CADL — what changed in the latest 10-Q

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

• We are a clinical stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Our engineered viruses are designed to induce a systemic anti-tumor response due to induction …

• The immune cells induced by these viral immunotherapies are believed to target patients’ specific tumor antigens, potentially enhancing anti-tumor immune activity in immunologically “hot” tumors while at the same time infiltrating the tumor microenvironment, transforming non-inflamed “cold” tumors w…

• placebo + prodrug). Both arms received standard-of-care external beam radiation therapy (EBRT) +/- short course androgen deprivation therapy (ADT) (≤6 months) and were stratified by NCCN risk group and ADT use. Three intraprostatic injections of aglatimagene (5x10 11vp/2mL) or placebo were administe…

• Exploratory subset analysis showed that improvement in prostate cancer-specific DFS was observed, independent of the use of short-term ADT and independent of the type of EBRT (conventional EBRT vs. moderate hypofractionated EBRT)

• We expect to announce supportive data on prostate cancer-specific outcomes (prostate cancer-specific DFS, time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy) after extended follow-up during a plenary oral presentation at the American Urological Association (AUA)…

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

• We are a clinical stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Our engineered viruses are designed to induce a systemic anti-tumor response due to induction …

• stratified by NCCN risk group and ADT use. Three intraprostatic injections of CAN-2409 (5x10 11vp/2mL) or placebo were administered, each followed by 14 days of prodrug.

• Exploratory subset analysis showed that prostate cancer-specific improvement in DFS was observed, independent of the use of short-term ADT

• We expect to announce supportive data on prostate cancer-specific outcomes (prostate cancer-specific DFS, time to salvage anti-cancer therapy, and time to metastasis) after extended follow-up in the second quarter of 2026. In addition, we expect to announce immunological biomarker data from a suppor…

• A phase 2 randomized, double-blind, placebo-controlled clinical trial in the United States evaluating patients with low-to-intermediate risk, localized prostate cancer undergoing active surveillance. We completed enrollment of this trial in May 2019.

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

• The terms of the RTW Purchase Agreement place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RTW Purchase Agreement, our results of operations and financial condition may be harmed.

• The RTW Purchase Agreement contains covenants that impose on us certain obligations with respect to payment, diligence, reporting, intellectual property, license agreements, and certain other actions, as well as indemnification obligations. The RTW Purchase Agreement also contains covenants that lim…

• Further, the Purchase Agreement and our payment obligations to the Purchaser could have important negative consequences to our stockholders. For example, a portion of our cash flow from operations will be needed to make required payments to the Purchaser and will not be available to fund future oper…

• Furthermore, the Purchase Agreement is subject to customary closing conditions. If we are unable to satisfy the closing conditions set forth in the Purchase Agreement, our business, financial condition and results of operations may be adversely impacted.

• Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any even…

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

• The risk factors denoted with a “*” are newly added or have been materially updated from those included in our Annual Report on Form 10-K for the year ended December 31, 2024.

• Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any even…

• Although we assess our banking and customer relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors t…

• Furthermore, even if we obtain regulatory approval for CAN-2409, CAN-3110 or any other product candidates we develop, we will still need to develop a commercial infrastructure, expand our manufacturing capabilities or develop relationships with collaborators to commercialize, establish a commerciall…

• case with many oncology therapies, that there may be side effects associated with their use. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory…

Text added 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…

• Paul Peter Tak, M.D., Ph.D., FMedSci (Chief Executive Officer, President and Director)

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

• Earlier of (i) June 30, 2027 and (ii) the completed sale of the maximum aggregate number of securities under the plan

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

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

• During the three months ended September 30, 2025, 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)…

• (1) Intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c).

• (2) As of the date of termination of such Rule 10b5-1 trading arrangement, Dr. Nichols sold 47,034 shares of our common stock pursuant to the terms of such trading plan