LONA — what changed in the latest 10-Q

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

• our ability to obtain funding for our operations, including funding necessary to develop and commercialize our drug candidates and funding necessary for the payment of future milestone and other payments that may be earned by our collaboration partners;

• our potential to complete the Phase 3 ELAINE-3 clinical trial for lasofoxifene and any subsequent clinical trials to show the clinical benefits of lasofoxifene;

• the potential of our Phase 2 ATH-1105 clinical trial and any subsequent clinical trials to show the beneficial characteristics, safety and efficacy of ATH-1105;

• the potential learnings from our ongoing clinical trials and their ability to inform and improve future clinical development plans;

• the potential for lasofoxifene to be a new standard of care in the genetically defined patient group;

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• our ability to obtain funding for our operations, including funding necessary to develop and commercialize our drug candidates;

• the timing or likelihood of regulatory filings and approvals;

• the potential learnings from our ACT-AD and SHAPE trials, LIFT-AD independent unblinded interim efficacy and futility analysis, and LIFT-AD trial and their ability to inform and improve future clinical development plans;

• the potential of our Phase 1 ATH-1105 clinical trial and any subsequent clinical trials to show the clinical benefits of ATH-1105;

• our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and

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

• We are developing lasofoxifene to treat breast cancer. Lasofoxifene is a novel SERM that inhibits estrogen receptor signaling in both wild-type and ESR1-mutated breast cancer. Unlike other endocrine agents that lose potency in the presence of ESR1 mutations such as Y537S and D538G, lasofoxifene main…

• We have limited evidence regarding the efficacy, safety and tolerability of lasofoxifene. We or a future partner may ultimately determine that lasofoxifene does not possess certain properties required for therapeutic effectiveness. We or a future partner may spend substantial funds attempting to dev…

• Our approach to targeting neurotrophic factors through the use of small molecules like ATH-1105 is based on a novel therapeutic approach, which exposes us to unforeseen risks. We have limited data from preclinical studies and clinical trials to date, including for ATH-1105, and we cannot be certain …

• We have discovered and are developing small molecule drug candidates to treat neurodegenerative diseases, including ALS. Our drug candidates target an endogenous neurotrophic factor which is expected to protect and repair neuronal networks, which we believe could ultimately result in improvements in…

• For example, fosgonimeton, a first-generation small molecule designed to positively modulate the neurotrophic HGF system for potential treatment of CNS disorders, was tested in Phase 1 to 2/3 clinical trials. The primary and all secondary endpoints of our Phase 2 ACT-AD clinical trial of fosgonimeto…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We have discovered and are developing small molecule drug candidates to treat neurodegenerative diseases. Our drug candidates target an endogenous neurotrophic factor which is expected to protect and repair neuronal networks, which we believe could ultimately result in improvements in clinical outco…

• The primary and all secondary endpoints of our Phase 2 ACT-AD clinical trial of fosgonimeton in AD were not met by protocoled analysis. A subsequent post hoc analysis of the data in a pre-specified subgroup from patients on fosgonimeton without background AChEIs showed a meaningful, but not statisti…

• The topline data from our Phase 2/3 LIFT-AD clinical trial of fosgonimeton in AD showed that neither the trial’s primary endpoint (the Global Statistical Test, or GST, a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23)) nor its key secondary endpoints of ADAS-…

• Following the readout of topline data from LIFT-AD, in September 2024 we announced our intention to focus on advancing the clinical development program for ATH-1105 as a potential treatment for ALS. We completed our first-in-human Phase 1 clinical trial in healthy volunteers evaluating the safety an…

• Advancing ATH-1105 as a small molecule aimed at restoring neuronal health creates significant challenges for us or a future partner, including:

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

• On May 5, 2026, our board of directors, upon recommendation from the nominating and corporate governance committee of our board of directors, or the Nominating and Corporate Governance Committee, appointed Natalie Holles, Fred Callori, and Peter B. Silverman as members of our board of directors, eff…

• As previously disclosed in a Current Report on Form 8-K and a Current Report on form 8-K/A filed with the SEC on December 18, 2025, we previously entered into the PIPE Securities Purchase Agreement, with certain accredited investors, including Commodore and TCGX. In connection with the entry into th…

• There are no transactions and no proposed transactions between Ms. Holles, Mr. Callori, or Mr. Silverman or any member of their immediate family and us or our subsidiaries that would require disclosure under Item 404(a) of Regulation S-K under the Securities Act, and there is no other arrangement or…

• Ms. Holles, Mr. Callori, and Mr. Silverman will each participate in our standard compensation plan for non-employee directors, including an initial stock option grant to purchase 56,000 shares of common stock. The standard compensation plan for non-employee directors is described in our Annual Repor…

• In addition, on May 4, 2026, John M. Fluke, Jr. submitted his resignation from our board of directors, including the Audit Committee, effective immediately. Mr. Fluke’s resignation was not the result of any disagreement with us on any matter relating to our operations, policies or practices.