SRSEC Reporting Desk

Industries

Pharmaceuticals & Biotech

21 SEC staff comments and 15 disclosure examples from companies in this industry.

SIC codes included: 2834 Pharmaceutical Preparations, 2836 Biological Products, (No Diagnostic Substances), 2833 Medicinal Chemicals & Botanical Products, 2835 In Vitro & In Vivo Diagnostic Substances

Disclosure examples by topic

What the SEC staff asked companies in this industry

Segment Reporting (ASC 280) (6)Exhibits, Certifications & Signatures (5)MD&A: Results & Known Trends (4)ASC 606: Revenue Recognition (3)R&D Expense Disclosure (2)Business Description (Item 101) (2)Business Combinations & Significance (2)Financial Statement Requirements (Reg S-X) (2)Fair Value & Investments (2)Goodwill & Asset Impairment (2)KPIs, Metrics & Earnings Calls (1)Capitalization, Equity & Escrow (1)

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)
COMPUGEN LTD (CGEN) · 2026-07-17 · . Form 20-F for Fiscal Year Ended December 31, 2025 · Comment 2 Agreed to revise
Staff comment: As it relates to your 2023 Gilead License Agreement, you disclose that you identified three distinct performance obligations and that the transaction price was allocated to these performance obligations based on their relative standalone selling price. Please revise your future filings to quantify the amount of the transaction price allocated to each unsatisfied (or partially satisfied) performance obligation as of the end of each reporting period and an explanation as to the period over which you expect to recognize the remaining revenue. In this regard, we note that $35.9 million remains unrecognized as deferred revenue, and that you expect to recognize 31% of the remaining performance… letter →
Company response: The Company respectfully advises the Staff that, upon inception of the 2023 Gilead License Agreement, it identified three performance obligations. The agreement also provided Gilead with an option to purchase drug supply of GS-0321. The Company concluded that this option did not provide a material right and therefore did not represent a separate performance obligation. During the first half of 2026, Gilead exercised its option to purchase additional goods and services related to the supply of GS-0321. The Company undertakes to update its disclosure in future filings with the Commission to reflect the exercise of this option. The Company further advises the Staff that revenue associated with… response letter →
ASC 606: Revenue RecognitionKPIs, Metrics & Earnings Calls
Scilex Holding Co (SCLX, SCLXW) · 2026-04-24 · mpany Registration Statement on From S-3 Filed April 16, 2026 · Comment 1 · Important Information Incorporated by Reference, page 44 Explained / pushed back
Staff comment: Your Form 10-K for the fiscal year ended December 31, 2025, which has been forward incorporated by reference into your registration statement, reflects the acquisition of Vivasor Holding Company on December 5, 2025. Based on the purchase consideration transferred, this acquisition would appear to exceed the significance thresholds set forth in Rule 1-02(w) of Regulation S-X. As such, please tell us how you have complied with the requirements of Item 2.01 of Form 8-K and Rule 3-05 of Regulation S-X as it relates to this acquisition. letter →
Company response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it reviewed the requirements of Rule 3-05 of Regulation S-X and Item 2.01 of Form 8-K in connection with its evaluation of whether the acquisition of certain equity interests in Vivasor Holding Company (“ Vivasor ” and such interests, the “ Vivasor Equity ”) meets any of the significance thresholds set forth in Rule 1-02(w) of Regulation S-X and whether such acquisition constitutes a significant amount of assets under Item 2.01 of Form 8-K and has determined that in each case it complies with the requirements of Item 2.01 of Form 8-K and Rule 3-05 of Regulation S-X as it relates to this acquisition of the… response letter →
Business Combinations & SignificanceFinancial Statement Requirements (Reg S-X)
Scilex Holding Co (SCLX, SCLXW) · 2026-04-24 · mpany Registration Statement on From S-3 Filed April 16, 2026 · Comment 2 · Exhibits Explained / pushed back
Staff comment: Please tell us why you have not publicly filed your December 5, 2025 Share Transfer Agreement with Vivasor. For reference, please refer to Item 601(b)(2) and (b)(10) of Regulation S-K. letter →
Company response: The Company also respectfully advises the Staff that it has reviewed the requirements of Item 601(b)(2) and (b)(10) of Regulation S-K and has determined that the Share Transfer Agreement, dated December 5, 2025, between the Company and Vivasor is not a material plan of acquisition under Item 601(b)(2) of Regulation S-K or a material contract under Item 601(b)(10) of Regulation S-K. With respect to the Company’s analysis of materiality, the Company considered quantitative and qualitative factors including the quantitative factors described above in the Company’s response to Comment 1. response letter →
Exhibits, Certifications & SignaturesCapitalization, Equity & Escrow
VERTEX PHARMACEUTICALS INC / MA (VRTX) · 2026-03-18 · Vertex Pharmaceuticals, Inc. Form 10-K for Fiscal Year Ended December 31, 2025 · Comment 1 · Out-license Agreements, page F-20 Partly revised / explained
Staff comment: We note your disclosure stating that you entered into collaboration agreements with Zai Lab Limited and Ono Pharmaceuticals Co. Ltd. In future filings, if material, please expand your disclosure to describe the material terms of these agreements including, but not limited to, the termination provisions and any royalty or milestone payment requirements. Disclose the royalty rate or a range not exceeding 10%. In addition, tell us how you considered whether to file the agreements as exhibits. letter →
Company response: The Company acknowledges the Staff’s comment, and respectfully advises the Staff that the Company has concluded that its agreements with Zai Lab Limited (the “Zai Agreement”) and Ono Pharmaceuticals Co., Ltd. (the “Ono Agreement,” and together with the Zai Agreement, the “Agreements”), while beneficial, are not material to the Company and, therefore, are not required to be filed as exhibits to the Company’s filings with the Commission, including the 2025 10-K, pursuant to Item 601(b)(10) of Regulation S-K. The Company reached this conclusion based on the following primary considerations: • Immaterial financial value . The upfront consideration paid to the Company and potential future… response letter →
Exhibits, Certifications & Signatures
Aprea Therapeutics, Inc. (APRE) · 2026-03-16 · (the “Company”) Registration Statement on Form S-3 Filed February 20, 2026 · Comment 1 · Staff Comment Explained / pushed back
Staff comment: We note that you filed this registration statement more than 45 days after the end of your fiscal year. As such, you do not appear to meet the age of financial statement requirements of Rule 8-08(b) of Regulation S-X. Please revise to include audited financial statements for the fiscal year ended December 31, 2025. letter →
Company response: The Company respectfully advises the Staff that the Company has filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, on March 16, 2026. As a result, the audited financial statements for the fiscal year ended December 31, 2025, are now on file with the Commission and incorporated by reference into the Registration Statement in accordance with the incorporation by reference provisions of the Registration Statement. The Company respectfully believes that the filing of the Form 10-K addresses the Staff’s comment. The Company acknowledges the Staff may have further questions and will respond promptly to any additional comments. Please do not hesitate to contact the… response letter →
Financial Statement Requirements (Reg S-X)
Tilray Brands, Inc. (TLRY) · 2026-03-05 · Form 10-K for the fiscal year ended May 31, 2025 Form 10-Q for the quarterly period ended August 31, 2025 · Comment 1 · Results of Operations, page 28 Agreed to revise
Staff comment: We have read your response to comment one. Please further revise your future filings as applicable to highlight that the change in fair value of contingent consideration of $15.0 million recognized during the three months ended August 31, 2025, resulted in net income for the period then ended, when we note you historically report a net loss. letter →
Company response: to comment one. Please further revise your future filings as applicable to highlight that the change in fair value of contingent consideration of $15.0 million recognized during the three months ended August 31, 2025, resulted in net income for the period then ended, when we note you historically report a net loss. We appreciate the Staff’s comment and respectfully submit that we will revise our future filings pursuant to your comment above. response letter →
MD&A: Results & Known TrendsFair Value & Investments
ELITE PHARMACEUTICALS INC /NV/ (ELTP) · 2026-03-04 · Elite Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended March 31, 2025 Filed June 30, 2025 · Comment 1 · Revenue Recognition, page F-8 Agreed to revise
Staff comment: We note your disaggregation of revenue disclosure provided on page F-9 as well as the information provided in your February 20, 2024 response letter, specifically your response to comment four. You state that you disaggregate your revenue based on type of good or service (e.g., manufacturing and license fees) and regulatory pathway (e.g., ANDA vs NDA). Please address the following: • Given that you have paused further development of NDAs and do not appear to have engaged in business activities in this segment since 2021, explain to us how disaggregation by regulatory pathway provides a meaningful level of disaggregation of your revenues. • In your February 20, 2024 response to prior comment… letter →
Company response: letter, specifically your response to comment four. You state that you disaggregate your revenue based on type of good or service (e.g., manufacturing and license fees) and regulatory pathway (e.g., ANDA vs NDA). Please address the following: ● Given that you have paused further development of NDAs and do not appear to have engaged in business activities in this segment since 2021, explain to us how disaggregation by regulatory pathway provides a meaningful level of disaggregation of your revenues. U.S. Securities and Exchange Commission ● In your February 20, 2024 response to prior comment four, you stated that when determining the level of revenue disaggregation, you considered the… response letter →
ASC 606: Revenue RecognitionSegment Reporting (ASC 280)Risk Factors
ELITE PHARMACEUTICALS INC /NV/ (ELTP) · 2026-03-04 · Elite Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended March 31, 2025 Filed June 30, 2025 · Comment 2 · Note 14. Segment Results, page F-23 Agreed to revise
Staff comment: You disclose that Consolidated Loss from Operations is the measure of segment profit or loss that is regularly reviewed by your CODM and that this measure is reported in your Consolidated Statements of Operations. Your disclosure on page F-24, however, of Operating Income by Segment does not tie to your Consolidated Statements of Operations. With a view towards future disclosure, clarify for us your measure of segment profit or loss and provide us with the components of such measure and illustrate how it ties to your Consolidated Statements of Operations. Please also ensure that all of the information required by ASC 280-10-50-22 is disclosed in your future filings. letter →
Company response: The Company acknowledges the Staff’s comment and clarifies that the Chief Operating Decision Maker (“CODM”) regularly reviews Consolidated Income from Operations as the measure of segment profit or loss, which is reported in the Company’s Consolidated Statements of Operations. The Company notes that the presentation of Operating Income by Segment in Note 14 did not clearly reconcile to the Consolidated Statements of Operations. The Company will include Income (Loss) from Operations as a line item within the segment results table to facilitate reconciliation in future filings as follows: For the Years Ended March 31, 2025 2024 Operating income by segment $ 32,121,818 $ 19,473,752 Corporate… response letter →
Segment Reporting (ASC 280)
ELITE PHARMACEUTICALS INC /NV/ (ELTP) · 2026-03-04 · Elite Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended March 31, 2025 Filed June 30, 2025 · Comment 3 · the information required by ASC 280-10-50-22 is disclosed in your future filings. Agreed to revise
Staff comment: As a related matter, with a view towards future disclosure, provide us with the information required by ASC 280-10-50-26A through 50-26C as it relates to significant segment expenses and other segment items. letter →
Company response: The Company acknowledges the Staff’s comment and confirms there are no significant segment expenses or other segment items that are separately provided to the CODM beyond research and development and general and administrative expenses. The CODM does not receive segment-level information related to depreciation, amortization, capital expenditures, or other non-cash items, and therefore such items are excluded. Going forward, the Company will enhance its segment disclosures to explicitly address the requirements of ASC 280-10-50-26A through 50-26C, including clarifying that significant segment expenses are presented in the Consolidated Statements of Operations and that no additional… response letter →
Segment Reporting (ASC 280)
Benitec Biopharma Inc. (BNTC) · 2026-02-24 · Form 10-K for Fiscal Year Ended June 30, 2025 · Comment 1 · Report of Independent Registered Public Accounting Firm, page F-2 Agreed to revise
Staff comment: We note the signature of Baker Tilly US, LLP has been omitted from their audit report. Please amend your filing to provide a signed audit report. Refer to Rule 2-02(a)(2) of Regulation S-X. letter →
Company response: to the Staff’s comment, the Company is filing today Amendment No. 1 (the “Amendment No. 1”) to its Annual Report on Form 10-K for the year ended June 30, 2025 (the “Original 10-K”) to include a conformed signature on the audit report that was included in its Original 10-K. As indicated in the Explanatory Note to Amendment No. 1, the conformed signature on the audit report was inadvertently omitted from the version that was originally filed with the Original 10-K. The signed audit report was provided to the Company by Baker Tilly US, LLP prior to the filing of the Original 10-K. Please feel free to contact me at 323-388-2352 or mboston@benitec.com if there are any further questions. response letter →
Auditor & Audit ReportExhibits, Certifications & Signatures
Twist Bioscience Corp (TWST) · 2026-02-19 · oration Form 10-K for Fiscal Year Ended September 30, 2025 Form 10-Q for Quarterly Period Ended December 31, 2025 · Comment 1 · Exhibits Agreed to revise
Staff comment: We note the certifications provided in Exhibits 31 and 32 refer to the incorrect form and period. Please file a full amendment to your Form 10-Q with corrected certifications that refer to the proper form and period. Refer to Item 601(b)(31) and (b)(32) of Regulation S-K and Regulation S-K C&DI 246.14. letter →
Company response: The Company acknowledges the Staff’s comment and advises that the Company has filed Amendment No. 1 to the Original 10-Q on Form 10-Q/A concurrently herewith (the “ Amended 10-Q ”) in accordance with Regulation S-K C&DI 246.14. The Amended 10-Q includes corrected certifications in Exhibits 31.1, 31.2, 32.1, and 32.2 that fix the previous typographical errors and refer to the proper form (Form 10-Q) and the proper reporting period (the quarterly period ended 2 December 31, 2025) in accordance with Item 601(b)(31) and (b)(32) of Regulation S-K. No other changes have been made to the Original 10-Q. response letter →
Exhibits, Certifications & Signatures
Tilray Brands, Inc. (TLRY) · 2026-02-18 · Form 10-K for the fiscal year ended May 31, 2025 Form 10-Q for the quarterly period ended August 31, 2025 · Comment 1 · Results of Operations, page 28 Agreed to revise
Staff comment: You state on page 39 that "During the three months ended August 31, 2025, the Company recognized $15.0 million of change in the fair value of contingent consideration as the likelihood of achievement decreased to 0% of such contingent consideration related to the Montauk Brewing acquisition." However, we note from page 110 of your May 31, 2025 Form 10-K that the probability of achieving such contingent consideration was "100%" as of that date. Please explain to us in detail and revise your future filings as necessary to describe the events that transpired during the three months ended August 31, 2025 that resulted in your determination that the $15.0 million payout was no longer likely to… letter →
Company response: to the Staff’s comment, the Company respectfully submits that we will revise our future filings, as necessary, to describe the events that transpired during the three months ended August 31, 2025 that resulted in our determination that the $15.0 million payout was no longer likely to occur at all. response letter →
MD&A: Results & Known TrendsFair Value & Investments
Tilray Brands, Inc. (TLRY) · 2026-02-18 · Form 10-K for the fiscal year ended May 31, 2025 Form 10-Q for the quarterly period ended August 31, 2025 · Comment 2 · Results of Operations, page 47 Awaiting / response not in dataset
Staff comment: We note the discussions of the changes in your revenue and gross margin for each of the reportable segments on pages 51-54 do not provide quantifications of the significant factors that you have identified as impacting those changes for the periods presented. For example, on page 52, you state that the decrease in adult-use cannabis, your largest cannabis channel, was driven by, among other things, your "renewed focus on preserving gross margin and maintaining a higher average selling price in growing categories such as vapes that have experienced a high degree of price compression." Without quantification of selling price and price compression, a reader is not able to fully understand the… letter →
Segment Reporting (ASC 280)MD&A: Results & Known Trends
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)
PRECIGEN, INC. (PGEN) · 2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 1 · 6. Inventory, page 22 Agreed to revise
Staff comment: Regarding your inventory-related costs previously expensed as research and development (R&D) expenses (also referred to as your "pre-launch inventories"), please disclose the following beginning in your Form 10-K for the fiscal year ended December 31, 2025: • the amount of estimated revenues, if applicable, represented by your pre-launch inventories on hand at December 31, 2025; • when you expect to finish selling the pre-launch inventories; • the shelf life of your inventory and your consideration of whether or not any additional inventory will be determined to be obsolete in future periods; and • your estimate of what the gross margin percentage will be after the pre- launch inventories… letter →
Company response: We respectfully acknowledge the Staff’s comment and provide the following information in response. Papzimeos™ (zopapogene imadenovec-drba), is manufactured in three stages: 1) the Company manufactures bulk drug substance which yields the active pharmaceutical ingredient (“API”), zopapogene imadenovec-drba; 2) our contract manufacturer then develops bulk drug product utilizing the bulk drug substance manufactured by the Company, which yields filled drug product vials containing formulated zopapogene imadenovec-drba (i.e., Papzimeos); and 3) our contract manufacturer then performs the labeling, serialization, and packaging of the filled drug product vials in individual cartons, which yields a… response letter →
PRECIGEN, INC. (PGEN) · 2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 2 · 15. Segments, page 31 Agreed to revise
Staff comment: Please address the following related to your disclosure regarding the realignment of your former two operating segments, Biopharmaceuticals and Exemplar, into one operating segment during the first quarter of 2025: • Tell us and revise your future filings to clarify whether Biopharmaceuticals and Exemplar remain separate reporting units. • Please provide us with your analysis for the aggregation of these components into one operating segment, noting they appear to possess dissimilar economic and other characteristics. Refer to ASC 350-20-35-33 through 35-36. • Tell us how you determined that your presentation of a single operating segment is appropriate under the guidance of ASC 280-10-50. letter →
Company response: We respectfully acknowledge the Staff’s comment and provide the following information in response. For your convenience, each bullet of the Staff’s comment is reproduced in italicized type below, followed by our responses thereto: • Tell us and revise your future filings to clarify whether Biopharmaceuticals and Exemplar remain separate reporting units. The Company respectfully acknowledges the Staff's comment and advises the Staff that Biopharmaceuticals and Exemplar remain separate reporting units for purposes of ASC 350-20. We also advise the Staff that as of December 31, 2025, there was no intangible assets nor goodwill associated with the Exemplar reporting unit subsequent to an… response letter →
Segment Reporting (ASC 280)Goodwill & Asset Impairment
PRECIGEN, INC. (PGEN) · 2025-12-23 · Form 10-K for the fiscal year ended December 31, 2024 Form 10-Q for the quarterly period ended September 30, 2025 · Comment 3 · Results of operations, page 37 Agreed to revise
Staff comment: Please tell us and revise to disclose, beginning with your Form 10-K for the year ended December 31, 2025, whether you track research and development (R&D) expenses by candidate or program and, if not, explain why not. To the extent you track any of your R&D expenses by candidate or program, provide a breakout of such amounts. For the R&D expenses you do not track by candidate or program, revise to provide a quantitative breakout of remaining R&D expenses by type, which should reconcile to total R&D expenses on your Consolidated Statements of Operations for each period presented. letter →
Company response: The Company respectfully acknowledges the Staff's comment and provides the following information in response. We do not track research and development (“R&D”) expenses by candidate or program. Therefore, preparing such information solely for external disclosure would not reflect management’s view of the business or how R&D activities operate and are managed. A significant portion of our R&D spending relates to the development, optimization, and operation of our core therapeutic platforms rather than any single drug candidate. The Company will disclose the fact that it does not track R&D expenses by candidate or program in our MD&A. The Company tracks R&D by the nature of the following… response letter →
MD&A: Results & Known Trends
Eton Pharmaceuticals, Inc. (ETON) · 2025-12-19 · Form 10-K for the Fiscal Year Ended December 31, 2024 filed March 18, 2025 Form 8-K filed November 6, 2025 · Comment 1 · Note 4 - Business Combination, page 53 Awaiting / response not in dataset
Staff comment: We note your disclosures in Notes 4 and 15, and Form 8-K/A filed November 18, 2025, of the October 2, 2024 Asset Purchase Agreement with Ipsen Biopharmaceuticals, Inc. (“Ipsen”) for the acquisition of Increlex, which includes an obligation to purchase additional inventory over 30 months, in an amount not to exceed €15,000. Please tell us the following: • Tell us your accounting under ASC 805 for the additional inventory purchase obligation as no portion of the purchase price was allocated to this consideration. • Please describe to us the payment terms of the related liability to Ipsen for this additional inventory. • Clarify if your disclosures related to "Remaining Inventory" in the… letter →
Business Combinations & SignificanceExhibits, Certifications & Signatures
Eton Pharmaceuticals, Inc. (ETON) · 2025-12-19 · Form 10-K for the Fiscal Year Ended December 31, 2024 filed March 18, 2025 Form 8-K filed November 6, 2025 · Comment 2 · general Awaiting / response not in dataset
Staff comment: We note the tabular reconciliations in your earnings release where you reconcile non- GAAP financial measures to the most directly comparable GAAP measures appear to essentially represent full non-GAAP statements of operations. Please explain why you believe your disclosures comply with Question 102.10 of the Compliance and Disclosure Interpretations on Non-GAAP Financial Measures or revise your disclosures in future filings. letter →
Non-GAAP: Reconciliation & Usefulness
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 →
R&D Expense Disclosure

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