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SEC Comment Letter for BICYCLE THERAPEUTICS PLC (BCYC) (CIK 0001761612) (BCYC) — Apr 4, 2019

BICYCLE THERAPEUTICS PLC (BCYC) (CIK 0001761612)
Date: April 4, 2019 · CIK: 0001761612 · Accession: 0000000000-19-006564

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 4, 2019
Author
Lee Kalowski
Form
UPLOAD
Company
BICYCLE THERAPEUTICS PLC (BCYC) (CIK 0001761612)

Letter

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

Show Raw Text
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