AARD — what changed in the latest 10-Q

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

• our ability to successfully restart or complete our clinical trials;

• not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon them.

• TAS2Rs are a family of 26 different nutrient-sensing G protein-coupled receptors (GPCRs) that are broadly expressed among vertebrates. TAS2Rs are present in the oral cavity to convey bitter taste and are highly expressed in many other tissues throughout the body where they are key in regulating meta…

• ARD-101 has limited systemic absorption, which we believe reduces the potential for systemic toxicity and has contributed to ARD-101 being well-tolerated in our Phase 1 and 2 trials. We have completed a Phase 1 clinical trial of ARD-101 in healthy volunteers and a Phase 2 clinical trial in subjects …

• In the second quarter of 2025, we initiated dosing for a Phase 3 clinical trial for hyperphagia associated with PWS, which we refer to as the HERO (Hunger Elimination or Reduction Objective) trial. We previously reached alignment with the FDA on a protocol for a Phase 3 clinical trial, which we init…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• The forward-looking statements made in this Quarterly Report relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report to reflect events or

• Our wholly-owned lead product candidate, ARD-101, is an oral gut-restricted small-molecule agonist of certain TAS2Rs expressed in the gut lumen for which we have initiated a Phase 3 clinical trial for hyperphagia associated with Prader-Willi Syndrome (PWS), which is referenced as the HERO (Hunger El…

• We have delayed indefinitely our plans to evaluate ARD-101 in a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO), which was referenced as the HONOR (Hypothalamic Obesity Neutralized On TAS2R) trial. This will allow us to direct more resources to focus on the applicati…

• ARD-201 is planned to be a fixed-dose combination of the active ingredient in ARD-101 and a dipeptidyl peptidase-4 (DPP-4) inhibitor. Currently, both drugs are administered separately, but for ease of nomenclature, the combination treatment is referred to as ARD-201 throughout this document as it re…

• The additional trial focusing on ARD-201 will be the STRENGTH (Sitagliptin and TAS2R for weight Reduction with Exercise, Nutrition, and GLP-1RA Trial and Hunger assessment) trial. This trial, which we expect will be a Phase 2 clinical trial, will explore the remaining key questions that were intende…

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

• There were no changes to our internal control over financial reporting that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Material Weakness in Internal Control over Financial Reporting

• We identified deficiencies in our internal controls over financial reporting related to a lack of controls in the financial reporting process, including a lack of segregation of duties and the documentation and design of formalized processes and procedures, and a material weakness related to these d…

• The material weakness in our internal controls over financial reporting relates to a lack of controls in the financial reporting process, including a lack of segregation of duties and design and documentation of formalized processes and procedures. Specifically, we lack a sufficient number of qualif…

• To remediate the deficiencies described above and prevent similar deficiencies in the future, in late 2024, we began to take steps to address the material weakness through our remediation plan, which includes the hiring of additional experienced accounting and financial reporting personnel, formaliz…

• Although we have begun the implementation of these remediation efforts, the material weakness will not be considered fully remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effect…

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

• We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

• We have relied and expect to continue to rely on third parties to conduct our preclinical studies and clinical trials, as well as investigator-initiated trials. If those third parties do not perform as contractually required, fail to satisfy legal or

• regulatory requirements, miss expected deadlines or terminate the relationship, our development programs could be delayed, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.

• We currently have an effective shelf Registration Statement on Form S-3 (File No. 333-294537) that became effective on April 3, 2026, which allows us to undertake various equity and debt offerings up to $400.0 million. In addition, on March 23, 2026, we entered into an Equity Distribution Agreement …

• The time required to obtain approval or other marketing authorizations by the FDA and comparable foreign regulatory authorities is unpredictable, and it typically takes many years following the commencement of clinical trials and depends upon

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• We have relied and expect to continue to rely on third parties to conduct our preclinical studies and clinical trials, as well as investigator-initiated trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss expected deadlines …

• delayed, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.

• We have identified a material weakness in our internal control over financial reporting. If we fail to remediate this material weakness, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, w…

• Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

• Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, debt financings or other capital sources, including potential grants, collaborations, licenses and other similar arrangements. We do not currently have any other…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Aggregate Number of Shares of Common Stock to be Sold Pursuant to Trading Arrangement

• *The trading arrangement permits transactions through and including the earlier to occur of (a) the date that all shares subject to the trading arrangement have been sold and (b) the date listed in the table.