KRYS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• •our commercialization plans in the United States, the European Union, Japan, and elsewhere for our first commercial product, VYJUVEK® (beremagene geperpavec-svdt) for the treatment of dystrophic epidermolysis bullosa (“DEB”), including timing of pricing negotiations and potential commercial launche…

• •the design, initiation, enrollment, timing, progress, and results of clinical trials for our product candidates, as well as expected timing of regulatory filings and reporting of data readouts from our clinical trials;

• •our beliefs about our proprietary HSV-1 based vector platform;

• •our expectations regarding future fluctuations in revenue and anticipated increases in certain expenses; and

• •our commercialization, marketing, and manufacturing capabilities and strategy.

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• •our commercialization plans in the United States, the European Union (“EU”), Japan, and elsewhere for our first commercial product, VYJUVEK® (beremagene geperpavec-svdt), which was approved by the U.S. Food and Drug Administration (“FDA”) in May 2023, the European Commission (“EC”) in April 2025, a…

• •our plans and expected timing of commercial launches of VYJUVEK in Europe outside of Germany and France and expected timing of pricing negotiations in Germany and France;

• •our plans for commercialization of B-VEC outside of the United States, major European markets, and Japan;

• •the initiation, timing, progress, and results of clinical trials for our product candidates, as well as expected timing of reporting of data readouts from our clinical trials;

• •our expectations regarding revenue, research and development expenses, selling, general and administrative expenses, and our primary uses of capital;

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• We had cash, cash equivalents and short-term investments of $823.4 million as of March 31, 2026, which consisted primarily of money market funds, commercial paper, corporate bonds and U.S. government agency securities. The investments

• in these financial instruments are made in accordance with an investment policy which specifies the categories, allocations and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the inco…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• We had cash, cash equivalents and short-term investments of $731.1 million as of September 30, 2025, which consisted primarily of money market funds, commercial paper, corporate bonds and U.S. government agency securities. The investments in these financial instruments are made in accordance with an…

• paper, all with various maturity dates. Based on our current investment portfolio, we do not believe that our results of operations or our financial position would be materially affected by an immediate change of 10% in interest rates.

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• There was no change in our internal control over financial reporting 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.

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• In June 2025, we implemented a new procure to pay (“P2P”) system that integrates with our existing enterprise resource planning system. As necessary, we are adding to or modifying the design and documentation of internal control processes and procedures relating to the new P2P system to simplify and…

• Other than as discussed above, no change in our internal control over financial reporting occurred during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• On March 9, 2026, Daniel Janney, one of our directors, terminated a Rule 10b5-1 trading arrangement that was originally adopted on November 25, 2025. The Rule 10b5-1 trading arrangement was terminated during the Company’s unrestricted trading window and at a time when Mr. Janney was not in possessio…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• On September 4, 2025, Suma Krishnan, our President and a member of our Board of Directors, adopted a Rule 10b5-1 trading arrangement (the “Trading Arrangement”) that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act for the sale of up to 100,000 share…