ZNTL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-12

• In 2022, the global ovarian cancer market was approximately $3 billion, with significant growth expected over the next several years. PROC is a subset of the ovarian cancer market. Based on our retrospective, historical analysis utilizing our IHC cutoff, we estimate that approximately 50% of PROC pa…

• We believe there is additional market opportunity for azenosertib in earlier lines of treatment for ovarian cancer, and across other solid tumor types.

• ◦DENALI Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on our proprietary IHC cutoff. Part 2 consists of three cohorts across a seamless design that may support accelerated approval in patients with Cyclin E1-positive PROC, pending positive study outcomes…

• ▪Part 2a: Dose confirmation in patients with 1-3 prior lines of therapy, or up to 4 prior lines allowed in prior mirvetuximab treatment in patients with high FRα. Two doses were evaluated, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. In April 2026, we announ…

• ▪Part 2b: Enrollment expansion in the same patient population as Part 2a at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at that dose in Part 2a. This cohort is currently enrolling.

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

• In 2022, the global ovarian cancer market was approximately $3 billion, with significant growth expected over the next several years. PROC is a subset of the ovarian cancer market. Based on our analysis utilizing our IHC cutoff, we estimate that approximately 50% of PROC patients overexpress Cyclin …

• azenosertib in Cyclin E1-positive PROC patients. Moreover, the successful launch of mirvetuximab soravtansine in PROC patients with high folate receptor alpha, or FRα-high, expression underscores the demand for biomarker-directed therapies for PROC patients. The limited overlap between FRα-high PROC…

• We believe there is additional market opportunity for azenosertib as a combination therapy, in earlier lines of treatment for ovarian cancer, and across other solid tumor types.

• ◦DENALI Part 2 is designed to enroll approximately 100 patients with Cyclin E1-positive PROC at the selected dose who have received one to three prior lines of therapy, or for patients whose tumors are also FRα-high and who have received mirvetuximab soravtansine, one to four prior lines of therapy.…

• •Monotherapy – Phase 3 Clinical Trial in Cyclin E1-positive PROC. We plan to conduct a randomized, controlled Phase 3 confirmatory clinical trial of azenosertib versus standard-of-care chemotherapy for the treatment of patients with Cyclin E1-positive PROC, with the goal of supporting an application…

Text added vs the prior filing · source: 10-Q · 2026-05-12

• substantial research and development and other expenses as we discover, develop and market additional potential products.

• As of March 31, 2026, we had cash and cash equivalents and marketable securities of $211.8 million. Based on current business plans, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expend…

• which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

• azenosertib, if approved, including for supplies of drugs that we are testing in combination with azenosertib;

• In addition, even if we obtain approval of our product candidates, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may impose significant limitations

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

• diagnostic tools for biomarkers for any future product candidates and any additional biomarkers for azenosertib;

• expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully comp…

• As of September 30, 2025, we had cash and cash equivalents and marketable securities of $280.7 million. Based on current business plans, we believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our operating expenses and capita…

• more limited indication or a narrower patient population than we originally requested. We have not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that neither azenosertib nor any product candidates we may seek to develop in the future will ever obtain r…

• related applications) are now fully subject to the provisions of the CTR. Compliance with the CTR requirements by us, our collaborators and third-party service providers, such as CROs, may impact our development plans.