AN2 Therapeutics Reports Third Quarter 2024 Financial Results, Provides Important EBO-301 Update and Highlights Progress Across Boron Chemistry Pipeline
AN2 Therapeutics (ANTX) reported Q3 2024 results and provided updates on its epetraborole program. The company's epetraborole-treated patients showed statistically significant clinical improvements in QOL-B respiratory domain and MACrO2 measures for treatment-refractory MAC lung disease. Financial highlights include cash position of $93.4M, expected to fund operations through 2027, and a 50% reduction in expenditures through restructuring. Q3 net loss was $12.7M compared to $16.7M in the same period 2023. The company plans to meet with FDA to discuss potential reinitiation of Phase 3 clinical study while advancing its boron chemistry pipeline in areas including Chagas disease, melioidosis, and oncology.
AN2 Therapeutics (ANTX) ha riportato i risultati del Q3 2024 e fornito aggiornamenti sul suo programma epetraborolo. I pazienti trattati con epetraborolo hanno mostrato miglioramenti clinici statisticamente significativi nel dominio respiratorio del QOL-B e nelle misure MACrO2 per la malattia polmonare MAC refrattaria al trattamento. Punti salienti finanziari includono una posizione di cassa di 93,4 milioni di dollari, che si prevede coprirà le operazioni fino al 2027, e una riduzione del 50% delle spese attraverso una ristrutturazione. La perdita netta del Q3 è stata di 12,7 milioni di dollari rispetto ai 16,7 milioni di dollari dello stesso periodo del 2023. L'azienda prevede di incontrare la FDA per discutere la possibile ripresa dello studio clinico di Fase 3 mentre avanza nel suo pipeline di chimica del boro in aree tra cui la malattia di Chagas, la melioidosi e l'oncologia.
AN2 Therapeutics (ANTX) reportó los resultados del tercer trimestre de 2024 y proporcionó actualizaciones sobre su programa de epetraborolo. Los pacientes tratados con epetraborolo mostraron mejoras clínicas estadísticamente significativas en el dominio respiratorio del QOL-B y en las mediciones de MACrO2 para la enfermedad pulmonar MAC refractaria al tratamiento. Destaques financieros incluyen una posición de efectivo de 93,4 millones de dólares, que se espera financie las operaciones hasta 2027, y una reducción del 50% en los gastos a través de una reestructuración. La pérdida neta del tercer trimestre fue de 12,7 millones de dólares en comparación con los 16,7 millones de dólares del mismo período en 2023. La compañía planea reunirse con la FDA para discutir la posible reiniciación del estudio clínico de Fase 3 mientras avanza en su pipeline de química de boro en áreas como la enfermedad de Chagas, la melioidosis y la oncología.
AN2 Therapeutics (ANTX)는 2024년 3분기 실적을 발표하고 에페트라보롤 프로그램에 대한 업데이트를 제공했습니다. 에페트라보롤로 치료받은 환자들은 QOL-B 호흡기 영역과 치료에 반응하지 않는 MAC 폐 질환에 대한 MACrO2 측정에서 통계적으로 유의미한 임상 개선을 보였습니다. 재무 강조 사항으로는 9340만 달러의 현금 포지션이 포함되어 있으며, 이는 2027년까지 운영 자금을 지원할 것으로 예상되며, 구조 조정을 통해 지출을 50% 줄였습니다. 3분기 순손실은 1,270만 달러로, 2023년 같은 기간의 1,670만 달러에 비해 줄어들었습니다. 회사는 3상 임상 연구의 재개 가능성에 대해 논의하기 위해 FDA와 만날 계획이며, 차가스병, 멜리오이드, 종양학 등을 포함한 붕소 화학 파이프라인을 진행하고 있습니다.
AN2 Therapeutics (ANTX) a annoncé les résultats du troisième trimestre 2024 et a fourni des mises à jour sur son programme d'épétrabore. Les patients traités par épétrabore ont montré des améliorations cliniques statistiquement significatives dans le domaine respiratoire du QOL-B et les mesures MACrO2 pour la maladie pulmonaire MAC réfractaire au traitement. Points forts financiers incluent une position de trésorerie de 93,4 millions de dollars, qui devrait financer les opérations jusqu'en 2027, et une réduction de 50 % des dépenses grâce à une restructuration. La perte nette pour le troisième trimestre était de 12,7 millions de dollars par rapport à 16,7 millions de dollars pour la même période en 2023. L'entreprise prévoit de rencontrer la FDA pour discuter de la potentielle réinitiation de l'étude clinique de Phase 3 tout en avançant dans sa pipeline de chimie du bore dans des domaines tels que la maladie de Chagas, la mélioïdose et l'oncologie.
AN2 Therapeutics (ANTX) hat die Ergebnisse für das 3. Quartal 2024 veröffentlicht und Updates zu seinem Epetraborol-Programm bereitgestellt. Die mit Epetraborol behandelten Patienten zeigten statistisch signifikante klinische Verbesserungen im respiratorischen Bereich des QOL-B und bei den MACrO2-Messungen bei therapieresistenter MAC-Lungenkrankheit. FinanzielleHighlights umfassen eine Liquiditätsposition von 93,4 Millionen US-Dollar, die voraussichtlich die Betriebe bis 2027 finanzieren wird, sowie eine 50%ige Reduzierung der Ausgaben durch Umstrukturierungen. Der Nettoverlust im 3. Quartal betrug 12,7 Millionen US-Dollar im Vergleich zu 16,7 Millionen US-Dollar im gleichen Zeitraum 2023. Das Unternehmen plant, sich mit der FDA zu treffen, um die potenzielle Wiederaufnahme der klinischen Studie der Phase 3 zu besprechen, während es seine Borchemie-Pipeline in Bereichen wie der Chagas-Krankheit, Melioidose und Onkologie voranbringt.
- Clinical improvements demonstrated in epetraborole-treated patients with statistical significance
- Strong cash position of $93.4M expected to fund operations through 2027
- 50% reduction in expenditures achieved through restructuring
- Reduced net loss to $12.7M from $16.7M year-over-year
- No evidence of induced epetraborole resistance in treated patients
- Phase 3 trial halted in August 2024
- Restructuring resulted in $2.2M charges for severance payments
- R&D expenses decreased due to reduced clinical trial activities
Insights
The updated analysis of epetraborole in treating MAC lung disease reveals promising clinical significance. The drug demonstrated statistically significant improvements in two key patient-reported outcomes:
- QOL-B Respiratory Domain showed a
6.90% improvement vs placebo (p=0.0365) - MACrO2 scores improved by -5.81 points vs placebo (p=0.0433)
Notably, these improvements align with FDA's current guidance for NTM-MAC studies and mirror endpoints used in competitor Arikayce's trials. The strong cash position of
The financial restructuring has significantly improved AN2's operational efficiency, achieving a
Epetraborole-treated patients demonstrated clinical improvements in QOL-B and a post-hoc analysis of MACrO2 with nominal statistical significance when evaluated as continuous measures
First drug candidate with statistically favorable patient reported outcome (PRO)-based improvement in treatment-refractory Mycobacterium avium Complex (TR-MAC) population
Company plans to meet with FDA to gain alignment on a development path for epetraborole, including potentially reinitiating a Phase 3 clinical study, while advancing its boron chemistry pipeline
Achieved
Cash, cash equivalents, and investments of
“Treatment options for patients with refractory MAC lung disease are extremely limited. Many of these patients are significantly more challenging to convert microbiologically due to the microbial complexity of their infections as well as their very complex lung anatomy, and often experience severe clinical symptoms at this advanced stage of disease. The fact that epetraborole appears to have demonstrated improvements based on two patient reported outcome measures is highly encouraging,” said Stephen J. Ruoss, M.D., Professor of Medicine, Pulmonary and Critical Care Medicine at Stanford University School of Medicine. “By potentially improving both their quality of life and clinical outcomes, epetraborole represents a potentially significant advancement in treatment possibilities.”
"We are encouraged by this recent data analysis, which indicate that epetraborole may provide clinical improvement in patients with treatment-refractory MAC lung disease, as measured by two patient-reported outcome instruments, including the same instrument recently selected for the primary endpoint in the Arikayce TN-MAC pivotal trial," stated Eric Easom, Co-Founder, Chairman, President, and Chief Executive Officer of AN2 Therapeutics. "We look forward to engaging with the FDA in the near-term to discuss next steps for the epetraborole program, including the potential reinitiation of a pivotal Phase 3 trial for treatment-refractory MAC lung disease.”
Easom continued, “With a strong cash runway and optimized operating plan, we continue to advance our diverse pipeline of boron-based compounds to address unmet patient needs. This includes the recent strategic expansion into oncology, underscoring our dedication to innovating and improving patient outcomes across multiple therapeutic areas."
Third Quarter & Recent Updates:
Ongoing Analysis from Epetraborole Phase 2/3 Clinical Study in TR-MAC Lung Disease
The Company has provided an update from its ongoing analysis of the Phase 2 portion of the EBO-301 Phase 2/3 study. Two PROs evaluated in the trial indicated statistically significant clinical response, the QOL-B Respiratory Domain (Table 1) and MACrO2 (post-hoc analysis, Table 2), using continuous response measures instead of the binary responder methodology previously reported. Patients treated with epetraborole indicated clinical response using the same PRO instrument (QOL-B respiratory domain) and analysis method (least squares mean change from Baseline to Month 6) that was recently reported as the primary endpoint in the Arikayce ENCORE trial, after alignment with FDA. These EBO-301 PRO findings appear to align with FDA’s current recommendation for PRO-based primary endpoints in NTM-MAC trials.
Table 1: Quality of Life – Bronchiectasis (QOL-B respiratory domain) (least squares mean change from Baseline to Month 6)*
EBO-301 prespecified secondary endpoint
|
Epetraborole + OBR
|
Placebo + OBR
|
LS Mean
|
p-value |
Change from Baseline to Month 6 |
7.20 |
0.30 |
6.90 |
0.0365 |
*Measures of patient improvement for QOL-B are shown by positive changes in the score measured from baseline. |
||||
- Epetraborole treated patients showed nominally statistically significant improvements in the QOL-B respiratory domain measured from baseline to month 6.
- The p-value is termed “nominal” because this was not the prespecified primary endpoint in the Phase 2 part of the trial.
Table 2: MACrO2 PRO (least squares mean)*
Post-hoc analysis
|
Epetraborole + OBR
|
Placebo + OBR
|
LS Mean
|
p-value |
Change from Baseline to Month 6 |
-12.91 |
-7.10 |
-5.81 |
0.0433 |
*Measures of patient improvement for MACrO2 are shown by negative changes in the score measured from baseline. The least squares mean calculation for MACrO2 utilized the same approach as the prespecified QOL-B LSM in the EBO-301 statistical analysis plan. |
||||
- Epetraborole treated patients showed nominally statistically significant improvements in MACrO2 measured from baseline to month 6 in post-hoc analysis.
There was a high rate of MAC resistance to background antimycobacterial therapies at baseline, including approximately one-third of the patients with macrolide resistance and
Further analysis showed no change in the previously reported safety profile; epetraborole was generally well-tolerated, with 2 (
Epetraborole: Next Steps
The Company believes these findings are particularly noteworthy given the severe refractory status of the patients studied, and that improvements in QOL-B and MACrO2 appear to align with FDA’s current guidance for the primary efficacy endpoint in NTM-MAC studies. The Company will seek an End-of-Phase 2 meeting with FDA in the first half of 2025, with the goal of leveraging insights from the Phase 2 results to evaluate potential reinitiation of a pivotal Phase 3 TR-MAC study. In addition, the Company also plans to seek alignment with the FDA on a statistical analysis plan for the 97 patients who completed six months of treatment in the Phase 3 portion of EBO-301 at the time the Company halted the trial in August 2024. The Company anticipates releasing top-line Phase 3 data from these patients in mid-2025, subject to the timing of discussions with the FDA.
Other AN2 Boron Chemistry Pipeline Programs
Chagas Disease
During the quarter, the Company advanced preclinical activities aimed to initiate clinical studies in chronic Chagas disease, a disease that affects an estimated 6-7 million people worldwide, including approximately 300,000 in the
Melioidosis
The Company completed enrollment in a 200-patient observational trial for epetraborole in acute melioidosis in October 2024 and these data will inform a Phase 2 proof of concept study that is planned to initiate enrollment in the second half of 2025. Melioidosis is a deadly bacterial infection and global bioterrorism threat with a 90-day mortality rate of approximately
Boron Chemistry Pipeline
Additional development programs are underway and focused on targets in infectious diseases and oncology with high unmet needs. The Company anticipates delivering up to three development compounds in 2025.
Global Health
In October, the Company announced that it received a second-year continuation of a research grant from the Bill & Melinda Gates Foundation to discover novel boron containing small molecules for the treatment of tuberculosis and malaria. The Company will continue its efforts to tackle global health disease through non-dilutive funding.
Selected Third Quarter Financial Results
-
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were
$8.3 million $14.4 million -
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2024 were
$3.5 million $3.8 million -
Restructuring Charges: Restructuring charges for the third quarter of 2024 were
$2.2 million -
Other Income, Net: Other income, net for the third quarter of 2024 was
$1.3 million $1.5 million -
Net loss: Net loss for the third quarter of 2024 was
$12.7 million $16.7 million -
Cash Position: The Company had cash, cash equivalents, and investments of
$93.4 million 50% reduction in expenditures, extending AN2’s expected cash runway through 2027.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, NTM, and melioidosis, along with early-stage programs focused on targets in infectious diseases and oncology. 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: the potential of the Company’s boron chemistry platform and early-stage pipeline programs; design, initiation and timing of the Company’s clinical trials and results; anticipated inflection points and related timing; cash runway and cost savings related to restructuring; analysis and expectations regarding data analysis from the Phase 2/3 trial in treatment-refractory MAC lung disease, including the potential to re-initiate Phase 3 development; regulatory meetings and pathway and alignment with FDA guidance; future development of epetraborole for other forms of NTM; development of AN2-502998 for Chagas disease; development of epetraborole for melioidosis; development of compounds for infectious diseases and oncology targets; global health initiatives and non-dilutive funding; 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: future trials of epetraborole in NTM-MAC and the ability to show clinical efficacy consistent with PRO-based data observed in prospective and post-hoc analyses to date; potential disruptions related to AN2’s ability to implement its plans for its internal boron chemistry platform and early-stage 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 National Institute of Allergy and Infectious Disease (NIAID) of AN2’s development program for melioidosis; 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 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
|
|
Nine Months Ended
|
||||||||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
8,287 |
|
|
$ |
14,429 |
|
|
$ |
35,091 |
|
|
$ |
39,952 |
|
General and administrative |
|
|
3,484 |
|
|
|
3,751 |
|
|
|
10,856 |
|
|
|
10,868 |
|
Restructuring charge |
|
|
2,243 |
|
|
|
— |
|
|
|
2,243 |
|
|
|
— |
|
Total operating expenses |
|
|
14,014 |
|
|
|
18,180 |
|
|
|
48,190 |
|
|
|
50,820 |
|
Loss from operations |
|
|
(14,014 |
) |
|
|
(18,180 |
) |
|
|
(48,190 |
) |
|
|
(50,820 |
) |
Other income, net |
|
|
1,267 |
|
|
|
1,473 |
|
|
|
4,391 |
|
|
|
2,986 |
|
Net loss attributable to common stockholders |
|
$ |
(12,747 |
) |
|
$ |
(16,707 |
) |
|
$ |
(43,799 |
) |
|
$ |
(47,834 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.47 |
) |
|
$ |
(2.22 |
) |
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
|
29,841,169 |
|
|
|
25,645,421 |
|
|
|
29,809,839 |
|
|
|
21,532,537 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
||||||||
Unrealized (loss) gain on investments |
|
|
139 |
|
|
|
(3 |
) |
|
|
(163 |
) |
|
|
252 |
|
Comprehensive loss |
|
$ |
(12,608 |
) |
|
$ |
(16,710 |
) |
|
$ |
(43,962 |
) |
|
$ |
(47,582 |
) |
AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) |
||||||||
|
|
September 30,
|
|
|
December 31,
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
33,504 |
|
|
$ |
15,647 |
|
Short-term investments |
|
|
59,922 |
|
|
|
91,648 |
|
Prepaid expenses and other current assets |
|
|
4,263 |
|
|
|
3,212 |
|
Long-term investments |
|
|
— |
|
|
|
27,194 |
|
Other assets, long-term |
|
|
— |
|
|
|
1,043 |
|
Total assets |
|
$ |
97,689 |
|
|
$ |
138,744 |
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
1,711 |
|
|
$ |
2,676 |
|
Other current liabilities |
|
|
8,306 |
|
|
|
11,367 |
|
Total liabilities |
|
|
10,017 |
|
|
|
14,043 |
|
Stockholders’ equity |
|
|
87,672 |
|
|
|
124,701 |
|
Total liabilities and stockholders’ equity |
|
$ |
97,689 |
|
|
$ |
138,744 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241113258923/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 were AN2 Therapeutics (ANTX) Q3 2024 financial results?
What were the clinical results for epetraborole in the Phase 2 trial?
When does ANTX plan to meet with FDA regarding epetraborole?
