Oncternal Therapeutics Inc. (ONCT) stock became bullish in the after-hours on news of its agreement with the FDA. On January 04, the company announced an agreement with the FDA on Phase 3 Registrational Study Design for Zilovertamab.
In regular trading, the stock had a bearish momentum as it lost 3.70% at its closing price of $2.34. Following the announcement, ONCT rallied after hours to gain 8.97% at a heavy after-hours volume of 4.85 million shares. Consequently, the stock was trading at $2.55 per share in the after hours.
Currently, the novel oncology therapies developer has a market capitalization of $120.11 million. Further, the company has 49.43 million shares outstanding in the market.
ONCT’s Agreement with FDA
As per Tuesday’s announcement, the company and FDA agreed on the key elements of its Phase 3 clinical study of zilovertamab. Moreover, the key design features, operational details, and statistical analysis plan was also reviewed and agreed upon. These details were a result of a successful End-of-Phase 2 meeting with the U.S. FDA. Currently, the statistical analysis plan is being finalized as per the FDA’s suggestions.
Zilovertamab is ONCT’s investigational therapy for the treatment of MCL (mantle cell lymphoma) or CLL (chronic lymphocytic leukemia).
The Phase 3 Trial
The Phase 3 trial (ZILO-301) is a randomized, double-blind, placebo-controlled, multi-center study of Zilovertamab (plus Ibrutinib, VS Ibrutinib) for relapsed or refractory MCL. Furthermore, the primary endpoint of the study is progression-free survival (PFS). This will support Biologic License Application submission for regular FDA approval.
In addition, the study is planned to be conducted in at least 50 centers internationally. The study is expected to commence in the second quarter of 2022.
Added to ZILO-301, ONCT also plans to conduct an open-label companion study of zilovertamab plus ibrutinib, ZILO-302. The ZILO-302 study will be conducted in patients having progressive disease during the initial four months of monotherapy in ZILO-301.
Q3 Financial Results
On November 04, the company announced its financial results for the third quarter of 2021.
In the third quarter of 2021, the company received multiple grant awards for its various ongoing studies. Subsequently, this resulted in grant revenue of $2.1 million in Q3 of 2021.
ONCT ended the third quarter of 2021, with cash and cash equivalents of $97.4 million on September 30, 2021. The company believes it has enough cash runway for operation into 2023.
