LONA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• We have enrolled 495 of the ~600 participants in our ELAINE-3 clinical trial for lasofoxifene to date. We expect to complete enrollment in the fourth quarter of 2026 and to have topline data in the second half of 2027 for the ELAINE-3 trial. We expect to provide an update on the timing of our propos…

• Research and development expenses consist primarily of direct and indirect costs incurred for our research activities, including our drug discovery efforts and the development of our drug candidates, including lasofoxifene and brelgometon. Direct costs include laboratory materials and supplies, cont…

• The following table summarizes our results of operations for the periods presented:

• The following table shows the primary components of our research and development expenses for the periods presented:

• Research and development expenses increased by $15.2 million, from $8.0 million for the six months ended June 30, 2025 to $23.2 million six months ended June 30, 2026. The increase was driven primarily by increases in lasofoxifene program costs

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

• Research and development expenses consist primarily of direct and indirect costs incurred for our research activities, including our drug discovery efforts and the development of our drug candidates, including lasofoxifene and ATH-1105. Direct costs include laboratory materials and supplies, contrac…

• Comparison of the Three Months Ended March 31, 2026 and 2025

• Sermonix Pre-funded Warrant change in fair value increased by $16.3 million, from $0 million for the three months ended March 31, 2025 to $16.3 million for the three months ended March 31, 2026. Refer to Note 3 to our unaudited condensed consolidated financial statements included elsewhere in this r…

• Since our inception, we have funded our operations primarily with proceeds from the sale and issuance of common stock, convertible preferred stock, common stock warrants, prefunded common stock warrants and convertible notes, and to a lesser extent from grant income and stock option exercises. From …

• On December 18, 2025, we entered into the PIPE Securities Purchase Agreement with a select group of investors, including Capital LP, or Commodore, TCGX Crossover Management LLC, or TCGX , Perceptive and other accredited investors, one of which is affiliated with a member of our board of directors, p…

Text added vs the prior filing · source: 10-Q · 2026-08-14

• From time to time, we may publicly disclose preliminary or topline data from our nonclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review …

• Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. As of June 30, 2026, we had cash, cash equivalents and investments of $51.1 million. Based upon our current operating plan, we estimate that our existing cash, cash equivalents and invest…

• Obtaining approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, …

• any application or may decide that our data are insufficient for approval and require additional nonclinical, clinical or other data. Even if we eventually complete clinical testing and receive approval for our drug candidates, the FDA and other comparable foreign regulatory authorities may approve …

• biological materials, genetic data, and other sensitive data of American patients to parties located in China. Further, FDA's “real-time” release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materia…

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

• anticipated to occur sometime after completion of enrollment. While the purpose of this futility analysis will be solely to determine whether or not the trial should continue, and is thus not an assessment of efficacy, there can be no assurance regarding the results of the analysis, how long it will…

• risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The results from nonclinical testing or early clinical trials of a drug candidate may not be predictive of the results that will be obtained in later stage clinical trials of…

• From time to time, we may publicly disclose preliminary or topline data from our nonclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to

• change following a more comprehensive review of the data related to the particular study or clinical trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all dat…

• enrolling the targeted number of subjects in our trials, the FDA and other regulators may request additional clinical trials with larger numbers of subjects as a condition to any regulatory approval.

Text removed 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.