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AN2 Therapeutics, Inc.
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AN2 Therapeutics, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2023-04-10
AN2 Therapeutics, Inc.
Summary
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Company responded
2023-04-11
AN2 Therapeutics, Inc.
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AN2 Therapeutics, Inc.
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Company responded
2022-03-22
AN2 Therapeutics, Inc.
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2022-03-22
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SEC wrote to company
2021-12-03
AN2 Therapeutics, Inc.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-16 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-04-15 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | 333-294956 | Read Filing View |
| 2023-04-11 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-04-10 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-03-22 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-03-22 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-22 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-15 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | 333-294956 | Read Filing View |
| 2023-04-10 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-22 | SEC Comment Letter | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-16 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-04-11 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-03-22 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-03-22 | Company Response | AN2 Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-04-16 - CORRESP - AN2 Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP AN2 Therapeutics, Inc. 1300 El Camino Real, Suite 100 Menlo Park, California 94025 April 16, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards Re: AN2 Therapeutics, Inc. Registration Statement on Form S-3 Filed April 9, 2026 File No. 333-294956 To the addressee set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-294956) (the “ Registration Statement ”) of AN2 Therapeutics, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on April 20, 2026, or as soon as practicable thereafter, or at such other time thereafter as our counsel, Latham & Watkins LLP may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Richard Kim at (650) 470-4980. Thank you for your assistance in this matter. Very truly yours, AN2 T HERAPEUTICS , I NC . By: /s/ Joshua Eizen Joshua Eizen Chief Legal Officer and Chief Operating Officer cc: Eric Easom, AN2 Therapeutics, Inc. Kathleen M. Wells, Latham & Watkins LLP Richard Kim, Latham & Watkins LLP
2026-04-15 - UPLOAD - AN2 Therapeutics, Inc. File: 333-294956
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 15, 2026 Eric Easom President and Chief Executive Officer AN2 Therapeutics, Inc. 1300 El Camino Real, Suite 100 Menlo Park, California 94025 Re: AN2 Therapeutics, Inc. Registration Statement on Form S-3 Filed April 9, 2026 File No. 333-294956 Dear Eric Easom: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Richard Kim </TEXT> </DOCUMENT>
2023-04-11 - CORRESP - AN2 Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP April 11, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jason Drory Re: AN2 Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-271174 Acceleration Request Requested Date: April 13, 2023 Requested Time: 4:00 PM Eastern Daylight Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-3 (File No. 333-271174) (the “Registration Statement”) to become effective on April 13, 2023 at 4:00 p.m. Eastern Daylight Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Josh Seidenfeld of Cooley LLP, or, in his absence, Sally Kay of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Josh Seidenfeld of Cooley LLP, counsel to the Registrant, at (650) 843-5862, or, in his absence, Sally Kay of Cooley LLP, counsel to the Registrant at (650) 843-5582. Very truly yours, AN2 Therapeutics, Inc. By: /s/ Eric Easom Eric Easom Chief Executive Officer cc: Josh Seidenfeld, Cooley LLP Sally Kay, Cooley LLP Anitha Anne, Cooley LLP
2023-04-10 - UPLOAD - AN2 Therapeutics, Inc.
United States securities and exchange commission logo
April 10, 2023
Eric Easom
President and Chief Executive Officer
AN2 Therapeutics, Inc.
1800 El Camino Real, Suite D
Menlo Park, CA 94027
Re:AN2 Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 6, 2023
File No. 333-271174
Dear Eric Easom:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Anitha Anne
2022-03-22 - CORRESP - AN2 Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP AN2 Therapeutics, Inc. 1800 El Camino Real, Suite D Menlo Park, California 94027 March 22, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Gary Guttenberg, Christine Westbrook Re: AN2 Therapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-263295) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, AN2 Therapeutics, Inc. (the “Company”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration Statement on Form S-1 (as amended to date, the “Registration Statement”) and declare the Registration Statement effective as of 4:00 p.m. Eastern time, on March 24, 2022, or as soon thereafter as possible, or at such other time as its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. Once the Registration Statement has been declared effective, please orally confirm that event with Josh Seidenfeld of Cooley LLP at (650) 843-5862 or, in his absence, Sally Kay of Cooley LLP at (650) 843-5582. Under separate cover, you will receive today a letter from the managing underwriters of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. Very truly yours, AN2 Therapeutics, Inc. /s/ Eric Easom By: Eric Easom Title: Chief Executive Officer cc: Eric Easom, AN2 Therapeutics, Inc. Lucy Day, AN2 Therapeutics, Inc. Josh Seidenfeld, Cooley LLP Sally Kay, Cooley LLP Anitha Anne, Cooley LLP Emily Roberts, Davis Polk & Wardwell LLP Alan F. Denenberg, Davis Polk & Wardwell LLP
2022-03-22 - CORRESP - AN2 Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Cowen and Company, LLC 599 Lexington Avenue New York, New York 10022 SVB Securities LLC 53 State Street, 40th Floor Boston, Massachusetts 02109 Evercore Group L.L.C. 55 East 52nd Street New York, New York 10055 March 22, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Gary Guttenberg, Christine Westbrook Re: AN2 Therapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-263295) Request for Acceleration of Effective Date Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of AN2 Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1 so that it becomes effective as of 4:00 p.m. Eastern time on March 24, 2022, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, COWEN AND COMPANY, LLC SVB SECURITIES LLC EVERCORE GROUP L.L.C. As representatives of the several underwriters listed in Schedule I to the Underwriting Agreement COWEN AND COMPANY, LLC By: /s/ Mariel A. Healy Name: Mariel A. Healy Title: Managing Director SVB SECURITIES LLC By: /s/ Murphy Gallagher Name: Murphy Gallagher Title: Senior Managing Director EVERCORE GROUP L.L.C. By: /s/ Edmund D. Baxter Name: Ed Baxter Title: Senior Managing Director [Signature Page to the Underwriters’ Acceleration Request]
2021-12-03 - UPLOAD - AN2 Therapeutics, Inc.
United States securities and exchange commission logo
December 3, 2021
Eric Easom
Chief Executive Officer
AN2 Therapeutics, Inc.
1800 El Camino Real, Suite D
Menlo Park, CA 94027
Re:AN2 Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 19, 2021
CIK No. 0001880438
Dear Mr. Easom:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted November 19, 2021
Prospectus Summary
Our Solution: Epetraborole, page 3
1.We note your response and revisions related to prior comment 1. Please also balance your
disclosure in this section with discussion of three clinical trials that were terminated as a
result of clinical resistance, as referenced on pages 106-107. Please also briefly explain
clinical resistance in the summary.
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
December 3, 2021 Page 2
FirstName LastNameEric Easom
AN2 Therapeutics, Inc.
December 3, 2021
Page 2
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies, Significant Judgments and Use of Estimates
Stock-Based Compensation
Common Stock Valuations, page 85
2.Please refer to prior comment 13. Your revised disclosure addresses the specific
methodology and key assumptions used to determine the fair value of your common stock.
Please revise to explain how you determined the enterprise value, which as you state on
page 85, is allocated across classes and series of capital stock to determine the estimated
fair value of common stock at each valuation date. Please also disclose the nature of the
assumptions used in determining the enterprise value.
Business
Prior Clinical Experience with Epetraborole, page 106
3.We note that you added disclosure stating the observations of clinical resistance were
similar to those for rifampicin. It is inappropriate to imply that you are likely to achieve
similar results. Please revise your disclosure accordingly.
Adjuvant Global Health Agreement, page 115
4.We note your response to prior comment 17. You state on page 115
that given "substantially all NTM development activities, including toxicology studies,
clinical trials and manufacturing, overlap with tuberculosis and melioidosis development
activities, we believe the risk of repayment related to any future potential investment is
low." Please revise this statement in light of the fact that regulatory strategies, product
registration, and seeking funding from governmental grants and other granting sources
may not overlap with NTM activities.
License Agreement with Anacor Pharmaceuticals, Inc. , page 116
5.We note your response to prior comment 18. Please clarify, if true, that you sublicense to
Brii Biosciences Limited intellectual property licensed from Anacor Pharmaceuticals.
Ensure that your revisions clarify the circumstances under which a breach of your
agreement by Brii Biosciences could result in a breach of your agreement with Anacor
Pharmaceuticals.
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
December 3, 2021 Page 3
FirstName LastName
Eric Easom
AN2 Therapeutics, Inc.
December 3, 2021
Page 3
You may contact Franklin Wyman at 202-551-3660 or Mary Mast at 202-551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Gary Guttenberg at 202-551-6477 or Christine Westbrook at 202-551-5019 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Josh Seidenfeld, Esq.
2021-10-22 - UPLOAD - AN2 Therapeutics, Inc.
United States securities and exchange commission logo
October 22, 2021
Eric Easom
Chief Executive Officer
AN2 Therapeutics, Inc.
1800 El Camino Real, Suite D
Menlo Park, CA 94027
Re:AN2 Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted September 24, 2021
CIK No. 0001880438
Dear Mr. Easom:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 Submitted September 24, 2021
Prospectus Summary
Overview, page 1
1.Please revise the disclosure in your Summary to make clear that your clinical development
of epetraborole is limited to the ongoing Phase 1b trial being conducted in healthy
volunteers in Australia. Address in your revisions that you anticipate enrolling 56
volunteers, as referenced on page 108, and include the number of volunteers enrolled to
date. Please also expand your discussion to substantiate your statement that you believe
your planned Phase 2/3 trial will be sufficient to proceed to a marketing application for
epetraborole. In this regard, we note your disclosure on page 17 that differences with prior
clinical trials, including differences in patient populations, targeted indication, formulation
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
October 22, 2021 Page 2
FirstName LastNameEric Easom
AN2 Therapeutics, Inc.
October 22, 2021
Page 2
and trial design will limit the use of prior clinical data for epetraborole. Please also
balance your disclosure with discussion of the following:
•Earlier clinical trials were not conducted in patients with non-tuberculous
mycobacterial (NTM) lung disease, as referenced on page 17; and
•That clinical resistance was observed in a Phase 2 clinical trial and three other
clinical trials were terminated as a result of these observations, as disclosed on pages
102-103.
Given the current stage of development, please revise your statement concerning the
potential for epetraborole to become the backbone of a multi-drug treatment regimen for
patients suffering from NTM lung disease as such statements are premature and
speculative.
2.We note you cite a "substantial pharmacokinetic and safety data package [that is] expected
to reduce risk in the development program" as a reason why epetraborole is an attractive
opportunity. Please revise to remove any implication that you will successfully mitigate
clinical development risk.
3.On page 3, when describing epetraborole, you discuss results from a "previous Phase 1
clinical trial." Please clarify whether this clinical trial was conducted by a third party or
whether you are referring to your ongoing Phase 1b trial.
Our Pipeline, page 1
4.Please revise your presentation to shorten the arrow corresponding to your Phase 1 trial
for the treatment of treatment-refractory MAC to make clear the current status. In this
regard we note that enrollment is ongoing. As written, your presentation implies that you
are half way to completion. Your presentation should not imply that earlier trials were
conducted in your target indications.
5.It appears your development of epetraborole for the treatment of meliodidosis and
tuberculosis is limited to preclinical research discussed on pages 110-111 and that you
have not secured funding for these programs. Please provide us with your analysis
supporting the materiality of these programs to your business such that inclusion in your
pipeline table is appropriate. Alternatively, please remove these programs from the table.
Our Solution, page 3
6.We note your statement that in previous clinical trials epetraborole was “generally safe
and well-tolerated.” Please revise these and any similar statements throughout your
registration statement that imply your product candidate is safe or effective as such
determinations are made solely by the FDA or comparable regulatory bodies. As a non-
exhaustive list of examples only, we note the following disclosures:
•Epetraborole has demonstrated broad antimycobacterial activity against MAC…; and
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
October 22, 2021 Page 3
FirstName LastNameEric Easom
AN2 Therapeutics, Inc.
October 22, 2021
Page 3
•Based on the potent in vivo efficacy seen in preclinical mouse models….
7.We note your disclosure that you intend to conduct trials and pursue marketing
authorizations with epetraborole in additional geographies outside of the United States and
Europe, with an initial focus in Japan. Please discuss regulatory approval requirements in
Europe and Japan under an appropriate heading in the Business section.
Risks Associated with our Business, page 5
8.Please add a bullet point highlighting the risks associated with your licensing
arrangements, including that you are dependent on your license agreement with
Anacor and that a breach by Brii Biosciences of your out-license agreement could result in
a breach under your in-license agreement with Anacor, as referenced on page 39.
Implications of Being an Emerging Growth Company, page 6
9.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risk Factors , page 12
10.Please revise this section to relocate any generic risk factors you present to the end of the
section under the caption "General Risk Factors." Refer to Item 105(a) of Regulation S-K.
Risks Related to Regulatory Approval of Epetraborole..., page 49
11.Please revise your discussion of the FDA’s limited-population antibacterial drug (LPAD)
pathway to remove any implication that the FDA’s approval of Insmed’s Arikayce under
this pathway makes it more likely that you will secure marketing approval for
epetraborole. Please also revise to disclose the labeling requirements applicable under this
pathway.
Risks Related to this Offering...
Our amended and restated certificate of incorporation will provide that the Court of Chancery...,
page 61
12.We note your disclosure on page 160 that your choice of forum provision would not apply
to claims brought to enforce any duty or liability created by the Securities Exchange Act.
Please revise your risk factor disclosure to so state and ensure that the exclusive forum
provision in your governing documents states this clearly. Please also disclose that your
forum selection provisions may increase costs for an investors to bring a claim. Please
also revise your disclosure concerning your federal forum selection provision to disclose
that there is uncertainty as to whether a court would enforce such provision. In this regard,
we note that Section 22 of the Securities Act creates concurrent jurisdiction for federal
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
October 22, 2021 Page 4
FirstName LastNameEric Easom
AN2 Therapeutics, Inc.
October 22, 2021
Page 4
and state courts over all suits brought to enforce any duty or liability created by the
Securities Act or the rules and regulations thereunder.
Management's Discussion and Analysis
Stock-Based Compensation
Common Stock Valuations, page 83
13.Please disclose the specific methodology used to determine your enterprise value and the
nature of any significant assumptions used.
Business
Prior Clinical Experience with Epetraborole, page 102
14.We note that your disclosure that previous epetraborole studies were discontinued in 2010
due to "clinical resistance." Please explain the term "clinical resistance" and provide
specific examples.
15.We note your statement on page 104 that in the SAD/MAD Phase 1 study, there were no
deaths, serious adverse events (SAEs) or any adverse events leading to withdrawal from
the study. Throughout this section, ensure that you disclose all SAEs and the number of
patients who experienced them for all SAEs that were determined to be treatment related
or that the investigator could not determine were not treatment related.
Our Global Health Initiatives, page 110
16.Please expand your disclosure to discuss the preclinical mouse model and in vitro studies
referenced in this section, including when they were conducted. Please revise statements
that present your conclusions regarding efficacy, such as "Epetraborole has demonstrated
effectiveness [in] in vitro and in vivo mouse models of melioidosis." You may present
results from your study but may not conclude that the data establishes efficacy.
Additionally, given the early stage of development for these indications, please revise
your disclosure concerning the potential of epetraborole to have a significant impact on
the global health system as such statements are premature and speculative.
Adjuvant Global Health Agreement, page 111
17.We note your disclosure that you have obligations under the Adjuvant Global Health
Agreement to, among others, use reasonably diligent efforts to develop epetraborole for
melioidosis and tuberculosis and to develop regulatory strategies and pursue necessary
product registrations and actively seek funding from governmental grants and other
granting sources. You state that if you do not maintain compliance with these and other
program-related investment commitments, Adjuvant may be entitled to repayment of any
portion of its investment that is not used for the purposes outlined in the agreement. Please
revise to clearly explain the terms under which Adjuvant would be entitled to repayment.
To the extent your activities to date pursuant to your obligations are limited to preclinical
research referenced on pages 110-111, please revise to so state. Alternatively, please
FirstName LastNameEric Easom
Comapany NameAN2 Therapeutics, Inc.
October 22, 2021 Page 5
FirstName LastName
Eric Easom
AN2 Therapeutics, Inc.
October 22, 2021
Page 5
describe your activities to date. Additionally, please file the agreement as an exhibit to
your registration statement. Refer to Item 601(b)(10) of Regulation S-K.
Licensing Agreements
License Agreement with Anacor Pharmaceuticals, Inc., page 112
18.Please revise this section to disclose aggregate potential milestone payments segregated
by development, regulatory and commercial sales milestones. Where applicable, disclose
the royalty rate or range not to exceed ten percentage points per tier. Additionally, please
provide the number of years related to the royalty term and the anticipated expiry of
exclusivity and the last-to-expire patent licensed under the agreement. Please also clarify
the financial terms triggered by your out-license agreement with Brii Biosciences Limited.
License Agreement with Brii Biosciences Limited , page 113
19.Please revise this section to disclose aggregate potential milestone payments segregated
by development, regulatory and commercial sales milestones. Where applicable, disclose
the royalty rate or range not to exceed ten percentage points per tier. Additionally, please
disclose the royalty term, duration of the agreement and termination provisions.
6. Commitments and Contingencies
Adjuvant Global Health Agreement, page F-16
20.Describe and quantify the covenants you are required to maintain governing your
contingent obligation to repay Adjuvant for "any portion of its investment that is not used
for purposes outlined in the Global Health Agreement." Tell us supplementally why you
believe repayment will not be required.
You may contact Franklin Wyman at 202-551-3660 or Mary Mast at 202-551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Gary Guttenberg at 202-551-6477 or Christine Westbrook at 202-551-5019 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Josh Seidenfeld, Esq.