In a Nov. 30 research note, analyst Ram Selvaraju reported CytoDyn Inc. (CYDY:OTCQB) announced positive clinical data for its PCaTest, a gene-based prostate cancer prognostic test. PCaTest applies proprietary algorithms to 14 gene biomarker signatures to determine "therapeutic substratification" and prognosis of a patient's prostate cancer.
Selvaraju noted that "together with data from three prior studies of 348 patient samples, the new results support the company's strategy for seeking U.S. Food and Drug Administration (FDA) approval for the PCaTest."
The findings showed "substantial additive discriminative value for predicting outcomes of prostate cancer patients compared to the Gleason score, the current standard," in that it characterized patients as being at low or high risk, Selvaraju added.
Specifically, the recent clinical study assessed 218 patients who had been followed for 10 or more years after their initial prostate cancer diagnosis. These patients had a Gleason score of 7, "considered indeterminate or intermediate."
Selvaraju also reported the FDA approved CytoDyn's investigational new drug application for a Phase 1b/2 trial of PRO 140, or leronlimab, in patients with metastatic triple negative breast cancer (TNBC). The study, to be conducted from five already chosen clinical sites, will enroll up to 48 patients. CytoDyn plans an initial data readout on the first dosed patients in Q1/19.
"Leronlimab may provide a viable treatment option to TNBC patients with poor prognosis, in our view," wrote Selvaraju.
Also slated for Q1/19 is completion of biologics license application filings, to get underway soon, for approval of its PRO 140 as a combination therapy for human immunodeficiency virus (HIV). "PRO 140's efficacy compares favorably to those of marketed drugs for the CCR5-tropic HIV-1 population, in our view, and suggests attractive commercial prospects," Selvaraju indicated.
H.C. Wainwright reiterated its Buy rating and $1.50 per share price target on CytoDyn, whose stock is currently trading at around $0.57 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., CytoDyn Inc., Company Update, November 30, 2018
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., Yi Chen, Ph.D. CFA and Karthik Sunkesula, 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 CytoDyn, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of October 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of CytoDyn, Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know 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 did not receive compensation from CytoDyn, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in CytoDyn, Inc. as of the date of this research report.