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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 7, 2024

 

 

AN2 THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-41331   82-0606654
(State or Other Jurisdiction
of Incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

 

1800 El Camino Real, Suite D  
Menlo Park, California   94027
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 331-9090

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.00001 par value   ANTX   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


Item 2.05 Costs Associated with Exit or Disposal Activities.

On August 7, 2024, the Board of Directors of AN2 Therapeutics, Inc. (the “Company”) approved a reduction in force that is intended to result in the termination of approximately 50% of the Company’s employee workforce. The reduction in force was approved in connection with the Company’s planned shift in focus following discontinuation of the EBO-301 study and to further extend the Company’s operating capital and align personnel towards executing its ongoing strategy. The reduction in force is expected to be substantially complete by the end of 2024.

As a result of the reduction in force, the Company estimates that it will incur aggregate charges of approximately $2-$3 million, including severance and other employee-termination related expenses.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

As part of the restructuring described under Item 2.05 above, Paul Eckburg, M.D., the Company’s Chief Medical Officer, will depart the Company effective as of August 30, 2024 (the “Transition Date”). Pursuant to the Company’s severance plan, Dr. Eckburg will receive, subject to the execution and delivery of an effective release of claims in favor of the Company and continued compliance with all applicable restrictive covenants, (i) a lump sum amount equal to 75% of his annual base salary and (ii) if Dr. Eckburg timely elects continued group health plan continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (“COBRA”), the COBRA premiums on behalf of Dr. Eckburg and his eligible dependents for nine months following termination. Effective as of the Transition Date, Dr. Eckburg will continue to provide services to the Company as a consultant for up to one year following the Transition Date. Under his consulting arrangement, Dr. Eckburg’s previously granted outstanding equity awards will continue to vest while he provides services to the Company.

Item 7.01 Regulation FD Disclosure.

A copy of the Company’s press release titled “AN2 Therapeutics Provides Update on EBO-301 Phase 2/3 Study Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium Complex (MAC) Lung Disease,” dated August 8, 2024, is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

The information in this Item 7.01, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 8.01 Other Events.

The Company plans to discontinue its EBO-301 study evaluating epetraborole for treatment-refractory MAC lung disease following topline results from the Phase 2 part of the study. 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 (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64).

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.    Description
99.1    Press Release of AN2 Therapeutics, Inc. dated August 8, 2024.
104    Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AN2 Therapeutics, Inc.
Date: August 8, 2024     By:  

/s/ Joshua Eizen

      Joshua Eizen
      Chief Legal Officer

Exhibit 99.1

AN2 Therapeutics Provides Update on EBO-301 Phase 2/3 Study Evaluating

Epetraborole for Treatment-Refractory Mycobacterium avium Complex (MAC)

Lung Disease

EBO-301 study to be discontinued following topline results from Phase 2 part of the

study in treatment-refractory patients with MAC lung disease

AN2 plans to shift focus to internal boron chemistry platform and ongoing pipeline programs

Company restructuring and cost savings associated with discontinuation of the EBO-301 study expected to extend cash runway through 2027

Menlo Park, CA – August 8, 2024 – AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform today 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 (OBR) 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 (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64).

In February, the Company voluntarily paused new patient enrollment in the Phase 3 part of the study due to potentially lower-than-expected efficacy observed in blinded aggregate data. Based on the topline data announced today, the Company will terminate the Phase 2 (80 patients) and Phase 3 parts of the EBO-301 trial (97 patients enrolled prior to pause). Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns.

“These results are deeply disappointing as there is a high unmet need for new therapies in treatment-refractory MAC lung disease,” said Eric Easom, Co-founder, Chairman, President and CEO. “We sincerely thank the patients, investigators, study site staff and AN2 employees who were part of the journey to investigate the prospects of epetraborole in this very difficult-to-treat patient population.”

“In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions regarding potential future development of epetraborole for NTM lung disease in other patient populations. In the near-term, we plan to accelerate our R&D efforts on our boron chemistry platform where we believe we have several promising programs in infectious diseases and oncology. We plan to embark on a strategic restructuring and expect to extend our cash runway through 2027, focusing our cash resources on advancing our pipeline through multiple milestones,” said Easom.


AN2’s core technology approach is based on the use of boron chemistry for its research and development initiatives. Boron has a distinctive ability to bind with biological targets through a reversible covalent bond and the potential to address biological targets that have been difficult to inhibit using traditional carbon-based molecules.

Pipeline Programs/ Milestones

 

   

Chagas Disease: The Company plans to initiate Phase 1 clinical development of its product candidate aimed to cure chronic Chagas disease, a disease that affects an estimated 6-7 million people worldwide including approximately 300,000 in the U.S. and causes severe cardiac disease and death.

 

   

Melioidosis: The Company plans to initiate a Phase 2 study with epetraborole in melioidosis, a deadly bacterial infection and global bioterrorism threat, with a goal of significantly reducing the 3-month mortality rate of ~50%.

 

   

Early-Stage Pipeline: Additional research programs are underway and focused on targets in infectious diseases and oncology with high unmet needs. The Company anticipates multiple development compounds within its cash runway.

 

   

Global Health: The Company will continue its efforts to tackle global health disease areas through non-dilutive funding, including tuberculosis and malaria, funded by the Gates Foundation.

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; strategic restructuring; cash runway; further evaluation of the results from the EBO-301 study and any future development of epetraborole for NTM lung disease; acceleration of R&D efforts on the Company’s boron chemistry platform; potential for the identification of development compounds in infectious disease or oncology; 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 reports filed with the U.S. Securities and Exchange Commission (SEC), including AN2’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. These filings, when made, are available on the investor relations section of AN2’s website at investor.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.

Company Contacts:

Lucy O. Day

Chief Financial Officer

l.day@an2therapeutics.com

Anne Bowdidge

Investor Relations

abowdidge@an2therapeutics.com

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