CADL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo after a median follow-up of 58 months.

• The Company observed consistently favorable trends in the ITT population across all secondary and exploratory endpoints, including time to biochemical failure (TTBF), time to metastasis (TTM), rate of metastasis, and time to salvage anti-cancer therapy (time to new treatment (TTNT)), when comparing …

• Within the intermediate-risk subgroup (635 patients, 85% of the ITT population), the aglatimagene arm demonstrated 41% improvement in PCa-specific DFS relative to placebo. In addition, descriptive analyses showed 52% improvement in TTBF (HR 0.48, CI 0.22, 1.03), 90% improvement in TTM (HR 0.1, CI 0.…

• In addition, in the third quarter of 2026, we will present novel immunological biomarker data in patients with localized prostate cancer at the 2026 ASTRO Annual Meeting.

• Molecular profiling of paired baseline and post-treatment tumor biopsies revealed that long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and antigen presentation. In particular, enhanced interferon signaling and activation of myeloid and antigen-p…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• In addition, in the third quarter of 2026, we expect to present novel immunological biomarker data in patients with localized prostate cancer.

• Molecular profiling of paired baseline and post-treatment tumor biopsies revealed that long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and

• antigen presentation. In particular, enhanced interferon signaling and activation of myeloid and antigen-presenting cell programs were observed, including a significant increase in the expression of IFNγ, CSF1, CX3CL1, and IL1β (p = 0.010, 0.026, 0.013, and 0.034, respectively).

• Based on these positive findings, we plan to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous NSCLC progressing on ICI treatment in the second quarter of 2026. Following an end-of-phase 2 meeting, the FDA acknowledged that this trial could serve as …

• We have recently completed enrollment in arm C and expect to present mature mOS data and an update on long-term survivors in the fourth quarter of 2026.

Text added vs the prior filing · source: 10-Q · 2026-08-13

• In addition to the potentially small target populations for our planned clinical trials, particularly in brain cancer, the eligibility criteria will further limit the pool of available trial participants as we will require that patients have specific characteristics, such as a certain severity or st…

• competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, the availability of genetic sequencing information for patient tumors so that we can identify patients with the targeted genetic mutations, and the patient referral practices of …

• The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In additi…

• jurisdictions. These regulatory requirements may require us to amend our clinical trial protocols, including to comply with the protocols of any applicable SPA we receive from the FDA; conduct additional preclinical studies or clinical trials that may require regulatory or independent IRB approval; …

• If aglatimagene, linoserpaturev and future product candidates are associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which th…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• In addition to the potentially small target populations for our planned clinical trials, particularly in brain cancer, the eligibility criteria will further limit the pool of available trial participants as we will require that patients have specific characteristics, such as a certain severity or st…

• The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In additi…

• If aglatimagene, linoserpaturev and future product candidates are associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which th…

• Even though we have received Fast Track Designation for aglatimagene and linoserpaturev or even if we receive Fast Track Designation for our future additional indications for aglatimagene and linoserpaturev, we may not experience a faster development process, review or approval compared to conventio…

• authority. Such changes could be further delayed due to development of clinical-scale manufacturing and commercial-scale manufacturing operations. This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinica…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• During the three months ended June 30, 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted, terminated or modified a Rule 10b5-1 trading arrangement or any “non-Rule 10b5-1 trading agreement” (as defined in Item 408(c) of R…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• The following table describes contracts, instructions or written plans for the sale or purchase of our securities adopted by our directors and certain officers during the three months ended March 31, 2026, each of which is intended to satisfy the affirmative defense conditions of Exchange Act Rule 1…

• Charles Schoch (Chief Financial Officer, Treasurer and Secretary)

• Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

• Earlier of (i) June 30, 2028 and (ii) the completed sale of the maximum aggregate number of securities under the plan

• Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)