KLRS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• In July 2026, we announced positive additional data from our Phase 1a single-ascending dose (“SAD”) clinical trial of TH103 for nAMD. The expanded Phase 1a SAD dataset included a total of 17 treatment-naive patients, as well as an additional three treatment-experienced patients which were included i…

• We are currently conducting a Phase 1b/2 multiple ascending dose clinical trial of TH103 in patients with nAMD, which is intended to build upon our Phase 1a single ascending dose clinical trial. The Phase 1b/2 dose-finding trial is designed to evaluate multiple dose levels of TH103 in up to 80 nAMD …

• Assuming successful completion of the ongoing Phase 1b/2 clinical trial of TH103, and subject to the favorable results from such trial and discussions with regulators, we intend to initiate Phase 3 clinical trials of TH103 for nAMD by year-end 2027. We also

• plan to expand the development of TH103 beyond nAMD into other prevalent VEGF-mediated retinal diseases, such as Diabetic Macular Edema (“DME”), diabetic retinopathy (“DR”), and Retinal Vein Occlusion.

• Since our inception in September 2019, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, acquiring technology, establishing our intellectual property portfolio and performing research and development of our product candidate. We do not…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We are investigating TH103 as a treatment for patients with nAMD, a leading cause of blindness in the United States and Europe that affect an estimated 1.6 million adults in the United States. We are currently conducting a Phase 1b/2 multiple ascending dose clinical trial of TH103 in patients with n…

• Since our inception in September 2019, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, acquiring technology, establishing our intellectual property portfolio and performing research and development of our product candidate. We do not…

• From inception through March 31, 2026, we have received gross proceeds of $67.5 million from sales of redeemable convertible preferred stock, issuances of convertible promissory notes and a SAFE, we received cash and cash equivalents of AlloVir of approximately $102.1 million in the Merger, and we r…

• As of March 31, 2026, we had $104.9 million in cash, cash equivalents and marketable securities. Based on our current operating plans, our management expects that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requiremen…

• In April 2021, we entered into a license agreement with UCSD (as amended, the “UCSD Agreement”) pursuant to which we obtained (i) an exclusive license under the patent rights to make, use, sell, offer for sale, and import licensed products and (ii) a non-exclusive license to use the technology with …

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• We have identified, assessed, and communicated appropriate internal control objectives to key stakeholders across the organization and implemented a risk assessment over financial reporting which is updated and reassessed on a periodic basis. We have also formalized the scoping of relevant processes…

• We engaged a third-party to assist us in performing walkthroughs of our in-scope processes and systems and developing process flowcharts and detailed risk and control matrices. We have made substantial progress on the design and implementation of policies, procedures and controls around key business…

• We have formalized our control environment using the criteria described in “Internal Control - Integrated Framework” (2013) issued by the COSO.

• We have identified key reports and spreadsheets used in the execution of key controls and implemented manual procedures to validate the completeness and accuracy of these reports and spreadsheets.

• We have performed a segregation of duties assessment to identify conflicting roles and responsibilities. Where applicable, we also evaluated the design of compensating controls intended to mitigate the conflicts identified.

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We engaged a third-party to assist us with the implementation of internal controls over financial reporting. Specifically, with their assistance, we have begun to design and implement policies, procedures and controls around key business reporting processes and general information technology control…

• We have identified, assessed, and communicated appropriate internal control objectives to key stakeholders across the organization and implemented a risk assessment over financial reporting which is updated and reassessed on a periodic basis.

• We have begun to perform manual procedures to validate the completeness and accuracy of certain reports generated from various financial systems that are relevant to the preparation of the financial statements.

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• We may never succeed in these activities and, even if we do, we may never generate revenues that are significant enough to achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain…

• million, respectively, and federal and state research and development tax credit carryforwards totaling $1.7 million and $0.9 million, respectively.

• Given the nature of biologics manufacturing, there is a risk of contamination during manufacturing. Any contamination could materially harm our or our CDMOs’ ability to produce TH103 or any other product candidate it may develop on schedule and could

• harm our results of operations and cause reputational damage. Some of the raw materials that we require in our manufacturing process are derived from biologic sources. Such raw materials may be difficult to procure and may be subject to contamination or recall.

• Problems with the manufacturing process, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims, insufficient inventory or potentially delay progression of our clinical developmen…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We may never succeed in these activities and, even if we do, we may never generate revenues that are significant enough to achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual

• basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our product development efforts, diversify our pipeline or even continue our operations.

• distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing, obtaining marketing approval …

• these events could prevent us from achieving or maintaining market acceptance of a particular product candidate, if approved, and could significantly harm our business, financial condition, and results of operations.

• claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to cover such claims and our business operations could be impaired.