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BICYCLE THERAPEUTICS PLC
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BICYCLE THERAPEUTICS PLC
Response Received
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SEC wrote to company
2020-06-10
BICYCLE THERAPEUTICS PLC
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Company responded
2020-06-11
BICYCLE THERAPEUTICS PLC
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BICYCLE THERAPEUTICS PLC
Response Received
3 company response(s)
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SEC wrote to company
2019-05-16
BICYCLE THERAPEUTICS PLC
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Company responded
2019-05-20
BICYCLE THERAPEUTICS PLC
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2019-05-20
BICYCLE THERAPEUTICS PLC
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Company responded
2019-05-20
BICYCLE THERAPEUTICS PLC
References: May 16, 2019
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BICYCLE THERAPEUTICS PLC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-05-07
BICYCLE THERAPEUTICS PLC
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Company responded
2019-05-13
BICYCLE THERAPEUTICS PLC
References: May 7, 2019
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BICYCLE THERAPEUTICS PLC
Response Received
2 company response(s)
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SEC wrote to company
2019-04-04
BICYCLE THERAPEUTICS PLC
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Company responded
2019-04-26
BICYCLE THERAPEUTICS PLC
References: April 4, 2019
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Company responded
2019-05-01
BICYCLE THERAPEUTICS PLC
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BICYCLE THERAPEUTICS PLC
Awaiting Response
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SEC wrote to company
2019-02-12
BICYCLE THERAPEUTICS PLC
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2025-08-12 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | 333-289423 | Read Filing View |
| 2020-06-11 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2020-06-10 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-16 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-13 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-07 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-01 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-04-26 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-04-04 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-02-12 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | 333-289423 | Read Filing View |
| 2020-06-10 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-16 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-07 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-04-04 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-02-12 | SEC Comment Letter | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2020-06-11 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-20 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-13 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-05-01 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
| 2019-04-26 | Company Response | BICYCLE THERAPEUTICS PLC | United Kingdom | N/A | Read Filing View |
2025-08-12 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm Bicycle Therapeutics plc Blocks A & B, Portway Building Granta Park Great Abington, Cambridge CB21 6GS United Kingdom August 12, 2025 Via Edgar United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jessica Dickerson RE: Bicycle Therapeutics plc Registration Statement on Form S-3 File No. 333-289423 Acceleration Request Requested Date: August 14, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-289423) (the " Registration Statement ") to become effective at 4:00 p.m. Eastern Time on Thursday, August 14, 2025, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Jaime L. Chase of Cooley LLP, counsel to the registrant, at (202) 728-7096. [ Signature page follows ] Sincerely, Bicycle Therapeutics plc By: /s/ Alethia Young Alethia Young Chief Financial Officer cc: Kevin Lee, Chief Executive Officer, Bicycle Therapeutics plc Laura A. Berezin, Cooley LLP Jaime L. Chase, Cooley LLP
2025-08-12 - UPLOAD - BICYCLE THERAPEUTICS PLC File: 333-289423
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 12, 2025 Alethia Young Chief Financial Officer Bicycle Therapeutics plc Blocks A & B, Portway Building Granta Park Great Abington, Cambridge CB21 6GS United Kingdom Re: Bicycle Therapeutics plc Registration Statement on Form S-3 Filed August 8, 2025 File No. 333-289423 Dear Alethia Young: 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 Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jaime L. Chase, Esq. </TEXT> </DOCUMENT>
2020-06-11 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm BICYCLE THERAPEUTICS PLC B900, Babraham Research Campus Cambridge CB22 3AT United Kingdom June 11, 2020 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey Gabor RE: Bicycle Therapeutics plc Registration Statement on Form S-3 File No. 333-238996 Acceleration Request Requested Date: June 15, 2020 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-238996) (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on Monday, June 15, 2020, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Jaime L. Chase of Cooley LLP, counsel to the registrant, at (202) 728-7096. [Signature page follows] Sincerely, BICYCLE THERAPEUTICS PLC By: /s/ Lee Kalowski Lee Kalowski Chief Financial Officer and President cc: Kevin Lee, Chief Executive Officer, Bicycle Therapeutics plc Laura A. Berezin, Cooley LLP Ryan S. Sansom, Cooley LLP Jaime L. Chase, Cooley LLP
2020-06-10 - UPLOAD - BICYCLE THERAPEUTICS PLC
United States securities and exchange commission logo
June 10, 2020
Kevin Lee, Ph.D., MBA
Chief Executive Officer
BICYCLE THERAPEUTICS PLC
B900, Babraham Research Campus
Cambridge CB22 3AT
United Kingdom
Re:BICYCLE THERAPEUTICS PLC
Registration Statement on Form S-3
Filed June 5, 2020
File No. 333-238996
Dear Dr. Lee:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jaime L. Chase, Esq.
2019-05-20 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP
1
filename1.htm
Goldman Sachs & Co. LLC
Jefferies LLC
Piper Jaffray & Co.
As representatives of the several Underwriters
named in Schedule I of the Underwriting Agreement
c/o Goldman Sachs & Co. LLC
200 West Street
New York, NY 10282
c/o Jefferies LLC
520 Madison Avenue
New York, NY 10022
c/o Piper Jaffray & Co.
345 Park Avenue, 12th Floor
New York, NY 10154
May 20, 2019
Via EDGAR Submission
Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, DC 20549-7010
Attn: Chris Edwards and Liz Walsh
Re:
Bicycle Therapeutics Ltd.
Registration Statement on Form S-1, as amended (File No. 333-231076)
Request for Acceleration of Effective Date
Dear Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as the representatives of the several underwriters, hereby join in the request of Bicycle Therapeutics Limited (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 p.m. Eastern Time on May 22, 2019, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective.
Pursuant to Rule 460 under the Act, we, as the representatives of the several underwriters, wish to advise you that between May 13, 2019 through the date hereof we and the other prospective underwriters have distributed approximately 3,070 copies of the Company’s Preliminary Prospectus dated May 13, 2019 to prospective underwriters, dealers, institutional investors and others.
We, the undersigned, as the representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
(signature page follows)
2
Very truly yours,
GOLDMAN SACHS & CO. LLC
JEFFERIES LLC
PIPER JAFFRAY & CO.
As representatives of the several underwriters listed in Schedule I to the Underwriting Agreement
GOLDMAN SACHS & CO. LLC
By:
/s/ Elizabeth Wood
Name:
Elizabeth Wood
Title:
Managing Director
JEFFERIES LLC
By:
/s/ Charles Glazer
Name:
Charles Glazer
Title:
Managing Director
PIPER JAFFRAY & CO.
By:
/s/ Chad E. Huber
Name:
Chad E. Huber
Title:
Managing Director
(Signature Page to Acceleration Request Letter)
2019-05-20 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm VIA EDGAR May 20, 2019 U.S. Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards and Liz Walsh Re: Bicycle Therapeutics Ltd. Acceleration Request for Registration Statement on Form S-1 File No. 333-231076 Acceleration Request Requested Date: May 22, 2019 Requested Time: 4:00 p.m., Eastern Time Dear Mr. Edwards and Ms. Walsh: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Bicycle Therapeutics Ltd. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to May 22, 2019, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling James Xu at (617) 570-1483. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: James Xu, by facsimile to (617) 801-8920 or by email at JXu@goodwinlaw.com. [Remainder of page left intentionally blank] If you have any questions regarding this request, please contact James Xu of Goodwin Procter LLP at (617) 570-1483. Sincerely, Bicycle Therapeutics Ltd. /s/ Kevin Lee Kevin Lee, Ph.D., MBA Chief Executive Officer cc: Kevin Lee, Bicycle Therapeutics Limited Lee Kalowski, Bicycle Therapeutics Limited Kristopher D. Brown, Goodwin Procter LLP Jonathan A. Schur, Goodwin Procter LLP Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Richard Segal, Cooley LLP 2
2019-05-20 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm May 20, 2019 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards and Liz Walsh Re: Bicycle Therapeutics Ltd. Registration Statement on Form S-1 Filed May 13, 2019 CIK 0001761612 Dear Mr. Edwards and Ms. Walsh: This letter is submitted on behalf of Bicycle Therapeutics Ltd (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed on May 13, 2019 ( “Amendment No. 1”), as set forth in the Staff’s letter dated May 16, 2019 addressed to Lee Kalowski, Chief Financial Officer of the Company (the “Comment Letter”). For reference purposes, the text of the Comment Letter has been reproduced herein with responses below the numbered comment. For your convenience, we have italicized the reproduced Staff comment from the Comment Letter. Unless otherwise indicated, page references in the description of the Staff’s comment refer to Amendment No.1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. Amendment No. 1 to Registration Statement on Form S-1 filed on May 13, 2019 Summary Consolidated Financial Data Statement of Operations Data, page 13 1. We note from your disclosure on page 11 that you intend to grant options to purchase an aggregate of 1,311,061 ordinary shares to certain of your directors and officers upon the effectiveness of this registration statement. Please expand your disclosure to provide a narrative description of the pro forma effects of this transaction to the extent that the grant would materially impact your net loss and pro forma net loss per share attributable to ordinary shareholders, basic and diluted, in accordance with Article 11 of Regulation S-X. Your disclosure should include the impact of the transaction by income statement line item, as applicable. Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 20, 2019 Page 2 RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it does not believe that the impact of the option awards described would be material to potential investors in the offering. The Company advises the Staff that based on the midpoint of the price range presented on the cover of the prospectus contained in Amendment No. 1, the Company expects to recognize an aggregate of approximately $17.0 million as a result of these option grants over the three-year vesting term, which would be approximately $5.7 million on an annual basis. However, their financial impact is limited to non-cash charges that will be recognized in future periods over the three-year vesting period as a component of research and development expenses and general and administrative expenses in the consolidated statements of operations and comprehensive loss, and no expense will be recorded at the time of issuance. These option grants would not result in any adjustments to the historical financial information included in Amendment No.1. In addition, Company advises the Staff that the share option grants will not impact pro-forma net loss per share attributable to ordinary shareholders, basic and diluted, because their impact is anti-dilutive. Based on its interactions with investors in prior testing the waters meetings and on its road show for the offering, its knowledge of the biotechnology industry in which the Company operates, and disclosure practices of the Company’s peers in its industry, the Company respectfully advises the Staff that it does not believe that potential investors would view the disclosure of the expected financial impact of the option grants to be material or have a material impact on their investment decision, as the investors are primarily focused on the cash balance and cash used in operations to fund the Company’s operating activities until the next inflection point in its development efforts, and the expected issuance of the options to purchase ordinary shares has been disclosed. The Company advises the Staff that once the offering price is determined at pricing following effectiveness of the Company’s Registration Statement, which will be used to measure the compensation expense that will be recognized in future periods for the share options granted, the Company intends to disclose such estimated amount of aggregate compensation expense and the period of expense recognition in its final prospectus for the offering. In addition, the Company intends to disclose the compensation charges in future periods as they are recognized in its periodic reports following the offering. Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 20, 2019 Page 3 If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1483. Sincerely, /s/ James Xu James Xu, Esq. cc: Kevin Lee, Bicycle Therapeutics Limited Lee Kalowski, Bicycle Therapeutics Limited Kristopher D. Brown, Goodwin Procter LLP Jonathan A. Schur, Goodwin Procter LLP Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Richard Segal, Cooley LLP
2019-05-16 - UPLOAD - BICYCLE THERAPEUTICS PLC
May 16, 2019
Lee Kalowski
Chief Financial Officer
Bicycle Therapeutics Ltd.
4 Hartwell Place
Lexington, Massachusetts 02421
Re:Bicycle Therapeutics Ltd.
Amendment No. 1 to Registration Statement on Form S-1
Filed May 13, 2019
File No. 333-231076
Dear Mr. Kalowski:
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 these comments, we may have additional comments.
Amendment No. 1 to Form S-1 filed on May 31, 2019
Summary Consolidated Financial Data
Statement of Operations Data, page 13
1.We note from your disclosure on page 11 that you intend to grant options to purchase an
aggregate of 1,311,061 ordinary shares to certain of your directors and officers upon the
effectiveness of this registration statement. Please expand your disclosure to provide a
narrative description of the pro forma effects of this transaction to the extent that the grant
would materially impact your net loss and pro forma net loss per share attributable to
ordinary shareholders, basic and diluted, in accordance with Article 11 of Regulation
S-X. Your disclosure should include the impact of the transaction by income statement
line item, as applicable.
You may contact Jim Dunn at (202) 551-3724 or Isaac Esquivel at (202) 551-3395 if you
have questions regarding comments on the financial statements and related matters. Please
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
May 16, 2019 Page 2
FirstName LastName
Lee Kalowski
Bicycle Therapeutics Ltd.
May 16, 2019
Page 2
contact Liz Walsh at (202) 551-3696 or Chris Edwards at (202) 551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jonathan Schur
2019-05-13 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm May 13, 2019 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards and Liz Walsh Re: Bicycle Therapeutics Ltd. Registration Statement on Form S-1 Filed April 26, 2019 CIK 0001761612 Dear Mr. Edwards and Ms. Walsh: This letter is submitted on behalf of Bicycle Therapeutics Ltd (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on April 26, 2019 (the “Registration Statement”), as set forth in the Staff’s letter dated May 7, 2019 addressed to Lee Kalowski, Chief Financial Officer of the Company (the “Comment Letter”). The Company is concurrently filing Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express four (4) copies of each of this letter and Amendment No. 1 (marked to show changes from the Registration Statement). Registration Statement on Form S-1 filed on April 26, 2019 Description of American Depositary Shares, page 212 1. We note the revised disclosure regarding the waiver of jury trial provision in page 223 of your registration statement. Please further revise your disclosure to address any questions as to enforceability of such waiver and to state that, by agreeing to the terms of the deposit agreement, investors will not be deemed to have waived our or the depositary’s compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder. RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on pages 69 and 235 of Amendment No. 1 in response to the Staff’s comment. *** 2 If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1483. Sincerely, /s/ James Xu James Xu, Esq. cc: Kevin Lee, Bicycle Therapeutics Limited Lee Kalowski, Bicycle Therapeutics Limited Kristopher D. Brown, Goodwin Procter LLP Jonathan A. Schur, Goodwin Procter LLP Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Richard Segal, Cooley LLP 3
2019-05-07 - UPLOAD - BICYCLE THERAPEUTICS PLC
May 7, 2019
Lee Kalowski
Chief Financial Officer
Bicycle Therapeutics Ltd.
4 Hartwell Place
Lexington, Massachusetts 02421
Re:Bicycle Therapeutics Ltd.
Registration Statement on Form S-1
Filed April 26, 2019
CIK 0001761612
Dear Mr. Kalowski:
We have reviewed your 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.
Registration Statement on Form S-1 filed on April 26, 2019
Description of American Depositary Shares, page 212
1.We note the revised disclosure regarding the waiver of jury trial provision in page 223 of
your registration statement. Please further revise your disclosure to address any questions
as to enforceability of such waiver and to state that, by agreeing to the terms of the deposit
agreement, investors will not be deemed to have waived our or the depositary's
compliance with U.S. federal securities laws and the rules and regulations promulgated
thereunder.
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.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
May 7, 2019 Page 2
FirstName LastName
Lee Kalowski
Bicycle Therapeutics Ltd.
May 7, 2019
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Jim Dunn at 202-551-3724 or Isaac Esquivel at 202-551-3395 if you
have questions regarding comments on the financial statements and related matters. Please
contact Liz Walsh at 202-551-3696 or Christopher Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jonathan Schur
2019-05-01 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 CONFIDENTIAL TREATMENT REQUESTED BY BICYCLE THERAPEUTICS LIMITED CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. OMITTED INFORMATION HAS BEEN REPLACED IN THIS LETTER AS FILED VIA EDGAR WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” May 1, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards and Liz Walsh Re: Bicycle Therapeutics Ltd. Draft Registration Statement on Form S-1 Submitted December 21, 2018 CIK 0001761612 Dear Mr. Edwards and Ms. Walsh: This letter is submitted on behalf of Bicycle Therapeutics Ltd (the “Company”) to supplement the Company’s prior responses to the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on April 26, 2019 (the “Registration Statement”). On behalf of the Company, we are supplementally providing the following: 1. A bona fide estimate of the range of the offering price for the Company’s ADSs representing ordinary shares offered by the Registration Statement (before giving effect to the effectiveness of a share capital reorganization prior to the completion of this offering, which is intended to have the effect of a share split of our share capital (the “Stock Split”), as disclosed in the section titled “Share Capital Reorganization and Re-Registration” in the Registration Statement), and a discussion of the factors that the Company believes led to the increase in the value of its ordinary shares between the recent valuations of its ordinary shares and the estimated price range for the offering, attached hereto as Exhibit A. Each ADS is expected to represent one (1) ordinary share of the Company. Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 1, 2019 Page 2 2. For the Staff’s convenience, a table summarizing share options granted since January 1, 2018, which reflects the issuance of options to purchase ordinary shares and restricted shares granted by the Company, and has been included in the Registration Statement, attached hereto as Exhibit B. The Company advises the Staff that the general approach taken by the Company in determining the fair value of its ordinary shares, including as of May 31, 2018, which was used for the fair value assessment of the share option grants on September 18, 2018; as of September 30, 2018, which was used for the fair value assessment of the share option grants on November 30, 2018 and December 1, 2018; as of December 31, 2018, which was used for the fair value assessment of the share option and restricted share grants on December 17, 2018 and share options grants on January 31, 2019; and as of March 31, 2019, which was used for the contemporaneous fair value assessment of the share option grants on April 25, 2019 are set forth beginning on page 111 of the prospectus included in the Registration Statement. The Company advises the Staff, that as disclosed in the Registration Statement, the exercise prices per the respective share options and the subscription price of restricted shares are in pounds sterling. The amounts in this letter are translated to U.S. Dollars at the rate of $1.2763 to £1.00, which was the noon buying rate of the Federal Reserve Bank of New York on December 31, 2018, the last business day of the year ended December 31, 2018. As described in the Registration Statement, the Company’s retrospective valuations of ordinary shares as of May 31, 2018 and September 30, 2018, as well as its contemporaneous valuation on December 31, 2018 were prepared using the option-pricing method (“OPM”) back-solve approach. The OPM treats ordinary and convertible preferred shares as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the ordinary shares only have value if the funds available for distribution to shareholders exceed the value of the convertible preferred shares liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. The ordinary shares are modeled as a call option on the underlying equity value at a predetermined exercise price. In this model, the exercise price is based on a comparison with the total equity value rather than, as in the case of a regular call option, a comparison with a per share price. Thus, ordinary shares are considered to be a call option with a claim on the enterprise at an exercise price equal to the remaining value immediately after the convertible preferred share liquidation preference is paid. The Company used the OPM back-solve approach to estimate the enterprise value under the OPM. The OPM back-solve approach uses the OPM to derive an implied equity value for one type of a company’s equity securities from a contemporaneous sale transaction involving another type of the Company’s equity securities. For the March 31, 2019 valuation, the Company used a hybrid method, which is a hybrid between the OPM and the probability-weighted expected return method (“PWERM”). The hybrid method estimates the probability-weighted value across multiple scenarios, but uses the OPM to estimate the allocation of value within one or more of the scenarios. The hybrid method Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 1, 2019 Page 3 can be a useful alternative to explicitly modeling all PWERM scenarios in situations when the company has transparency into one or more near term exits, but is unsure what will occur if the current plans fall through. The PWERM is a scenario-based methodology that estimates the fair value of securities based upon an analysis of future values for the company, assuming various outcomes. The securities’ value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each share class. The future value under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the ordinary shares. May 31, 2018 Valuation The fair value of the Company’s ordinary shares of $3.77 per share as of May 31, 2018 was retrospectively determined with the assistance of an independent third-party valuation firm. This valuation was used to support the fair value of the Company’s ordinary shares with respect to share options granted on September 18, 2018. This valuation utilized the OPM back-solve approach to obtain the equity value of the Company, based in part on the most recent sale of Series B1 preferred shares in September 2017, which was led by a new unrelated third-party investor. To account for an increase in value created in the period between the most recent financing and the valuation date, this equity value reflected an increase in the enterprise value based on recent events in the market including changes in the Dow Jones Industrial Average, NASDAQ Composite Index, S&P 500, and a selection of biotechnology indices and the Company’s continued progress on its business plan. The valuation utilized the OPM to allocate the equity value to the various preferred and ordinary share classes in order to arrive at the ordinary shares valuation in both an IPO and a non-IPO scenario. The valuation assumed a [***]% probability of an IPO and an [***]% probability of a non-IPO scenario. A discount for lack of marketability of [***]% was then applied to the ordinary shares value for both scenarios to arrive at the fair value as of May 31, 2018. September 30, 2018 Valuation The fair value of the Company’s ordinary shares of $4.87 per share as of September 30, 2018 was retrospectively determined with the assistance of an independent third-party valuation firm. This valuation was used for the retrospective fair value assessment of the share option grants on November 30, 2018 and December 1, 2018. This valuation utilized the OPM back-solve approach to obtain the equity value of the Company, based in part on the most recent sale of Series B1 preferred shares in September 2017 as discussed above. To account for an increase in value created in the period between the most recent financing and the valuation date, this equity value reflected an increase in the enterprise value based on recent events in the market including changes in the Dow Jones Industrial Average, NASDAQ Composite Index, S&P 500, and a selection of biotechnology indices and the Company’s continued progress on its business plan. The valuation utilized the OPM to allocate the equity value to the various preferred and ordinary share classes in order to arrive at the ordinary shares valuation in both an IPO and a non-IPO scenario. The valuation assumed a [***]% probability of an IPO and a [***]% probability of a non-IPO scenarios. A discount for lack of marketability of [***]% was then Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 1, 2019 Page 4 applied to the ordinary shares value for both scenarios to arrive at the fair value as of September 30, 2018. December 31, 2018 Valuation The fair value of the Company’s ordinary shares of $6.87 per share as of December 31, 2018 was determined by the Company’s board of directors with the assistance of an independent third-party valuation firm. This valuation was used for the fair value assessment of the share option and restricted share grants on December 17, 2018 and for share option grants on January 31, 2019. This valuation utilized the OPM back-solve approach to obtain the equity value of the Company, based in part on the most recent sale of Series B2 preferred shares in December 2018, which was led by a new unrelated third-party investor. The valuation utilized the OPM to allocate the equity value to the various preferred and ordinary share classes in order to arrive at the ordinary shares valuation. In addition, in December 2018, the Company received new information related to a patent dispute, which indicated that warrants for Series B1 preferred shares might not be exercisable prior to or in conjunction with IPO or non-IPO exit scenario based on their contractual terms. As such, the valuation assumed a [***]% probability that the warrants could be exercised by their contractual terms in the IPO and non-IPO exit scenarios, and a [***]% probability that the warrants could not be exercised by their contractual terms in the IPO and non-IPO exit scenarios. The valuation assigned values in an IPO scenario and in a non-IPO scenario, with separate values in each scenario in which the warrants were exercisable and in one in which the warrants were not exercisable. The valuation assumed a [***]% probability of an IPO and a [***]% probability of a non-IPO scenario. A discount for lack of marketability of [***]% was then applied to the ordinary shares value for both scenarios to arrive at the fair value as of December 31, 2018. March 31, 2019 Valuation The fair value of the Company’s ordinary shares of $11.62 per share as of March 31, 2019 was determined by the Company’s board of directors with the assistance of an independent third-party valuation firm. This valuation was used for the fair value assessment of the share option grants on April 25, 2019. This valuation utilized the hybrid method, which considered the value of the Company’s ordinary shares in both IPO and non-IPO scenarios. The present value of the Company’s ordinary shares in an IPO scenario was calculated based on metrics observed from then-recent IPOs in the biotechnology industry. In addition, in March 2019, the Company reached agreement with the holders of Series B1 preferred warrants for the exercise of [***]% of the warrants in an IPO scenario, and thereafter a single valuation was assigned to the Series B1 preferred warrants in an IPO scenario. The value of the Company’s ordinary shares in a non-IPO scenario was calculated using the OPM back-solve approach to obtain the equity value of the Company. To account for an increase in value created in the period between the most recent financing and the valuation date, this equity value reflected an increase in the enterprise value based on recent events in the market including changes in the Dow Jones Industrial Average, NASDAQ Composite Index, S&P 500, and a selection of biotechnology indices and the Company’s continued progress on its business plan. The valuation continued to assume a [***]% probability that the Series B1 warrants could be exercised by their contractual terms in the non-IPO scenario. The valuation assumed a [***]% probability of an IPO and a [***]% probability of Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 1, 2019 Page 5 a non-IPO scenario. A discount for lack of marketability of [***]% and [***]% was applied to the IPO and non-IPO scenarios, respectively. The weighting attributed to the IPO scenarios in each of the valuations above reflected assessments as to the likelihood of an IPO and the uncertainty concerning whether investors might be receptive to making an investment in the Company. The Company also considered macroeconomic and overall market conditions, including the Company’s subjective assessment of market conditions for IPOs of companies similarly situated to the Company and the Company’s subjective assessment as to the likelihood of successfully executing an IPO in the coming months, among other factors. The Company respectfully requests that the Staff return to us this letter and the information provided pursuant to Exhibits A and B pursuant to Rule 418 of the Securities Act of 1933, as amended, once the Staff has completed its review. We have provided a self-addressed stamped envelope for this purpose. In addition, the Company requests confidential treatment under 17 C.F.R. § 200.83 (1992) for this letter and the information provided pursuant to Exhibits A and B of this letter and has submitted a separate request for confidential treatment in accordance therewith to the Commission’s Office of Freedom and Information Privacy Act Operations. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1483. Sincerely, /s/ James Xu James Xu, Esq. cc: Kevin Lee, Bicycle Therapeutics Limited Lee Kalowski, Bicycle Therapeutics Limited Kristopher D. Brown, Goodwin Procter LLP Jonathan A. Schur, Goodwin Procter LLP Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Richard Segal, Cooley LLP Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission May 1, 2019 Page 6 Exhibit A The Company supplementally advises the Staff that the estimated price range for the ADSs representing ordinary shares in the Company’s proposed initial public offering (“IPO”) is between $[***] to $[***] per share. Each ADS is expected to represent (1) ordinary share of the Company. Please note that the Company expects to effect a share capital reorganization prior to the completion of this offering, which is intended to have the effect of a share split as disclosed in the section titled “Share Capital Reorganization and Re-Registration” in the Registration Statement, and the price range above does not reflect the impact of the anticipated share split. This estimated bona fide price range is based on a nu
2019-04-26 - CORRESP - BICYCLE THERAPEUTICS PLC
CORRESP 1 filename1.htm April 26, 2019 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards and Liz Walsh Re: Bicycle Therapeutics Ltd. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted March 22, 2019 CIK 0001761612 Dear Mr. Edwards and Ms. Walsh: This letter is confidentially submitted on behalf of Bicycle Therapeutics Ltd (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 1 to the Company’s Draft Registration Statement on Form S-1, confidentially submitted on March 22, 2019 (“Amendment No. 1”), as set forth in the Staff’s letter dated April 4, 2019 addressed to Lee Kalowski, Chief Financial Officer of the Company (the “Comment Letter”). The Company is concurrently publicly filing its Registration Statement on Form S-1 (the “Registration Statement”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to Amendment No. 1, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express four (4) copies of each of this letter and the Registration Statement (marked to show changes from Amendment No. 1). Amendment No. 1 to Draft Registration Statement on Form S-1 submitted March 22, 2019 Prospectus Summary Beyond Oncology, page 5 1. We note your response to prior comment 4. Please also revise your prospectus summary to describe the ongoing Phase I clinical trial of THR-149. Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission April 26, 2019 Page 2 RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page 6 of the Registration Statement in response to the Staff’s comment. Business Our Collaborations Our Other Collaborators AstraZeneca, page 144 2. We note your statement that, pursuant to your collaboration agreement with AstraZenaca, you could receive more than $1 billion in milestone payments and royalties. We also note your disclosure that, pursuant to the collaboration agreement, AstraZeneca owes you milestone fee of $8 million for the first drug candidate selected from each research program, and you are eligible to receive up to an additional $162 million in development, regulatory and commercial milestones on a research program by research program basis, as well as tiered royalty payments of mid-single digits based on a percentage of net sales. Please provide further details regarding how these amounts could total over $1 billion. RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on pages 142 and 143 of the Registration Statement in response to the Staff’s comment. Management Executive Officers, page 168 3. We note your updated disclosure regarding your Chief Business Officer, Peter Leone. Please clarify Mr. Leone’s activities between April 2016 and 2012. Please see Item 401(e)(1) of Regulation S-K. RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page 167 of the Registration Statement in response to the Staff’s comment. *** Mr. Christopher Edwards and Ms. Liz Walsh United States Securities and Exchange Commission April 26, 2019 Page 3 If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1483. Sincerely, /s/ James Xu James Xu, Esq. cc: Kevin Lee, Bicycle Therapeutics Limited Lee Kalowski, Bicycle Therapeutics Limited Kristopher D. Brown, Goodwin Procter LLP Jonathan A. Schur, Goodwin Procter LLP Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Richard Segal, Cooley LLP
2019-04-04 - UPLOAD - BICYCLE THERAPEUTICS PLC
April 4, 2019
Lee Kalowski
Chief Financial Officer
Bicycle Therapeutics Ltd.
4 Hartwell Place
Lexington, Massachusetts 02421
Re:Bicycle Therapeutics Ltd.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted March 22, 2019
CIK 0001761612
Dear Mr. Kalowski:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted March 22, 2019
Prospectus Summary
Beyond Oncology, page 5
1.We note your response to prior comment 4. Please also revise your prospectus summary
to describe the ongoing Phase I clinical trial of THR-149.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
April 4, 2019 Page 2
FirstName LastName
Lee Kalowski
Bicycle Therapeutics Ltd.
April 4, 2019
Page 2
Business
Our Collaborations
Our Other Collaborators
AstraZeneca, page 144
2.We note your statement that, pursuant to your collaboration agreement with
AstraZenaca, you could receive more than $1 billion in milestone payments and royalties.
We also note your disclosure that, pursuant to the collaboration
agreement, AstraZeneca owes you milestone fee of $8 million for the first drug candidate
selected from each research program, and you are eligible to receive up to an additional
$162 million in development, regulatory and commercial milestones on a research
program by research program basis, as well as tiered royalty payments of mid-single digits
based on a percentage of net sales. Please provide further details regarding how these
amounts could total over $1 billion.
Management
Executive Officers, page 168
3.We note your updated disclosure regarding your Chief Business Officer, Peter Leone.
Please clarify Mr. Leone's activities between April 2016 and 2012. Please see Item
401(e)(1) of Regulation S-K.
You may contact Jim Dunn at 202-551-3724 or Isaac Esquivel at 202-551-3395 if you
have questions regarding comments on the financial statements and related matters. Please
contact Liz Walsh at 202-551-3696 or Christopher Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jonathan Schur
2019-02-12 - UPLOAD - BICYCLE THERAPEUTICS PLC
February 12, 2019
Lee Kalowski
Chief Financial Officer
Bicycle Therapeutics Ltd.
4 Hartwell Place
Lexington, Massachusetts 02421
Re:Bicycle Therapeutics Ltd.
Draft Registration Statement on Form S-1
Filed December 21, 2018
CIK 0001761612
Dear Mr. Kalowski:
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.
DRS Form S-1
Prospectus Summary
Overview, page 1
1.Please provide the expected timing for reporting preliminary data for the Phase I part of
the clinical trial of BT1718.
Introduction to Bicycles, page 2
2.We note your disclosure that the Bicycle's "renal route of elimination" minimizes liver
exposure. Please provide further details as to the benefits of this route of elimination and
why it does not result in increased renal exposure.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
February 12, 2019 Page 2
FirstName LastNameLee Kalowski
Bicycle Therapeutics Ltd.
February 12, 2019
Page 2
Our Pipeline, page 4
3.Please revise you pipeline table to include columns for each stage of further development
and provide more specific details regarding each type of oncology indicator. In addition,
we note your disclosure that BT1718 is undergoing a Phase I/IIa clinical trial; however,
your table seems to indicate that BT1718 is currently undergoing a Phase I clinical trial
only. Please revise or explain.
4.Your pipeline table shows that THR-149, the subject of your collaboration agreement with
Oxurion, is currently undergoing a Phase I clinical trial. Please describe the Phase I trial
in the Business section.
5.Please revise your pipeline table to remove the programs that are in the discovery phase.
Because you have not identified a product candidate for these programs, it is premature to
include them in a product pipeline table.
Implications of Being an Emerging Growth Company, page 9
6.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
Risks Related to the Discovery, Development and Regulatory Approval of Our Product
Candidates, page 19
7.Here or elsewhere in your Risk Factors section, please disclose that upon the completion
of the Phase I/IIa clinical trial for BT1718, you have the right to obtain a license to the
results of the clinical trial from CRUK upon the payment of a milestone, in cash and
ordinary shares, and any related risks or impact on your ability to continue to develop
and/or commercialize BT1718. We note your related disclosure on page 95.
Our current or future product candidates may cause undesirable side effects or have other
properties when used alone... , page 24
8.We note your statement that your current and future product candidates have undergone
[...] safety testing. Please revise your disclosure, if true, to state that certain of your
products are currently undergoing safety testing in the form of Phase I and Phase I/IIa
clinical trials, as appropriate, and none of your products have completed this testing to
date.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
February 12, 2019 Page 3
FirstName LastNameLee Kalowski
Bicycle Therapeutics Ltd.
February 12, 2019
Page 3
Risks Related to Our Dependence on Third Parties
If conflicts arise with our development and commercialization collaborators or licensors, they
may act in their own self-interest..., page 48
9.We note your disclosure on page 162 regarding the notices of opposition filed by Pepscan
in respect of each of European patents 2 257 624 and 2 474 613. If material, please revise
your Risk Factor disclosure to describe such notices of opposition, as well as any potential
material consequences on your business or operations.
Risks Related to Our Intellectual Property
Cyber-attacks or other failures in telecommunications or information technology systems could
result in information theft..., page 62
10.Please provide further details regarding the cyber-attack you experienced in 2018,
including any material impact of the attack on your business or financial condition.
Capitalization, page 86
11.We note that your pro forma adjustments will give effect to the conversion of all
outstanding preferred shares as of September 30, 2018 into ordinary shares and the
effectiveness of your amended and restated memorandum and articles of association upon
the closing of this offering. We also note from your disclosure on page 85 (Share Capital
Reorganization...) that, pursuant to Part 17 of the Companies Act, you will reduce your
share capital and that amount will be reclassified to reserves available for distribution.
Please tell us if the reclassification of share capital will be disclosed in these pro forma
adjustments, and if so, revise your filing to indicate that such disclosure will be made. If
not, please tell us why the reclassification of share capital is not applicable to these pro
forma adjustments.
Overview, page 92
12.We note that BT1718 is being developed to treat tumors with high MT1-MMP. Here or
elsewhere in your prospectus, please provide further details about the percentage or
volume of tumors with high MT1-MMP, and any resulting impact on the
potential commercialization opportunities for BT1718. Please also provide similar details
for EphA2 and Nectin-4.
13.To the extent material, please disclose the Materials Transfer Agreement into which you
entered in October 2018, along with the material terms and conditions of such
Agreement. In this regard, we note your disclosure in Note 17 to your Consolidated
Financial Statements on page F-59.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
February 12, 2019 Page 4
FirstName LastNameLee Kalowski
Bicycle Therapeutics Ltd.
February 12, 2019
Page 4
Financial Overview, page 93
14.Please clarify the breakdown of revenues produced by each of your collaboration
agreements. In addition, please clarify whether or not the $20.5 million in revenue
cumulatively earned from your collaboration agreements includes the $5.0 million to be
paid in January 2019 pursuant to the terms of your collaboration agreement with
AstraZeneca.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Components of Our Results of Operations
Expenses, page 95
15.We note your disclosure regarding your Clinical Trial and License Agreement with CRTL
and CRUK pursuant to which you are entitled to receive revenue sharing of a "mid to high
double digit percentage of the net revenue." Please revise your disclosure to present a
range of not more than 10 percentage points. Please similarly revise your disclosure
regarding your potential tiered royalty payments pursuant to the terms of the Bioverativ
collaboration agreement on page 139 and the Oxurion collaboration agreement on page
141.
Results of Operations
Research and Development Expenses, page 102
16.We note from your disclosure here that you have incurred research and development costs
for several product candidates (i.e. BT1718 (MT1), BT5528 (EphA2) and BT8009
(Nectin-4)), and your lead product candidate, BT1718 (MT1), has incurred these costs
since at least 2016. Please revise your filing to disclose research and development costs
for each of your product candidates incurred from inception to date.
Business
Properties of Bicycles as Therapeutic Agents, page 121
17.Please clarify whether you can always identify a compound for development in only six to
12 months after a target has been selected, or if this is an average amount of time.
Our Oncology Programs, page 124
18.To the extent not disclosed, please provide the endpoint for each of your clinical trials and
preclinical studies.
Preclinical Experience, page 127
19.We note your disclosure that, in the docetaxel resistant model, BT1718 at both doses
tested was associated with significant responses. Please clarify whether this response was
statistically significant, and if so, please indicate the p-value by which you measured
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
February 12, 2019 Page 5
FirstName LastNameLee Kalowski
Bicycle Therapeutics Ltd.
February 12, 2019
Page 5
statistical significance. Please also explain how "p-value" is used to measure statistical
significance.
Founder Royalty Arrangements, page 142
20.Please provide further details about each of your founder royalty agreements, including
the parties to each agreement and any other material terms. In this regard, we note your
disclosure in Note 12 to your Consolidated Financial Statements on page F-55.
Intellectual Property, page 142
21.Please expand your disclosure regarding your patent portfolio to disclose the type of
patent protection provided by the patents or patent applications (e.g., composition of
matter, method of use).
Executive Compensation
Employment Agreements with Our Named Executive Officers, page 172
22.We note that pursuant to the terms of their respective employment agreements, each of
Kevin Lee, Lee Kalowski and Maria Koehler are entitled to annual discretionary cash
bonuses if certain performance targets are met. Please provide further details regarding
such performance targets.
Note 2 - Summary of Significant Accounting Policies
Share-based Compensation, page F-20
23.You disclose at the top of page F-21 four factors used to determine the fair value of your
ordinary shares at each grant date. Once you have an estimated offering price or range,
please explain to us in further detail how you determined the fair value of the common
stock underlying your equity issuances and the reasons for any differences between the
recent valuations of your common stock leading up to the initial public offering and the
estimated offering price. This information will help facilitate our review of your
accounting for equity issuances of stock compensation.
Note 7 - Warranty Liability, page F-29
24.We note that your warrants are remeasured to fair value at each reporting date. We also
note that your warrants are classified within Level 3 of the fair value hierarchy. Please
revise your filing to disclose the following:
•Quantitative information about the significant unobservable inputs used in the fair
value measurement of these warrants (e.g. risk-adjusted discount rate, present value
periods, equity values calculated under the OPM, et al); and
•A narrative description of the sensitivity of the fair value measurement to changes in
the unobservable inputs.
Refer to ASC 820-10-50-2(bbb)(2) and 50-2(g), respectively.
FirstName LastNameLee Kalowski
Comapany NameBicycle Therapeutics Ltd.
February 12, 2019 Page 6
FirstName LastName
Lee Kalowski
Bicycle Therapeutics Ltd.
February 12, 2019
Page 6
General
25.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.
You may contact Jim Dunn at (202) 551-3724 or Isaac Esquivel at (202) 551-3395 if you
have questions regarding comments on the financial statements and related matters. Please
contact Liz Walsh at (202) 551-3696 or Chris Edwards at (202) 551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jonathan Schur