AN2 Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business and Scientific Highlights
- Strong cash position of $134.5 million as of December 31, 2023.
- Phase 2/3 trial (EBO-301) for TR-MAC lung disease ongoing, with Phase 2 topline results expected in summer 2024.
- Positive momentum in boron chemistry pipeline with licensing agreement for Chagas disease therapy and grant from Bill & Melinda Gates Foundation for TB and malaria treatment.
- Received grant from Bill & Melinda Gates Foundation for novel boron-containing small molecules for TB and malaria treatment.
- Presented new data on epetraborole at IDWeek 2023 conference.
- Executed license from University of Georgia Research Foundation to develop boron-containing product candidates for Chagas disease.
- Voluntarily paused Phase 3 enrollment in the Epetraborole Pivotal Phase 2/3 Clinical Study due to potentially lower than expected efficacy based on aggregate data from ongoing Phase 2 study.
Insights
The financial health of AN2 Therapeutics, Inc. is a pivotal aspect for current and potential investors. With a reported cash, cash equivalents and investments totaling $134.5 million at the end of 2023, the company appears to have a robust runway to fund its operations and clinical trials. This is particularly significant considering the increase in Research and Development (R&D) expenses to $54.9 million for the year, up from $29.5 million in the previous year. The uptick in R&D expenses is indicative of the company's aggressive investment in its pipeline, especially in clinical trial activities.
However, it's important to note the net loss widened to $64.7 million for the year 2023 from $41.0 million in the prior year. This could be a point of concern for investors as it may indicate a longer path to profitability. The increase in General and Administrative (G&A) expenses, although not as steep as R&D, also reflects the growing operational scale of the company. On the other hand, the rise in other income, net to $4.9 million for the year, benefited from higher interest rates and suggests prudent financial management of the company's cash reserves.
Looking forward, the anticipated Phase 2 topline results in summer 2024 will be a critical milestone that could significantly influence the company's stock performance. The data will not only impact the clinical development pathway but also investor confidence in the company's ability to bring epetraborole to market.
The clinical development of epetraborole for treatment-refractory Mycobacterium avium Complex (TR-MAC) lung disease is at the heart of AN2 Therapeutics' value proposition. The Phase 2/3 trial's progress is a key indicator of the potential for epetraborole to meet a high unmet medical need. The voluntary pause in Phase 3 enrollment, while not due to safety concerns, suggests the company is taking a cautious approach in response to potentially lower than expected efficacy in the ongoing Phase 2 study. This decision underscores the complexity of treating TR-MAC, especially given the patient population's characteristics, which include complex comorbidities and refractory to the only FDA-approved drug, Arikayce.
From a medical research perspective, the continuation of dosing in the current trial participants and the planned discussions with the FDA are positive steps towards optimizing the development strategy. The company's expansion into other infectious diseases, such as Chagas disease and melioidosis, through its boron chemistry pipeline, diversifies its portfolio and could mitigate risk associated with the TR-MAC program.
The grant received from the Bill & Melinda Gates Foundation to discover novel treatments for tuberculosis and malaria further validates the potential of AN2's boron-based technology platform. This external support not only provides financial assistance but also adds credibility to the company's research initiatives.
Phase 2/3 trial (EBO-301) in treatment-refractory Mycobacterium avium Complex (TR-MAC) continues with Phase 2 topline results expected in summer 2024 and Phase 3 enrollment pause in place during continued analysis of incoming data; plan to discuss with FDA
Cash, cash equivalents, and investments of
“AN2’s cash position remains strong as we advance our innovative boron-based pipeline. Following the recent meeting of the independent Data Safety Monitoring Board, we continue to believe in the potential of epetraborole to become an important component of the backbone therapy for NTM lung disease,” said Eric Easom, Co-Founder, President and Chief Executive Officer. “Patients enrolled in the epetraborole Phase 2/3 trial in treatment refractory lung disease caused by MAC continue to be dosed while new enrollment in the Phase 3 part of the trial remains paused. Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer. Analysis of the baseline patient demographics from the trial show a highly complex and refractory patient population, which we plan to discuss with the FDA in the coming months.”
Easom continued, “We are pleased with the momentum across our boron chemistry pipeline. We signed a licensing agreement last fall with the University of Georgia Research Foundation to develop a novel therapy for chronic Chagas disease, which is in late preclinical development and we are also progressing an IV formulation of epetraborole for melioidosis, in addition to advancing other research programs. We believe epetraborole, along with these other promising boron therapy candidates, has the opportunity to help address significant unmet patient need.”
Fourth Quarter & Recent Business Updates:
Epetraborole Pivotal Phase 2/3 Clinical Study in TR-MAC Lung Disease
This double-blind, placebo-controlled trial is comparing epetraborole plus a background regimen versus placebo plus background regimen in patients with TR-MAC lung disease. In February 2024, the Company announced that it had voluntarily paused Phase 3 enrollment in the seamless Phase 2/3 clinical trial, pending further data review. The voluntary pause was instituted following an analysis of blinded aggregate data from the ongoing Phase 2 study, which showed potentially lower than expected efficacy. The aggregate baseline characteristics reveal patients with complex comorbidities, prolonged NTM lung disease, and high levels of cavitary disease, as well as patients who are refractory to Arikayce, the only FDA-approved drug for refractory NTM caused by MAC, as part of their background regimen. The decision to pause Phase 3 enrollment was not due to safety concerns. While the Phase 3 part of the trial is paused for new enrollment (n=97), the Company is continuing to dose existing patients enrolled in the Phase 2/3 trial under the existing protocol.
The Company plans to provide further details on the epetraborole development strategy after discussion with FDA and continued review of the accumulated blinded data. The Company expects to announce topline data from the Phase 2 part of the trial in summer 2024.
Presented New Epetraborole Data at Infectious Disease Society of America (IDSA) IDWeek 2023 Conference. In October 2023, three poster presentations and two oral presentations were presented at the IDWeek 2023 conference that detailed the potential of epetraborole in treating NTM (nontuberculous mycobacteria) lung disease caused by MAC and Mycobacterium abscessus. The Company also presented data on its melioidosis program.
Executed License from University of Georgia Research Foundation to Develop Boron-Containing Product Candidates for Chagas Disease. In October 2023, AN2 announced that it had executed an exclusive license from the University of Georgia Research Foundation to advance the development of a boron-containing small molecule, AN2-502998 (formerly AN15368), for Chagas disease. This boron-based molecule was originally discovered by researchers at Anacor Pharmaceuticals, Inc. (a wholly owned subsidiary of Pfizer), which included some of the current AN2 team, and the University of
Received Grant from Bill & Melinda Gates Foundation. In September 2023, AN2 announced that it received a grant from the Bill & Melinda Gates Foundation to discover novel, boron containing small molecules for the treatment of tuberculosis and malaria.
Selected Fourth Quarter and Full Year 2023 Financial Results
-
Research and Development (R&D) Expenses: R&D expenses for the full year 2023 were
$54.9 million $29.5 million $14.9 million $8.8 million -
General and Administrative (G&A) Expenses: G&A expenses for the full year 2023 were
$14.8 million $12.8 million $3.9 million $3.7 million -
Other Income, Net: Other income, net for the full year 2023 was
$4.9 million $1.3 million $1.9 million $0.6 million -
Net loss: Net loss for the full year 2023 was
$64.7 million $41.0 million $16.9 million $11.8 million -
Cash Position: The Company had cash, cash equivalents, and investments of
$134.5 million
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 initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (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: continued analysis of incoming data; continuation of the Phase 2 and 3 parts of the EBO-301 trial; continuation of the enrollment pause in Phase 3 of the EBO-301 trial; FDA meetings and discussions; reporting of topline data from Phase 2 of the EBO-301 trial and other updates; potential of epetraborole, AN-502998, and the Company’s boron chemistry pipeline; timing and initiation of preclinical and clinical studies; the advancement of candidates for Chagas disease and melioidosis; 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 recommendations of the Data Safety Monitoring Board following future reviews of unblinded data; the number of patients who remain enrolled in the Phase 2/3 trial; the ability of AN2 to resume enrollment in the Phase 2/3 trial, in the event the determination to resume enrollment is made; meetings with FDA; the ability of AN2 to effectively and timely make amendments to the Phase 2/3 pivotal trial design based on its analysis of the Phase 2 portion of the study and/or pursuant to additional FDA feedback; possible changes to AN2’s plans or priorities as it assesses study data; potential for protocol modifications, redesign, or study termination; timely enrollment of patients in AN2’s existing 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 Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and AN2’s other reports filed with the
AN2 THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) |
||||||||||||||||
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
14,919 |
|
|
$ |
8,752 |
|
|
$ |
54,871 |
|
|
$ |
28,511 |
|
Research and development—related party |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
General and administrative |
|
|
3,896 |
|
|
|
3,724 |
|
|
|
14,764 |
|
|
|
12,751 |
|
Total operating expenses |
|
|
18,815 |
|
|
|
12,476 |
|
|
|
69,635 |
|
|
|
42,262 |
|
Loss from operations |
|
|
(18,815 |
) |
|
|
(12,476 |
) |
|
|
(69,635 |
) |
|
|
(42,262 |
) |
Other income, net |
|
|
1,917 |
|
|
|
634 |
|
|
|
4,903 |
|
|
|
1,306 |
|
Net loss |
|
|
(16,898 |
) |
|
|
(11,842 |
) |
|
|
(64,732 |
) |
|
|
(40,956 |
) |
Accretion to redemption value and cumulative dividends on preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,820 |
) |
Net loss attributable to common stockholders |
|
$ |
(16,898 |
) |
|
$ |
(11,842 |
) |
|
$ |
(64,732 |
) |
|
$ |
(42,776 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.61 |
) |
|
$ |
(2.74 |
) |
|
$ |
(2.79 |
) |
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
|
29,735,397 |
|
|
|
19,352,854 |
|
|
|
23,600,107 |
|
|
|
15,340,134 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on investments |
|
|
397 |
|
|
|
167 |
|
|
|
649 |
|
|
|
(347 |
) |
Comprehensive loss |
|
$ |
(16,501 |
) |
|
$ |
(11,675 |
) |
|
$ |
(64,083 |
) |
|
$ |
(41,303 |
) |
AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) |
||||||
|
December 31, |
|||||
|
2023 |
2022 |
||||
Assets |
|
|
||||
Cash and cash equivalents |
$ |
15,647 |
$ |
27,219 |
||
Short-term investments |
|
91,648 |
|
68,840 |
||
Prepaid expenses and other current assets |
|
3,212 |
|
2,562 |
||
Long-term investments |
|
27,194 |
|
3,219 |
||
Other assets, long-term |
|
1,043 |
|
720 |
||
Total assets |
$ |
138,744 |
$ |
102,560 |
||
|
|
|
||||
Liabilities and stockholders’ equity |
|
|
||||
Accounts payable |
$ |
2,676 |
$ |
2,122 |
||
Other current liabilities |
|
11,367 |
|
5,064 |
||
Other liabilities, long-term |
|
— |
|
2 |
||
Total liabilities |
|
14,043 |
|
7,188 |
||
Stockholders’ equity |
|
124,701 |
|
95,372 |
||
Total liabilities and stockholders’ equity |
$ |
138,744 |
$ |
102,560 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240328333538/en/
Company Contacts:
Lucy O. Day
Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge
Investor Relations
abowdidge@an2therapeutics.com
Source: AN2 Therapeutics, Inc.
FAQ
What is AN2 Therapeutics' cash position as of December 31, 2023?
What is the status of the Phase 2/3 trial (EBO-301) for TR-MAC lung disease?
What positive developments have occurred in AN2 Therapeutics' boron chemistry pipeline?
What recent presentation did AN2 Therapeutics make at the IDWeek 2023 conference?
What license did AN2 Therapeutics execute in October 2023?
Why was Phase 3 enrollment in the Epetraborole Pivotal Phase 2/3 Clinical Study paused?
