Charles S. Kim +1 (858) 550-6049 ckim@cooley.com |
May 31, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
| Attn: | Gary Newberry, Lynn Dicker, Doris Stacey Gama, Joshua Gorsky |
| Re: | Structure
Therapeutics Inc. Form 10-K for Fiscal Year Ended December 31, 2023 File No. 001-41608 |
Ladies and Gentlemen:
On behalf of Structure Therapeutics Inc. (the “Company”), we submit this letter in response to the comment (the “Comment”) received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 31, 2024 with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Commission on March 8, 2024 (the “Annual Report”). Set forth below is the Company’s response to the Comment. Page references in the text of this response letter correspond to the page numbers of the Annual Report and reference to the prior comment is to the comment provided by the Staff in its letter dated May 22, 2024. Capitalized terms used in this letter but not otherwise defined herein have the same meanings set forth in the Annual Report.
Annual Report on Form 10-K
Risk Factors
Risks Related to Our Reliance on Third Parties
We rely on third parties for the manufacture of our product candidates for preclinical and clinical development … page 82
| 1. | We note your response to prior comment 1. Please revise your proposed disclosure to explain that the current U.S. House of Representatives version of the BIOSECURE Act identifies WuXi AppTec and WuXi Biologics as biotechnology companies of concern and clarify whether WuXi STA is a subsidiary or affiliate of WuXi AppTec and/or WuXi Biologics. |
Response: In response to the Staff’s comment, the Company respectfully submits to the Staff that it plans to revise the proposed disclosure provided in the Company’s response letter dated May 24, 2024 (the “Prior Response Letter”) as follows (with the new added language from the Prior Response Letter in underlined text below):
“We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
Cooley
LLP 10265 Science Center Drive San Diego, CA 92121-1117
t: (858) 550-6000 f: (858) 550-6420 cooley.com
U.S. Securities and Exchange Commission Page Two |
We
do not own or operate manufacturing facilities and have no plans to build our own clinical or commercial scale manufacturing capabilities.
We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates and related raw materials for
preclinical and clinical development, as well as for commercial manufacture if any of our product candidates receive marketing approval.
This reliance increases the risk that we will not have sufficient quantities of our product candidates or products, if approved, or such
quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. Our active
pharmaceutical ingredients and drug product for our product candidates are currently provided by a single-source supplier, WuXi STA,
a subsidiary of WuXi AppTec, and we expect to rely on this supplier for the foreseeable future. However, certain Chinese biotechnology
companies and CMOs may become subject to legislation, trade restrictions, sanctions, and other regulatory requirements by the U.S. government,
which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting the supply of material to
us. For example, the recently proposed BIOSECURE Act introduced in the U.S. House of Representatives,
and a substantially similar bill in the U.S. Senate, target U.S. government contracts, grants, and loans for entities that use equipment
and services from certain specific named Chinese biotechnology companies, which currently include WuXi AppTec
and WuXi Biologics and certain of their respective subsidiaries and affiliates, and authorizes the U.S. government to include additional
Chinese biotechnology companies of concern. The current House version of the BIOSECURE Act provides
a grandfathering provision with respect to a contract or agreement entered into with a designated biotechnology company of concern before
the effective date until January 1, 2032. Given the current legislative climate, the pathway and timing for the BIOSECURE Act or
its provisions to become law are uncertain. Should the BIOSECURE Act or its provisions become law with the currently proposed grandfathering
provisions, we expect such grandfathering provisions will allow adequate time to identify and execute agreements with alternative manufacturers
if necessary. In addition to the BIOSECURE Act, any additional executive action, legislative action or potential sanctions applicable
to our current and any future suppliers could materially impact our relationship with such suppliers. U.S. executive agencies have the
ability to designate entities and individuals on various governmental prohibited and restricted parties lists. Depending on the designation,
potential consequences can range from a comprehensive prohibition on all transactions or dealings with designated parties, or a limited
prohibition on certain types of activities, such as exports and financing activities, with designated parties. If any current or future
supplier, is designated on any U.S. government prohibited party lists, such designation could impact and potentially restrict our engagement
with such suppliers. We have contracted, or are in the process of pursuing contracts, with alternative suppliers or manufacturers outside
of China for our active pharmaceutical ingredients and drug product for our product candidates. While we believe that our current manufacturing
plan will provide us with alternative sources for such supplies, there is a risk that, if supplies are interrupted, or the quality of
ingredients provided by such alternative sources is not to our specification, it would cause delays in our supply chain and increase
the cost of manufacturing our drugs, which could materially harm our business.”
Cooley
LLP 10265 Science Center Drive San Diego, CA 92121-1117
t: (858) 550-6000 f: (858) 550-6420 cooley.com
U.S. Securities and Exchange Commission Page Three |
* * *
Please do not hesitate to contact me at (858) 550-6049 or Patrick Loofbourrow of Cooley LLP at (619) 840-4824 if you have any questions.
Sincerely,
| /s/ Charles S. Kim |
Charles S. Kim
Cooley LLP
| cc: | Raymond Stevens, Ph.D., Structure Therapeutics Inc. |
Jun Yoon, Structure Therapeutics Inc.
Patrick Loofbourrow, Cooley LLP
Carlos Ramirez, Cooley LLP
Su Lian Lu, Cooley LLP
Cooley LLP
10265 Science Center Drive San Diego, CA 92121-1117
t: (858) 550-6000 f: (858) 550-6420 cooley.com