CRVO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• We are a clinical-stage biotechnology company developing treatments for age-related brain disorders. Our lead drug candidate, neflamapimod, is an investigational, orally administered small-molecule drug that readily crosses the blood–brain barrier and selectively inhibits the enzyme p38α, a key driv…

• We believe we are a leader in the industry in developing a treatment for DLB, a disease with no approved therapies in the US or European Union despite being the second most common progressive dementia. Neflamapimod is the only clinical drug candidate that, to our knowledge, has shown statistically s…

• As of March 31, 2026, we had cash, cash equivalents, and marketable securities of approximately $12.9 million. To date, we have not had any products approved for sale and have not generated any revenue from product sales, and our ability to do so in the future will depend on the successful developme…

• Our accumulated deficit as of March 31, 2026 was $105.7 million. We have never been profitable, and we will continue to require additional capital to develop neflamapimod and fund operations for the foreseeable future. We have historically incurred net losses in each year since inception. Our net lo…

• advance neflamapimod through clinical trials, including our planned Phase 3 trial in DLB, subject to available funding;

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• We are a clinical-stage biotechnology company developing treatments for age-related brain disorders. Our lead drug candidate, neflamapimod, is an oral, small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinfla…

• We believe we are a leader in the industry in developing a treatment for DLB, as neflamapimod is the only clinical drug candidate of which we are aware that has shown statistically significant improvements compared to placebo in a Phase 2a clinical trial (our AscenD-LB Trial) and improved outcomes (…

• Our recently completed RewinD-LB Trial is a Phase 2b study in 159 participants with DLB funded primarily by a $21.3 million grant from the NIA. Patients with AD co-pathology, as assessed by plasma ptau181 levels at screening, were excluded from the trial. Intended to confirm the efficacy findings fr…

• In July 2025, we reported 32-week data from the Extension showing a 54% risk reduction in clinically significant worsening (≥ 1.5-point increase in CDR-SB) compared to control at Week 32 of Batch B neflamapimod treatment (p=0.0037). This risk reduction improved to 64% (p=0.0001) among patients who h…

• In November 2025, we announced alignment with the FDA on key aspects of our proposed Phase 3 clinical trial of neflamapimod for the treatment of DLB. Based on FDA feedback, we plan to initiate a single, global, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the effica…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• In connection with the audit of our consolidated financial statements for the years ended December 31, 2024, 2023, and 2022, a material weakness in our internal control over financial reporting was identified in relation to the absence of effective controls regarding the accurate identification, eva…

• On August 16, 2023, we completed the Merger. For financial reporting purposes, EIP was determined to be the accounting acquirer and, accordingly, for all periods prior to the Merger, EIP’s historical financial statements and results of operations replace and are deemed to be our financial statement …

• Except as set forth above, there were no changes in our internal control over financial reporting (as such term is defined in Exchange Act Rule 13a-15(f)) that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal …

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• Material Weaknesses in Internal Control over Financial Reporting

• In connection with the audit of the Company’s consolidated financial statements for the years ended December 31, 2024, 2023, and 2022, a material weakness in the Company’s internal control over financial reporting was identified in relation to the absence of effective controls regarding the accurate…

• A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements would not be prevented or detected on a timely basis. The identified mater…

• On August 16, 2023, we completed the Merger. For financial reporting purposes, EIP was determined to be the accounting acquirer and, accordingly, for all periods prior to the Merger, EIP’s historical financial statements and results of operations replace and are deemed to be the Company’s financial …

• Notwithstanding the material weaknesses in internal control over financial reporting described above, our management has concluded that our condensed consolidated interim financial statements included in this Quarterly Report are fairly stated in all material respects in accordance with U.S. GAAP.