SRSEC Reporting Desk

Business Description (Item 101)

What to check in your filing: Review recent comments below against your own disclosure.

38 staff comments from 17 companies. Outcomes: Awaiting / response not in dataset: 23, Agreed to revise: 10, Responded: 3, Explained / pushed back: 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 →
ASC 606: Revenue RecognitionR&D Expense DisclosureBusiness Description (Item 101)
FiEE, Inc. (FIEE) · 2026-04-30 · · Comment 1 · General Agreed to revise
Staff comment: We note that beginning in March 2025, the Company has derived all its revenues from Hong Kong. Please revise your filing to provide specific and prominent disclosures about the legal and operational risks associated with having your business in this location, consistent with the guidance in our Sample Letter to Companies Regarding China-Specific Disclosures and our Sample Letter to China-Based Companies, which were posted to our website July 17, 2023, and on December 20, 2021. U.S. letter →
Company response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company has revised the disclosure beginning on page 1 of the Form 10-K/A and beginning on page 4 of the Public Filing Form S-3 to address the legal and operational risks associated with having the Company’s revenue generating business in Hong Kong. Additionally, the Company has revised the disclosure beginning on page 13 of the Form 10-K/A to include risk factors related to doing business in Hong Kong. Please note that the Form 10-K/A is incorporated by reference into the Public Filing Form S-3. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Technology If you should… response letter →
China-Based IssuersBusiness Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-04-07 · · Comment 1 · Grow the Research and Development..., page 27 Awaiting / response not in dataset
Staff comment: We note your revisions in response to prior comment 3. Please address the following: • We note that your disclosure on page 6 indicates that one or more submissions to EMA would be required prior to commercializing Scenesse for treatment of EPP in adolescents. Accordingly please revise the gray bar in the table so that it does not extend into the “Commercial” column. • We note you are developing novel formulations of the melanocortin adrenocorticotropic hormone (“ACTH”) as NEURACTHEL® in multiple dosage forms. You disclose that the NEURACTHEL Instant candidate is a generic and that you have not conducted any clinical trials. Accordingly, please revise the graphic itself to reflect that you… letter →
Business Description (Item 101)
Waton Financial Ltd (WTF) · 2026-03-24 · Waton Financial Limited Form 20-F for Fiscal Year Ended March 31, 2025 · Comment 1 · B. Business Overview, page 44 Agreed to revise
Staff comment: We note your disclosure of the non-GAAP financial measures 'Adjusted Net Income' and 'Adjusted Net Loss' in your business overview on page 45 when discussing results of operations in the periods presented. Please represent to us that, in future filings, you will provide all the non-GAAP disclosures required by Item 10(e)(1)(i) of Regulation S-K. letter →
Company response: The Company acknowledges the Staff’s comment. In future filings, the Company will provide all of the disclosures required by Item 10(e)(1)(i) of Regulation S-K with respect to any non-GAAP financial measures presented. response letter →
Non-GAAP: Adjustments & LabelsNon-GAAP: Reconciliation & UsefulnessBusiness Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 2 · Item 4. Information on the Company, page 22 Awaiting / response not in dataset
Staff comment: We note that your January 12, 2026 press release announced a significant expansion of your VALLAURIX Research, Development and Innovation (RD&I) Centre in Singapore. With reference to Items 4.D. and 10.C. of Form 20-F, please revise to discuss this project and its impact or advise. letter →
Business Description (Item 101)IFRS & Foreign Private Issuers
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 3 · Grow the Research and Development Capacities and Broaden Therapeutic Portfolio, page 27 Awaiting / response not in dataset
Staff comment: We note your response to prior comment 8, as well as the inclusion of the pipeline table appearing on page 28. In this regard: • We note that the row reflecting SCENESSE in adolescent EPP indicates that the next anticipated program milestone is a "filing in H2 2026." Please revise to clarify the relevant regulator or jurisdiction as appropriate. • Revise the row reflecting SCENESSE in adolescent and adult vitiligo to (1) clarify in a footnote or otherwise, that the ongoing Phase 3 CUV105 trial is evaluating SCENESSE with adjunctive phototherapy and not as a monotherapy and (2) to include the year in which you expect topline results from the CUV105 trial. • We note your disclosure on page 27… letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 4 · disclosure is a more appropriate place to discuss the PhotoCosmetics program. Awaiting / response not in dataset
Staff comment: We acknowledge your response to prior comment 11, which we reissue with respect to the bullet points below. In this regard, we note that your pipeline table should be a visual reflection of the narrative discussion in the prospectus, which discussion should provide proper context and thoroughly address all completed, ongoing, and planned preclinical and clinical trials of your material product candidates. • The pipeline table, and your narrative disclosure on page 28 regarding the expected marketing submission for NEURACTHEL in the EU, suggests that all clinical trials of NEURACTHEL for IS and MS are complete. However, it does not appear that the design of these clinical trials, or the… letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 5 · Page 3 Awaiting / response not in dataset
Staff comment: Please revise page 28 to disclose the jurisdiction(s) where you plan to apply for regulatory approval for SCENESSE in adolescent and adult vitiligo and in variegate porphyria, and, as appropriate, in which order. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-03-19 · · Comment 6 · SCENESSE, page 28 Awaiting / response not in dataset
Staff comment: We note your statement that "[c]urrently, the largest market opportunity is seen in vitiligo..." To provide insight into the size of the market opportunity, please revise to discuss the estimated size of the vitiligo patient population in adolescents and adults worldwide and/or in markets that are material to your business prospects. Similarly, with respect to your late-stage NERUACTHEL program, provide the estimated size of the patient population with infantile spasms and acute exacerbations of MS, which you state you believe would benefit from NEURACTHEL treatment. letter →
Business Description (Item 101)
AEHR TEST SYSTEMS (AEHR) · 2026-03-17 · Inc. Form 10-K for the Fiscal Year Ended May 30, 2025 Form 10-Q for the Three and Six Months Ended November 28, 2025 · Comment 4 · Note 13. Segment and Concentration Information, page 19 Explained / pushed back
Staff comment: We see your discussion in MD&A that the rapid advancement of generative artificial intelligence (AI) and the accelerating electrification of transportation and global infrastructure represent two of the most significant macro-trends impacting the semiconductor industry today. These appear to represent two different end markets for your products as well, one with decreasing sales, and one with increasing sales, based on your reporting. Tell us how the changes in your business and related end markets impact how management reviews the business, your determination of operating segments, and all other general segment disclosures, including revenue by end market. letter →
Company response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that management has considered the impact of changes in its business and related end markets, including demand associated with generative AI and the electrification of transportation and infrastructure, in its determination of operating segments and related disclosures. As disclosed in Note 16 to the Company’s fiscal 2025 Annual Report on Form 10-K and Note 13 to the Company’s Quarterly Report on Form 10-Q for the quarter ended November 28, 2025, the Company has concluded that it operates as a single operating and reportable segment. The Company’s Chief Operating Decision Maker (“CODM”) reviews financial… response letter →
Segment Reporting (ASC 280)MD&A: Results & Known TrendsBusiness Description (Item 101)Concentrations & Receivables
AEHR TEST SYSTEMS (AEHR) · 2026-03-17 · Inc. Form 10-K for the Fiscal Year Ended May 30, 2025 Form 10-Q for the Three and Six Months Ended November 28, 2025 · Comment 5 · all other general segment disclosures, including revenue by end market. Agreed to revise
Staff comment: In this regard, tell us how the acquisition of Incal Technology impacted your business segments and related disclosures. letter →
Company response: The Company respectfully advises the Staff that the acquisition of Incal Technology did not change the Company’s conclusion that it has one operating segment and one reportable segment. The acquisition of Incal Technology added complementary products that allow the Company to offer a broader range of testing products for both wafer-level and packaged-part burn-in applications. Following the acquisition, Incal’s operations were integrated into the Company’s existing organizational structure, including manufacturing, finance, sales, research and development, and other administrative functions. Consistent with that integration, the Company relocated Incal employees to Aehr’s principal Fremont… response letter →
Segment Reporting (ASC 280)Business Description (Item 101)
AEHR TEST SYSTEMS (AEHR) · 2026-03-17 · Inc. Form 10-K for the Fiscal Year Ended May 30, 2025 Form 10-Q for the Three and Six Months Ended November 28, 2025 · Comment 6 · Operations, page 20 Agreed to revise
Staff comment: We see that you include only a short Overview in MD&A that focuses primarily on your products. In light of the significant changes to your business and the end markets for your products, revise your discussion in future filings to provide information about the quality of, and potential variability of, the company's earnings and cash flow, so that investors can ascertain the likelihood that past performance is indicative of future performance. Identify and disclose known trends, events, demands, commitments and uncertainties that are reasonably likely to have a material effect on financial condition or operating performance. letter →
Company response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it will enhance its MD&A in future filings, including the Overview section, to provide a more robust discussion of the quality of its earnings and cash flows and the potential variability of its operating results. 5 As disclosed in the Company’s filings, the Company’s business has experienced significant changes in product mix and end-market demand, including reduced near-term demand in certain silicon carbide applications tied to electric vehicle market softness, and increased activity in artificial intelligence, data center, silicon photonics, Gallium Nitride, and packaged-part burn-in applications,… response letter →
MD&A: Results & Known TrendsBusiness Description (Item 101)
Atkore Inc. (ATKR) · 2026-03-10 · Form 10-K for the Year Ended September 30, 2025 Filed November 26, 2025 · Comment 1 · Business Factors Influencing our Results of Operations, page 37 Agreed to revise
Staff comment: We note the discussion of economic conditions influencing your operations beginning on page 37. You indicate that you generally sell your products on a spot basis and as such, were exposed to sales prices on your products that decreased faster than the cost of the related raw materials. We further note the analysis of segment results indicates the Electrical segment's average selling price decreased while its input costs increased and the Safety & Infrastructure segment's input costs decreased faster than its selling prices decreased, both of which seem somewhat different from the statement on page 37. Please explain to us in more detail the meaning of the disclosure on page 37 and how it… letter →
Company response: The disclosure referenced on page 37 that states, "We generally sell our products on a spot basis and as such, were exposed to sales prices on our products that decreased faster than the cost of the related raw materials" was intended 1 to convey an aggregated trend at the consolidated level and is reflected in the consolidated net sales and cost of sales explanations, on pages 40 and 41, where we disclose that "Net sales for fiscal 2025 decreased. . .primarily attributed to decreased average selling prices of $381.8 million" and "Cost of sales increased $50.1 million. . .the increase. . .was partially offset by lower input costs of $10.1 million." As the segment discussions are using… response letter →
Segment Reporting (ASC 280)MD&A: Results & Known TrendsBusiness Description (Item 101)
AMDOCS LTD (DOX) · 2026-03-10 · Amdocs Limited Form 20-F for the Fiscal Year Ended September 30, 2025 · Comment 1 · Operating and Financial Review and Prospects, page 27 Agreed to revise
Staff comment: We note you quantify and discuss managed service backlog and renewals in your earnings releases and investor presentations. In addition, in Exhibit 99.1 of the Form 6-K furnished on December 16, 2025, you refer to near 100% renewal rates as one of your strategic pillars and include 12-month backlog in your list of key financial highlights. Please tell us whether these metrics are key performance indicators used in managing your business and if so, revise to include a quantified discussion of these metrics for each period presented. Refer to SEC Release No. 33-10751. letter →
Company response: The Company respectfully acknowledges the Staff’s comment and confirms that future annual reports on Form 20-F, including our Annual Report on Form 20-F for the fiscal year ending September 30, 2026, will present managed service renewal rates and 12-month backlog as key performance indicators (until and unless we conclude in the future that such metrics are no longer key performance indicators for our business and cease disclosing them). For the Staff’s reference, here is a markup of the relevant language we expect to include in our future filings (with this language reflecting what would have been included in the Annual Report): Revenue from managed services arrangements is a significant… response letter →
KPIs, Metrics & Earnings CallsExhibits, Certifications & SignaturesBusiness Description (Item 101)Funds & BDCs (ASC 946, N-CSR)
NetApp, Inc. (NTAP) · 2026-03-09 · Form 10-K for the Year Ended April 25, 2025 Form 10-Q for the Period Ended January 23, 2026 · Comment 1 · Risk Factors, page 21 Awaiting / response not in dataset
Staff comment: You indicate that a reduction in U.S. government demand could materially harm your business, operating results, financial condition or cash flows. To provide greater context to investors about the significance of this customer to your business, please revise to quantify revenues from the U.S. government for the periods presented. As a related matter, please disclose the amount of revenue attributed to U.S. public sector markets for each period presented as part of your Management's Discussion and Analysis on page 40. We note that you provided this information in Exhibit 99.1 to your Form 8-Ks filed on May 29, 2025 and February 26, 2026. letter →
MD&A: Results & Known TrendsRisk FactorsKPIs, Metrics & Earnings CallsExhibits, Certifications & SignaturesBusiness Description (Item 101)
Johnson Controls International plc (JCI) · 2026-02-26 · Form 10-K for the Fiscal Year Ended September 30, 2025 · Comment 1 · 31 Agreed to revise
Staff comment: We note your disclosure on page 6 indicates that management uses backlog and orders as tools to monitor the performance of the business and provide management with a deeper level of insight into the progress of specific strategic and growth initiatives. Please revise to include a qualitative and quantitative discussion of such metrics for each period presented to enhance a readers understanding of your business similar to slides 9 and 10 of your Fiscal Q4 2025 Earnings Conference Call investor presentation which addresses changes by segment and solution. Refer to SEC Release No. 33-10751. letter →
Company response: The Company acknowledges the Staff’s comment and hereby confirms to the Staff that it will include in future periodic reports a qualitative and quantitative discussion of orders and backlog similar in scope to the information included in the Company’s Q4 Fiscal Year 2025 earnings presentations. Johnson Controls, Inc. 5757 N Green Bay Ave, Milwaukee, WI 53209 Segment Analysis, page 35 response letter →
Segment Reporting (ASC 280)KPIs, Metrics & Earnings CallsBusiness Description (Item 101)
Doximity, Inc. (DOCS) · 2026-02-23 · Form 10-K for the Year Ended March 31, 2025 Form 10-Q for the Period Ended December 31, 2025 · Comment 4 · Comparison of the Fiscal Years Ended , page 50 Explained / pushed back
Staff comment: You indicate that average revenue per existing Marketing Solutions customer increased by 22% during fiscal 2025. In your May 15, 2025 earnings call, your CEO indicated that newsfeed was both your most widely used and most monetized product. Please show us how you intend to revise to provide greater insight to investors about your revenue trends over time by disclosing disaggregated revenues by modules (Newsfeed, Workflow, and Peer) for each period presented. It appears you have this information readily available and that management is actively using it to evaluate your business. Refer to Item 303(b)(2) of Regulation S-K. letter →
Company response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has considered the disclosure requirements of Item 303(b)(2) of Regulation S-K, however, the Company does not track or manage revenue at the individual module level, and its financial systems do not have the capability to identify or allocate revenue by module. Although the Company tracks module usage for operational purposes, and available data indicates that the newsfeed module was the most widely used product during the period, management does not use module-level usage data to assess revenue performance. As noted in the Company’s response to comment 2 above, the Company does not believe user… response letter →
KPIs, Metrics & Earnings CallsBusiness Description (Item 101)
PRECIGEN, INC. (PGEN) · 2026-02-10 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 1 · 15. Segments, page 31 Agreed to revise
Staff comment: Please address the following regarding your response to prior comment two with a view toward ascertaining the extent to which Biopharmaceuticals and Exemplar continue to constitute two separate operating segments as defined in ASC 280-10-50-1: • Regarding the second bullet, you have told us that you have two separate components or reporting units that were not aggregated under ASC 350-20-35-33 through 35-36. You also appear to indicate that your chief operating decision maker (CODM) continues to receive at least some level of separate discrete financial information for these reporting units. Please tell us what financial information is received by the CODM, and how it changed in the first… letter →
Company response: to prior comment two with a view toward ascertaining the extent to which Biopharmaceuticals and Exemplar continue to constitute two separate operating segments as defined in ASC 280-10-50-1: · Regarding the second bullet, you have told us that you have two separate components or reporting units that were not aggregated under ASC 350-20-35-33 through 35-36. You also appear to indicate that your chief operating decision maker (CODM) continues to receive at least some level of separate discrete financial information for these reporting units. Please tell us what financial information is received by the CODM, and how it changed in the first quarter of 2025 and subsequent periods. · Clarify how… response letter →
Segment Reporting (ASC 280)Goodwill & Asset ImpairmentBusiness Description (Item 101)
XChange TEC.INC (XHG) · 2026-02-04 · Amendment No 1. to Registration Statement on Form F-3 Filed October 29, 2025 · Comment 1 · General Awaiting / response not in dataset
Staff comment: We note your response to prior comment 1 to our letter dated September 17, 2025 related to your Annual Report on Form 20-F for the fiscal year ended September 30, 2024. Based on your response it appears that you have sold 25,770,000 ADSs since December 2023, the date when your business changed from "technology-driven long- term apartment rental platform in China" to the "insurance agency and insurance technology business" in the PRC. Please provide us with legal analysis as to why the acquisition of the new insuretech business did not constitute a fundamental change that required you to file a post-effective amendment to the registration statement on Form F- 3, file no. 333-258187, to… letter →
China-Based IssuersBusiness Description (Item 101)IFRS & Foreign Private Issuers
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 3 · Page 2 Awaiting / response not in dataset
Staff comment: Based on your patent disclosures beginning on page 39, it appears that certain patents in various jurisdictions related to the method for treatment of photodermatoses will expire in 2027. As appropriate, please provide risk factor disclosure discussing the extent to which you face material risk stemming from the expiration of these patents, or otherwise advise. letter →
Risk FactorsBusiness Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 8 · jurisdictions. Awaiting / response not in dataset
Staff comment: Please tell us your consideration of including a pipeline table depicting all material pharmaceutical candidate programs, the specific indications and patient populations being pursued, and the status of development for each product candidate, including separate columns of equal width for preclinical development, Phase 1, Phase 2 and Phase 3 clinical trials with arrows showing how far each program has progressed. As applicable, consider a column indicating the next material milestone for each program (e.g., submission of an IND or equivalent, timing of expected data from ongoing trials, etc.). letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 9 · etc.). Awaiting / response not in dataset
Staff comment: We note your disclosure on page 28 that in addition to the current use of SCENESSE® for the treatment for adult EPP patients, you are (1) focused on treating a wider group of EPP patients, most notably adolescent EPP patients, and (2) exploring its use as a drug therapy in other indications such as vitiligo and variegate porphyria. Additionally, we note that you are developing additional pharmaceutical products, such as novel formulations of the melanocortin adrenocorticotropic hormone (“ACTH”) as NEURACTHEL® in multiple dosage forms for patients with neurological, endocrinological, and degenerative disorders. With respect to each of your development- stage programs, please: • Revise your… letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 10 · treatment of vitiglio to indicate the applicable clinical trial phase. Awaiting / response not in dataset
Staff comment: With respect to each of your development-stage pharmaceutical product candidates, please disclose the location(s) of completed, ongoing, and planned clinical trials. As appropriate, disclose that clinical data generated in a jurisdiction outside of the United States may not be accepted by the FDA or comparable foreign regulatory authorities and if so, may result in the need to conduct additional trials. Additionally, revise to include Risk Factor disclosure to this effect. letter →
Risk FactorsBusiness Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 11 · Risk Factor disclosure to this effect. Awaiting / response not in dataset
Staff comment: We note references here and elsewhere throughout to studies and clinical trials of your product candidates, such as a recently completed pharmacokinetic study in adolescent and adult EPP patients. We also note references on page 46 to "the CUV104 Phase II pilot monotherapy vitiligo study and the CUV803 Phase II stroke study." In your discussion of the preclinical and clinical development of your currently material programs, please revise your disclosure to specify the following information with respect to the preclinical studies and/or clinical trials that you have conducted, are currently conducting, or plan to conduct: • regulatory authorization(s) received or required to be received to… letter →
Risk FactorsBusiness Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 12 · supporting p-values, as applicable. Awaiting / response not in dataset
Staff comment: You state on pages 24 and 28 that you are "developing and commercializing novel formulations of the melanocortin adrenocorticotropic hormone (“ACTH”) as NEURACTHEL®..." Please remove or revise the present-tense reference to "commercializing," or otherwise advise. In this regard, we note that it does not appear from your disclosure that you have received any regulatory approval for NEURACTHEL, which will seemingly be required prior to commercialization. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 13 · NEURACTHEL, which will seemingly be required prior to commercialization. Awaiting / response not in dataset
Staff comment: We note your disclosures on page 29 and 35 concerning your plans to launch a number of non-pharmaceutical PhotoCosmetics products for the general population based on melanocortin technology, including products to assist DNA repair and melanocyte- stimulating hormone (“MSH”)-response for assisting risk-free bronzing "in the next few years." In this regard: • Please revise where appropriate to describe the remaining material steps, if any, that must be completed prior to fully launching your CYACÊLLE products, and when you plan for such steps to be completed, or otherwise advise. • Briefly describe your various "PhotoCosmetic M-lines," including the "Preserve" and "Bronze" product ranges… letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 14 · completed. Awaiting / response not in dataset
Staff comment: We note your disclosure on page 45 indicating that EPP is a rare metabolic disorder. To provide insight into the size of the market opportunity, please revise to discuss the estimated size of the EPP patient population worldwide and/or in markets that are material to your business prospects. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 16 · Enhance the Distribution Network and Expand into New Geographic Markets, page 26 Awaiting / response not in dataset
Staff comment: Please revise your disclosure on page 27 to indicate when you received approval to commercially distribute SCENESSE in Australia and explain whether you plan to start distribution in Australia in the near term. To the extent that you have had this regulatory approval for an extended period, revise to explain the decision to initiate distribution now. With respect to Australia, Colombia and Argentina, discuss the key steps, if any, that must be completed in each jurisdiction prior to commercialization. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 19 · from the approval process in adult populations. Awaiting / response not in dataset
Staff comment: You state on page 27 that "[f]urther platform products – liquid injectable controlled- release doses for melanocortin delivery – developed in CLINUVEL’s RD&I Centre in Singapore, have recently been announced." Please revise to disclose the development status of these announced platform product candidates (i.e., preclinical or clinical), and describe your near- and longer-term development plans for such candidates. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 20 · NEURACTHEL®, page 28 Awaiting / response not in dataset
Staff comment: Please revise to expand your statement that you are "preparing regulatory submissions to the U.S. FDA and other regulatory agencies." Explain the type(s) of submission to which you refer, and explain when you plan to make such submissions. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 21 · Manufacturing and Logistics, page 32 Awaiting / response not in dataset
Staff comment: Please revise to discuss the availability of raw materials, including a description of whether prices of principal raw materials are volatile. Refer to Item 4.B.4 of Form 20-F. letter →
Business Description (Item 101)IFRS & Foreign Private Issuers
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 22 · Patents, page 39 Awaiting / response not in dataset
Staff comment: Please revise your intellectual property disclosure to disclose for each material patent and/or patent application the specific products or technologies to which such patents or patent applications relate. Also clearly describe on an individual basis the type of patent protection granted for each product or technology (composition of matter, use, or process) and whether the patents are owned or licensed. For instance, it should be clear when patent protections covering Scenesse will expire in the US and Europe. letter →
Business Description (Item 101)
Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) · 2026-01-30 · · Comment 25 · C. Research and Development, Patents and Licenses, page 50 Awaiting / response not in dataset
Staff comment: Please revise your disclosure for each of your pipeline candidates to discuss each program's current phase of development, any prior material preclinical or clinical studies and results, and any regulatory submissions made to date. letter →
Business Description (Item 101)
indie Semiconductor, Inc. (INDI) · 2026-01-14 · Form 10-K for the Fiscal Year Ended December 31, 2024 Form 8-K Filed November 6, 2025 Response Dated September 26, 2025 · Comment 1 · Exhibit 99.1, page 1 Agreed to revise
Staff comment: We note your response to prior comment 6, including your statements that you do not present GAAP gross profit or GAAP gross margin in your Consolidated Statements of Operations because certain costs related to contract revenues are expensed as incurred and included in research and development expenses and it is not practicable to allocate such expenses to cost of sales. We also note you now believe the adjusted non-GAAP gross profit and adjusted non-GAAP gross margin measures you present should be categorized as Key Performance Metrics (KPMs) because: (1) they are consistent with how you reflect your business in internal financial statements; (2) they are consistent with how your leadership… letter →
Company response: to prior comment 6, including your statements that you do not present GAAP gross profit or GAAP gross margin in your Consolidated Statements of Operations because certain costs related to contract revenues are expensed as incurred and included in research and development expenses and it is not practicable to allocate such expenses to cost of sales. We also note you now believe the adjusted non-GAAP gross profit and adjusted non-GAAP gross margin measures you present should be categorized as Key Performance Metrics (KPMs) because: (1) they are consistent with how you reflect your business in internal financial statements; (2) they are consistent with how your leadership and Chief Executive… response letter →
Non-GAAP: Adjustments & LabelsNon-GAAP: Reconciliation & UsefulnessKPIs, Metrics & Earnings CallsExhibits, Certifications & SignaturesBusiness Description (Item 101)
Kuber Resources Corp (KUBR) · 2025-12-15 · Form 10-K for the Fiscal Year Ended December 31, 2024 Form 10-Q for the Quarterly Period Ended September 30, 2025 · Comment 6 · that give the company power and economics over the VIE. Responded
Staff comment: Disclose qualitative information about involvement with the VIE, including the nature, purpose, size, and activities of the VIE. Also include a description of the recognized and unrecognized revenue-producing assets that are held by the VIE. These assets may include licenses, trademarks, other intellectual property, facilities or assembled workforce. Refer to ASC 810-10-50-5A.d. letter →
Company response: The Company refers the Staff to its response to Comment 5 contained herein concluding there is no VIE. response letter →
China-Based IssuersBusiness Description (Item 101)
Viant Technology Inc. (DSP) · 2025-12-08 · Form 10-K for the Fiscal Year Ended December 31, 2024 · Comment 1 · Operations, page 46 Responded
Staff comment: We note you no longer include active customer count given your strategic shift to focus on higher value customers that have the ability to scale. We also note you quantify and discuss the percentage increase in the number of spend customers generating over $1 million in contribution ex-TAC and the contribution ex-TAC across your top 100 customers in your earnings calls. Please tell us whether these are key performance measures used in managing your business and if so, revise to include a quantified discussion of these metrics for each period presented in your periodic filings. Refer to SEC Release No. 33-10751. letter →
Company response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the percentage increase in the number of spend customers generating over $1 million in contribution ex-TAC and the contribution ex-TAC across the Company’s top 100 customers are not key performance measures used by management to manage the business within the meaning of Item 303 of Regulation S-K and Commission Release No. 33-10751. The Company’s key performance measures are disclosed in “ Management’s Discussion and Analysis of Financial Condition and Results of Operations—Key Operating and Financial Performance Measures ” sections of its periodic reports. These measures are used by management to manage… response letter →
KPIs, Metrics & Earnings CallsBusiness Description (Item 101)
Cloopen Group Holding Ltd (RAASY) · 2025-11-21 · · Comment 3 · a material adverse effect on our business..., page 35 Responded
Staff comment: We note you made changes to the disclosure on page 35 from what you previously disclosed in the Form F-1/A filed on February 3, 2021, regarding the legal and operational risks associated with operating in China and PRC regulations. It is unclear to us that there have been changes in the regulatory environment in the PRC since your initial registration statement that would warrant such revisions, which mitigate the challenges you face and related disclosures. In future filings, please restore your disclosure. For additional guidance, please refer to the Division of Corporation Finance’s Sample Letter to China-Based Companies, issued December 2021 and July 2023. letter →
Company response: In response to the Staff’s comment, the Company respectfully undertakes to revise the relevant disclosure in its future Form 20-F filings as follows (with deletions shown in strikethrough and additions in underline showing the changes against the disclosure in the 2024 Form 20-F), subject to such updates and adjustments to be made in connection with any material developments of the subject matter being disclosed. “ D. Risk Factors … Risks Related to Doing Business in China Changes in China’s economic, political or social conditions or government policies could have a material adverse effect on our business and operations. We generate substantially all of our revenues from our operations in… response letter →
Debt, Equity & DerivativesChina-Based IssuersBusiness Description (Item 101)
MASIMO CORP (MASI) · 2025-11-13 · oration Item 2.02 Form 8-K filed February 25, 2025 Response dated August 6, 2025 · Comment 1 · Staff’s comment is repeated below in bold, followed by the Company’s response. Awaiting / response not in dataset
Staff comment: We have reviewed your supplemental information letter. We continue to believe that the expenses associated with your consumer products inventory write-downs represent costs that are normal operating costs of your business. Please revise future filings to not include these adjustments to your non-GAAP performance measures. See Question 100.01 of the SEC's Non-GAAP Financial Measures Compliance and Disclosure Interpretations (“CD&I”). The Company respectfully acknowledges the Staff’s comment and, although the Company believes that its consumer products inventory write-down adjustments were appropriate and complied with Question 100.01 of the SEC’s Non-GAAP Financial Measures CD&I, the Company… letter →
Non-GAAP: Adjustments & LabelsNon-GAAP: Reconciliation & UsefulnessBusiness Description (Item 101)
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