Lately, the pharmaceutical companies are trying to use cannabis-based therapies to treat all sorts of medical conditions. Zynerba (NASDAQ: ZYNE ) is another contender in this increasingly-crowded field. Whether that's a good or bad thing for Zynerba stock remains to be seen.
After all, they appear to have a pretty interesting play within the space. Their ZYN002 drug candidate is, according to the company, "the first and only pharmaceutically-produced CBD formulated as a permeation‑enhanced gel for transdermal delivery".
They are running studies on this CBD gel for a variety of conditions. They are investigating treatments for Fragile X, Tourette's, and seizures, among other conditions.
Understanding The Fragile X Syndrome Therapeutic Landscape
Fragile X Syndrome is a relatively rare condition occurring in roughly 1 out of every 4,000 boys and 1 out of every 8,000 girls. Researchers believe that the condition is caused by a DNA defect. Fragile X often presents symptoms in children by age 2 including intellectual disability and physical characteristics such as long face and a prominent jaw.
It is sometimes a complicated diagnosis as Fragile X can look like other developmental disorders. Many Fragile X children have Attention Deficit Disorder. Additionally, many exhibit features of autism disorders. Furthermore, a significant number of Fragile X patients have frequent seizures.
This leads to an interesting position for Zynerba. The company states that there are no approved drug therapies for Fragile X. However, it notes that doctors use various drugs off-label to treat various Fragile X symptoms. That makes sense, as there are treatments for things such as seizures.
Directly, as far as competition, Zynerba notes that Neuren Pharmaceuticals , Ovid Therapeutics (NASDAQ: OVID ) and Marinus Pharmaceuticals (NASDAQ: MRNS ) are all active in the research space seeking a treatment directly for Fragile X syndrome.
That's not all. Zynerba has focused on the treatment of seizures in particular. Within that particular space, it faces cannabinoid-based competition on several fronts. GW Pharma (NASDAQ: GWPH ), with its more than $4 billion market cap, is targeting this space and is widely thought of as a leader in cannabinoid research.
Additionally, Insys (NASDAQ: INSY ) is researching CBDs for seizures and infantile spasms as well. So, should Zynerba's ZYN002 be a clinical success, it won't necessarily be the first or best therapy that reaches the market.
Why Zynerba Stock Popped Recently
On January 28th, Zynerba stock shot up 30% to reach $4.80. In subsequent days, it rallied further, reaching as high as the $6 mark. What happened on Jan. 28 that set the rally in motion? There doesn't appear to be much in the way of hard news, but the company did give a high-profile presentation and it appears this set investor enthusiasm in motion.
In this presentation, the company confirmed that things are moving along as planned for its combination Phase 2/3 CONNECT trail for Fragile X syndrome. Zynerba also expects to release results for its Phase 2 trial for developmental and epileptic encephalopathies in the latter half of 2019.
To add to that, Zynerba remains in reasonably strong financial position. The company reported $59.8 million in cash as of December 31st, 2018.
Given its current burn rate, that should give Zynerba funds to continue its current research through the second half of 2020. While Zynerba will have to raise more funds at some point, it still has plenty of time to deliver its crucial trial results later in 2019 before going back to the market for more money.
The CBD Factor
It's difficult to consider ZYNE stock without thinking about the X factor here: investor enthusiasm for marijuana-related stocks. Since late December the Alternative Harvest (NYSEARCA: MJ ) marijuana ETF has ripped 50% higher off the lows. Stocks like Aphria (NYSE: APHA ) and Canopy Growth (NYSE: CGC ) are soaring almost every day.
Zynerba itself hadn't participated in this enthusiasm, at least not until recently. However, that may be changing. Recently, famous TV host Jim Cramer talked up so-called "marijuana-adjacent" biotech firms as stocks with big potential in 2019.
"These are not pot companies. They are drug companies focused on developing artificial cannabinoids that mimic what cannabis does to your body […] As we get more and more data showing the efficacy of medicinal marijuana, I think more investors will embrace actual medicines that do the same thing as marijuana, but they do it more reliably."
With ZYNE stock, you are getting a call option on this thesis playing out later in 2019.
Zynerba Stock Verdict
I rarely invest in clinical stage biotech companies. It's a difficult industry; far more companies fail than succeed. Be careful with these sorts of stocks and don't invest more than you can afford to lose.
That said, Zynerba has an interesting drug candidate, and is certainly positioned in a hot sector of the market. With plenty of cash to make it into mid-2020, and key data coming before then, ZYNE stock has plenty of speculative value for active traders.
One upcoming catalyst to watch out for. On February 11th, CEO Armando Anido will be giving a presentation at the 2019 BIO CEO and Investor Conference. With ZYNE stock remaining volatile in recent days, any further data releases or business updates in this presentation could cause a big move in Zynerba shares.
At the time of this writing, Ian Bezek held no positions in any of the aforementioned securities. You can reach him on Twitter at @irbezek.
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