AN2 Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business and Scientific Highlights
Cash, cash equivalents, and investments of
“We reported results from the EBO-301 Phase 2/3 study in patients with treatment-refractory MAC lung disease last week and over the coming months will further analyze the data to determine next steps in NTM lung disease,” said
Termination of Epetraborole Pivotal Phase 2/3 Clinical Study in TR-MAC Lung Disease
AN2 recently announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of an optimized background regimen in treatment-refractory MAC lung disease. The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm vs. placebo + OBR. However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms. Based on the topline data, the Company has terminated the Phase 2 and Phase 3 parts of the EBO-301 trial. Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns. The Company plans to further analyze the EBO-301 data to better understand the results and their impact on the ongoing development of epetraborole for nontuberculous mycobacteria (NTM) lung disease.
Published New Epetraborole Data in Antimicrobial Agents in Chemotherapy
In July, the company published a study in the journal Antimicrobial Agents in Chemotherapy, which highlighted the efficacy of epetraborole against M. abscessus in a mouse lung infection model. The study suggests that epetraborole could become an important therapy to address the high unmet need for effective oral treatment options for M. abscessus lung disease.
Selected Second Quarter Financial Results
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Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2024 were
$12.1 million compared to$13.5 million for the same period during 2023 due to decreased chemistry manufacturing and controls activity and decreased expenses for completed Phase 1 clinical trials, partially offset by increased Phase 2/3 clinical trial costs, increased consulting and outside service costs and increased personnel-related expenses. -
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were
$3.7 million compared to$3.1 million for the same period during 2023 due to an increase in personnel-related expenses and professional and outside services. -
Other Income, Net: Other income, net for the second quarter of 2024 was
$1.4 million compared to$0.8 million for the same period during 2023 due to increased interest income based on higher interest rates and higher cash, cash equivalents and investment balances. -
Net loss: Net loss for the second quarter of 2024 was
$14.4 million , compared to$15.8 million for the same period during 2023. -
Cash Position: The Company had cash, cash equivalents, and investments of
$104.5 million atJune 30, 2024 , which is expected to fund operations through 2027.
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 Company’s plans to shift its focus to its internal boron chemistry platform and ongoing pipeline programs; cash runway; analysis and expectations regarding data analysis from the Phase 2/3 trial in treatment-refractory MAC lung disease; future development of epetraborole for M. abscessus and other forms of NTM; initiation, advancement and timing of the Company’s clinical trials; achievement and timing of potential inflection points; the ability to identify development candidates for infectious diseases or oncology targets; development of AN2-502998 for Chagas disease; development of epetraborole for melioidosis; potential of the Company’s boron chemistry platform and epetraborole; 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: potential disruptions related to AN2’s restructuring plans and its ability to implement its plans for its internal boron chemistry platform and ongoing pipeline programs; timely enrollment of patients in AN2’s existing and future clinical trials; AN2’s ability to procure sufficient supply of its product candidates 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 candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued funding by the
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CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) |
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Three Months Ended
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Six Months Ended
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2024 |
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2023 |
|
2024 |
|
2023 |
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Operating expenses: |
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|
|
|
|
|
|
|
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Research and development |
|
$ |
12,149 |
|
|
$ |
13,538 |
|
|
$ |
26,804 |
|
|
$ |
25,523 |
|
|
General and administrative |
|
|
3,731 |
|
|
|
3,063 |
|
|
|
7,372 |
|
|
|
7,117 |
|
|
Total operating expenses |
|
|
15,880 |
|
|
|
16,601 |
|
|
|
34,176 |
|
|
|
32,640 |
|
|
Loss from operations |
|
|
(15,880 |
) |
|
|
(16,601 |
) |
|
|
(34,176 |
) |
|
|
(32,640 |
) |
|
Other income, net |
|
|
1,445 |
|
|
|
797 |
|
|
|
3,124 |
|
|
|
1,513 |
|
|
Net loss attributable to common stockholders |
|
$ |
(14,435 |
) |
|
$ |
(15,804 |
) |
|
$ |
(31,052 |
) |
|
$ |
(31,127 |
) |
|
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.48 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.04 |
) |
|
$ |
(1.60 |
) |
|
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
|
29,824,725 |
|
|
|
19,497,494 |
|
|
|
29,794,001 |
|
|
|
19,442,010 |
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
||||||||
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Unrealized (loss) gain on investments |
|
|
(80 |
) |
|
|
56 |
|
|
|
(302 |
) |
|
|
255 |
|
|
Comprehensive loss |
|
$ |
(14,515 |
) |
|
$ |
(15,748 |
) |
|
$ |
(31,354 |
) |
|
$ |
(30,872 |
) |
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CONDENSED BALANCE SHEETS (in thousands) |
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Assets |
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Current assets: |
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|
|
|
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Cash and cash equivalents |
$ |
26,769 |
$ |
15,647 |
||
|
Short-term investments |
|
77,771 |
|
91,648 |
||
|
Prepaid expenses and other current assets |
|
2,898 |
|
3,212 |
||
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Long-term investments |
|
— |
|
27,194 |
||
|
Other assets, long-term |
|
1,043 |
|
1,043 |
||
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Total assets |
$ |
108,481 |
$ |
138,744 |
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|
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Liabilities and stockholders’ equity |
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|
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Current liabilities: |
|
|
|
|
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Accounts payable |
$ |
1,885 |
$ |
2,676 |
||
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Other current liabilities |
|
8,242 |
|
11,367 |
||
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Total liabilities |
|
10,127 |
|
14,043 |
||
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Stockholders’ equity |
|
98,354 |
|
124,701 |
||
|
Total liabilities and stockholders’ equity |
$ |
108,481 |
$ |
138,744 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240813783660/en/
Chief Financial Officer
l.day@an2therapeutics.com
Investor Relations
abowdidge@an2therapeutics.com
Source:
