In a Nov. 7, 2018, research note, H.C. Wainwright & Co. analyst, Dr. Swayampakula Ramakanth, reported that Tyme Technologies Inc. (TYME:NASDAQ) has several catalysts happening in calendar year 2019.
He listed and explained them.
The first catalyst, he noted, expected to occur next year, in January, is the readout of interim safety and efficacy data from the first stage of Tyme's Phase 2 pancreatic cancer trial, TYME-88-PANC. The study is evaluating use of Tyme's combination therapy SM-88 in patients with recurrent metastatic pancreatic cancer who have failed one or more prior chemotherapies.
In the first of TYME-88-PANC's two study parts, two SM-88 doses are being tested in 36 patients. "Of the two doses, the more effective dose could be used for the expansion cohort in the second stage of the Phase 2 study," Ramakanth pointed out.
Chronologically, the second catalyst, anticipated in Q1/19, is the release of updated safety and efficacy data from Tyme's Phase 1b/2 prostate cancer study. In the trial, Tyme's combination therapy SM-88 is being evaluated in eight patients with biochemically recurrent prostate cancer.
Ramakanth recapped that trial results to date demonstrated that patients tolerated the treatment well, with no related significant adverse events. Additionally, all of them showed a "greater than 20% reduction in circulating tumor cell levels by cycle two with no radiographic progression reported."
The third catalyst, slated for sometime in H1/19, is the start of the Precision Promise Phase 2/3 pivotal trial conducted by the Pancreatic Cancer Action Network. The study purpose is to compare the outcomes of new, potential pancreatic cancer treatments with those of the standard of care.
One such treatment to be evaluated is Tyme's SM-88, as a monotherapy for second line pancreatic cancer patients. "The participation in Precision Promise is a highly cost effective way to evaluate the therapeutic potential of SM-88," noted Ramakanth.
In the research report, the analyst also reviewed the biotech's financial results for its fiscal year (FY) Q2/19, which ended Sept. 30, 2018, along with forecasts for FY19. For the past quarter, the company posted zero revenue and a $0.07 per share net loss, which were in line with H.C. Wainwright's projections. For FY19, Tyme is projected to not generate revenue and sustain a greater net loss, of $0.30 per share.
The company's cash on hand at September's end was $21.1 million, which, Ramakanth asserted, "is sufficient to fund operations until FY Q1/20."
The analyst reiterated H.C. Wainwright's Buy rating and $9.50 per share price target on Tyme, whose current stock price is about $2.02 per share.
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Disclosures from H.C. Wainwright & Co., Tyme Inc., Earnings Update, November 7, 2108
I, Swayampakula Ramakanth, Ph.D. and Sean Lee, 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.
A research analyst of the firm and/or the research analyst's household has a financial interest in and own the securities of Tyme Technologies, 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 Tyme Technologies Inc.
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 receive compensation from Tyme Technologies, 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 Tyme Technologies, Inc. during the past 12 months.
The Firm does not make a market in Tyme Technologies, Inc. as of the date of this research report.
