CRVS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• mg oral twice per day, 200 mg oral once per day, 200 mg oral twice per day and 400 mg oral once per day. Patients would be treated for 28 days and are then followed for an additional 30 days with no therapy. The primary endpoints included safety and tolerability, and efficacy, measured by improvemen…

• On January 20, 2026, we announced positive results from cohort 4 of our randomized, blinded, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The cohort 4 data demonstrated favorable safety and efficacy results consistent with r…

• Biomarker highlights and immunologic studies from the soquelitinib Phase 1 atopic dermatitis clinical trial were also presented at the SID Annual Meeting in May 2026. The results from these studies support soquelitinib’s mechanism of action, including the potential for drug-free remissions:

• ●Blocking Th2 and Th17 function and their related downstream cytokines (IL-4, IL-5, IL-13).

• ●Increasing persistent Treg cells, both during treatment and in the post-treatment, drug-free period, by regulating the switch to Treg cells from Th17 cells.

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• score, Investigator Global Assessment (“IGA”), reduction in itch and various cytokine biomarkers. EASI scores are also evaluated by the percent of patients that achieve a specified percent reduction in EASI score – EASI 50 for patients that achieved a 50% reduction; EASI 75 for a 75% reduction; and …

• On January 20, 2026, we announced positive results from cohort 4 of our randomized, blinded, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. Based on the encouraging results from cohorts 1-3, cohort 4 was prospectively redesign…

• The cohort 4 data demonstrated favorable safety and efficacy results consistent with results from cohorts 1-3, including a deepening of responses in cohort 4 over the 8-week treatment period compared to the 4-week treatment period. The results also showed clinical activity in patients who had receiv…

• In March 2026, we initiated a Phase 2 clinical trial of soquelitinib for the treatment of atopic dermatitis. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. The trial is anticipat…

• Angel Pharmaceuticals, our partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitin…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed

• to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitat…

• As required by Rule 13a-15(b) under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026 the end of the period covered by this Quarterly Repor…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports t…

• As required by Rule 13a-15(b) under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026 the end of the period covered by this Quarterly Repo…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Beginning January 1, 2027, we will no longer qualify as a smaller reporting company, which will increase our costs and demands on management, which will be further increased if and when we lose our status as a non-accelerated filer and become subject to auditor attestation requirements.

• Based on the market value of our common stock held by our non-affiliates as of June 30, 2026, we will no longer be a smaller reporting company as of January 1, 2027, and thus will be subject to additional disclosure requirements beginning with our Quarterly Report on Form 10-Q for the quarter ended …

• As a smaller reporting company, we have been allowed to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not smaller reporting companies, including reduced disclosure obligations regarding executive compensation in our Annual Rep…

• Pursuant to Section 404 of Sarbanes-Oxley, if and when we become an accelerated or large accelerated filer, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. We will continue to be a non-accelerated fil…

• The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation. To continue to comply with the requirements of being a reporting company under the Exchange A…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

• We are a smaller reporting company, which allows us to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not smaller reporting companies, including not being required to comply with the auditor attestation requirements of Section …

• Pursuant to Section 404 of Sarbanes-Oxley, if and when we no longer qualify as a smaller reporting company, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. The rules governing the standards that must …

• We cannot assure our stockholders that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our finan…

• changes in our management without the consent of our board of directors. The provisions in our charter documents include the following: