ANRO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-12

• ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect through multiple robust randomized, placebo-controlled clinical trials, and ondansetron, an antiemetic, selective 5-H…

• We acquired ALTO-207 (formerly known as CTC-501) from Chase Therapeutics Corporation, or Chase. The scientific rationale for ALTO-207 is supported by the results from multiple independent clinical trials and a Phase 2a clinical trial conducted by Chase prior to our acquisition. In Chase’s randomized…

• We believe the profile of ALTO-207 will enable higher dosing of pramipexole while mitigating the significant rates of nausea and vomiting that have limited its use for depression.

• A blinded pharmacokinetic, or PK, analysis from the first cohort of patients in this trial demonstrated that 96% of samples for ALTO-100 qualified as PK positive. A sample was considered PK positive if observed drug levels were above a pre-specified minimum threshold. We believe these results unders…

• Following the topline data readout of the Phase 2 proof-of-concept study, further analyses have been completed and the findings reflect a potential product profile suitable for a range of cognitive disorders. Specifically, further analyses identified large and statistically significant effects of AL…

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• In October 2025, we entered into a Securities Purchase Agreement, or the 2025 PIPE Purchase Agreement, with certain institutional and other accredited investors, or the 2025 PIPE Purchasers, pursuant to which we sold and issued to the 2025 PIPE Purchasers in a private placement transaction, or the 2…

• In March 2026, we entered into a Securities Purchase Agreement, or the 2026 PIPE Purchase Agreement, with certain institutional investors, or the 2026 PIPE Purchasers, pursuant to which we sold and issued to the 2026 PIPE Purchasers in a private placement transaction, or 2026 Private Placement: (i) …

• ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect through multiple robust randomized, placebo-controlled clinical trials, and ondansetron, an antiemetic, selective 5-H…

• In May 2025, we acquired ALTO-207 (formerly known as CTC-501) from Chase Therapeutics Corporation, or Chase. Prior to the acquisition, Chase completed a randomized, placebo-controlled Phase 2a clinical trial evaluating CTC-501 in 32 patients with depression. CTC-501 met the primary and secondary end…

• Our acquisition of ALTO-207 was motivated by the results from the PAX-D study conducted by the University of Oxford. Results, which were published in The Lancet Psychiatry, showed pramipexole augmentation of antidepressant treatment, at a target dose of 2.5mg, demonstrated a large (Cohen’s d=0.87) r…

Text added vs the prior filing · source: 10-Q · 2026-08-12

• There was no change in our internal control over financial reporting that occurred during the quarter ended June 30, 2026 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

• There was no change in our internal control over financial reporting that occurred during the quarter ended March 31, 2026 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-08-12

• On June 30, 2026, Nicholas Smith, our Chief Financial Officer and Chief Business Officer, adopted a Rule 10b5-1 trading plan for the potential sale of up to 134,886 shares of our common stock. Transactions under Mr. Smith’s plan were based upon pre-established dates and stock price thresholds and wo…

• Mr. Smith’s plan is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• On March 13, 2026, Amit Etkin, M.D., Ph.D., our President, Chief Executive Officer, and Chair of the Board, terminated a Rule 10b5-1 trading plan effective March 17, 2026. No sales of common stock occurred under the plan prior to its termination. Prior to its termination, the plan had provided for t…

• On March 11, 2026, Nicholas Smith, our Chief Financial Officer and Chief Business Officer, terminated a Rule 10b5-1 trading plan effective March 13, 2026. No sales of common stock occurred under the plan prior to its termination. Prior to its termination, the plan had provided for the potential sale…

• Both Dr. Etkin’s plan and Mr. Smith’s plan were intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.