R&D Expense Disclosure
What to check in your filing: Break out R&D expense by program or product candidate (or explain why you cannot) in MD&A.
5 staff comments from 3 companies. Outcomes: Awaiting / response not in dataset: 3, Agreed to revise: 2
COMPUGEN LTD (CGEN) · 2026-07-17 · . Form 20-F for Fiscal Year Ended December 31, 2025 · Comment 1 Agreed to revise
Staff comment: Considering the significant research and development expenses you have historically incurred and expect to continue to incur, in future filings, please expand your disclosures to include disaggregated disclosures for your research and development expenses, for example by product candidates, by program, and/or by nature of costs. Please also disclose whether you track external costs by product candidates and/or by program, and if not, please disclose that fact and the reason in future filings. Note 2. Significant Accounting Policies j. Revenue Recognition, page F-16 letter →
Company response: The Company acknowledges the Staff’s Comment and respectfully advises the Staff that the Company tracks external research and development expenses on a clinical trial-specific basis while aggregating such expenses for its preclinical studies. The Company undertakes to provide disclosure substantially in the form presented below in its future filings with the Commission. Research and development expenses consist primarily of costs incurred for the discovery and development of our product candidates. Given the number of programs that we have and, because some of our clinical trials may combine more than one program, we track the external research and development costs incurred per clinical… response letter →
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-04-07 · · Comment 3 · A. Operating Results - Research and Development, page 46 Awaiting / response not in dataset
Staff comment: We acknowledge your response to prior comment seven and partially reissue our comment. • Please revise to include in your disclosures a statement regarding whether you track direct research and development costs by program area. • Revise your disclosure to disaggregate 'Direct R&D clinical site and program costs' currently included in 'other costs' for each period presented. We do not believe potential competitive harm is a valid reason for omitting this material information. letter →
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 7 · Research and Development, page 46 Awaiting / response not in dataset
Staff comment: We acknowledge your response to prior comment 24 and partially reissue our comment. Please revise to disclose the following: • Whether you track your research and development costs by program area; and • As 'Other costs' is over 40% of 2025 research and development expense, please revise to quantify and disclose its components and whether this material trend is expected in future periods. letter →
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 24 · Research and Development, page 46 Awaiting / response not in dataset
Staff comment: Please tell us whether you track your research and development costs by program area. If so, revise to provide disaggregate disclosure of your research and development expenses by program for each period presented. If not, revise to state that fact and disclose other quantitative and qualitative disclosure that provides transparency as to the types of costs incurred (i.e. preclinical and clinical and by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations. letter →
Silence Therapeutics plc (SLN, SLNCF) · 2025-12-18 · Form 10-K fo the fiscal year ended December 31, 2024 · Comment 1 · Research and Development Expenses, page 82 Agreed to revise
Staff comment: You disclose on page 79 that you have not historically tracked research and development expenses on a program-by-program basis for your preclinical product candidates. Please provide revised disclosure to be included in future filings to break out clinical research and development expense by program. If you do not track clinical costs by program, revise to disclose that fact and explain the reason. letter →
Company response: We have reviewed your letter requesting further disclosure of research and development expenses on a program-by-program basis for our development programs. As requested, we will further break out research and disclosure expenses on a program-by-program basis for our clinical development candidates. We will include this additional disclosure in Management’s Discussion and Analysis of Financial Condition and Results of Operation when we report our next Form 10-K for fiscal year ended December 31, 2025. response letter →
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