0000000000-18-038336.txt : 20190920 0000000000-18-038336.hdr.sgml : 20190920 20181218091931 ACCESSION NUMBER: 0000000000-18-038336 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20181218 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Cyclerion Therapeutics, Inc. CENTRAL INDEX KEY: 0001755237 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 831895370 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 301 BINNEY STREET CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-621-7722 MAIL ADDRESS: STREET 1: 301 BINNEY STREET CITY: CAMBRIDGE STATE: MA ZIP: 02142 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4-)>+CS],-"CD@,"!O8FH-/#PO3&EN96%R:7IE9" Q+TP@,S0S M-#0O3R Q,2]%(#(X,C$W+TX@,B]4(#,T,#0W+T@@6R T-34@,30Y73X^#65N M9&]B:@T@(" @(" @(" @(" @(" @(" @#0HQ-B P(&]B:@T\/"]$96-O9&50 M87)M7!E+UA2968O5ULQ(#(@,5T^/G-T0HM M#0IE;F1S=')E86T-96YD;V)J#3$P(# @;V)J#3P\+TUE=&%D871A(#,@,"!2 M+U!A9V5S(#<@,"!2+U1Y<&4O0V%T86QO9SX^#65N9&]B:@TQ,2 P(&]B:@T\ M/"]#;VYT96YT%LP(# @-C$R(#,C17,% PM% P-U&P ML=%W2BQ.=%#(, @P 8!0VPPT*96YD)S%5\ERXS80O?,K^JA461R".W/SV)XI)S7)V%95SA ) M2N!'X/L! 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MU8\Z]M4_\'#+70>_()-]-94D62/HH5[@FFO3A:>-B,9"'.#"N0J(+E$(.0OW M66K<28[+D5S7+=&HEE@\ERW)I0)1DRP&FE13CBLX=*4)R>ELA9"24B3-H;KI M0? 68 #.F4+X#0IE;F1S=')E86T-96YD;V)J#38@,"!O8FH-/#PO1&5C;V1E M4&%R;7,\/"]#;VQU;6YS(#,O4')E9&EC=&]R(#$R/CXO1FEL=&5R+T9L871E M1&5C;V1E+TE$6SPS1$0X144S-38X,C(X038F)@8&!BS+-D8F#H9V)@G\G$P/<5R)[ Q, DQ<18 MS0)D,P($& !,KP0:#0IE;F1S=')E86T-96YD;V)J#7-T87)T>')E9@T*,3$V )#0HE)45/1@T* end TEXT-EXTRACT 2 filename2.txt December 17, 2018 Mark Currie President Cyclerion Therapeutics, Inc. 301 Binney Street Cambridge, MA 02142 Re: Cyclerion Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form 10 Submitted on December 6, 2018 CIK 0001755237 Dear Dr. Currie: 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 10 submitted December 6, 2018 Exhibit 99.1 Information Statement Summary Cyclerion Overview, page 12 1. We note your response to comment 5 and your disclosure that you intend to out license praliciguat to a "leader in cardiometabolic diseases." Please revise your disclosure to remove the implication that you have a prospective agreement with a licensee or collaboration partner for this product candidate. Alternatively, please tell us the basis for this statement. Mark Currie Cyclerion Therapeutics, Inc. December 17, 2018 Page 2 Unaudited Pro Forma Combined Financial Statements Notes to Unaudited Pro Forma Combined Financial Data, page 65 2. Regarding pro forma adjustment (C), you include the shares to be issued in the intended private placement in determining the number of Cyclerion shares of common stock used to compute basic earnings per share. Please tell us how you determined that the private placement is factually supportable and directly attributable to the separation transaction. Please also tell us how you determined that it was appropriate to include these shares in your pro forma EPS calculation given that the proceeds from the issuance of these shares are not reflected as an adjustment in your pro forma Statement of Operations. Business Praliciguat for Cardiometabolic Diseases Our Solution, page 96 3. We note your response to comment 8 and your disclosure that results of your Phase 2a study of praliciguat suggested that patients had improvements in insulin sensitivity and in endothelial function. Please revise your disclosure to remove the implication that treatment with praliciguat resulted in the measurements cited. You may describe any objective observations from the trials without indicating that praliciguat is responsible for these observations. You may contact Sasha Parikh at 202-551-3627 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Christine Westbrook at 202-551-5019 or Suzanne Hayes at 202-551-3675 with any other questions. Sincerely, FirstName LastNameMark Currie Division of Corporation Finance Comapany NameCyclerion Therapeutics, Inc. Office of Healthcare & Insurance December 17, 2018 Page 2 cc: Will Michener, Esq. FirstName LastName