0000000000-20-006549.txt : 20200909 0000000000-20-006549.hdr.sgml : 20200909 20200717181308 ACCESSION NUMBER: 0000000000-20-006549 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200717 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Compass Therapeutics, Inc. CENTRAL INDEX KEY: 0001738021 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 245 FIRST STREET, 3RD FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-500-8099 MAIL ADDRESS: STREET 1: 245 FIRST STREET, 3RD FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: Olivia Ventures, Inc. 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MB8&#@1E$L#"F'()P64$$ V-9'9#(V@T18V0LF@IA,3&6)@$E2B')E9@HS +,#8V-@HE)45/1@H! end TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo July 16, 2020 Thomas J. Schuetz, M.D., Ph.D. Chief Executive Officer Compass Therapeutics, Inc. 245 First Street 3rd Floor Cambridge, Massachusetts 02142 Re: Compass Therapeutics, Inc. Form 8-K Filed June 23, 2020 File No. 000-55939 Dear Dr. Schuetz: We have reviewed your filing 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 these comments 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 our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 8-K filed June 23, 2020 Description of Business, page 9 1. Throughout this section, please remove all statements that reference efficacy and safety, including synonyms and similar terms (e.g., "robust" and "potent cytotoxic activity"), as safety and efficacy determinations are solely within the authority of the Food and Drug Administration or other regulatory agencies. Overview, page 9 2. We note that you state that you "plan to rapidly advance [your] product candidates through clinical development." Please revise your disclosure here and throughout your filing to remove any implication that you will be successful in commercializing your product candidates in a rapid or accelerated manner, as such statements are speculative. Thomas J. Schuetz, M.D., Ph.D. FirstName LastNameThomas Compass Therapeutics, Inc. J. Schuetz, M.D., Ph.D. Comapany July NameCompass Therapeutics, Inc. 16, 2020 July 16, Page 2 2020 Page 2 FirstName LastName Pipeline, page 11 3. Please revise the chart on page 11 to clarify the term "TAA" and provide a brief narrative below of what this line in the chart is depicting. Please also include the specific indication(s) for which your product candidates are being developed. Figure 1. We have assembled a panel of proprietary antibodies against a broad panel of key immune targets, page 13 4. Please provide a brief narrative of what your graphic is depicting. Phase 1 clinical trial data as of May 24, 2020, page 20 5. We note your disclosure that the ongoing Phase 1 trial of CTX-471 was designed to evaluate the safety and tolerability of your product candidate, but it appears that you are presenting efficacy data from this trial on page 21. Please revise to remove the statements regarding efficacy if it is not being measured in the current trial, or revise to clarify the current trial phase and disclose the efficacy endpoints of the trial. License Agreement, page 29 6. Please disclose that you have additional milestone payments due under your collaboration agreement and quantify the aggregate potential milestone payments due. Management's Discussion and Analysis of Financial Condition and Results of Operation Overview, page 99 7. We note you will need substantial additional funding to support your continuing operations and pursue your growth strategy. Please disclose how far in the development of your product candidates you expect to reach with your current capital resources. Results of Operations, page 104 8. We note that you have multiple products in varying stages of development and clinical testing. Please revise to disclose more detail for your research and development expenses each period presented, including but not limited to by product candidate and the nature of the expenses. 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. Thomas J. Schuetz, M.D., Ph.D. Compass Therapeutics, Inc. July 16, 2020 Page 3 You may contact Eric Atallah at 202-551-3663 or Brian Cascio at 202-551-3676 if you have questions regarding comments on the financial statements and related matters. Please contact Courtney Lindsay at 202-551-7237 or Mary Beth Breslin at 202-551-3625 with any other questions. FirstName LastNameThomas J. Schuetz, M.D., Ph.D. Sincerely, Comapany NameCompass Therapeutics, Inc. Division of Corporation Finance July 16, 2020 Page 3 Office of Life Sciences FirstName LastName