Pain Therapeutics, Inc. (NASDAQ:PTIE) is a small cap worth watching closely.
In the past few days, its price has proven to be very volatile.
Within the last month, the price has fluctuated between $3 and just over $6.
Here, you’ll find the details behind the company and factors that led to the unusual price movement.
Take a look at the price movement below:
The company’s announcement of the completion of a Phase I clinical study for a new experimental drug for Alzheimer’s disease and a massive grant from a research institute has helped to boost investor’s confidence in the company.
Pain Therapeutics, Inc. was founded by Remi Barbier and Barry M. Sherman in May 1998 and is headquartered in Austin, TX. The company develops proprietary drugs that offer significant improvements to patients and healthcare professionals.
The company generally focuses its drug development efforts on disorders of the nervous system, such as chronic pain. Its expertise consists of developing new drug candidatessuch as REMOXY, which is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use and guiding these through various regulatory and development pathways in preparation for their eventual commercialization.
For over a decade, the firm has pioneered technology, tools and techniques that enable the development of Abuse-Deterrent Formulations, or ADFs. ADFs are intended to make opioid drugs difficult to abuse yet provide steady pain relief when used appropriately by patients. ADFs are intended to help in the fight against prescription drug abuse.
In September, the company announced it was awarded an approximately $1.8 million research grant from the National Institutes of Health (NIH).This grant will support innovative technology developed by the Company to diagnose Alzheimer’s disease with a simple blood test.
The CEO, Remi Barbier articulated that finding a way to diagnose disease at an early-stage is vitally important and blood tests may be able help in detecting Alzheimer’s disease before symptoms occur, or rule out other possible causes of memory problems, or could also be used as a biomarker to measure the efficacy of drug candidates during clinical trials.
The NIH’s National Institute on Aging awarded this research grant to Pain Therapeutics following a competitive, in-depth evaluation of its technology for scientific and technical merit.
The research grant is a technical-milestone based award that will enable Pain Therapeutics to work collaboratively with leaders in the field to develop a blood-based diagnostic for Alzheimer’s. The diagnostic technology is related to PTI-125, Pain Therapeutics’ clinical-stage drug candidate for Alzheimer’s disease, whose underlying science has been published in Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, PLOS-One and other peer-reviewed scientific journals.
By October 2017, Pain Therapeutics Inc announced the conclusion of a study for conducted on PTI-125. The purpose of the study was to study the effects on healthy users. At the end of the study, it was reported that the drug was safe at any dosage level
Remi Barbier, President & CEO of Pain Therapeutics said:
“The clinical data are encouraging…Given the absence of dose-limiting effects in healthy adults, an excellent non-clinical safety database, a strong scientific rationale, and multiple peer-reviewed publications and research grant awards, we are eager to move this drug program to the next level of development.”
To conduct the study, the impact of PTI-125 was assessed in twenty-four willing persons in the US. They were all given single dose of PTI-125 ranging from fifty to two hundred milligrams and the drug had no adverse effects on all of the volunteer for the different dosage levels.The full results of the study are to be released in November 2017.
A few days ago, the company announced that it received a complete response letter from the Food and Drug Administration saying its new drug application for the opioid Remoxy ER could not be approved in its present form. The company said it was evaluating the letter and plans further discussions with the FDA. For the time being however, Durect Corp. said it has licensed to Pain Therapeutics the exclusive right to develop and commercialize Remoxy ER and other opioid analgesics utilizing its extended-release, abuse-deterrent technology.
The company released the results for the second quarter in June 2017. It was disclosed in the report that net loss for the three months ended June 30, 2017 was $4.2 million, or $0.64 per share, compared to a net loss of $3.0 million, or $0.46 per share, for the three months ended June 30, 2016. Net cash used during the three months ended June 30, 2017 was $3.2 million. Cash and investments were $14.1 million as of June 30, 2017, with no debt. The Company continues to expect net cash usage in 2017 may be approximately $10.0 million.
Research and development expenses for the three months ended June 30, 2017 were $3.1 million compared to $1.6 million in the prior year period. The increase was primarily due to increased activities related to REMOXY NDA resubmission. Research and development expenses included non-cash stock-related compensation of $0.3 million in the three months ended June 30, 2017 compared to $0.4 million in the prior year period.
Pain Therapeutics Inc has a lot of potential although the delay in the approval of its solutions has halted it growth. It is expected that once this hurdle is scaled, it will be on the rise once more.
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Disclosure: We have no position in PTIE and have not been compensated for this article.