In a May 20 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported and reviewed the data Oncternal Therapeutics Inc. (ONCT:NASDAQ) just released from two studies.
The first set of results comes from Oncternal's Phase 1/2 trial of cirmtuzumab + ibrutinib in mantle cell lymphoma (MCL) and lymphocytic leukemia. This combination "continues to deliver benefit in MCL," Selvaraju wrote, having now shown an 83% objective response rate and a 39% complete response rate in 18 relapsed or refractory MCL patients previously treated with a median of two therapeutics.
Selvaraju noted that after a median follow-up of 18.9 months, these study participants did not achieve median progression-free survival or median overall survival. However, he added, the benefit of the combination "appears favorable" given the results of a historical trial of only ibrutinib. That study, done in a similar population of 370 patients, demonstrated a 66% objective response rate, a 20% complete response and a 12.8-month median progression-free survival.
The second data set Oncternal just released is an update of results from the ongoing Phase 1/2 trial of TK216 + vincristine in Ewing sarcoma. These data show "consistent efficacy in a larger sample size," Selvaraju indicated. Specifically, at the recommended Phase 2 TK216 dose, 31 patients, with relapsed or refractory Ewing sarcoma and a median of three prior therapies, had a 9.7% objective response rate and a 1.8-month median progression-free survival.
"These results are consistent with what has been previously reported for TK216," wrote Selvaraju.
Given TK216's rare pediatric disease designation, Selvaraju pointed out, were the U.S. Food and Drug Administration to approve the therapeutic, Oncternal might be able to get a priority review voucher (PRV) for it.
"Receipt of a PRV upon approval of TK216 and successful sale of such an asset could constitute material upside to our forecasts," he added.
H.C. Wainwright maintains its Buy rating and $9 per share price target on Oncternal Therapeutics. Its current share price is about $5.61.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Oncternal Therapeutics, Inc., Company Update, May 20, 2021
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D. and Robert Burns , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Oncternal Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of April 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Oncternal Therapeutics, Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Oncternal Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from Oncternal Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Oncternal Therapeutics, Inc. during the past 12 months.
The Firm does not make a market in Oncternal Therapeutics, Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.