Pain Therapeutics, Inc. (NASDAQ:PTIE) Reports Promising Regulatory Projection For REMOXY™ ER

Pain Therapeutics, Inc. (NASDAQ:PTIE)

Pain Therapeutics, Inc. (NASDAQ:PTIE) reported positive regulatory projection from a recent meeting with the U.S. FDA regarding REMOXY, its major drug candidate. Remi Barbier, the CEO and President, reported that in recent weeks they have worked closely with the U.S. FDA. They  understand the new needs and consider that they are on track to make  a refiling of the REMOXY NDA.

The updates

Pain Therapeutics, Inc. (NASDAQ:PTIE) and the FDA met in February, to discuss REMOXY. An agreement was made on additional trials that are required for REMOXY’s approval. They anticipate to close these trials by year-close 2017, at a cost of $3 to $4 million. Following completion of these trials, they plan to have a pre-NDA discussion with the FDA, subsequent to resubmission of the REMOXY NDA, with expected Priority Review.

Final Minutes of FDA discussions shows two requirements are required for the refiling of the REMOXY NDA, and they are to perform a clinical “abuse potential” trial through the intranasal route of abuse and secondly to perform a non-clinical abuse prospective trial utilizing household solvents.

REMOXY is a high-viscosity gel, sticky preparation that cannot be snorted. Hence, the intranasal trial will state human volunteers to self-administer into nostrils REMOXY, an active comparator or placebo. Promising reports in one intranasal trial is adequate to provision a label claim versus the intranasal route of abuse. They previously recorded promising report utilizing REMOXY under comparable test circumstances in a large animal model.

REMOXY’s high-viscosity, sticky formulation cannot be drawn via a normal size syringe. This feature makes it tough to abuse REMOXY through simple injection. Hence, they will perform an abuse potential trial in a lab utilizing thin films of REMOXY on glass plates to evaluate how household solvents impact the formulation. Promising data in this trial is adequate to advance a label claim against the injection route of abuse. They previously recorded promising results utilizing REMOXY under a similar test scenario.

The recent discussions with the U.S. FDA didn’t raise any concerns around drug efficacy, safety, stability, manufacturing or other drug advancement topics.

Shares of Pain Therapeutics, Inc. (NASDAQ:PTIE) gained over 16% on Thursday, hitting $0.898. However, this gain was not supported by strong volumes.

4/06/2017
Ticker Symbol PTIE
Last Price a/o 3:21 PM EST  $0.90
Average Volume 1.10M
Market Cap (mlns) $ 40.25M
Shares Outstanding (mlns) 44.84M
Share Float (mlns) 33.66M
Inside Ownership 23.38%
Short Float 2.49%
Short Interest Ratio 0.76
Quarterly Return 46.21%
YTD Return 57.44%
Year Return -58.25%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Pain Therapeutics, Inc. (NASDAQ:PTIE) Rebounds from Loss of Pfizer Collaboration

Pain Therapeutics, Inc. (NASDAQ:PTIE)

Austin, TX-based Pain Therapeutics, Inc. (NASDAQ:PTIE) is up over 58% in the pre-market on large volumes. This morning the biotech firm announced it has secured positive guidance from the Food and Drug Administration (FDA) for it lead drug candidate Remoxy ER – an opioid. This news points to an expedited path towards the company’s resubmission of a New Drug Application (NDA). The NDA will be coup for the small biotech firm after Pfizer (NYSE:PFE) ended their development agreement in 2013. That news sent PTIE shares down over 50% – their largest one-day decline ever at the time.

On February 13, 2017 a meeting was held between Pain Therapeutics, Inc. (NASDAQ:PTIE) and the FDA. In that meeting a decision was reached that Remoxy ER posed no safety or efficacy risks to the public. However, it was decided that further study was warranted to assess potential abuse of the drug. It is estimated that the studies will cost Pain Therapeutics, Inc. (NASDAQ:PTIE) an estimated $3-$4 million. Pain Therapeutics reported $18.7 million in cash-on-hand in their 2016 financials. Expenses for 2016 totaled $12.6 million.

Pain Therapeutics, Inc. (NASDAQ:PTIE) has a novel approach to deterring abuse. Remoxy ER is produced as a thick gel. This makes it difficult for possible abuse to occur through the normal forms such as smoking or snorting. The FDA considers it important for opioid developers to address the abuse and addiction that have accompanied new drugs. Each day, an average of 91 American lives are lost through opioid addiction.

Pain Therapeutics, Inc. (NASDAQ:PTIE) has a 52-week low of $0.51 and a 52-week high of $3.00. Insider ownership is listed at 23.4% and institutions own over 42% of PTIE shares. Importantly, the number of outstanding PTIE shares has remained stable since 2012. The lack of dilutive share offerings should attract mainstream investors who may normally shy away from a biotech firm that has posted no sales since 2013 ($41.1 million). In 2012 the number of outstanding PTIE shares was 44.75 million. That number was listed at 45.64 million at the end of 2016.

Pain Therapeutics, Inc. (NASDAQ:PTIE) is also developing a small-molecule drug for Alzheimer’s patients. In July of 2015, Pain Therapeutics received a $1.5 million grant from the National Institutes of Health for development of their small molecule drug candidate PTI-125.

Only one firm follows Pain Therapeutics, Inc. It rates PTIE shares a “Hold” with a price target of $2.50.

3/21/2017
Ticker Symbol PTIE
Last Price a/o 7:55 AM EST  $                      1.06
Average Volume                    408,350
Market Cap (mlns)  $                    31.36
Sales (mlns) $0.00
Shares Outstanding (mlns) 46.12
Share Float (mlns) 33.66
Shortable Yes
Optionable Yes
Inside Ownership 23.38%
Short Float 2.43%
Short Interest Ratio 2
Quarterly Return 10.01%
YTD Return 19.26%
Year Return -67.46%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.