Good Monday morning, folks. As promised in Friday's edition of the newsletter, we've got a new trading idea for you today. Time is of the essence too. The company just published a press release that could really get the market's attention, and if you want to be out on front of the crowd you'll want to start doing your due diligence now.
There are multiple contexts for this particular idea, but one of them is the simple fact that biotech as an industry is ripe for a bullish reversal following a tough past six months for these stocks. (We talked about it in detail on Friday. If you missed it, we really recommend you go back and read through that edition, since it's a primer for today's look.)
Another one of the key contexts for this particular trade right now: It's a biotech outfit with real - and realistic - demonstrable value.
This was another one of the details we discussed late last week. Up until September of last year, some biotech companies and a lot of biotech investors just got a bit sloppy, setting up the 30% pullback the group suffered between September and earlier this month. Traders aren't going to fall into that same trap for a while though, and will demand that a biotech organization justify its valuation with its portfolio and pipeline. Today's company does just that.
Enough fanfare - let's just get to it. Today's new trading idea is Pivot Pharmaceuticals (PVOTF), and we see a bright near-term and long-term future for it.
Pivot Pharmaceuticals is taking immediate aim at a couple of cancers that only affect women... metastatic endometrial cancer and triple-negative breast cancer therapy, both of which are underserved aspects of the $80 billion cancer drug market.
What's compelling about PVOTF is that it's not taking a scattershot approach to find a cancer cure-all, where it would have to compete with a dozen other drugs. It's focusing on a small niche within the cancer world that's (1) currently not well addressed, and (2) where Pivot can dominate the market. Those cancers are for metastatic endometrial cancer with recurrent metastatic disease (PVT-005), and triple-negative breast cancer for patients with DNA repair deficiencies (PVT-006). Those specific markets are worth at least $250 million and $200 million per year, respectively. For perspective, PVOTF is only a $41 million organization.
But how underserved are those specific indications? Pivot expects to receive the FDA's so-called "orphan drug" designation for these two drugs, which would guarantee each drug gets seven years of exclusive marketing protection in the United States as opposed to the typical five years of protection non-orphan drugs get.
There's another side of Pivot Pharmaceuticals you have to embrace, however.
While PVT-005 and PVT-006 will go through the FDA-required three phases of development, Pivot's got another path to revenue that will take much less time.
Ever heard of rule 505(b)(2)? It's an FDA rule that lets pharmaceutical companies circumvent the regular, lengthy three-phase development of a drug when it's not actually a new drug, but rather, a reformulation or repackaging or repurposing of an existing drug. This can include a new means of delivering these drugs. Well, Pivot has a sizeable handful of intellectual property and access to several possible drugs that could be turned into marketable products relatively quickly. In fact, it's specifically evaluating a dysmenorrhea and LUTS (lower urinary tract symptoms) therapy that could be worth more than $460 million and more than $300 million per year, respectively.
Point being, PVOTF has some tangible near-term value to offer, but also has some key long-term growth drivers. Both the near-term and the long-term aspects of the story open the door to a lot of progressive news, and as you trading veterans know, in the biotech world, it's all about news catalysts.
In fact, Pivot has already lined some of those catalysts up for this year.
You have to dig into the company's website - into its most recent investor presentation - to see it, but it's there... 2016 is going to be a real breakout year for the development of Pivot Pharmaceuticals' pipeline. As of right now, the company aims to begin its IND (investigational new drug) pre-work in Q1, should start another developmental program in Q2, wrap-up its pre-IND discussions by the end of the third quarter, and will start a clinical trial by Q4. It's also going to continue building its leadership team that whole time, and continue to look at ways to expand its existing pipeline and portfolio.
There's going to be more for the company to tout this year than there's ever been up until this point.
And if you want some proof that PVOTF is a high-odds bet when it comes to getting drugs approved and on the market, chew on this: The company's current leadership team has collectively commercialized twelve drugs representing global sales of more than $10 billion.
Fast forward to today. The company just posted a press release telling the market some of the things you just read. This shareholder letter alone could light a fire under the stock, but there were a couple of new items we've not yet talked about. One is, Pivot Pharmaceuticals has already identified a new "fast follower" molecule it's tentatively calling PVT-007... suggesting it could be a third drug put in the long-term development pipeline. Second, the company is planning an uplisting to the NASDAQ. One or the other is attention-getting. To see them both announced at the same time, however, could be a game-changer for the stock. That's the urgency behind this morning's newsletter.
There's a lot more to this story. Namely, the underlying science of its pipeline -- Pyrrolobenzodiazepine dimers (PBDs) -- is worth a closer look for those of you who like to get into the nuts and bolts of new drugs. I'll refer you to the company's website and the SCN's research report for more on that. We just want to wrap things up today for everyone else with this...
Once again, it comes down to a matter of risk versus reward. Sure, there's risk with PVOTF, but there's a lot of reward potential too. In fact, Pivot Pharmaceuticals may have one of the most attractive risk-vs-reward profiles we've seen in a long, long time. And the company just beefed up the "reward" side of the equation with a couple of new entries on the ledger today. There's apt to be more good news in the cards this year too, now that the R&D ball's rolling.
The usual rules apply, of course. That is, use intelligent limit orders and stop-losses to protect yourself on the way in and once you're in. It also wouldn't be a bad idea to lay out some profit-taking objectives ahead of time. You just read the story, though -- Pivot Pharmaceuticals is in the right place (the biotech industry) at the right time (right in front of a rebound for the industry) with the right pipeline (marketable orphan drugs in the long-term, and 505b2 drugs in the meantime). We couldn't ask for much more than that.
Here's this morning's press release.
Pivot Pharmaceuticals Provides Shareholder Update
BOSTON, MA and VANCOUVER, BC--(Marketwired - Feb 29, 2016) - Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) ("Pivot" or the "Company"), an emerging biotechnology company engaged in the development of therapeutics to address unmet medical needs in women's health, is pleased to provide the following shareholder update.
Pivot has had a very busy start in 2016 after a year filled with many achievements in 2015. The Company would like to thank its shareholders for their investment, engagement, and support of our efforts to develop and bring innovative and novel drugs to market.
Highlights:
Acquisition of IndUS results in strengthened drug pipeline and IP Estate
Advancement of Pivot's anticancer drugs towards clinical trials in 2016
Actively seeking to license or acquire a late-stage asset
Board and management team solidified with new members
Company to seek up-listing to Nasdaq Stock Market
Strengthening of Product Pipeline
In Q3 2015 Pivot completed the acquisition of a privately-held, Boston-based, emerging biotech company, IndUS Pharmaceuticals. As a result, Pivot now has a pipeline of novel anticancer drug candidates that have shown excellent promise in preclinical studies for the treatment of refractory cancers in women such as metastatic endometrial cancer (mEC) and basal-like-triple-negative breast cancer (BL-TNBC). This represents an "orphan" drug opportunity for the Company allowing for a longer exclusivity period following marketing approval of the drugs. The immediate addressable market size for these two anticancer drugs is estimated to be $500 million annually. The Company has initially prioritized two novel drug candidates from its portfolio of multiple anticancer molecules for these two indications (PVT-005 and PVT-006). Pivot has also identified a 'fast follower' molecule (PVT-007) to diversify and broaden its pipeline of drug candidates.
Intellectual Property Estate
The Company has a strong intellectual property position on multiple anticancer candidates and continues to aggressively protect and expand its intellectual property estate. A key benefit of the IndUS acquisition is that Pivot now has a global drug development platform that combines the strengths of the United States, Canada and India, allowing for accelerated drug development strategies that result in a much faster time-to-market and greater capital-efficiency.
Corporate and Organizational Development
Pivot added significant strength and talent to its team in 2015. Following the acquisition of IndUS Pharmaceuticals, the Company retained the services of IndUS' CEO, Pravin Chaturvedi, PhD as its President & Chief Executive Officer. Dr. Chaturvedi has had a long and successful career in the pharmaceutical and biotech industry. For over 25 years, he has attained significant experience in drug development, as well as, founding and financing biotech start-up ventures. Dr. Chaturvedi joined the existing members of Pivot Pharmaceuticals' management team including Ahmad Doroudian, PhD, who serves as the Chairman of the Company and Moira Ong, who is Pivot's Chief Financial Officer. Collectively the Pivot team has developed and/or commercialized 12 drugs representing global sales in excess of $10 billion.
The Company also added two members to its Scientific Advisory Board (SAB). Steven Grossman, MD, PhD, joined Pivot Pharmaceuticals as the SAB's Chair. Dr. Grossman is a renowned physician-scientist with a long standing interest in basic and translational initiatives involving response of tumor cells to DNA damage to improve therapeutic benefit in cancer patients. Grannum Sant, MD, FRCS, FACS, is a distinguished key opinion leader (KOL) in the fields of urology and oncology in men's and women's health. Dr. Sant is an accomplished physician-scientist and has published widely in the fields of urology and cystitis
Pivot now has its drug development and operational base in Boston, a major hub of the biotechnology industry, which allows the Company access to the intellectual and financial resources available in the Greater Boston area.
Finance
In January 2016 Pivot's Executive Team attended the JP Morgan Health Care Conference in San Francisco. During the course of five days they met with several groups who expressed interest in financing Pivot's drug development programs. The Company is currently in discussions with interested parties.
2016 Goals and Objectives
Advance Anticancer Drugs into Clinical Trials:
Pivot will be significantly expanding its drug development efforts in 2016, allowing the Company to conduct additional pre-clinical studies and support the filing of an Investigational New Drug (IND) application with the regulatory authorities to initiate clinical trials in cancer patients. These clinical studies will evaluate the safety and clinical efficacy of one or both of Pivot's novel anticancer drug candidates (PVT-005 and PVT-006). To further complement the current executive, the Company expects to add new management team members accomplished in drug development, regulatory affairs, corporate licensing, program management, and marketing.
Expanding our Pipeline & Intellectual Property Estate:
To augment its anticancer pipeline, Pivot continues to opportunistically evaluate additional licensing opportunities for proprietary and patented molecules addressing unmet medical needs affecting women's health. Acquisition of a late-stage asset remains a top priority. Pivot will also continue to strengthen its intellectual property (IP) position through aggressive prosecution of patent applications.
Enhance shareholder communication:
It is important to educate the marketplace of the virtues of investing in Pivot Pharmaceuticals Inc. (OTCQB: PVOTF), as well as build a market for our stock to trade. We will continue to travel and connect with our investors and shareholders around the world to ensure more frequent communications, affording them a better understanding of our plans to build shareholder value. Pivot is represented by PCG Advisory Group which continues to refine our investor relations needs and better serve our shareholders.
Up-listing Application to Nasdaq
As the Company continues to execute its business strategy it is well positioned to up-list to the NASDAQ Stock Market, a move that will provide us increased visibility, greater access to capital, a broader investor base and ultimately help us implement our growth initiatives. The Company's objective is to meet the NASDAQ listing requirements. These requirements include meeting minimum thresholds for shareholder equity, the number of shareholders, market capitalization, and share price.
PIVOT: Poised for Success
The Company is confident that it has aggregated the requisite pieces that are required for sustainable long-term success and value creation. With a proven leadership team and a robust pipeline, Pivot will earn a significant share of the market with its novel treatments for unmet medical needs in women's cancers. Pivot's strong IP estate will allow for significant strategic partnering and licensing options. Biotech companies focused on novel drug development activities continue to represent a very high growth sector. For further information please read Pivot's Corporate Presentation and Executive Summary, available on its website.
About Pivot Pharmaceuticals, Inc.
Pivot is an emerging pharmaceutical company engaged in the development of novel therapies to address unmet medical needs in women's health including oncology and urology. The Company has a strategic emphasis on innovative drugs that will provide new treatment options for women's cancers as well as for unmet gynecological and urological problems. Pivot has a portfolio of novel anticancer candidates for the treatment of gynecological and breast cancers and it is also developing novel treatments to address disturbances such as lower urinary tract symptoms (LUTS). The Company has a global drug development platform that combines the strengths of the United States, Canada and India which allows accelerated drug development strategies to provide novel therapeutic options to address unmet medical needs in women's health.
Cautionary Statement
Except for historical information contained herein, the matters set forth above may be forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ from those in the forward-looking statements. Words such as anticipate, believe, estimate, expect, intend, and similar expressions, as they relate to Pivot Pharmaceuticals or its management, identify forward-looking statements. Such forward-looking statements are based on the current beliefs of management, as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, such as the level of business and consumer spending, the amount of sales of Pivot's products, the competitive environment within the industry, the ability of Pivot to continue to expand its operations, the level of costs incurred in connection with Pivot's expansion efforts, economic conditions in the industry, and the financial strength of Pivot's customers and suppliers. Pivot does not undertake any obligation to update such forward-looking statements. Investors are also directed to consider all other risks and uncertainties.
Contact Information
Contact:
PCG Advisory Group
www.pcgadvisory.com
Sean Leous
Chief Communications Officer
(646) 863-8998