In a Jan. 18 research report, H.C. Wainwright & Co. analyst Swayampakula Ramakanth noted that the "unwarranted" decline of Tyme Technologies Inc.'s (TYME:NASDAQ) stock following the company's reporting of "positive" clinical results has created a buying opportunity.
Ramakanth explained the reported results were initial findings from TYME-PANC-88, a clinical evaluation of two different doses of SM-88 as a second-line treatment in metastatic pancreatic cancer. Endpoints in the trial are overall survival, overall response rate, progression-free survival rate and safety. Tyme presented these data at the American Society of Clinical Oncology's 2019 gastrointestinal cancers symposium on Jan. 18.
The analyst provided the highlights. In part one, or the dose evaluation component of the trial, of the 28 evaluable patients, 19, or 68%, remained alive as of Jan. 6, 2019, "with a median follow-up of 4.3 months (range 1.3–8.3 months)." Of the 17 evaluable patients who had a two-month scan taken, one patient, or 6%, achieved a partial response and seven patients, or 41%, achieved stable disease, based on Response Evaluation Criteria In Solid Tumors. Improvement in other metrics, such as PET scans, CA-19.9 biomarker levels and number of circulating tumor cells, demonstrated a benefit from SM-88.
As for safety so far, patients in the study overall tolerated SM-88 well. The exception was one patient who experienced severe adverse events that cleared. The patient remains in the trial.
These TYME-PANC-88 findings are consistent with those of the SM-88 Phase 1 study, in which 10 patients with pancreatic cancer achieved a median overall survival of five months, Ramakanth stated. Further, these data "compare favorably to previous second-line treatments."
He added, "Overall, we are very encouraged by these signs of clinical efficacy achieved in the most rigorous clinical study the company has conducted to date and believe that SM-88 could become one of the most promising therapies for refractory metastatic pancreatic cancer patients."
Tyme will continue enrolling evaluable patients in TYME-PANC-88 until it reaches 36, following which it will meet with the FDA to discuss the second trial component, or expansion. "Since no differences have been observed between the two different dose groups so far, we believe the company is likely to move forward with the lower, 460 milligram per day, dose for part two," noted Ramakanth. This meeting with the FDA and a subsequent clinical trial update are expected in H1/19 and by year-end 2019, respectively.
H.C. Wainwright has a Buy rating and a $9.50 per share target price on Tyme, whose stock is currently trading at around $2.14 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Tyme Inc., First Take, January 18, 2109
I, Swayampakula Ramakanth, Ph.D., Sean Lee and Sean Kang, 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 December 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.