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Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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SEC wrote to company
2022-06-02
Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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Entera Bio Ltd.
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2018-01-19
Entera Bio Ltd.
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2018-01-19
Entera Bio Ltd.
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2018-01-29
Entera Bio Ltd.
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2018-01-29
Entera Bio Ltd.
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SEC wrote to company
2018-06-12
Entera Bio Ltd.
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Company responded
2018-06-15
Entera Bio Ltd.
References: June 11, 2018
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2018-06-25
Entera Bio Ltd.
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2018-06-25
Entera Bio Ltd.
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Entera Bio Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2018-06-22
Entera Bio Ltd.
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2018-06-25
Entera Bio Ltd.
References: June 22, 2018
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Entera Bio Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2017-11-17
Entera Bio Ltd.
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2017-11-20
Entera Bio Ltd.
References: November 17, 2017
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Entera Bio Ltd.
Awaiting Response
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2017-10-05
Entera Bio Ltd.
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Entera Bio Ltd.
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2017-08-11
Entera Bio Ltd.
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Entera Bio Ltd.
Awaiting Response
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Medium
SEC wrote to company
2015-05-01
Entera Bio Ltd.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-04 | SEC Comment Letter | Entera Bio Ltd. | Israel | 333-287676 | Read Filing View |
| 2025-06-04 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2025-05-23 | SEC Comment Letter | Entera Bio Ltd. | Israel | 001-38556 | Read Filing View |
| 2025-05-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2025-05-06 | SEC Comment Letter | Entera Bio Ltd. | Israel | 001-38556 | Read Filing View |
| 2024-02-14 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-07 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-07 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-07-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-07-17 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-06-22 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-06-11 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-26 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-26 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-22 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-15 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-12 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-19 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-19 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-17 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-17 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-08-11 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-04 | SEC Comment Letter | Entera Bio Ltd. | Israel | 333-287676 | Read Filing View |
| 2025-05-23 | SEC Comment Letter | Entera Bio Ltd. | Israel | 001-38556 | Read Filing View |
| 2025-05-06 | SEC Comment Letter | Entera Bio Ltd. | Israel | 001-38556 | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-07-17 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-06-11 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-26 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-22 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-12 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-17 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-08-11 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | SEC Comment Letter | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-04 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2025-05-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2024-02-14 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-07 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2022-06-07 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-07-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2020-06-22 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-26 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-25 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-06-15 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-19 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2018-01-19 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-20 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
| 2017-11-17 | Company Response | Entera Bio Ltd. | Israel | N/A | Read Filing View |
2025-06-04 - UPLOAD - Entera Bio Ltd. File: 333-287676
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 4, 2025 Miranda Toledano Chief Executive Officer Entera Bio Ltd. Kiryat Hadassah Minrav Building - Fifth Floor Jerusalem, Israel 9112002 Re: Entera Bio Ltd. Registration Statement on Form S-3 Filed May 30, 2025 File No. 333-287676 Dear Miranda Toledano: 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: Sami B. Ghneim, Esq. </TEXT> </DOCUMENT>
2025-06-04 - CORRESP - Entera Bio Ltd.
CORRESP 1 filename1.htm Entera Bio Ltd. Minrav Building – Fifth Floor Jerusalem, Israel 9112002 June 4, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Jason Drory RE: Entera Bio Ltd. (the “Company”) Registration Statement on Form S-3 (the “Registration Statement”) Filed May 30, 2025 File No. 333-287676 Dear Mr. Drory: The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:00 p.m. on June 6, 2025, or as soon thereafter as practicable. [Signature page follows] Very truly yours, Entera Bio Ltd. By: /s/ Miranda Toledano Name: Miranda Toledano Title: Chief Executive Officer
2025-05-23 - UPLOAD - Entera Bio Ltd. File: 001-38556
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 23, 2025 Dana Yaacov-Garbeli Chief Financial Officer Entera Bio Ltd. Minrav Building Fifth Floor Jerusalem, Israel 9112002 Re: Entera Bio Ltd. Form 10-K for the fiscal year ended December 31, 2024 File No. 001-38556 Dear Dana Yaacov-Garbeli: We have completed our review of your filing. 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. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-05-20 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
May 19, 2025
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-7010
Attention: Vanessa Robertson
Kevin Vaughn
RE: Entera Bio Ltd.
Form 10-K for the Fiscal Year Ended December 31, 2024
File No. 001-38556
Dear Ms. Robertson and Mr. Vaughn,
On behalf of Entera Bio Ltd., a company organized under the laws of the State of Israel (the “ Company ”), we respectfully submit this letter in response to the comment letter, dated May 6, 2025 (the “ Comment
Letter ”), received by the Company from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ SEC ”) concerning the Company’s Form 10-K for the fiscal year ended December 31, 2024.
For ease of reference, we have reproduced the text of the Staff’s comment in bold italicized face, followed by the Company’s response. In the responses below, references to “we,” “our,” and “us” refer to the Company.
Form 10-K for Fiscal Year Ended December 31, 2024
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research and Development Expenses, page 84
1.
You disclose on page 83 that research and development expenses for the years ended December 31, 2024 and 2023 were primarily for the development of EB613, EB612 and your collaboration with
OPKO related to GLP-2 and OXM. Please provide revised disclosure to be included in future filings to break out research and development expenses by product candidate or by indication. For amounts that are not tracked by program, provide other
quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. by nature or type of expense) for each period presented which should reconcile to total research and
development expense on the Statements of Operations.
Company’s Response:
The Company respectfully acknowledges the Staff’s comment and advises that in future filings, beginning with its Quarterly Report on Form 10-Q for the quarter ending June 30, 2025, it will enhance its
disclosure in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Components of Results of Operations – Research and Development Expenses” to provide
greater detail with respect to the Company’s research and development expenses.
It should be noted that until the second quarter of 2025, the majority of our research and development costs were associated with our EB613 clinical program, as such no allocation of the internal
expenses by program was performed. Following the signing of the collaboration agreement with OPKO Biologics, Inc. (hereafter – OPKO), commencing the second quarter of 2025, we are required to gather the relevant research and development expenses
incurred in the collaboration with OPKO on the OXM program; as such these expenses will be disclosed separately in future filings.
In addition, the Company will enhance its disclosure to break out external research and development costs associated with EB613 (including costs related to the new generation platform) separately from
those related to other programs, including EB612 and the GLP-2 program, which are currently at earlier stages of development, and the costs for which will be presented in aggregate.
Internal and certain external research and development expenses, such as employee compensation, rent and facility-related costs, general laboratory supplies and consumables, and certain consulting
fees, support multiple product candidates and development programs. As these costs are not tracked by individual program but support the Company’s overall research and development efforts, the Company will present them by nature of expense. These
disclosures will be reconciled to the total research and development expense reported in the Statements of Operations.
Set forth below is an example of the disclosure that the Company intends to include in future filings in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.
* * * * *
Research and Development Expenses
Research and development expenses consist of costs incurred for the development of our N-Tab™ technology platform and our product candidates. We expense both internal and external research and
development expenses to operations for the periods in which they are incurred. We mapped the majority of external research and development costs incurred for our product candidates and development programs.
Internal and certain general external research and development expenses support multiple product candidate research and development programs, include:
•
employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function;
•
costs associated with our research and development platform used across programs, process development, manufacturing, consulting fees and preclinical development for earlier stage programs and new technologies;
•
expenses incurred in operating our laboratories including our small-scale manufacturing facility; and
•
depreciation of research and development equipment, allocated overhead, rent and facilities-related expenses.
External research and development expenses for our main clinical development programs include:
•
expenses incurred under agreements with CROs and investigative sites that conduct our clinical trials;
•
other costs associated with pre-clinical and clinical activities;
•
supply, development and manufacturing costs relating to clinical trial materials; and
•
certain consulting and advisory services related to the program;
Research and development activities are the primary focus of our business. Product candidates in later stages of clinical development generally have higher development costs than those in earlier
stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase significantly in future periods as we advance our clinical candidates
into later stages of clinical development and invest in additional preclinical candidates.
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical
trials and the enrollment of patients in clinical trials. Research and development expenses for the three and six months ended June 30, 2025 were primarily for the development of EB613 and our collaboration with OPKO related to OXM and for the three
and six months ended June 30, 2024 were primarily for the development of EB613. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the
efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing
drugs, including:
•
the uncertainty of the scope, rate of progress, results and cost of our clinical trials, nonclinical testing and other related activities;
•
the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop;
•
the number and characteristics of product candidates that we pursue;
•
the cost, timing and outcomes of regulatory approvals;
•
the cost and timing of establishing any sales, marketing, and distribution capabilities; and
•
the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder.
A change in the outcome of any of these variables with respect to the development of EB613, OXM or any other product candidate that we may develop could significantly change the costs and timing
associated with the development of any such product candidate. For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the
completion of clinical development, if we experience significant delays in enrollment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial
resources and time on the completion of the clinical development.
Our research and development expenses for the three and six months ended June 30, 2025 and June 30, 2024 are summarized as follows:
Six Months Ended June 30,
(unaudited)
Three Months Ended June 30,
(unaudited)
2025
2024
2025
2024
(In thousands)
(In thousands)
External Expenses related to EB613
$
$
$
$
Internal and External expenses related to OXM collaboration with OPKO
Internal and External expenses related to other development program:
Payroll and related expenses
Share-based compensation
Rent and related expenses
Other development expenses
Research and development expenses
$
$
$
$
* * * * *
If you or any other member of the Staff should have any further comments or questions regarding this response, please do not hesitate to contact the undersigned at +972-52-7555346.
Sincerely,
Entera Bio Ltd.
By: /s/ Dana Yaacov-Garbeli
Dana Yaacov-Garbeli
Chief Financial Officer
cc: Drew M. Altman, Esq., Greenberg Traurig, P.A.
2025-05-06 - UPLOAD - Entera Bio Ltd. File: 001-38556
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 6, 2025 Dana Yaacov-Garbeli Chief Financial Officer Entera Bio Ltd. Minrav Building Fifth Floor Jerusalem, Israel 9112002 Re: Entera Bio Ltd. Form 10-K for the fiscal year ended December 31, 2024 File No. 001-38556 Dear Dana Yaacov-Garbeli: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the fiscal year ended December 31, 2024 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and Development Expenses, page 84 1. You disclose on page 83 that research and development expenses for the years ended December 31, 2024 and 2023 were primarily for the development of EB613, EB612 and your collaboration with OPKO related to GLP-2 and OXM. Please provide revised disclosure to be included in future filings to break out research and development expenses by product candidate or by indication. For amounts that are not tracked by program, provide other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. by nature or type of expense) for each period presented which should reconcile to total research and development expense on the Statements of Operations. In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, May 6, 2025 Page 2 action or absence of action by the staff. Please contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2024-02-14 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera Bio Ltd.
Minrav Building – Fifth Floor
Jerusalem, Israel 9112002
February 14, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Doris Stacey Gama
RE:
Entera Bio Ltd. (the “Company”)
Registration Statement on Form S-3, as amended (the “Registration Statement”)
Filed February 2, 2024
File No. 333-276844
Dear Ms. Gama
The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended,
acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:15 p.m. on February 14, 2024, or as soon thereafter as practicable.
Very truly yours,
Entera Bio Ltd.
By:
/s/ Miranda Toledano
Name: Miranda Toledano
Title: Chief Executive Officer
2022-06-07 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera Bio Ltd.
Minrav Building – Fifth Floor
Jerusalem, Israel 9112002
June 7, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Michael Davis
RE: Entera Bio Ltd. (the “Company”)
Registration Statement on Form S-3 (the “Registration Statement”)
Filed May 27, 2022
File No. 333-265291
Dear Mr. Davis:
The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended,
acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 5:00 p.m. on June 9, 2022, or as soon thereafter as practicable.
[Signature page follows]
Very truly yours,
Entera Bio Ltd.
By:
/s/ Spiros Jamas
Name: Spiros Jamas
Title: Chief Executive Officer
2022-06-07 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera Bio Ltd.
Minrav Building – Fifth Floor
Jerusalem, Israel 9112002
June 7, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Michael Davis
RE: Entera Bio Ltd. (the “Company”)
Registration Statement on Form S-3 (the “Registration Statement”)
Filed May 27, 2022
File No. 333-265286
Dear Mr. Davis:
The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended,
acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 5:00 p.m. on June 9, 2022, or as soon thereafter as practicable.
[Signature page follows]
Very truly yours,
Entera Bio Ltd.
By:
/s/ Spiros Jamas
Name: Spiros Jamas
Title: Chief Executive Officer
2022-06-02 - UPLOAD - Entera Bio Ltd.
United States securities and exchange commission logo
June 1, 2022
Spiros Jamas
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem, Israel 9112002
Re:Entera Bio Ltd.
Registration Statement on Form S-3
Filed May 27, 2022
File No. 333-265286
Dear Spiros Jamas:
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 Michael Davis at 202-551-4385 or Joe McCann at 202-551-6262 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Drew M. Altman
2020-07-20 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
July 20, 2020
Re:
Entera Bio Ltd.
Registration Statement on Form F-3
Filed on July 13, 2020
Registration No. 333-239843
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933,
as amended, the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above
be accelerated so that it will be declared effective at 9:00 a.m. Eastern Daylight Time on July 22, 2020 or as soon thereafter
as is practicable.
Sincerely,
Entera Bio Ltd.
By:
/s/ Adam Gridley
Name: Adam Gridley
Title: Chief Executive Officer
Via EDGAR
2020-07-17 - UPLOAD - Entera Bio Ltd.
United States securities and exchange commission logo
July 17, 2020
Adam Gridley
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem, Israel
Re:Entera Bio Ltd.
Registration Statement on Form F-3
Filed July 13, 2020
File No. 333-239843
Dear Mr. Gridley:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Yasin Keshvargar, Esq.
2020-06-22 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
June 22, 2020
Re:
Entera Bio Ltd.
Registration Statement on Form F-3
Filed on June 5, 2020
Registration No. 333-238988
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933,
as amended, the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above
be accelerated so that it will be declared effective at 9:00 a.m. Eastern Daylight Time on June 24, 2020 or as soon thereafter
as is practicable.
Sincerely,
Entera Bio Ltd.
By:
/s/ Adam Gridley
Name: Adam Gridley
Title: Chief Executive Officer
Via EDGAR
2020-06-11 - UPLOAD - Entera Bio Ltd.
United States securities and exchange commission logo
June 11, 2020
Adam Gridley
Chief Executive Officer
Entera Bio Ltd.
Minrav Building - Fifth Floor
Jerusalem, Israel
Re:Entera Bio Ltd.
Registration Statement on Form F-3
Filed June 5, 2020
File No. 333-238988
Dear Mr. Gridley:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Yasin Keshvargar, Esq.
2018-06-26 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 701 5800 fax
sophia.hudson@davispolk.com
June 26, 2018
Re:
Entera Bio Ltd.
Amendment No. 6 to Registration Statement on Form F-1
Submitted June 15, 2018
CIK No. 0001638097
CONFIDENTIAL
Ms. Ada D. Sarmento and Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Sarmento and Ms. Breslin,
On behalf of our client, Entera Bio Ltd., a company incorporated
in Israel with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to Amendment No. 6 to the Company’s
Registration Statement on Form F-1 (the “Registration Statement”) contained in the Staff’s letter dated
June 26, 2018 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company
has revised the Registration Statement and is filing an amended Registration Statement (“Amendment No. 7”) together
with this response letter.
Set forth below are the Company’s responses to the Staff’s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff’s comments are repeated below, followed by the Company’s response to the comments as well as
a summary of the responsive actions taken. We have included page numbers to refer to the location in Amendment No. 7 where the
revised language addressing a particular comment appears.
Ms. Ada D. Sarmento,
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
2
June 26, 2018
Amended Registration Statement on Form F-1 filed June 25,
2018
Exhibits
1. Please
have counsel revise Exhibit 5.2 to delete the assumption in the last paragraph on page 1 that the warrants have been duly authorized,
executed and delivered by the company insofar as Israeli law is concerned and the assumptions in the first paragraph on page 2
with respect to the company. It is inappropriate to assume that the company has been duly incorporated and is validly existing
under the laws of the jurisdiction of its organization and that it has taken the required steps to authorize entering into the
obligation under the law of the jurisdiction of organization. In addition, it is inappropriate for counsel to assume items (a)
through (d) with respect to the company. As counsel did not specifically opine on these matters, the “provided” clause
does not appear to have any effect. Alternatively, tell us why these assumptions are necessary and appropriate. Refer to Section
II.B.1.e of Staff Legal Bulletin No. 19 for guidance.
Response: In response to the Staff's comment, the Company has filed an updated Exhibit 5.2 to the Registration Statement. The Company
respectfully submits that, consistent with Section (B)(1)(e) of Staff Bulletin 19, Davis Polk & Wardwell LLP, as U.S. counsel
to the Company, has assumed the due authorization of the warrants based upon the opinion regarding the due authorization of the
warrants included in the opinion of Herzog Fox & Neeman, the Company's Israeli counsel, filed as Exhibit 5.1 of the Registration
Statement.
Please do not hesitate to contact me at (212) 450-4762, (212)
701-5800 (fax) or sophia.hudson@davispolk.com or Michael Kaplan at (212) 450-4111, (212) 701-5800 (fax) or michael.kaplan@davispolk.com
if you have any questions regarding the foregoing or if I can provide any additional information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
cc:
Via E-mail
Dr. Phillip Schwartz, Chief Executive Officer
Mira Rosenzweig, Chief Financial Officer
Entera Bio Ltd.
Michael Kaplan, Davis Polk
Ivan Blumenthal, Mintz Levin
2018-06-26 - UPLOAD - Entera Bio Ltd.
June 26, 2018
Phillip Schwartz
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem 9112002
Israel
Re:Entera Bio Ltd.
Amendment No. 6 to Registration Statement on Form F-1
Filed June 25, 2018
File No. 333-221472
Dear Dr. Schwartz:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amended Registration Statement on Form F-1 filed June 25, 2018
Exhibits
1.Please have counsel revise Exhibit 5.2 to delete the assumption in the last paragraph on
page 1 that the warrants have been duly authorized, executed and delivered by the
company insofar as Israeli law is concerned and the assumptions in the first paragraph on
page 2 with respect to the company. It is inappropriate to assume that the company has
been duly incorporated and is validly existing under the laws of the jurisdiction of its
organization and that it has taken the required steps to authorize entering into the
FirstName LastNamePhillip Schwartz
Comapany NameEntera Bio Ltd.
June 26, 2018 Page 2
FirstName LastName
Phillip Schwartz
Entera Bio Ltd.
June 26, 2018
Page 2
obligation under the law of the jurisdiction of organization. In addition, it is inappropriate
for counsel to assume items (a) through (d) with respect to the company. As counsel did
not specifically opine on these matters, the "provided" clause does not appear to have any
effect. Alternatively, tell us why these assumptions are necessary and appropriate. Refer
to Section II.B.1.e of Staff Legal Bulletin No. 19 for guidance.
You may contact Franklin Wyman at 202-551-3660 or Mark Brunhofer at 202-551-3638
if you have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551- 3625 with any
otherquestions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2018-06-25 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 701 5800 fax
sophia.hudson@davispolk.com
June 25, 2018
Re:
Entera Bio Ltd.
Amendment No. 5 to Registration Statement on Form F-1
Submitted June 15, 2018
CIK No. 0001638097
CONFIDENTIAL
Ms. Ada D. Sarmento and Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Sarmento and Ms. Breslin,
On behalf of our client, Entera Bio Ltd., a company incorporated
in Israel with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to Amendment No. 5 to the Company’s
Registration Statement on Form F-1 (the “Registration Statement”) contained in the Staff’s letter dated
June 22, 2018 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company
has revised the Registration Statement and is filing an amended Registration Statement (“Amendment No. 6”) together
with this response letter. We are also sending, under separate cover, a copy of Amendment No. 6 (including newly-filed exhibits)
and three marked copies of the Registration Statement showing the changes to the Registration Statement publicly filed on June
15, 2018.
Set forth below are the Company’s responses to the Staff’s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff’s comments are repeated below, followed by the Company’s response to the comments as well as
a summary of the responsive actions taken. We have included page numbers to refer to the location in Amendment No. 6 where the
revised language addressing a particular comment appears.
Ms. Ada D. Sarmento,
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
2
June 25, 2018
Draft Amendment No. 5 to Registration Statement on Form F-1
Dilution, page 60
1. Your tabular disclosure illustrating the per share
dilution from the transactions includes a caption titled "Pro forma as adjusted net tangible book value per ordinary share."
Please remove the term, "as adjusted," from this caption in order to conform with the description in the preceding narrative.
Response: In response to the Staff’s comment, the Company has revised the disclosure on page 60 of the Registration Statement.
Exhibit 5.1, page II-8
2. Please have counsel revise the opinion to opine that
the warrants are a binding obligation of the company in accordance with Section II.B.1.f of Staff Legal Bulletin No. 19.
Response: In response to the Staff’s comment, the Company has filed Exhibit 5.2 to the Registration Statement.
Please do not hesitate to contact me at (212) 450-4762, (212)
701-5800 (fax) or sophia.hudson@davispolk.com or Michael Kaplan at (212) 450-4111, (212) 701-5800 (fax) or michael.kaplan@davispolk.com
if you have any questions regarding the foregoing or if I can provide any additional information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
cc:
Via E-mail
Dr. Phillip Schwartz, Chief Executive Officer
Mira Rosenzweig, Chief Financial Officer
Entera Bio Ltd.
Michael Kaplan, Davis Polk
Ivan Blumenthal, Mintz Levin
2018-06-25 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
MAXIM
GROUP LLC
405 Lexington Avenue, 2nd floor
New
York, NY 10174
June 25,
2018
VIA EDGAR
United States Securities and Exchange
Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Entera Bio Ltd.
Registration Statement on Form F-1, as amended
File No. 333-221472
Ladies and Gentlemen:
Pursuant to
Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933,
as amended, Maxim Group LLC, as representative of the underwriters, hereby requests acceleration of the effective date of the
above-referenced Registration Statement so that it will become effective at 4:30 p.m. Eastern Time on June 27, 2018, or as soon
thereafter as practicable.
Pursuant to
Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter, who is reasonably anticipated
to be invited 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.
The undersigned
confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating
dealers that they have complied with, or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934,
as amended, in connection with the above-referenced issue.
Very
truly yours,
Maxim Group LLC
By:
/s/
Clifford A. Teller
Name:
Clifford
A. Teller
Title:
Executive
Managing Director, Head of Investment Banking
2018-06-25 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera
Bio Ltd.
Kiryat
Hadassah
Minrav
Building – Fifth Floor
Jerusalem
9112002
Israel
June 25, 2018
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628
Attn:
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Re:
Entera Bio Ltd.
Registration Statement on Form F-1
Registration No. 333-221472
Dear Ms. Sarmento and Ms. Breslin,
Pursuant to Rule 461 under the
Securities Act of 1933, as amended, the undersigned registrant hereby requests that the effective date for the Registration Statement
referred to above be accelerated so that it will be declared effective at 4:30 p.m. Eastern Daylight Time on June 27, 2018 or
as soon thereafter as is practicable. By separate letter, the underwriters of the issuance of the securities being registered
join in this request for acceleration.
Please do not hesitate to contact
Sophia Hudson of Davis Polk & Wardwell LLP at (212) 450-4762 with any questions or comments with respect to this letter.
[Signature
Page Follows]
Sincerely,
ENTERA BIO LTD.
By:
/s/ Dr. Phillip
Schwartz
Name: Dr. Phillip Schwartz
Title: Chief Executive Officer
Via EDGAR
CC: Sophia Hudson, Davis Polk
& Wardwell LLP
2018-06-22 - UPLOAD - Entera Bio Ltd.
June 22, 2018
Phillip Schwartz
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem 9112002
Israel
Re:Entera Bio Ltd.
Amendment No. 5 to Registration Statement on Form F-1
Filed June 15, 2018
File No. 333-221472
Dear Dr. Schwartz:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 5 to Registration Statement on Form F-1
Dilution, page 60
1.Your tabular disclosure illustrating the per share dilution from the transactions includes a
caption titled "Pro forma as adjusted net tangible book value per ordinary share." Please
remove the term, "as adjusted," from this caption in order to conform with the description
in the preceding narrative.
FirstName LastNamePhillip Schwartz
Comapany NameEntera Bio Ltd.
June 22, 2018 Page 2
FirstName LastName
Phillip Schwartz
Entera Bio Ltd.
June 22, 2018
Page 2
Exhibit 5.1, page II-8
2.Please have counsel revise the opinion to opine that the warrants are a binding obligation
of the company in accordance with Section II.B.1.f of Staff Legal Bulletin No. 19.
You may contact Franklin Wyman at 202-551-3660 or Mark Brunhofer at 202-551-3638
if you have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551- 3625 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2018-06-15 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 701 5800 fax
sophia.hudson@davispolk.com
June 15, 2018
Re:
Entera Bio Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Submitted May 17, 2018
CIK No. 0001638097
CONFIDENTIAL
Ms. Ada D. Sarmento and Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Sarmento and Ms. Breslin,
On behalf of our client, Entera Bio Ltd., a company incorporated
in Israel with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to Amendment No. 4 to the Company’s
Registration Statement on Form F-1 (the “Registration Statement”) contained in the Staff’s letter dated
June 11, 2018 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company
has revised the Registration Statement and is filing an amended Registration Statement (“Amendment No. 5”) together
with this response letter. The amended Registration Statement also contains certain additional updates and revisions. We are also
sending, under separate cover, a copy of Amendment No. 5 (including newly-filed exhibits) and three marked copies of the Registration
Statement showing the changes to the Registration Statement publicly filed on May 17, 2018.
Set forth below are the Company’s responses to the Staff’s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff’s comments are repeated below, followed by the Company’s response to the comments as well as
a summary of the responsive actions taken. We have included page numbers to refer to the location in Amendment No. 5 where the
revised language addressing a particular comment appears.
Ms. Ada D. Sarmento,
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
2
June 15, 2018
Draft Amendment No. 4 to Registration Statement on Form F-1
Use of Proceeds, page 9, 10 and 56
1. We note your revised disclosure that you will need to
raise additional capital for the Phase 2b/3 trial of EB612 and for the Phase 2a trial for EB613. Please further revise to describe
how far in the clinical development, and specifically these trials, you expect to reach with the proceeds from this offering.
Response: In response to the Staff’s comment, we have revised the disclosure on pages 9, 10 and 56 of the Registration Statement.
Please do not hesitate to contact me at (212) 450-4762, (212)
701-5800 (fax) or sophia.hudson@davispolk.com or Michael Kaplan at (212) 450-4111, (212) 701-5800 (fax) or michael.kaplan@davispolk.com
if you have any questions regarding the foregoing or if I can provide any additional information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
cc:
Via E-mail
Dr. Phillip Schwartz, Chief Executive Officer
Mira Rosenzweig, Chief Financial Officer
Entera Bio Ltd.
Michael Kaplan, Davis Polk
Ivan Blumenthal, Mintz Levin
2018-06-12 - UPLOAD - Entera Bio Ltd.
June 11, 2018
Phillip Schwartz
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem 9112002
Israel
Re:Entera Bio Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed May 17, 2018
File No. 333-221472
Dear Dr. Schwartz:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment No. 4 to Form F-1 filed May 17, 2018
Use of Proceeds, page 58
1.We note your revised disclosure that you will need to raise additional capital for the Phase
2b/3 trial of EB612 and for the Phase 2a trial for EB613. Please further revise to describe
how far in the clinical development, and specifically these trials, you expect to reach with
the proceeds from this offering.
You may contact Franklin Wyman at 202-551-3660 or Mark Brunhofer at 202-551-3638
if you have questions regarding comments on the financial statements and related
FirstName LastNamePhillip Schwartz
Comapany NameEntera Bio Ltd.
June 11, 2018 Page 2
FirstName LastName
Phillip Schwartz
Entera Bio Ltd.
June 11, 2018
Page 2
matters. Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-
3625 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2018-01-29 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building – Fifth
Floor
Jerusalem 9112002
Israel
January 29, 2018
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628
Attn: Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Re:
Entera Bio Ltd.
Registration Statement on Form F-1
Registration No. 333-221472
Dear Ms. Sarmento and Ms. Breslin,
Reference is made to our letter, filed as correspondence via
EDGAR on January 19, 2018, in which we requested the acceleration of the effective date of the above-referenced registration statement
for Tuesday, January 23, 2018, at 4:00 p.m. Eastern Time, in accordance with Rule 461 under the Securities Act of 1933, as amended.
We are no longer requesting that such registration statement be declared effective at this time and we hereby formally withdraw
our request for acceleration of the effective date.
[Signature Page Follows]
Sincerely,
ENTERA BIO LTD.
By:
/s/ Phillip Schwartz
Name: Phillip Schwartz
Title: Chief Executive Officer
Via EDGAR
CC: Michael Kaplan, Davis Polk & Wardwell LLP
Sophia Hudson, Davis Polk & Wardwell
LLP
2018-01-29 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Oppenheimer
& Co. Inc.
85 Broad Street
New
York, NY 10004
January 29, 2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Entera Bio Ltd.
Withdrawal
of Acceleration Request- Registration Statement on Form F-1, as amended
File
No. 333-221472
Ladies and Gentlemen:
Reference is made to our letter, filed as
correspondence via EDGAR on January 19, 2018, in which we, as representative of the several underwriters of Entera Bio Ltd.’s
proposed initial public offering of ordinary shares, joined Entera Bio Ltd.’s request for acceleration of the effective date
of the above-referenced Registration Statement for Tuesday, January 23, 2018, at 4:00 p.m. Eastern Time. Entera Bio Ltd. is no
longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our request
for acceleration of the effective date.
Very truly yours,
Oppenheimer & Co. Inc.
By:
/s/ Michael Margolis
Name:
Michael Margolis
Title:
Managing Director
2018-01-19 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building – Fifth Floor
Jerusalem 9112002
Israel
January 19, 2018
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628
Attn: Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Re:
Entera Bio Ltd.
Registration Statement on Form F-1
Registration No. 333-221472
Dear Ms. Sarmento and Ms. Breslin,
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above be accelerated
so that it will be declared effective at 4:00 p.m. Eastern Daylight Time on January 23, 2018 or as soon thereafter as is practicable.
By separate letter, the underwriters of the issuance of the securities being registered join in this request for acceleration.
Please do not hesitate to contact Sophia Hudson of Davis
Polk & Wardwell LLP at (212) 450-4762 with any questions or comments with respect to this letter.
[Signature Page Follows]
Sincerely,
ENTERA BIO LTD.
By:
/s/ Phillip Schwartz
Name: Phillip Schwartz
Title: Chief Executive Officer
Via EDGAR
CC: Sophia Hudson, Davis Polk & Wardwell LLP
2018-01-19 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
Oppenheimer
& Co. Inc.
85 Broad Street
New
York, NY 10004
January
19, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re: Entera
Bio Ltd.
Registration
Statement on Form F-1, as amended
File
No. 333-221472
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933,
as amended, Oppenheimer & Co. Inc., as representative of the underwriters, hereby requests acceleration of the effective date
of the above-referenced Registration Statement so that it will become effective at 4:00 p.m. Eastern Time on January 23, 2018,
or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter, who is reasonably
anticipated to be invited 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.
The
undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed
by participating dealers that they have complied with, or will comply with, Rule 15c2-8 promulgated under the Securities Exchange
Act of 1934, as amended, in connection with the above-referenced issue.
Very
truly yours,
Oppenheimer
& Co. Inc.
By: /s/
Michael Margolis
Name:
Michael Margolis
Title:
Managing Director
2017-11-20 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 701 5800 fax
sophia.hudson@davispolk.com
November 20, 2017
Re:
Entera Bio Ltd.
Registration Statement on Form F-1
Submitted
November 3, 2017
CIK No. 0001638097
CONFIDENTIAL
Ms.
Ada D. Sarmento and Ms. Mary B. Breslin
Division
of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear
Ms. Sarmento and Ms. Breslin,
On
behalf of our client, Entera Bio Ltd., a company incorporated in Israel with limited liability (the “Company”),
we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) relating to the Company’s Registration Statement on Form F-1 (the “Registration
Statement”) contained in the Staff’s letter dated November 17, 2017 (the “Comment Letter”).
In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is publicly
filing an amended Registration Statement (“Amendment No. 1”) together with this response letter. The amended
Registration Statement also contains certain additional updates and revisions. We are also sending, under separate cover, a copy
of Amendment No. 1 (including newly-filed exhibits) and three marked copies of the Registration Statement showing the changes
to the Registration Statement publicly filed on November 9, 2017.
Set
forth below are the Company’s responses to the Staff’s comments in the Comment Letter. The responses and information
below are based on information provided to us by the Company. For convenience, the Staff’s comments are repeated below,
followed by the Company’s response to the comments as well as a summary of the responsive actions taken. We have included
page numbers to refer to the location in Amendment No. 1 where the revised language addressing a particular comment appears.
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 20, 2017
Draft Registration Statement on Form F-1
Summary, page 3
1. Please revise your table to disclose the “Additional
Platform Molecules” that are in the discovery phase and specify the additional indications they address. Alternatively,
remove them from the pipeline table.
Response: In response to the Staff’s comment, we have revised the disclosure on pages 5, 85 and 87 of the Registration Statement.
Exhibits
2. Please file Exhibit A-2 to Exhibit 10.1 and an execution
version of Exhibit 10.12.
Response: In response to the Staff’s comment, the Company has filed a revised copy of Exhibit 10.1, which now includes the Exhibit
A-2.
The Company respectfully advises
the staff that in connection with the Convertible Promissory Note and Loan Agreements (the “2016 Loan Agreements”)
to which Exhibit 10.12 relates, the Company entered into 25 such 2016 Loan Agreements relating to loans aggregating approximately
$7.44 million. Each such agreement is substantially identical in all material respects except for the lender and the amount for
which the loan was made. For this reason, the Company chose to file a form agreement. In response to the Staff’s comment,
the Company has revised the reference to this agreement in the exhibit index to the Registration Statement to clarify that such
agreement is presented as a form, and the Company has included with the exhibit a schedule detailing the parties to the 2016 Loan
Agreements and the amounts to which each such party’s 2016 Loan Agreement relates.
Please do not hesitate to contact me at (212) 450-4762, (212)
701-5800 (fax) or sophia.hudson@davispolk.com or Michael Kaplan at (212) 450-4111, (212) 701-5800 (fax) or michael.kaplan@davispolk.com
if you have any questions regarding the foregoing or if I can provide any additional information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 20, 2017
cc:
Via E-mail
Dr. Phillip Schwartz, Chief Executive Officer
Mira Rosenzweig, Chief Financial Officer
Entera Bio Ltd.
Michael Kaplan, Davis Polk
Ivan Blumenthal, Mintz Levin
2017-11-17 - CORRESP - Entera Bio Ltd.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 701 5800 fax
sophia.hudson@davispolk.com
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
November 17, 2017
Re:
Entera Bio Ltd.
Registration Statement on Form F-1
File No. 333-221472
CIK No. 0001638097
CONFIDENTIAL
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Ada D. Sarmento and Ms. Mary B. Breslin,
On behalf of our client, Entera Bio Ltd.,
a company incorporated in Israel with limited liability (the “Company”), we are providing the information that
follows to the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
in response to comment number 8 contained in the Staff’s letter dated August 10, 2017 (the “Comment Letter”)
relating to the Company’s Draft Registration Statement on Form F-1, originally confidentially submitted on July 14, 2017
(the “Registration Statement”), in connection with the initial public offering of the Company’s ordinary
shares (the “Offering”).
The response and information below are based
on information provided to us by the Company. For convenience, the Staff’s comments are repeated below in italics, followed
by the Company’s response to the comment. Capitalized terms used but not defined herein are used herein as defined in the
Registration Statement.
Critical Accounting Policies and Estimates
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Share-Based Compensation, page 67
8. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion
features. Once you have an estimated offering
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 17, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
price, please provide us an analysis explaining
the reasons for the differences between recent valuations of your ordinary shares leading up to the IPO and the estimated offering
price.
Historical Fair Value Determination Methodology
For an explanation of how the Company determined
the fair value of the ordinary shares underlying its issuances of equity, the Company respectfully refers the Staff to the discussion
of its general approach set forth in the Registration Statement in “Management's Discussion and Analysis of Financial Condition
and Results of Operations—Share-Based Compensation” and “Note 10. Share Capital” to the Company’s
audited consolidated financial statements as of and for the periods ended December 31, 2016 and 2015, as well as “Note 4.
Financial Risk Management and Financial Instruments” to the Company’s unaudited condensed consolidated financial statements
as of and for the period ended June 30, 2017.
As there has been no public market for the Company’s ordinary
shares to date, the estimated fair value of the Company’s ordinary shares has been determined by the Company using a variety
of methods. The estimated fair value of the Company’s ordinary shares was determined using the Probability Weighted Expected
Return Method (“PWERM”) model, based on possible scenarios that the Company foresees. This model considered the value
of the Company as a whole and allocated such value to the ordinary shares and preferred shares under an option pricing model within
each applicable exit scenario of the Company (the “Hybrid Method”).
For the purpose of determining the value of the Company, the
Company used the discounted cash flow, or DCF, method. Under the DCF method, the Company’s projected after-tax cash flows
were discounted back to present value using a particular discount rate. The discount rate, known as the weighted average cost of
capital, or WACC, accounts for the time value of money and the appropriate degree of risk inherent in the Company’s business.
The DCF method requires significant assumptions, in particular, regarding the Company’s projected cash flows and the discount
rate applicable to the Company’s business.
As of September 30, 2017, the fair value of the Company’s
ordinary shares was based on the market approach and used a price per share of $908.78 per Series B preferred share from the Company’s
preferred share issuance in October 2017 as a basis for fair market value.
Various objective and subjective factors
that the Company believed were relevant in determining estimated fair value per ordinary share during each reporting period included:
· the results of a third-party valuation
obtained as of October 4, 2017, which resulted in an estimated fair value per ordinary share of $819. This valuation was prepared
using the Probability-Weighted Expected Return Method model based on possible scenarios for the Company and Backsolve option pricing
method model.
· the price at which the Company sold preferred
shares and the superior rights and preferences of the Company’s preferred shares relative to the ordinary shares at the
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 17, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
time of each grant. As detailed
above, as of October 4, 2017, the fair value of ordinary shares was valued based on the market approach and used the price per
share of $908.78 per Series B preferred share from the Company’s preferred share issuance in October 2017 as a basis for
fair market value.
· the progress of the Company’s research
and development programs, including the status of preclinical studies and clinical trials for its lead product candidates, EB612
and EB613;
· the Company’s stage of development
and its business strategy, external market conditions affecting the biotechnology industry, and trends within the biotechnology
industry, the Company’s financial position, including cash on hand, and its historical and forecasted performance and operating
results;
· the lack of an active public market for
the ordinary shares and preferred shares;
· the likelihood of achieving a liquidity
event, such as an initial public offering, in light of prevailing market conditions; and
· the analysis of initial public offerings
and the market performance of similar companies in the biopharmaceutical industry.
Estimated Offering Price
The Company hereby advises the Staff
that the underwriters in the Offering have indicated to the Company that the anticipated offering price to the public of the
Company’s ordinary shares in the Offering is expected to be between approximately $[***Redacted***] and
$[***Redacted***] per share. Please note that this price range does not reflect the effect of an anticipated share
split before the initial public offering. The Company has calculated an approximate pre-money valuation of
$[***Redacted***] million using the treasury stock method.
The actual price range to be included on
the cover of the Company’s preliminary prospectus (which will comply with the Staff’s interpretation regarding the
parameters of a bona fide price range) has not yet been finally determined and remains subject to adjustment based on factors outside
of the Company’s control. However, the Company believes that the foregoing indicative price range will not be subject to
significant change and that the actual price range will be within the range stated above (adjusting for the exchange ratio that
will be determined in conjunction with the finalizing of the actual price range).
The Company notes that, as is typical in
initial public offerings, the estimated price range for the Offering was not derived using a formal determination of fair value,
but was determined by negotiation between the Company and its underwriters for the Offering. Among the factors that were considered
in setting this range were the Company’s prospects and the history of and prospects for its industry, the general condition
of the securities markets, the recent market prices
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 17, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
of, and the demand for, publicly traded
shares of generally comparable companies and preliminary discussions with the underwriters for the Offering regarding potential
valuations of the Company.
Since January 1, 2016, the Company has issued
the following equity awards in the form of options with the following fair value per ordinary share.
Period
Number of
options granted
Exercise
price per
share
Fair value
per ordinary share
March 2016
1,133
$479.38
$1,030
May-June 2016
8
NIS 0.01*
$1,020
July-September 2016
12
NIS 0.01*
$1,010
August 2016
494
$479.00
$1,010
November 2016
4
NIS 0.01*
$990
February 2017
12
NIS 0.01*
$980
April 2017
1,133
$980
$970
October 2017**
8,578
$820
$819
November 2017
4,650
$820
$819
* As of November 2017, NIS 0.01 was equal
to less than USD 0.01
**
In April 2017, the Company’s shareholders approved granting these options pending certain triggering conditions. However,
the options did not become exerciseable until October 2017 when a relevant triggering condition was met. For accounting purposes,
the Company treated the awards as performance-based awards. Given that the performance condition was probable as of September
30, 2017, the Company recognized expenses with respect to this grant.
In October 2017, the company raised $12.4 million through the sale of its Series B preferred shares (the “Series B Financing”).
As a result, as of October 4, 2017, the Company used the market approach to determine the fair value of its ordinary shares. The
Company derived the fair value of its ordinary shares by using the price of $908.78 per Series B preferred share, the price at
which the Company sold preferred shares to investors in the Series B Financing.
In order to derive the fair value of its ordinary
shares, the Company used the Hybrid Method and Backsolve option pricing method model. Based on the market approach described above,
the Company determined that the fair value per ordinary share in October 2017 was $819, based on a fair value per ordinary share
of $[***Redacted***] for the initial public offering scenario (weighted at [***Redacted***]%). If the Company had
applied a weighting of [***Redacted***]% to the initial public offering scenario, the fair value of the Company’s
common stock in the October 2017 valuation would have been $[***Redacted***] per share.
The Company additionally performed a sensitivity analysis to
examine what the total amount of option compensation would have been if the Company had calculated the fair value of the options
granted in prior periods using $819 as the fair value of the Company’s ordinary shares for the relevant period, and the effect
was immaterial.
As discussed above, the fair value per ordinary share derived
from the market approach in October 2017 was $819, an overall decrease of 20.5% from March 2016. This decrease in fair value was
mainly due to difficulties experienced by the Company in raising capital over this period as well as
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 17, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
consideration of a short-term liability of approximately $9 million
in convertible loans that was required to be repaid in December 2017 unless converted to shares before that date (such loans were
converted to Series B-1 preferred shares in connection with the Series B Financing). In October 2017, the Company raised capital
in the form of the issuance of Series B preferred shares, which shares have superior preference liquidation rights versus ordinary
shares. As a result, the fair value of the Company’s ordinary shares decreased.
With respect to the Staff’s request for the reasons explaining
the difference between the estimated offering price and recent valuations of the Company’s ordinary shares, the Company believes
that the differences in value reflected between the estimated price range for the Offering and the fair value per share for each
of the periods set forth in the table above were primarily the result of the following factors and circumstances:
· The Company entered into the Series B Financing
in October 2017. The option awards granted in October 2017 have exercise prices of $819 for grants issued under the Company’s
Share Incentive Plan to certain directors, reflecting the fair value of the ordinary shares based on a market approach that uses
the price per share of $908.78 per Series B preferred share from the Company’s preferred share issuance in October 2017 as
a basis for fair market value.
· The Company engaged underwriters in September
2017 in connection with the Offering and submitted a confidential draft registration statement to the Commission in July 2017.
Thereafter, the Company commenced testing-the-waters meetings with potential investors in which the Company received favorable
feedback and as a result of which the Company elected to continue to pursue the Offering. In November 2017, the Company publicly
filed the Registration Statement with the Commission to position itself for the anticipated launch of the Offering.
· The Offering is expected to create liquidity,
and the estimated price range assumes that an initial public offering has occurred, a public market for the Company’s ordinary
shares has been created and the Company’s preferred shares have converted into ordinary shares in connection with the offering.
The estimated price range excludes any marketability or illiquidity discount for the Company’s ordinary shares.
· The Company expects to accrue significant
benefits as a result of becoming publicly traded through the Offering, including (i) a substantial increase in the Company’s
cash position after receiving the net proceeds from the IPO, (ii) an improved ability to raise equity and debt capital going forward,
including from the public equity and debt markets, and at a lower expected cost of capital and with reduced borrowing costs, and
(iii) the expected increased attractiveness of the Company’s equity as a currency to raise capital, compensate employees
and complete strategic transactions.
· The Company’s currently outstanding
preferred shares have economic rights and preferences superior to the Company’s ordinary shares, in particular, a liquidation
preference with interest of 5% per annum, depending on the series of preferred shares.
Ms. Ada D. Sarmento
Ms. Mary B. Breslin
Division of Corporation Finance
U.S. Securities and Exchange Commission
November 17, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Entera Bio Ltd.
The estimated price range reflects
the contemplated conversion of the Company’s preferred shares into ordinary shares in the initial public offering and the
corresponding elimination of such superior economic rights and preferences.
· The estimated price range for the Offering
is based only upon a scenario in which the Company completes the Offering and is not probability weighted, in contrast to the Company’s
prior valuations of the Company’s ordinary shares in connection with its option gra
2017-11-17 - UPLOAD - Entera Bio Ltd.
November 17, 2017
Phillip Schwartz
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem 9112002
Israel
Re:Entera Bio Ltd.
Amendment No. 2 to
Draft Registration Statement on Form F-1
Filed November 3, 2017
CIK No. 0001638097
Dear Dr. Schwartz:
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.
DRS/A submitted November 3, 2017
Summary, page 3
1.Please revise your table to disclose the "Additional Platform Molecules" that are in the
discovery phase and specify the additional indications they address. Alternatively,
remove them from the pipeline table.
FirstName LastNamePhillip Schwartz
Comapany NameEntera Bio Ltd.
June 16, 2017 Page 2
FirstName LastName
Phillip Schwartz
Entera Bio Ltd.
November 17, 2017
Page 2
Exhibits
2.Please file Exhibit A-2 to Exhibit 10.1 and an execution version of Exhibit 10.12.
You may contact Franklin Wyman at 202-551-3660 or Mark Brunhofer at 202-551-3638
if you have questions regarding comments on the financial statements and related
matters. Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-
3625 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2017-10-05 - UPLOAD - Entera Bio Ltd.
October 4, 2017 Phillip Schwartz Chief Executive Officer Entera Bio Ltd. Kiryat Hadassah Minrav Building - Fifth Floor Jerusalem 9112002 Israel Entera Bio Ltd. Amendment No. 1 to Draft Registration Statement on Form F-1 Filed September 20, 2017 CIK No. 0001638097Re: Dear Dr. Schwartz: 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. Unless we note otherwise, our references to prior comments are to comments in our August 10, 2017 letter. Amendment No. 1 to Draft Registration Statement on Form F-1 Risk Factors We may not be successful in our efforts to use and expand our drug delivery technology to other product candidates, page 22 1. We note your response to our prior comment 6 and reissue in part. We note your statement in this risk factor that your synthesized PTH molecule has an established safety profile. Please remove statements suggesting that your product candidates are safe and Phillip Schwartz Entera Bio Ltd. October 4, 2017 Page 2 effective as approval by the FDA and other regulatory agencies is dependent on such agencies making this determination. Preclinical and Clinical Development of EB612, page 85 2. Please disclose how many possibly-related mild adverse events of anemia and nausea were reported and why you were not able to determine whether such events were drug- related. Preclinical and Clinical Development of EB613, page 89 3. Please disclose the number of participants that experienced the drug-related adverse events discussed in this section. The Israeli Innovation Authority Grant, page 92 4. We note your revised disclosure in response to prior comment 11 that you believe the UK agreement will not affect the royalty rates to be paid to the IIA. Please expand your disclosure to quantify the amount of the grants that you have received that could be payable to the IIA. You may contact Franklin Wyman at (202) 551-3660 or Mark Brunhofer at (202) 551- 3638 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551-3798 or Mary Beth Breslin at (202) 551- 3625 with any other questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Sophia Hudson, Esq.
2017-08-11 - UPLOAD - Entera Bio Ltd.
August 10, 2017
Phillip Schwartz
Chief Executive Officer
Entera Bio Ltd.
Kiryat Hadassah
Minrav Building - Fifth Floor
Jerusalem 9112002
Israel
Entera Bio Ltd.
Draft Registration Statement on Form F-1
Submitted July 14, 2017
CIK No. 0001638097Re:
Dear Dr. Schwartz:
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 F-1
Summary
Our Business, page 3
1. Please provide the basis for your statement that multiple dosing per day has been shown
to more effectively treat the symptoms of hypoparathyroidism than a once-daily injection,
thus reducing the serious side effects of supplement treatment and improving patient
outcomes.
Phillip Schwartz
Entera Bio Ltd.
August 10, 2017
Page 2
2. We note your disclosure that you will be conducting a Phase 2b/3 trial for EB612. Please
disclose the requirements for a clinical trial to be considered a Phase 2b/3.
3. Please revise your disclosure in the third paragraph on page 3 where you compare the
results of your Phase 2a trial for EB612 to the pivotal trial used to obtain regulatory
approval of the competing product Natpara. As currently written, the disclosure implies
that EB612 is likely to obtain FDA approval because your Phase 2a trial "showed similar
efficacy" as the Netpara pivotal trial; however, we note this was only a Phase 2a trial and
that you have not yet begun a Phase2b/3 trial designed to "possibly" be a pivotal study for
registration.
Implications of Being an "Emerging Growth Company", page 8
4. 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
Even if this offering is successful, we will need substantial additional capital in order to satisfy our
long-term growth strategy, page 15
5. Please disclose in this risk factor how long you will be able to fund your current
operations based on your current financial standing and how much additional capital you
will need to fund your operations for the next 12 months.
We may not be successful in our efforts to use and expand our drug delivery technology to other
product candidates, page 22
6. We note your statement in this risk factor that your synthesized PTH molecule has
clinically proven efficacy and an established safety profile. Please remove statements
suggesting that your product candidates are safe and effective as approval by the FDA
and other regulatory agencies is dependent on such agencies making this determination.
Use of Proceeds, page 55
7. We note your disclosure that you intend to use the proceeds of this offering, together with
cash and cash equivalents, to fund the research and development expenses of oral PTH,
development of other therapeutics, repayment of outstanding indebtedness and for
working capital and general corporate purposes. Please indicate the approximate amount
of the proceeds of this offering intended to be used for each such purpose. Please also
disclose the amount and sources of other funds needed to the extent that the proceeds of
the offering will not be sufficient to fund all of the proposed purposes. Refer to Item
3.C.1 of Form 20-F. With respect to the repayment of outstanding indebtedness, please
provide the information required by Item 3.C.4 of Form 20-F.
Phillip Schwartz
Entera Bio Ltd.
August 10, 2017
Page 3
Critical Accounting Policies and Estimates
Management's Discussion and Analysis of FInancial Condition and Results of Operations
Share-Based Compensation, page 67
8. We may have additional comments on your accounting for equity issuances including
stock compensation and beneficial conversion features. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between recent valuations of your ordinary shares leading up to the IPO and the estimated
offering price.
Business, page 76
9. We note your disclosure that EB612 and EB613 experienced negligible safety issues in
preclinical and clinical development on pages 85 and 89, respectively. Please describe
these safety issues and disclose how many of the enrollees in the trials experienced them.
Our Product Candidates, page 79
10. Please explain what a PK/PD study is the first time it is used in this section.
The Israeli Innovation Authority Grant, page 92
11. Where you describe the restrictions that could result in your having to pay up to 600% of
the grant amount plus interest, please expand your disclosure to address to extent to
which your March 2017 agreement to outsource manufacturing activities to an entity in
the United Kingdom impacts your obligations under the grant program.
Principal Shareholders, page 127
12. Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by Centillion Fund and Gakasa Holdings LLC.
Notes to the Financial Statements
Note 6--Intangible Assets, page F-17
13. Please tell us why it is appropriate to evaluate your intangible assets for impairment at the
cash generating unit level of your company as a whole. Reference for us the authoritative
literature you rely upon to support your accounting.
Note 8--Preferred Shares and Warrants to Purchase Preferred Shares, page F-21
14. Please explain how you determined the fair value of the liability to issue preferred shares
and warrants and how the movement in this liability during the three years ended
December 31, 2016 reflects your failure to file a registration statement for an initial
public offering by November 1, 2014 under the first milestone of the amended agreement
with Centillion and the likelihood that you will consummate an initial public offering on
or prior to October 1, 2017 under the second milestone.
Phillip Schwartz
Entera Bio Ltd.
August 10, 2017
Page 4
15. Please provide an analysis that describes and quantifies the factors underlying the 2016
decrease of $4,866,000 in the fair value of preferred shares and associated warrants and
liabilities.
16. Please revise your disclosure in Note 8b to indicate the current "then-applicable
conversion price" and how the conversion rate can change. To the extent that the
conversion rate will change based on your offering price for this offering, revise your
disclosures in capitalization on page 57 and dilution on page 58 to provide the impact on
both for offerings at the minimum and maximum offering prices.
Note 13--Basic and Diluted Loss per Share, page F-29
17. Please provide an analysis supporting your calculation of diluted earnings per share for
2016 and compliance with guidance in IAS 33. In particular, address the following
matters in your response.
• Explain how you calculated "income from the change in fair value of financial
liabilities" of $4,125,000 for the year ended December 31, 2016, including a description
of those financial instruments to which this amount pertains, and how it reconciles to the
corresponding amounts in the statement of comprehensive loss and the tables in Note 7b
on page F-20 and Note 8d on page F-23.
• Explain how you calculated the "additional shares issuable upon the assumed
conversion" of 17,563 shares and describe those financial instruments to which these
shares pertain.
• You state that the 2015 convertible loan, 2016 convertible loan, warrants and liability
to issue preferred shares were not included in the diluted loss per share calculations for
2016 and 2015, as the conversion terms governing these instruments "depend on future
events." Explain how these conversion terms differ from those governing the 2012
convertible loan, preferred shares and warrants to purchase preferred shares included in
your diluted loss per share computation and those events referenced in the term, "depend
on future events." In addition, as warrants are generally "exercised" and not "converted"
tell us how your disclosure is appropriate.
• Explain why each of the 2015 convertible loan, 2016 convertible loan, warrants and
liability to issue preferred shares is excluded from the 2016 calculation of diluted loss per
share, indicating whether or not, and if so how, each is anti-dilutive.
General
18. Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary
prospectus. Please note that we may have comments regarding this material.
Phillip Schwartz
Entera Bio Ltd.
August 10, 2017
Page 5
You may contact Franklin Wyman at (202) 551-3660 or Mark Brunhofer at (202) 551-
3638 if you have questions regarding comments on the financial statements and related
matters. Please contact Ada D. Sarmento at (202) 551-3798 or Mary Beth Breslin at (202) 551-
3625 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2015-05-01 - UPLOAD - Entera Bio Ltd.
April 30, 2015 Via E -mail Dr. Phillip Schwartz Chief Executive Officer Entera Bio Ltd. Kiryat Hadassah Minrav Building -Fifth Floor Jerusalem 9112002 Israel Re: Entera Bio Ltd. Draft Registration Statement on Form F -1 Submitted April 3, 2015 CIK No. 0001638097 Dear Dr. Schwartz: 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 registra tion statement or filed registration statement, we may have additional comments. Market and Industry Data, page 2 1. We note your statement that you have not independently verified the material obtained from publicly available information and independent industry publications and reports included in your registration statement. As it is not appropriate to state or imply that you do not have liability for any portion of your disclosure, please either remove that statement or include a statement here express ly accepting liability for this material regardless of your not having verified it. Dr. Phillip Schwartz Entera Bio Ltd. April 30, 2015 Page 2 Summary Our Business, page 3 2. Please briefly state how, when and from whom you acq uired your proprieta ry large molecule oral drug delivery technology . 3. In the chart on page 4 and the corresponding one on page 72, you include a row concerning the “additional oral biologics” you ar e developing. Your disclosure indicates that you have conducted initial feasibility studies with a number of non -PTH programs but it is unclear which of them, if any, has advanced to a point where a clinical trial in 2016 is feasible. If one or more has do ne so, please revise your table to include specific information about these programs, including the indication(s) they are intended to treat. However, if you are unable to provide such information at this time, please remove this row from both charts as th e programs are in too preliminary a stage to be included in a chart intended to summarize your product pipeline. Our Product Candidates, page 5 4. In your discussion of EB612 for hypoparathyroidism , please explain the significance of an orphan drug designation, note that Natpara also has received this designation and state that unless you demonstrate EB612’s clinical superiority over Natpara you will be unable to obtain regulatory approval for it un til January 2022. 5. In your product pipeline chart, you state that you expect to initiate a Phase 2a trial for your oral PTH product intended to treat non -union bone fractures in 2016. Please indicate here and wherever else relevant in your disclosure if and when you intend to conduct a Phase 1 trial for this product and, if not, the reason(s) you believe you can advance this product directly from preclinical development to a Phase 2a trial. Risk Factors Risks Related to Our Intellectual Property “If we fail to establish, maintain and enforce intellectual property rights . . .,” page 37 6. Please amend this risk factor to describe the subject matter of your proprietary technology, including technology related to your issued patents and pending patent applications. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates Share -Based Compensation, page 64 7. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences Dr. Phillip Schwartz Entera Bio Ltd. April 30, 2015 Page 3 between recent valuations of your common stock leading up to the IPO and the estimated offering price. Financial Overview Fair Value of Financial Liabilities Through Profit or Loss, page 65 8. Please describe the key assumptions that you used in determining t he value of your equity at $72 million as of December 31, 2014 that in turn resulted in your recording a $19.4 million loss. Please include the discount rate you applied in your explanation. Jobs Act Exemptions, page 70 9. Please revise your disclosure herein to be consistent with your disclosure on page 8 that says you will not be able to avail yourselves of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Business Our Product Candidates, page 74 10. In the chart on page 74, you indicate that Oral PTH for non -union fractu res is in a Phase 1 stage of development. As it appears from your disclosure that you have not yet commenced clinical trials for this product candidate, please change the status in this table to preclinical , consistent with the table on page 4 . 11. In your discussion of the Phase 1a clinical tr ial for EB612, please explain the term “Cmax.” 12. Please describe the “negligible safety issues” you have identified in your preclinical and Phase I clinical development of EB612, including the number of enrollees in the Phase 1 trial who have experienced t hem. 13. Where you discuss EB613, please explain how this product candidate differs from Forteo other than its being non -injectable. If there are no significant differences between the two products other than how they are administered, please clarify this in your disclosure. Principal Shareholders, page 117 14. In the relevant footnotes to your beneficial ownership table, please indicate the individual(s) who have voting and/or dispositive power over the shares held by Centillon Fund and Europa International, Inc. Dr. Phillip Schwartz Entera Bio Ltd. April 30, 2015 Page 4 Other Comments 15. Please suppl ement ally provide us with copies of all written communications, as defined in Rule 405 und er the Securities Act, that you, or anyone authori zed to do so on your behalf, present to po tential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. 16. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. 17. We note that your exhibits have yet to be submitted for our review. Please submit these exhibits to us as soon as practicable after their completion. Please be advised that once you file your registration statement publicly you must also file each exhibit as well, even if you have already submitted them to us as part of your confidential submission. You may contact Frank Wyman at (202) 551 -3660 or Sasha Parikh at (202) 551 -3627 if you have questions regarding comments on the financial statements and relat ed matters. Please contact Scot Foley at (202) 551 -3383 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Jeffrey P. Ried ler Jeffrey P. Riedler Assistant Director cc: Richard D. Truesdell, Jr. Sophia Hudson Davis Polk & Wardwell LLP 450 Lexington Av enue New York, NY 10017