry manufacturing and controls costs and other expenses. -
General and Administrative (G&A) Expenses: G&A expenses increased for the three months ended
September 30, 2023 , compared to the same period during 2022 due to increased personnel-related expenses and professional service fees, partially offset by a decrease in insurance costs. -
Other Income, Net: Other income, net was
$1.5 million for the three months endedSeptember 30, 2023 , compared to$0.4 million in the same period in 2022 due to increased interest and investment income based on higher interest rates and higher cash, cash equivalents and investment balances. -
Net loss: Net loss was
$16.7 million for the three months endedSeptember 30, 2023 , compared to$11.3 million in the same period during 2022. -
Cash Position: On
August 15, 2023 , the Company sold an aggregate of 7,777,778 shares of the Company’s common stock at a purchase price of$9.00 per share under an underwritten offering. This resulted in aggregate gross proceeds to the Company of approximately$70.0 million , before deducting underwriting discounts and commissions and offering expenses. The Company expects that current cash and investments of$150.2 million atSeptember 30, 2023 will be sufficient to fund its operating expenses through summer 2025.
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; anticipated timing of the data readout of the Phase 2 portion of AN2’s pivotal Phase 2/3 trial; timing of enrollment in the Phase 3 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 to address unmet needs for patients with NTM lung disease and melioidosis; 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: 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; global macroeconomic conditions and global conflicts; 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
|
|
Nine Months Ended
|
||||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
14,429 |
|
|
$ |
7,428 |
|
|
$ |
39,952 |
|
|
$ |
19,759 |
|
Research and development—related party |
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
|
|
1,000 |
|
General and administrative |
|
|
3,751 |
|
|
|
3,342 |
|
|
|
10,868 |
|
|
|
9,027 |
|
Total operating expenses |
|
|
18,180 |
|
|
|
11,770 |
|
|
|
50,820 |
|
|
|
29,786 |
|
Loss from operations |
|
|
(18,180 |
) |
|
|
(11,770 |
) |
|
|
(50,820 |
) |
|
|
(29,786 |
) |
Other income, net |
|
|
1,473 |
|
|
|
431 |
|
|
|
2,986 |
|
|
|
672 |
|
Net loss |
|
|
(16,707 |
) |
|
|
(11,339 |
) |
|
|
(47,834 |
) |
|
|
(29,114 |
) |
Accretion to redemption value and cumulative dividends on preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,820 |
) |
Net loss attributable to common stockholders |
|
$ |
(16,707 |
) |
|
$ |
(11,339 |
) |
|
$ |
(47,834 |
) |
|
$ |
(30,934 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.59 |
) |
|
$ |
(2.22 |
) |
|
$ |
(2.21 |
) |
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
|
25,645,421 |
|
|
|
19,347,148 |
|
|
|
21,532,537 |
|
|
|
13,987,862 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on investments |
|
|
(3 |
) |
|
|
(181 |
) |
|
|
252 |
|
|
|
(514 |
) |
Comprehensive loss |
|
$ |
(16,710 |
) |
|
$ |
(11,520 |
) |
|
$ |
(47,582 |
) |
|
$ |
(29,628 |
) |
CONDENSED BALANCE SHEETS (in thousands) |
||||||||
|
|
|
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
32,616 |
|
|
$ |
27,219 |
|
Short-term investments |
|
|
91,202 |
|
|
|
68,840 |
|
Prepaid expenses and other current assets |
|
|
2,591 |
|
|
|
2,562 |
|
Long-term investments |
|
|
26,356 |
|
|
|
3,219 |
|
Other assets, long-term |
|
|
1,043 |
|
|
|
720 |
|
Total assets |
|
$ |
153,808 |
|
|
$ |
102,560 |
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
4,877 |
|
|
$ |
2,122 |
|
Other current liabilities |
|
|
9,962 |
|
|
|
5,064 |
|
Other liabilities, long-term |
|
|
— |
|
|
|
2 |
|
Total liabilities |
|
|
14,839 |
|
|
|
7,188 |
|
Stockholders’ equity |
|
|
138,969 |
|
|
|
95,372 |
|
Total liabilities and stockholders’ equity |
|
$ |
153,808 |
|
|
$ |
102,560 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109308786/en/
Company Contacts:
Chief Financial Officer
l.day@an2therapeutics.com
Investor Relations
abowdidge@an2therapeutics.com
Source: