DSGN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-04-28

• In June 2025, we received a clinical hold notice from the FDA regarding our IND application for DT-216P2. In December 2025, the clinical hold was lifted and we received clearance from the FDA to initiate clinical studies for DT-216P2.

• marketing, sales, manufacturing and distribution, if we obtain marketing approval for any of our product candidates, and incur additional costs associated with operating as a public company.

• Research and Development Expenses. The decrease in research and development expenses compared to the same period of the prior year was primarily due to a reduction in expenses associated with our FA and FECD programs.

• Other direct expenses associated with our early-stage programs, that are not allocated on a program-by-program basis, decreased due to the movement of DM1 expenses to a separate program subcategory because of its shift to clinical development. The increase in indirect expenses compared to the same p…

• The following table summarizes our research and development expenses by program, direct and indirect costs for the three months ended March 31, 2026 and 2025 (in thousands):

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• DT-216P2 has been generally well-tolerated in these clinical trials. Based on the data from these clinical trials and non-clinical studies of DT-216P2, we believe the injection site thrombophlebitis seen with the prior DT-216 product candidate is no longer an issue limiting continued development of …

• In June 2025, we received a clinical hold notice from the FDA regarding our IND application for DT-216P2. The FDA’s request pertains to the starting dose in the United States, which we plan to address with clinical data and, if needed, nonclinical data, in order to initiate studies for DT-216P2 in t…

• Research and Development Expenses. Research and development expenses for our FA program increased during the three months ended September 30, 2025 compared to the same period of the prior year primarily due to costs attributable to DT-216 clinical activities and costs for additional development acti…

• Expenses for our FECD program increased compared to the same period of the prior year primarily due to costs associated with DT-168 clinical activities and costs for additional development activities.

• Other direct expenses increased compared to the same period of the prior year primarily due to additional activities related to our early stage research programs. The increase in indirect expenses compared to the same period of the prior year was primarily due to employee related expenses including …

Text added vs the prior filing · source: 10-Q · 2026-04-28

• We are early in our development efforts. Our lead FA GeneTAC® small molecule, DT-216, formulated as the prior DT-216 product candidate (DT-216P1), entered into a Phase 1 SAD clinical trial in March 2022, the first clinical trial for one of our product candidates, and we completed the Phase 1 MAD cli…

• develop DT-216P2 with improved properties, including favorable injection site tolerability and the absence of other unacceptable side effects on the timeframe we expect, or at all, or that we will be able to achieve our anticipated clinical development and data timelines for the RESTORE-FA trial. In…

• Additionally, the policies of the FDA and other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. For example, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterpris…

• disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

• FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We are early in our development efforts and most of our operations to date have been limited to developing our platform technologies and conducting drug discovery and nonclinical studies. Our lead FA GeneTAC® small molecule, DT-216, formulated as the prior DT-216 product candidate, entered into a Ph…

• limiting continued development of DT-216. However, there can be no assurance that we will be able to successfully develop DT-216P2 with improved injection site tolerability and the absence of other unacceptable side effects on the timeframe we expect, or at all, or that we will be able to achieve ou…

• Additionally, the policies of the FDA and other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. For example, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterpris…

• future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the early, interim, topline or preliminary data that we report differ from actual results, or if others including regulatory authorities, disagree with the conclusions …

• Any Breakthrough Therapy designation that we may receive from the FDA for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.