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AN2 Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business and Scientific Highlights

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AN2 Therapeutics (Nasdaq: ANTX) reported Q2 2024 financial results and recent business updates. Key points include:

  • Cash position: $104.5 million as of June 30, 2024, expected to fund operations through 2027
  • Termination of epetraborole Phase 2/3 study in TR-MAC lung disease due to similar sputum culture conversion rates between treatment arms
  • Pipeline advancement: Two development programs expected to enter clinical trials in 2025
  • Q2 2024 financials: R&D expenses $12.1 million, G&A expenses $3.7 million, net loss $14.4 million

Despite setbacks in the MAC lung disease study, AN2 remains focused on advancing its boron chemistry platform in infectious diseases and oncology.

AN2 Therapeutics (Nasdaq: ANTX) ha riportato i risultati finanziari del secondo trimestre 2024 e aggiornamenti recenti sull'attività. I punti chiave includono:

  • Posizione di cassa: 104,5 milioni di dollari al 30 giugno 2024, prevista per finanziare le operazioni fino al 2027
  • Terminazione dello studio di Fase 2/3 di epetraborole nella malattia polmonare TR-MAC a causa di tassi di conversione simili dei culturi di espettorato tra i gruppi di trattamento
  • Avanzamento della pipeline: Due programmi di sviluppo previsti per entrare in sperimentazione clinica nel 2025
  • Finanziaria del Q2 2024: spese per R&D 12,1 milioni di dollari, spese generali e amministrative 3,7 milioni di dollari, perdita netta 14,4 milioni di dollari

Nonostante le difficoltà nello studio sulla malattia polmonare MAC, AN2 rimane concentrata sull'avanzamento della propria piattaforma di chimica del boro nelle malattie infettive e oncologiche.

AN2 Therapeutics (Nasdaq: ANTX) informó los resultados financieros del segundo trimestre de 2024 y las actualizaciones recientes sobre el negocio. Los puntos clave incluyen:

  • Posición de efectivo: 104,5 millones de dólares al 30 de junio de 2024, se espera que financie las operaciones hasta 2027
  • Terminación del estudio de fase 2/3 de epetraborole en la enfermedad pulmonar TR-MAC debido a tasas de conversión similares en los cultivos de esputo entre los grupos de tratamiento
  • Avance de la pipeline: Se espera que dos programas de desarrollo ingresen a ensayos clínicos en 2025
  • Financieros del Q2 2024: gastos de I+D 12,1 millones de dólares, gastos generales y administrativos 3,7 millones de dólares, pérdida neta 14,4 millones de dólares

A pesar de los contratiempos en el estudio de la enfermedad pulmonar MAC, AN2 sigue enfocada en avanzar su plataforma de química de boro en enfermedades infecciosas y oncología.

AN2 Therapeutics (Nasdaq: ANTX)는 2024년 2분기 재무 결과와 최근 비즈니스 업데이트를 보고했습니다. 주요 사항은 다음과 같습니다:

  • 현금 보유: 2024년 6월 30일 기준으로 1억 4백5십만 달러, 2027년까지 운영 자금으로 사용될 것으로 예상됨
  • 제거: 치료 그룹 간의 유사한 가래 배양 전환률로 인해 TR-MAC 폐 질환에 대한 epetraborole 2/3상 연구 종료
  • 파이프라인 발전: 두 개의 개발 프로그램이 2025년에 임상 시험에 진입할 예정
  • 2024년 2분기 재무: R&D 비용 1천2백10만 달러, 일반 관리비 370만 달러, 순손실 1천4백40만 달러

MAC 폐 질환 연구의 어려움에도 불구하고 AN2는 감염병 및 종양학 분야에서 붕소 화학 플랫폼을 발전시키는 데 집중하고 있습니다.

AN2 Therapeutics (Nasdaq: ANTX) a publié les résultats financiers du deuxième trimestre 2024 ainsi que des mises à jour récentes sur l'entreprise. Les points clés incluent :

  • Situation de trésorerie : 104,5 millions de dollars au 30 juin 2024, prévu pour financer les opérations jusqu'en 2027
  • Résiliation de l'étude de Phase 2/3 du tétraborole dans la maladie pulmonaire TR-MAC en raison de taux de conversion similaires des cultures d'expectorations entre les groupes de traitement
  • Avancement du pipeline : Deux programmes de développement devraient entrer dans des essais cliniques en 2025
  • Finances du T2 2024 : dépenses en R&D 12,1 millions de dollars, dépenses G&A 3,7 millions de dollars, perte nette 14,4 millions de dollars

Malgré des revers dans l'étude de la maladie pulmonaire MAC, AN2 reste concentré sur l'avancement de sa plateforme de chimie du bore dans les maladies infectieuses et l'oncologie.

AN2 Therapeutics (Nasdaq: ANTX) hat die finanziellen Ergebnisse des zweiten Quartals 2024 sowie aktuelle Geschäftsnachrichten veröffentlicht. Die wichtigsten Punkte umfassen:

  • Liquiditätsposition: 104,5 Millionen Dollar zum 30. Juni 2024, voraussichtlich zur Finanzierung der operativen Tätigkeiten bis 2027
  • Beendigung der Phase 2/3-Studie von Epetraborole zur TR-MAC-Lungenerkrankung aufgrund ähnlicher Sputumkultur-Konversionsraten zwischen den Behandlungsgruppen
  • Fortschritt der Pipeline: Zwei Entwicklungsprogramme sollen 2025 in klinische Studien eintreten
  • Finanzen Q2 2024: F&E-Ausgaben 12,1 Millionen Dollar, allgemeine und Verwaltungsausgaben 3,7 Millionen Dollar, Nettoverlust 14,4 Millionen Dollar

Trotz Rückschlägen in der MAC-Lungenerkrankungsstudie bleibt AN2 darauf fokussiert, ihre Borchemie-Plattform in den Bereichen Infektionskrankheiten und Onkologie voranzutreiben.

Positive
  • Cash runway expected to fund operations through 2027
  • Two development programs advancing to clinical trials in 2025
  • Epetraborole 500 mg daily was generally well-tolerated in the EBO-301 study
  • Published study highlighting epetraborole's efficacy against M. abscessus in a mouse lung infection model
  • Increased other income due to higher interest rates and cash balances
Negative
  • Termination of epetraborole Phase 2/3 clinical study in TR-MAC lung disease
  • Sputum culture conversion rates similar between treatment arms in EBO-301 study
  • Net loss of $14.4 million in Q2 2024

Insights

The Q2 2024 results for AN2 Therapeutics present a mixed financial picture. While the company reported a reduced net loss of $14.4 million compared to $15.8 million in Q2 2023, the termination of their pivotal Phase 2/3 study for epetraborole is a significant setback. The cash position of $104.5 million provides a runway through 2027, which is important given the need to pivot their research focus.

The 10.3% decrease in R&D expenses to $12.1 million reflects completed Phase 1 trials but may not fully capture the impact of the terminated epetraborole study. G&A expenses increased by 19.4% to $3.7 million, indicating ongoing operational expansion. The 75% increase in other income to $1.4 million is a positive, reflecting effective cash management in a higher interest rate environment.

The termination of the epetraborole Phase 2/3 study for treatment-refractory MAC lung disease is a significant clinical setback. While the primary objective of validating a novel patient-reported outcome tool was met, the critical secondary endpoint of sputum culture conversion showed no significant difference between treatment arms. This highlights the challenges in developing treatments for complex respiratory infections.

However, the company's pivot to other indications, including Chagas disease and melioidosis, demonstrates a diversified pipeline strategy. The planned Phase 1 trial for AN2-502998 in Chagas disease and Phase 2 trial for epetraborole in melioidosis represent potential new avenues for growth. The published data on epetraborole's efficacy against M. abscessus in a mouse model also suggests ongoing potential in NTM lung disease, despite the recent setback.

Cash, cash equivalents, and investments of $104.5 million at June 30, 2024; cash runway anticipated to fund operations through 2027

MENLO PARK, Calif.--(BUSINESS WIRE)-- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform today reported financial results for the quarter ended June 30, 2024.

“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 Eric Easom, Co-Founder, Chairman, President and CEO. “Despite this setback, we remain well positioned as a company - we have a boron chemistry platform with two development programs that are expected to advance into clinical trials in 2025. AN2-502998 is expected to enter Phase 1 with an aim to cure chronic Chagas disease, a potentially life-threatening illness that causes severe cardiac disease and where there are limited to no treatment options. We also plan to initiate a Phase 2 trial with epetraborole for the treatment of melioidosis, a deadly bacterial infection and global bioterrorism threat. Additionally, we have a pipeline of internally developed boron-based compounds in research targeting high unmet needs in infectious disease and oncology and we have the financial runway to allow us to achieve multiple inflection points over the next three years.”

Second Quarter & Recent Business Updates:

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

  • 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 at June 30, 2024, which is expected to fund operations 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 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 National Institute of Allergy and Infectious Disease (NIAID) of the Company’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 U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

AN2 THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

2024

 

2023

 

2024

 

2023

Operating expenses:

 

 

 

 

 

 

 

 

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:

 

 

 

 

 

 

 

 

Unrealized (loss) gain on investments

 

 

(80

)

 

 

56

 

 

 

(302

)

 

 

255

 

Comprehensive loss

 

$

(14,515

)

 

$

(15,748

)

 

$

(31,354

)

 

$

(30,872

)

AN2 THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

 

 

June 30,
2024
(unaudited)

December 31,
2023

Assets

 

 

Current assets:

 

 

 

 

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

Long-term investments

 

 

27,194

Other assets, long-term

 

1,043

 

1,043

Total assets

$

108,481

$

138,744

 

 

 

Liabilities and stockholders’ equity

 

 

Current liabilities:

 

 

 

 

Accounts payable

$

1,885

$

2,676

Other current liabilities

 

8,242

 

11,367

Total liabilities

 

10,127

 

14,043

Stockholders’ equity

 

98,354

 

124,701

Total liabilities and stockholders’ equity

$

108,481

$

138,744

 

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) key financial results for Q2 2024?

AN2 Therapeutics reported a net loss of $14.4 million, R&D expenses of $12.1 million, and G&A expenses of $3.7 million for Q2 2024. The company had $104.5 million in cash, cash equivalents, and investments as of June 30, 2024.

Why did AN2 Therapeutics (ANTX) terminate the epetraborole Phase 2/3 study?

AN2 Therapeutics terminated the epetraborole Phase 2/3 study in TR-MAC lung disease due to similar sputum culture conversion rates at Month 6 between the treatment and placebo arms, despite meeting the primary objective of demonstrating a higher PRO-based clinical response rate.

What are AN2 Therapeutics' (ANTX) plans for pipeline advancement in 2025?

AN2 Therapeutics plans to advance two development programs into clinical trials in 2025: AN2-502998 for chronic Chagas disease (Phase 1) and epetraborole for melioidosis treatment (Phase 2).

How long is AN2 Therapeutics' (ANTX) current cash expected to fund operations?

AN2 Therapeutics' current cash position of $104.5 million as of June 30, 2024, is expected to fund operations through 2027.

AN2 Therapeutics, Inc.

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